Medical Device Preemption Decision May Hinge on FDA Position

A Supreme Court decision on federal preemption authority for medical devices may hinge on the FDA’s position, and the agency has come out in favor of preemption.

The Supreme Court will hear Riegel v. Medtronic Dec. 4 to examine 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. The FDA has filed a brief in favor of Medtronic.

In nearly all Supreme Court cases regarding federal agency preemption, the court’s decision corresponds with the position argued by the relevant federal agency, according to Catherine Sharkey, a professor at the New York University School of Law.

Charles Riegel and his wife sued Medtronic after he was injured when a balloon catheter burst during an angioplasty procedure. Medtronic moved to dismiss the lawsuit, and a federal district court dismissed the case. It was appealed to the U.S. Court of Appeals for the Second Circuit.

The two previous rulings in the case have stipulated that the Medical Device Amendments to the FDCA provide for the FDA’s regulatory authority in these matters.