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.