Facts of the Case

The Federal Food, Drug, and Cosmetic Act (FDCA) and the Medical Device Amendments of 1976 (MDA) regulate medical devices. Under the MDA, Class III devices "present a potential unreasonable risk of illness or injury" and thus require the Food and Drug Administration's (FDA) strictest regulation. In 1985, after a previously failed attempt, the AcroMed Corporation sought approval for its orthopedic bone screw device, a Class III device, for use in spinal surgery with the assistance of Buckman Company, a regulatory consultant to medical device manufacturers. The FDA also denied the second application. On the third attempt, instead of trying to show the bone screw device was "substantially equivalent" to similar devices already on the market and thus as safe and effective, AcroMed and Buckman split the device into its component parts, renamed them, and altered the intended use of the parts. Thus, the FDA approved the component devices for long bone surgery. Subsequently, the Judicial Panel on Multidistrict Litigation has directed over 2,300 civil actions related to these medical devices to the Federal District Court. Many actions claim, under state tort law, that AcroMed and Buckman made fraudulent representations to the FDA as to the intended use of the bone screws and that, as a result, the devices were improperly given market clearance, which injured the plaintiffs. The District Court dismissed the fraud claims as pre-empted by the MDA. The Court of Appeals reversed.

Question

Does the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device Amendments of 1976, pre-empt civil actions related to the alleged fraudulent approval of orthopedic bone screw devices?

Conclusion

Yes. In an opinion delivered by Chief Justice William H. Rehnquist, the Court held that the plaintiffs' state-law fraud-on-the-FDA claims conflicted with, and were therefore pre-empted by, the FDCA, as amended by the MDA. "The conflict," wrote Chief Justice Rehnquist for the Court, "stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Agency, and that this authority is used by the Agency to achieve a somewhat delicate balance of statutory objectives. The balance sought by the Agency can be skewed by allowing fraud-on-the-FDA claims under state tort law." Chief Justice Rehnquist concluded that the "FDA...has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud upon the Agency." Justices John Paul Stevens and Clarence Thomas concurred.