Buckman v. Plaintiffs’ Legal Committee

Plaintiffs’ Legal Committee (plaintiffs), a group of patients injured by use of an orthopedic bone screw device during their spine surgeries, sued Acro-Med Corporation (Acro), a consulting company that assisted the device manufacturer to get premarket approval from the Food and Drug Administration (FDA). The patients alleged that Acro made fraudulent representations to the FDA about the devices’ intended use and that, as a result, the devices were improperly given market clearance and were subsequently used to the patients’ detriment. Acro had sought FDA-approval under the § 501(k) process, which allows a new medical device to get approved by establishing its similarity to a predicate device (one already on the market) and thereby avoid the more rigorous and time-consuming premarket application process. Acro twice sought § 501(k)-approval for the bone screw device for use in spinal surgery and was denied each time by the FDA because the device lacked substantial equivalence to a predicate device. Acro then split the device into its component parts and renamed them “nested bone plates” and sought § 501(k)-approval for use in long bones of the arms and legs. The FDA approved the devices for this purpose. The district court initially dismissed the claims for being preempted by the Food, Drug, and Cosmetic Act of 1938 (FDCA) as amended by the Medical Device Amendments of 1976 (MDA) then after the Supreme Court’s decision in Medtronic, Inc. v. Lohr on grounds that the claims constituted improper private rights of action under the FDCA. The Court of Appeals for the Third Circuit reversed, and Acro sought a writ of certiorari in the Supreme Court.