Riegel v. Medtronic, Inc.
Citation
552 U.S. 312 (2008). Supreme Court of the United States.
Facts
Charles Riegel suffered injuries when a Medtronic balloon catheter — which had received FDA premarket approval (PMA) under the Medical Device Amendments (MDA) — burst during heart surgery. He sued in state tort, claiming the device was negligently designed and manufactured and inadequately labeled. Medtronic argued state tort claims were expressly preempted by the MDA.
Issue
Does the MDA’s express preemption clause preempt state tort law claims against a medical device that received FDA premarket approval?
Holding
The Court held that the MDA expressly preempts state tort claims that impose requirements “different from or in addition to” the specific federal PMA requirements applicable to the device.
Rule / Doctrine
The MDA preempts any state “requirement” that is (1) with respect to a device subject to a specific federal requirement and (2) different from or in addition to that federal requirement. State tort law imposes “requirements” within the meaning of the preemption clause. Because FDA PMA approval establishes device-specific federal requirements after rigorous review, state negligence and strict liability claims are preempted to the extent they would impose different design, manufacturing, or labeling standards. Parallel state claims tracking federal requirements are not preempted.
Significance
Riegel broadly protects PMA-approved devices from state tort liability, generating debate about accountability and the adequacy of FDA review as a substitute for common law remedies. It is a leading case on express federal preemption and the scope of the MDA preemption clause.