OCTOBER TERM, 2000
certiorari to the united states court of appeals for the third circuit
No. 98-1768. Argued December 4, 2000—Decided February 21, 2001
Respondent represents plaintiffs claiming injuries caused by the use of orthopedic bone screws in the pedicles of their spines. Petitioner assisted the screws' manufacturer in securing approval for the devices from the Food and Drug Administration (FDA or Administration), which has regulatory authority under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Medical Devices Amendments of 1976 (MDA). While the screws are in a class that normally must go through a time-consuming process to receive premarket approval (PMA), they were approved under an exception, known as the § 510(k) process, for predicate devices—devices that were already on the market when the MDA was enacted—and for devices that are "substantially equivalent" to predicate devices. The § 510(k) application filed by petitioner and the manufacturer sought clearance to market the screws for use in arm and leg bones, not the spine. Claiming that the FDA would not have approved the screws had petitioner not made fraudulent representations regarding their intended use, plaintiffs sought damages under state tort law. The District Court dismissed these fraud-on-the-FDA claims on, inter alia, the ground that they were pre-empted by the MDA. The Third Circuit reversed.
Held: The plaintiffs' state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, the FDCA, as amended by the MDA. Pp. 347-353.
(a) The relationship between a federal agency and the entity it regulates is inherently federal because it originates from, is governed by, and terminates according to federal law. Because petitioner's FDA dealings were prompted by the MDA and the very subject matter of petitioner's statements were dictated by that statute—and in contrast to situations implicating "federalism concerns and the historic primacy of state regulation of [health and safety matters]," Medtronic, Inc. v. Lohr, 518 U. S. 470, 485—no presumption against pre-emption obtains in this case. The conflict here stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Administration, and the Administration uses this authority to achieve a delicate balance of statutory objectives that can be skewed by allowing state-law fraud-on-the-FDA claims. While the § 510(k)
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