There is an editorial in this month’s New England Journal of Medicine on Riegel v. Medtronic, the preemption case soon to be decided by the Supreme Court that has pharmaceutical and medical device companies sitting on the edge of their seats.
Quick background: A man was injured when a balloon catheter exploded during an angioplasty. The manufacturer, Medtronic, moved to dismiss the case on the grounds that the Food, Drug, and Cosmetic Act of 1976 immunizes Medtronic from any state law torts claims for medical devices because the device received pre-market approval from the FDA.
The authors of the New England Journal of Medicine editorial set forth the history and rationale of the Food, Drug and Cosmetic Device Act, pointing out that arguments in this case are just another version of the same arguments Medtronic offered in Medtronic v. Lohr, a case in which the Supreme Court rejected the preemption of state court claims arguments. The authors note that this case addresses “just how reliable the FDA pre-marketing approval process is and how much weight to give it.” The authors do not explicitly answer this question but it is hard to argue that the FDA is an effective watchdog of pharmaceutical and medical device companies.
The authors close the editorial with a list of questions that the Supreme Court should address to determine what is best for the country. “Is it in the people’s interest to shield medical-device companies from product-liability claims? Would such a decision benefit patients by making more lifesaving medical devices available, or would there be adverse effects on the overall safety of devices? Is the FDA pre-marketing approval process sufficiently rigorous and comprehensive enough to justify immunization of the industry against tort claims? And if medical-device manufacturers are shielded from liability, what about drug manufacturers? Or would society be better served if patients retained their right to seek legal redress when they believe they have been damaged by a faulty medical device? In the long run, would this result in safer medical devices for patients?” The authors conclude if the Supreme Court wants to protect patients, it should reject Medtronic’s request for immunity.
The authors also note that if the Supreme Court comes to the “wrong conclusion” patients injured by defective medical devices have a remedy in Congress (who, by the way, have never to my knowledge questioned the Court’s holding in Medtronic v. Lohr). This is how it might play out because I think Congress would then clarify its position on preemption. But if this happens, it might jeopardize the claims of patients who currently have lawsuits pending against medical device companies.
By the way, the Drug and Device Law Blog has a ton of posts on Riegel v. Medtronic. If drug and medical device manufacturers were like political parties, the Drug and Device Law Blog would serve as the text of the party platform for drug and medical device manufacturers. The authors, Jim Beck and Mark Herrmann, two mega-firm pharmaceutical defense lawyers, rarely if ever deviate from the party line. But the blog is incredibly well written and provides quality and current analysis of the issues in medical device and pharmaceutical drug litigation. It is a shame that more quality defense lawyers do not blog because the truth is that most of the great writing talent among lawyers resides in huge defense firms.
You can access the New England Journal of Medicine article here although I’m not sure how long it will be available for free.