Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 8 (2001)

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348

BUCKMAN CO. v. PLAINTIFFS' LEGAL COMM.

Opinion of the Court

of petitioner's statements were dictated by that statute's provisions. Accordingly—and in contrast to situations implicating "federalism concerns and the historic primacy of state regulation of matters of health and safety," Medtronic, 518 U. S., at 485—no presumption against pre-emption obtains in this case.

Given this analytical framework, we hold that the plaintiffs' state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, federal law.2 The conflict stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Administration, and that this authority is used by the Administration to achieve a somewhat delicate balance of statutory objectives. The balance sought by the Administration can be skewed by allowing fraud-on-the-FDA claims under state tort law.

As described in greater detail above, the § 510(k) process sets forth a comprehensive scheme for determining whether an applicant has demonstrated that a product is substantially equivalent to a predicate device. Among other information, the applicant must submit to the FDA "[p]roposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use," 21 CFR § 807.87(e) (2000), and a statement attesting to and explaining the similarities to and/or differences from similar devices (along with supporting data), see § 807.87(f). The FDA is also empowered to require additional necessary information. See § 807.87(l). Admittedly, the § 510(k) process lacks the PMA review's rigor: The former requires only a showing of substantial equivalence to a predicate device, while the latter involves a time-consuming inquiry into the risks and efficacy of each device. Nevertheless, to achieve its limited purpose, the § 510(k) process imposes upon applicants a variety of requirements that are designed to enable the FDA to

2 In light of this conclusion, we express no view on whether these claims are subject to express pre-emption under 21 U. S. C. § 360k.

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