International Regulatory Compliance

Holding Registrars And Notified Bodies Accountable In ISO 9001 Lawsuits

Introduction

In several blogs I have mentioned the standard, ISO/IEC 17021: 2006 Conformity assessment – Requirements for bodies providing audit and certification of management systems. In a previous blog, I reviewed working as Legal Expert in a lawsuit where ISO 9001: 2000 became a central focus of litigation between a US plaintiff and defendant. In this particular case, the opposing party stated that they did not have a recall or quarantine procedure for their products, further, they did not have records concerning the product in question.

The law student intern who first contacted me for the law firm said he thought that the opposing party was certified to ISO 9001. I replied that I could find out if they were certified and if they were, what records and documents could be obtained in legal discovery. After filing an Affidavit identifying the opposing party’s certification to ISO 9001 and identifying the records and documents we wanted to examine, their response was, “Oh those records!” The judge was not amused by their duplicity and ordered the company to produce the records and documents requested.

In their response, one of the corporations employees stated that he was the management representative and that he worked with all of the plants in question concerning this product. His statement resulted in a second Affidavit where I noted that his comment was interesting because management representatives usually report to a plant manager. However, since he worked with several plants involved in manufacturing the product in question, this meant that he was a management representative at the corporate level and reported to corporate management. It also meant that in addition to the plants being certified to ISO 9001 there was a corporate ISO 9001 certification.

The immediate response was no, we do not have corporate ISO 9001 certification, however, within a couple of weeks a full corporate Quality Manual, Procedures, Documents and Records were sent to our attorneys and “lo and behold”, there was a formal corporate recall and quarantine policy. By now the judge was approaching livid, not amused and quite angry.

Enter The ISO 9001 Registrar 

The Registrar in this case was well known to me. I was familiar with their work as a notified body for the EU Medical Devices Directive and had recommended them to some clients who wanted to CE Mark their medical devices. They always acted professionally. I also was familiar with their work as a Registrar for ISO 9001 and had visited their US Registrar headquarters. Consequently, I was startled by their behavior vis-á-vis their client in this lawsuit.

ISO/IEC 17021: 2006 Conformity assessment – Requirements for bodies providing audit and certification of management systems

To provide a basis for evaluating the behavior of the Registrar in this case, I wrote a Critique for the law firm to use in deposing the Registrar and consider bringing them into the lawsuit if their behavior could adversely affect the outcome of the lawsuit. The basis for such a move would derive from comparing their behavior with their client (the opposing party in this lawsuit) with the requirements of the International Standard (ISO/IEC 17021: 2006) that governs their behavior as a third party ISO 9001: 2000 Registrar.

In the Critique I stated my opinion that the Registrar violated its role as an impartial third party and instead:

1) chose to act on behalf of their client to deny access to information regarding the ISO 9001 certification status of their client;

2) chose to help their clients obtain a consultant to address the company’s certification to ISO 9001; and

3) chose retroactively to change the long standings certification status (seven years) of a company site during a lawsuit between the company and our client to help their client win their lawsuit.

This Registrar, along with all ISO 9001:2000 Quality Management System certification Registrars must abide by the requirements set forth in ISO/IEC 17021:2006 Conformity assessment – Requirements for bodies providing audit and certification of management systems.  This Critique will draw from the requirements of the standard to substantiate and highlight these points.

1.) When I called the US headquarters of the Registrar, I asked if the opposing party in this lawsuit was a client of theirs, if they had certified several plants and the corporate headquarters to ISO 9001:2000. I was told that they would have to consult with their attorneys to see if they could divulge such information. A few hours later I received a call stating that their attorneys advised them that such information could not be given without their client’s consent. (Basically, US attorneys are clueless about international compliance standards, unless informed of such standards by their clients.)

 ISO/IEC 17021:2006, Clause 4.5 Openness

4.5.1 A certification body needs to provide public access to, or disclosure of, appropriate and timely information about its audit process and certification process, and about the certification status (i.e., the granting, extending, maintaining, renewing, suspending, reducing the scope of, or withdrawing of certification) of any organization, in order to gain confidence in the integrity and credibility of certification. Openness is a principle of access to, or disclosure of, appropriate information.

 

4.5.2 To gain or maintain confidence in certification, a certification body should provide appropriate access to, or disclosure of, non-confidential information about the conclusion of specific audits (e.g. audits in response to complaints) to specific interested parties.

2.) Certification bodies (e.g. Registrars) must maintain impartiality in their operations. Recommending an ISO 9001:2000 consultant to a client violates their duty of impartiality and creates a conflict of interest for the Registrar.

3.) The Registrar retroactively changed the long-standing corporate certification status of their client during the lawsuit to help the client win its case.

5.1 Legal and contractual matters

5.1.1 Legal responsibility

The certification body shall be a legal entity, or a defined part of a legal entity, such that it can be held legally responsible for all of its certification activities. A governmental certification body is deemed to be a legal entity on the basis of its governmental status.

5.2 Management of Impartiality

5.2.1 The certification body shall have top management commitment to impartiality management system certification activities. The certification body shall have a publicly accessible statement that it understands the importance of impartiality in carrying out its management system certification activities, manages conflict of interest and ensures the objectivity of its management system certification activities.

5.2.5  The Certification body and any part of the same legal entity shall not offer or provide management system consultancy. This also applies to that part of government identified as a certification body.

5.2.1.2 All Certification by personnel, either internal or external, or committees, who could influence the certification activities, shall act impartially and shall not allow commercial, financial or other pressures to compromise impartiality.

5.2.13 Certification bodies shall require personnel, internal and external, to reveal any situation known to them that may present them or the certification body with a conflict of interests. Certification bodies shall use this information as input to identifying threats to impartiality raised by the activities of such personnel or by the organizations that employ them, and shall not use such personnel, internal or external, unless they can demonstrate that there is no conflict of interests.

Conclusion

What you have read is an abbreviated portion of my 16 page Critique of the Registrar for a lawsuit. We conducted some preliminary depositions and were preparing to return for more in depth depositions that would be used to bring the Registrar into the lawsuit, however, the opposing party signaled that they would like to settle the case. The results, of course, were sealed.

Most appalling in this case was the either the ignorance and indifference (or both) of the Manager of the Registrar who wanted to please a wealthy client, not realizing the liability exposure for his company. Further, the Registrar would face potential sanctions from ANAB (ANSI-ASQ National Accreditation Board), assuming that ANAB Registrar oversight is rigorous. Unfortunately, this is one of several times that I have watched third parties like Registrars or Notified Bodies demonstrate unethical behavior – the absence of a Moral Compass.   

My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal Court. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding ISO 9001 or CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com. 

IS FDA's 510(k) A Plausible Solution For the EU's CE Marking Problem With Silicon Breast Implants?

 

Introduction

The preceding four blogs discussed some of the problems I have observed with clients concerning private for-profit Notified Bodies and regulatory compliance with the three EU Medical Devices Directives. In the January 31, 2012 blog, I wrote the following paragraph concerning one possible alternative Notified Body approach to Medical Device approvals: 

“Something akin to an FDA 510(k) also should be created with device efficacy built in as major requirement. It isn’t a perfect solution because the 510(k) predicate device requirement doesn’t always avoid device defects in design and materials, but it is overseen by FDA not a private third party.”

The Mutual Recognition Agreement (MRA) signed between the US and EU in 1997, covered four areas, one being medical devices. The MRA provided for the creation of CABs (Conformity Assessment Bodies) approved by FDA to administer 510(k)s for selected Class II Medical Devices. Several of these CABs also are EU Notified Bodies. In this blog I want to return to the statement, “It isn’t a perfect solution because the 510(k) predicate device requirement doesn’t always avoid device defects in design and materials.”

US Politics Today 

Presently, there is a move in the US House of Representatives supported by some Senators to ease medical device regulations for Medical Device Manufacturers, hypothetically to encourage innovation and speed devices to the market. Even though the US has just begun to emerge from the disaster of deregulation of the US economy that allowed financial institutions to run amuck and create the worst financial crisis since the Great Depression, a convoluted ideology continues to appeal, i.e., regulation is bad, deregulation is good! Political ideology is a powerful force, uninformed by scientific knowledge and intelligence. Teddy Roosevelt and Abe Lincoln would have been appalled.  

The regulatory and enforcement problem afflicting CE Marking breast implant manufacturing and enforcement for the EU Medical DEvices Directives is different from the regulatory problem in the US, namely the weakness of the 510(k) approach. On February 1^st my wife received the following correspondence from Jim Guest, the President of Consumer Reports.

“It's a nightmare scenario. The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you.
This isn't science fiction. Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled - 700 different products a year.

And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were "similar" to products already on the market.

Tell Congress we don't want to be guinea pigs anymore!

Every new prescription drug must undergo rigorous testing on humans before it can be sold, even if it is similar to another drug already in use. Not so with medical devices. Because of this loophole in our safety laws, more than 90 percent of medical devices aren't safety tested before being sold nor are they routinely tracked afterwards to identify safety problems.

For example, a metal hip implant marketed by Johnson & Johnson was approved in 2005 without first undergoing clinical safety trials. It was recalled five years later after having a 1 in 8 failure rate in the UK, and releasing potentially toxic metals into the body. Countless patients had to undergo a second, painful 'revision' surgery.

It's time safety standards for medical devices are as strong as those for prescription drugs! E-mail your members now!

The device industry has unleashed an army of lobbyists and they don't want things to change. It will take a wave of consumers weighing in to make sure medical devices are safe and effective. Please take action, then forward this to friends and family. Thank you!

Sincerely,

Jim Guest
President, Consumer Reports

(Note: Consumer Reports is the largest and oldest independent non-profit testing and information organization in the US, serving only consumers since 1936.)

What are some of the problems with the 510(k)? 

Today the 35 year-old 510(k) System is used by FDA to review 90 percent of medical device applications each year. After numerous problems and ongoing billion dollar lawsuits concerning 510(k) approved medical devices, in 2009 FDA commissioned the Institute of Medicine (IOM) to study the problem and report back to FDA, which they did in August 2011.

The IOM report stated, “the process of using existing or “predicate” devices as the basis for evaluating the safety and effectiveness of a new device is “untenable.” The authors recommended that the FDA immediately stop using the protocol for Class III devices – considered to pose the highest potential risk to patients. “As devices have evolved and become more complex, our device-approval system has become incapable of assuring safety and effectiveness,” wrote New England Journal of Medicine executive editor Dr. Gregory Curfman and Dr. Rita Redberg, editor of the Archives of Internal Medicine. The system we use today was created 35 years ago in an era of much simpler and fewer devices and it is now outdated.

The New England Journal of Medicine editorial discussing the IOM report, specifically pointed out the ongoing problems with metal-on-metal hip implants including Johnson & Johnson’s DePuy ASR Acetabular System and DePuy ASR Hip Resurfacing System. The DePuy ASR XL Acetabular System was introduced in the US in 2005.

 The [DePuy] ASR was constructed by borrowing a metal alloy cup from a different hip device known as the [DePuy] ASR Hit Resurfacing System and retrofitting it onto a standard hip implant. The manufacturer successfully made the case that the reengineered implant was “substantially equivalent” to a predicate device. Its marketing clearance was therefore based not on trials or other clinical data but on bench testing in a laboratory, which was inadequate to simulate the stresses that would be placed on it in patients’ bodies. It soon became clear that the device failed at the astonishing rate of at least one in eight. (Brett Emerson, Injury Board.com, October 20, 2011) 

The metal-on-metal hip implants were found to shred minute metal particles into patients’ bloodstreams over time.

What Are The Institute of Medicine Recommendations? 

To begin the IOM, recommended that the agency (FDA) ditch the program entirely and replace it with an “integrated pre-market and post-market regulatory framework. It’s not clear that the 510(k) process is serving the needs of either the industry or patients, and simply modifying again will not help, said David Challoner who chaired the committee that wrote the report. The 510(k) Process cannot achieve its stated goals – to achieve innovation and make safe, effective devices available to patients in a timely manner – because they are fundamentally at odds with statutes that govern how FDA must implement the process.

Other IOM recommendations are:

• Boosting post-market surveillance and strengthening the FDA’s post-market authority;

• Ban all Class III devices, those of the highest risk, from the 510(k) fast-track process;

• Eliminate clearance using multiple predicate devices, by which a new device can be cleared by demonstrating equivalence to device that was also cleared through equivalence, forming a chain of devices that were never clinically tested, and 
• 
  
• Implement a formal post-market surveillance program.

The [IOM] report concluded that it was impossible for 510(k) clearance to assure safety and effectiveness, because it assesses neither, instead establishing only “substantial equivalence” to an existing device. 

 Summary 

As anticipated, the medical device industry rose up to complain about the reforms even though billion-dollar product liability lawsuits are working their way through the courts right now and will cost medical device companies a substantial amount of money. Not to mention that patients who suffer pain from the existing device and need to have the devices explanted and a new device inserted with no clear indication of how the surgical costs will be covered.

To return to the question about whether FDA’s 510(k) might serve as a model for EU regulation of its medical devices directives, the answer is no. The two regulatory systems face different issues:

• In the EU the issue is the competence of Notified Body device experts, the effectiveness of 70 for-profit Notified Bodies overseeing medical device manufacturers’ ISO 13485 Quality Management Systems, and the professional quality of oversight by 27 EU competent bodies.

• In the US the issue is a regulatory process that employs two strategies, (1) clinical trials for new high-risk device medical device, and (2) a 510(k) System focused “substantial equivalence” and expedience that doesn’t assure the safety and effectiveness of medical devices and consequently doesn’t focus on patient safety and product (device) safety.

Both the EU and US will have to work out their respective regulatory systems in the context of what presently exists but is not working. It’s not a simple process and it will take some work but it is essential that it be resolved in both the EU and US. Hopefully, private self-interest, political interference and intrusion won’t create a corrupted process that worsens what exists today.

My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in compromised product safety and product liability lawsuits. In particular, I focus on product safety, patient safety and the steps necessary to create a safe product. I would be happy to help. If you have questions regarding CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com. 

Notified Bodies And CE Marking – Potential Legal Issues In US Lawsuits #4

 

Continuation 

In this blog I want to focus specifically on the Silicon Breast Implant controversy involving the breast implant manufacturer Poly Implants Prothèses (PIP) and the EU regulatory structure for CE Marking medical devices. In my preceding three blogs times I have noted several problems concerning medical device product quality. In the first blog I quoted former European Commission Vice President Martin Bangemen.

In his preface to The Guide to the Implementation of Community Harmonization Directives Based on the New Approach and the Global Approach, Brussels, 1995, Vice President of the European Commission, Martin Bangeman stated the following:

The novelty of this new approach resides essentially in the use of community technical rules of “quality instruments” such as European Standardization and conformity assessment procedures (testing, product certification, certification of manufacturers’ quality control procedures, accreditation, etc.). These instruments, drawn up on the basis of consensus of all the economic partners involved, enable manufacturers to affix the CE marking--a real “technical passport”--to their industrial products, which must conform to these community directives.

The idea of separating compliance into product quality and process quality seemed like a good and workable idea at the time. However, looking backward from 2012, the growth of the EU to 27 Member States and a population of 500 million people, the separation into product quality and process quality needs to be readdressed. 

EU Medical Device Oversight Structure 

Medical Device Product Quality

In the EU, device regulations are not conducted by member state Competent National Authorities, instead they are conducted by one of the 70 approved for-profit Notified Bodies that must be approved by one of the EU’s 27 Competent National Authorities (called competent bodies) to act as a Notified Body for one of the three Medical Devices Directives. Consequently, member states are removed from direct legal oversight and legal enforcement of medical device regulations and hampered in their ability to oversee medical device failures.

To reason that 70 for-profit Notified Bodies can employ 70, 60 or 50 device experts for hundreds of different medical devices in multiple offices around the world isn’t credible. Consequently, the dearth of available device experts will continue to negatively affect the quality of medical devices being manufactured. While it might be reasoned that large established Notified Bodies could field multiple device experts, even they struggle to provide adequate product safety oversight. The Notified Body chosen by Poly Implants Prothèses (PIP) was TUV Rheinland, a well-established and respected Notified Body. The inspection however, occurred with advanced warning at the PIP plant in China, which raises a whole set of questions.

I have talked with principals at several Notified Bodies who privately admit that it is difficult for them to hire and retain qualified medical device experts. The number of silicon breast medical device manufacturers approved by the EU Notified Body structure has been estimated in various newspaper accounts at 80 to 120. If this is even remotely true, it is outrageous. In the US FDA has approved 6 medical device manufacturers for silicon breast implants.

While 6 silicon breast implant manufacturers approved for 313 million people in the US might seem small, 80 to 120 silicon breast implant manufacturers for 500 million people in the EU is preposterous and beyond oversight. Further, FDA requires that US manufacturers must be able to continually demonstrate the efficacy of their medical devices. No such requirement exists in the EU. 

Medical Device Product Quality Recommendations

• While several approaches to correct the administrative structure should be explored, one approach that might work would be to draw upon CEN and EU Member State Standards Bodies (DIN, AFNOR, BSI, etc.) to identify and/or provide medical device  experts to evaluate medical devices. Their services could be paid for by Notified Bodies, but they must not be employees of for profit Notified Bodies so that their judgments could be compromised.

• Something akin to an FDA 510(k) also should be created with device efficacy built in as major requirement. It isn’t a perfect solution because the 510(k) predicate device requirement doesn’t always avoid device defects in design and materials, but it is overseen by FDA not a private third party.

Medical Device Process Quality

All in all, Notified Bodies do a better job with process quality oversight, not perfect but better than their oversight of medical device product quality. Unfortunately, in their zeal to obtain business, some Notified Bodies could be accused of providing the best oversight money can buy. 

Medical Device Process Quality Recommendations

• Notified Body process quality oversight must be improved, which means that Member State Competent Body oversight of Notified Bodies must improve. Notified Bodies also must have greater awareness of their liability exposure. Thus far they have dodged the proverbial litigation bullet, but this will change in the US as well as in the EU. Presently there are several US lawsuits involving CE marked PIP breast implants in the US and the number of lawsuits will increase.

• FDA’s QSIT (Quality System Inspection Technique) adopted in 1999 as a guidance tool for FDA inspectors and an instructional tool for medical device manufacturers was a clever move that accompanied the adoption of FDA’s Quality System Regulation (QSR) in 1996. It introduced the use of a quality management system as a Good Manufacturing Practices regulatory approach to medical device manufacturing in the US. It also set a serious tone concerning what to expect when FDA conducts a medical device plant inspection. The Internal Quality Management Audit Checklist (ISO 13485:2003/ISO 9001:2000) is the closest approximation I could find to QSIT for the EU. A formal adoption of such a structure for use by EU Notified Bodies and oversight by Member State Competent Bodies could serve the same purpose. Every US medical device manufacturer conducts QSIT audits before being visited by FDA. The same type of rigor should exist for the EU.

• In addition to Member State Competent Bodies acting as Third Party Registrars overseeing their Notified Bodies, some effort should be made to instruct their Notified Bodies to be conversant with and abiding by the legal requirements of ISO/IEC 17021:2006 Conformity Assessment – Requirements for bodies providing audit and certification of management systems. In 2008, I served as legal expert in a national lawsuit in a US Federal Court in Los Angeles. As we proceeded to collect material in legal discovery, I contacted the Registrar for the opposing company to verify that they were the ISO 9001:2000 Registrar for the company. Since the Registrar was a division of a European Third Party that also was a Notified Body with whom I had worked with for some of my EU medical device clients, I anticipated no problem. Instead, I was informed that their attorneys advised them that they could not share such information, which was in clear violation of ISO/IEC 17021:2006. I know that US attorneys are clueless when it comes to such standards, but it quickly became clear that the Registrar also was clueless about the standard. From that point on, the Registrar proceeded to violate the requirements of ISO/IEC 17021:2006 with impunity, including modifying he scope of their ISO 9001:2000 Certification three years after it had been granted, to accommodate their corporate client. We began preparing expanded depositions and inclusion of the Registrar in the lawsuit when the case was settled. Clearly, the Registrar had no moral compass whatsoever. Also, my opinion of the related Notified Body went downhill.

• Notified bodies also must be made aware of their legal obligations in the event of a product liability lawsuit. For example, litigants in US Federal Courts have a legal right to ask for relevant records and documents in discovery such as the Quality Manual and Quality Procedures, Contract Records, Certification Audits, Surveillance Audits, Management Review Minutes, Non Conformity Records, Corrective and Preventive Action Minutes and records, Internal Audit Minutes, design records, process control records, Technical File records, complaints, etc. It makes no difference if these records and documents describe devices manufactured outside of the US. If they are relevant to devices sold in the US, they must be produced or the company can be held in contempt of court and fined. It doesn’t end there. Additional fines and potential criminal prosecution could follow. I mention this because presently I am working as legal expert on a CE Marking lawsuit in US Federal Court where a German manufacturer has been resisting our requests for discovery of their ISO 9001 records and documents and CE Marking Technical Files, etc. under the mistaken impression that a US Federal Court can not compel discovery from a non US manufacturer, not realizing that any manufacturer that sell products in the US is subject to US law.

Conclusion

There is a lot I like about the EU approach to the administration of its new approach Directives. However after seeing first hand the problems with Notified Bodies attempting to find medical device experts and observing mixed success with their administration of quality management system oversight, something must be done to improve the regulatory administrative approach. Also, consideration must be given to the efficacy of their approach as applied in different countries.

When working with a company in Atlanta three years that owned a manufacturing plant in China, I was asked to review their CE Marking materials from China. They had concluded that their Chinese counterparts didn’t understand CE Marking and decided to shift the administration of CE Marking their products to the US. It was about the same time that a US Manufacturer of Heparin was caught up in a controversy where 80 people died and several others were gravely ill from their Heparin sold in the US. The response from the American manufacturer was that they bought their supplies from Consolidation Laboratories in China. At the same time I was looking at pictures in the New York Times of diseased pig intestines draped over concrete sinks in rural China being rinsed with dirty water and shipped to Consolidation Laboratories. The American manufacturer never checked the full depth of their supply chain.

The use of industrial grade silicon instead of medical grade silicon and the resulting problems it has caused thousands of women in the EU and throughout the world is appalling. It is encouraging that the French police have detained the founder of the company. I trust that he might also spend a substantial amount of his remaining time in a French prison.

Clearly it is time to revaluate the effectiveness of the approach for the manufacture of medical devices. I hope that some of my suggestions prove to be useful. As mentioned in my previous blog I would be happy to help. My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding CE Marking lawsuits or medical device regulatory oversight you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com.  

Notified Bodies And CE Marking – Potential Legal Issues In US Lawsuits #3

Continuation

I want to return to the issue of Notified Bodies and the problem with silicon breast implants in the EU. As noted in my two previous blogs, I have observed various problems with Notified Bodies and CE Marking clients over time. Medical devices present a more complex regulatory dimension for CE Marking. In the US, FDA regulates medical devices using its Quality System Regulation (QSR) for medical device design and manufacturing. While FDA employs a quality management system similar to the EU’s ISO 13485, FDA oversight is far more rigorous and intensive with an ability to impose a range of legal sanctions from Warning Letters to Civil and Criminal penalties. Further, FDA can issue a Federal Consent Decree and fines, (e.g. $100 million, $60 million and extended oversight follow up) for the most egregious cases. The key issue is public health and safety.

In the EU, device regulations are not conducted by member state Competent National Authorities, instead they are conducted by one of the 70 approved for-profit Notified Bodies that must be approved by one of the EU’s 27 Competent National Authorities (called competent bodies) to act as a Notified Body for one of the three Medical Devices Directives. Consequently, member states are removed from direct legal enforcement of medical device regulations and hampered in their ability to oversee medical device failures. There is no comparable enforcement structure to FDA.

In the US all medical device manufacturers must have a FDA compliant QSR quality management system. Unless a company wants to manufacture a Class I medical devices not requiring CFR 820.30 design controls it generally must submit a 510(k) to receive FDA approval before manufacturing a medical device or seek Pre Market Approval from FDA and conduct a Clinical Trial to obtain FDA approval before manufacturing a new type of (generally Class III) medical device. FDA has the legal authority to enforce its regulations.

Problems With Notified Body Governmental Oversight

As mentioned in my previous blog, Notified Bodies perform two oversight functions, evaluating and approving medical devices (product safety) and ongoing evaluation of manufacturers’ ISO 13485 Quality Management Systems (process quality). Of the two functions, product quality is the most difficult because of the lack of device experts. To reason that 70 for-profit Notified Bodies can employ 70, 60 or 50 device experts for hundreds of different medical devices in multiple offices around the world isn’t credible. Consequently, the dearth of available device experts will continue to negatively affect the quality of medical devices being manufactured.

As a result, most Notified Bodies focus on the quality management system, ISO 13485 and process quality. The certification audit and surveillance audits operate much like ISO 9001 certification and surveillance audits except that the requirements of the relevant Medical Device Directive are incorporated into the ISO 13485 Quality Management System. Likewise the type of Medical Device(s) will be central to the QMS.

As noted in my previous blog, the quality of Notified Body QMS oversight isn’t always as rigorous as it should be, certainly not as rigorous as an FDA plant inspection. No Notified Body has issued anything comparable to FDA’s QSIT (Quality System Inspection Technique) setting forth the procedure and questions a manufacturer should expect and be able to answer when FDA conducts an on-site inspection of a manufacturing plant. AdvaMed – Advanced Technology Association has developed papers, Different Points to Consider When Preparing For An FDA Inspection for different QSIT Subsystems. There is no comparable preparation for an audit by a Notified Body.

This is not to say that audits by Notified Bodies are treated lightly by medical device manufacturers rather it speaks to the legal authority of an FDA audit when compared to the legal authority of Notified Body audits. In addition to the audit example described in my previous blog where a Notified Body wrote good observations for a Class III medical device manufacturer but failed to issue non-conformities, did not serve their client well. Whether this was done to placate a client to retain their business isn’t clear. What it did accomplish was to prompt their client to ask me if I thought they would survive an FDA site inspection, to which I said no. 

In contrast, FDA at the very least would have issued a Warning Letter and might even have shut down the facility until major changes were implemented. This is not the only case where I have observed a Notified Body conduct an “audit-lite.” A few other examples are listed below:

• A colleague and I spent two days at a medical device manufacturer’s only US CE Marking plant in Arizona while conducting a GAP Analysis for the manufacturer. They wanted to extend CE Marking capability to all of their US manufacturing plants and asked if we could evaluate their Arizona operation. When we arrived at the plant we asked to examine their Technical Files for medical devices being manufactured at the Arizona plant. To which the plant manager responded, “What’s a Technical File?” Following this exchange we proceeded to conduct our audit. We found storage of medical devices in a warehouse lacking heating and cooling was having a serious adverse effect on device quality. We also found boxes containing devices that were marked with the corporate address 1000 miles away, but not the address of the plant in Arizona that was CE Marking the devices. Several more problems were found. We recommended that they identify the unique features of each QMS, but integrate their QSR and ISO 13485 Quality Management Systems for greater control in the future.

• I recently received a call from a Medical Device Manufacturer in Atlanta asking if I could meet them at their corporate office for consultation. They had just been told by their Notified Body that they received two major non-conformances on their most recent surveillance audit and had one month to make the necessary correction or they could no longer CE Mark their medical devices. The quality and regulatory managers flew in from the manufacturing plant in question with the surveillance audit report. The managers were shocked because this was their fifth surveillance audit report and previously they had not received any non-conformances. Nothing had changed in their manufacturing operation. The Notified Body informed them that their Competent National Authority (competent body) had just completed a review of all of their audits and found problems with their findings. The Notified Body was informed that they had to meet with all of their clients and inform of these changes and the reason for the changes or the Notified Body would be stripped of its CE Marking authority. Fortunately, my client was able to make the necessary corrections and continue CE Marking their medical devices.

• In another case I visited another manufacturing client in California at the request of their medical device insurance company to examine their Quality Management System and complaint handling system. The manufacturer had experienced some difficulties and wanted a legal perspective on corrective steps that might be taken. The quality manager mentioned that they had a recent surveillance audit from their Notified Body. (The manufacturer made radioactive plates for Magnetic Resonance Imaging machines.) They were surprised that the Notified Body device expert seemed to be afraid of entering the manufacturing area for fear of exposure to radiation. They weren’t convinced that he was much of an expert. The company has dealt with many experts in radioactive devices throughout their operation.

These are not idiosyncratic observations. While I have worked with several exceptional Notified Bodies administering CE Marking regulatory oversight for the EU Medical Devices Directives, they too have experienced glitches and these have been corrected when discovered. Clearly, strong Competent Body oversight is vital to the process. 

As mentioned previously there also are Notified Bodies more motivated by making money than quality medical device regulatory oversight. A colleague of mine encountered one such Notified Body a few years ago when working with a company that manufactured active implantable medical devices. He helped the manufacturer meet with the FDA regional office and review their quality management system. He was then asked by the manufacturer if he would review their most recent Notified Body surveillance audit, which he did. They asked his opinion and he said it was inadequate, which angered the Notified Body.

He subsequently learned that the company, however, was not fully candid with him, the FDA and the Notified Body. Not only were there manufacturing problems, four people had died from their implants and several others were experiencing serious problems with the device. FDA took action and several product liability lawsuits followed.

Had plaintiffs’ attorneys realized the role of the Notified Body in CE Marking these devices they could have sought Technical Files, ISO 13485 records, documents and notified body Certification Audits and Surveillance Audits in discovery to see what additional useful information could be obtained for use in the lawsuits. Notified Bodies are not exempt from US lawsuits. Further, the Notified Bodies could have been sued directly if their regulatory behavior could be partially attributed to device failures. The irony here is that the notified Body never realized how close they came to becoming a part of the lawsuits.

Observation – Privatized Oversight

The concept of privatized regulatory oversight is not unique. However, fragmented regulatory oversight involving 27 different Competent National Authorities (Competent Bodies) of different size, expertise and financial capability overseeing 70 Notified Bodies operating on their behalf is unique and extremely cumbersome. Until the structure is corrected, problems will continue to arise. The Friday January 27, 2012 issue of the New York Times contains an article about the breast implant manufacturer Poly Implants Prothèses, the founder Jean-Claude Mas and the apparently undetected use of industrial grade silicon in place of medical grade silicon.

The problem now is the immediate solution and the long-term solution. I understand the desire to create a strong EU structure while preserving national sovereignty. My political science and legal training tells me that it is possible, not easy but possible. I would be happy to help. 

My next blog will conclude this series and specifically address the problem with the silicon breast implants and prospective solutions. My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com. 

Notified Bodies And CE Marking – Potential Legal Issues In US Lawsuits #2

Introduction 

The preceding Blog reviewed the Minimum criteria to be taken into account by Member States for the notification bodies set forth in Annex XI of the 2006/42/EC Machinery Directive. I want to revisit the criteria to consider how they might come into play in a lawsuit. Several issues need to be kept in mind when dealing with notified bodies in lawsuits. To begin, notification varies for each directive. Therefore, it is critical to know what notification means for the Directive or Directives relative to a particular lawsuit and the role of notified bodies vis-à-vis your client.

Not All Notified Bodies Play According To The Rules

You must be aware that not all notified bodies behave ethically concerning their notified status. I have encountered notified bodies implying that their services are officially sanctioned (i.e., notified) by a Member State Competent National Authority to the European Commission for a Directive, such as the Machinery Directive, when in fact they are acting as consultants. This has been especially true for the Machinery Directive, where notification is confined to Annex IV of the Directive. Everything outside of Annex IV, is consulting with no official sanction by a Member State Competent National Authority. 

I mentioned previously an instance in 2003 where a Dutch Notified Body issued two EC Type Examination Certificates for machines a manufacturer wanted to CE Mark for the EU. They also issued a paper stating that other machines couldn’t be CE marked until certain steps were taken. Since none of these machines were listed in Annex IV, the issuance of the CE Type Examination Certificates was outside the legal authority of the notified body. The statements on the other machines were not identified as comments by a consulting body. Instead they were presented as the authoritative judgments of a governmentally recognized notified body. To accomplish these tasks the Dutch notified body sent a team to the US to conduct their work at great expense to my client.

Clearly, the notified body was aware that their American Clients didn’t understand CE Marking or the legal requirements of the Machinery Directive. I informed my client that their two EC Type Examination Certificates were worthless and had no standing in EU law or US law, however, if something happened where the certificates would be important in a lawsuit, the notified body could be sued for fraud. 

Since I had been working with representatives in the UK’s Department of Trade and Industry DTI (now the Department for Business, Enterprise and Skills BIS) on other projects, I asked them for help in contacting the Dutch Competent National Authority to complain about the behavior of the Dutch notified body. DTI tried for several months to contact the Dutch Competent National Authority and received no response.

They suggested that I should try to make contact directly and see if I fared any better. I wrote e-mails for several months to the Dutch Competent National Authority and even wrote directly to the head of the Dutch Competent National Authority and received no response. Finally, I transmitted my long train of e-mails to DTI & the Dutch to EU Commissioner Liikanen chief administrator of the EU Directorate General responsible for Machinery explaining what had transpired. Three weeks later I received a letter on March 23, 2004 from Mr. Fabrizio Sachetti of the Committee on Machinery affirming that our position was correct. They copied the Dutch Competent National Authority and the Dutch notified body of their statement. 

What Is The Operating Structure For Notified Bodies?

• Given the fact that notification varies with each Directive, it is essential that the precise legal authorization for notified bodies be known. It varies widely from Directive to Directive. The most stringent oversight was created for the Medical Devices Directives, however, recently the quality of notified body oversight of the Medical Devices Directive has been called into question concerning failed silicon breast implants in the EU and the French medical device manufacturer PIP (Poly Implant Prothèse). I will return to this case in my next blog.

• Every third party that wants to become a notified body for a new approach Directive must submit their credentials to the Competent National Authority of the country in which they are located. Presumably, each Competent National Authority has the technical expertise to evaluate the ability of the notified body to approve a CE Mark for a medical device and conduct effective continuous oversight of their notified bodies. Clearly, however, not all EU Member State Competent Authorities are equal. France, Germany, the UK, Italy, the Netherlands, Denmark, Ireland, Sweden and Finland have well developed oversight Competent National Authorities and are capable of being effective oversight bodies. Some of the smaller countries will not take on this task. A critical follow-up question is how effective is the oversight of the Member State Competent Authorities by the European Commission?

• Recall the discussion in my previous blog of January 9, 2012 regarding the dual function of many notified bodies concerning product safety and process quality. The dual function is particularly important to the oversight of medical device manufacturers. I have found, however, that some notified bodies address their dual function very well and others have been sloppy. This can be a problem when it comes to medical devices.

• Process Quality: Depending on the device classification, process quality refers to the type of Quality Management System, e.g. ISO 13485 used to assure that the medical devices are manufactured at a consistent quality level. The notified body conducts the certification audit and the surveillance audits to assure that process quality is being maintained. Basically, a medical device manufacturer contracts with a notified body as its "private FDA" for manufacturing medical devices for the EU, whereas in the US medical device manufacturers must follow FDA’s Quality System Regulation (QSR) and are subject to FDA oversight.

• Product safety: Medical device safety in the EU is governed by the classification of a device set forth in the Active Implantable, Medical Devices or In Vitro Diagnostic Directives. Once the classification has been determined, it is necessary to identify which Essential Requirements apply to a device, which EN Standards will allow a manufacturer to demonstrate conformity to the Essential Requirements and finally determine which Conformity Assessment Procedure applies to the manufacturing of a particular medical device.

• A medical device manufacturer in the EU, US, Canada, China, etc. can choose to contract with the notified body of their choice for a particular product, which means that manufacturers can shop around for price, service and convenience. While notified bodies are headquartered in the country where they have been approved, they have offices throughout the world. A fair question is the competence of the notified bodies in a country like China to carry on day-to-day functions as opposed to their US counterparts. I have worked with manufacturers who were not happy with the CE Marking abilities Chinese notified bodies and moved it to the US or EU.

What Are Some Of The Concerns Regarding Notified Bodies?

• Notified bodies must operate in accordance with the rules set forth in the particular Directive for which they have been approved by their Competent National Authority. While it might be obvious, it should be noted that each notification is different for each Directive. Notification for one Directive has nothing to do with another Directive.

• In spite of sincere pledges to create a firewall to prevent a conflict of interest between their official status as a notified body for a Directive and consulting for the same Directive, notified bodies are aware that Americans do not understand these subtleties and believe that consulting by a notified body is officially sanctioned by an EU Member State. A few years ago when I was working on a project with the California Manufacturing Technology Center in Fresno, we submitted a bid to a California packaging machine manufacturer. When we lost the bid, I asked my colleague in Fresno, if we were too high and he said no, the notified body quote was four times higher than ours. The manufacturer was under the impression the notified body was officially sanctioned by the German Government.

• Notified bodies are private for profit organizations. While most conduct themselves in a respectful manner, I am aware from a few former colleagues who have worked on a contract basis that a few notified bodies are rather mercenary with their employees violating criteria number two on the list, The body and its staff shall carry out the verification tests with the highest degree of professional integrity and technical competence and shall be free from all pressures and inducements, particularly financial… Some notified bodies essentially drive their employees to produce quotas or be dismissed, especially when conducting Quality Management System Certification and Surveillance Audits.

• Medical devices pose a special problem when it comes to device expertise. Often it is difficult for them to find and hold onto experts who can evaluate devices because medical device manufacturers will offer better pay to these persons. It speaks well to the quality of their expertise, but it creates a serious device quality and potential safety problem nonetheless.

