486
Opinion of Stevens, J.
marily on "a fair understanding of congressional purpose." Cipollone, 505 U. S., at 530, n. 27 (opinion of Stevens, J.). Congress' intent, of course, primarily is discerned from the language of the pre-emption statute and the "statutory framework" surrounding it. Gade, 505 U. S., at 111 (Kennedy, J., concurring in part and concurring in judgment). Also relevant, however, is the "structure and purpose of the statute as a whole," id., at 98 (opinion of O'Connor, J.), as revealed not only in the text, but through the reviewing court's reasoned understanding of the way in which Congress intended the statute and its surrounding regulatory scheme to affect business, consumers, and the law.
With these considerations in mind, we turn first to a consideration of petitioner Medtronic's claim that the Court of Appeals should have found the entire action pre-empted and then to the merits of the Lohrs' cross-petition.
IV
In its petition, Medtronic argues that the Court of Appeals erred by concluding that the Lohrs' claims alleging negligent design were not pre-empted by 21 U. S. C. § 360k(a). That section provides that "no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter." Medtronic suggests that any common-law cause of action is a "requirement" which alters incentives and imposes duties "different from, or in addition to," the generic federal standards that the FDA has promulgated in response to mandates under the MDA. In essence, the company argues that the plain language of the statute pre-empts any and all common-law claims brought by an injured plaintiff against a manufacturer of medical devices.
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