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In all pre-emption cases, and particularly in those in which Congress has legislated in a field which the states have traditionally occupied, the historic police powers of the states are not to be superseded by the federal act unless that is the clear and manifest purpose of Congress. A presumption against the pre-emption of state police power regulations supports a narrow interpretation of such an express command.
Relying on Florida common law, the injured sued the manufacturer for damages when the wife's pacemaker failed. The manufacturer argued, and the lower court held, that the Medical Device Amendments of 1976 (MDA), particularly 21 U.S.C.S. § 360(k), pre-empted state common law actions against the manufacturer for negligent manufacturing or failure to warn, but allowed claims based on negligent design. The United States Court of Appeals for the Eleventh Circuit reversed in part and affirmed in part the dismissal of cross-petitioner injureds' complaint, holding that (1) common-law actions were state requirements within the meaning of 360k(a); (2) the claims based on negligent design were not pre-empted by 360k(a); and (3) the claims based on negligent manufacture and failure to warn were pre-empted by 360k(a).
Were any of the injureds’ claim preempted by 21 U.S.C.S. § 360(k)?
The Court held that § 360(k) did not deny a state the right to provide traditional remedies for violations of common law duties when those duties paralleled federal requirements. According to the Court, pre-emption would have had the effect of granting complete immunity from design defect liability to an entire industry that needed stringent regulation because there was no explicit private cause of action against manufacturers in the MDA. Legislative history also showed that it was not Congress's intent to pre-empt most general common law duties enforced by damages actions. The federal requirements reflected generic concerns about device regulation generally, not concerns regarding a specific device that the statute was designed to protect from potentially contradictory state requirements.