American Journal of Law & Medicine

Medical devices: Food, Drug, and Cosmetic Act preempts state law fraud claims.

Medical Devices: Food, Drug, and Cosmetic Act Preempts State Law Fraud Claims--Buckman Co. v. Plaintiffs' Legal Comm.(1)--The Supreme Court of the United States held that the Plaintiffs' Legal Committee's ("PLC") state law fraud-on-the-FDA claims conflict with, and are therefore preempted by, the Food, Drug, and Cosmetic Act ("FDCA"), as amended by the Medical Device Amendments ("MDA").(2) PLC represented patients claiming to have suffered injuries from implantation of orthopedic bone screws into pedicles of their spines.(3) PLC brought suit in state court, alleging that the regulatory consultant, Buckman Co., who was used by the screw manufacturer to navigate the federal regulatory process, made fraudulent representations to the Food and Drug Administration ("FDA") in the course of obtaining approval to market the screws. …

Log in to your account to read this article – and millions more.