342
Syllabus
process lacks the PMA review's rigor, the former does set forth a comprehensive scheme for determining substantial equivalence with a predicate device. Other provisions give the FDA enforcement options that allow it to make a measured response to suspected fraud upon the Administration. This flexibility is a critical component of the framework under which the FDA pursues its difficult (and often competing) objectives of regulating medical device marketing and distribution without intruding upon decisions committed by the FDCA to health care professionals. Pp. 347-350.
(b) State-law fraud-on-the-FDA claims inevitably conflict with the FDA's responsibility to police fraud consistently with the Administration's judgment and objectives. Complying with the FDA's detailed regulatory regime in the shadow of 50 States' tort regimes will dramatically increase the burdens facing potential applicants, who might be deterred from seeking approval of devices with potentially beneficial off-label uses—an accepted medical practice in which a device is used for some other purpose than that for which the FDA approved it—for fear of being exposed to unpredictable civil liability. Conversely, applicants' fear that their disclosures to the FDA will later be judged insufficient in state court might lead them to submit information that the Administration neither needs nor wants, thus delaying the comparatively speedy § 510(k) process, and, in turn, impeding competition and delaying the prescription of appropriate off-label uses. Respondent's reliance on Silkwood v. Kerr-McGee Corp., 464 U. S. 238, is misplaced. Silkwood was based on traditional state tort law principles, not on a fraud-on-the-agency theory, and, unlike Silkwood, there is clear evidence here that Congress intended that the MDA be enforced exclusively by the Federal Government. In addition, the MDA's express pre-emption provision does not bar the ordinary working of conflict pre-emption principles. Geier v. American Honda Motor Co., 529 U. S. 861, 869. And although Medtronic can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not stand for the proposition that any FDCA violation will support a state-law claim. Pp. 350-353.
159 F. 3d 817, reversed.
Rehnquist, C. J., delivered the opinion of the Court, in which O'Connor, Scalia, Kennedy, Souter, Ginsburg, and Breyer, JJ., joined. Stevens, J., filed an opinion concurring in the judgment, in which Thomas, J., joined, post, p. 353.
Kenneth S. Geller argued the cause for petitioner. With him on the briefs were Alan E. Untereiner and Sharon Swingle.
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