• Medical Device Quality System oversight is another area where potential problems can arise. A few years ago I worked with a medical device manufacturer of a Class 3 Medical in California who had just completed a surveillance audit from their notified body. They asked if I would review the audit and write an Executive Summary. Their biggest concern was how I thought they would fare when FDA conducted an on site inspection. While it was a good audit, it had no teeth. It made some excellent observations, but it issued no non-conformities. I told my client that I thought they would not survive an FDA and could be shut down. They asked if I would highlight the areas for improvement in my executive summary. I did so and they called six months later to say they passed their FDA inspection with no write up in a FDA 483 Warning Letter.

Conclusion

The preceding are just a few experiences I have encountered working with notified bodies. It isn’t all negative, I have had excellent experience with several notified bodies and enthusiastically recommend their services to my clients. The recent experience with the French silicon breast manufacturer, however, points to areas where improvements are critically necessary. I also want to spend some time discussing notified bodies and potential US Federal Lawsuits since this area is beginning to heat up. Information provided in Technical Files could become fair game for CE Marked medical devices in legal discovery. Finally, I want to compare the European approach to medical device regulation with FDA’s medical device regulatory approach.

My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com. 

Notified Bodies And CE Marking – Potential Legal Issues In US CE Marking Lawsuits #1

Introduction

I received an e-mail this week asking this question, “Are you aware whether or not the notified bodies in Europe are expected to possess professional indemnity insurance, to cover them in cases of a poor opinion of compliance or failure of post Market surveillance, with thanks for your advice.”

I answered, “Yes, in every new approach Directive there is an Annex that spells out the criteria for notified bodies. For Example, in the 2006/42/EC Machinery Directive, Annex XI sets forth, "Minimum criteria to be taken into account by Member States for the notification of bodies" Paragraph 6 states, "The body shall take out liability insurance unless its liability is assumed by the State in accordance with national law or the Member State itself is directly responsible for the tests."

Notified Body Requirements

The question about notified body “indemnity insurance” raises a number of questions that should be explored concerning the EU legal requirements for notified bodies and their potential legal implications in US courts. The full list is stated below:

Minimum criteria to be taken into account by Member States for the notification bodies 

1. The body, its director and staff responsible for carrying out the verification tests shall not be the designer, manufacturer, supplier, or installer of machines which they inspect, nor the authorized representative of any of these parties. They shall not become involved, either directly or as authorized representatives, in the design, construction, marketing or maintenance of the machines. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.

2. The body and its staff shall carry out the verification tests with the highest degree of professional integrity and technical competence and shall be free from all pressures and inducements, particularly financial, which might influence their judgments on the results of their inspection, especially from persons or groups with an interest in the result in result of verifications.

3. For each category of machinery for which it is notified, the body must possess personnel with technical knowledge and sufficient and appropriate experience to perform a conformity assessment. It must have the means necessary to complete the technical and administrative tasks connected with the implementation of the checks in an appropriate manner, it must also have access to the equipment necessary for the exceptional checks.

4. The staff responsible for inspection shall have:

-- sound technical knowledge and vocational training,

-- satisfactory knowledge of the requirements of the tests they carry out and adequate experience of such tests,

-- the ability to draw up the certificates, records and reports required to authenticate the performance of the tests.

5. The impartiality of inspection staff shall be guaranteed. The remuneration shall not depend on the number of tests carry out or on the results of such tests.

6. The Body shall take liability insurance unless its liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the tests.

7. The staff of the body shall be bound to observe professional secrecy with regard to all information obtained in carrying out its tasks (except vis-à-vis the competent administrative authorities of the State  in which its activities are carried out) under this Directive or any provision of national law giving effect to it.

8. Notified bodies shall participate in coordination activities. They shall also take part directly or be represented in European standardization, or ensure that they know the situation in respect of relevant standards.

9. Member states may take all necessary measures they regard as necessary in order to ensure that, in the event of cessation of the activities of a notified body, the files of its customers are sent to another body or are made available to the Member State which has notified it.

Notified Bodies 

Notified bodies are created by each New Approach Directive.  The criteria are established by each Directive.  Notification may be to a specific clause, such as Annex IV of the Machinery Directive dealing with dangerous machines, which is the only clause to which a body may be notified for that Directive. Notification also may be confined to those clauses for which it has technical competence or it may extend to all of the clauses of a directive.  The decision belongs to Competent National Authorities who use the EN 45000 series to evaluate notified bodies. When a Competent National Authority approves one of their third parties for a Directive, they “notify” the European Commission. The Commission periodically publishes the list of notified bodies in The Official Journal of the European Communities.

Product Safety and Process Quality--Two Elements of CE Marking A Product 

In his preface to The Guide to the Implementation of Community Harmonization Directives Based on the New Approach and the Global Approach, Brussels, 1995, Vice President of the European Commission, Martin Bangeman stated the following:

The novelty of this new approach resides essentially in the use of community technical rules of “quality instruments” such as European Standardization and conformity assessment procedures (testing, product certification, certification of manufacturers’ quality control procedures, accreditation, etc.).  These instruments, drawn up on the basis of consensus of all the economic partners involved, enable manufacturers to affix the CE marking--a real “technical passport”--to their industrial products, which must conform to these community directives.

Considered one of the architects of the new approach, vice president Bangeman’s quote deserves some attention.  To begin, when he talks about a “consensus of all the economic partners involved” he is referring to the fact that the CEN, CENELEC and ETSI working groups that draft EN safety standards are comprised of manufacturer representatives, representatives of Member State standards organizations (e.g., BSI, DIN, AFNOR, etc.), testing laboratories, academic faculty and in some cases consumer representatives.  While Member State standards organizations direct working group schedules, there is a conviction that the affected parties are participating in writing the standards.

The reference to “quality instruments” such as European standardization and conformity assessment procedures points to two aspects of virtually all new approach directives.  One aspect is the element of product safety. The technical file referred to in most directives contains a checklist of the directive’s essential safety requirements and the EN harmonized safety standards and/or the tests performed and approvals granted which a manufacturer has used to demonstrate conformity to the Directive’s essential safety requirements.  Generally, among those tests will be an application of the principles of safety integration applied to the product in question and a risk assessment. The technical file should demonstrate and record the companies’ efforts to achieve an acceptable level of product safety.

The second aspect is the element of process quality. Once an acceptable level of product safety has been built into a product, the manufacturing process must be able to assure consistent quality so that products number 5, 905, and 20,005 are of consistent and dependable quality. This dual objective of achieving acceptable product safety and consistent process quality will be familiar to manufacturers of regulated products such as medical devices using ISO 13485, and ISO 9001 for manufacturers of products covered by other Directives.

Conclusion

Notified bodies play an integral role in New Approach Directives such as the Medical Devices Directives and variable role in other New Approach Directives, e.g. except for Annex IV of the Machinery Directive where notified body involvement is required, manufacturers self-certify to the requirements of the Directive.

The areas where third parties are “notified” varies for each Directive. Since Notified Bodies (along with ISO 9001 Registrars) will increasingly become involved in CE Marking lawsuits in US Federal Courts, I want to examine notified body involvement and behavior since the beginning of CE Marking products and identify areas where notified body involvement in US lawsuits should be anticipated.

My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com.  

CE Marking Lawsuits – Applying Forensic Law To Evidence & Discovery

Introduction

As I mentioned in my previous Blog, US Federal Courts – The New Venue For CE Marking Lawsuits, posted on November 30, 2011, we can expect to see an increasing number of CE Marking lawsuits in US Federal Courts. The rationale for the increased number of lawsuits is spelled out in the Blog. I have previously mentioned that I am serving as legal expert in three such lawsuits in US Federal Courts. The earliest lawsuit is nearing completion and appears to have met with success in translating European EN Safety Standards and EU Directive Essential Safety Requirements in a US courtroom. The other two lawsuits are still underway. I also mentioned having served as legal expert in lawsuits involving ISO 9001. These have been settled out of court, however, based on some recent inquiries I anticipate more such lawsuits in the future.

The purpose of today’s Blog is to revisit a few of the previous observations and amplify the points being made. I noted previously that US litigation attorneys often proceed in a somewhat routine fashion not fully understanding the different product safety requirements of EU New Approach Safety Directives and EN safety standards. Also as noted, I have seen botched discovery requests and frustrated Judges regarding ISO 9001 records and document requests in discovery. 

New Territory

This area, CE Marking New Approach Safety Directives, often intermingled with a quality management system, such as ISO 9001 is new territory that requires competent legal understanding if litigation attorneys and defense counsel hope to succeed on behalf of their respective clients.

To begin there are 27 New Approach Safety Directives, drafted at different times. Several are in various states of revision and new Directive combinations. These Directives affect approximately 65% of products entering the EU. They range from Directives addressing Machinery Safety, Medical Devices (General, Active Implantable, In Vitro Diagnostic), Toy Safety, Low Voltage, Electromagnetic Compatibility, Pressure Equipment, Equipment and Protective Systems in Potentially Explosive Atmospheres (ATEX), Construction Products, Personal Protective Equipment, Radio and Telecommunications Terminal Equipment to mention some of the more prominent Directives. 

Each Directive also has Essential Safety Requirements and EN standards that allow for demonstration of conformity to the Directive’s essential safety requirements. There are thousands of standards that are reviewed every 5 to 7 years to consider whether they should be maintained in their present state, revised or eliminated. As noted in the prior Blog, the revision of these standards is now coordinated between the EU Standards Bodies, CEN, CENELEC and ETSI and ISO and IEC to improve the revision process and invite EU standards expertise into these considerations. Also participating in ISO and IEC deliberations on behalf of United States is the American National Standards Institute (ANSI). Consequently, these revised standards will become both American and EU standards. Therefore, the time when a product is manufactured could determine if a standard in question was also an American Standard, if that issue is relevant to a lawsuit.

Also, depending on the Directive or Directives in question and the nature and safety of a product, a company might have chosen what the Europeans call a Conformity Assessment Procedure to assure that the product is manufactured at a consistent quality level. In these cases, third parties which the Europeans call “Notified Bodies” will be involved in the product compliance process. Therefore, notified body records, often including ISO 9001 Quality Management System documents and records could be involved.

It is critical for litigation attorneys and defense counsel to understand how these safety standards are applied and how this information could critically impact a lawsuit affecting their clients. Sophomoric American assumptions could adversely affect the outcome of a lawsuit. 

Timing

As noted in my previous Blog, timing is critical to understanding the relevant facts concerning a lawsuit. It is important to know when a product is manufactured in order to determine the legal status of a Directive, e.g. whether or not it had been revised at the time of design and manufacture, and it is important to know which standards apply to a product. If a Conformity Assessment Procedure was involved and a Notified Body also was involved, certification audits and surveillance audits could become important to the disposition of a lawsuit. Likewise, it is important to know how many Directives might be involved in the manufacture of a product.

For example, I have worked with machinery manufacturers whose machines had to comply with the Machinery Directive, Low Voltage Directive, Electromagnetic Compatibility Directive, Pressure Equipment Directive and the Explosive Atmospheres Directive. Therefore the requirements of each directive and the standards necessary to comply with the requirements of each directive need to be examined. Likewise, it is critical to know what requirements were in place when the product was manufactured. Of course, attorneys will want to know how this all might be litigated in a US Federal Court. 

Observation

In previous Blogs where the topic was a malfunctioning product such as machine, specific compliance with the requirements of these New Approach Safety Directives can be examined to see if the company actually attempted to satisfy the requirements of the Directives and the relevant standards. In one case presently being litigated in a US Federal Court, it was clear that the company, a US machinery manufacturer, did not create a Technical File containing all of the steps required by the manufacturer to comply with the Directive. The file also contained no risk assessment standard and risk assessment judgments.  Further, after two accidents that killed one worker in the EU and maimed another worker in the US who will require 24 medical care for the rest of his life, it was clear that the company did not comply with the safety requirements of the directive and this failure caused both accidents. 

Forensic Law   

In order to address these cases and effectively use this information in a US Federal Court, it is necessary how these Directives and their Standards interplay and the status of each at the time the machine in question was designed and manufactured. Simple assumptions will not work. Knowing when critical components were manufactured also is important as well as the date that the product itself is manufactured. Knowing how the EU directives and standards work is different, but it can be successfully tackled and lawsuits can be won.

I first encountered the term “forensic” when I received a call several years ago from young man was working with a law firm applying the requirements of ISO 9001 and ISO 9004 to some product failure cases in Atlanta. I asked what his background was and he said he was a forensic engineer. 

Since then, and in a totally different application in California involving a product that was causing a medical device manufacturer to experience manufacturing difficulties with diabetic test trips, I was asked to determine if a supplier had failed to follow requirements of its ISO 9001 Quality Management System and if that failure caused the test strip difficulties. It did. I also was working with a forensic accounting firm who were determining if the financial loss calculated by the manufacturer was accurate. It was. 

The term forensic applies equally to the law and litigation. Attorneys continually attempt to dissect products and events to understand what happened and apply this knowledge on behalf of their clients. In the case of the 27 EU New Approach Safety Directives and thousands of EN harmonized safety standards the forensic analysis is complex, but doable. The biggest problem I have observed are US attorneys who transmogrify an EU legal issue into a more familiar American setting thereby mutilating the critical issues and facts affecting their clients.  

Conclusion

To successfully tackle a CE Marking lawsuit, it is necessary to apply forensic analysis to the Directives and Standards that apply to a case. As noted in my prior Blog, while it can be hard breaking litigation and defense attorneys of some bad habits and reining in their egos, it is to their advantage to approach a lawsuit having all of their facts in order and achieving the best possible result for their client. Fortunately, I’ve worked with several attorneys who have achieved this objective and prevailed on behalf of their clients.

My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a Federal or State courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions concerning EU Directives and Standards and product liability litigation, you can contact me for a free preliminary consultation at my new e-mail address jameskolka@gmail.com.

US Federal Courts – The New Venue For CE Marking Lawsuits

 

Introduction

I have discussed the CE Marking implications of product liability lawsuits in US Federal Courts several times. I want to expand on this topic. As mentioned in previous blogs, presently, I am serving as legal expert in three lawsuits involving the EU Machinery Directive in US Federal Courts. ISO 9001 also is involved in two of these cases. 

As long as one of the litigants is a US resident (individual or corporation), the dollar amount meets federal monetary requirements and a legitimate cause of action exists, the suit can proceed. This means the following types of lawsuits can be filed:

• Non US citizens, corporations or companies that suffer injury and/or damage from a CE Marked product manufactured by a US corporation or company can file a lawsuit, e.g. product liability claim, breach of warranty, breach of contract, etc. in a US Federal Court.

• US citizens, corporations or companies that suffer injury and/or damage from a CE Marked product manufactured by a US, EU or other foreign corporation or company can file a lawsuit, e.g. product liability claim, breach of warranty, breach of contract, etc. in a US Federal Court.

What Does This Mean?

To begin, it means that citizens of other countries who are injured by a CE Marked product manufactured by a US company can bring a product liability lawsuit against a company, a legal remedy not available in their own country. It also means that a foreign manufacturer of a CE Marked product that injures a US resident or company can be sued for damages in a US product liability lawsuit. It is a reason that manufacturers can anticipate product liability lawsuits for their CE Marked product failures in US Federal Courts. It is one of the reasons that I am presently serving as legal expert in three CE Marking lawsuits in three different Federal Courts. I have also served as a legal expert in ISO 9001 lawsuits between US corporations and EU corporations. 

For foreign companies selling their CE Marked products in the US it likely will be their first exposure to legal discovery. From what I have experienced thus far, it means that many of these companies will experience requests for information and documentation for the first time and try to resist turning over anything that might be injurious to their legal position. That certainly has been the behavior of some German corporations involved in a few product liability lawsuits. Thus far, it has not been the behavior of ISO 9001 lawsuits between UK corporations and US corporations. The sample, however, is quite small.

Another surprise is the request for CE Marking Technical Files. As mentioned in previous blogs, one of the cases I am working on involves a US corporation manufacturing a CE Marked machine. They turned over a Technical File that has to be described as a junk file or gibberish. Clearly, the company had not paid attention to or chose to ignore the specific requirements of the Machinery Directive. The manufacturer also was found to be duplicitous in their dealings with UK authorities and opposing counsel. Fortunately, as this case moves along, the failure to comply with the requirements of the Directive have become apparent to the Court and likely will result in an adverse judgment which most likely will be settled out of court to the monetary detriment of the US machinery manufacturer. 

Of course, the request for information contained in Technical Files will be an even bigger surprise for EU manufacturers of CE Marked products and the intense scrutiny concerning the quality of compliance of these manufacturers with EU Directives. One attorney asked me why EU EN harmonized standards would be relevant in a US court. After all they are not  American standards.

I told him that EN standards like all ISO and IEC standards are revised on a periodic basis, approximately every 5 to 7 years. By agreement between the European Committee for Standardization (CEN) and ISO and the European Committee for Electotechnical Standardization (CENELEC) with IEC the new standards that emerge from this collaboration will be both International and European standards. In addition and even more important in the US, ANSI (American National Standards Institute) participates in all of the ISO and IEC standards deliberations and revisions. Consequently, at the end of the revision process the new standards also will be both European and American standards.

Litigation Attorneys

The role of litigation attorneys dealing with CE Marking Directives, CE Marked products, European standards and occasionally ISO 9001 or ISO 13485 is another issue. Often I have found that the attorneys proceed in a somewhat routine fashion not fully understanding the product requirements and the issues they are dealing with. On occasion, I have seen botched discovery requests and frustrated Judges regarding ISO 9001 records and documents requests.

Also, I have seen some, not all, attorneys become rather arrogant and possessive about "their" lawsuit and not helpful in providing information so that I can be of greater value to their case. They tend to think they can puzzle their way through the CE Marking process. However, with 27 New Approach Directives in various stages of revision and new combinations and thousands of EN harmonized standards in various stages of revision, it isn’t remotely as simple as it might appar. When I do work with attorneys who are open and share the issues at hand, the collaboration can work extremely well. My role is to serve as a legal expert not a litigation attorney.

Timing

Timing is critical to understanding the relevant facts concerning a lawsuit. For example, in some of the Machinery Directive lawsuits it is important to know when the machine was manufactured, the status of the Directive, e.g. revisions of the relevant EN standards that should have been followed to satisfy the Annex I Essential Health and Safety and Requirements.  It is also important to know what other Directives may be involved. I have worked on CE Marking several machines that involved the Machinery Directive, Low Voltage Directive, EMC Directive, Pressure Equipment Directive and Explosive Atmospheres (ATEX) Directive. Other Directives could be added today, e.g. RoHS2. This information may seem arcane, but it could be quite critical to the manufacturer’s actions regarding the machine. The same is true for ISO 9001, e.g. are we talking about ISO 9001:1994, ISO 9001: 2000 or ISO 9001: 2008? I’ve seen several instances where the attorneys did not understand the revision of the standards and didn’t realize that there was continuity in compliance with one standard to the next.

The same issue comes into play regarding EN standards. For example, I recently discovered that CE Marked components that were incorporated in a machine by a client were in fact “out of date.” We called the component manufacturer and brought this matter to their attention saying that we have to have components that comply with current EN standards. After some grumbling, the component suppliers produced components compliant with the most recent standards. This may seem like a small matter, but it could be quite costly for the manufacturer in case of a product liability lawsuit.

Conclusion

While it can be hard breaking litigation attorneys of some bad habits and reining in their egos, it is to their advantage to approach a lawsuit having all of their facts in order to achieve the best possible result for their client. Fortunately, I’ve worked with several attorneys who have achieved this objective and prevailed on behalf of their clients. My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a Federal or State courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions concerning medical device litigation, you can contact me for a free preliminary consultation at my new e-mail address jameskolka@gmail.com.

Don’t Listen To Anyone Who Says You Don’t Have to CE Mark Your Product For The EU!

 

Introduction

I don’t know how many times I have heard words from distributors, buyers, politicians, clinics, etc. in the EU anxious to sell or buy new products saying, not to worry you don’t have to CE Mark your products for the EU. The first time was several years ago when the Mayor of a small town in Portugal wanted to assure a Michigan machinery manufacturer that he would take care of the CE Marking issue. Of course, he could not. The Mayor was so excited that a large US manufacturer was going to locate a new plant near his town he didn’t want anything to interfere with the process. The Michigan manufacturer had an order to deliver a machinery assembly line to manufacture fuel injection systems for an automobile plant. They were aware that CE Marking was required for machines.

Not too long before another Michigan manufacturer had shipped a non CE Marked machine to a plant they owned in Northern Ireland. A workman spotted the machine and reported it to his foreman as required by the EU Workplace Safety Act who then reported it to the British Government.

When the company was informed of their transgression, they said that it was their machine built in their Michigan plant and it was to be installed in their Northern Ireland plant so they asserted it didn’t have to be CE Marked. British authorities reminded the company that their plant was on sovereign British soil subject to UK & EU law. They gave the plant manager a six month suspended sentence under the Criminal Code, fined the company, told them to remove the machine until it complied with the Machinery Directive and said never do it again.

Placing A Product On The EU Market

The operative words in all EU New Approach Directives are very clear. For Example, the new Toy Safety Directive 2009/48/EC of 18 June 2009 states:

Chapter I

General Provisions

Article 1

Subject Matter

This Directive lays down rues on the safety of toys and on their free movement in the Community.

Article 2

Scope

1. This Directive shall apply to products designed or intended, whether or not exclusively, for use in play by children 14 years of age (hereinafter referred to as toys).

Article 3

Definitions

For the purposes of the Directive, the following definitions shall apply:

1. ’making available on the market’ means any supply of a toy for distribution, consumption, or use on the Community market in the course of commercial activities, whether in return for payment or free of charge. (emphasis added in bold print)

2. ’placing on the market’ means the first making available of a toy on the Community market. (emphasis added in bold print)

The same language can be found in all of the CE Marking new approach Directives. Any product that requires CE Marking, whether for payment or free, must be CE Marked. The liability for failing to CE Mark a product falls on the manufacturer, not the buyer. 

In the new Toy Safety Directive 2009/48/EC, the EU has set forth:

• Article 7, Obligations of distributors

• Article 8, Cases in which obligations of manufacturers apply to importers and distributors

• Article 9, Identification of economic operators

While its nice to see the EU set forth legal expectations for Distributors, Importers and Economic Operators, this does not take the “monkey off the back” of manufacturers. If a manufacturer places a non-marked product on the EU market that should have a CE Mark, that manufacturer is legally liable. 

What is the Legal Liability for Failing to CE Mark a Product? 

The new Toy Safety Directive spells out several steps that can be taken for placing a toy on the market that should be CE Marked;

• Chapter VI sets forth the “Obligations And Powers Of Member States” 

• Article 39 establishes the “Precautionary Principle”

• Article 40 establishes the “General Obligation To Organize Market Surveillance” in accordance with Articles 15 to 29 of Regulation (EC) No 765/2008 of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and Repealing Regulation (EEC) No 339/93

• Article 41 sets forth “Instructions to the notified body”

• Article 42, Procedure for dealing with toys presenting a risk at national level

• Article 43, Community safeguard procedures

• Article 44, Exchange of information – Community Rapid Information Exchange System

Finally, Article 45 defines what is meant by Formal non-compliance:

1.Without prejudice to Article 42, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a) that the CE marking has been affixed in violation of Article 16 [General principles of the CE marking] or 17 [Rules and conditions for affixing the CE marking];

(b) that the CE marking has not been affixed;

(c) that the EC declaration of conformity has not been drawn up;

(d) that the EC declaration of conformity has not been drawn up correctly;

(e) that the technical documentation is either not available or complete.

2. Where the non-compliance referred in paragraph 1 persists, the Member State concerned shall take appropriate measures to restrict or prohibit the toy being made available on the market, or shall ensure that it is recalled or withdrawn from the market. (emphasis added in bold print)

Summary

The reason I chose the Toy Safety Directive was a question this week from a client with whom I am working to CE Mark their products who was told by two distributors that their toy didn’t have to be CE Marked for sale in the EU. Whether the two distributors were incredibly ignorant, previously lucky in evading the law or duplicitous is beside the point they still try to persuade manufacturers to sell them non CE Marked toys. Fortunately, my clients were suspicious and suspected that the distributors were not telling the truth.

Finally, take a close look at Article 45 above, Formal non-compliance. Those of you who have been reading my recent Blogs, especially the last three posted on July 30, August 15 and August 17 respectively should recognize that the manufacturer who manufactured the machine that killed a worker in the UK and maimed another worker for life in the US did not satisfy any of these requirements! The Machinery Directive has the very same requirements as the Toy Safety Directive. 

The EU has adopted excellent legislation on Market Surveillance, however, I am still concerned with the quality of implementation. I think these types of steps are essential for effective Market Surveillance for the EU new approach Directives As noted previously, I would like to work with the EU to enforce market surveillance so that consumers aren’t injured or killed. I also would like to work with European manufacturers concerning steps  for them to take to reduce their liability exposure in the US market. It seems to fit the European philosophical approach to product safety and would help EU firms concerned about the litigious nature of the US marketplace. If anyone is interested in exploring these topics further, please contact me at jameskolka@gmail.com or  jim@jameskolka.com. 

Market Surveillance #3 – To Be Or Not To Be – When, Is The Question

 

Continuation

I decided to add a third installment to my blog on Market Surveillance and the revised Machinery Directive 2006/42/EC. As noted several times the impetus for these comments has been driven by serving as legal expert in a lawsuit involving a CE Marked machine that has killed one worker and injured another worker who will need 24 hour care for the rest of his life. These accidents involved the same machine model in two separate incidents in two different countries.

While the Technical File was a junk file that did not comply with the requirements of the Machinery Directive, the contents of the file and the pathetic state of compliance was unknown until the first accident occurred and the file was turned over to the Health and Safety Executive (HSE) in the UK. In reality, the pathetic state of compliance is still unknown because, as noted in the previous blog, HSE investigates workplace accidents and BIS (Department for Business Innovation and Skills) the Competent UK Authority that oversees CE Marking for the Machinery Directive has not received the HSE investigation report. Meanwhile, the non-compliant machines are still on the market.

CE Marking Litigation And Its Future

I only reiterate these facts because in the past two weeks, I have received calls from two new clients involved in lawsuits in the US concerning CE Marking for the Machinery Directive. I anticipate more in the future. There are several reasons for this increased litigation activity, among them:

• CE Marking safety requirements and standards for machines have grown in number and sophistication since the Machinery Directive was first published on 14 June 1989.

• Following the Vienna and Dresden agreements between the EU Standards Bodies (CEN and CENELEC) with ISO and IEC respectively (to avoid duplicating standards writing efforts) these new international standards writing activities automatically include the participation of ANSI (American National Standards Institute) in drafting ISO & IEC standards resulting in EN ISO and EN IEC standards that are also American National Standards, recognized by US Courts of Law. In sum, EN standards are rapidly becoming American standards.

• US Federal Courts offer a litigation venue for product liability, Breach of Warranty and Breach of Contract lawsuits concerning CE Marking between US Citizens and US machinery manufacturers, US Citizens and EU machinery manufacturers and EU Citizens and US machinery manufacturers.

• The oft cited 2002 Minnesota case where a California Packaging Machinery Manufacturer sold a less safe machine in the US injuring a worker who will require 24 hour care for the rest of his life (it didn’t have a laser light curtain to turn off the machine when a worker entered the area of machinery activity), but sold safer CE Marked machines with laser light curtains in the EU for 6 years because of the Machinery Directive safety requirements, resulted in a $35 million punitive damages award (the manufacturer knew how to make a safer machine and chose not to do so). This means that US manufacturers who follow the same path of selling less safe machines in the US and safer machines in the EU and EU manufacturers who sell non CE Marked less safe machines in the US can expect a similar result in US Courts. It is a whole new area of litigation for American trial attorneys.

• Just as trial attorneys can ask for ISO 9001 records and documents that are relevant to a product liability lawsuit in the US and EU, they can now ask for Machinery Directive Technical File records and documents in discovery in Product Liability, Breach of Warranty and Breach of Contract lawsuits. The fact that these records and documents may belong to a European manufacturer is irrelevant. Whether the EU manufacturer is suing or being sued the cause of action arises from doing business in the US, making the litigants subject to US Courts and US rules of civil procedure.

These are a few of the legal nuances for US Courts of Law brought about by the evolution of the Machinery Directive and its supporting standards writing activities.

The Response of EU Competent Authorities 

In future blogs I will spend more time examining the substance of Decision No 768/2008/EC of the European Parliament and the Council of 9 July 2008 On a Common Framework For the Marketing Of Products and Repealing Council Decision 93/465/EEC. In the preceding two blogs (July 30 & August 15) and this blog, however, I have concentrated on administrative issues not touched on in Decision No 768/2008/EC that I believe are critical to the success of effective Market Surveillance as it relates to the Machinery Directive.

In the section titled “A View Thoughts” in the preceding August 15 blog, my Fifth recommendation was, “once a complaint or accident involving a CE Marked machine is recorded by a Competent Authority, a checklist protocol should be developed utilizing Annex VII of Machinery Directive 2006/42/EC to determine if all the elements of a Technical File contained in A. Points 1,2 & 3 are compliant. Listed below are those points

1. The technical files shall comprise the following:

  (a) a  construction file including:

-- a general description of the machinery,

-- the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery,

-- full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements,

-- the documentation on risk assessment demonstrating the procedure followed, including:

  (i) a list of the essential health and safety requirements which apply to the machinery,

  (ii) the description of the protective measures implemented to eliminate identified hazards or to reduce risks, when appropriate, the indication of the residual risks associated with machinery,

-- the standards and other technical specifications used, including the essential health and safety requirements covered by these standards,

-- any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorized representative,

-- a copy of the instructions for the machinery,

-- where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery,

-- a copy of the EC declaration of conformity.

 (b) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.

The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file.

2. The Technical file referred to in point 1 must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of machinery or, in the case of series manufacture, for the last unit produced. (Emphasis added)

The technical file does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity. (I suggested 48 hours, similar to the Medical Devices Directives)

The Technical file does not have to include detailed plans or any other specific information as regards the subassemblies used for the manufacture of the machinery unless a knowledge of them is a central for verification of conformity with the essential health and safety requirements.

3. Failure to present the technical file in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements. (Emphasis added)

Conclusion

As noted in the two previous blogs, I think these types of steps are essential for effective Market Surveillance for the revised Machinery Directive 2004/42/EC. I also noted previously that I would like to work with European manufacturers and companies on steps to reduce their liability exposure in the US market. It seems to fit the European philosophical approach to product safety and would help EU firms concerned about the litigious nature about the US marketplace. If anyone is interested in exploring these topics further, please contact me at jameskolka@gmail.com or jim@jameskolka.com. 

Market Surveillance #2 – To Be Or Not To Be – When, Is The Question

The Quandary

The preceding blog described some of the issues and concerns I have encountered working with companies CE Marking their products for the EU. Recently, however, my concern has been heightened by issues raised in an ongoing lawsuit in the US & EU regarding a machinery manufacturer whose machines have caused the death of one worker and a severe injury to another worker who will require 24 hour care for the rest of his life. 

While Decision No 768/2008/EC of the European Parliament and the Council of 9 July 2008 On a Common Framework For the Marketing Of Products and Repealing Council Decision 93/465/EEC presumably went into effect on 1 January 2010, the implementation details are evolving rather slowly.

The lawsuit underscores some of problems. In the UK, an industrial workplace accident is investigated by HSE (Health and Safety Executive). The fact that a machine is CE marked is of no immediate concern to HSE, their focus, as it should be, is on the accident. When they conclude their investigation, they will pass on their findings to BIS (Department for Business Innovation & Skills) the CE Marking Conformity Assessment Body in the UK. It is a nice linear progression, but it delays immediate action concerning the CE Mark of the machinery manufacturer and disadvantages the family of the worker who was killed in the accident and leaves similar machines in place throughout the EU to potentially cause more workplace injuries.

As noted in previous blogs, in my opinion the machine in question did not begin to satisfy CE Marking requirements of the Machinery Directive 93/37/EC at the time the machine in question was manufactured:

A Comparison – The Manufacturer vs. Annex V, paragraph 3

The requirements for the technical file can be found in Annex V, paragraph 3 of the Machinery Directive where it is identified as a, “technical construction file”:

“(a.) a technical construction file comprising:

-- an overall drawing of the machinery together with drawings of the control circuits,

-- full detailed drawings, accompanied by any calculation notes, test results, etc., required to check the conformity of the machinery with the essential health and safety requirements

-- a list of:

   -- the essential requirements of this Directive (a sample checklist and sample

      identification of relevant EN harmonized technical standards is attached) 

   -- standards, and

-- a description of methods adopted to eliminate hazards presented by the machinery,

-- if he so desires, any technical report or certificate obtained from a competent body or laboratory,

-- if he declares conformity with a harmonized standard which provides therefore, any technical report giving the results of tests carried out in his choice either by himself or by a competent body or laboratory

-- a copy of the instructions for the machinery;

(b.) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.

The manufacturer must carry out necessary research or tests on components, fittings or the completed machine to determine whether by its design or construction, the machine is capable of being erected and put into service safely.

Failure to present the documentation in response to a duly substantiated request by the competent national authorities may constitute sufficient grounds for doubting the presumption of conformity with the requirements of the directive."

While the language is quaint, it sets forth the substance of a technical file. The reference above in (b.) to series manufacture refers to the quality system.

As noted in previous blogs, in my opinion the machine in question did not begin to satisfy CE Marking requirements of the Machinery Directive:

• There was no coherent Technical File

• No Part A providing an index containing all of the elements in the file

• No Annex I Essential Health and Safety Requirements Checklist identifying which essential health and safety requirements the manufacturer applied to their Product Family Machines

• No complete listing of EN harmonized standards selected to demonstrate conformity to the relevant Essential and Safety Requirements of the Directive

• No listing of EMC standards

• No ISO 14121-1:1999 Risk Assessment, FMEA, FTA

• No identification of the manufacturer’s certification to ISO 9001: 2000

• No complete EC Declaration of Conformity

• No identification of an Authorized Representative on the Declaration of Conformity

From my perspective, the machinery manufacturer clearly failed to satisfy the safety requirements of the Machinery Directive. There is Prima Facie evidence that the machine is not compliant with the Machinery Directive. I believe that the manufacturer should have had his machines impounded until he could present documentation demonstrating compliance.

Annex V, paragraph 3 (b), final paragraph:

Failure to present the documentation in response to a duly substantiated request by the competent national authorities may constitute sufficient grounds for doubting the presumption of conformity with the requirements of the directive."

There is no reason that parallel investigations cannot proceed, each triggered by a machine that caused a fatal accident. I just received an e-mail from an engineer, “I am working on a project in Ireland and curious to know what penalty a manufacturer would face if they knowingly provided an EC Declaration of Conformity under the Machinery Directive for a machine that did not comply with the Essential Safety Requirements.” I suggested that he contact the Competent Authority in Ireland and the country where the machine was manufactured. I wish I had confidence that he would be listened to carefully and could expect action if he is correct in his assertion

Presently, I don’t know what will happen. While it may not be intended, the HSE handoff to BIS suggests a certain bureaucratic logical cleanliness in response. I don’t blame HSE because they are doing what OSHA (Occupational Safety and Health Administration) would do in the United States in the case of an accident. In the US, however, there is no BIS Competent Authority overseeing machinery safety. Perhaps a complaint could be lodged with the US Consumer Products Safety Commission and action might be taken. Unfortunately, the aversion of some Americans to any kind of regulation coupled with corporate distaste for all regulation make it difficult to create a regulatory response in the US akin to FDA oversight for drugs and medical devices.

The most effective response in the US comes through the court system via product liability, breach of warranty, breach of contract and other lawsuits challenging manufacturers in a court of law. At present, there is no equivalent legal response in the EU, so the oversight of Competent Authorities in the EU Member States is critical to the successful implementation of the Machinery Directive and related Directives. The issue then is how to go about this task to improve compliance.

A Few Thoughts

In my first “Market Surveillance” blog posted on 30 July 2011, I mentioned several issues and possible responses concerning self-certified machines:

• First, I believe it is critical that Part A of a Technical File should be a requirement of all machinery manufacturers (past and present) and it should be filed with a reliable entity, in my opinion a Competent Body, and it should be entered electronically in a shared European Commission Competent Body Database.

• Second, I also believe that an Annex I Essential Health and Safety Requirements Checklist identifying which essential requirements apply to the machine in question and which EN harmonized standards will be used to demonstrate conformity, linked to Part A of the Technical File should be filed with the same Competent Body entered into the same shared European Commission Competent Body Database.

• Third, as noted in my prior blog, I don’t think either Authorized Representatives or Notified Bodies should assume this task. In my personal experience, I have found both to be widely variable in behavior and capability and too anxious to make money in most everything they do.

• Fourth, a protocol should be developed to trigger a response to complaints about CE Marked products and potential investigation of reports of accidents involving CE Marked products, independent of workplace accident investigations conducted by agencies such as HSE. The two responses should be separate from one another. While accidents must be investigated, non-compliant CE Marked machines should be impounded or removed so that additional accidents don’t occur.

• Fifth, once a complaint or accident involving a CE Marked machine is recorded by a Competent Authority, a checklist protocol should be developed utilizing Annex VII of Directive 2006/42/EC to determine if all of the elements of a Technical File contained in A. Points 1, 2 & 3 are compliant. The same could be done for "B. Relevant technical documentation for partly completed machinery." Machinery manufacturers should be asked to provide this information within 48 hours of a request, similar to medical device manufacturers for the Medical Devices Directives.

• Sixth, all manufacturers of machines should be instructed to create the required documentation to comply with the Machinery Directive and Related Directives within a set time period and to make certain that all new machines and modified machines are compliant with the most recent revision of EN standards. (Last year I found three suppliers of Declarations of Incorporation had not updated their products to meet new standards.)

