Supreme Court limits device suits.

The U.S. Supreme Court has bolstered medical device manufacturers' argument that FDA approval confers special protection against liability suits. The justices voted 8-1 in finding that the Medical Device Amendments of 1976 supersede state law. That federal law regulates devices that have gone through the premarket approval process, the most rigorous path to approval. Plaintiff Charles Riegel's estate had sued Medtronic Inc., alleging that a catheter that ruptured during cardiac surgery was designed, labeled, and manufactured in violation of New York law. But the justices said that FDA approval "bars common-law claims challenging the safety or effectiveness of a medical device...." They upheld two previous lower court decisions; Justice Ruth Bader Ginsburg was the sole dissenter. Members of Congress involved in crafting the original amendments were not pleased. "Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices," said Sen. Ted Kennedy (D-Mass.) in a statement. "Congress obviously needs to correct the court's decision," he said.