Riegel v. Medtronic
Issues
Do the Medical Device Amendments, which were intended to replace state regulation of medical devices with centralized federal regulation, forbid injured patients from asserting state-law claims against manufacturers that received premarket approval from the Food and Drug Administration?
In 1996, a catheter burst during Charles Riegel's angioplasty. Riegel and his wife filed a product liability complaint against the catheter's manufacturer, Medtronic, Inc. A federal district court dismissed the complaint, holding that the Medical Device Amendments ("MDA") preempted most of the claims. The U.S. Court of Appeals for the Second Circuit affirmed the dismissal and the Riegels appealed to the U.S. Supreme Court. The MDA generally forbids states from imposing requirements on devices that received premarket approval from the Food and Drug Administration ("FDA"). Because the complaint depends on state law, Medtronic argues that letting it proceed would impose state requirements, usurp the power of the FDA, and stifle innovation in the medical field. Mrs. Riegel, who was substituted as plaintiff after her husband died, argues that while Congress gave the FDA power to regulate medical devices, it never meant to stop private citizens from suing negligent manufacturers. The outcome in this case will likely depend on the Supreme Court's style of statutory interpretation as well as its beliefs about the best way to manage the complex world of medical devices.
Questions as Framed for the Court by the Parties
Whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. ยง 360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration.
In 1996, Dr. Eric Roccario attempted to unclog a "diffusely diseased" and "heavily calcified" artery supplying Charles Riegel's heart. See Riegel v. Medtronic, Inc., 451 F.3d 104, 107 (2d Cir.