Conclusion

Presently there are tens of thousands of CE Marked machines in the EU market with Technical Files that range from full compliance to incomplete compliance to junk compliance to drivel. Finding out that compliance is a farce and records are a mess, as we discovered in the lawsuit, is unacceptable. I fully support self-certification, but I think it needs to have effective enforcement. As noted in my last blog, I would be happy to work with interested parties, including EU authorities, to improve the quality of EU oversight. I have developed some templates for Checklists and Part A of the Technical File which could be adapted to provide a measure of uniformity to the process that would make it easier for machinery manufacturers to understand compliance and Competent Authorities to determine compliance. 

As noted previously, I would like to work with European manufacturers and companies on steps that can be taken to reduce their liability exposure in the US market. It seems to fit the European philosophical approach to product safety and would help EU firms concerned about the litigious nature of the US marketplace. 

Also, as noted previously I enjoyed working with several colleagues on an Enterprise Risk Management Program for a US medical device manufacturer that had been acquired by a European parent corporation. It was an excellent approach to future planning that I greatly enjoyed. Which is to say, that I think my philosophical sensibilities and interests in risk management are European. If anyone is interested in exploring this topic further, please contact me at jameskolka@gmail.com or jim@jameskolka.com. 

Market Surveillance #1 – To Be Or Not To Be – When, Is The Question

Introduction

This is the first of two blogs about market surveillance in the EU. The first blog addresses some concerns evolving from my experience with self-certification with new approach Directives and possible ways to address those concerns. The second blog will address my experience with Member State response to accidents and fatalities in light of Decision No 768/2008.

I suppose it seems odd that an American is concerned about the issue of EU market surveillance, however, I have seen continued abuses and it irritates me. Those of you who have been reading my recent blogs are aware that I am serving as a legal expert in a lawsuit involving a non-compliant CE marked machine that has killed one person in the UK and so badly injured another that he will require 24 care for the rest of his life. What was put forth as a Technical File by the manufacturer could best be called a “junk file.” The manufacturers’ compliance with EN safety standards was a farce! Further, there was no Annex I Health and Safety Requirements Checklist indicating which Essential Requirements the manufacturer thought applied to all of the machines listed in their “Product Family Technical File.” And of course there was no meaningful Risk Assessment following EN ISO 14121-1: 2007.

One of the most troubling aspects of the case is the fact that the “junk file” and lack of serious compliance could only be discovered after the accident. It is a particular concern with new approach Directives when “self-certification” is an option. The new approach Directives and EN harmonized safety standards are a significant contribution to global product improvement and product safety. Unfortunately, all the potential gains are washed away if regulatory oversight is ineffective.

As a consultant, it is difficult to work with manufacturers who want to do as little as possible and whom I avoid as clients. I want my clients to fully comply with the requirements of the new approach safety Directives. Conversely, as an attorney it presents an opportunity to serve as a legal expert in product liability lawsuits against manufacturers who didn’t attempt to comply and whose machines have caused injury to persons and property. It is a perverse consultant/attorney dichotomy driven by a desire to improve product safety.

Decision No 768/2008/EC of the European Parliament and the Council of 9 July 2008 On a Common Framework For the Marketing Of Products and Repealing Council Decision 93/465/EEC

I wrote about this decision in a blog posted 30 October 2009. At the time it was exciting because it promised to address some of the issues concerning new approach directives and in particular improve market surveillance starting 1 January 2010. The machinery manufacturer lawsuit discussed in my recent blogs, however, brought home the problems inherent in self-certification where little regulatory discipline is exercised by Member State Competent Authorities over machines placed on the market in their countries. 

Unless an effort is made to require that Part A (the index) of a Technical File and an Annex I Checklist exist and are filed electronically with a member State Competent Authority, manufacturers will be able to play “fast and loose” with Directive requirements. While Part A of a Technical File and an Annex I Checklist don’t eliminate evasion and fraud, they do commit manufacturers to state which Essential Health and Safety Requirements apply to their products and which EN harmonized standards will be used to demonstrate conformity with those requirements.

Authorized Representatives

Hypothetically, Authorized Representatives also could hold Part A of a Technical File and an Annex I Checklist, but I have found Authorized Representatives to be a mixed bag. They range from manufacturers’ EU subsidiaries, to distributors, to an attorney’s post office box to professional Authorized Representatives, who range from modest to exorbitant in their fees.

In one instance I worked with a client who had been notified by their Authorized Representative that they would be reported to the Dutch Competent Authority if they didn’t produce their CE marking documents within eight days. Naturally, the company was panicked. Fortunately, they made a Class I non-sterile non-measuring medical device which meant that they could self-certify. Consequently, we were able to respond and the company was able to e-mail their documentation to the Authorized Representative and disaster was averted. 

I found it interesting that the Authorized Representative offered a “Dutch company” who could help my client meet these requirements. No doubt, it would have been expensive. It also raised the question of possible conflict of interest/collusion between the Authorized Representative and the “Dutch company.” Needless to say, I have become cynical about the business ethics of some of the professional Authorized Representatives.

Notified Bodies

EU Notified Bodies also could serve as Authorized Representatives, however, my concerns about their non-monetary ethical integrity is even greater than EU professional Authorized Representatives. I have worked with and have great respect for several Notified Bodies. Unfortunately, many others have not performed professionally. My concerns range from encountering outright malpractice to lax oversight to monetary ambitions that appear to dominate their behavior and quality of work. A few examples should suffice.

(1.) A few years ago I worked with a company that had requested a visit from a Dutch notified body to examine their Machinery Directive CE Marking Technical Files to see if they satisfied EU requirements to place two machines on the EU market. Representatives of the notified body flew to Atlanta from Amsterdam and spent time with the company going over their files. At the conclusion of their visit, they issued two EC Type Examination Certificates for two different machines and made extensive comments on the remaining machines not being ready for CE marking. The EC Type Examination Certificates were inappropriate because they could only be used for dangerous machines listed in Annex IV. Neither of these machines were listed in Annex IV.

My client assumed that the certificates that could be used in a court of law in the future. The notified body knew that the company was ignorant about the legal nature of their notification and the fact that they were acting as a consulting body and had no notified body status in this case. I first raised the question with the Department of Trade and Industry and the UK and they offered to contact the Dutch Competent Authority. After three months of no response, they suggested that I should try which I did for another three months, including e-mailing the head of the Competent Authority, again no response.

Finally I wrote to Commissioner Liikanen of the European Commission whose Directorate had oversight of the Machinery Directive as well as other Directives and received an e-mail letter three weeks later stating that I was correct in my concern, copying the Dutch Competent Authority and Dutch Notified Body of that fact.

(2.) In my last blog I described a weak surveillance audit by a German notified body of a California manufacturer of Class III medical devices. The company was concerned about how it might fare in a FDA plant inspection. They requested that I write an Executive Summary of the surveillance audit. Although the notified body audit made good observations, they did not issue any major or minor nonconformities calling for improvement. As a consequence, the surveillance audit was not helpful. I told the company that if they did not make significant improvements, they would fail an FDA plant inspection. I spelled out the weaknesses in the surveillance audit and what needed to be done to address those weaknesses.

I was aware from a colleague that the same notified body conducted a weak audit of another Class III Medical Device manufacturer in California. My colleague also was asked to address the quality of the manufacturer’s most recent surveillance audit. He said it was weak and inadequate. The Medical Device manufacturer then shared my colleague’s assessment with their notified body. The notified body in turn called the UK managers of our Training and Consulting firm and complained about his assessment. He stood by his assessment.

Shortly after my colleague’s visit, the company was cited for patient deaths from their devices. A few months later the Wall Street Journal announced that another medical device company dropped its acquisition offer for this company by $500,000 dollars. I don’t think the notified body ever realized how close they came to a lawsuit, if the acquisition had been aborted.

Summary

Previously, I have mentioned that I would be happy to work with interested parties to improve the quality of EU regulatory oversight. It doesn’t need a sledgehammer, but it does need strengthening to be effective. We have no such regulatory oversight in the US. Perhaps the best protection for the US market is product liability litigation. Recently, a congressman from New York suggested that the US Consumer Product Safety Commission should diminish its regulatory involvement with toy safety. (Swell bring back the lead paint and melamine!)

I also would like to work with European manufacturers and companies on steps that can be taken to reduce their liability exposure in the US market. It seems to fit the European philosophical approach to product safety and would help EU firms concerned about the litigious nature of the US marketplace.

In an earlier blog I describe working with several colleagues on an Enterprise Risk Management Program for a US medical device manufacturer that had been acquired by a European parent corporation. It was an excellent approach to future planning that I greatly enjoyed. Which is to say, that I think my philosophical sensibilities and interests in risk management are European. If anyone is interested in exploring this topic further, please contact me at jameskolka@gmail.com or jim@jameskolka.com. 

My Experience With Differences in FDA & EU Medical Device Regulatory Oversight – Not Equal Yet

Introduction

A few years ago I worked with a California Medical Device Company that made FDA and EU Class III medical devices. The company contacted their insurance company asking for help for their employees to better understand the similarities and differences between the two regulatory approaches. I conducted a GAP analysis that was used in training workshops at their two locations over two days in the Los Angeles Area. 

The company had encountered some difficulties in device labeling and wanted a complete review of their quality management system. They had recently been visited by their notified body and asked if I would read the notified body’s most recent surveillance audit and critique the findings. Among the questions they wanted addressed was whether they were ready for an FDA plant inspection. Consequently, the notified body surveillance audit provided a good recent snapshot of how well they were doing.

Notified Body Surveillance Audit

After reading the audit, I found it to be disconcerting both ethically and legally. The comments made were excellent, but they were not identified as major or minor nonconformities or even observations. Consequently, they may have been well-written but they carried no weight. My ethical concern was that if the comments had been given greater weight, it would have been helpful to the manufacturer in making needed changes to their quality management system. My legal concern was that a third-party conducting a surveillance audit of a Medical Devices Directive Class III Medical Device should be of equal rigor to an FDA plant inspection. It was not.

The FDA would not have issued its finding in such a low-key manner. Most likely, FDA would have issued a number of findings on a 483. In my opinion, both FDA and notified body audits ought to have the same level of rigor so that medical device manufacturers can feel that they are receiving the same level and quality of scrutiny whether it be from FDA or an EU sanctioned notified body. Consequently, when a medical device manufacturer completes a notified body audit, they ought to feel that they are fully prepared to sustain an FDA inspection. 

The question being asked by the manufacturer was, “were they in good enough shape to sustain an FDA inspection?” The answer was no. I suggested that they examine FDA’s Guide to Inspections and Quality Systems contained in Quality System Inspection Technique (QSIT) so they can see the questions FDA would ask during an inspection. At present, the manufacturer faced the distinct possibility that FDA might shut them down.

Observations

The full list is too extensive for a blog. Following are a few of the notified body observations contained in the notified body surveillance audit broken into two categories; (1) EU Medical Devices Directive, and (2) ISO 13485 

Medical Devices Directive

• There needs to be a quality system procedure on how to write a Declaration of Conformity and each Declaration of Conformity should specify the specific models (the product family) for which the declaration is applicable. The same can be found in the GAP analysis. 

• There needs to be a defined and documented quality system procedure to support the translation of device instructions and labeling into Member state user languages. The same observation can be found in the GAP analysis.

• Risk analysis reports should be controlled documents with a record number, revision status, dated and signed.

• The observation that risks should be reassessed whenever product or manufacturing changes are made and information from the post-marketing surveillance system is received identifying problems about new risks is sound and should be implemented. This should be implemented at all three levels – design, production and post-production.

• The observation that the company’s procedure for CE marking and labeling should be included in Part A of the Technical File, but was not found in the technical file is valid. My biggest concern here is what I was able to see as a Technical File did not in my opinion constitute a Technical File.

• The requirement that a quality system procedures specify that Part A of the Technical File be sent to your EU authorized Representative is valid.

 Quality System

• The request the quality objectives be defined and reviewed annually is a good suggestion. More clearly defined objectives and metrics to better measure performance and ensure continued effectiveness and suitability of the quality system would be particularly appropriate at this time. 

• The observation that the contents of the most recent Management Review Meeting minutes did not fully represent agenda items listed within the company’s Management Review Procedure is significant. While FDA will not look at the minutes of the meetings, they will look at the procedure to determine if you are doing what you say you are going to do. If FDA discovers that procedures are not being followed, it would be taken seriously. 

• The observation that Device Master Records are not being clearly defined documented and linked to the requirements of the Quality Manual would be taken seriously by FDA. Device Master Records should exist for all products, both CE marked and non CE marked

• The requirement for a mandatory independent evaluation of the design and development of a product is new from a notified body (at that time), but parallel to the requirement by FDA to have independent input in the design review process. It is a good recommendation.

• Clarification of the design change process (major vs. minor) should be made clear in the design control procedures and specifically in the design change procedure.

• The observation that the company should maintain relevant procedures, available at entry, for gowning and egress from a controlled environment is a valid requirement that would be a significant concern for FDA. This should have been written as a minor conformity that would’ve required a quick response.

• The observation that the controlled environment Worker Training Manual should become a control document also should have been written as a minor nonconformity. It would have required a very simple response, but assured that the matter had been attended to quickly. This would be a concern for FDA.

• The request that advisory notices and product recalls be further defined is excellent. A procedure on advisory notices and recalls should specify the methods of communication to be used and the system for determining the disposition or return product. This too would be a concern for FDA.

• The observation that compliance with high-level requirements should be checked during internal quality audits is sound. The requests that the Auditor Training Module be comprehensive and support the qualification of auditors is good suggestion. I recommend that training be expanded to include FDA’s Quality System Regulation in addition to the EU requirements. The internal quality audit should be looking at both EU and FDA requirements during the same audits.

• Finally, the observation that training records are not current and do not reflect the revision status upon which the training is based is legitimate. In general, training should be reviewed to make certain that people have been trained, the training outcome has been effectively measured and the information is current in each employees training record. It is an area that FDA will look at closely.

Summary 

It would be helpful for people to review this Executive Overview, the GAP analysis and relevant FDA documents affecting their area of operation and responsibility at the company. Becoming familiarized with the FDA’s Quality System Regulation and FDA’s expectations represented in QSIT will provide major insight on what to anticipate during an FDA inspection. Concurrently, QSIT will provide clues on what FDA expects in quality systems of companies that manufacture medical devices.

One of the first questions I was asked is what is an SOP? In short it stands for Standard Operating Procedure. Further, FDA expects that every company has a Standard Operating Procedure to write SOPs. The question, however, tells you that you have a way to go with your employees before you are able to survive an FDA inspection.

Conclusion

Eight months later I received a call from the company telling me that they had just finished a full plant inspection by FDA and didn’t receive a single write up on a 483. Unfortunately, the notified body did not provide the quality of assistance that would have been helpful had they elevated their observations to minor nonconformities requiring a prompt response.

This is not the only time that I have observed notified bodies operating at a more lenient and less helpful level than FDA. They are not equal yet. If you have questions about EU and FDA medical device regulations, product liability lawsuits and preventive steps such as product safety/product liability audits to reduce product liability exposure, you can contact me at my e-mail address jameskolka@gmail.com.  

 

 

Until Medical Device Manufacturers Conduct Product Safety & Product Liability Audits, Risk Management Does Not Exist!

Background

Several times since I began this blog in February 2009, I have mentioned a private “in-depth” litigation study conducted by a medical device insurance company of its litigation history. Since virtually all of their lawsuits have been settled out of court, there is no public record of mistakes to guide other medical device manufacturers, thereby allowing them to repeat the same mistakes over and over.

Quality Management Systems such as FDA’s Quality System Regulation (QSR), the EU’s Medical Devices Directives combined with ISO 13485:2003 Medical Devices – Quality will management systems – Requirements for regulatory purposes and Canada’s application of ISO 13485:20032 medical devices must be understood from a legal perspective.  They contain Quality Manuals and Quality Procedures developed by each company to comply with governmental regulatory requirements to manufacture a medical device. The system must be documented and must identify the processes that will be used to manufacture medical devices.

Quality system documents and records contain a wealth of information that can be obtained during discovery to determine if a company is satisfying governmental regulatory requirements and if a company is satisfying its own quality management procedures. Failure to follow regulatory requirements and/or follow the company’s quality management system requirements can be used against a company in litigation. Depending upon the seriousness of the regulatory failure, it could provide vital information to plaintiffs’ attorneys. 

Quality Manuals and Quality System Documents are intended to guide the operation of a company’s Quality Management System. Quality system documents are neither intended nor constructed to provide evidence of a company’s concern for patient safety and product safety. If a company wants to prove that it cares about patient safety and make safe products, it will have to build documentation to prove that point. 

Litigation

The three major areas of product liability litigation – Design, Manufacturing, and Post Sale Surveillance are specifically addressed by clauses in each regulatory Quality Management System. For example, to design a medical device using FDA’s Quality System Regulation (QSR), a company that wants to manufacture a Class III, Class II and certain Class I medical devices must follow 21 CFR 820.30 Design Controls. This means that there should be documents and records describing the stages of design development: 820.30 (b) Design and development planning, (c) Design input, (d) Design output, (e) Design review, (f) Design verification, (g) Design validation, (h) Design transfer, (i) Design changes, (j) Design history file. This means that records should exist documenting each of those stages, including risk analyses where and as needed. If records don’t exist, the device was not designed in accordance with FDA regulations 

All of this design information is available to plaintiffs’ attorneys in product liability lawsuits. Manufacturing a medical device follows its own set of QSR regulatory clauses. To be effective and not be blindsided by plaintiff’s allegations citing quality system breakdowns, corporate counsel and defense attorneys must understand regulatory Quality Management Systems in depth.

Quality Management Systems are audited internally following an audit protocol that visits each department at least once annually, more often if problems are found. Problems identified as nonconformities must be addressed by Corrective and Preventive Action CAPA). Departments are asked to make corrections following a timeline.  Internal audits, nonconformities and corrective actions are reviewed at least once annually (generally more often) by top management.  Management review minutes are kept. Internal audit records, nonconformities, corrective and preventive actions and management review minutes constitute a rich source of information for plaintiffs’ motions to compel. Consequently, corporate counsel and defense attorneys must understand what type of information and records are generated and be prepared to address these issues with their manufacturers.

What does this mean for product liability litigation?

The medical device insurance companies litigation study revealed several concerns regarding weaknesses of medical device manufacturers in product liability lawsuits. Remember the old saying, the question isn’t “if you are sued, will you be prepared” rather “when you are sued, will you be prepared!” A few of the findings are listed below:

• Several medical device manufacturers constructed Quality Management Systems to satisfy FDA and EU medical device regulatory requirements, but contained no documented methods, processes or procedures for communicating product safety concerns and/or incorporating those concerns into their business processes, thereby demonstrating no commitment to product safety.

• The study found a lack of internal processes and procedures in companies Quality Management Systems for escalating product safety concerns and a review of those concerns as well as a lack of any kind of cross functional committee to deal with product safety issues. Plaintiffs’ attorneys alleged that this demonstrated a lack of due care and concern for product and patient safety.

• The study found several instances of biotech firms failing to protect their documentation by asserting that attorney-client privilege prevented plaintiffs’ from examining their documentation during discovery, which assertion was not accepted by the court.

• The study found misconceptions by management of medical device manufacturers that compliance with FDA’s Quality System Regulation was enough to prevent product liability claims.

• The study found that management frequently continued to underestimate the risk of product liability litigation to the success and/or survival of their business.

• The study found that design research documents and agreements often contain hidden product liability exposures – the agreements were not reviewed by legal counsel familiar with clinical research or by insurers or brokers reviewing coverage limits and indemnification clauses.

• The study found a lack of qualified in-house personnel available to integrate product liability avoidance principles into the firm’s quality management system and establish an infrastructure for product safety, resulting in product liability post-production legal defense problems.

• The study found that company postproduction corrective and preventive actions were deemed to be inadequate for the degree of risk presented by individual complaint investigations resulting in both FDA regulatory actions and product liability lawsuits. 

Summary

These are but a few of the problems uncovered by the litigation study. The actual list is quite long and quite disturbing. The lack of training for product liability exposure is extraordinary. Virtually no firms conduct product liability audits or product safety audits of their operations. The assumption appears to be that compliance with FDA and EU regulations is sufficient. From my experience, quality managers do not see legal issues as their responsibility and therefore will pass them off to regulatory managers, corporate counsel and management. In turn regulatory managers do not focus on product liability exposure.

The focus on product safety and patient safety is inadequate and will continue to cause trouble. The maintenance of records often is poor. The wording of documents pays no attention to the legal consequences of what is said. Consequently, it appears that product liability lawsuits will continue to plague medical device manufacturers. There are steps that can be taken training personnel to conduct product liability audits, product safety audits and learn how to write documents so that the words don’t become minefields for litigation.

My wife has often told me that people don’t like to read they prefer getting their information in little word bites and sound bites. I generally respond that attorneys have always liked to read and will analyze what is said how it is said and use it in a court of law. If you have questions about product liability lawsuits and preventive steps such as product safety/product liability audits to reduce product liability exposure, you can contact me at my e-mail address jameskolka@gmail.com.

 

FDA Levies $ Billion Dollar Fines For Off Label Marketing Of Drugs

Background

A week ago yesterday, the Wall Street Journal reported that FDA is seeking $1 billion dollars from Johnson & Johnson to resolve a long running probe into the company’s marketing of an antipsychotic drug Risperal. The settlement of $1 billion would be among the largest in a string of settlements related to off-label marketing of drugs in recent years.  Since 2004 the federal government has been investigating whether J&J’s Janssen pharmaceutical unit improperly promoted Risperal for unapproved uses. The company said it set aside an unspecified amount of money for a potential settlement and it would likely face civil and criminal litigation if it didn’t settle.

Officials at J&J said they were surprised at the size of the sum that prosecutors are seeking. Prosecutors have been citing a benchmark $1.4 billion dollar settlement that Eli Lilly & Co. reached in 2009 to resolve a probe into alleged improper marketing of its antipsychotic drug Zyprexa. Lilly’s alleged off label marketing took place over a longer period of time. Under federal law, companies cannot market medicines for uses other than those approved by the Food and Drug Administration, although doctors can prescribe drugs for unapproved uses.

Prosecutors argue that Medicaid and other government programs are wasting tens of millions of dollars paying for medicines that drug makers encourage physicians to prescribe for uses that FDA hasn’t determined are safe and effective.  In 2009, Pfizer Inc. paid the pharmaceutical industry’s biggest settlement agreeing to pay $2.3 billion dollars to resolve an investigation into the marketing of the painkiller Bextra, which now has been withdrawn.

Since 2001, drug makers have paid more than $11 billion dollars in off-label marketing and other whistleblower fraud cases. The J&J case, like many others started as a whistleblower case. Company insiders (whistleblowers) can receive a portion of the settlement, if the government recovers money. Industry officials are upset about the millions of dollars that whistleblowers can earn from a successful case and argue that these people are often disgruntled employees whose allegations are taken out of context.

A guilty verdict could mean that medicines, e.g. drugs could no longer receive reimbursement from Medicaid and other government programs. Further, an unsuccessful court challenge by drug companies could result in expensive litigation brought by patients and might provoke some states, that don’t participate in the settlement, to seek reimbursement. While the allegations that prosecutors in Philadelphia and Washington DC are pursuing in the J&J case haven’t been disclosed, the FDA has approved Risperdal for treatment of schizophrenia and bipolar disorder. The agency, however, has warned that the drug should not be given to dementia related psychosis including elderly patients.

Off-Label Marketing of Drugs and Medical Devices

Off-label marketing has been an ongoing concern for FDA. The amount of money that drug and device companies can make from off-label marketing can run in the billions of dollars. It also can result in serious to fatal consequences for patients. Since Medicaid pays substantial amounts of money for these off-label abuses, the Federal Government has a dual interest in this problem, as a consumer and prosecutor. 

As a consequence, FDA and federal prosecutors are seeking to levy settlements to discourage companies from directly and indirectly encouraging off-label uses. FDA also has decided to take aim at corporate executives to rein in Pharma abuses. FDA warned in November 2010 and that it was resurrecting a 1970s legal doctrine to bring criminal charges against top executives.

The goal, said Eric Blumberg, FDA deputy chief counsel for litigation, was to ”change the corporate culture” at firms that have shrugged off $1 billion dollar penalties. “It is clear that fines are not working here”, Blumberg told a food and drug Law Institute meeting in Philadelphia. “We need to put something else on a scale to make people think twice, three times.” Blumberg was talking about illegal drug marketing.

FDA’s weapon of choice is the Park Doctrine, based on a 1975 case against Acme Markets president John Park. FDA charged Park personally with sanitation violations following multiple warning notices. The US Supreme Court agreed that Park as company president was ultimately responsible for ensuring compliance.

In 2007, three executives of Purdue Frederick Co. pled guilty to charges of misbranding OxyContin. The three paid $634.5 million to the Virginia Medicaid Fraud Unit and were barred from federal health care programs for 12 years.   

In 2010, four executives of Synthes pled guilty for off-label promotion of a bone cement. The four face fines of up to $10,000 each and a year in federal prison.

Other recent targets include former GlaxcoSmithKline vice president Lauren Stevens, indicted for making false statements and obstructing an FDA investigation into illegal marketing of Wellbutrin SR (buproprian sustained release) and former KV Pharmaceutical CEO and Chairman of the Board Marc Hamertin barred from participating in federal healthcare programs for 20 years.

Protecting the Nations Health

It is a remarkable when there is a push in Congress to ease up on regulations in the healthcare industry with the logic that it stifles innovation and slows delivery of new medicines to the market. It is understandable that the delivery of new medicines should be expedited as soon as possible, but not at the expense of patient safety and product safety.

It is difficult not to be cynical when there is a push in congress to ease up on regulating healthcare abuses. It is reminiscent of the words of Gordon Gekko, the main antagonist in Oliver Stone’s 1986 film Wall Street, when he said, “Greed, for lack of a better word, is good!” Apparently, that sentiment is alive and well in portions of America’s Healthcare Industry.

We read of medical mistakes in hospitals and hasty decisions by doctors that cause 100,000+ deaths each year. Compounding these problems with corporate greed is sad and troubling for the nation’s healthcare system. Unfortunately, it is nothing new. Prosecuting these abuses with adequate civil and criminal penalties appears to be the only way to dampen the onslaught.

Reducing regulations, while wildly popular among a few who dislike government oversight, enriches the few and hurts the many. If you have questions about healthcare abuses, product liability lawsuits and preventive steps such as product safety/product liability audits to reduce product liability exposure, you can contact me at my e-mail address jameskolka@gmail.com.

FDA Compliance & Product Liability Exposure

Introduction

In several blogs I have discussed a private study conducted by a medical device insurance company examining their litigation history, successes and failures. I want to revisit some of the findings as they relate to life science firms (medical devices, biotech, pharmaceuticals). In particular, I want to examine the issue of Quality Management Systems – (FDA’s Quality System Regulation, ISO 13485, ISO 9001) regulatory compliance and product liability exposure.

As often happens in a corporate setting or for that matter any large organization, responsibilities are defined in a structure that discourages or punishes “thinking outside the box”. Consequently, if a quality manager raises the question about regulatory issues or potential liability exposures, the response to their suggestions often is “stay in your own box” legal issues are the responsibility of the legal department. Likewise, if a regulatory manager suggests examining product liability issues they too may be chastised for stepping outside of their job description.

I saw this happen to a quality manager in the very first medical device firm I worked with on CE Marking their medical devices. The Quality Manager learned very quickly – “if I mention legal issues my hands will be slapped.” Therefore, if I see something that might have legal implications I am not going to get involved. That is for the legal apartment to find out and solve by themselves.

Unfortunately, this sort of separation of responsibilities and jealousy if anyone moves into another person’s area of responsibility is all too common. It happens in every organization. It happens in the government. It happens in universities. It happens in the military. Efforts to break down these walls/silos are difficult and the inability to communicate across job responsibilities and/or disciplines is extremely difficult. It strangles effective cross disciplinary communication.

Medical Device Litigation Study And The Product Liability Consequences

The medical device litigation study conducted by the medical device insurance company found several areas where the inability to address product liability exposure resulted in litigation losses, in some cases substantial losses and increased insurance premiums. Listed below are a few of the more prominent institutional failures to address product liability exposure.

• The study noted a lack of internal processes and procedures including company quality management systems for escalating product safety concerns or review of those concerns as well as a lack of any kind of cross functional committee to deal with product safety issues. Plaintiffs’ attorneys noted this failure and alleged that the failing demonstrate a lack of due care and concern for safety resulting in an expensive out-of-court settlement.

• The study found that management continued to underestimate the risk of product liability litigation to this success and/or survival of their business.

• The study noted that life science firms often lack a clear understanding of the potential risks and product liability exposure resulting from misunderstood and poorly written safety documents and communications.

• The study recorded a lack of qualified in-house personnel available to integrate product liability avoidance principles into the firm’s quality management system and establish an infrastructure for product safety, resulting in product liability post-production legal defense problems.

• Often post-production complaint data was poorly managed and not escalated to the attention of senior management and/or was ignored by senior management resulting in regulatory sanctions and product liability lawsuits.

• The Study noted that life science firms often did not conduct post legal settlement reviews and analyses over claims in an effort to learn from their litigation experience. Consequently, where a case was settled and believed to be over and finished, the failure to learn from experience often resulted in a similar case arising a few months later.

• Often, documented critical safety information was found to be carelessly worded and/or prepared and used against the firm to support the allegation of a lack of attention to patient safety and product safety resulting in product liability lawsuits and expensive out-of-court settlements.

• Too often life science firms did not conduct diligent reviews of their Internet websites and advertising materials for misleading claims and ‘testimonials’ resulting in the use of these claims and testimonials against the firms in product liability lawsuits.

Conclusion

Quality Managers and Regulatory Managers are not trained to understand or think about product liability exposure. They don’t know how to conduct product safety or product liability audits of their processes, documents and regulatory quality management systems for potential areas of product liability exposure. Therefore, it isn’t surprising that the number of product liability lawsuits is increasing. The phrase, “the best offense is a good defense” is an axiom apparently without meaning in the life science regulatory world.

Product liability lawsuits are a continual threat to the financial success and prosperity of life science firms. Unfortunately, too often the threat isn’t taken seriously. In addition, life science firms are subject to regulatory action by FDA and its counterparts in the EU, Canada, Australia and Japan. Failure to abide by FDA and other country regulations could lead to regulatory sanctions that in turn provide fuel for trial lawyers and product liability lawsuits.

Corporate counsel and product liability litigation attorneys do not fully understand and appreciate the impact of documented regulatory Quality Management Systems (QMS) on product liability litigation. Plaintiffs’ attorneys are becoming increasingly effective in using these regulatory quality management systems against life science firms in product liability lawsuits. To date, plaintiffs have only scratched the surface and are just beginning to examine the internal structure, quality procedures and documents required to operate these systems. Broken or failed QMS systems are rich with data and potential that can be used in product liability lawsuits.

Therefore, it is critical for life science firms and their attorneys to better understand the regulatory and legal milieu in which they exist and take pro-active steps to improve their lot by better grasp the legal significance of their regulatory Quality Management Systems and by practicing product liability avoidance, known also as lost control and preventive law. If you have questions about Life Science Firms, product liability lawsuits and preventive steps such as product safety/product liability audits to reduce product liability exposure, you can contact me at my new e-mail address jameskolka@gmail.com.  

CE Marking Machinery & US Product Liability – The Lawsuits Begin #3

Introduction

This blog is a continuation of two blogs posted on February 25, 2011 and March 31, 2011 respectively. I noted in the second blog my frustration with EU Market Surveillance and the Machinery Directive. I have examined many manufacturers' Machinery Directive Technical Files, some well done and too many done badly.

In spite of early efforts by the European Commission to structure Technical Files into Part A (the index of the file) and Part B (the substance of the file in hardcopy, electronic copy,  samples, etc.) the concept appears never to have gained traction. The virtue of a Technical File divided into two parts with an index is the ability to look at Part A and see if a company attempted to fully comply with the requirements of the Machinery Directive and related Directives.

As a consequence, the mess I have described in the two previous blogs has materialized into a legal case in the UK & US. I have been examining a presumed Technical File that does not contain a comprehensive list of the Directives, Standards and elements required for compliance with the requirements of the Machinery Directive. If I were cynical, I could conclude that the company in question deliberately constructed a “junk file” to cover their tracks in the event of a lawsuit. Or, I might conclude that the personnel who constructed the file were sloppy, indifferent and incompetent. Either conclusion is plausible. 

The only section of the file constructed by the company that purports to resemble a type of index is their EC Declaration of Conformity which is incomplete and inaccurate, e.g. not all standards are cited and several cited are inaccurate, e.g., wrong date of publication, expired or missing. Unfortunately, this pathetic document came to light only after a worker had been killed and another severely injured. These documents should have been reviewed before the manufacturer placed these machines on the EU Market.

Some Ideas for Improving Market Surveillance of the Machinery Directive and Related Directives

While I believe that self-certification can work well and that notified body oversight isn’t necessary, save for exceptional circumstances, I think that there should be a requirement that every manufacturer that places a CE Marked Machine on the EU market should file a document with a member state competent authority that briefly provide the basic elements of the machine which also is shared electronically with the Competent Authorities of all 27 Member States and the European Commission Enterprise and Industry. Further, I think that document should be Part A of their Technical File.

I construct a Part A Technical File for every manufacturer I help to CE Mark their machines.For example, in a recent Part A Technical File developed for a client that recorded the following:

• Annex I Health and Safety Requirements Checklist identifying every essential requirement, the answer (Yes, No, N/A) and if Yes the EN Harmonized Standard(s) that will be used to demonstrate conformity with the requirement  
• EN ISO 14121–1:2007 Safety of machinery – Risk assessment (56 pages written and edited by me and the company’s engineering staff)
• A list of EU Directives – Machinery, Low Voltage, Electromagnetic Compatibility
• A list of 16 EN harmonized standards relevant to the manufacture of this machine
• The overall design, detail drawings and diagrams describing the machine
• Standards calculations
• Guide to the application of the Machinery Directive 2^nd Edition
• EU Compliance Protocol for the machine written by me for my client identifying all of the legal requirements and how they were satisfied
  
• A copy of the EC Declaration of Conformity
• Operating Manual
• Maintenance Manual
• Training Manual
• Sales Materials describing the machine
• Protocol for translating Manuals
• Instructions, Cautions and Warnings
• EC Declaration of Conformity for an electric motor manufactured by another company
• EC Declaration of Conformity for laser equipment manufactured by another company
• IEC System for Conformity Testing and Certification of Electrical Equipment provided by Underwriters Laboratories
• Certificate of Calibration for a machine component
• EC Declaration of Conformity for an Electromagnetic component. 

All of this information was contained in a two-page matrix of 20 items in Part A of a Technical File. Since this was a one-of-a-kind machine, no quality standard was cited. The manufacturer shared this information with their client in the EU as the machine was being constructed. I have provided this level of information for every client with whom I have worked and it is often shared with clients and occasionally member state Competent Authorities. In the case of three different machines being shipped to Turkey where CE Marking was stipulated, the company had to courier all of the CE documents for review by the client company and Turkish national authority for clearance before the ship could be docked and the machines unloaded. I thought this was a fair requirement.

Summary

The only other document that is required for machines to be shipped into the EU is an EC Declaration of Conformity, however it is prepared primarily for customs and, in my opinion, far too cryptic to be useful for the purpose described here. Further, customs officials are far too busy to scrutinize these documents for compliance with the Machinery Directive. In the case of the manufacturer of a deadly machine described in my first two blogs in this series, the only recognizable document in their “junk technical file” was an EC Declaration of Conformity, most notable for what required information wasn’t provided.

Recommendation

In order to exercise some control over the plethora of machines flooding the EU market, I recommend that that the concept of a Technical File with two parts (Part A & Part B) be revived. Further, I recommend that Part A be filed with a legal entity such as a Member State Competent Authority and digitally transmitted to all Member State Competent Authorities and the European Commission, Enterprise and Industry. Part A should include reference to all of the elements required to comply with the requirements of the Directive and related Directives (which will vary for each machine).

Further, I think some type of effort should be made to deal with all of the “junk technical files” for machines already on the market. This could be accomplished in part by citing Decision No. 768/2008/EC of the European Parliament and Of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/ EEC and requiring every machine to submit Part A for existing machines as well as reminding manufacturers that starting 1 January 2010 they had to comply with revised Directives and revised EN standards.

I would be happy to help with this effort, if there is an interest. In my opinion, the EU Machinery Directive is the most significant contribution to the improvement of machinery safety that has been made. Its ripple effects extend globally to improve machine safety. If you have any questions about the EU machinery Directive and its US product liability implications, you can contact me for a free preliminary consultation at my new e-mail address at jameskolka@gmail.com.

 

 

CE Marking Machinery & US Product Liability – The Lawsuits Begin #2

Legal Issues in the EU and EU Member States

This is a continuation from blog #1 posted on February 25, 2011 concerning a fatal accident in the UK and severe accident in the US involving the same CE Marked machine. This blog focuses on the legal issues and social consequences of the UK fatal accident. A future blog will examine the US product liability implications of the severe accident involving the same CE Marked machine.

As noted in that blog, I have been examining what purports to be a Technical File for a machine manufactured in 2005. In addition to the Technical File being sloppy, seemingly inaccurate and lacking critical details, there appear to be few records retained that can be examined concerning the design the machine, such as the design records for ISO 9001:2000 and series manufacture. 

Because most machines CE Marked for the Machinery Directive are self-certified, Technical Files aren’t examined until something happens, such as an accident. It is only then for the first time that a hodgepodge Technical File materializes to be examined for potential problems. The first governmental agency that examines workplace accidents usually is that country’s equivalent of the US OSHA (Occupational Safety and Health Administration) concerned about workplace safety.

