Riegel v. Medtronic: A Win for Federal Preemption and Medical Device Makers

February 26, 2008
For the first time in over a decade, the U.S. Supreme Court, in Riegel v. Medtronic, revisited express preemption of product liability claims involving medical devices. In an 8-1 decision, it held that the preemption provision in the Medical Device Amendments of 1976 bars most state tort claims challenging the safety of medical devices that received PMA—a major victory for the industry. This article analyzes the Riegel decision and its implications for both medical device and pharmaceutical manufacturers.