SW Legal Educational Publishing

Medical Devices Regulation Preempts Tort Claims Based on State Law
Description The Supreme Court held that under the Medical Device Amendments, the FDA's comprehensive regulatory scheme governs devices under its control. Congress expressly gave the FDA control, including the power to punish fraud against the agency, so a claim may not be brought under state law claiming a medical device maker engaged in fraud against the agency.
Topic Consumer Protection
Key Words FDA; Medical Devices; Fraud; Torts
C A S E   S U M M A R Y
Facts Patients who claimed to have suffered injuries from the implantation of orthopedic bone screws sued Buckman, a regulatory consultant to the screw manufacturer that helped obtain FDA approval for surgical use of the screws, as required under the Medical Devices Amendment (MDA). The patients claimed that Buckman made fraudulent representations to the FDA regarding the intended use of the screws. A showing of fraud may allow the patients to sue the screw maker in tort, which is otherwise restricted by the MDA. The district court dismissed the fraud-on-the-FDA claims. The appeals court reversed. Buckman appealed to the Supreme Court.
Decision Reversed. This matter is controlled by federal law since the issue involves FDA regulations under the MDA. The FDA's regulatory scheme, under a grant of power by Congress, empowers the agency to punish and deter fraud against the agency. A state-law claim of fraud-on-the-FDA would upset this balance of power. The FDA followed its normal procedure in this case and it has the ability to deal with fraud based upon its judgment. The tort law of the 50 states is not to be imposed on top of the FDA regulatory scheme, or that scheme may be made less effective. Congress intended for the MDA to be enforced exclusively by the federal government, so claims based on state law must fail.
Citation Buckman Co. v. Plaintiffs' Legal Committee, - S.Ct. - (2001 WL 167647, Sup. Ct., 2001)

Back to Consumer Protection Listings

©1997-2002  SW Legal Studies in Business. All Rights Reserved.