In the UK, that would be HSE (Health and Safety Executive). Only at the next level when CE Mark issues are turned over to the UK agency responsible for the Machinery Directive, BIS (Department for Business Innovation & Skills) is there any technical knowledge of the CE Marking process and Directive requirements, (e.g. Directive Annex I Essential Health and Safety Requirements, EN harmonized standards to demonstrate conformity, Risk Assessment, EC Declaration of Conformity, etc.). Only then are the workplace safety responsibilities of a manufacturer considered vis-à-vis the Machinery Directive.

If this occurs promptly after an accident, in tandem with the HSE investigation, compliance with the Machinery Directive and the CE Mark compliance or noncompliance of the machine will receive consideration on a timely basis. Unfortunately, the fractured Technical File and apparent noncompliance with the requirements of the Machinery Directive and related Directives (Low Voltage Directive and EMC Directive) may be reviewed so late in the process that injured workers and their families may be denied appropriate compensation, time having expired for prompt consideration. It is a perverse Catch 22.

The EU Machinery Directive 98/37/EC in place in 2005 when the machine that caused these accidents was manufactured and the subsequent revised Machinery Directive 2006/42/EC both contain the Article 7 Safeguard Clause that allows for the removal of a CE Marked machine that is not in compliance with the requirements of the Machinery Directive. It states:

1.Where a Member State ascertains that:

--machinery bearing the CE marking, or

--safety components are accompanied by the EC declaration of conformity, used in accordance with their intended purpose are liable to endanger the safety of persons, and, where appropriate domestic animals or property, it shall take all appropriate measures to withdraw such machinery or safety components from the market, to prohibit the placing on the market, putting into service or use thereof to restricted free movements thereof.

Member States shall immediately inform the Commission of any such measure, indicating the reason for its decision and, in particular, whether nonconformity is due to:

(a) failure to satisfy the essential requirements referred to in Article 3;

(b) incorrect applications of these standards referred to in Article 5(2);

(c) shortcomings in the standards themselves referred to in Article 5(2).

3.Where:

-- machinery which does not comply bears the CE marking,

-- a safety component which does not comply is accompanied by an EC declaration of conformity, the competent Member State shall take appropriate action against whom so ever has affixed the marking or drawn up the declaration and shall so inform the Commission and other Member States.

4. The Commission shall ensure that Member States are kept informed of the progress and outcome of this procedure.   

In other words, the Article 7 Safeguard Clause could have been used to remove noncompliant CE marked machines from the EU market. Unfortunately, since no effort was and/or is made to review incomplete, inaccurate or faulty technical files, knowledge to invoke the Article 7 Safeguard Clause would always be “after the fact”. Only if a consumer or more likely a competitor complained about a machine would the Safeguard Clause be used.

Regulation (EC) No 765/2008 setting out the Requirements for Accreditation and Market Surveillance Relating to the Marketing of Products and Repealing Regulation (EEC) 339/93

 The subject matter and scope of the new regulation as set forth in Article 1.

1.This Regulation lays down rules on the organization and operation of the accreditation of conformity assessment bodies performing conformity assessment activities.

2.This Regulation provides a framework for the market surveillance of products to ensure that those products fulfilled requirements providing a high-level protection of public interest, such as health and safety in general and safety in the workplace, the protection of consumers, protection of environment and security.

3.This Regulation provides a framework for controls on products from third countries. [e.g., US, China, Japan, etc.]

 4.This regulation lays down the general principles of the CE marking.

 (As noted in earlier blogs, the implementation date for this new Regulation was 1 January 2010)

Among the initiatives set forth by the new regulation are:

•  Market surveillance measures
  

•  Products presenting a serious risk

•  Restrictive measures

•  Exchange of information – Community Rapid Information System

When EU market authorities find a product that presents a serious risk, they will take measures to prohibit the product from being placed on the market and mark products and documentation with:

•  Dangerous product – release  for free circulation not authorized – Regulation (EC) No 765/2008

When the product is not in conformity with CE marking requirements, the marketing surveillance authority shall require the authorities in charge of external border controls not to release the product for free circulation and market it:

•  Product not in conformity – release for free circulation not authorized – Regulation (EC) No 765/2008

 

Timing & Transparency 

 To date nothing has happened concerning the machine in question and consideration of applying the Article 7 Safeguard Clause to remove it from the marketplace. It may have to move through BIS to and an accreditation authority. The final disposition has not been resolved and the machine and its garbled technical file remain on the market. Clearly, the prospect that a noncompliant machine can only be discovered if a customer complains, a competitor complains or fatal or serious accident occurs is not an acceptable outcome and certainly doesn’t result in improved market surveillance.

I have some ideas to improve supervision of compliance with the Machinery Directive that I will expand upon in my 3rd blog on this topic. I greatly respect the improvement in machine safety already delivered and promised by the EU Machinery Directive and the ambition to improve market surveillance. As a legal consultant, however, it is difficult to persuade US manufacturers to adhere to Directive Requirements if they know of companies treating them lightly, trying to do as little as possible. The legal consequences in the US will be profound! If you have any questions about the EU Machinery Directive and its US product liability legal implications, you can contact me for a free preliminary consultation at my new e-mail address jameskolka@gmail.com

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CE Marking Machinery & US Product Liability – The Lawsuits Begin #1

Prologue

I have been writing about and working with machinery manufacturers on the EU Machinery Directive since 1991. In 1992, another attorney, Gregory Scott, and I wrote "European Community Product Liability and Product Safety Directives", Published by CEEM Information Services, Fairfax, VA, which included several chapters about the Machinery Safety Directive and Product liability Directive. In 1995, Bruce McIntosh, the Product Safety Manager for Graco, Inc. in Minneapolis, and I wrote "The European Union Machinery Directive: Compliance Manual for Trade", published by Simcom, Inc., Atlanta, GA. In December, 1996 in Washington DC I chaired an American Society for Quality Control Seminar (now the American Society for Quality ASQ), “CE Marking in the U.S.: An Overview”, which reviewed the Machinery Directive with Trade Associations and notified bodies. In 1998, I discussed the legal implications of the Machinery Directive in "ISO 9000… A Legal Perspective", co-published by, ASQ, Milwaukee, WI & Inform, Montclair, VA.

I have been teaching public Seminars on the Machinery Directive since 1992 at the University of Wisconsin, School of Engineering, Madison, WI, Georgia Institute of Technology, Atlanta, GA, Clemson University, Charlotte, NC, Indiana University Purdue University, Indianapolis, IN, QSI Qualified Specialists Inc, Houston, TX and CMTC California Manufacturing Technology Centers, Los Angeles, CA, Ontario, CA & Fresno, CA. I have worked with manufacturing companies CE Marking Machinery throughout the US and Canada, written numerous articles and for the past two years posted 40 blogs on my blog site jameskolka.typepad.com.

Finally, I have worked with numerous manufacturers shipping machinery into the EU requiring a CE Mark (UK, Spain, France, Italy, Germany, the Netherlands, Cyprus, Turkey, etc.) On one occasion I served as legal expert and successfully filed a grievance concerning the legal scope of a Dutch notified body authorization with Commissioner Liikanen and the Machinery Committee of the European Commission. During the past decade, I have served as attorney legal/expert in US product liability lawsuits involving ISO 9001, the Machinery Directive & related Directives, the Medical Devices Directives and FDA’s Quality System Regulation. 

Litigation: US Product Liability, The Machinery Directive & Related Directives

Presently, I am working on litigation in the UK & US concerning a CE Marked machine that has caused a death and severe injury requiring lifetime medical care for operators of a specific machine. A review of the manufacturer’s Technical File or what the manufacturer alleges is a Technical File reveals sloppy and incomplete documentation. It does not contain a Part A index of the File, does not contain an Annex I Essential Requirements Checklist identifying (Yes, No or N/A) answer for each of the essential requirements and does not identify which EN or EN ISO harmonized standards will be used to address the “Yes” marked essential requirements to allow for a presumption of conformity.

While the EC Declaration of Conformity lists EN 1050:1996 as its Risk Assessment standard (it should have been 1997, and given the date of manufacture of the machine in 2005 it should have been EN ISO 14121-1:1999), there is no Risk Assessment following that standard. It appears that the manufacturer assumed that compliance with a C Standard could substitute as the Risk Assessment standard for the machine. I can not! There is no Hazards Analysis/Risk Assessment that would allow for a reasoned determination of Cautions, Warnings and Instructions if hazards could not be designed out or guarded against. This is particularly important in establishing the legitimacy of such language in the US.

The EC Declaration of Conformity listed the Machinery, EMC and Low Voltage Directives, but identified no EMC Standards used for emissions or shielding the machine (nor is there a EMC Certificate from a Competent Body approved test facility identified elsewhere in the Technical File). In addition to listing EN 1050 with the wrong date and not identifying the replacement Risk Assessment standard EN ISO 14121-1:1999, the EC Declaration of Conformity listed EN 12100-1:2001 and EN 12100-2:2001 which for the UK should have been BS EN ISO 12100-1: 2003 and BS EN ISO 12100-2: 2003. Further, reading of the calculations in the file mentions EN 292-1 and EN 292-2, which had been replaced by 2005. (It isn’t clear if the manufacturer simply replaced EN292-1 with BS EN ISO 12100-1 without understanding the substantive changes that had been made.)  As observed earlier, the kindest word for the file would be sloppy. The EC Declaration of Conformity also does identify an Authorized Representative in the EU.                  

Finally, mention is made of ISO 9001 in the body of the file, but not listed in the EC Declaration of Conformity. Since these machines were not “one-of-a-kind”, they would also need to satisfy Annex V, paragraph 3 (b.) for series manufacture, the internal, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive. Given the 2005 date of the manufacture of the machine, the Quality management System Standard would be BS EN ISO 9001: 2000. This means that the design requirements for the standard should also be examined – 7.3 Design and development, including 7.3.1 Design and development planning, 7.3.2 `Design and development inputs, 7.3.3 Design and development outputs, 7.3.4 Design and development review, 7.3.5 design and development verification, 7.3.6 Design and development validation, and 7.3.7 Control of design and development changes.

ISO 9001: 2000 also has records requirements that could be useful to attorneys wanting to examine the types of steps taken to design the machine. Annex V, paragraph (b) The Documentation referred to in 3 above must be retained and kept available for the competent authority [member state national agency for the Machinery Directive] for at least 10 years following the date of manufacture of the unit produced or of the last unit produced, in the case of series manufacture.

Summary

Thus far I have only discussed some of the issues relevant to the UK and EU. In my next blog, I will expand on additional UK and EU issues and expand the discussion to product liability litigation in the US. Also, remember that this litigation involves a machine manufactured in 2005 and the Directives and Standards current at that time. Since all of the Directives and many of the Standards have been revised, the machine and the accidents would be approached differently at this time. However, new EU Regulations now exist that could be invoked at this time. I will discuss these issues in my next blog and a third blog will discuss EU regulatory compliance and the US product liability implications of the EU Machinery Directive in 2011 – they are not the same thing. If you have questions about the EU Machinery Directive and its US product liability legal implications, you can contact me for a free preliminary consultation at my new e-mail address jameskolka@gmail.com.

Litigation Risk Management © & Regulatory Compliance – CE Marking for EU Directives – Machinery & Related Directives

Introduction

This blog follows my November 30, 2010 blog, Litigation Risk Management © & Regulatory Compliance – ISO 9001, ISO 13485 & FDA’s QSR. As with that blog the focus is on Litigation Risk Management ©, in particular, product safety and liability exposure in the US legal system resulting from CE Marking products for the EU. I have written several articles and blogs about CE Marking and liability exposure in the US. With several revised Directives, and revised EN standards also becoming EN ISO and EN IEC standards, the legal playing field has shifted.

The 22 EU New Approach Directives were adopted to improve product safety and open market entry in the EU. Except for the Medical Devices Directives that fairly closely mirror FDA’s Quality System Regulation (QSR), we have no governmental regulatory equivalent in the US. Most of our standards are developed by Trade Associations or private groups such as the Society for Automotive Engineering (SAE), Underwriters Lab (UL), Air Transport Association (ATA), American National Standards Institute (ANSI), American Society for Testing and Materials (ASTM) and the American Petroleum Institute (API), to mention a few.

The New Approach

While the American standards efforts are significant and steadily improving, they often are permissive in nature. They do not have the directive force and breadth of the EU new approach standards. In contrast to the old approach standards, which the EU continues to use, the European Commission adopted the “new approach” which sets forth the scope of the directive in a basic framework, outlines the conformity assessment procedures from which a company can choose to demonstrate compliance and lists the Directive’s Essential Safety Requirements with which a company must comply.  In turn, each new approach directive has prompted the writing of EN harmonized safety standards that help companies demonstrate compliance with the directive’s essential safety requirements.

Before it is complete, it is estimated that 10,000 new standards will have been written to address the Essential Safety Requirements. Basically, the Essential Safety Requirements (ESRs) state what must be done and the EN harmonized standards provide the path for demonstrating conformity with the ESRs (how it is to be done). By using the EN harmonized standards the EU will presume conformity to the Directives Essential Safety requirements.

To deal with the thousands of new EN safety standards required to implement these broad new approach directives, the Commission turned the standards writing program over to the European Regional Standards Organizations: CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization). These two organizations represent 29 of the 30 EU and EFTA (European Free Trade Association) nations.  (The only country missing is Liechtenstein.)  To this group have been added two new standards organizations: ETSI (European Telecommunications Standards Institute) and EOTA (European Organization for Technical Approvals).  ETSI deals with telecommunications standards and EOTA deals mainly with construction products.

The final step under the new approach structure is the writing of a Declaration of Conformity and affixing of a CE mark that is a legal requirement for the sale of new approach products in Europe.  CE, the French acronym for Conformité Européenne (European Conformity in English) is the only EU required safety mark that must be affixed for these products to travel freely throughout the EU. While most directives require the existence of a technical file containing the compliance requirements and many require an approved process control quality assurance system such as ISO 9001 or ISO 13485 (if medical) it is the CE mark and Declaration of Conformity that they all share in common.

The European regional standards organizations work with national standards organizations such as BSI (British Standards Institute), DIN in Germany, AFNOR in France as well as Professors from EU Universities, technical representatives from European Companies affected by the standards and in some cases public participation. It is a massive effort and it takes a great deal of time. We simply don’t have an equivalent structure or technical regulatory effort in the US.

Finally, through agreements with the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) in Geneva, most revised EN standards undergo a joint review at the European and International level. Since ANSI participates in the drafting of ISO and IEC standards, the new EN ISO and EN IEC standards also will be US standards. This is a legally significant point.

CE Marking for the Machinery Directive and Product Liability Exposure in the US

As everyone knows who has helped companies prepare the required documentation to CE Mark machines for the EU, except for very few machines, and those 23 dangerous machines identified in Annex IV of the Machinery Directive 2006/42/EC, the remaining machines can be self-certified.

I think it is an outstanding Directive that already has made a significant contribution to machinery safety. Unfortunately, it is also a Directive that can be easily abused by those companies, consultants and consulting organizations that want to cut corners and pay light attention to the Directives’ and required standards.

• The first instance of a US product liability lawsuit stemming from the Machinery Directive in the US was lawsuit in a Minnesota State Court in October 2002 when a worker in a packaging plant had his scull crushed between a moving mechanical arm and a conveyor belt moving below the arm. The 35 year-old worker became blind in one eye, losing sight in his other eye and would need 24 hour care for the rest of his life. The California manufacturer of the machine, the George M. Martin Co. sold the same machine in the EU with a laser light curtain required by the Machinery Directive that would shut the machine off if someone walked into the area of the machinery’s operation. Since a laser light curtain wasn’t required in the US, it wasn’t added. When the jury discovered that the company made a safe machine for the EU, but not for the US it was clear that they knew how to make a safe machine. The judge entered a punitive action judgment for $35,322,626 million dollars, the largest such judgment in the history of the state.  

• A few years after this case I was called by the corporate counsel of a company I had worked with to CE Mark large machines for their oilfield division. They asked me to study the litigation history in another division that manufactured several machines for use in a different industry. While conducting my review I looked at the Technical Files for two machines that they were making for the EU. The files had been examined by a Dutch notified body that sent a team to the US to conduct an expensive “on site” evaluation of their CE Marking activities. I discovered that the notified body had issued two EC Type Examination Certificates for two machines that weren’t listed in Annex IV of the Machinery Directive. The certificates were bogus! After receiving no answer from the Dutch notified body and Dutch national authority (competent body) for six months, I wrote to the European Commissioner responsible for this area and received a response in three weeks stating that I was correct and a cc to the Dutch informing them they could not issue the certificates. Long story short, the Certificates gave the company the impression they had legal documents that could be used in court, if necessary. Unfortunately, several notified bodies have implied an “official stamp of approval” when they are acting as consultants. Each directive specifies what constitutes official notification for that directive and it varies for each directive.

• EU companies that CE mark for the EU but not in the US will be held to the same accountability as US companies for machinery safety. In short, they can’t sell less safe machines in the US than the EU.

• EU Documents such as Technical Files, the content of those Files, including the EN ISO 14121-1:2007 Risk Assessment Standard must be available for legal discovery in a US Court, even if the machine isn’t CE Marked, to make certain that a less safe machine isn’t being sold in the US. I frequently conduct forensic examinations of Technical Files to make certain that what was declared was actually accomplished. This is particularly important when self certification is involved. A forensic engineer also might be involved to check technical compliance.

• Several Directives such as Machinery, Low Voltage, Electromagnetic Compatibility and Medical devices have been revised. On January 1, 2010 the EU is checking that every product entering the EU complies with the new Directives. They also stipulate that the EN standards used to demonstrate conformity with the Directives are up to date. This includes standards used to manufacture component parts from suppliers (see my October 30, 2010, July 31 & August 25, 2010 blogs discussing these topics).

• EN standards are now ISO & IEC and therefore ANSI American standards. Previously, some companies would argue that compliance with EN standards didn’t carry over to the US. This is no longer true. The revised EN standards have been drafted with parallel ISO and IEC standards committees with ANSI participation. Consequently, these ANSI standards are US standards which are recognized by US Courts. The EU Machinery Directive approach to product safety is going to be playing a much role in US product liability litigation in the future.

Conclusion

I could only cover a small portion on the Machinery Directive in this blog. I will devote more attention to the breadth of the revised Directive in future blogs. My focus here has been like the preceding blog posted on November 30, 2010, the requirements of regulatory authorities and the legal implications of compliance. In this case the legal implications of the EU Machinery Directive that could result in a lawsuit in a Federal or State courtroom.

As noted in my previous blog, I have decided to look for professional affiliations with organizations interested in Litigation Risk Management © and improving product safety. This can occur on both sides of a lawsuit. I am looking for US and/or EU affiliations for the future. If anyone is interested, please contact me at jameskolka@gmail.com.

Litigation Risk Management © & Regulatory Compliance – ISO 9001, ISO 13485 & FDA’s QSR

Introduction

After posting ninety-four blogs, I decided to spend a little time on my particular perspective on ISO 9001, ISO 13485 and FDA’s QSR. The second blog in this series will concentrate on CE Marking for Medical Devices, Machinery, related Directives and their legal implications.

To begin, I always use a Litigation Risk Management © focus when dealing with Quality Management System Standards.

When I first learned about the 1^st edition of ISO 9001:1987 in 1990, I thought it provided an excellent platform to reduce liability exposure. At that time a colleague and I both said, “The good news about ISO 9001 is that you now have a paper trail in the event of a lawsuit and the bad new is, you now have a paper trail in the event of a lawsuit.” If the documentation proves that product safety was a concern, it can be demonstrated by the paper trail but if the documentation is weak and makes little mention or no mention of product safety, it can be used to demonstrate that product safety was not a significant concern.

In truth, however, consultants at that time had (and today have) no interest in product safety and the legal implications of ISO 9001 certification. Quality managers do not accept product liability exposure as their legitimate responsibility. If anything, the thought that lawyers might become involved with ISO 9001 seemed unfair to them. Their interest was confined to obtain certification for their company, or if consultants, for their clients. Any suggestion that companies also should consult the Guidance Standard ISO 9004:1987 was rejected out of hand because it wasn’t required for certification.

The original ISO 9004:1987 Guidance Standard had a short section that addressed Product Liability which was promptly removed by the drafters of ISO 9004:1994. The drafters and their constituency wanted nothing in print that might hint at legal liability in ISO 9004:1994. Of course ISO 9001:2000 and ISO 9004:2000 retreated further from any hint of legal implications. The fact that I or anyone else would suggest that ISO 9001 & ISO 9004 might be important in a lawsuit was never given consideration by consultants. They didn’t want to ruin a good thing!

Product Safety

To attorneys, the idea that any human activity such as an ISO 9001:1987 Quality Management System (QMS) or ISO 9004:1987 Guidance Document should somehow be exempt from the law or potential litigation is absurd. Human activity and the law have been intertwined since recorded human civilization first emerged in ancient Mesopotamia 5000 years ago, probably earlier.

When I first encountered ISO 9001 & ISO 9004, I thought the combination would make an excellent platform to increase product safety and reduce liability exposure, so I drafted a Product Liability Control (PLC) System © following each clause in ISO 9001 with my own Liability/Safety (PLC)© clause. Because ISO 9001:1987 was especially weak when it came to product safety, my system emphasized product safety as key to reducing liability exposure. I also developed a Product Liability Audit Program © and Product Safety Audit Program © and an associated Product Liability Training Program © and Product Safety Training Program ©. 

Unfortunately, the subsequent versions of the ISO 9000 standards, ISO 9001:1994, ISO 9001:2000 and ISO 9001:2008 have continued to ignore product safety and product liability as a critical issue and continue to ignore ISO 9004 as a meaningful Guidance Standard to be used to improve certification.

Where Are We Now?

The illusion persists that ISO 9001 Quality Management Systems have not been involved in litigation in the US. Further, quality publications avoid the topic fearing it will turn off readers and potentially damage the QMS enterprise. It reminds me of Ibsen’s play, The Wild Duck where Doctor Ekdal finds that the water supply of a small town dependant on tourism is contaminated and wants to impose a quarantine until the problem is resolved. The community fearing economic hardship, of course, wants the Doctor to say nothing. The same is true with ISO 9001 – consultants say nothing about potential lawsuits.

Quality Management Systems & The Emperor’s New Clothes

The fact is that ISO 9001 and other Quality Management Systems such as FDA’s QSR have been involved in litigation involving millions of dollars. Most of these lawsuits and legal actions have been settled out of court leaving no court record. Consequently, the illusion continues to persist that Quality Management Systems do not have to worry about legal actions and protect themselves with preventive law and product liability audits.

• Defense Industry – In my March 09, 2009 blog, I discussed US Defense Department litigation concerning four defense contractors and ISO 9001. Between 2006 & 2008 Defense Contractors paid over $100 million dollars in penalties to the US Department of Defense for ISO 9001 Quality Management Systems that were broken and delivered shoddy merchandise. In some cases, merchandise such as bullet proof vests that had failed to protect military and police personnel, resulting in serious injuries and death. Defense cases involving ISO 9001 continue to be filed by the US Department of Justice.

• Civil Lawsuits Involving ISO 9001 – One of the first large product liability cases involving ISO 9001 was a class action lawsuit Case IH Cotton Picker Fire Products Liability Litigation filed in the US District Court for the Eastern District of Arkansas. The case involved 140 fires between 1994 and 1997 involving cotton pickers valued between $90,000 and $200,000. Plaintiffs requested ISO 9001 documentation stating, “The number of fires alone caused alarm and concern. However, the problem is magnified by the fact that these losses were preventable and that Defendant is doing nothing to correct and prevent the losses as required by its’ own ISO 9001 program.” The case was significant because it addressed several issues concerning ISO 9001 documents and records. The case was settled out of court for an amount reported by the Wall Street Journal to be in the mid 8 figures (approximately $50 million dollars). (You can find a more extensive discussion of the case in my March 23 & 30, 2009 blogs.)

• My Work With ISO 9001 Lawsuits – In the past six years, I have served as the ISO 9001 legal expert in four lawsuits involving ISO 9001. As with the Cotton Picker case, ISO 9001 was key to litigation in these cases. The Quality Management System Manual, Procedures, Documents and Records have been central in these cases. The requested documents and records have been key to claims by plaintiffs, but often not understood by defense counsel. In one case the provisions concerning contracts and design were pursued with corporate executives in depositions, where allegations of breach of contract and failure to follow design procedures were central. All of these cases were settled out of court and involved millions of dollars.

• FDA’s Quality System Regulation (QSR) – The biggest fine levied by FDA for failure to comply with the QSR was a $100 million dollar consent decree with Abbott Laboratories in November 3, 1999. Following that decree several lawsuits were filed by plaintiffs’ attorneys alleging damage to plaintiffs from in vitro diagnostic tests falsely diagnosing diseases that resulted in unnecessary expensive medical treatments. The following year FDA levied a $60 million dollar fine and obtained a guilty plea to federal criminal charges by Johnson & Johnson’s Lifescan Division for defective glucose monitors.

• Medical Device Insurance Company’s Litigation Study – I have discussed this twelve-year litigation study in several blogs. Perhaps the biggest surprise was the increased sophistication of plaintiffs’ attorneys in using FDA’s QSR, ISO 13485 and ISO 9001to demonstrate the failure of medical device companies to focus on patient safety and product safety. In addition, FDA has issued an increasing number of 483 Warning Letters citing failures of companies to comply with FDA’s QSR resulting in adulterated devices, followed shortly by product liability lawsuits. Almost all of these cases were settled out-of-court resulting in millions of dollars in damages. (It should be noted that these are the findings from only one insurance company.)

Conclusion

While it isn’t possible to give a complete tally in damages and losses from ISO 9001, ISO 13485 and FDA’s QSR quality management system breakdowns, a low estimate would be $500 million dollars and it is probably double that amount. A few observations are in order from the Medical Device Insurance Company Litigation Study:

• QSR Certification and Compliance do not address legal issues and Litigation Risk Management ©.
• QSR Document Control does not address legal issues, liability exposure and Litigation Risk Management ©. It isn’t just the existence of documents, but how they are written, what is said and their legal implications.
• QSR Design Control does not address Litigation Risk Management © including Product Safety and Product Liability Exposure.
• Regulatory Managers and Quality Managers are not trained in QSR Litigation Risk Management © and Liability Exposure.
• Top management generally does not understand the difference between QSR Compliance and Litigation Risk Management © and Liability Exposure.
• Corporate counsel and defense counsel generally do not understand the legal responsibilities of top management, QSR Litigation Risk Management © and Liability Exposure.

I have decided to look for professional affiliations with organizations interested in Litigation Risk Management © and working with companies to improve product safety and reduce litigation risk exposure. After working on projects involving Enterprise Risk Management for European Companies, I have concluded that Litigation Risk Management © and Product Safety appear to be of greater interest in the EU than the US. However, I am looking for US and/or EU affiliations for the future. If any one is interested in discussing the development of a Litigation Risk Management © Program, please contact me at jameskolka@gmail.com.

FDA’s 510(k), Adverse Events And Product Liability Lawsuits

Introduction

 Recently, I received an inquiry from a reader of one of my blogs:

Good evening.  I came upon an article from you while doing some research this evening.  I have a product liability question. It pertains to what would happen if a manufacturer is marketing and selling a product for which it has not received the necessary 510k clearance from the FDA and an adverse event occurs on a patient.  Who would be responsible if the hospital and surgeon were knowingly using a product that did not have a 510k from the FDA.  The product in question is a Class II invasive device?

Good question. The answer is quite simple. A trial attorney will include everyone in a product liability lawsuit, the surgeon, the hospital and the company that placed the medical device on the market without obtaining FDA clearance. The trial attorney’s objective is to pursue all possible persons involved (including their insurance companies) and make certain to reach the deepest pockets to pay for the physical and emotional damage to the patient as well as seek punitive damages. It is this type of careless behavior that often results in a financial loss that bankrupts a medical device company. It is also is extremely foolish, because it is so unavoidable.

Never place a medical device in the market that requires 510(k) clearance without first obtaining FDA clearance.

 

Medical Device Insurance Company Litigation Analysis

 In several of my earlier blogs, I referenced the private findings of a medical device insurance company after reviewing its twelve-year litigation history. Over 95% of these lawsuits resulted in out-of-court settlements. My colleague (who conducted the study for the insurance company) and I have been reviewing the findings and have made the following observations about medical device lawsuits:

• The findings revealed that researchers often did not reveal to patients that the device had not received FDA clearance at this stage in the device’s manufacture, thereby opening the door to product liability lawsuits.

• During the early development of a medical device, e.g. obtaining 510(k) clearance from FDA, it is critical for device firms to be in compliance with FDA regulations. Product liability claims during this time will use any negative regulatory information to prove their case.

• The lack of a product safety policy statement or reference to patient safety and product safety in a company’s quality management system statements often led company management to mistakenly believe that they would not be accused of indifference to safety in a product liability lawsuit.

• The lack of documented methods, processes or procedures for communicating product safety concerns and/or including these methods in the company’s business processes demonstrating the company’s commitment to product safety, has resulted in companies losing product liability lawsuits.                                     

• Several product liability claims that were taken to jury trials have used companies Quality Management Systems and Quality Manuals against manufacturers. Trial attorneys often noted that company’s own quality processes were not followed or audited.

• Often company managers were unaware of FDA Regulations or EU Medical Device Directives requirements for notification to the appropriate regulatory bodies and unaware of the attention regulators would place on these requirements.

• Attorneys have discovered that no documented methods, processes or procedures for communicating product safety concerns and/or including these methods in a company’s businesses process resulted in demonstrating the lack of a company’s commitment to product safety.

• Often companies lacked a Standard Operating Procedure (SOP) for obtaining 510(k) clearance from FDA when needed.

• The insurance company litigation study also found that philosophical conflicts often occurred in new management teams seeking 510(k) clearance wanting to fight FDA and their “observations” or “483 warning letters”, rather than mutually cooperate and resolve an implementation plan for integrating the observations into their manufacturing processes.

• Attorneys discovered that researchers and physicians who participated in implanting unauthorized devices that had not received 510(k) clearance assumed incorrectly that they were protected from liability exposure by the company that provided the medical device.

• Finally, as noted in a New York Times article on November 15, 2010, "Putting Money on Lawsuits, Investors Share in the Payouts", investment groups are backing product liability lawsuits including medical malpractice and device failure lawsuits. Consequently, there is more than enough money from investment groups to pursue device companies if a device that did not obtain FDA 510(k) clearance caused significant harm to the patient. Clearly, 510(k) compliance is more critical than ever.

Summary

It was clear from the medical device insurance company study, that many medical device “start ups” did not pay sufficient attention to FDA’s Quality System Regulation (QSR) resulting in FDA 483 Warning Letters followed by product liability lawsuits. The 510(k) submissions should have been incorporated into 21 CFR 820.30 Design Control as a beginning exercise in quality systems compliance. Unlike a CE Marking Quality Management System (QMS) such as ISO 13485: 2003 where a third party (notified body) will conduct a certification audit followed by surveillance audits, FDA will first view your compliance with their FDA Quality System Regulation when they visit your manufacturing facility. There is no practice audit or 3^rd party audit to use as a baseline for improvement, unless your company also complies with ISO 13485 or ISO 9001. Consequently, it will be necessary to be especially diligent in creating a QMS that will comply with FDA’s QSR.

My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a Federal or State courtroom. I also focus on product safety and the steps necessary to create a safe product. In my next blog, I will spend some time further delineating this approach. If you have questions concerning medical device lawsuits, you can contact me for a free preliminary consultation at my new e-mail address jameskolka@gmail.com.

 

ISO 9001& ISO 9004: A Framework for Disaster Preparedness Revisited – Risk, What Risk? Catastrophe in the Gulf #5

Introduction

This is the fifth and last in this series of blogs on ISO 9001 & ISO 9004: A Framework for Disaster Preparedness Revisited. (The preceding blogs were posted on December 29, 2009, & January 4, January 14 & February 12, 2010.) For those familiar with the first two blogs, you will recall that they briefly recapped a two-part article that appeared in the February 2002 issue of Quality Progress in response to a request from the editors for an article that applied ISO 9001 & ISO 9004 to the events of September 11, 2001.

The 3^rd blog described in brief outline a comprehensive Disaster Recovery and Service Continuity Plan for a major metropolitan area in the Northeast to identify the potential risks that could affect the provision of health care facilities. It involved the identification and analysis of risks and the preparation of a plan to respond to emergencies and the preservation of health care resources. The 4^th blog focused on the Political, Ideological and Geographic Problems with Disaster Planning. Since these four blogs were published, the Deepwater Horizon Oil Spill occurred. It is not my purpose to rehash the spill, but instead concentrate on the risk management decisions/non-decisions and regulatory weakness in response to the spill. 

Regulatory Oversight

At the time of the Deepwater Horizon explosion and spill US regulatory oversight was the responsibility of Minerals Management Service an agency of the U.S. Department of the Interior. In addition to leasing federal lands to oil and natural gas, the Minerals Management Service (MMS) collected leasing revenue, one of the largest revenue sources for the federal government after the IRS. Unfortunately, rigorous regulatory oversight was not the mission given to MMS in the first decade of the 21^st Century, nor for that matter, was rigorous collection of revenues owed to the federal government.

Consequently, MMS never appeared to receive a petition to drill that it didn’t like and it certainly didn’t request anything resembling a Disaster Preparedness Plan (if it ever conceived of such an eventuality) if anything went wrong while drilling. Questions were never asked about the potential risks of deep water drilling at different depths and what contingency plans a company and its contractors might have created to contain a deep water disaster should one occur. Questions were never asked about potential environmental risks and company financial liabilities for such a disaster. Questions appeared to never have been raised about the responsibility of MMS to the federal government, the American public and more specifically to the agency’s role to safeguard the environmental integrity of the delicate ecosystem in the Gulf of Mexico for the people who lived on the Gulf.

To say that MMS planning was sloppy is much too kind, it appears that no meaningful planning existed that even contemplated a disaster, since only minor disasters had occurred in the American portion of the Gulf. An earlier disaster had occurred in the Mexican portion of the Gulf, but that was never factored into agency thinking. Also, bigger disasters had occurred in Nigeria that still soak marshes in oil today, as well as drill site oil leaks in other parts of the world. A genuine “What me worry?” still attitude prevailed.

The concept of requiring a Hazards Analysis and Risk Analysis before drilling, (requirements for manufacturing medical devices and machinery for CE Marking), appears never to have entered the consciousness of the agency. Their managerial prowess was more akin to an adult Lemonade Stand instead of an agency responsible for serious oversight of drilling for oil in the Gulf and collecting revenue for the United States (which they did badly falling billions of dollars short).

Company Oversight

Company oversight was terrible as well. Four approaches to risk management should have been taken:

Disaster Preparedness – Given the depth at which BP was drilling in the Gulf of Mexico and the potential ecological and human consequences that could occur, this should have been a first step. In particular questions should have been asked, if an accident occurred (e.g., explosion, leak, break in the pipe, etc.) what could be the potential extent of the disaster (e.g., the well, the workers, the ecosystem and the affected population)? What must we (the company) do to control and limit the damage to the affected populations? How would the damage be limited? Do we have a strategy and the technological know how to accomplish this? What will be the cost? If we don’t have the technological know how, should we wait until we are able to drill a well at this depth? None of these questions were systematically asked by MMS or BP.

Enterprise Risk Management – Given the Global risks undertaken by BP, it should have employed the strategy taken by several other European Corporations and hired an outside firm to help conduct an assessment of corporate risks (e.g., physical, financial, geographic, political, ecological) faced by the corporation in its various global operations. Eventually, the risks would be refined and passed on to BP management, the CEO and members of the Board to consider. Such a list should be bold in concept to assure that risks aren’t ignored because they might disturb the sensibilities of key managers and Board members. Eventually, the list is prioritized and becomes the basis for future planning. Unfortunately, the only risks that seemed to occupy the company at the time were financial risks, i.e., how to reduce the cost of drilling and cut corners, which some commentators suggested helped precipitate the disaster. The objective is protect the future of the company

Hazards Analysis/Risk Analysis – This should have been a first step with any project that presented a degree of risk and it should have been revisited at key stages to make certain that all hazards and risks were visited and revisited to assess all of the possible risks presented by deep water drilling. It is an essential FDA & EU requirement for manufacturing any medical device and an essential requirement for manufacturing any product that is going to be CE Marked. It also is an essential requirement for equipment for NASA, but does not appear to been given a concern by BP. A program entitled Drill was aired by Frontline on PBS on October 26, 2010 reviewing the history of BP in the Texas City Refinery explosion, the largest pipeline spill on the North Slope of Alaska, the sinking of BP’s Thunder Horse oil platform in the Gulf of Mexico and finally the Deep Water Horizon explosion and leak in the Gulf of Mexico. Instead of assessing risk and taking steps to reduce the risks, the program, commentators safety specialists, investigators and other oil company CEO’s testifying before congress suggested that BP took unnecessary risks.

 Crisis Management – Crisis management appears to be the one area that received attention. It is the plan of action to limit the damage from adverse publicity when an event happens that could adversely affect the company. For example, in the case of Pepsi-Cola several years ago when syringes were reported to be in cans of Pepsi, it was necessary to dispel the rumors and control the damage. In the case of BP in the Deep Water Horizon the desire to deal with adverse publicity or “control the spin” was true.

Risk Management and Disaster Preparedness

The zeal to pursue offshore drilling of oil and natural gas on federal land in the Gulf of Mexico or anywhere else whatever the risks (“drill baby drill”) and the contempt of politicians for federal regulation in the first decade of the 21^st Century foredoomed the creation of a federal agency with any meaningful responsibility or clout. Following the Deep Water Horizon Disaster, MMS has been reformed into two major programs, Offshore Energy and Minerals Management and Minerals Revenue Management. Both are under the US Department of Interior. Deep water drilling and revenue are now tightly regulated. It remains to be seen how effective the new regulatory powers are exercised.

