In an earlier blog, I discussed a Medical Device Insurance Company that examined its litigation history to identify the types of recurring patterns of lawsuits that the insurance company had seen over and over again. A colleague and I reviewed the findings, separated the patterns into categories and addressed the categories in a series of internal position papers.
One area of particular concern to FDA and a source of product liability lawsuits for medical devices, pharmaceuticals and biologics is Warnings, Symbols & User Instructions. In an earlier blog on document control, I mentioned that a “product” such as a medical device “includes the physical product, catalog data, service manual, advertising, labels, shipping package, Field assembly, installation, service, warranty, owners manual and sales brochure.” To this list should be added “user instructions.”
Whenever a “product” such as a medical device, pharmaceutical or biologic is designed, all of the attributes of the product must be considered as an element of design because a patient, health service professional and physician needs every bit of information to understand the characteristics of the product, how it works and possible adverse consequences if it doesn’t work, is improperly installed or in the case of a pharmaceutical and biologic, the possible physical side effects. Consequently, information about the “product” is as critical as the “physical product” itself.
The medical device insurance company litigation study found the following patterns in lawsuits:
• When the adequacy of warnings, symbols and user instructions were challenged by plaintiff’s attorneys, companies often had no method to counter the allegations. Product warning labels and instructions were incorporated, without documentation of the testing of the warnings or instructions to demonstrate the adequacy of the warnings. Further, there often were no standard operating procedures (SOPs) or guidelines to document how the warnings and instructions were developed.
• It was discovered that drug and device firms, when they learn of post-sale product risks and hazards and delay corrective actions or attempt to cover-up the severity of the potential risks are in an indefensible position in product liability lawsuits.
• In numerous instances plaintiff’s attorneys have alleged that medical device, drug and chemical warnings and packaging are inadequate to warn users of potential risks and hazards.
• For many medical device and pharmaceutical firms, critical safety information was carelessly worded or prepared and subsequently used against the firm by plaintiff’s attorneys to support their allegations of product liability.
• A growing area for product liability lawsuits are internet websites containing misleading claims, advertising and “testimonials.”
• Established medical device and drug companies with established markets have been accused by plaintiffs’ attorneys of a lack of adequate warning labels, symbols and warning communications as part of the companies product development and design process as well as a failure to follow up on identified risks and hazards.
• In numerous instances, biotech companies cite product safety recall communications as the item that triggers product liability claims and lawsuits.
This is a brief list of the types of information incidents that triggered product liability lawsuits litigated by the insurance company for their clients. Over 90% of the suits were settled out of court. The lack of information often lulls device, drug and biologic companies with a false sense of security about their legal exposure. Actions by FDA against a medical device, pharmaceutical or biologic firm are available through the Freedom Of Information Act (FOIA). They also provide plaintiffs’ attorneys with information for product liability lawsuits.
After settling a lawsuit, however, these companies often find their share of any future lawsuits will be greater because their deductable has increased. Failing to account for exposure to product liability litigation is a lose-lose proposition, an expensive lose-lose proposition.
If you have product liability and risk assessment concerns concerning the FDA's QSR and EU Medical Devices Directives Directives, you can contact me for a free preliminary consultation at firstname.lastname@example.org