High Court Finds Suits Over FDA-Approved Medical Devices Preempted

WASHINGTON, D.C. - The U.S. Supreme Court has affirmed 8-1 that federal law preempts state-law tort actions involving medical devices that are pre-market approved by the U.S. Food and Drug Administration. Riegel, et ux. v. Medtronic Inc., No. 06-179 (U.S. Sup. Ct.).

The court ruled on Feb. 20 that the preemption provision of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act bars Charles Riegel's claims that Medtronic Inc. is liable for injuries he suffered when one of the company's balloon catheters burst during his angioplasty procedure (Section 360[k][a] of U.S.C. §§ 301 et. seq.).

Riegel underwent …