Claims (Present and Future) Arising from Failed Medical Devices

James Veach


Three veterans of litigation and claims involving "Defective Medical Devices and Insurance Exposures" introduced us to the future of claims involving not only hip, knee, and other transplants, but the growing world of prosthetics, implants, and nano-technology and the harm that can be done when these devices fail.

Rudy Dimmling, a Senior Director with Alvarez & Marsal's Insurance Advisory Services (“A&M”), and a veteran run-off and turnaround executive with Trenwick Re and Centre Group Holdings, led a panel discussion that included Christina Reisinger, also with A&M and a former risk manager with Cephalon, Inc. and Sanofi-Aventis, John Roberts, a partner with Edwards Wildman in Chicago and general counsel to several durable medical equipment suppliers and surgical centers, and Ellen Relkin, a partner at Weitz & Luxenberg, and former co-lead counsel on the DePuy MDL litigation and a member of several committees for hip implant products liability litigation (the “Panel”).

Ms. Reisinger led off with a statistical overview of these medical devices, their definition, and growing use. For example, in the U.S., artificial knees are becoming the most commonly implanted medical device and were the most frequently inserted device in 2012. Ear tubes lead the pack with respect to the total number of medical devices in use today, but only by a slim margin over implantable cardiovascular devices, pacemakers, artificial hips, spinal screws, breast implants, IUDs and coronary stents.

The Panel traded views with respect to the role of the Food and Drug Administration (“FDA”) in approving and recalling these devices. The Panel pointed out the difference between clinical trials for drugs, which may begin with laboratory trials, animal testing, and then controlled tests with human subjects and FDA approval for medical devices, which cannot be tested on humans under laboratory-like conditions. Or, as Ms. Relkin put it, when it comes to sophisticated medical devices, the "customer is the guinea pig."

Speaking from the plaintiff's perspective, Ms. Relkin provided graphic photographic evidence of the damage caused by certain metal-on-metal hip replacements and the cobalt/chromium toxic tissue damage caused by some of these devices, including fretting and corrosion of the device itself. Ms. Relkin and her co-panelists also discussed the relationship between medical device manufacturers and the doctors that insert these devices. For the most part, manufacturers choose not to proceed against hospitals and physicians - their customers. (None of the 1,000+ actions now managed by the Weitz firm involve suits or third party claims against treating physicians.)

Mr. Roberts outlined the most frequently asserted causes of action and the most common defenses. Plaintiffs usually rely on: (1) strict liability; (2) negligence; (3) consumer fraud; (4) common law fraud; (5) failure to monitor; (6) failure to warn; and (7) breach of warranty. Defenses to these allegations include: (1) contributory negligence; (2) federal preemption (express and implied); (3) the learned intermediary doctrine (the treating physician's failure to advise); (4) assumption of risk; (5) lack of standing; and, (5) where available, Restatement of Torts defenses based on the lack of any better design alternatives for the device.

With respect to issues to be confronted in the future, the Panel alluded to the potential for insurer subrogation against the successful plaintiff and the efforts by organizations such as Broadspire to manage and treat claims from patients suffering from defective medical devices. The Panel also touched on the difficulty and cost incurred in removing defective medical devices.

Ms. Reisinger and Mr. Dimmling brought the discussion to a close with a look at the future, specifically the growing use of medical devices that now feature nano-technology and synthetic tissues. Defective medical device claims are quickly becoming the new frontier that experienced run-off managers will have to address.