531 U.S. 341 (2001), 98-1768, Buckman Co. v. Plaintiffs Leg. Comm.

Docket Nº:Case No. 98-1768
Citation:531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854, 69 U.S.L.W. 4101
Case Date:February 21, 2001
Court:United States Supreme Court

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531 U.S. 341 (2001)

121 S.Ct. 1012, 148 L.Ed.2d 854, 69 U.S.L.W. 4101




Case No. 98-1768

United States Supreme Court

February 21, 2001

Argued December 4, 2000



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.


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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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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Irving L. Gornstein argued the cause for the United States as amicus curiae urging reversal. With him on the brief were Solicitor General Waxman, Assistant Attorney General Ogden, Deputy Solicitor General Kneedler, Douglas N. Letter, Peter J. Smith, Margaret Jane Porter, and Patricia J. Kaeding.

Michael D. Fishbein argued the cause for respondent. With him on the brief were Arnold Levin, Sandra L. Duggan, and John J. Cummings III. [*]

Chief Justice Rehnquist delivered the opinion of the Court.

Respondent represents plaintiffs who claim injuries resulting from the use of orthopedic bone screws in the pedicles of their spines. Petitioner is a consulting company that assisted the screws' manufacturer, AcroMed Corporation, in navigating the federal regulatory process for these devices. Plaintiffs say petitioner made fraudulent representations to the Food and Drug Administration (FDA or Administration) in the course of obtaining approval to market the screws. Plaintiffs further claim that such representations were at least a "but for" cause of injuries that plaintiffs sustained from the implantation of these devices: Had the representations not been made, the FDA would not have approved the devices, and plaintiffs would not have been injured. Plaintiffs sought damages from petitioner under state tort law.

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We hold that such claims are pre-empted by the Federal Food, Drug, and Cosmetic Act (FDCA), 52 Stat. 1040, as amended by the Medical Device Amendments of 1976 (MDA), 90 Stat. 539, 21 U.S.C. § 301 (1994 ed. and Supp. V).


Regulation of medical devices is governed by the two Acts just named. The MDA separates devices into three categories: Class I devices are those that present no unreasonable risk of illness or injury and therefore require only general manufacturing controls; Class II devices are those possessing a greater potential dangerousness and thus warranting more stringent controls; Class III devices "presen[t] a potential unreasonable risk of illness or injury" and therefore incur the FDA's strictest regulation. § 360c(a)(1)(C)(ii)(II). It is not disputed that the bone screws manufactured by AcroMed are Class III devices.

Class III devices must complete a thorough review process with the FDA before they may be marketed. This pre-market approval (PMA) process requires the applicant to demonstrate a "reasonable assurance" that the device is both "safe . . . [and] effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof." §§ 360e(d)(2)(A), (B). Among other information, an application must include all known reports pertaining to the device's safety and efficacy, see § 360e(c)(1)(A); "a full statement of the components, ingredients, and properties and of the principle or principles of operation of such device," § 360e(c)(1)(B); "a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device," § 360e(c)(1)(C); samples of the device (when practicable), see § 360e(c)(1)(E); and "specimens of the labeling proposed to be used for such device," § 360e(c)(1)(F). The PMA process is ordinarily quite time consuming because

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the FDA's review requires an "average of 1,200 hours [for] each submission." Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996) (citing Hearings before the Subcommittee on Health and the Environment of the House Committee on Energy & Commerce, 100th Cong., 1st Sess. (Ser. No. 100-34), p. 384 (1987); Kahan, Premarket Approval Versus Premarket Notification: Different Routes to the Same Market, 39 Food Drug Cosm. L. J. 510, 512-514 (1984)).

An exception to the PMA requirement exists for devices that were already on the market prior to the MDA's enactment in 1976. See 21 U.S.C. § 360e(b)(1)(A). The MDA allows these "predicate" devices to remain available until the FDA initiates and completes the PMA process. In order to avoid the potentially monopolistic consequences of this predicate-device exception, the MDA allows other manufacturers to distribute (also pending completion of the predicate device's PMA review) devices that are shown to be "substantially equivalent" to a predicate device. § 360e(b)(1)(B).

Demonstrating that a device qualifies for this exception is known as the "§ 510(k) process," which refers to the section of the original MDA containing this provision. Section 510(k) submissions must include the following: "Proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use," 21 CFR § 807.87(e)...

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