Cite as: 518 U. S. 470 (1996)
Opinion of Stevens, J.
cerns about the primary issue motivating the MDA's enactment: the safety of those who use medical devices.
The legislative history also confirms our understanding that § 360(k) simply was not intended to pre-empt most, let alone all, general common-law duties enforced by damages actions. There is, to the best of our knowledge, nothing in the hearings, the Committee Reports, or the debates suggesting that any proponent of the legislation intended a sweeping pre-emption of traditional common-law remedies against manufacturers and distributors of defective devices. If Congress intended such a result, its failure even to hint at it is spectacularly odd, particularly since Members of both Houses were acutely aware of ongoing product liability litigation.13 Along with the less-than-precise language of § 360k(a), that silence surely indicates that at least some common-law claims against medical device manufacturers may be maintained after the enactment of the MDA.
13 Furthermore, if Congress had intended the MDA to work this dramatic change in the availability of state-law remedies, one would expect some reference to that change in the extensive contemporary reviews of the legislation. We have been able to find no such reference. See, e. g., Lesparre, Industry Spokesman Comments on Medical Device Amendments of 1976, 50 Hospitals 99, 103 (Sept. 16, 1976); A. Levine, Device Failure and the Plaintiff's Lawyer, in Proceedings of the Second Annual AAMI/FDA Conference on Medical Device Regulation 54 (1975); Medical Device Amendments of 1975, Hearings before the Subcommittee on Health and the Environment of the House Committee on Interstate and Foreign Commerce, Ser. No. 94-39, 94th Cong., 1st Sess., 271 (1975) (statement of Anita Johnson, Public Citizen's Health Research Group) (arguing that the pre-emption provision should not be included, but making no mention of common law, and specifically discussing only a positive California enactment regarding the safety of intrauterine contraceptive devices); Medical Devices and Equipment Liability Avoidance (Frost & Sullivan pub. June 1977) (comprehensive 2-volume, 600-page review of published medical device product liability cases from 1910 to 1976, suggesting nowhere that MDA had mooted or even altered the longstanding ability of plaintiffs to seek and receive damages awards under state law).
491
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