In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the Supreme Court held that the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act (MDA), 21 U.S.C. § 360k(a), does not preempt state-law claims based on injuries caused by a medical device when the Food and Drug Administration (FDA) has not evaluated the device for safety and effectiveness. The Court held in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), that § 360k(a) does preempt state-law claims based on injuries caused by a medical device when the FDA has granted premarket approval based on evaluation of the device’s safety and effectiveness.
This case presents a question on the border of those two cases: whether § 360k(a) preempts state-law claims for injuries caused by a medical device when the device received premarket approval for one use but the manufacturer sold it for a different use, not evaluated or approved by the FDA, and the patient suffered serious injury as a result of that conduct by the manufacturer. In support of the plaintiff-appellant, Public Citizen filed an amicus brief to explain that, under the reasoning of Lohr and Riegel, the answer to this question is no.
In a short opinion, the court held that a properly pleaded claim of manufacturing defect would not be preempted and that a state-law claim of “misbranding” based on failure to update labeling in accordance with new intended uses was not preempted, but held that design-defect and negligence per se claims were preempted.