BUCKMAN COMPANY v. Plaintiffs' LEGAL COMMITTEE (531 U.S. 341)
U.S. Supreme Court · decided February 21, 2001 · Supreme Court Database (Spaeth)
- Citation
- 531 U.S. 341 · 121 S. Ct. 1012
- Decided
- February 21, 2001
- Term
- October Term 2000
- Vote
- 9–0
- Majority author
- Justice Rehnquist
- Issue area
- Federalism
- Disposition
- Reversed
- Outcome
- Petitioning party won
- Ideological direction
- Liberal
Opinion excerpt
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 pedi-cles of their spines. Petitioner is a consulting company that assisted the screws’ manufacturer, AeroMed 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. 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. Y). H-1 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’ll devices are those…
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