It will take years to learn the extent of damage to the Gulf’s sensitive ecosystem. It is not as horrible as Chernobyl, but it isn’t slight. Hopefully, future drilling will be more responsible. Only time will tell.

The cove pictured above in the photograph is virtually identical to the same cove captured by Salvador Dali in two of early his paintings in 1920 and 1921. The cove is on Cap de Creus near the resort town of Cadequés on Spain’s Costa Brava. Dali’s home and studio are located nearby and can be visited today. Fortunately, no mineral deposits or oil are found nearby to lure companies and destroy the beauty of the area.

If you would like to talk about comprehensive strategies concerning Disaster Preparedness, Enterprise Risk Management, Hazards Analysis/Risk Analysis or Crisis Management for a free preliminary consultation at my new e-mail address jameskolka@gmail.com.  

CE Machinery Malpractice: “The Whole Machine Must Be Greater Than The Sum Of Its Parts!” #2

Introduction  

In my July 31 blog #1, I discussed US companies combining drive systems, such as a generator mounted on a flatbed truck attached to partly completed machines such as a drilling rig or an excavator, then declaring the combination “Voila” to be a complete machine. It is a lazy way to CE Mark a machine and it is a form of malpractice. I’m sure manufacturers in other third countries (the EU term for all countries outside the EU) are doing the same thing, however, it is illegal. This blog is going to explore this issue in greater depth, using the Guide to application of the Machinery Directive 2006/42/EC, 2^nd Edition, June 2010, General Editor, Ian Fraser published by the European Commission Enterprise and Industry.  

Machinery Directive Definitions  

Article 2, Definitions States, “For the purposes of this Directive, ‘machinery’ designates the products listed in Article 1 (1)(a) to (f).   The following definitions shall apply:  

-- an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,  

-- an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,  

-- an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or structure,  

(g)’partly completed machinery’ means an assembly which is almost machinery but which cannot in itself perform a complete a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies.  

The Problem  

There are companies that manufacture partly completed machinery such as drilling rigs and excavators that claim to have CE Marked their equipment before being connected to a drive system, such as a generator, which isn’t legally possible. Instead, they must issue a Declaration of Incorporation. As noted in the June 2010 Guide Section  

§18 However, the manufacturer of partly completed machinery must state, in a Declaration of Incorporation, which of the essential health and safety requirements he has fulfilled – see §385: comments on Annex II 1 B, and §394: comments on Annex VII, B.  

In addition, the June 2010 Guide states:  

For machinery to be supplied without a drive system:  

-- the manufacturer’s risk assessment must take into account all the risks associated with the machinery, including those relating to the drive system to be fitted to the machinery – see §158: comments on General Principle 1 of Annex I;  

-- the machinery manufacturer must set out in his instructions all the necessary specifications for the drive system to be fitted such as the type, power and means of connection, and provide precise fitting instructions for the drive system – see §264: comments on section 1.7.4.2 (i) of Annex I;  

-- the conformity assessment of the machinery must cover the specifications of the drive system to be fitted and the fitting instructions ;  

-- the CE-Marking on the machinery and the EC Declaration of Conformity that accompanies the machinery must cover the specifications and instructions relating to the drive system to be fitted.  

§ 37 Machinery to be installed on a specific support  

The third indent of the definition of machinery refers to machinery intended for installation on a means of transport or in a building or structure.  

If such machinery is mounted on road vehicles or trailers that are excluded from the scope of the Machinery Directive, the requirements of the Machinery Directive do not apply to the vehicle or the trailer itself, however the requirements of the Machinery Directive apply both to the mounted machinery and to all aspects of the interface between the machinery and the chassis on which it is mounted which may affect the safe travel and operation of the machinery.  

The third indent of the definition of machinery implies that the manufacturer of machinery intended to be installed on a means of transport or installed in a building or structure is responsible for the conformity of the machinery with the relevant health or safety requirements. He must affix the CE-marking on the machinery and draw up and sign the EC Declaration of Conformity. The manufacturer of such machinery must take into account in his risk assessment all the risks associated with the machine, including those relating to installation of the machinery on the chassis of a vehicle or trailer or an a supporting structure. (Emphasis added)  

Manufacturers of machinery intended to be installed on a means of transport must therefore specify the vehicles or trailers on which such machinery can be safely installed, either by reference to their technical characteristics or, were necessary to specific models of vehicle.  

The conformity assessment of machinery intended to be installed on a means of transport or in a building or structure covers the machinery itself, the specifications for the supporting structure and the installation instructions. The necessary tests and inspections must be carried out on the machinery installed on its support in order to check the conformity with the essential health and safety requirements. The CE-marking on the machine and the EC Declaration of Conformity that must accompany the machine cover the conformity itself and the specifications and instructions relating to its installation. (Emphasis added)  

What Does All of this Mean? 

The manufacturer of CE Marked machinery mounted on a means of transport is responsible for the conformity of the machinery with the Machinery Directive Annex I Essential Health and Safety Requirements applicable to the complete assembly and the Final Risk Assessment taking into account all of the risks associated with the machine, including those relating to the installation of the machinery on the chassis of a vehicle or trailer; including the partly completed drill rig or excavator and the partly completed generator.  

Both partly completed machines should have documents detailing what Annex I Essential Health and Safety Requirements apply to their partly completed machines, the EN standards that allow for a presumption of conformity, an ISO 14121-1:2007 Risk Assessment and an EC Declaration of Incorporation. The generator also should demonstrate how it satisfies the revised Electromagnetic Compatibility Directive 2004/108/EC, the CE Marking Directive 2000/14/EC of 8 May 2000 relating to the noise emission in the environment by equipment for use outdoors and EU Directive 2004/26/EC relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery.  

Legal Implications of CE Marking Machinery Malpractice  

Market Surveillance – The revised Machinery Directive in …”The ninth and tenth recitals introduce several provisions in the new Machinery Directive which establish a stronger legal basis for market surveillance and enforcement action.”  

Product Safety Directive – The revised EU Product Safety Directive 2001/95/EC strengthened the requirement that “products placed on the market are safe”  

US Product Liability Exposure – Any US Machinery manufacturer who places a machine on the EU market can be sued for cause in a US District Court for failing to manufacture a safe machine, i.e. one that complies with the safety requirements of the EU Machinery Directive. While this may seem a little far-fetched, I have served as legal expert in lawsuits filed in a US District Court by European Companies against American manufacturers. The rationale is quite simple, since European Courts do not encourage product liability lawsuits and US Courts are receptive to product liability lawsuits and the two parties meet the legal requirements to sue in a US Court, then why not use US law to seek monetary relief? Expect an increase in such lawsuits in the future. If you have product liability concerns regarding the Machinery Directive & related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net

Brussels You Have a Problem! – Out Of Date CE Marked Components & EC Declarations Of Conformity – Machinery #2

Introduction  

The first blog of this title identified the problem of out of date CE Marked Components and EC Declarations of Conformity, EC Declarations of Incorporation and EN Standards. Presumably, 1 January 2010 marked the date when CE Marked products must contain the latest revised EU Directives and latest EN harmonized standards. It is now six months later. As noted in my first blog on this topic, I discovered that component suppliers to my customers have been lax on this account. Not only have they not updated their EC Declarations of Conformity, EC Declarations of Incorporation and EN harmonized standards, in far too many cases they are out of synch by several years. This is a technical problem and potentially serious legal problem for component suppliers and their customers in both the EU and US. It also is extremely lazy and sloppy.  

Machinery Directive Market Surveillance  

I concluded the first blog in this set with a brief reference to provisions that were inserted into the Machinery Directive to improve market surveillance when the Directive was adopted in 2006. Below you will find those three provisions from the prior blog followed by several other provisions set forth in the revised Machinery Directive which are now supposed to be in force:  

·      Monitor conformity of machines with the relevant Directives  

·      Empower authorities to take action with necessary speed to remove machines from the EU market  

·      Fix rules concerning legal sanctions for non-compliance  

·      Organize surveillance activities to cover all stages of a machine lifecycle (placing on the market, use, withdrawal including recovery, recycling and destruction)  

·      Record and ensure the follow-up of complaints or reports concerning non-compliant machines  

·      Monitor accidents and damage to health concerning machines on the market  

·      Implement market surveillance programs for categories of machines and categories of risk  

·      Carry out checks of conformity of machines on the market  

·      Require the necessary documents and information for machines on the market

·      Where relevant, sample machines and subject them to the necessary inspections and tests  

·      Initiate the relevant infringement procedures for non-compliant machines  

·      Ensure that machines comply with the essential requirements of the relevant Directives  

·      Exchange market surveillance information with member states  

·      Develop joint member state projects for market surveillance  

·      Survey machines on the market to assure that CE marking and documentation requirements have been met and that machines have been designed and manufactured in accordance with the essential requirements of the relevant directives and don’t present any danger to personnel  

·      Create rapid and confidential exchange of information where machines could present a serious and immediate risk to the public interest  

·      Increase involvement of the machine manufacturer in the procedure  

·      Check for documents (essential requirements checklists, technical data, EN harmonized standards, risk analyses, notes, certificates of conformity, etc.)  

·      Physically examine machines, check on the presence of CE marking, other markings and possible regulatory labels  

·      Physically check on the name and address of the manufacturer and/or the person responsible for placing the machine on the market (authorized representative)  

·      Physically check for undue or incorrect CE marking or other regulatory marking

·      Where necessary, conduct laboratory tests to determine the conformity of the machine with the essential requirements of the relevant Directives  

·      Use robust practices to detect serious cases of non-conformity and the probability of risk  

·      Ensure effective communication and coordination between market surveillance activities and other organizations that intervene in the field of safety of machines (health and safety at work authorities and customs authorities)  

·      Provide for the rapid exchange of consumer machine information   ·      Implement EU Regulation 339/93 on the conformity of machines imported from third countries (now replaced by Regulation 765/2008)  

·      Take account of data concerning industrial accidents involving machines  

·      Link with the EU General Product Safety Directive  

·      Develop member state legal sanctions for non-compliant machines  

·      Improve administrative cooperation between EU member states for non-compliant machines  

·      Strengthen rules for worker safety and worker reporting on machines improperly CE marked  

Summary  

These are excellent steps and can’t be put in place soon enough. For those of us who take machinery safety seriously, enforcement of the rules would help us convince our clients in the US and other third countries that the EU is serious about machinery safety. Given the number of fly-by-night & bait-and-switch consultants filling the web pages with easy CE assurances and simple templates telling manufacturers that it won’t cost anything to CE Mark their products, serious enforcement can’t come fast enough.

The EU is unique in their systematic approach to product safety, and machinery safety in particular. Except for those products and machines covered by FDA, we have no comparable regulatory approach in the US. I would like to believe that US manufacturers share the EU belief in machinery safety (and some do share that belief), but I know better from personal experience.

Many clients have complained that safety increases the price of machines and makes them less competitive in the US market. I remind them of the 2002 Minnesota lawsuit where a US machinery manufacturer made a safe machine for the EU to satisfy CE Marking standards and a less safe machine for the US and paid the price in a $35 million punitive damages award to the plaintiff in a product liability lawsuit. Unfortunately, this fact doesn’t impress companies willing to take a risk, even if it harms people. Their question is, can I come up with an alternative?

I would love to work with the EU in improving their market surveillance and the hope for residual carryover to the US. As the world no doubt knows by now, antipathy to regulation runs high in the US (witness the US Materials Management Service paper mâché regulation of offshore drilling). Apparently, only catastrophe changes minds. If you have any questions concerning compliance and product liability vis-à-vis the revised Machinery Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net.

Brussels You Have a Problem! – Out Of Date CE Marked Components & EC Declarations Of Conformity #1

During the past few months I have worked with three clients preparing their CE Marking compliance materials (Applicable Directives, Annex I Checklist, Applicable EN Standards, Legal Protocol, Technical File, ISO 14121-1 Risk Assessment, identification of a Authorized Representative), for placing their machines on the market in the EU. In each case these clients purchased CE Marked Components for parts of their machines and received EC Declarations of Conformity from the component suppliers. All well and good!  

On closer examination, however, I noticed that one of the EC Declarations of Conformity for a part purchased in 2009, was dated November 2003 and listed four BS EN Standards dated 1997, 1994, 1999 & 1993. Out of curiosity I went to the BSI website and entered the numbers and titles of the standards. Three had been replaced in 2001. Only the 1994 standard was current. When contacted, the component supplier said, you purchased the component last year, ignoring the fact that three standards cited were even out of date when the Declaration was signed in 2003. My client was assured that the component satisfied the requirements of the 2001 standards, after some additional work by the components manufacturer.  

Another EC Declaration of Conformity from the supplier of a key component had to update 10 EMC & Low Voltage EN Standards that had been replaced by a more recent version of the standard. Only three of the standards remained the same. In this case, the recent versions of the standards had been used to manufacture the component, but the EC Declaration of Conformity had never been updated to reflect the changes.  

Following these two discoveries, I examined four other EC Declarations of Conformity for three clients and found all four to contain EN standards that had been replaced by a more recent version. To see if this same phenomena existed elsewhere, I called a client I will be working with in August and asked if he had received a Declaration of Incorporation for a machinery part we will be adding to his machine. He sent the Declaration to me and it too was out of date. The world of CE Marking compliance and market surveillance may have been tightened on 1 January 2010, but you couldn’t tell that from these component suppliers.  

Finally, I received a call from another client concerning CE Marking electrical components for the revised Low Voltage Directive. On one web site a components supplier listed compliance with a 1981 EN Standard. When I looked up the standard on the web, I found that the standard did not exist. It was so old that any connection to an existing replacement standard was lost, yet the company’s electrical components were proudly listed as CE Marked on their website. Further, the company somewhat sanctimoniously noted that they complied with the Low Voltage Directive 72/23/EEC as amended by 93/68/EEC. There was no mention that the new EU Low Voltage Directive 2006/95/EC repealed the prior Directive as of 16 January 2007. Clearly this supplier was and is out of date.

Some of these suppliers are American, some are multi-national and some are European. All were sloppy and somewhat peeved to have their shortcomings called to their attention. While my sample of 10 suppliers is small, I suspect that the failure to update may be widespread, if not endemic. Worse yet, these suppliers were not aware of the EU Regulation 765/2008 designed to tighten EU market surveillance. (For an expanded discussion of the regulation, see my October 30, 2009 blog.) 

Regulation (EC) No 765/2008 Setting out the Requirements for Accreditation and Market Surveillance Relating to The Marketing of Products and Repealing Regulation (EEC) No 339/93  

Presently, I want to underscore some additional aspects of the Market Surveillance measures of Regulation (EEC) No 339/93:  

·      Market surveillance measures – Article 19 (1.) Market surveillance authorities shall perform appropriate checks and, where appropriate, physical and laboratory checks on the basis of adequate samples. When doing so they shall take account of established principles of risk assessment, complaints and other information.  

·      Products presenting a serious risk – Article 20 (1.) Member states shall ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on the market is prohibited, and that the Commission is informed without delay thereof, in accordance with Article 22.  

·      Restrictive measures – Article 21 (1.) Member states shall ensure that any measures taken, pursuant to the relevant Community harmonization legislation, to prohibit or restrict the products being made available on the market, to withdraw it from the market or to recall it, is proportionate and states the exact grounds on which it is based.  

·      Exchange of information – Community Rapid Information System – Article 22 (2.) If a product presenting a serious risk has been made available on the market, Member States shall notify the Commission of any voluntary measures taken and communicated by economic operators.  

·      Controls of products entering the Community market – Article 27 (3.) The authorities in charge of external border controls shall suspend release of a product for free circulation on the Community market when any of the following findings are made in the course of the checks (on the characteristics of products)  

o   The product displays characteristics which give cause to believe that the product, when properly installed, presents a serious risk to health, safety, the environment or any other public interest  

o   The product is not accompanied by written or electronic documentation required by the relevant Community harmonization or is not marked in accordance with that legislation  

o   The CE marking has been affixed to the product in a false or misleading manner  

·      The authorities in charge of external border controls shall immediately notify the market surveillance authorities of any such suspension  

When The EU market authorities find a product that presents a serious risk, they will take measures to prohibit the product from being placed on the market and mark the products documentation with:  

‘Dangerous product – release for free circulation not authorized – Regulation (EC) No 765/2008.   When the product is not in conformity with CE marking requirements the market surveillance authorities shall require the authorities in charge of external border controls not to release the product for free circulation mark it:

‘Product not in conformity – release for free circulation not authorized – Regulation (EC) No 765/2008  

Summary  

In addition to being incredibly lazy and sloppy, I consider the problem of out of date EC Declarations of Conformity and EN harmonized standards to be quite serious. It has safety and liability implications for both the seller and buyer in the EU and US. It also is an area where machinery manufacturers do not expect to receive out of date components.  As of 1 January 2010 only revised Directives and the newest version of EN harmonized standards are to be identified on CE Marking Documents such as the EC Declaration of Conformity.  

When the revised Machinery Directive was adopted 2006, several provisions were inserted to improve market surveillance, such as:  

>Monitor conformity of machines with the relevant Directives  

>Empower authorities to take action necessary to remove non-compliant machines from the EU market  

>Fix rules concerning legal sanctions for non-compliance  

These are just a few of the new rules. I will expand the list in a future blog. If you have any questions concerning compliance and product liability questions concerning the revised Machinery Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net.

Medical Device Manufacturers – Product Liability Exposure & Product Liability Audits #3

Recap of the Two Previous Blogs  

Everybody loves a “one size fits all template;” it simplifies everything. It reminds me of the Greek myth about Theseus who traveled the road to Athens and encountered the bandit, Procrustes, the Stretcher, who had a bed which he offered to passers-by. He made his guests fit into the bed, either by stretching them to fit it or cutting off the feet of those who were too long. Fortunately, Theseus dispatched Procrustes and destroyed his bed.  

As you might gather, that is what I think of most templates designed to fit everyone; they are a cheap and simple approach sold by vendors and they don’t begin to address the complexity of issues that must be addressed by the buyer of the template. It’s bit of modern day “snake oil.”  

Blog 1# focused on FDA’s scrutiny of their Quality System Regulation. An increasing number of FDA 483 Warning Letters have emphasized the failure of medical device companies to abide by their quality system requirements. As noted, these letters are public via the Freedom of Information Act (FOIA) and used by plaintiffs’ attorneys as a platform for initiating product liability lawsuits. 

Blog 2# focused the litigation history of a medical device insurance company. Since over 90% of their product liability lawsuits were settled out of court, little was known about the nature of their product liability litigation. As noted in other blogs, increasingly plaintiffs’ attorneys have focused on the failure of medical device manufacturers to satisfy FDA QSR and ISO 13485 quality system requirements. The insurance company study also noted that medical device manufacturers did not examine their systems for product liability exposure. Instead, they assumed that their regulatory and quality personnel addressed these issues, which they didn’t. Basically, they possess neither the training nor the legal expertise to conduct such an examination.      

What also isn’t evident from recent product liability lawsuits is the financial magnitude of quality system product liability FDA sanctions and product liability losses. Two cases alone resulted in $160 million dollars in FDA fines and it is reasonable to assume that the real amount now exceeds $200 million dollars. (We already know that in non-medical device litigation that military contractors have paid in excess of $100 million dollars in sanctions for failed ISO 9001 Quality Management Systems.) Suffice to say quality management systems such as FDA’s QSR, ISO 13485 & ISO 9001 are fertile grounds for future product liability lawsuits.  

What To Do?  

By now, I am certain that you realize that a “one size fits all template” is not the answer. The approach will have to be diagnostic, sensitive to the medical device being manufactured and focus on the manufacturer’s quality management system, be it FDA’s Quality System Regulation, ISO 13485 or ISO 9001 or a combined effort incorporating more than one system. Critical legal information is contained in the quality manual, procedures, documents and records. Because medical devices are regulated, there are specific regulatory requirements for the manual, procedures, documents and records. In addition, every manufacturer tailors a quality management system to meet their unique needs.  

While corporate counsel and defense attorneys often fear documentation, remember that documentation cuts both ways – it allows a company to demonstrate its efforts to make a     medical device that was designed for patient safety and device safety. Little or no documentation means “if you can’t prove it, it doesn’t exist!” (For a larger review of Product Liability Lawsuits and Document Control read my March 30, 2009 & March 31, 2009 blogs.)  

As noted earlier, documents means all quality system documents, including audit reports, nonconformities, corrective and preventive action (CAPA), design documents, etc. In addition, other documents and communications include traditional memos, e-mail, voicemail, meeting minutes & discussions, human factors studies, hazards analysis/risk analysis, customer complaints, web site advertising and sales claims, etc. Documents be obtained in legal discovery by plaintiff’s request for production of documents. All parties named in a lawsuit will be deposed and answer questions about documents. Anything you say or have written can and will be used against you. Finally, destruction of documents after a lawsuit has been filed is a criminal offense. 

The Quality System Regulation, ISO 13485 and ISO 9001 do not focus on products and the liability exposure presented by those products. The persons who conduct internal and third party audits do not examine liability issues in a company’s Quality Management System. They don’t believe that this is part of their responsibility and they don’t feel competent to make such judgments. Most quality auditors would consider such behavior ”practicing law without a license.” It could expose them to personal liability. The question then is, What to do? First, examine what plaintiffs' attorneys use as their rationale for a lawsuit. 

What is the Basis for a Product Liability Lawsuit?  

Product Liability Lawsuits primarily focus on three areas – Pre-production (Device Design Defects), Production (Manufacturing Defects) and Post-Production/Post Sale Obligations. All three areas touch upon aspects of quality management systems. Pre-production - Design Defects include foreseeable risks that could have been reduced by adoption of a reasonable alternative design and this omission resulted in an unsafe product. Defective design also occurs where non-conformance with state-of-the-art design development or the allegation that alternative technologically feasible and practical designs were not used resulting in an unsafe product.  

Production – Manufacturing defects occur when a product departs from its intended design, is physically flawed, damaged or incorrectly assembled resulting in injury. Post-production/Post Sale Obligations occur when a product is in the marketplace and complaints arise concerning its effects on patients. For example, foreseeable risks in the use of a device could have been reduced by providing reasonable warnings and instructions to patients. The omission of these warnings and instructions renders the devices unsafe.  

Most Product Liability Lawsuits Are Based on Four Questions  

·      Did the manufacturer provide a product that was free of design defects?  

·      Was the product suitable for the use for which it was sold?  

·      Did the manufacturer establish an effective system to monitor and analyze post-sale problems and hazards?  

·      Did the manufacturer follow-up on its knowledge of hazards with appropriate and adequate action?  

Product Liability Audits  

Product Liability audits must examine every aspect of a medical device manufacturing operation with a special emphasis on patient safety and device safety. This includes the design, manufacture, sale and distribution of the device. Every aspect of communication must be examined and, including prompt attention to customer complaints. Further, FDA is placing increased attention on top management’s commitment and knowledge about the device(s) they manufacture and the Quality System Regulation that governs their manufacturing operations.

  The prudent step would be to engage a product liability attorney experienced with Quality management Systems to conduct a Product Liability Audit of a medical device manufacturer and help set up a Product Liability Training Program. If a company is interested in having such an audit conducted and developing a Product Liability Training Program, you can contact me for a free preliminary consultation/discussion at theguide1@comcast.net.    

Medical Device Manufacturers – Product Liability Exposure & Product Liability Audits #2

Product Liability Audits are one way to deal with the issue of product liability exposure. Such audits can also include, “Product Safety Audits”, “Preventive Law Audits” and “Loss Control Audits.” While the terms may vary and the emphases may vary, they share the objective of conducting some sort of in depth audit/review about how companies conduct their business and an attempt to reduce their exposure to product liability lawsuits.  

Concerning Medical Devices, however, the focus must be on the regulatory structure of Quality Management Systems, whether it is FDA’s Quality System Regulation (QSR), the EU’s Medical Devices Directives & ISO 13485: 2003 or Vendor compliance with ISO 9001:2000, now ISO 9001:2008. As mentioned numerous times in my previous blogs and underscored by the Medical Device Insurance Company’s Study of its litigation history (see previous blogs), plaintiffs’ attorneys are learning about the different quality management regulatory systems and successfully winning product liability lawsuits. The reason the outcomes of these lawsuits are unknown is that they are settled out of court.  

Consequently, there is no case law to study and there is an aversion by QMS consultants, trainers and publications to talk about the subject for fear that a discussion about the legal implications ISO 9001, ISO 13485 and FDA’s QSR could incite trial lawyers to use quality management systems for nefarious purposes. While the axiom “ignorance is bliss” may have some useful meaning (although I’m not sure what that could be), avoiding a topic because it might “threaten the QMS consulting, training, publication enterprise” gives new life to the “head in the sand” and “emperor’s new clothes” approach to knowledge about a topic. It is a profound disservice and it also allows consultants, trainers and publications to share their ignorance with their clients. Not very swift! 

FDA’s Quality System Regulation and Medical Devices Lawsuits  

As noted in previous blogs, medical device manufacturers have had serious problems with their Regulatory Quality Management Systems resulting in FDA 483 Warning Letters often followed by product liability lawsuits. In addition, plaintiffs’ attorneys also have successfully used manufacturers’ Quality Management Systems against medical device manufacturers in product liability lawsuits without an FDA 483 Warning Letter. To underscore this point, I am going to list QMS violations from the Medical Device Insurance Company Study that resulted in out of court settlements.  

·      Lawsuits successfully noting the lack of a QMS Quality policy Statement committing a manufacturer to “patient safety & product Safety”  

·      Lawsuits successfully revealing no manufacturer QMS documented methods, processes or procedures for communicating product safety concerns  

·      Lawsuits successfully revealing no concerns in the manufacturer’s QMS business processes demonstrating the company’s commitment to product safety  

·      Lawsuits where Plaintiffs’ attorneys successfully refer to medical device Quality Management Systems as “paper only” systems rather than a demonstrated commitment to patient safety and product safety  

·      Lawsuits where QMS documentation does not address product liability & product safety concerns allowing Plaintiffs’ attorneys to rely on manufacturers poorly conceived and written documents to win their cases  

·      Lawsuits where post-market incidents were not fully investigated and appropriate QMS CAPA actions taken, including design changes, resulting in Plaintiffs’ attorneys citing safety failures to win lawsuits  

·      Lawsuits where key aspects of QMS design control such as “hazards analysis/risk analysis” have been cited by Plaintiffs’ attorneys and ruled by courts to be inadequate for product safety

  ·      Lawsuits where Plaintiffs’ attorneys have successfully won lawsuits by citing manufacturers failure to comply with FDA QSR regulations for contract manufacturing agreements  

·      Lawsuits taken to jury trials successfully used manufacturers QMS, quality manual & quality procedures against the manufacturer because their quality processes were not followed or audited  

·      Lawsuits successfully revealed that “hazards analysis stage gates” in a company’s product development/product review processes often did not demonstrate adequate review of the sciences relating to human factors resulting in an adverse judgment against the manufacturer

  ·      Lawsuits where medical device manufacturers completed exhaustive testing of their device, but the Design History File poorly documented the hazards analysis/risk analysis resulting in adverse judgments  

·      Lawsuits where the hazards analysis/risk analysis did not include appropriate analysis of raw materials for biocompatibility or didn’t conform to a design specification for raw materials or components resulting in an adverse judgments  

·      Lawsuits successfully revealed that the lack of a triggering mechanism to provide an early warning within a manufacturer’s customer compliant handling system didn’t allow early intervention by QA/RA personnel resulting in an adverse judgments  

·      Lawsuits revealed misconceptions by management of biotech firms that compliance with FDA’s QSR or ISO 13485 standards was sufficient to prevent product liability claims  

·      Lawsuits revealed a lack of manufacturer management and staff training in product safety vis-à-vis quality management systems and the documentation of such training  

·      Lawsuits revealed that post-production complaint data often was poorly managed and not escalated to senior management and/or ignored by senior management  

·      Lawsuits revealed that post-production corrective & preventive actions were deemed to be inadequate based on the degree of risk presented in individual complaint investigations or in compiled complaint data  

·      Lawsuits revealed when the adequacy of warnings and user instructions were questioned, manufacturers had no method to counter the questions, because warnings, labels and instructions were not tested by a hazards analysis/risk analysis to demonstrate their appropriateness and adequacy  

Summary  

The list goes on, the monetary damages accumulate and the new insurance policies increase the premiums and the deductible (I mentioned in an earlier blog that I worked with a company where the insurance company increased their deductible to $2 million per lawsuit before the insurance company would pay for their next legal defense).   For medical device manufacturers several things must occur for a successful product liability audit:

·      The audit must focus on the product liability exposure created by a Medical Device Quality Management System, if not conducted by an attorney who is familiar with such systems, it should be critiqued by a product liability attorney, further the attorney should be familiar with the different QMS systems – FDA’s QSR, ISO 13485: 2003 & ISO 9001:2000 & ISO 9001:2008, including relevant EN harmonized standards such as ISO 14971: 2007  

·      The audit must focus on the primary causes of action against medical device manufacturers in product liability lawsuits, such as Design Defects (QMS requirements, foreseeable use, foreseeable misuse, failure to warn, incorrect labeling, inadequate hazards analysis/risk analysis, etc.); Manufacturing Defects (QMS requirements, process risk analysis, incoming raw materials and component parts inspection, finished device acceptance, verification, validation, processing controls, non conforming product, corrective & preventive action, handling, storage, packaging and distribution); Post-sale Obligations (QMS requirements, complaints, complaint handling, corrective & preventive action, device recalls & quarantine, design review, etc.)  

There are several additional issues to consider such as the product liability implications of FDA’s QSR, ISO 13485 & ISO 9001 documents, records and procedures which I will look at in my next blog. In addition, it is necessary to look at FDA Guidance Documents including Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk management, Design Control, Medical Device Quality System Manual: A Small Entity Compliance Guide, etc. and a full review of FDA’s Guide To Inspections Of Quality Systems (QSIT).  

All of these issues, however, must be looked at from both a Quality Management System perspective and a Product Liability Exposure perspective. While complementary, they are different. As noted several times plaintiffs' attorneys are rapidly learning about the legal implications of Quality Management Systems (they are not fully experienced yet), however, defense attorneys and corporate counsel have a very long way to go.  If you have product liability concerns regarding the US medical devices market, you can contact me for a free preliminary consultation at theguide1@comcast.net.  

Medical Device Manufacturers – Product Liability Exposure & Product Liability Audits #1

The Medical Device Insurance Company Litigation Study discussed in the previous two blogs frequently noted that there was an assumption by medical device manufacturers that compliance with FDA’s Quality System Regulation, ISO 13485 and/or ISO 9001 would be a sufficient defense in a product liability lawsuit. The insurance company litigators were especially surprised at the naïveté of management making this assumption. Further, the study found that medical device managers often assumed that their documents and records would answer any questions that might arise in the event of a lawsuit, a misguided assumption.  

The study found that very few medical device manufacturers looked at their Quality Management Systems from the perspective of product liability exposure – this included Top Management, Corporate Counsel, Quality Managers and Regulatory Affairs Managers. Further, no one thought to consult Defense Attorneys or Product Liability Attorneys about the company’s product liability exposure. The study noted that most medical device manufacturers have neither the personnel nor the expertise to conduct product liability or product safety audits. Consequently, medical device manufactures continue to be surprised when they receive a legal summons for a product liability lawsuit. The next blog will examine product liability audits. For the present, however, I want to look at the issue of product liability exposure.  

FDA Warning Letters  

I have discussed the issue of FDA Warning letters in previous blogs, in particular my July 24, 2009 blog, Lawsuits Involving ISO 9001: Hiding in Plain Sight. Just as Tigers and Lions wait for their prey to come and drink water, Plaintiffs’ attorneys read FDA 483 Warning Letters as a sign of potential medical device problems, knowing that they can use the FDA legal rationale to provide support for a product liability lawsuit. I have listed a three recent warning letters below to underscore this point. The focus here is failure to comply with FDA’s Quality System Regulation (QSR).  

Weartech International Inc., Santa Fe Springs, CA – September 29, 2009  

Weartech “manufactures dental alloy products.” An FDA inspection cited the following QSR failures:  

·      Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met as required by 21 CFR 820.30(a). For example, there are no design control procedures for the dental alloy products.  

·      Failure to establish and maintain a design history file (DHF) for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part, as required by 21 CFR 820.30(i). For example, there is no design history file for the Dentaflex and Dentalbond dental alloys.  

·      Failure to adequately ensure that when the results of a process can not be fully verified by subsequent inspection and test that the process be validated with a high degree of assurance and approved according to established procedures, as required in 21 CFR 820.75(a). For example, the following processes do not have established procedures for validation activities and results, nor documented validations: (a) Cleaning and polishing of the dental alloys; (b) cutting the dental alloys; and, (c) the mold process for the dentist.  

·      Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, the corrective and preventive actions procedures are inadequate in that they do not require the verification of corrective and preventive actions.  

·      Failure to adequately establish and maintain records of acceptable suppliers, contractors, and consultants, as required by 21 CFR 820.25(a)(3). For example, the vendors of the coolant, soap and ceramic used for manufacturing the dental alloys are not listed in the firms approved vendor list.  

Listed above are 5 of 15 failures cited in Weartech’s September 29, 2009 FDA 483 Warning Letter. Contemplate for a moment what a plaintiff’s attorney might do with this information. Dental alloys have been in the news following the discovery that a woman in Ohio had experienced pain and complications from lead found in a new crown. The tainted alloy material in the Ohio case came from a Chinese supplier whose material had not been adequately tested. How many similar cases might exist? This doesn’t suggest that Weartech committed a similar infraction, but it does create a paper trail and incentive for a potential lawsuit.  

Byrne Medical Inc. Conroe TX July 31 2009  

Byrne Medical Inc. “manufactures and distributes sterile disposable water bottle adapter tubing sets and accessories, and a peristaltic irrigation pump for use in endoscopy applications with original equipment manufacturers’ (OEM) endoscopes” An FDA inspection cited the following QSR failures.  

·      Failure to establish and maintain adequate procedures for implementing corrective and preventive actions as required by 21 CFR § 820.100(a), and a failure to document the adequate results of corrective and preventive action activities as required by 21 CFR § 100(b). See FDA 483, Observations 1,3,8, and 12.   

·      Failure to establish and maintain procedures for rework; failure to include retesting and reevaluation of the nonconforming product after rework; and failure to ensure that the product meets its current approved specifications, as required by 21 CFR § 820.90(b)(2). See FDA 483 Observation 16.  

·      Failure to establish and maintain adequate procedures for validating the device design in order to ensure that the devices conform to defined user needs and intended uses, as required by 21 CFR § 820.30(g). The design validation must include testing of production units under actual or simulated use conditions, and risk analysis, where appropriate. The design validation results must be adequately documented and filed in the design history file. See FDA Observation 11.  

Listed above are 3 of 7 failures cited in FDA’s 483 Warning Letter to Byrne Medical, Inc. on July 31, 2009. Again, contemplate what type of information in that letter might interest a plaintiff’s attorney. Since Byrne manufacturers and distributes equipment used in endoscopic surgery, it raises a question whether there have been any accidents or injuries to patients that might be attributable to Byrne equipment. If so, the failures cited in the FDA Warning letter could be useful in a product liability lawsuit.  

ELA Medical S.A.S. Montrogue France November 6, 2009  

ELA Medical S.A.S. manufacturers the Avalto 6750 Implantable Cardioverter Defribillator (ICD).   The FDA inspection “revealed that your Ovato 6750 with Situs OTW Lead devices are misbranded under section 502(t) of the Act, 21 U.S.C. 352(t)(2), in that the firm failed or refused to furnish materials or information respecting the device that is required under section 519 of the Act, 21 U.S.C. 360i and Title 21, Code of Federal Regulations (C.F.R.), Part 803 – Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:  

1. Failure to report to the FDA no later than 30 calendar days that your firm received or otherwise became aware of information, from any source, that reasonably suggests that your marketed device may have caused or contributed to a death or serious injury as required by 21 C.F.R. § 803.50(a)(1). For example:   a. Complaint No. (b)(4) was received by your firm on May 18, 2008, from France, for the Ovato 6750 (b)(6). The complaint indicates that the ICD was incapable of delivering shock during induction attempt of the ventricular fibrillation and that the patient was treated with external electrical shock.   b. Complaint No. (b)(4) was received by your firm on February 18, 2009, from Toledo, Ohio for the Ovato ICD 6550 (b)(6). The complaint indicates that the ICD failed to charge during implantation procedure and the patient received external shock.  

Listed above is 1 of 4 failures cited regarding ELA Medical S.A.S. defribillators. After listing the problems, FDA added language about immediate corrections before the company can import into the U.S. market. As with the preceding FDA 483 Warning Letters, plaintiff’s attorneys will examine the device failure vis-à-vis a potential product liability lawsuit.  

Summary  

I have only discussed a small portion of each FDA 483 Warning Letter and a very small sample of the list of FDA Warning Letters. These letters can be read on FDA’s excellent web site. Medical Devices are under the jurisdiction of the Center for Devices and Radiological Health (CDRH). Enter FDA Warning Letters and QSR if you want to focus on quality system issues.  

While FDA Warning Letters offer a good source of information to plaintiffs’ attorneys, they are not the only source of information. Most of the Medical Device Insurance Study examined lawsuit losses not involving FDA Warning letters. What is critical is that plaintiffs’ attorneys are beginning to use FDA’s QSR, ISO 13485 and ISO 9001 in product liability litigation. The second part of this blog will focus on product liability audits, product safety audits and preventive law as a way to reduce a company’s product liability exposure. This is particularly useful for medical device manufacturers concerned about liability exposure in the American Federal and State legal systems. If you have product liability concerns regarding the US medical devices market, you can contact me for a free preliminary consultation at theguide!@comcast.net.  

