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Momentous USSC decision in Riegel v Medtronic

In an 8-1 decision, the Supremes rejected design and warning claims that were held to conflict with federal law. Herewith the synopsis of the decision:

The Medical Device Amendments of 1976 (MDA) created a scheme of federal safety oversight for medical devices while sweeping back state oversight schemes. The statute provides that a State shall not "establish or continue in effect with respect to a device intended for human use any requirement-... (1) which is different from, or in addition to, any requirement applicable under [federal law] to the device, and ... (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under" relevant federal law. 21 U. S. C. ยง360k(a). The MDA calls for federal oversight of medical devices that varies with the type of device at issue. The most extensive oversight is reserved for Class III devices that undergo the premarket approval process. These devices may enter the market only if the FDA reviews their design, labeling, and manufacturing specifications and determines that those specifications provide a reasonable assurance of safety and effectiveness. Manufacturers may not make changes to such devices that would affect safety or effectiveness unless they first seek and obtain permission from the FDA.
Charles Riegel and his wife, petitioner Donna Riegel, brought suit against respondent Medtronic after a Medtronic catheter ruptured in Charles Riegel's coronary artery during heart surgery. The catheter is a Class III device that received FDA premarket approval. The Riegels alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. The District Court held that the MDA pre-empted the Riegels' claims of strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter, and their claim of negligent manufacturing insofar as the claim was not premised on the theory that Medtronic had violated federal law. The Second Circuit affirmed.
Held: The MDA's pre-emption clause bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA. Pp. 8-17.

This is the most momentous Supreme Court product liability decision in some time -- covering not only warnings but also design defects for FDA approved devices (at least, perhaps, for Class III devices). Justice Ginsburg, dissenting, vigorously defended state common law's survival in the face of FDA regulations, but was unable to muster other states' rights supporters in the face of a hard-to-get-around literal interpretation of the regulations' meanings.



Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.