The U.S. Supreme Court

The U.S. Supreme Court ruled that the manufacturer of a medical device approved by the United States cannot be sued under state law if the device causes an injury. The court ruled 8-1 in favor of Medtronic Inc. Riegel and his wife, Donna, sued the company in U.S. court, contending that the catheter had been designed, labeled and manufactured in a way that violated state law, and that those defects had caused severe and permanent injuries to Riegel. But a U.S. District Court and the 2nd U.S. Circuit Court of Appeals, in Manhattan, dismissed the Riegels's suit on the grounds that the catheter had been given pre-market approval by the Food and Drug Administration, thus protecting the manufacturer from liability under state law. The Supreme Court upheld the lower U.S. courts, with Justice Antonin Scalia writing for the majority that Medtronic, based in Minneapolis, and other manufacturers were protected under the Medical Device Amendments of 1976, which in a section on pre-emption bars states from imposing on medical devices any requirement which is different from, or in addition to, any requirement applicable under this chapter.