Medical Device Manufacturers – Product Liability Exposure & Product Liability Litigation #2

In Blog #1 I reviewed some of the findings of a US litigation study conducted by a Medical Device Insurance Company to identify recurring patterns of behavior resulting in product liability lawsuits. As noted earlier, because 90% of these cases were settled out of court and sealed, there is little public knowledge of what happened. Among the issues discussed in the last blog was the finding that plaintiffs’ attorneys have been successful in using medical device manufacturers’ quality management systems (FDA’s QSR, ISO 13485 & ISO 9001) against them to successfully support plaintiffs’ product liability claims.  

Product liability lawsuits are a continual threat to the financial success and prosperity of medical device manufacturers. Unfortunately, too often the threat isn’t taken seriously. Also, from my personal experience as a lawyer/legal expert in ISO 9001 litigation, I have found defense attorneys to be almost clownish in their efforts to deal with the legal implications of quality management systems, e.g. arguing that as soon as a product is discontinued, their QMS no longer has to receive and respond to customer complaints concerning that product.

Recurring Patterns in Product Liability litigation

Returning to the Medical Device Insurance Company’s recurring patterns of behavior resulting in product liability lawsuits, the following additional issues were identified:  

·      The study found when the adequacy of warnings and user instructions has been questioned manufacturers had no way to effectively counter these allegations. Too often device warning labels and instructions were incorporated without documentation of the testing of the warnings or instructions to demonstrate the adequacy of the warnings. More often than not, there were no Standard Operating Procedures (SOPs) or guidelines to follow to document how and why the manufacturer developed its warnings and instructions resulting in product liability lawsuits.  

·      The study revealed that warranty claims and allegations arise as failures in product liability pleadings from advertising materials when devices don’t work as claimed in medical device advertising documents  

·      Plaintiffs’ have successfully alleged that manufacturers’ internet web sites contained misleading claims and testimonials that should have been considered at the product design stage following a full hazards analysis/risk analysis.  

·      Manufacturers frequently lacked a clear understanding of the potential risks and product liability complications with misunderstood safety documents and communications.  

·      The study revealed a lack of qualified in-house personnel available to integrate product liability avoidance principles into the manufacturers quality management system to establish an infrastructure for device safety, resulting in product liability post-production legal defense problems. Regulatory personnel often were tasked with product safety and product liability responsibilities that exceeded their professional experience and expertise.  

·      Often post-production complaint data was poorly managed and not escalated to the attention of senior management and/or further compounded by being ignored by senior management resulting in regulatory sanctions by FDA followed by product liability lawsuits.  

·      Too often manufacturer post-production corrective and preventive actions have been deemed by FDA to be inadequate for the degree of risk presented by individual complaint investigations and compiled complaint data, resulting FDA regulatory actions and product liability lawsuits.  

·      Several cases were observed where manufacturers did not conduct post settlement reviews and analyses of claims in order to learn from their litigation experience. Consequently, when a case was settled and believed to be over and finished, the failure to learn from past experience often resulted in a similar case arising a few months later.  

·      A review of several similar cases revealed that when medical device manufacturers learn of post-sale device risks and hazards and take little corrective action or worse attempt to cover up the severity of the potential risk, they are in an indefensible position in product liability litigation.  

·      Often, documented critical safety information is carelessly worded and/or prepared and used against a manufacturer to support the allegation of a lack of attention to and concern for patient safety and device safety in product liability lawsuits.  

Documentation  

Medical device Quality Management Systems are document rich, accommodated by the document and records requirements of their QMS and driven by the document and record requirements of regulatory agencies such as FDA and their national counterparts in the EU, Canada, Australia and Japan. If a mandated document or record has been lost or destroyed, it can be seen as the illegal destruction of evidence. If it has been poorly articulated or prepared it can be seen as unacceptable incompetence.  

Paper trails exist everywhere, recording device design, design changes, device distribution, device complaints, process controls, non-conformance, corrective and preventive action, post-production reviews, device recalls, etc. Plaintiffs’ attorneys are aware of this rich source of data and defense attorneys and corporate counsel should be fully conversant with the same to better serve their manufacturer clients. They need to think like QMS auditors when using their legal antennae.  

Summary  

In an earlier blog I described working with Corporate Counsel and the Risk Manager of a Corporation concerning one of their Divisions that had been experiencing significant losses from a series of product liability lawsuits. They asked me to study the problem and make some recommendations. As I was conducting the study the Division was notified by their insurance company and litigation team that the insurance company was going to pay a $5 million dollar claim and raise their deductable to $2 million dollars per lawsuit in the future. The moral of this story is that product liability losses can quickly threaten profit margins and company survival  

Recently, I went to large building supply store to buy some non-latex gloves for my wife. She found that she had developed a rash on one of her hands when using latex gloves to clean a professional kitchen after teaching a cooking class. I mentioned that latex allergies can develop in people after continued use. Doctors and nurses had discovered this in hospitals and clinics.  

When I found the glove section in the supply store, most were latex and only two were non-latex. The glove markings were obscure. On the latex gloves there was a statement, “in the unlikely event that you might have an allergic reaction to these gloves, discontinue use.” It wasn’t that useful nor was it direct. In the EU these gloves would have had a CE Mark and a latex symbol indicating compliance with the Personal Protective Equipment Directive, instead of a snide self-serving “in the unlikely event” non-warning. The moral of this story is to provide intelligent warnings to potential users or anticipate a product liability lawsuit for failing to adequately warn. If you have product liability concerns regarding the US medical devices market, you can contact me for a free preliminary consultation at theguide1@comcast.net.  

Medical Device Manufacturers – Product Liability Exposure & Product Liability Litigation #1

In several blogs posted in March, April, May, June, July 2009, I discussed the private findings of a Medical Device Insurance Company that examined its litigation history to identify recurring patterns of behavior that resulted in product liability lawsuits. Since more than 90% of the cases were settled out of court, however, there is little public knowledge of what happened, i.e. what liability claim caused the case to come to trial and what, if any, were the critical errors?  

For EU medical device manufacturers, FDA sanctions followed by private product liability lawsuits, is a uniquely American phenomenon for two reasons: (1) EU medical device regulatory sanctions have yet to be made as rigorous as the FDA, and (2) there is little product liability litigation in the EU. I expect this to change over time, but for the present the US presents more pitfalls for manufacturers.

Except for the insurance company and their attorneys involved in this litigation, little is known in the way of product liability lessons to learn and pitfalls to avoid for medical device manufacturers. Also, little is known about the product liability litigation history of FDA’s Quality System Regulation, ISO 9001 and ISO 13485. This blog will review those patterns of manufacturer behavior resulting in medical device product liability lawsuits.  

Product Liability Litigation  

While attorneys are central to litigating product liability claims, their success depends upon their understanding of the regulatory process, the quality of information provided by their clients, medical device manufacturers, and it depends upon manufacturers working with their attorneys at key decision making stages to make certain that legal counsel is sought when needed.   

Medical device (also drug & biotech) litigation is a specialized field requiring knowledge of FDA and EU regulatory requirements and sanctions, and how they might impact litigation. Not every litigator is equipped with the necessary experience and skill to be successful in defending a medical device manufacturer in a product liability lawsuit. While corporate counsel, generally are not equipped to litigate a product liability claim, they can help in selecting a strong litigation team.

• The adoption of a Quality Management System (QMS) as a regulatory structure by FDA, Australia, the EU and Canada for medical device regulation is new to the legal world. Plaintiffs’ attorneys have just begun to exploit the QMS format and have had some initial success by alleging that patient safety and product safety should be contained in the quality policy if a company is serious about those issues. They have only begun to scratch the surface of how they can utilize elements of a regulated quality management structure in product liability litigation, but they are learning rapidly.

• Defense counsel and defendant litigators are neophytes in dealing with documented quality management systems and will need to develop a rapid learning curve to effectively defend their clients and not be overwhelmed. It is essential that they understand more about regulated quality management systems and how they can impact product liability litigation.

Recurring Patterns in Product liability Litigation  

Each bullet point listed below describes manufacturer problems that were decided in jury convictions or in out of court settlements against medical device manufacturers.  

·      The Insurance Company study revealed that plaintiffs’ attorneys have successfully used the absence of Quality Policy Statements “declaring that a manufacturer is committed to patient safety and device safety” as evidence that the medical device manufacturer is indifferent to patient safety and device safety.  

·      The study found a failure of many manufacturers to comply with FDA’s Quality System Regulation (QSR) for “contract manufacturing agreements.”  

·      Several medical device manufacturers “did not adequately investigate and analyze post sales medical device incidents and integrate reporting of these incidents” (non-conformities) in their FDA & EU mandated quality management systems.  

·      Several product liability claims successfully taken to jury trials “used the manufacturer’s quality management system and quality manuals against the manufacturer because their quality processes and quality procedures were not being followed or audited as required by FDA and EU notified bodies.”  

·      Several medical device manufacturers “created quality management systems to satisfy FDA & EU medical device regulatory requirements, but their QMS systems contained no documented methods, processes or procedures for communicating device safety concerns and/or incorporating those concerns into their business processes, thereby demonstrating no commitment to device safety.” 

·      Several product liability cases were recorded where a manufacturer’s “quality management system did not include aspects of device design as required by FDA & EU regulatory requirements, thereby opening regulatory non-compliance as evidence of design failure.”  

·      Several product liability cases were recorded where “customer complaint feedback was not treated as an indication of a non-conformity requiring corrective and preventive action in the manufacturer’s quality management system requiring a design review, risk analysis, design change and production change.”  

·      The study found numerous instances of medical device manufacturers “failing to protect and preserve their documentation by asserting attorney-client privilege prevented plaintiffs” from examining their documentation during discovery, which assertion was not accepted by the court.”

  ·      The study found several instances “where medical device manufacturers exhibited a lack of internal processes and procedures in manufacturer quality management systems for escalating device safety concerns and a review of those concerns, as well as an absence of any kind of cross functional committees to deal with device safety issues.” Plaintiffs’ attorneys successfully alleged that this failing demonstrated a lack of due care and concern for safety.  

Summary  

There is an old saying regarding medical device product liability litigation, “It’s not if you are sued will you be ready, but when you are sued will you be ready!” Medical device manufacturers continue to ignore product liability risks in medical device manufacturing, often at their peril. The costs of losing a product liability lawsuit can be financially devastating, compounded by the negative publicity for future sales, and increased insurance costs. Further, the “legal playing field” is fueled by negative findings by FDA that can be used by plaintiff’s to support their case.  

The litigious nature of US product liability lawsuits often looks like a legal minefield to medical device manufacturers planning to import products into the US market as well as contemplate building manufacturing facilities in the US. I will discuss these medical device product liability issues in future blogs as well as address a solution, “product liability audits” to reduce the risks. It is an approach I use when working with US & EU medical device manufacturers. If you have product liability concerns regarding the US medical devices market, you can contact me for a free preliminary consultation at theguide1@comcast.net .  

CE Marking Products for the EU – Product Liability Exposure in the US

I have discussed the topic of product liability exposure in several of my 2009 blogs. Recently, however, as I was helping a client find a company to make new metal plates with a CE Mark, company name and serial numbers for his machines, I came across advertisements from numerous consultants declaring that they could help companies CE Mark their products for modest amounts of money. Of course these claims often are understated only to have the client discover that it will cost a great deal more to finish the work, another form of “bait and switch.” And in other ads, manufacturers pursuing the lowest possible cost discover that they are buying a series of “fill-in-the-blank” templates, which are “one size fits all” for machines ranging from simple to complex. Both approaches could be categorized as a form of fraud.  

Caveat Emptor (Let the Buyer Beware!)

While Americans are suckers for anything cheap, “CE Marking Lite” for machines is a bad idea for several reasons. To comply with the revised Machinery Directive, it is necessary to identify the appropriate conformity assessment procedure for your machine and/or machine product family; it is necessary to construct an Annex I Checklist; identify the relevant EN harmonized standards that will allow the manufacturer to demonstrate a presumption of conformity with the Essential Requirements; it is necessary to conduct a complete ISO 14121-1: 2007 Risk Assessment and Hazards Analysis with documentation; create a Part A Technical File and EC Declaration of Conformity.  

The legal steps taken to comply with the EU revised Machinery Directive and related Directives should be clearly spelled out in your documentation so that the legal rationale and path taken is clearly written in a document for EU member state competent (national) authorities. In addition, this documentation will be vital to a legal defense in the event of a product liability lawsuit in a US Court of Law. This latter point also underscores the liability exposure for any EU based consultants in the UK, Ireland, the Netherlands, France, etc. working directly or via the internet in the EU with EU, US and other third country clients.  

If an EU based consultant or consulting firm accepts money from a US based company for CE Marking Assistance, they are subject to US Law in US Federal and State Courts. The fact that these consultants are physically based in the EU is irrelevant, because they are doing business in the US.  

Issues That Must Be Addressed When Complying with the Machinery Directive and Related Directives  

The primary focus of the Machinery Directive and other new approach Directives is product safety and in the case of machinery, machinery safety. To this end the Annex I Essential Health and Safety Requirements (ESHSR) were designed to address the various aspects of machine safety. This also means that new designs must incorporate the elements of the ESHER into the design of new machines and modify the designs of existing machines accordingly.  

To do this, it is necessary to identify the EN harmonized standards that will allow for a presumption of conformity. Many of these EN harmonized standards have been revised and are now EN ISO standards which means as ISO standards they also are American Standards, since the American National Standards Institute (ANSI) participates in the drafting of ISO standards (the implications of ANSI participation will become more apparent in future product liability litigation, see my July 10, 2009 & March 23, 2009 blogs). In short, ANSI standards are acceptable evidence to establish state-of-the-art in product safety in US Courts of Law.  

I have worked with machines from simple to extremely complex. The number of EN harmonized standards can range from as few as four to 30 or more. It depends on the number of ESHSR that apply to a specific machine. To assert that the certification for simple to complex machines can be handled for US$730.00 is not only absurd, it is wildly misleading. Further, it is necessary for each machine to conduct a hazards analysis and risk assessment for the design of the machine. To suggest that all hazards analyses and risk assessments are equal and can be handled for the same amount of money is equally stupid and misleading. A competent risk assessment can take a significant amount of time to do well. The more complex the machine, the greater amount of time and detail.  

Compliance with ISO 14121-1: 2007 Safety of machinery – Risk assessment – Part 1: Principles. Conducting a thorough risk assessment means that every possible hazard is identified and the reduction of that hazard to an acceptable level of machine safety by designing out all hazards, guarding against those hazards that can’t be designed out or guarded against and creating warnings and instructions for those hazards that can’t be designed out or guarded against.  

Every single question in the risk assessment standard must be answered Yes, No or N/A and the answer must be written in clear English so that it can be understood if a product safety issue arises. In most instances questions will arise several years later after the original writers of the risk assessment have moved on to other positions or retired. Therefore, the answers will have to stand on their own.  

Finally, it is only at the end of this process that a manufacturer can establish warnings and instructions for a machine and to determine how the machine should be marked for machine safety. Failure to issue warnings without conducting a full hazards analysis and risk assessment has resulted in punitive damage awards for plaintiffs against numerous manufacturers in product liability lawsuits in the US.  

Summary  

Product liability exposure will increase with the revised Machinery Directive, related Directives and the revised EN ISO standards. All companies, (domestic and foreign manufacturers, independent consultants and notified body consultants) active in the US marketplace will be subject to product liability exposure (see my July 10, 2009 blog, CE Marking Machinery – Future State-of-the-Art in American Product Liability Lawsuits). CE Marking will assume greater importance as soon as plaintiffs’ attorneys and subsequently defense attorneys begin to understand what is happening.  

While the one case to date that went to trial in Minnesota in 2002 resulting in a $35 million dollar punitive damages judgment involved safety standards, it was understood by the jury as a case where a California machinery manufacturer had been making a safer machine for the EU and a less safe machine for the US resulting in an injury that crushed the skull of a worker requiring 24 hour care for the rest of his life. The attorneys and the jury didn’t know that California machinery manufacturer implemented safety standards created for the EU Machinery Directive. What the jury did know was the fact that the California machinery manufacturer knew how to make a safer machine and had been doing so for 6 years, but chose to make a less safe machine for the US Market.  

How does this affect future product liability litigation in the US? Quite simple, a plaintiff’s attorney hires someone like me to serve as a legal expert to testify about the CE Marking process and how your company failed to meet the Directive’s Essential Health and Safety Requirements resulting in an injury to the attorney’s client or clients. It is similar to my involvement as a legal expert in product liability, design and contract litigation involving ISO 9001.  

Presently I am talking with some attorneys about serving as legal expert concerning accidents involving US manufactured machines. I discovered that two of the manufacturers sell their machines in the EU, which means that their EU machines should be CE Marked. Therefore, the question arises, are the EU machines safer? A perusal of their Technical Files, compliance with EU harmonized standards and hazards analysis/risk assessment will provide valuable information for the lawsuit. If you have product liability and risk assessment concerns vis-à-vis the US market regarding the revised Machinery Safety Directive and related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net.  

CE Marking Cosmetics & Pharmaceutical Machinery Starting 1 January 2010

Introduction 

I have just finished working with two clients CE Marking machines for the UK, Italy, Spain, Cyprus and Israel and will begin working with a client who wants to comply with the legal requirements of the Directive on Cosmetic Products and the Directive on Medicinal Products for Human Use which raises some interesting questions. While it may not be apparent, Cosmetics and Pharmaceuticals intersect with machinery in an interesting way in the revised Machinery Directive 2006/42/EC, namely in the Annex I Essential Health and Safety Requirements, Section 2.1 Foodstuffs Machinery and Machinery for Cosmetics or Pharmaceutical Products.  

The basic language of the revised Machinery Directive is straightforward:  

“Machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products must be designed and constructed in such a way as to avoid any risk of infection, sickness or contagion.”  

The following requirements must be observed:  

(a) materials in contact with or intended to come into contact with, foodstuffs or cosmetics or pharmaceutical products must satisfy the condition set down in the relevant Directives. The machinery must be designed and constructed in such a way that these materials can be cleaned before each use. Where this is not possible disposable parts must be used.

Conceptually, the expanded rules parallel FDA’s authorization under the Federal Food, Drug and Cosmetics Act, which has now been expanded to include tobacco. The big difference, however, is the focus here is on the machinery that manufactures foodstuffs, cosmetics and pharmaceuticals, whereas FDA’s focus is on the manufacturing of  these products. FDA doesn’t prescribe how to build machines, but they will inspect manufacturing processes to see if they are satisfying FDA’s Good Manufacturing Practices.  

Manufacturing Cosmetics and Pharmaceutical Products in the EU  

Prior to 1 January 2010 cosmetics and pharmaceutical machines had to be CE Marked to be used in manufacturing cosmetic and pharmaceutical products. This meant, however, that they only had to satisfy Section 1 Essential Health And Safety Requirements of Annex I of the Machinery Directive. Starting on 1 January 2010, under the revised Machinery Directive, cosmetic and pharmaceutical machines must also satisfy Section 1and Section 2 Supplementary Essential Health And Safety Requirements For Certain Categories of Machinery and Section 2.1 Foodstuffs Machinery And Machinery For Cosmetics Or Pharmaceutical Products. This means these machines now have to meet additional requirements, “to avoid any risk of infection, sickness or contagion”  

“The following requirements must be observed:”  

(a) materials in contact with or intended to come into contact with, foodstuffs, or cosmetics or pharmaceutical products must satisfy the conditions set down in the relevant Directives. The machinery must be designed and constructed in such a way that these materials can be cleaned before each use. Where this is not possible disposable parts must be used.  

(b) all surfaces in contact with foodstuffs or cosmetics or pharmaceutical products other than the surfaces of disposable parts, must:  

--be smooth and have neither ridges nor crevices which could harbor organic materials. The same applies to their joinings,  

--be designed and constructed in such a way as to reduce the projections, edges and recesses of assemblies to a minimum,  

--be easily cleaned and disinfected, where necessary after removing easily dismantled parts; the inside surfaces must have curves with a radius sufficient to allow thorough cleaning;  

(c) it must be possible for liquids, gases and aerosols deriving from foodstuffs, cosmetics or pharmaceutical products as well as from cleaning, disinfecting and rinsing fluids to be completely discharged from the machinery (if possible in a cleaning position);  

--(d) machinery must be designed and constructed in such a way as to prevent any substances or living creatures, in particular insects, from entering or any organic matter from accumulating in, areas that canny be cleaned;  

--(e) machinery must be designed and constructed in such a way that no ancillary substances hazardous to health, including the lubricants used can come into contact with foodstuffs, cosmetics or pharmaceutical products. Where necessary, machinery must be designed and constructed in such a way that continuing compliance with this requirement can be checked.  

Instructions  

The instructions for foodstuffs machinery and machinery for use with cosmetics, pharmaceutical products must indicate recommended products and methods for cleaning, disinfecting and rinsing, not only for easily accessible areas but also for areas to which access is impossible or inadvisable.  

How this will be enforced is not yet clear to me, but I have no doubt that it will be enforced. The EU is ramping up its market surveillance activities this year. To a degree, this falls into the same category as the new requirements for medical device machines having to satisfy both the Medical Devices and Machinery Directive. Also, the Cosmetics Directive is being revised with an expectation that the revised Directive will be published later this year. I expect some association with the new machinery requirements will be made in the revised Directive. I also expect greater emphasis on the  EN ISO 14121-1: 2007 Safety of Machinery Risk Assessment Standard to assure compliance,as well as other EN standards on basic Hygiene of food, cosmetics and pharmaceutical products.

What About the US And Third Countries?  

This new requirement to CE Mark machines should not only apply to EU manufactured foodstuffs, cosmetics and pharmaceutical products, but all foodstuffs, cosmetics and pharmaceutical products manufactured in third countries and placed by those companies on the EU market. This would apply to companies in the Third Countries like the US, Canada, Brazil, China, Australia, India, etc.  

Just as FDA will inspect any manufacturing facility in the world to make certain that they are satisfying FDA Health and Safety Good Manufacturing Practices before exporting to the US, I anticipate that the EU will develop a means to accomplish the same Health and Safety objectives about exporting into the EU. Therefore, this means that companies in the US should now be preparing their foodstuffs, cosmetics and pharmaceutical products in CE Marked machines to satisfy, EU Health and Safety Requirements. If you have any questions regarding the new Machinery Directive requirements for Foodstuffs, Cosmetics or Pharmaceutical Products, you can contact me for a free preliminary consultation at theguide1@comcast.net.      

ISO 9001& ISO 9004: A Framework for Disaster Preparedness Revisited #4

Before Disaster Planning – Vesuvius, Pompeii & Herculaneum 79 AD  

On August 24, 79 AD, the Roman Historian, Pliny the Younger was awakened by his mother to look at a huge cloud in the sky. “A cloud was forming over Vesuvius which looked very-much like a pine-tree. In fact it stretched upward like the trunk of a tall tree and then branched out wide.”(The picture above is such a pine-tree on the Amalfi Coast overlooking the Mediterranean, 40 miles South of Vesuvius.)   

Political and Cultural Problems with Disaster Planning  

I was raised in Eau Claire, Wisconsin where the Eau Claire River flows into the Chippewa, River. It is a former lumber town founded in 1856. By1885 the town contained 32 lumber mills and sawed 800 million board feet of lumber, the largest lumber town in the world at that time. The mills were fed by logs brought by train from as far away as Lake Superior, 250 miles distant. By 1917 the last log was sawed and the last lumber mill was shut down. The lumber industry moved West.

A by product of the two rivers merging and low lying areas of the town around the original mill sites was frequent flooding that occurred in the Spring when the snow melt swelled the rivers beyond their banks.   My father, Henry W. Kolka, who was a Professor of Geography and Chair of the Geography Department at the State University in Eau Claire, recommended that the city consider relocating houses from low lying areas to higher ground and clearing the flood prone areas to create City Parkland which would be relatively unaffected by periodic flooding. The city fathers were appalled at such a suggestion. In their minds it bordered on socialism. My father countered that spending money to constantly clean up flooded homes was a wasteful use of public funds. Many years later, however, the recommendation was adopted.  

Several years later, when I was a new faculty member at the University of Wisconsin-Green Bay and a member of an interdisciplinary research team studying a lake watershed in Northeastern Wisconsin, we made a similar recommendation about the County swapping high land for marshland and met with a similar response. (This example will be addressed at length in future environmental blogs.)

Both of these incidents are minor disasters and both underscore a critical problem in disaster planning – political structures and cultural perceptions. The political entity (City, County, State, Federal Government) has to be large enough to effectively address a problem and cultural perceptions have to be able to grasp potential solutions to a problem. The shopworn phrase, “Think Outside the Box.” runs up against another shopworn phrase, “If it ain’t broke, don’t fix it.” Neither phrase is useful when confronting a potential disaster.

Political, Ideological and Geographic Problems with Disaster Planning

While political boundaries are artificial human constructs, they are real boundaries when it comes to disaster planning. In addition to political systems planning for a potential disaster, these artificial human constructs are not well prepared to handle diverse geographic issues such as a River like the Mississippi which flows through several Cities and States to the Gulf of Mexico. As a navigable river it also is subject to the jurisdiction of the federal government. The Mississippi River has flooded several times throughout its history of human habitation.  

Therefore, a disaster preparedness solution must include these different political entities in the planning process. Add to the mix, the Army Corps of Engineers that regulates the flow of the river for barge navigation via a complex system of locks and you have a diverse political stew attempting to solve a common problem from very different political and geographic perspectives. 

The most recent Great Flood on the Mississippi occurred in 1993 causing $15+ billion dollars of damage in 10 States. Prior great Floods occurred in 1844, 1927, 1951 and 1973. As in the example of Eau Claire, cities along the Mississippi were settled when transportation was by water. Consequently, low-lying cities on the waters edge have flooded numerous times. Finally, after the 1993 flood several cities opted to move to higher ground in Illinois and avoid another flood in the future.

Hurricane Katrina  

The most striking example of a failure in disaster planning and disaster preparedness in the United States was Hurricane Katrina in August 2005. No political entity – the City of New Orleans, the States of Louisiana, Mississippi, Alabama, Florida and the Cities, Parishes and Counties along the Gulf Coast were prepared for the catastrophe, least of all the US Government which kept calling it a State or City problem.

It was a pathetic breakdown in any kind of planning and an absence of a useful emergency response plan. FEMA (Federal Emergency Management Authority) proved to be inept and slow, preferring to blame the States and City of New Orleans. Once the President focused he did not intervene to address the situation in a timely fashion. There were 1,836 persons confirmed dead and 705 missing. The damage has been calculated at $90.9 billion (2009) dollars, the worst natural catastrophe in US history.  

On November 18, 2009, US District Court Judge Stanwood Duval ruled that the Army Corps of Engineers failure to properly maintain the Mississippi River Canal Outlet (MRGO), linking New Orleans, Louisiana to the Gulf of Mexico led to catastrophic flooding during Hurricane Katrina.

“   It is the court’s opinion that the negligence of the Corps, in this instance by failing to maintain the MRGO property, was not policy, but insouciance, myopia and short-sightedness.” “For over 40 years the Corps was aware that the Reach II levee protecting Chalmette and the Lower Ninth Ward was going to be comprised by the continued deterioration of the MRGO…The Corps had an opportunity to take a myriad of actions to alleviate this deterioration or rehabilitate the deterioration and failed to do so. Clearly, the expression ‘talk is cheap’ applies here.”   

Who Is Responsible For Disaster Preparedness?  

Unfortunately, this is the key question, amplified by the inept political response to Hurricane Katrina – no one appeared to be in charge and fingers pointed in all directions while a city and its people were in desperate condition. The world looked on and couldn’t believe that such a calamity could happen in America. It looked more like a developing country that lacked the political structure and resources to address such a crisis. There were even debates about the proper role of government.  

Since the Federal Government is the only political entity that governs the entire region and is responsible (via the Army Corps of Engineers) for maintaining the Mississippi River Canal Outlet, it should take the lead in working with the states and cities in addressing the crisis so that it isn’t repeated in the future, but isn’t clear if disaster preparedness planning is happening now in any coherent way. I am quite certain that the EU would be far more aggressive in disaster preparedness planning if faced with a similar crisis. Infrastructure development is far more advanced in he EU and its member states than in the US.  

Blog number #5 will address other types of disasters and what is being done to address disaster preparedness in those areas. It also will draw upon ISO 9001 & ISO 9004 to provide an enhanced framework for disaster preparedness. If you have disaster preparedness concerns, you can contact me for a free preliminary discussion at theguide1@comcast.net.  

ISO 9001& ISO 9004: A Framework for Disaster Preparedness Revisited #3

The Disaster Setting  

In Spring 2004, I was contacted by a health care group from a major metropolitan area in the Northeast – they had read my February 2002 Quality Progress article using ISO 9001 & ISO 9004 for Disaster Preparedness. They asked for assistance in preparing a Disaster Recovery and Service Continuity Planning effort for their metropolitan area concerning the provision of healthcare services in the event of a disaster. What follows is a brief outline of my proposed plan.  

The Disaster Preparedness Outline  

To begin it is necessary to establish a map of health care resources and facilities in the metropolitan area and then determine what will be included in the Disaster Preparedness Plan. Next it is necessary to establish what secondary and tertiary resources and facilities will be needed to provide services in the event of a disaster. The provision of resources and facilities will require several alternative backup strategies since the nature and impact of a disaster is unknown and could adversely impact hospitals, health care facilities and surge resources included in one version of a disaster of a disaster plan.  

Next it will be necessary to identify the potential risks that could affect the provision of health care facilities. Once the risks have been analyzed, it is possible to prepare a plan to respond to emergencies more effectively as well as preserve health care resources. A disaster plan will:  

·      Help the planning authority fulfill its moral responsibility to protect citizens, health care workers, healthcare resources, the community and the environment;  

·      Facilitate compliance with government agencies;  

·      Enhance the healthcare community’s ability to recover from destroyed facilities, personnel losses, financial losses and the interruption of services;  

·      Reduce time loss in restoring services and facilities;  

·      Enhance image and credibility with the community. 

Elements Needed In A Disaster Recovery Plan  

The plan should be in two parts. The first part should evaluate operations, beginning by defining goals and appointing a steering committee. It should look for capabilities and resources, as well as hazards and vulnerabilities. It should look at evacuation plans, safety and health programs, physical security and risk management plans that may already exist and might be used. In addition, it is necessary to look for those areas that are vulnerable in the event of a disaster such as critical equipment and supplies, critical services – electricity, water, heat and cooling, vital personnel, etc.    

The second part is the plan. It is necessary to compile a list of emergencies and the likelihood of their occurrence. Based on this list, it will be possible to prepare a plan to minimize the effects of these occurrences on health care operations. The implementation of a plan would include employee training, as well as conducting drills, testing equipment and coordinating activities with the communities in the metropolitan area.  

Senior management (which must be identified and agreed upon) sets the tone for this project by issuing and supporting a mission statement. In it senior management should link the success of this recovery plan to the provision of healthcare services. In addition, the mission statement should define the purpose and help foster an atmosphere of cooperation.  

Project Initiation and Planning  

Project Initiation – Initiating a project for disaster recovery planning requires that certain factors be considered by senior management during initial planning, including: ·      Establishment of project objectives ·      Mission statement issued by senior management  

Project Planning – The purpose of project planning is to clearly identify the project tasks to be completed, responsibility for their completion and the schedule, including: ·      Determining what facilities, departments and processes will be reviewed ·      Establishing project milestones, including timelines ·      Assigning personnel and scheduling  

The Steering Committee – The development of a Disaster Recovery Plan must be completed by a group rather than a single individual. This group, the Disaster Recovery Steering Committee, reports directly to senior management and is chaired by a member of senior management. It provides the management vehicle for the project. They arrange for the necessary resources and report to senior management. Important responsibilities of the steering subcommittee are operations, information services, finance, auditing, personnel, risk management, safety and security personnel.  

Assessment of Risks and Vulnerabilities – The various healthcare facilities in the metropolitan area, at the very least, have liability, property insurance and workers compensation in place. This coverage will afford some financial support in the event of an emergency. FEMA also should be contacted for the potential range of their support (especially following the disaster of Hurricane Katrina). Other items would be a safety and health program, a process safety evaluation using ISO 9001/ISO 9004, a facilities closing plan, and so on.  

Threats and vulnerabilities need to be evaluated based on their potential impacts. Determination of the maximum permissible downtime for healthcare operations as a whole and key operations in particular must be gauged. Further determination needs to be made as to how long the healthcare operation can be down without a significant negative impact on any one critical application or function. The maximum permissible downtime will determine how quickly an alternative healthcare processing system or operating system must be made available. Again, ISO 9001/ISO 9004 can speed evaluation of health care processes.  

Elements of the Plan  

One of the first actions to be taken during the planning process is the most effective method of operation during backup. Where there is no backup capability, it is necessary to look for actions to mitigate downtime. Emergency operating methods must address both immediate and long-term backups. The three-phase of emergency operations are:  

Emergency Backup – actions taken during this phase are reactionary. The purpose is to protect life and property and minimize loss. This phase is measured in hours.  

Immediate Backup – this phase provides short-term operating capability for critical activities, usually in a degraded mode. The speed with which an organization must move into immediate backup after a disruption in services is a function of the maximum allowable downtime. This phase is measured in days. 

Long Term Backup – when there is major damage to a facility, provision must be made for alternative operating methods and sites where operations can be brought back to acceptable levels. This phase is usually measured in weeks or months.  

Off-Site Storage of Critical Supplies – an important action that must be taken early in the planning process is the establishment of off-site storage of critical records, data and software as well as healthcare supplies The specific materials should be identified in the risk analysis phase of the project. Information technology is a critical element of disaster recover and contingency planning.  

Summary  

The importance of a well organized and fully documented Disaster Preparedness Plan can’t be overemphasized. Policies and procedures governing activities prior to, during, and following an emergency situation must be understood by all persons involved in the planning process. Use of ISO 9001/ISO 9004 is employed throughout the planning process. While blog space doesn’t permit an in-depth  discussion of disaster preparedness planning, this brief outline provides an understanding of how ISO 9001/ISO 9004 can be applied to healthcare services in a metropolitan area. If you have disaster preparedness concerns, you can contact me for a free preliminary consultation at theguide1@comcast.net.  

ISO 9001& ISO 9004: A Framework for Disaster Preparedness Revisited #2

Applying ISO 9001 and ISO 9004

This is the second blog revisiting my 9/11 Disaster Preparedness article in the February 2002 issue of Quality Progress. How can ISO 9001 & ISO 9004 be used in disaster planning? While these standards provide a basic structure from which to approach the planning process systemically, the focus must be on developing a comprehensive disaster plan, not just on managing processes.

Once a basic set of questions has been developed after meeting with senior management, the focus can be further refined to tailor the plan to meet the needs of the organization. In the section entitled “Questions to Ask,” sample questions are framed within some of the elements of ISO 9001 & ISO 9004.

As noted in the article, no one likes to be surprised, least of all senior management. Senior management will expect to review the plan as it evolves. The following points are critical:

·       Companywide planning objectives must be established.

·       A mission statement must be issued by senior management before the disaster planning   

      process begins.

·       The scope of the review, planning milestones and timelines must be established.

·       Personnel must be assigned to tasks and schedules established.

A Systemic Focus

Companies using ISO 9001 & ISO 9004 to develop a strategic disaster plan do not need to become certified to ISO 9001, but it can be helpful. Once clauses from the two standards have been used to provide a systemic focus to the planning effort, planners can revisit the elements to determine what might be missing. For example, since financial planning and R&D often are not included in many ISO 9001 Quality Management Systems, these functions would need to be incorporated into a viable disaster plan.

Questions to Ask

The following sample questions are framed within the structure of one element of ISO 9001 and ISO 9004. The objective is to illustrate how the standards can be used in the planning process. Of course they must be adapted to the needs and type of organization.

Managing Systems and Processes

·      What are the needs of the organization?

·      What organizational and management structure is used to accomplish these objectives?

·      What is the legal structure of the organization?

·      Who are the stakeholders?

·      What is the overall planning structure of the organization?

·      What plans are in place at present?

·      How many corporate divisions and sites are managed by the organization, and what is their  

     function (for example, corporate management, R&D, production or service delivery)?

·      What is the financial structure of the organization?

·      What type of security systems are employed in the divisions and at different sites?

·      What type of information & communications systems (hardware and software) are used to operate the business and manage production and services?

·      Do any fail-safe backup systems exist?

·      How is proprietary information and intellectual property handled?

·      What contingency plans exist for shifting production and service delivery to alternative  

     locations?

·      How much and what type of insurance is carried by the organization?

·      What are the processes used to manage the organization?

·      What are the sequence of these processes and their interaction?

·      What criteria and methods are used to ensure that the operation and control of these processes are effective?

·      How are these processes monitored, measured and analyzed?

·      Are any processes that affect product conformity outsourced?

·      If so, how are these processes monitored within the quality system?

The February 2002 Quality Progress article developed additional ISO 9001 & ISO 9004 questions to illustrate the approach for Documentation; Statutory and Regulatory Requirements; Quality Policy; Responsibility; Authority and Communication; Production and Service Operations; Control of Nonconformity; Corrective Action; Resource Management; Human Resources; Infrastructure; Work Environment; Information; Financial Resources; Design and Development Planning.

Again, the demonstration of the approach did not use all of the elements of ISO 9001 & ISO 9004 and did not develop the full complement of possible questions for each element. The objective was to demonstrate how this type of approach would work.

Critical Issues to Remember

Timing is critical. Catastrophic events happen quickly and, in most cases, without warning. It is necessary to develop an emergency response procedure and create a crisis management team to deal with the public and press.

·      Companies need to have both immediate and long-range responses that are planned and timed. The impact of downtime will depend on how rapidly a company is able to begin intermediate and later long-term operations.

·      Clearly, all critical information, including operational records and documents and environmental compliance records should also be stored off-site so that they can be retrieved when needed. Also, the QMS manual, procedures, records, work instructions, flowcharts, minutes and other critical data should be in electronic form and also stored off-site as well.

