Cite as: 518 U. S. 470 (1996)
Opinion of O'Connor, J.
Justice O'Connor, with whom The Chief Justice, Justice Scalia, and Justice Thomas join, concurring in part and dissenting in part.
Section 360k(a), the pre-emption provision of the Medical Device Amendments of 1976 (MDA), provides that no State may establish or continue in effect "any requirement" "which is different from, or in addition to," any requirement applicable under the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) to the device. As the Court points out, because Congress has expressly provided a pre-emption provision, "we need not go beyond that language to determine whether Congress intended the MDA to pre-empt" state law. Ante, at 484. We agree, then, on the task before us: to interpret Congress' intent by reading the statute in accordance with its terms. This, however, the Court has failed to do.
The cases require us to determine whether the Lohrs' state common-law claims survive pre-emption under § 360k. I conclude that state common-law damages actions do impose "requirements" and are therefore pre-empted where such requirements would differ from those imposed by the FDCA. The plurality acknowledges that a common-law action might impose a "requirement," but suggests that such a pre-emption would be "rare indeed." Ante, at 502. To reach that determination, the opinion—without explicitly relying on Food and Drug Administration (FDA) regulations and without offering any sound basis for why deference would be warranted—imports the FDA regulations interpreting § 360k to "inform" the Court's reading. Accordingly, the principal opinion states that pre-emption occurs only "where a particular state requirement threatens to interfere with a specific federal interest," ante, at 500, and for that reason, concludes that common-law claims are almost never pre-empted, ante, at 502-503, and that the Lohrs' claims here are not pre-empted. This decision is bewildering and seemingly without guiding principle.
509
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