Supreme Court to Rule on Federal Preemption for Devicemaker

Medtronic announced the Supreme Court granted review in Riegel v. Medtronic, marking the first time the Supreme Court will decide whether a patient can seek state court remedies against the manufacturer of a device approved through the FDA’s premarket approval (PMA) process.

The case involves an FDA-approved balloon catheter that Medtronic said “was used contrary to labeling instructions” by the patient’s physician.

An Evergreen balloon catheter — a product Medtronic no longer manufactures — was inflated by the physician beyond the labeling restrictions and used in a patient for whom it was contraindicated, the company said.

A court in Albany, N.Y., dismissed the suit, finding that the patient was not entitled to state law remedies in light of the prior FDA approval of the device, Medtronic said. The Second Circuit Court of Appeals upheld that decision. All but one of the seven federal circuit courts that have addressed the question of preemption of PMA medical devices has upheld the doctrine. The Supreme Court will hear the case in the term beginning in October.