354
Stevens, J., concurring in judgment
This would be a different case if, prior to the instant litigation, the FDA had determined that petitioner had committed fraud during the § 510(k) process and had then taken the necessary steps to remove the harm-causing product from the market. Under those circumstances, respondent's state-law fraud claim would not depend upon speculation as to the FDA's behavior in a counterfactual situation but would be grounded in the agency's explicit actions. In such a case, a plaintiff would be able to establish causation without second-guessing the FDA's decisionmaking or overburdening its personnel, thereby alleviating the Government's central concerns regarding fraud-on-the-agency claims.
If the FDA determines both that fraud has occurred and that such fraud requires the removal of a product from the market, state damages remedies would not encroach upon, but rather would supplement and facilitate, the federal enforcement scheme. Cf. Medtronic, Inc. v. Lohr, 518 U. S. 470, 495 (1996) (holding that the presence of a state-law damages remedy for violations of FDA requirements does not impose an additional requirement upon medical device manufacturers but "merely provides another reason for manufacturers to comply with . . . federal law"); id., at 513 (O'Connor, J., concurring in part and dissenting in part) (same).2
2 Though the United States in this case appears to take the position that fraud-on-the-FDA claims conflict with the federal enforcement scheme even when the FDA has publicly concluded that it was defrauded and taken all the necessary steps to remove a device from the market, see Brief for United States as Amicus Curiae 24, 30, that has not always been its position. As recently as 1994, the United States took the position that state-law tort suits alleging fraud in FDA applications for medical devices do not conflict with federal law where the FDA has "subsequently concluded" that the device in question never met the appropriate federal requirements and "initiated enforcement actions" against those responsible for fraudulently obtaining its approval. Brief for United States as Amicus Curiae in Talbott v. C. R. Bard, Inc., No. 94-1951 (CA1), reprinted in App. to Pet. for Cert. in Talbott v. C. R. Bard., Inc., O. T. 1995, No. 95-1321, p. 84a.
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