Cite as: 518 U. S. 470 (1996)
Opinion of O'Connor, J.
I agree with the Court that the Lohrs' defective design claim is not pre-empted by the FDCA's § 510(k) "substantial equivalency" process. The § 510(k) process merely evaluates whether the Class III device at issue is substantially equivalent to a device that was on the market before 1976, the effective date of the MDA; if so, the later device may be also be marketed. Because the § 510(k) process seeks merely to establish whether a pre-1976 device and a post-1976 device are equivalent, and places no "requirements" on a device, the Lohrs' defective design claim is not pre-empted.
I also agree that the Lohrs' claims are not pre-empted by § 360k to the extent that they seek damages for Medtronic's alleged violation of federal requirements. Where a state cause of action seeks to enforce an FDCA requirement, that claim does not impose a requirement that is "different from, or in addition to," requirements under federal law. To be sure, the threat of a damages remedy will give manufacturers an additional cause to comply, but the requirements imposed on them under state and federal law do not differ. Section 360k does not preclude States from imposing different or additional remedies, but only different or additional requirements.
I disagree, however, with the Court's conclusion that the Lohrs' claims survive pre-emption insofar as they would compel Medtronic to comply with requirements different from those imposed by the FDCA. Because I do not subscribe to the Court's reading into § 360k the additional requisite of "specificity," my determination of what claims are pre-empted is broader. Some, if not all, of the Lohrs' common-law claims regarding the manufacturing and labeling of Medtronic's device would compel Medtronic to comply with requirements different from, or in addition to, those required by the FDA. The FDA's Good Manufacturing Practice (GMP) regulations impose comprehensive requirements relating to every aspect of the device-manufacturing process,
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