I decided to add a fourth Blog on Preventable Risks and Medical Device Manufacturers. While it should be obvious that Product Liability Exposure is especially critical for medical device manufacturers, it can’t even be called “the elephant in the room.” It receives little attention, because it is not acknowledged as a potential litigation landmine and generally receives no attention until a lawsuit is filed and then manufacturers’ tend to throw a lot of money at the lawsuit to make it go away.
While steps can be taken to reduce the probability and damage of a lawsuit, little is done to address the issue. Compliance with FDA’s Quality System regulation is no guarantee against being sued. As mentioned in earlier Blogs, no one wants to take responsibility for product liability avoidance – Quality Managers, Regulatory Managers and Executive Management do not see product liability avoidance as their responsibility. Consequently, plaintiffs’ attorneys continue to file product liability lawsuits aware that no one will take responsibility to reduce the company’s product liability exposure:
- Compliance with FDA’s QSR and ISO 13485 does not constitute product liability avoidance. Plaintiffs’ attorneys have won lawsuits because a medical device manufacturer’s Quality Policy satisfied the FDA but didn’t mention patient safety or device safety.
- Quality System Documentation is critical and available in legal discovery. Quality documents will be examined by attorneys with a fine toothcomb for what is written, how it is written and how it is followed or not followed regarding every aspect of the quality management system. Nothing will be spared from scrutiny.
- FDA Warning Letters are public documents available to everyone. They are screened carefully by Plaintiffs’ trial attorneys for potential causes of action.
- FDA penalties and fines also are screened carefully by attorneys for potential causes of action related to their clients
- FDA negative judgments on manufacturer's device safety communications trigger plaintiff product safety claims and lawsuits.
- CE marked medical device documentation, including ISO 13485 QMS compliance, Technical Files, etc. for medical devices sold on the US market, in addition to FDA’s QSR, will be obtained in legal discovery and examined carefully.
- Product warning labels and user instructions will be examined to see if there is documentation of the testing of warnings and instructions that demonstrate a deliberative hazards analysis process for the adequacy of warnings and instructions. Warnings and instructions are the end product of the device design process. Also examined will be SOP guidelines followed to document how manufacturers develop their warnings and instructions.
- Carelessly worded clinical safety information has been used against device manufacturers to support plaintiffs’ allegations of lack of attention to patient safety and device safety.
- The adequacy of warnings and communications have been successfully challenged by attorneys on the basis that warnings were not evaluated from a human factors viewpoint and documented during the design phase of device development.
- Raw materials that fail to include appropriate analysis for biocompatibility are examined for conformity to design specifications for raw materials. Too often device manufacturers will buy from US suppliers without asking about the origin of the raw materials.
- Incoming inspection of raw materials, supplies and components are evaluated to see if the manufacturer failed to test materials to see if they met specifications.
- Management’s failure to require documented methods, processes or procedures for communicating product safety concerns during product development, product design, or innovation has been used successfully by plaintiffs’ attorneys in product liability lawsuits.
- Customer complaint feedback often is not treated as an indication of a non-conformity requiring corrective and preventive action by the device manufacturer resulting in product liability lawsuits.
- 21 CFR 820.3 (b) states that “Complaint means any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution.” Plaintiffs’ attorneys fully understand the broad meaning of what is meant by a complaint and CFR 820.198 Complaint files.
- Plaintiffs’ attorneys will examine all device advertising in hardcopy and on the manufacturer’s web site to see ifadvertising claims, descriptions could mislead device users and see if non-approved device uses are implied or recommended.
- The absence of internal processes for identifying and escalating device safety concerns, the review of those concerns and the lack of any type of cross functional committee to address product safety issues has been successfully alleged by plaintiffs’ attorneys to be a lack of due care and concern for safety in product liability lawsuits.
- False or Misleading Labeling is called misbranding by FDA. “It is not a necessary condition that labeling should be blatantly false for FDA to take action. The word ‘misleading’ in the FD&C (Food, Drug and Cosmetics Act) means that labeling is deceptive if it creates or leads to a false impression in the mind of the reader.” FDA actions and penalties for misbranding are public and swiftly followed by product liability lawsuits.
- Change control is a complex process. Failure to have an adequate change control system can cause equally “complex” results. Inadequate change control exposes a company to product liability actions, results in product recalls, causes internal confusion, and is a serious violation of FDA’s Quality System Regulation. (Medical Device Quality Systems Manual: A Small Entity Compliance Guide. First Edition, CDRH, Rockville Maryland)
- Change control activities and procedures apply to: design; components, including software; labeling and packaging; device manufacturing processes; production equipment; manufacturing materials; and all associated documentation such as quality system procedures, standard operating procedures, quality acceptance procedures and data forms, and product specific documentation. (Medical Device Quality Systems Manual: A Small Entity Compliance Guide. First Edition, CDRH, Rockville Maryland)
- Component manufacturers, remanufacturers, custom device manufacturers, contract manufacturers, contract testing laboratories, re-packagers, re-labelers and specification developers are all subject to FDA regulations. The agreement between manufacturers must be documented in a written contract. The absence of a contract often results in a FDA formal sanction followed by product liability lawsuits and manufacturer v contract manufacturer, etc. lawsuits.
- Medical Device manufacturers often lack a clear understanding of the potential risks and legal complications of misunderstood safety documents and device communications in written material and on the web resulting in FDA sanctions followed by product liability lawsuits.
- Virtually no medical device companies have competent legal help to examine their product liability exposure and recommend steps to be taken for product liability avoidance.
Everything is fair game in a lawsuit!
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 QMS as a platform for Product Liability Avoidance, including document management and “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 in lawsuits 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