Supreme Court Hears Arguments in Device Preemption Case

The Supreme Court heard oral arguments in Riegel v. Medtronic last week and will rule on whether the express preemption provision of the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with FDA premarket approval (PMA).

Charles Riegel and his wife sued Medtronic after he was injured when a Medtronic balloon catheter burst during an angioplasty procedure. The Riegels alleged state-law claims for negligent design, testing, inspection, manufacture, distribution, labeling, marketing and sale of the device, as well as strict liability and breach of express and implied warranty.

Medtronic sought summary judgment on grounds of express preemption under the Medical Device Amendments to the FDCA. The district court granted Medtronic’s motion and the U.S. Court of Appeals for the Second Circuit affirmed the ruling.

The outcome of this case is significant for the most technologically sophisticated companies that must use PMA applications for approval rather than 510(k) notifications, James Beck, counsel with law firm Dechert’s product liability group, said.