Federal Law Preempts Most State Products Liability Claims
posted on June 7th, 2008 in Medical Devices, Preemption by clintWhat happens if you sue a medical device maker for products liability, and it moves to dismiss based on the federal preemption doctrine? It could be the end of your case. The Medical Device Amendments to the Food Drug & Cosmetics Act of 1976 include C.F.R. § 803.1 et seq., which preempt state common law claims of products liability. These federal regulations govern Class III medical devices that receive FDA Premarket Approval. There is one exception. A claim that the manufacturer failed to comply with FDA regulations is not preempted. There is no preemption when a medical device manufacturer negligently fails to comply with FDA regulations because a finding of wrongdoing would not be “different from or in addition to” those requirements imposed by federal law. In Isbell v. Medtronic, Inc., 97 F.Supp.2d 849 (W.D.Tenn.1998), a district court in Tennessee held there was no preemption when a defect in Class III medical device was caused by the manufacturer’s violation of: (1) FDA approved design specifications, (2) manufacturing processes, or (3) labeling requirements. See also Kemp v. Medtronic, Inc., 231 F.3d 216, 230 (6th Cir.2000); Cupek v. Medtronic, Inc., 405 F.3d 421, 422-23 (6th Cir.2005). You need to plead federal violations!