Preemption: Food, Drug & Cosmetic Act
After suffering serious injury when a balloon catheter burst while he was undergoing an angioplasty procedure, Charles Riegel and his wife sued the catheter's manufacturer, Medtronic, Inc. Medtronic moved to dismiss the lawsuit, arguing that the Food, Drug, and Cosmetic Act expressly preempts state-law damages actions brought by patients who have been injured by medical devices that received premarket approval from the Food and Drug Administration. The court agreed and dismissed the case.
Public Citizen represented the Riegels on appeal and before the U.S. Supreme Court. In February 2008, the Supreme Court ruled for the manufacturer, holding that the express preemption provision of the Act preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the FDA. The Supreme Court decided in favor of the respondent.