Medtronic has won a case that went to the U.S. Supreme Court over whether patients could sue manufacturers of PMA-approved devices in state courts. The high court ruled 8-1 that because FDA has already made a determination about the safety and effectiveness of the product, state lawsuits are barred when they would impose different requirements. The ruling, which pertained to a patient named Charles Riegel who was injured by a Medtronic catheter, was released this morning, reports the Associated Press.
Medical device news of the decade! I'm not really kidding either, no one talks about medical devices. It would be mildly entertaining if a medical device maker tries to convince the FDA that they fall under a PMA instead of a 510(k) now.