The Supreme Court ruled in an 8-1 decision last week that medical device makers in the United States cannot be sued for devices that have received approval from the U.S. Food and Drug Administration.
According to the Associated Press, the case, Reigel v. Medtronic, has significant implications for the $75 billion-a-year health care technology industry.
Plaintiff Charles Reigel sued the Fridley, Minn., company after a balloon catheter burst in his coronary artery during angioplasty in 1996. Reigel, who passed away in December 2004, suffered serious injuries as a result of the rupture, and alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law.
In an opinion delivered by Justice Antonin Scalia, the Supreme Court ruled that state product-liability suits are barred to the extent that they would impose requirements different from federal regulatory standards.