·      Backup computer operations (hardware and software) should exist in duplicate form so that they can be accessed whenever necessary. Quality records and documents such as design documents, production records, financial records and supplier records also should be stored in duplicate off-site so that operations can begin again as quickly as possible.

·      Companies that manufacture one-of-a-kind products should have duplicate design records. Companies that CE Mark products should have their Technical Files (Parts A&B) stored electronically off-site as well.

·      Depending on the nature of the disaster (for example, flood, mudslide, explosion, terror attack, sabotage, etc.), personal liability lawsuits could ensue. Operational data will become critical in defending the company.

·      Product liability and criminal liability lawsuits also could be initiated after a plant or facility is destroyed by disaster. Such lawsuits often occur several years after a product is first manufactured. Without data to prove that products were designed to be safe, production was under control and complaints were dealt with in a timely fashion, an organization could be at the mercy of juries that must determine the facts of a case. The truth is that if you can’t prove it doesn’t exist.

The shopworn American aphorism, “If it ain’t broke, don’t fix it” is meaningless in disaster planning. If you don’t plan for all possibilities, your company likely will be out of business.

Summary  

When writing the February 2002 article, I remembered three events in my life that made vivid impressions concerning disaster planning. First, when I was in Law School a fire broke out in some commercial buildings that had been acquired by the University of Wisconsin for graduate student offices and laboratories. The newspaper accounts said that the work and records for over 40 doctoral dissertations were destroyed. Second, when I was a doctoral candidate at the University of Kansas, I made duplicate copies of my dissertation and as soon as a chapter was finished, I stored three separate copies at three separate locations in the city. Finally, when I was vice president of a university, I discovered that student records and transcripts have always been created in duplicate and stored in different locations to avoid any possibility of a records disaster.

Parts 3 and 4 of this blog will deal with disaster planning and the response to catastrophic events since 9/11. Have any lessons been learned? If you have disaster preparedness concerns, you can contact me for a free preliminary consultation at theguide1@comcast.net.  

ISO 9001& ISO 9004: A Framework for Disaster Preparedness Revisited #1

In October 2001, I received a call from the editor of Quality Progress asking if I would write an article about ISO 9001 & ISO 9004 as a Framework for Disaster Preparedness in response to 9/11. The two-part article appeared in the February 2002 issue of Quality Progress. Then as now, I believe that ISO 9001 & ISO 9004 provide an excellent Framework for Disaster Preparedness. Unfortunately, now as then, too many companies (large, medium and small) and governments (county, city, state and national) are woefully unprepared for disasters. In Parts #2 & #3 of this blog I will discuss some recent disasters that could have benefited from an ISO 9001 & ISO 9004 Framework.  

Prior to writing the article, a colleague and I were asked to develop a strategic disaster plan for a company in Israel concerned about the impact a disaster could have on its global business operations. Disaster planning is different from the Enterprise Risk Management Plan described in my September 21^st blog. Enterprise Risk Management examines and prioritizes risks and identifies those risks that should receive the most immediate attention. Disaster planning assumes that everything is at risk and then calculates what must be done to save the organization from destruction.  

As noted in the article, a timely disaster plan must go beyond minimum compliance with an international quality management standard such as ISO 9001 and ISO 9004. It requires a comprehensive examination of the business from multiple perspectives, top-down and bottom-up.

By definition, planning for a disaster is broad based, encompassing overall organizational operations including: adequacy of insurance, the ability to recover from financial losses, responsibilities to stakeholders (including shareholders, employees and affected communities), exposure to civil and criminal liability, compliance with statutory requirements and regulatory agency rules, consumer perception, image, credibility and short and long term viability in the marketplace. Planning must consider legal, financial, personnel, environmental, social, operational and marketing issues.  

The Elements of Planning  

Prior to writing the February 2002 article, I had directed and participated in developing strategic plans for a private university campus, a state university system and businesses with global operations. Each of these efforts was precipitated for different reasons – financial stress, system consolidation of its 27 campuses and businesses dealing with global risk management. The approach to planning was different for each one. Disaster preparedness is greater than any of those efforts.  

·      The type of organization – whether it provides a private sector service (such as insurance, education, lodging, retail sales, recreation, food, travel, travel reservations, computer support of marketing and marketing research) manufacturing (such as heavy machinery, toys, automobiles and auto parts, computer equipment, medical devices, pharmaceuticals, or aircraft) will affect a plan. Or a plan may address governmental services such as postal delivery, hospitals, fire, police, transportation and education.  

·      While both large and small organizations can develop disaster plans, size proportionately affects the plan’s complexity. For a small organization, ISO 9001 can provide systemic path to consider the elements of a disaster plan.  

·      Large organizations likely will develop plans for specific sites – such as a manufacturing plant, hotel or package delivery operation – and for their entire enterprise, no matter how large the scope.  

·      Plans for organizations with multiple sites in the United States and/or global operations must take into account physical and cultural geography, environmental conditions, social and cultural issues to name a few. A risk assessment should be conducted concerning each of these factors. Concerning the use of ISO 9001, ISO 9004 should be incorporated into the plan as well. Excluding “guidelines” because “they just are guidelines,” as generally happens when companies certify to ISO 9001, isn’t just pathetic, it is extremely ignorant. Disasters aren’t polite and selective. Every possibility must be taken into account.  

·      Where several ISO 9001 Quality Management Systems and ISO 14001 Environmental Management Systems exist at a single site, it will be necessary to develop an overall disaster plan for the site incorporating all of these systems. 

·      The objective is to create a plan that looks at all possible risks and exposures and considers all possible contingencies. Everything has to be examined if the plan is going to be useful and effective in an uncertain future. It requires “thinking the unthinkable”, a term coined by Herman Kahn in the 1960’s and 1970’s when developing strategies for surviving a thermonuclear war.  

·      ISO 9001 & ISO 9004 can provide a useful platform from which to think strategically and help frame an organization’s disaster plan.  

Summary  

To be effective, the planning process and the resulting plan must be understood and blessed by senior management, shareholders and stakeholders and must bring in all of the key business areas such as insurance, legal, safety, production, service delivery, maintenance, security, human resources, R&D, planning, marketing and sales. The key areas will be different for each enterprise.             

Part 2 of this blog will focus on the application of the clauses of ISO 9001 & ISO 9001 to disaster planning and Part 3 will focus on some case studies since February 2002. If you have disaster preparedness concerns, you can contact me for a free preliminary consultation at theguide1@comcast.net.

FDA’s QSR & CE Marking to the Medical Devices Directive – Case Study of a Custom Device Manufacturer #2

My first blog in this case study reviewed some of the unique issues facing a manufacturer of custom-made devices for the EU. As noted in that blog, FDA does not use the term custom-made for devices prescribed by a dentist for a specific patient. It does, however, differentiate between an orthodontic lab and a medical device manufacturer concerning on site inspections.

Since my client decided to consider becoming a manufacturer of orthodontic components, they  began constructing a quality management system that would satisfy FDA’s Quality System Regulation (QSR). Also, a measure of alarm had spread among orthodontic labs in the US because of FDA inspections of “offshore labs” in the Caribbean and Central America, causing all manner of rumors to spread that FDA was going to inspect all of the orthodontic labs in the US. My client asked me to call to FDA to confirm or deny the rumor. FDA said it was untrue. FDA, however, was becoming concerned about “offshore labs” because FDA was not monitoring their operations and suppliers resulting in tainted orthodontic products reaching US patients. Nonetheless, the rumors continued to spread.  

Many of my client’s orthodontic devices were Class II medical devices requiring an FDA 510(k). My client therefore obtained licenses from various orthodontic labs to manufacture their devices. At one point they decided that they wanted to put together their own 510(k) for a new orthodontic device and asked if I would take on that task, which I did. After reviewing the alternative paths to a 510(k), we decided to follow the traditional path as that best suited their device. My client provided me with some sample 510(k) predicate devices and I went online to find some additional choices. It is an interesting process requiring time and patience to succeed. It also requires following an FDA prescribed path. The submission went rather smoothly and was aided by assistance from the FDA reviewer.

Shortly after we received notice from FDA that our 510(k) was approved, my client called to say that we would have to rename our 510(k) because a competing orthodontic lab called and threatened to sue for name infringement. My first reaction was “Oh No” we will have to start over from scratch and take another six months. A name change is not a simple thing, it is an integral component of a 510(k) submission. I asked what was the alleged infringement and he said the name [Orthodontic Infuser](not the real name) in the title. I replied that the term [Orthodontic Infuser] is an FDA product classification and consequently is in the public domain. Your competitor can’t sue for infringement because they don’t own the name! Every manufacturer of sequential aligners who has a 510(k) is entitled to use the name provided that they add their own designation, e.g. XYZ Orthodontic Infuser, ClearView Orthodontic Infuser, QRS Orthodontic Infuser, etc. Crisis averted.  

About the same time, my client asked if I had done any Trademark work, to which I replied that I had worked on three Trademarks for a client earlier in my professional career. It wasn’t something I trained for in law school, but law school also taught me that you can develop new legal skills throughout your career. (For example, CE Marking and ISO 9001, ISO 13485 and FDA’s Quality System Regulation didn’t exist when I went to law school.) My client asked if I could help with some Trademarks for orthodontic components they wanted to manufacture and sell in the US. They had initiated four Trademark applications earlier that needed additional attention. Fortunately, the work can be done online, but the process is prescriptive and precise. I reviewed the work to date and signed on as the attorney of record for my client and for one examiner had to prove that I was a member of a state bar association. Each trademark had been assigned randomly to four different attorneys in the US Patent and Trademark Office. I soon discovered that each attorney acted quite independently and had their own discretion on the process just as US District Court Judges operate independently within a general framework. It took a while, but we successfully obtained the Trademarks.  

While preparing for CE Marking manufacturing in the future, my client was notified by a Norwegian dentist that he had CE Marked one of their Trademarked orthodontic components and sent them a letter informing them of his action. I said he can’t do that, he is not the manufacturer of the device component you are! He couldn’t possibly have an ISO 13485 QMS approved by a notified body in place for manufacturing a Class IIa device, because he isn't the manufacturer he only plans to sell your manufactured component. Further, you haven’t placed it on the EU market for sale. Clearly, the Norwegian dentist didn’t grasp the basics of the CE Marking process for medical devices. My client contacted the dentist and he was indignant and threatened to sue. I suggested that we contact the European Commission asking that they forward the issue to the Directorate General Medical Devices Committee for review and possible action. Hopefully, the new EU market surveillance that will go into effect on January 1, 2010 will address some of these kinds of issues.  

The irony is that Norway participates in the CE Marking protocol because they are one of the three remaining non EU members of the European Free Trade Association (EFTA) that is allowed to participate in CE Marking (Iceland and Lichtenstein are the other two). (The other three former EFTA members, Austria, Finland and Sweden joined the EU.)          

I have enjoyed working with this client, because the new challenges are varied and fascinating. I do think, however, that orthodontic medical devices will come under increasing scrutiny in the future, especially in regard to suppliers and the quality of supplies. The incident of a lady in Ohio suffering because of lead from China in her dental crown occurred in the US. Not all US suppliers are as careful as they should be when it comes to purchasing supplies.   After all, most suppliers are Middlemen who purchase materials from a wide variety of sources. Not all scrutinize the origins of their sources. As a consequence, my client sends all of their orthodontic material to labs for analysis before using them in their devices. If you have a product liability or hazards analysis/risk analysis concerns with CE Marking custom-made medical devices for the Medical Devices Directive or FDA’s QSR, you can contact me for a free preliminary consultation at theguide@comcast.net  

EU Regulation To Tighten CE Market Surveillance & Regulatory Enforcement On January 1, 2010

In an effort to tighten the EU market and prevent products from entering the EU that are not CE Marked, illegally CE Marked and/or do not satisfy the CE Mark requirements of new approach safety Directives, on 9 July 2008 the European Parliament and Council adopted Regulation (EC) No 765/2008 “setting out the requirements for accreditation and market surveillance relating to the marketing of products and Repealing Regulation (EEC) No 339/93. The subject matter and scope of the new Regulation is set forth in Article 1.

1.     This Regulation lays down rules on the organization and operation of accreditation of conformity assessment bodies performing conformity assessment activities.  

2.     2.   This Regulation provides a framework for the market surveillance of products to ensure that those products fulfill requirements providing a high level of protection of public interests, such as health and safety in general, health and safety in the workplace, the protection of consumers, protection of the environment and security.

  3.     This Regulation provides a framework for controls on products from third countries. [e.g., US, China, Japan, etc.]  

4.     This Regulation lays down the general principles of the CE Marking. [emphasis added]

 

The implementation date for this new Regulation is January 1, 2010. The reasons for this new Regulation are obvious. All manner of evasions have been created to schlep products into the EU under the guise of CE Marking. Listed below are a few examples from my experience:

 

·      CE Marks stamped on products that have not satisfied any health or safety requirements, simply a CE stamp. This first appeared from Asian toy manufacturers in the early 1990s and gave rise to the first market Regulation 339/93 in February 1993.  

·      Products shipped into the EU stating that they satisfy EC safety requirements, with no paperwork to prove their point.  

·      Custom-made orthodontic devices stating on their EC Declaration of Conformity “This device conforms to Annex I Essential requirements” on a form used by most if not all custom-made orthodontic manufacturers. Except for a client discussed in my October 20 blog, custom-made orthodontic manufacturers have no clue about what this statement means. Who knows how many other types of custom-made medical devices have entered the EU market equally clueless about Medical Devices Directive Annex I Health and Safety Requirements?  

·      Products from China stamped CE only to reveal that this stands for Chinese Exports.  

·      Non CE Marked metal cribs from a US manufacturer headed for children’s hospitals in the EU that are not CE Marked because the manufacturer doesn’t want the bother or expense of satisfying the requirements of the Medical Devices Directive. It would only seem fair that EU hospitals purchasing the cribs should be sanctioned as well.  

·      Machines shipped from a US manufacturer that have Technical Files containing bogus EC Declarations of Conformity issued for non-dangerous machines by a Dutch notified body and which contain no Risk Assessments, leaving the US manufacturer with inadequate safety documentation. 

·      Machinery self certification documents that are a hodgepodge of foolishness with no evidence of compliance with EN harmonized standards, a risk assessment or Checklist of Annex I Essential Health and Safety Requirements. 

·       CE marks on products that can’t be CE marked, from books of matches, to small pieces of hardware, electrical pieces, etc. This type of violation is found more frequently in the EU.  

These are only a few examples of misuses of CE Marking products under the 20+ new approach directives. Another type of issue I encountered within the last few months was a manufacturer who wanted to CE Mark their products for the EU. When I visited their manufacturing facility they showed me a few products that had already been CE Marked and shipped into the EU.  

Since they really hadn’t done anything to demonstrate compliance with the directives that applied to their products, I noted that they were in the market illegally. When asked why, I replied that the operative words in EU legislation were “placing on the market” or “ making available on the market”, whether for sale or free. They found my response to be irritating, to which I said it’s their law. They decided that they didn’t want any help. As I left their plant I picked up a pamphlet describing their products and their Christian religious commitment as a business. Interesting!  

Article 2, paragraph 1 of the new Regulation states:   ‘making available on the market’ shall mean any supply of a product for distribution, consumption or use on the Community market in the course of commercial activity, whether in return for payment or free of charge. [emphasis added]  

I sincerely hope that the new Regulation is more effective than its predecessor. I like the EU new approach health and safety directives. Such a comprehensive standards effort would not occur in the US. Too many competing interests, protection of turf and arrogance that such an effort would be antithetical to the US way of doing things. So we will have to inherit most of our safety standards via ANSI, ISO and IEC from our European friends and the international community.  

The best cooperative effort between the US and the EU is with FDA and their European counterparts in medical device regulation. It has been a great success and will get better.  It has opened markets for US medical device manufacturers that were not as available prior to CE Marking. In addition the US/EU June 1997 Mutual Recognition Agreement (MRA) addressing six product sectors (electrical safety, electromagnetic compatibility (EMC), pharmaceutical good manufacturing practices (GMPs), recreational craft and telecommunications) holds considerable promise.  

January 1, 2010  

Several EU publications have admonished manufacturers to update their CE Marking products to comply with the various Directive and EN standards revisions and updates by January 1. This applies to Medical Devices, Machinery (including medical machinery – see my October 26 blog) EMC and Low Voltage to mention a few of the more prominent examples. It will be easy for customs and member state national accreditation bodies to examine EC Declarations of Conformity and see if manufacturers are complying with the new requirements for Directives and EN harmonized standards. Time will tell how effective this new EU Market Surveillance is working. If you have any questions or concerns about the new CE Marking requirements, you can contact me for a free preliminary consultation at theguide1@comcast.net  

Ostomy Appliances & FDA’s QSR – A Case Study

 

Shortly after FDA’s Quality System Regulation went into affect, I received a call from a medical device manufacturer in Central Connecticut that manufactured rubber Ostomy appliances. They were aware of FDA’s QSR and wanted help in preparing to meet the new requirements. The first step was to conduct a GAP Analysis to determine where they were and what would need to be done to bring the company into compliance.

The company was started by the owner’s father in his garage in Brooklyn, New York and subsequently moved to a building they constructed in rural Connecticut. It was a nice facility with ample space for expansion. The particular type of Ostomy appliances they manufactured were made from rubber, rather than latex or plastic and were made to physicians’ specifications for their patients.

The GAP Analysis revealed not only that they had no quality system in place, but that the manufacturing operation was casual to say the least. For example, I asked what type of system they had for determining the size of the ostomy appliance. The owner said that Margaret was responsible for assembling the pieces of the appliance. When asked how this was done she walked over to a wall on which hung multiple flat wooden forms in multiple shapes and took one down for me to inspect. The form was then placed on a rubber sheet onto which a pattern was drawn that would be used to cut both sides of the bag.

The owner said that Margaret worked four days a week cutting out forms. I asked if there was a written procedure for receiving orders, determining the size, drawing the pattern and cutting the sides of the bags. He said no, it was entirely within Margaret’s hands and she was the only employee with that responsibility. I said, I don’t mean to be impolite, but what would happen if Margaret was hit by a Mack Truck and incapacitated, what would you do? He seemed alarmed at the question. I then asked if we could have Margaret write down each step of her operation so that we could create a procedure for their new quality management system. First, it would be necessary to create a standard operating procedure SOP to satisfy FDA’s Quality System Regulation and follow that procedure. Margaret said she would be glad to write down the steps and did an excellent job of writing a standard operating procedure for her operation.

I asked what happened next in the manufacturing operation and the owner walked over to a bank of autoclaves into which the assembled Ostomy appliances were placed and heated to temper the rubber and achieve a solid seal. He identified how long the appliances were heated in the autoclaves. I asked about the calibration cycle for the autoclaves and he looked puzzled. I asked how do you know if they are performing according to their manufacturer’s requirements? He said we don’t calibrate the autoclaves, should we? To which I responded yes and suggested that he contact the autoclave manufacturer to ask for calibration instructions and then create SOPs for both the calibration of and use of the autoclaves.

The rest of the visit to the plant continued in a similar fashion. There was no order to their operation and clearly no system in place. I was amazed that they had not been inspected by FDA for 20 years, since their move to Connecticut. Meanwhile, the owner’s father had died and he was now the sole source of management. It took some time for them to create a functioning quality management system that would satisfy FDA’s QSR requirements. I suggested that they also consider certifying to ISO 9001 to develop some rigor in their system and use internal audits and registrar audits as a check on their compliance (this was before ISO 13485). Otherwise, an FDA plant inspection could be a rude awakening resulting in multiple write-ups on a 483 letter from FDA. Over time their quality management system was put into place.

Observation

This wasn’t the first time that I visited a medical device company where news of FDA’s Quality System Regulation was a surprise. I have discussed other visits in earlier blogs. Quite often, these manufacturers had grown accustomed to the prior cGMPs and did not understand the quality management system structure and rigor of the QSR. In most cases these were small companies that were not certified to ISO 9001. Consequently, the new structure came as a surprise, if not a shock.

Another anomaly are those companies that manufacture a non-measuring, non-sterile Class I medical device and are able to self certify to the EU Medical Devices Directive. Since these manufacturers will not be visited by an EU notified body, they don't need an ISO 9001 (now ISO 13485) QMS. When told, however, that they will need a QMS to satisfy FDA's Quality System regulation, they are surprised

If you have any product liability and risk assessment concerns regarding FDA and EU regulation of medical devices, you can contact me for a free preliminary consultation at theguide1@comcast.net

CE Marking to the Low Voltage Directive & the GS mark certification scheme

This blog originated last week when a new client called and asked me about the GS mark. They had been told by a local test lab in Atlanta that they should have the GS mark in addition to the CE mark for their electrical products they wished to sell in the EU. My first thought, the test labs are at it again selling services that aren’t needed to Americans who don’t understand EU CE Marking requirements.

I immediately went to the Internet and Googled the German GS Mark and there they were, several test labs selling their services explaining that only a German accredited lab may confer the GS Mark and that it is recognized by consumers in the EU as a symbol of safety and quality. One of the web sites, however, did mention that it is a voluntary mark. 

Another posting that caught my attention was a letter from EICTA, the European Trade Association that represents the European digital technology industry to The European Commission, Directorate General Enterprise and Industry concerning the German GS mark certification scheme. EICTA sent the letter to Mr. Pedro Ortun Director, Directorate I, New Approach Industries, Tourism and CSR. Their concern was the GS mark certification scheme and EU Test mark because it was initiated by a single member state (Germany) and it challenges the EU New Approach [Safety Directives] opening a window to a gradual fragmentation of the single market.

While the preceding language probably is confusing to most Americans, it is critical to the cohesion and integrity of the EU market, known also as the “single market”. When a member state such as Germany can reference a mark such as the GS Mark while transposing a Directive such as the revised Low Voltage Directive into German law attaching a voluntary national mark to the Directive, it erodes the uniform adoption of EU law into national law. Further, if all 27 EU member states decided to attach voluntary national marks while transposing EU law into national law it would open a window to fragmentation of the single market introducing barriers to trade re-introducing “eurosclerosis” to the EU marketplace.

EICTA recommended the following:

EICTA recommendations.

EICTA has on many occasions stressed the importance of the single market concept for the competitiveness of industry and benefit to consumers. The New Approach directives have played an important role in maintaining harmonised rules for placing products on the EU market. However, the reference to GS Mark in German transposition of EU Directives and the proposed EU test Mark challenge the consistent use and implementation of the EU New Approach, open a window to a gradual fragmentation of the single market for ICT products, and potentially introduce barriers to trade.

As the European Community expands and new member states join, vigilance will be required to sustain the single market. In particular, there is a duty on established member states to demonstrate commitment to the concept.

Based on the above EICTA urges the Commission to complete its analysis of the situation and to take measures which will bring the matter to a quick and satisfactory conclusion. In so doing EICTA recommends that:

>Requirements for safety and health related to ICT equipment must be harmonized throughout the EU market and implemented via harmonized standards where possible,

>National requirements that are not harmonized within the EU shall be avoided,

>Any reference to voluntary certificate in national regulations shall be prohibited because it leads to de facto national legal requirements specific to the country and distorts public's perception of the voluntariness of the certification,

>Any national requirements for placing products on the EU market or putting into service shall be aligned with the EU harmonized requirements,

>If a risk assessment leads to new requirements for safety and health, Authorities and Industry shall forward these items for discussion on EU level as foreseen in the procedures of the EU Directives safeguard clauses. Implementing new requirements in harmonized standards is the consequential and correct way to assure protection of all users within the EU,

> Marks shall remain "voluntary" and in order to avoid any confusion with the CE marking, they shall refer to requirements complementary to the ones covered by CE marking.

I have written to the author of the letter, Tony Graziano, Director of Technical and Regulatory Policy for EICTA asking about the European Commission response to EICTA concerns and will share that response in a future blog. Meanwhile, I have written to some other EU organizations for their take on the issue. As mentioned in two previous blogs, I wrote a letter in March 2004 to Commissioner Liikanen concerning notified body misuse of The Machinery Directive and received a helpful response within three weeks later in April.

Finally, I think it would be helpful for those interested in this topic to understand the purpose of EICTA and its membership. It is a significant trade association.

EICTA MEMBERSHIP

About EICTA:

EICTA, founded in 1999 is the voice of the European digital technology industry, which includes large and small companies in the Information and Communications Technology and Consumer Electronics Industry sectors. It is composed of 55 major multinational companies and 38 national associations from 27 European countries. In all, EICTA represents more than 10,000 companies all over Europe with more than 2 million employees and over EUR 1,000 billion in revenues.

The membership of EICTA:

Company Members:

Adobe, Agilent, Alcatel-Lucent, Apple, Bang & Olufsen, Blaupunkt, Brother, Canon,

Cisco Systems, Corning, Dell, EADS, Elcoteq, Epson, Ericsson, Fujitsu, Hitachi, HP, IBM, Infineon, Intel, JVC, Kenwood, Kodak, Konica Minolta, Lexmark, LG Electronics, Loewe, Micronas, Microsoft, Motorola, NEC, Nokia, Nortel, NXP, Océ, Panasonic, Philips, Pioneer, Qualcomm, Research In Motion, Samsung, Sanyo, SAP, Sharp, Siemens, Sony, Sony Ericsson, Sun Microsystems, Symantec, Texas Instruments, Thales, Thomson, Toshiba, Xerox.

National Trade Associations:

Austria: FEEI; Belgium: AGORIA; Bulgaria: BAIT; Czech Republic: SPIS; Denmark: ITEK, IT-Branchen; Estonia: ITL; Finland: TIF; France: ALLIANCE TICS, SIMAVELEC; Germany: BITKOM, ZVEI; Greece: SEPE; Hungary: IVSZ; Ireland: ICT Ireland; Italy: ANIE, AITech-ASSINFORM; Latvia: LIKTA; Lithuania: INFOBALT; Malta: ITTS; Netherlands: ICT-Office, FIAR; Norway: ABELIA, IKT Norge; Poland: KIGEiT, PIIT; Slovakia: ITAS; Slovenia: GZS; Spain: AETIC, ASIMELEC; Sweden: IT Företagen; Switzerland: SWICO, SWISSMEM; Turkey: ECID, TESID, TUBISAD; Ukraine: IT Ukraine; United Kingdom: INTELLECT

Summary

Last week I also talked with the representative of a US company that supplies CE Marked equipment and components. He said he had just talked with a company that spent $7,000 for GS mark tests. He told them that’s too bad, you could have purchased the same equipment from us already CE Marked, you wasted your money. It brings to mind the old English legal axiom, “Caveat Emptor”, Let the Buyer Beware! Concentrate on CE Marking, not on voluntary national marks!

If you have questions regarding CE Marking to the Low Voltage Directive, Machinery Safety Directive, Medical Devices Directive, other new approach Directives and/or product liability concerns you can contact me for a free preliminary consultation at theguide1@comcast.net

 

Warnings, Instructions & Product Liability Lawsuits #3

The two previous blogs with this title discussed when warnings are necessary and offered some pointers on creating warnings and instructions. This blog will examine the legal consequences when warnings fail to warn and instructions fail to instruct. A few years ago I participated in a legal seminar on loss control sponsored by an insurance company. The seminar attendees were clients of the insurance company and the participants (mostly defense attorneys) represented the insurance company in various product liability lawsuits. The purpose of the seminar was to learn from past mistakes and avoid similar pitfalls in the future. The defense attorneys stressed that the question isn’t “If you are sued will you be ready?” The question is “When you are sued will you be ready?” What follows are lessons on what not to do.

Some Ways to Lose A Failure To Warn case

> Don’t disclose risks revealed by your hazards analysis. 

A properly done hazards analysis will reveal a number of risks associated with the use and misuse of a product, including information about the probability and severity of harm. The hazards analysis is a road map for the creation of product warnings. It represents your company’s best efforts to analyze the potential risks in a product, to design out hazards, guard against those that can’t be designed out and warn against those that can’t be designed out or guarded against. Therefore, a warning is a last resort. A hazards analysis should be performed by competent personnel who identify and classify all potential hazards, including information about the probability and severity of harm to serve as a basis for drafting warnings and instructions. 

Remember, plaintiffs attorneys dream of discovering risks that a manufacturer knew about and didn’t disclose to the end user. Further, expect plaintiffs’ attorneys to ask for your hazards analysis, design material, ISO 14121-1:2007, ISO 14971:2007, Technical File, etc., and have it examined by experts for flaws.

> Create warnings to compensate for shortcomings in design.    

Warnings are not a substitute for adequate design. If there are feasible design alternatives that will reduce the inherent risk of harm posed by a product, the furnishing of warnings about product hazards, whether obvious or not, will not protect a manufacturer from liability. For example, The Massachusetts Supreme Judicial Council stated;

An adequate warning may reduce the likelihood of injury to the user of a product in some cases. We decline, however, to adapt any rule which permits the manufacturer or designer to discharge its total responsibility to workers by simply warning of the dangers of a product. Whether or not adequate warnings are given is a factor to be considered on the issue of negligence, but warnings cannot absolve the manufacturer or designer of all responsibility for the safety of the product…. Balanced against the somewhat limited effectiveness of warnings is the designer’s ability to anticipate and protect against possible injury. We think that in such a case the burden to prevent needless injury is best placed on the designer or manufacturer rather than on the individual user of a product. (Uloth v. City Tank Corp., 384 N.E.2^nd 1188, 376 Mass. 874, 1978)

The American Law Institute Restatement (Third) of Torts: Products Liability has adopted a new approach to the sufficiency of warning. Comment I provides, inter alia:

Reasonable designs and instructions or warnings both play important roles in the production and distribution of reasonably safe products. In general, when a safer design can reasonably be implemented and risks can reasonably be designed out of a product, adoption of the safer design is required over a warning that leaves a sufficient residuum of such risks. For example, instructions and warnings may be ineffective because users of the product may not be adequately reached, may be likely to be inattentive, or may be insufficiently motivated to follow the instructions or heed the warnings… Warnings are not… a substitute for the provision of a reasonably safe design.

Consequently, manufacturers may, more than ever, bear the burden of eliminating risks by design, not by supplying warnings.

> Have your marketing people design the labeling. 

Marketing likes to sell products, not scare potential customers. Warnings should be devised by an appropriate labeling committee or product safety committee. First of all, that’s who you want to tell the jury designed the labeling, and second, that’s who you really want to design labels so that it delivers the warning and instructions in the most effective fashion. Plaintiffs’ attorneys love to put marketing people on the witness stand.

> Have your salespeople make express representations that are in contradiction to the labeling.

If your sales force or marketing people are going to make representations about the characteristics or use of the product that undercut or contravene warnings and instructions, you might as well take all the labels off now, for all the good they will do you in court.  Plaintiffs’ attorneys love to find salespeople or advertising materials that minimize, undercut or contradict the labeling. It is important to sensitize the marketing staff of a company to the liability risk created by such representations, as difficult as this might be.

> Take inadequate steps to deliver your warnings to the end user. 

The best warning cannot work if it doesn’t get to the proper person. Are your warnings affixed to the product, or on a throwaway insert? If the product is reusable is the warning durable and indelible A warning worth giving is worth giving twice, or more. Consider putting it on the product, on the insert, and on any packaging. Anticipate the environment of use. In a medical device setting, is an operating nurse likely to be the only one to see the warnings and then discard them? If so, is there a way of delivering them to the physician?

> Ignore feedback from the field.

The creation of warnings is a dynamic, not a static process. As your knowledge or experience of the product grows, you need to consider whether any changes or additions to warnings are called for. What have you learned from field maintenance records, service calls, medical device reports and product liability claims or lawsuits? Are there any trends emerging that suggest there is room for improvement in warnings or instructions? Have you learned of new ways that your product can be misused? It is easy to view incidents as being the result of user error, but remember that user error may be induced by inadequate instructions and warnings regardless of what you conclude to the FDA. Keep an open mind as to the lessons that might be learned from product related mishaps. Resist the temptation to write them off as user error without examining them for feedback on your warnings and instructions.

Furthermore, do not take lightly the role of feedback from the field in creating situations where a “post-sale, pre-accident” duty to warn may be imposed. If there is a claim that the product is defective either in design or for lack of better warnings, you may find that the Court holds that you have a duty to conduct a notification campaign or a recall.

> Ignore what the competition is doing. 

Most companies have competitors. Perhaps their warnings are bigger, better, more detailed or different from yours. When you get to trial you should expect that the plaintiff will show the jury those bigger, better, longer, more detailed or different warnings and argue that if you had followed that path, the injury would have been avoided. What is different isn’t necessarily better, but you must be aware of what is going on in your industry, it is an aspect of  “state-of-the-art”. Custom and practice in an industry are relevant considerations and admissible in court on the issue of negligence and defect. 

At least consider that another company’s material might represent an improvement over your approach. When working on a company’s safety and maintenance manuals, I reviewed the approach used by all of their major competitors and found the competitions' warnings, cautions and instructions to be much more coherent than those of my client. Since my client had lost several product liability lawsuits, I recommended that they draft new manuals ASAP, making suggestions on how this should be done.

 

If you have product liability concerns with FDA's QSR, other FDA regulatory requirements, product liability lawsuits EU's Medical Devices Directives, EU machinery Directive, Product Liability Directive or EU Product Safety Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net

The two previous blogs with this title discussed when warnings are necessary and offered some pointers on creating warnings and instructions. This blog will examine the legal consequences when warnings fail to warn and instructions fail to instruct. A few years ago I participated in a legal seminar on loss control sponsored by an insurance company. The seminar attendees were clients of the insurance company and the participants (mostly defense attorneys) represented the insurance company in various product liability lawsuits. The purpose of the seminar was to learn from past mistakes and avoid similar pitfalls in the future. The defense attorneys stressed that the question isn’t “If you are sued will you be ready?” The question is “When you are sued will you be ready?” What follows are lessons on what not to do.

Some Ways to Lose A Failure To Warn case

> Don’t disclose risks revealed by your hazards analysis. 

A properly done hazards analysis will reveal a number of risks associated with the use and misuse of a product, including information about the probability and severity of harm. The hazards analysis is a road map for the creation of product warnings. It represents your company’s best efforts to analyze the potential risks in a product, to design out hazards, guard against those that can’t be designed out and warn against those that can’t be designed out or guarded against. Therefore, a warning is a last resort. A hazards analysis should be performed by competent personnel who identify and classify all potential hazards, including information about the probability and severity of harm to serve as a basis for drafting warnings and instructions. 

Remember, plaintiffs attorneys dream of discovering risks that a manufacturer knew about and didn’t disclose to the end user. Further, expect plaintiffs’ attorneys to ask for your hazards analysis, design material, ISO 14121-1:2007, ISO 14971:2007, Technical File, etc., and have it examined by experts for flaws.

> Create warnings to compensate for shortcomings in design.    

Warnings are not a substitute for adequate design. If there are feasible design alternatives that will reduce the inherent risk of harm posed by a product, the furnishing of warnings about product hazards, whether obvious or not, will not protect a manufacturer from liability. For example, The Massachusetts Supreme Judicial Council stated;

An adequate warning may reduce the likelihood of injury to the user of a product in some cases. We decline, however, to adapt any rule which permits the manufacturer or designer to discharge its total responsibility to workers by simply warning of the dangers of a product. Whether or not adequate warnings are given is a factor to be considered on the issue of negligence, but warnings cannot absolve the manufacturer or designer of all responsibility for the safety of the product…. Balanced against the somewhat limited effectiveness of warnings is the designer’s ability to anticipate and protect against possible injury. We think that in such a case the burden to prevent needless injury is best placed on the designer or manufacturer rather than on the individual user of a product. (Uloth v. City Tank Corp., 384 N.E.2^nd 1188, 376 Mass. 874, 1978)

The American Law Institute Restatement (Third) of Torts: Products Liability has adopted a new approach to the sufficiency of warning. Comment I provides, inter alia:

Reasonable designs and instructions or warnings both play important roles in the production and distribution of reasonably safe products. In general, when a safer design can reasonably be implemented and risks can reasonably be designed out of a product, adoption of the safer design is required over a warning that leaves a sufficient residuum of such risks. For example, instructions and warnings may be ineffective because users of the product may not be adequately reached, may be likely to be inattentive, or may be insufficiently motivated to follow the instructions or heed the warnings… Warnings are not… a substitute for the provision of a reasonably safe design.

Consequently, manufacturers may, more than ever, bear the burden of eliminating risks by design, not by supplying warnings.

> Have your marketing people design the labeling. 

Marketing likes to sell products, not scare potential customers. Warnings should be devised by an appropriate labeling committee or product safety committee. First of all, that’s who you want to tell the jury designed the labeling, and second, that’s who you really want to design labels so that it delivers the warning and instructions in the most effective fashion. Plaintiffs’ attorneys love to put marketing people on the witness stand.

> Have your salespeople make express representations that are in contradiction to the labeling.

If your sales force or marketing people are going to make representations about the characteristics or use of the product that undercut or contravene warnings and instructions, you might as well take all the labels off now, for all the good they will do you in court.  Plaintiffs’ attorneys love to find salespeople or advertising materials that minimize, undercut or contradict the labeling. It is important to sensitize the marketing staff of a company to the liability risk created by such representations, as difficult as this might be.

> Take inadequate steps to deliver your warnings to the end user. 

The best warning cannot work if it doesn’t get to the proper person. Are your warnings affixed to the product, or on a throwaway insert? If the product is reusable is the warning durable and indelible A warning worth giving is worth giving twice, or more. Consider putting it on the product, on the insert, and on any packaging. Anticipate the environment of use. In a medical device setting, is an operating nurse likely to be the only one to see the warnings and then discard them? If so, is there a way of delivering them to the physician?

> Ignore feedback from the field.

