This blog will analyze some of the aspects of a Quality Management System (QMS) that might be analyzed by a Plaintiff’s Attorney when preparing a client’s lawsuit verses a Medical Device Manufacturer or a Life Science Firm. Naturally, each lawsuit will depend on the facts of the situation that will determine the method of approach. For purposes of this blog I will use the FDA’s Quality System Regulation 21 CFR Part 820 as the Quality Management System in question. (The same approach can be applied to ISO 13485 or ISO 9001 where relevant.)
I have served as legal expert/expert witness in several lawsuits involving Quality Management Systems. What makes FDA’s QSR different is it is the QMS regulatory structure for Medical Device Manufacturing for the US Market. Therefore, understanding the legal nuances of a regulated QMS is critical to meaningful Risk Management. Unfortunately, the risk of product liability exposure is not given serious consideration by medical device manufacturers and life science firms. However, the legal nuances of FDA’s QSR are given serious consideration by plaintiffs’ trail attorneys.
Litigation Risk Management
In order to be successful in Product Liability Risk Avoidance and Product Liability Litigation, Medical Device Manufacturers and Life Science Firms CEO, President, CFO, Corporate Counsel, Regulatory Managers, Quality Managers and Defense Counsel must understand the type of legal platform created by a Quality Management System – how it works for you and how it can work against you. The fact that these Quality Management Systems are FDA and/or EU regulatory requirements, create additional legal opportunities for Plaintiffs’ Attorneys. For Example, FDA Warning Letters and Legal Sanctions are public information that can be used by Plaintiffs’ Attorneys to support their clients’ lawsuits. A few examples illustrate this point. Below you will find FDA Quality System Regulation observations from 2014 Warning Letters:
- Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). Specifically, no corrective or preventive action procedures were available for review upon request by the investigator. Mr. Calvin Knickerbocker III indicated that Shasta does not have CAPA procedures. Your firm’s response is not adequate.
- Your firm lacks Quality System procedures and instructions as required by 21 CFR 820.20(e) The deviations from current good manufacturing practice regulations observed during the inspection do not resolve your firms lack of Quality System procedures and instructions.
- Failure to establish procedures for receiving, reviewing and evaluating complaints by a formally designated unit is required by 21 CFR 821.198(a).
These are just three examples from three letters that go on to detail the failure of medical device manufacturers to satisfy FDA requirements. Plaintiffs’ trial attorneys will screen FDA 483 Warning Letters to see if any of these issues might have an impact on their client’s lawsuits. If so, the weight of FDA regulatory observations will be brought against the defendants. Further, plaintiffs’ trial attorneys will have obtained defendant’s Quality System Manual and Procedures to see if the language contained might be useful in supporting their lawsuit.
Examination of Quality System documents can be very useful in supporting the Plaintiff’s position in a Product Liability lawsuit. What is stated and how it is stated could be critical to winning a lawsuit. Consequently, it is critical that a medical device manufacturer give the same attention to their QMS that a Plaintiff's trial attorney will give their quality system manual and documents.
What Are Potential Product Liability Points of Attack?
The four major sources of Product Liability Lawsuits are – Product Design (all aspects of design including design review of a product failure), Manufacturing and Process Control, Post Sale Surveillance (which can feed back into a design review of a faulty medical device) & Corrective and Preventive Action (CAPA) and FDA Regulatory Oversight and Sanctions specifically addressed by documented procedures and clauses in every Quality Management System. How these sources are addressed will have a direct legal impact on any product liability litigation.
Corporate Counsel and Defense Counsel do not fully understand and appreciate the impact of documented regulatory Quality Management Systems (QMS) on product liability litigation. Plaintiffs’ Trial Attorneys are successfully using the requirements of FDA’s QSR and the EU’s Medical Devices Directives and ISO 13485 against Medical Device Manufacturers and Life Science Firms in product liability litigation. I have found that design documents and records often reveal a shallow understanding of the QSR and FDA expectations. More than once, design personal have said, “Why can’t we ignore prior design failures and begin with our successful design efforts?”
To date, Plaintiffs’ Attorneys have only scratched the surface of FDA’s QSR and are beginning to examine in depth the internal structure, quality manual, quality procedures, required documents and records necessary to operate these systems. Broken regulatory QMS systems are rich with data and potential to be used successfully against Medical Device Manufacturers and Life Science Firms. One shouldn't be surprised at the tired defense counsel ploy of handing over boxes of process control computer printouts demonstrating the company’s willingness to share meaningless information that wasn’t requested by plaintiff’s counsel.
Who Takes Responsibility For Product Liability Avoidance?
As noted in my July 31, 2013 blog “Medical Device Manufacturer’s – Hear No – See No – Speak No – Legal Risk!” – “no one takes responsibility, not Top Management nor Corporate Counsel, nor regulatory Managers and certainly not Quality Managers take responsibility for potential exposure to product liability lawsuits.” While risk management is spoken of with great reverence, the risks that are addressed are medical device safety risks identified in ISO 14971, which are critically important! But risks to the managerial and financial integrity of the medical device and life science enterprise are ignored. It’s a bit of a “sitting duck” response or “What I don’t know can’t hurt me!” In short, no one takes responsibility for product liability avoidance. Plaintiffs’ Trial Attorneys have an open field for litigation with few impediments.
What Needs To Be Done?
To begin, a Product Liability GAP Analysis is essential. It should include a Product Liability Exposure Review of the medical device manufacturer’s Quality Management System including steps to reduce product liability exposure. Since this shouldn’t be a one time event, there should be a consideration of a Product Liability Management Program, that includes a Product Liability Audit Program, Product Liability Document Control Program and a Product Safety Management System. Consideration should be given to identifying and training personnel to oversee such programs. Naturally, these programs should be tailored to the manufacturer’s needs.
As noted in previous, blogs I have joined a group of International Colleagues to work with medical device companies in the US and in the EU where there is a fear of product liability litigation in the US market. We combine legal expertise in risk management, human factors, document control, insurance, loss control, preventive law, product liability audits that can be applied to FDA’s Quality System Regulation, EU Medical Devices Directives, and ISO 13485 & ISO 9001 Quality Management Systems. We use the QMS as a platform for Product Liability Avoidance, including document management, “word control” training and the creation of a Product Safety Management System. We are preparing new approaches to work with medical device companies and life science firms to address these concerns. In particular we focus on the legal aspects of Product Liability Exposure.
My primary focus has been on International Regulatory Compliance, which includes both the requirements of US & EU 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 or state courts. I focus on product safety, product liability and the steps necessary to create a safe product. I also serve as Legal Expert/Expert Witness where safety has been compromised or ignored resulting in damage, injury and/or death. If you have questions regarding ISO 9001, ISO 13485, FDA’s Quality System Regulation or CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address email@example.com