Medical Device Manufacturers Free From Liability, Says Supreme Court

According to the New York Times, the U.S. Supreme Court has ruled that FDA regulations bar state court liability lawsuits against medical device manufacturers. The court's ruling is consonant with the Bush administration's position that pre-market approval by the FDA preempts claims for personal injury damages in state court. The court's majority opinion says that lawsuits in state court "disrupt the federal scheme" whereby the examination of the risks and benefits of medical devices has been assigned to the FDA. Senator Edward Kennedy was quoted by the New York Times as saying that "Congress obviously needs to correct the court's decision," stating that Congress never intended to grant blanket immunity to manufacturers when it enacted legislation on the FDA regulation of medical devices.

 

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