The creation of warnings is a dynamic, not a static process. As your knowledge or experience of the product grows, you need to consider whether any changes or additions to warnings are called for. What have you learned from field maintenance records, service calls, medical device reports and product liability claims or lawsuits? Are there any trends emerging that suggest there is room for improvement in warnings or instructions? Have you learned of new ways that your product can be misused? It is easy to view incidents as being the result of user error, but remember that user error may be induced by inadequate instructions and warnings regardless of what you conclude to the FDA. Keep an open mind as to the lessons that might be learned from product related mishaps. Resist the temptation to write them off as user error without examining them for feedback on your warnings and instructions.

Furthermore, do not take lightly the role of feedback from the field in creating situations where a “post-sale, pre-accident” duty to warn may be imposed. If there is a claim that the product is defective either in design or for lack of better warnings, you may find that the Court holds that you have a duty to conduct a notification campaign or a recall.

> Ignore what the competition is doing. 

Most companies have competitors. Perhaps their warnings are bigger, better, more detailed or different from yours. When you get to trial you should expect that the plaintiff will show the jury those bigger, better, longer, more detailed or different warnings and argue that if you had followed that path, the injury would have been avoided. What is different isn’t necessarily better, but you must be aware of what is going on in your industry, it is an aspect of  “state-of-the-art”. Custom and practice in an industry are relevant considerations and admissible in court on the issue of negligence and defect. 

At least consider that another company’s material might represent an improvement over your approach. When working on a company’s safety and maintenance manuals, I reviewed the approach used by all of their major competitors and found the competitions' warnings, cautions and instructions to be much more coherent than those of my client. Since my client had lost several product liability lawsuits, I recommended that they draft new manuals ASAP, making suggestions on how this should be done.

 

If you have product liability concerns with FDA's QSR, other FDA regulatory requirements, product liability lawsuits EU's Medical Devices Directives, EU machinery Directive, Product Liability Directive or EU Product Safety Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net

Warnings, Instructions & Product Liability Lawsuits #2

In the first segment of this blog, I discussed warnings and instructions vis-à-vis products and product liability lawsuits. This segment will focus on advice for writing warnings and instructions. Writing is a combination of art (it must be visible) and behavioral science (it must be understood by the user). It isn’t simple, but it is vital that it be effective.

Advice for Writing Warnings and Instructions*

• ·      Meet or exceed the laws, standards and industry practices

• ·      Make warnings part of a company-wide product safety/liability prevention effort – look at other documentation such as sales brochures, advertisements, web sites, media presentations, technical specifications, maintenance manuals, safety manuals, etc.

            * (this will help translation costs as well)

Know Your Product and its Physical Environment(s) of Use

• ·      Consider the entire life cycle of the product

• ·      Think of cleaning, maintenance, and service (hazards often show up here that aren’t present during normal operation)

• ·      Understand the intended use

• ·      Consider foreseeable misuse/modification

Know Your Products Real Users

• ·      Language and literacy

• ·      Age, sex, physical abilities

• ·      Skills, training

• ·      Diversity of backgrounds

• ·      Psychological and emotional environment of use

Know Possible Hazards

• ·      Do a hazards analysis (you can’t write warnings and instructions without first conducting a hazards analysis)

• ·      Do a risk assessment (ditto for a risk assessment)

 Respond to Hazards in Terms of Their Potential Harm

• ·      Design them out

• ·      Shield, guard, interlock against

• ·      Warn against

 Focus on the Greatest Danger First

• ·      Put important information first

• ·      Use selective repetition

•      Don’t overload warnings

Focus on Need-To-Know Information

Develop Warnings/Instructions and Product Together During the Design Stage (Work as a Team; Don’t Allow Silo Mentality)

Speak to the Product User as “You”

Use Simple Everyday Language

Use the Active Voice

Be Specific and Concrete (Especially for the Consequences of Actions – Touching the electrical generator when in operation can cause severe injury or death!) 

Keep your Sentences Short

Pay Attention to Type

• ·      Use larger font size

• ·      Avoid all “uppercase”

• ·      Don’t overemphasize with bold type

Pay Attention to Design

• ·      Use white space

• ·      Use lists (bullets, numbered sequence)

• ·      Use headings (to group, to help users navigate the text)

• ·      Avoid justified text

• ·      Avoid centered text

• ·      Remember “form follows function”

Use Visuals as Well as Text

•     Conform to standards
  

• ·    Make visuals big, simple, clear, accurate
  

Consider Multiple Languages (Translation will be critical)

Remember Translation

Test Your Warnings for Usability

Where Possible, Use Pictograms and/or Pictographs

Revisit your warnings periodically

• ·      Look for patterns (problems tend to appear in clusters or patterns)

• ·      Refresh the familiar

• ·      Make sure the information is accurate

• ·      As much as possible, follow the KISS principle (Keep It Simple Stupid)

Summary

As mentioned at the beginning of this blog, warnings and instructions are a mixture of art and behavioral science. When warnings and instructions move from one language and culture to multiple languages and cultures the issue becomes much more complicated. This, of course, applies to CE Marking products for use in the EU’s 27 Member States as well as US manufacturing sites with a diverse ethnic workforce. Idioms frequently do not transfer from one culture and language to another.

For example, while working in Costa Rica on a University of Kansas/University of Costa Rica Ford Foundation Research Grant while in Graduate School, I prepared a set of questions for use with populations in Cartago, Costa Rica; Leon Nicaragua; Fort William (now Thunder Bay), Ontario and Lawrence, Kansas. One of the tests was an Efficacy Test developed at the University of Chicago. Among the questions was, Government is like the weather, everyone talks about it, but no one does anything about it! The respondents could choose between Strongly Agree, Agree, N/A, Disagree, Strongly Disagree.

Respondents in Kansas and Ontario had strong feelings about the question while respondents in Costa Rica and Nicaragua showed no intelligible pattern in response. When I mentioned this to my friend who was the Dean of Arts and Sciences at the University of Nicaragua, he said in my country it is always hot, the only question is whether or not it will rain. The saying doesn’t mean anything here! We then discovered similar responses to other questions, so we had to develop sets of questions that would eliminate the cultural bias and elicit honest responses in all four countries. It took some time to do this.

 

The creation of cultural bias exists when writing warnings and instructions, however, the consequence of misunderstanding won’t be confusion over responses, it will be exposure to serious or potentially lethal hazards. Professional help should be sought before finalizing your warnings and instructions. It is far too serious to be left to amateurs. Everyday, I see warnings and read instructions that are a disaster waiting to happen, not to mention the basis for a product liability lawsuit. If you have product liability concerns with FDA’s QSR, other FDA regulatory requirements, EU’s Medical Devices Directives, EU Machinery Directive & related Directives, EU Product Liability Directive or EU Product Safety Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net.

Warnings, Instructions & Product Liability Lawsuits #1

Several previous blogs have discussed warnings and instructions in regard to medical devices, machinery, electrical equipment and product design, which the EU calls "the principles of safety integration" in its CE Marking new approach directives. To reiterate, a manufacturer first attempts to create a safe design by designing out hazards, guarding against those that can't be designed out and guarding against those that can't be designed out or guarded against.

In the United States, strict liability in tort means the manufacturer is liable if the product is defective regardless of negligence or warranty issues. The manufacturer is considered to be the "expert" in knowledge of the product and of standards in regard to the product. The manufacturer is liable if:

• the product has a defect
• the defect is present when the product leaves the manufacturers control
• the plaintiff suffers injury or damage
• the injury or damage is caused by the defect 

Under product liability law, a product can be defective

·       in design

·       in manufacture

·       in warnings

The manufacturer’s duty is

·       to provide a safe product

·       to provide proper instructions

·       to warn of hazards that are not “open and obvious”

The manufacturer must warn

·       against unreasonable dangers

·       anyone likely to come in contact with the product

·       after the sale as well as before the sale

·       against foreseeable misuse or modification of the product

The greater the degree of danger the greater the duty to warn. Failure to provide adequate warnings can make a product defective.

Warnings and instructions are considered to be inadequate when “the foreseeable risks of harm posed by the product could have been reduced or avoided by the probation of reasonable instructions and warning… and the omission of the instructions or warnings renders the product not reasonably” safe (3^rd Restatement of Torts). The standard is “reasonableness”, no easy guideline exist for courts to adopt in assessing the adequacy of product warnings and instructions… courts must focus on various factors, such as content and comprehensibility, intensity of expression and the characteristics of expected user groups (3^rd Restatement of Torts).

A good warning therefore, meets or exceeds laws and standards, communicates clearly by informing, reminding, getting the user’s attention and helping him/her avoid injury. A good warning seeks to protect the user and a good warning protects the company by protecting the user. While this may seem obvious, warnings and instructions often result in confusion and misunderstanding resulting in injury and giving rise to product liability lawsuits. American National Standards Institute (ANSI) standard Z535.4-2007 states that a good warning protects the user by:

·      identifying the hazard

·      indicating how to avoid the hazard

·      advising of the probable consequences of not avoiding the hazard

·      clearly communicating to the user.

The ANSI focus is the product user’s understanding of information, The word message should be written so that it can be understood by the target audience (i.e., those who are to use and/or service the product). It means choosing words that accurately describe the specific hazard and avoidance information in terms the intended audience will understand.” Warnings that protect the user:

·       attract attention

·       use everyday language

·       contains specific information

·       appear where they are needed

·       focus on the serious hazards.

 A sample of a user warning is:

“WARNING: This product contains chlorine. Missing this product with other household cleansers, such as toilet bowl cleaners, Ross removers, and products containing ammonium, may release deadly chlorine gas. Do not use this product with other chemicals!”

Warnings and instructions go wrong when they

·       assume too much

·       use ambiguous language

·       use confusing language structure

·       speak outside of the user’s world

 Examples of;

 Assuming too much “You can also use the mouse to move a partition into adjacent free space larger than the partition.’

 Using ambiguous language  “Use with adequate ventilation” or “Use proper oil bi-monthly”

 Using confusing structure  “Warnings come too late” or “Passive voice makes responsibility unclear”

 Speaking outside the users frame of reference “Take a piece of resin the size of a walnut” or “The mixing speed can be checked with a digital tachometer”

 Where else can warnings go wrong?

       the language level is too high “assiduously apply yourself”

·       partial or vague information is conveyed “look for gradations of black”

·       inconsistent terms are used “loosen the bolt”

·       jargon ( technical or in-house terms) are used

·       using idioms such as “everybody talks about the weather but nobody does anything about it”

·       weasel words such as “may be” or “it is recommended that”

We have only just begun to explore the topic of warnings and instructions. In the regulated sector, FDA enforces warnings and instructions for Medical Devices and Pharmaceuticals with product liability lawsuits following. In the unregulated sector, product liability lawsuits will come first from plaintiffs’ attorneys. If you have product liability concerns with FDA's QSR, other FDA regulatory requirements, product liability lawsuits, EU's Medical Devices Directives, EU Machinery Directive, EU Product Liability Directive or EU Product Safety Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net

CE Marking Training and Consulting for the Machinery & Medical Devices Directives

In previous blogs I have mentioned working with the California Manufacturing Technology Center (CMTC) during its start up phase. My role was to train their people on CE Marking for the Machinery & Medical Devices Directives and work with various field offices and their clients. Initially, I met with managers in their Hawthorne Headquarters in Los Angeles and then met with interested manufacturers in Long Beach and Ventura. Next I conducted a two-day training session on the EU Machinery and Medical Devices Directives at Loyola Marymount University in West Los Angeles.

Shortly after the preliminary visit I returned to California in March after first working with a Machinery Manufacturer in Buffalo, NY (where it was warm) via Chicago to meet with National Marine Manufacturers Association on a project (where it was chilly) to California (where it was pouring rain) in Ontario, Burbank and Fresno to meet with CMTC staff and interested manufacturers. I only mention the weather because it was a striking contrast to what one would normally find in New York and California at that time of year. The people were interested in CE Marking at all three sites, which resulted in follow-up meetings described in previous blogs.

It was an interesting approach to CE Marking that was being replicated in others states such as New York, where I had given an earlier presentation on CE Marking in Poughkeepsie. Because California and New York did not have a public technical assistance program, they created their own programs using some federal money, state money and charges for services rendered to create a non-profit technical effort to help businesses develop technical capabilities, including the ability to export their goods. CMTC offered assistance for ISO 9001 Quality Management Systems, ISO 14001 Environmental Management Systems, compliance with FDA’s Quality System Regulation and CE Marking products for EU new approach directives such as Machinery, Medical Devices, EMC, Low Voltage and Toy Safety. Working with various CMTC Centers we put together proposals for manufacturers wanting to ship products into the EU. Today, CMTC is known as California Manufacturing Technology Consulting.

The technical delivery system in Georgia is older and more established. Georgia Tech was created by the legislature in 1885 with a desire to build a manufacturing base in the State. The idea of creating Engineering Experiment Stations (EES) was initiated in1919, anticipating federal funding that never materialized. In 1934 EES (now the Georgia Research Institute) opened at Tech with a budget of $5,000 using no federal funds. In 1946 EES used matching state funds for regional economic analysis to identify opportunities for new industry. In 1956, the Industrial Development Branch (IDB) of EES was formed – the first time there was a specific budget for industrial development research at EES. In 1960 the Georgia Assembly passed a bill replacing the 1919 EES legislation and creating an Industrial Extension Service (IES) providing technical assistance to industries.

In 1985 EES became the Georgia Tech Research Institute (GTRI) In 1994, with funding from the Georgia General Assembly to support consortia, academia and government and federal funding, the Georgia Manufacturing Extension Alliance (GMEA) was created and expanded to 18 offices statewide. Georgia is one of 14 states with an Industrial Extension Program. Conceptually, the programs operate similar to the Agricultural Extension Programs created by Federal Morrrill Acts of 1862 and 1890 for Land Grant Universities.

In Georgia as in other states that aspired to improve their industrial base, the effort to create an Industrial Extension Program was considered essential to growth. Historically, Georgia Tech has had a profound effect on the economy of the state. Healthdyne and Scientific Atlanta (now a division of Cisco Systems) are just a few of the industries that started either in a lab at Georgia Tech and/or by a Georgia Tech grad. I first began to teach CE Marking for the Machinery and Medical Devices Directives at Georgia Tech in 1992

In recent years Georgia Tech has nurtured one of the more successful federally funded Centers for Business, Education and Research (CIBER) in their College of Management and in 2008 was awarded a European Union Center of Excellence (EUCE) by the European Commission. I continues to serve on the advisory committee for CIBER, give guest lectures on campus and work with the new European Union Center of Excellence.

 

If you have questions regarding CE Marking to the Medical Devices Directive, Machinery directive and related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net

 

FDA & EU Regulatory Oversight – Medical Device Manufacturers & Supplier Audits

Every medical device manufacturer knows that the quality of their supplies affects the quality of the medical device being manufactured. It is an issue of increasing concern to regulatory authorities as inferior and often toxic materials make their way into the supply chain. Over the past several years I have worked with a number of medical device manufacturers that have experienced problems with vendor supplies.

Sometimes the problem isn’t with the supplies, but with the quality of control that the manufacturer exercises over their vendors. One of the earliest calls I received was from a North Carolina manufacturer of liquid sutures. FDA had inspected their plant and complained that the manufacturer wasn’t auditing key suppliers frequently enough. I was asked to conduct a two-day supplier audit training course and work with the company to develop an audit schedule that would satisfy FDA. They made an excellent product, but were dependent on a few suppliers critical to the quality of their sutures. The manufacturer had to assure FDA that they were in full control of their device quality.

Another medical device company in the Atlanta area manufactured a medical device system to eliminate impacted bowels. The device was sound, but most of the component manufacturing occurred in China, with final assembly occurring at their US manufacturing plant. Both the EU notified body and FDA insisted that the supplier have a certified ISO 9001 Quality Management System in China. They also suggested that some supplier audits were required in order to assure supplier quality.

About the same time I worked with a company in metropolitan Detroit that manufactured (perhaps assembled would be the more appropriate term) barium enema bags and tubes and sold kits. All of the components were made in the US and the kits were assembled at their plant near Detroit. They wanted to CE Mark their products for sale in Europe. The first thing they discovered was that including the barium solution with the kit would require additional approval of a chemical solution in the EU which was not covered by their medical device CE Mark. Therefore, they wisely decided to eliminate the barium solution from their kit and instruct medical personnel to buy the solution at their local pharmacy.

Next, we reviewed the steps required to CE Mark their product and discovered that it was a Class I non-sterile, non-measuring device that would allow the company to self certify without notified body approval. We created an Annex I Checklist, identified the EN harmonized standards, EN 1441:1994 Medical Device Risk Analysis, Technical File (Parts A&B), Authorized Representative and EC Declaration of Conformity. I then mentioned the FDA Quality System Regulation that was coming into effect. While their Medical Device Class I self certification CE Marking requirements did not include an ISO 9001 Quality Management System for their device, FDA did require a QSR quality management system. They said they had been visited by FDA a few years earlier and their cGMP was in good order, to which I responded that the QSR changed its compliance structure.

While I had been brought in to help them with CE Marking and not FDA compliance, in my report to them after the visit, I repeated the admonition to create a QMS that satisfied FDA’s QSR. Approximately six weeks later I received a call from the CEO who said FDA had finished a site inspection and they received five citations in a FDA Warning Letter for not having implemented the Quality System Regulation. He said I guess we should have paid attention to your warning.

For the past five years I have worked with a manufacturer of orthodontic devices in North Georgia. They make different orthodontic devices for dentists who prescribe devices for specific patients. The EU classifies these orthodontic appliances as custom-made devices, but the FDA does not. While my client personally hasn’t experienced supplier problems, several offshore orthodontic manufacturers have been cited for supplier problems, such as importing supplies from unconfirmed sources. As a result, FDA has indicated that they intend to inspect offshore manufacturers more vigorously in the future alarming the manufacturers. FDA concern with orthodontic manufacturers amped up this year with the discovery in the US that a woman suffered pain from a crown made with material that contained lead. The lead had not been disclosed by a supplier from China.

In earlier blogs I have discussed problems with vendors and the analysis of its litigation settlements by a medical devices insurance company. A colleague and I reviewed their record of settlements and identified some of the reasons that these vendors and medical device manufacturers ended up in court. As mentioned previously, while all of these lawsuits were settled out of court, they involved the manufacturers Quality Management Systems. I mention this to dispel a current illusion that FDA’s QSR, ISO 9001 or ISO 13485 are not central to product liability lawsuits.

A few of the findings were:

•    The insurance study found a failure by several new life sciences technology firms to comply with FDA’s Quality System Regulation for vendors and suppliers.

 

•    Often medical device, drug and biologic firms did not apply a basic hazards analysis and risk analysis examination of raw materials or biocompatibility. Further, hazards analyses and risk analyses often did not conform to design specifications for the raw materials and components.

 

•    The study found that contract manufacturers of finished devices often were not aware that such manufacturers must comply with applicable requirements of their quality system and register their establishments with FDA. Further, they were unaware that under certain circumstances both the contractor and manufacturer may be held jointly responsible by FDA for the activities performed. Naturally, product liability lawsuits followed such FDA findings.

 

•    While some manufacturers were diligent in conducting audits and examining the credentials and capabilities of their suppliers and vendors, other manufacturers did not audit sufficiently unless instructed to do so by FDA or an EU notified body.

 

The topic of vendor and supplier quality has emerged as a hot topic over the past three years. Incidents such as toxic heparin being outsourced by suppliers in China and toxic dental materials also being outsourced by suppliers in China have raised serious questions about manufacturer oversight of supplies.

 

In the case of heparin, medical device companies in the US cited immediate medical suppliers in China, such as consolidation laboratories, completely ignoring that the raw material was being prepared in concrete sinks from diseased pigs using water supplies that were dirty and probably infected. In other words, the logic of the US companies that stopped at the doorstep of a laboratory consolidator that couldn’t and wouldn't account for the quality of its basic materials was incredibly ignorant in a global economy. Possibly 80 persons died in the US from toxic heparin.

 

Clearly, medical device, drug and biologic companies will have to account for the total supply chain from its origin to its receipt by them. It isn’t going to be easy and steps need to be taken immediately to prevent further harm. As noted earlier, I expect a considerable amount of product liability litigation will follow these incidents.

 

If you have product liability and risk assessment concerns concerning FDA and EU regulation of medical devices, you can contact me for a free preliminary consultation at theguide1@comcast.net

 

CE Marking, Corporate Structures and Unintended Consequences

One of my earlier experiences with CE Marking occurred when I was asked to conduct a CE Marking training course on the Medical Devices Directive (MDD) for a major medical device company at one of their plants in Eastern Pennsylvania where they manufactured eye surgical equipment. Because the company also made the session available to personnel from their other divisions, we were joined by design engineers from Tampa, where they designed and built blood pressure monitors. The contrast between the divisions was interesting, reflecting the different professional experiences of  the participants and their professional decision-making.

After reviewing the structure of the MDD, the application of Annex I to medical devices, using Annex IX to classify their respective devices, the construction of a Technical File (Parts A&B), conformity assessment procedures and options, risk assessment, EC Declaration of Conformity and Authorized Representative, I mentioned some legal issues they might want to consider. The Pennsylvania contingent immediately said they didn’t want to discuss anything legal, because that was a matter for legal, meaning the attorneys in the corporate legal department. The engineers from Tampa, however, said they would like to know about legal concerns, because they might be able to address the issues in future designs.

Over lunch I discovered that the Pennsylvania contingent, who were regulatory and quality managers, had previously raised legal issues regarding their work and were soundly beaten down by their corporate attorneys who made it clear that anything legal was the responsibility of the legal department. Consequently, they either ignored legal issues or told everyone that such questions should be forwarded to the legal department. The engineers from Tampa were not similarly intimidated and wanted to know about anything that might influence their design decisions.

I found this organizational dynamic to be fascinating. Because of an internal turf war in the medical device company, regulatory and quality personnel were never going to examine issues that might be of critical importance to them and attorneys were going to receive several pieces of “legal” information they would not understand and consequently would ignore.

It reminded me of a paper I presented at a Seminar for the Spanish Ministry of Education and the Universidad Santiago de Compostela on planning for the year 2000 in Vigo, Spain when the Chancellor of my University and I were asked to describe the dynamic of creating an interdisciplinary university with an environmental emphasis in Wisconsin and the structural and personal dynamics that were encountered. The Chancellor, in English with a translator, spoke to the interdisciplinary concept as the person who conceived and implemented the creation of the university. In turn, I described the structural and personal dynamics I witnessed and experienced in Spanish.

At this time I was an Associate Professor of Modernization Processes at the University, which title I’m certain must have confused a number of the 1500 people in attendance. Attendees at the Seminar were academicians from Spain, France, Germany, Portugal and elsewhere in Europe. The French found Americans to be quaint since we simply launched forth to create an interdisciplinary disciplinary without first conducting an in depth epistemological study of what we had in mind before creating the University. To some degree they may have been right, but had we followed their path the University never would have broken ground. By the time I gave the presentation in Spain, I along with many of my faculty colleagues, had participated in presentations at conferences throughout the United States about the creation of interdisciplinary universities. Suffice to say, most of these efforts were unsuccessful.

Back to the focus of this blog, one of the biggest problems encountered in creating an interdisciplinary university was the existence of the old departmental structure. My University inherited four two-year campuses that became a part of the new structure. In addition, I was among a flood of new faculty members from all over the US, Canada and Europe who arrived to build the new interdisciplinary structure. Time doesn’t allow for a discussion of the intellectual battles that ensued, here my focus is the rigidity of an existing structure that doomed most interdisciplinary universities from the start.

We had new interdisciplinary departments composed of faculty from many disciplines and old disciplinary departments composed of faculty from single disciplines such as history, chemistry, biology, etc. Each faculty member belonged to an interdisciplinary department and a disciplinary department. Unless the new interdisciplinary departments were vested with a budget, course development, faculty promotion and tenure, etc., the whole interdisciplinary concept would have been crushed by the exoskeleton of the old departmental structure. This is what happened in most interdisciplinary universities causing their failure. We were successful in vesting the budget in the new structure and the interdisciplinary focus survived, but not without scars.

It taught me a valuable lesson. Institutional structures have a powerful impact on the nature of communication and decision-making. Unfortunately, structural dynamics and communication receive little attention in companies and universities. It is more the province of sociological psychology and the behavioral sciences, which of course is antithetical to the “can do bravado” often found in companies. Nonetheless, it is important to examine company communication and decision making structures to make certain that your company isn’t the victim of unintended consequences.

If you have questions regarding CE Marking to the Medical Devices Directive and related Directives, and/or company structural concerns, you can contact me for a free preliminary consultation at theguide1@comcast.net

EU & FDA Medical Device Regulations – Enforcement Strategies & Product Liability Lawsuits #1

I have addressed aspects of this topic before in several blogs. This time I want to make it the primary focus of two blogs. FDA’s use of its Quality System Regulation is becoming well established. It also provides an insight into the shape of future US product liability lawsuits.

The EU is about to tighten its regulatory oversight of its market with EU Regulation No. 765/2008 of the European Parliament and The council of 9 July 2008 Setting out the Requirements for Accreditation and Market Surveillance Relating to the Marketing of Products and Repealing Regulation (EEC) No. 339/93. The new Regulation sets January 1, 2010 as the date for strengthened enforcement of CE Marking. This means that the company in western New York selling non CE Marked metal baby cribs to hospitals in the EU (mentioned in an earlier blog) can no longer smile that they are getting away with something and numerous companies selling non CE Marked or falsely CE Marked medical devices can anticipate being fined and thrown out of the EU, but more about that in the next blog.

FDA’s Enforcement Strategies

Now that there is an administration in Washington DC that believes that FDA should enforce the law (underscored by all manner of health disasters this past year with food recalls) we can anticipate stepped up QSR medical device enforcement in the future.

FDA Warning Letters

In my July 26 blog I printed parts of two recent FDA warning letters. An additional recent warning letter should help to emphasize this point.                        

On June 26, 2009 FDA sent a Warning Letter to Saint Jude Medical, inc. in Minnesota informing them, among other things, about the findings from FDA investigators visit to their Plano, Texas plant where Saint Jude manufactured implantable spinal chord stimulation systems. The following violations were cited in bold:

1.    Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a), and failure to document the results of corrective and preventive action activities as required by 21 CFR 820.100(b);

2.    Failure to investigate the cause of nonconformities relating to product, processes, and the quality system, as required by 21 CFR 820.100 (a)(2);

3.    Failure to establish and maintain adequate procedures for validating the device design in order to ensure that the devices conform to defined user needs and intended uses. The design validation must include testing of production units under actual or simulated use conditions, and risk analysis, where appropriate, and the design validation results must be documented, as required by 21 CFR 820.30(g);     

4.    Failure to establish adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria and that acceptance activities are documented and reviewed prior to releasing the device for distribution, as required by 21 CFR 820.80(d) and 820.80 (e);

5.    Failure to establish and maintain adequate complaint handling procedures for receiving, reviewing and evaluating complaints by a formally designated unit to ensure that all the requirements of 21 CFR 820.198 are met.

In responding to the Warning Letter St. Jude was informed:

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in enforcement action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.

FDA Civil Penalties

Another type of FDA action is to impose civil penalties for violations, including:

•    $10,000 a day for clinical trials information that is false, misleading or not submitted to the national registry,
•    $1 million dollars for violating FDA’s Risk Evaluation and Mitigation (REMS) Requirement and up to $10 million in additional fines for violations after notice from the Health & Human Services (HHS) Secretary,
•    $250,000 for the first instance of disseminating false or misleading direct-to-consumer (DTC) ads and $500,000 for each additional violation within a 3 year period advertising after notice from the HHS secretary.

FDA Consent Decrees

Except for Criminal Penalties, a Consent Decree is FDA’s toughest enforcement tool. The largest medical device consent decree to date (November 1999) was levied against Abbott Laboratories for $100 million dollars for failing to comply with FDA’s QSR with the possibility of significant additional fines if they failed to address their problems in accordance with their FDA timeline. Abbott had one year to satisfy FDA requirements or face additional fines. In addition, FDA would oversee Abbott for five years.

FDA Criminal Sanctions

Finally, FDA has the power to levy criminal sanctions. If convicted for a strict misdemeanor crime, a defendant, if an individual, could be jailed for up to one year. They also could be forced to pay a heavy criminal fine and penalties and ordered to “disgorge” profits gained through criminal conduct. In November 1998, a federal jury found Kenneth Thiefault and his wife Mardel Barber formerly of Jupiter, Florida guilty. They were sentenced in the US District Court for Southern Florida to prison terms that together totaled more than 8 years and fines adding up to $100,000 for illegally distributing ozone generators, devices that turn oxygen into ozone, claiming that the devices could cure a variety of diseases, including cancer and AIDS. (Modern day electronic snake oil.) 

Summary

FDA clearly has the ability to levy penalties and sanctions against companies for failing to follow its Quality System Regulation. As noted in a recent blog, enterprising trial attorneys and law firms review warning letters, civil penalties, consent decrees and criminal sanctions vis-à-vis prospective clients who may have experienced medical problems from these devices. For example, immediately after the announcement of the Abbott Consent decree, a Seattle law firm initiated a class-action product liability lawsuit alleging that Abbott “in vitro diagnostic test defects” caused the misdiagnosis of Tropoblast Disease and unnecessary medical treatment for thousands of women.

If you have any product liability, risk assessment or preventive law concerns vis-a vis ISO 9001, FDA’s QSR and other Quality Management Systems, you can contact me for a free preliminary consultation at theguide1@comcast.net

Lawsuits Involving ISO 9001 – Hiding in Plain Sight

I have written extensively about ISO 9001 and product liability lawsuits. A few days ago I received a telephone call from a law firm I have been working with as a legal expert for the past year and a half on a lawsuit involving ISO 9001. He called to tell me that the parties decided to settle their lawsuit out of court and seal the record. Otherwise, I was preparing to fly out to testify next week in a trial concerning my legal findings and observations. The call wasn’t surprising, I’m certain the other party realized that a trial discussing the damage caused by their failed product, their non-response to the failures and their denial that they had any records or documents would be commercially damaging in the media. This also underscores a point made in previous blogs, that almost all ISO 9001 product liability lawsuits are settled out of court.

Unfortunately, most ISO 9001 consultants have convinced themselves that ISO 9001 is impervious to litigation and, of course, any attorney knows that nothing is impervious to litigation. The only surprise to me has been how slow the plaintiffs’ bar has been in using ISO 9001 documents and records to obtain information to support their claims. The exception to this observation is FDA’s Quality System Regulation QSR which combines a good bit of ISO 9001 with FDA’s previous good manufacturing practices. Also, FDA uses the QSR as the principal component in its regulatory structure. Therefore, a reading of FDA 483 warning letters and consent decrees containing elements of the QSR are instructive about the impact of a failed QMS.

A Few FDA Examples to Underscore this Point:

On May 22, 2009 FDA sent a Warning Letter to Crystal Care International in Florida informing them, among other things of their:

1.    Failure to establish procedures for quality audits, as required by 21 CFR 820.22;

2.    Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b);

3.    Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100;

4.    Failure to establish and maintain procedures to control labeling activities as required by 21 CFR 820.120;

5.    Failure to establish procedures for receiving, reviewing and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

The Warning Letter goes on to cite five additional failures to comply with FDA’s QSR. It states the firm’s products are misbranded, their establishment registration is not current and the responses to an earlier FDA 483 were unacceptable. The company has 15 working days to indicate what specific steps have been taken to correct the violations, including an explanation of how the company plans to prevent these violations, or similar violations from occurring again in their Quality management System. They are to include documentation of the corrective action taken.

 On June 5, 2009 FDA sent a Warning Letter to Franz Design, Inc. in Texas informing them that their devices were adulterated within the meaning of 501(h) of the Act (Food Drug and Cosmetics Act), in that the methods used in, or facilities or controls used for, the manufacture, packing, storage or installation are not in conformity with the Current Good Manufacturing Practice (QSR), concerning their:

1.    Failure of the management with the executive responsibility to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization, as required by 21 CFR 820.20;

2.    Failure to establish and maintain procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i);

3.    Failure to validate with a high degree of assurance a manufacturing process whose results cannot be fully verified by subsequent inspection or test, approve validation according to established procedures, and document validation results and activities as required by 21 CFR 820.75(a).

The Warning Letter goes on to cite seven additional failures to comply with FDA’s QSR. The letter additionally states that the company has 15 working days to indicate what specific steps have been taken to correct the violations or similar violations, from occurring again. The company is instructed to include documentation of the action taken. (Failure to promptly address these issue could result in fines and additional actions from FDA.)

These are just two of hundreds of Warning Letters issued by FDA every year. Also, the letters are public. Consequently, enterprising attorneys and law firms review these letters vis-à-vis their clients or prospective clients who may have experienced medical problems from these devices. Clearly, a federal agency that must publicly report what it does is a different oversight entity affecting day-to-day business. It does, however, underscore the product liability vulnerability created by a nonperforming or ineptly performing Quality Management System.

I will return to discuss other aspects of FDA’s QSR and Warning Letters in future blogs. For the moment it serves to illustrate the two-sided nature of Quality Management Systems and product liability litigation. In 1991 I wrote an article Turn Your QMS into a Risk Management Platform: ISO 9001:2000/Risk Management: A Preventive Law Approach in the September 2001 The Informed Outlook. It was the culmination of eight preceding articles discussing ISO 9001: 2000 that had appeared in earlier articles in The Informed Outlook. (I will discuss the concept of a QMS risk management platform at greater length in future blogs)

An ISO 9001: 2008 QMS, or any other quality management system for that matter, would benefit from building risk management preventive law principles into their QMS. This means using the ISO 9001 platform to address product liability exposure and taking steps to reduce that exposure. Failure to do that means that the company’s QMS becomes a platform for supporting a product liability lawsuit. The choice is clear and simple but requires extra effort and consequently will be ignored by most companies. Also, quality managers do not see this as their responsibility and CEOs, CFOs and Corporate Counsel generally are oblivious to the legal opportunity and threat presented by their QMS.

If you have any product liability, risk assessment or preventive law concerns vis-a vis ISO 9001, FDA’s QSR and other Quality Management Systems, you can contact me for a free preliminary consultation at theguide1@comcast.net

CE Marking Medical Device Boundary Issues – Is it a Medical Device or Something Else?

Early in the implementation of CE Marking Directives, a Dutch notified body issued a CE Mark under the Medical Devices Directive to a company that manufactured radioactive seeds for use in prostate cancer tumors, only to discover that radioactive seeds were classified as an Active Implantable Medical Device. Since the notified body wasn’t notified to the Active Implantable Medical Devices Directive, they had to apologize, refund the company’s money and direct them to active implantable notified bodies. It was early in the CE Marking process and device classification was evolving.

A few years ago I flew into La Guardia and drove up the Connecticut coast to meet with a small company that manufactured lead aprons for use in dental x-rays. The company had requests from dentists and distributors in the EU and therefore wanted to CE Mark their aprons. Since it was not clear how the aprons should be classified under Annex IX of the Medical Devices Directive, I called the US Director of a medical devices notified body with whom I had worked several times and sent a fax describing the aprons and their use to the UK competent authority, the Medical Devices Agency MDA (now the Medicines and Healthcare Products regulatory Agency MHRA) for guidance. To my astonishment, both the notified body and MDA said they thought it was not a medical device, but instead was Personal Protective Equipment.

While their classification seemed absurd, it was necessary to obtain clarification before proceeding to CE Mark the aprons. The confusion was the assumption by both the notified body and MDA that we were asking about the classification of lead aprons to be worn by dental x-ray technicians, the people who take the x-rays. While it was clear that dental technicians were covered by the Personal Protective Equipment Directive, we were talking about dental patients. The difference in compliance was substantial to a small company. The Personnel Protective Equipment Directive would have required notified body approval and an ISO 9000 Quality Management System. By way of contrast, if the apron was a medical device, it would be a Class I non-measuring/non-sterile device allowing the company to self certify and CE Mark without requiring notified body approval.

After corresponding via fax and e-mail, the notified body and competent authority better understood our question and agreed that the aprons were a non-invasive medical device that allowed us to self certify and CE Mark them for export to the EU.

While this was a clear boundary issue, quite often the distinctions are not clear or are a consequence of different regulations in the EU and US. For example, FDA regulates several health care products as medical devices that are not classified as medical devices in the EU, among those products are feminine sanitary napkins. Not being able to CE mark such products means that the regulations are country by country requiring time, research and patience working your way through 27 national bureaucracies. In pursuit of national regulations for feminine sanitary napkins I found the British had their own system which was most helpful. The French and Germans also were helpful once we navigated the language issues. The Italians, however, were maddening. The officials in charge weren’t interested in answering our questions and wouldn’t return calls.

When it comes to cosmetics, another area governed by FDA (Federal Food, Drug and Cosmetic Act), the EU has a Cosmetics Directive that operates much like new approach directives. There is no CE Mark, but following the Directive concerning Cosmetic Products it is possible to manufacture cosmetics and sell them throughout the EU without going country by country for approval. It has recently been amended by Commission Directive 2009/36/EC of 16 April 2009 amending Council Directive 76/768/EEC, concerning cosmetics products for the purpose of adapting Annex III thereto to technical progress. It may not be a CE Mark, but compared to general health care products it is a blessing.

Finally, other types of boundary issues regarding classification undoubtedly will crop up in the future. Another boundary issue that will continue to materialize is the number of new approach directives that apply to a product. Thus far the greatest number of new approach directives I have worked with to CE Mark a product have been Machines that were subject to the Machinery, EMC, Low Voltage, Pressure Equipment and Explosive Atmospheres Directives.

If you have questions regarding CE Marking to the Machinery Safety Directive, Medical Devices Directive and other related Directives and product liability concerns you can contact me for a free preliminary consultation at theguide1@comcast.net