Do the Medical Device Amendments of 1976 pre-empt a state common-law negligence action against the manufacturer of an allegedly defective medical device?
No. In an opinion delivered by Justice John Paul Stevens, the Court held that the Court of Appeals decision was reversed insofar as it held that any of the claims were pre-empted and affirmed insofar as it rejected any pre-emption defense. In a 9-0 vote, the Court allowed the lawsuit based on alleged defects in the pacemaker's design to proceed. In a 5-4 vote, the Court allowed the lawsuit to proceed on its claims of alleged defects in its manufacturing and failure to warn. Justice Stevens reasoned that the MDA was not intended to pre-empt "traditional common-law remedies against manufacturers and distributors of defective devices," as long as they paralleled federal requirements.