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The Buckman Company v. Plaintiff’s Legal Committee
(U.S. Supreme Court)
Medical Devices Amendments of 1976 preempts fraud claims under state law
Resolving a circuit split, the Supreme Court held that the Food, Drug, and Cosmetic Act, as amended by the Medical Device Amendments of 1976, preempts state-tort-law claims predicated on an alleged fraud against the Food and Drug Administration ("FDA"). Plaintiffs were injured by bone screws surgically inserted in their spines, a use the FDA twice refused to approve. The plaintiffs alleged that Buckman, a consulting firm, helped the screw’s manufacturer fraudulently obtain FDA approval by misrepresenting that the screws would be used in arm and leg bones. The Court held that these "state-law fraud-on-the-FDA" claims were impliedly preempted. Writing for a seven-justice majority, Chief Justice Rehnquist explained that the FDA has ample power "to punish and deter fraud against the Agency," that it uses this power "to achieve a somewhat delicate balance of statutory objectives," and that state-law fraud-on-the-agency claims would upset that balance. This decision is important to all businesses whose products are subject to pre-marketing approval by a federal agency.
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