I have discussed this topic several times in previous blogs. It is little understood but will grow in significance in medical device product liability lawsuits. My first direct encounter with a CE Marking lawsuit occurred with the Machinery Directive and a machine that had killed a worker in the UK and injured a worker in the US who would need 24 hour care for the rest of his life. One of the key issues was the failure of the machinery manufacturer to follow the safety requirements of an EN standard that stipulated the thickness of a Plexiglass protective shield to protect the machine operator. The machine manufacturer installed a shield that was half of the stipulated thickness, providing inadequate protection. The lawsuit was settled out of court. There was an earlier US lawsuit where the US machinery manufacturer ignored CE Marking safety standards for machines sold in the US resulting, but installed a laser light curtain for machines sold in the EU. The lack of a light curtain for the US machine resulted in a machine failing to shut down if a worker was in the area of machine activity and striking a worker resulting in severe injury to 28 year-old worker who would require 24 care for the rest of his life. When the jury discovered that the US manufacturer provided less safety in the US than it provided for the same machine sold in the EU, they found him guilty and awarded the largest punitive damage award in Minnesota history at that time.
CE Marked Medical Devices
So what does this have to do with CE Marked medical devices in the US? To begin, both the US via FDA’s Quality System Regulation and the EU via ISO 13485 use regulatory quality management systems for conformity assessment. Both of these quality management systems can be accessed in a lawsuit through legal discovery. The fact that a CE Marked medical device is placed on the US Market, means that the supporting documentation, e.g., Technical File, Annex I Checklist, EN Harmonized Standards, EC Declaration of Conformity, etc. can be obtained in legal discovery. It adds additional information about the medical device.
I served as legal expert/expert witness in a lawsuit where the manufacturer offered a report from an EU consulting company that at best could be described as trash, but was touted as expert analysis. It was chaotic, disjointed, confusing and poorly written – an opposing attorney’s dream document in a courtroom. It didn’t serve the manufacturer well. In short, sloppy documents are fair game in a lawsuit.
A CE Marked QMS has notified body certification and surveillance audits. These documents also are available in legal discovery. In addition to FDA inspections and observations, notified body audits could be useful in a lawsuit along with FDA inspections. Also notified body misbehavior (refusing to cooperate with opposing counsel) can be challenged in court and to the Competent Authority (national agency) that approved the notified body using ISO/IEC 17021: 2011 Conformity assessment – Requirements for bodies providing audit and certification of management systems. I have used ISO 17021 twice when encountering notified body arrogance and resistance. It is generally a surprise and can be quite effective.
What Are Some of the Issues With CE Marked Medical Devices?
The biggest problem with CE Marked medical devices in a US lawsuit is the lack of understanding by US attorneys about the CE Marking process and the ISO 13485 QMS. Many attorneys don’t fully understand FDA’s Quality System Regulation let alone ISO 13485. While I have worked with a few attorneys who understand the legal nuances of quality management systems, many try to force their ignorance about a QMS system on the court by not being able to articulate how it applies to their argument and end up both confusing and irritating judges.
The second problem is the fact that there are three CE Marking Directives – Medical Devices Directive, Active Implantable Medical Devices Directive and the In Vitro Diagnostics Medical Devices Directive. (All three presently are being evaluated for enhancement.) In addition, as they review the Directives the European Commission has issued documents to clear up areas of confusion, such as the medical device classification that modifies Annex IX of the Medical Devices Directive.
On one occasion an attorney asked me for help understanding CE Marking and the role of EN harmonized standards. I prepared a breakdown of the relevant standards used by the medical device manufacturer to help him understand the salient issues from a EU perspective. In this case the US attorneys traveled to the EU to conduct depositions. They were successful in obtaining critical information that was key to settling their case out of court.
An additional concern among US attorneys is the relevance of EU standards in an American court of law. Some States are better than others in accepting new input. This issue is rapidly evolving as European EN standards are updated. When either an international standards organizations like ISO or IEC updates a standard or the EU standards bodies CEN, CENELEC and ETSI decide to update an EN standard, by mutual agreement they invite their counterparts to participate in the standards revision process. When international bodies participate, ANSI the American National Standards Institute also participates in the standards revision process. When ANSI participates these standards also become American Standards that are recognized by US Federal Courts.
This entry of EU citizens and companies in disputes with US citizens and companies in US Courts will increase in the future. US Courts offer access to product liability lawsuits to EU citizens and companies who qualify that is not available in EU national courts. I expect to see much more of this type of litigation in the future.
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 a QMS as a platform for Product Liability Avoidance, including document management and “word control” training and the creation of a Product Management System. We are preparing new approaches to work with companies 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 firstname.lastname@example.org