Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)

In Riegel v. Medtronic, Inc., the underlying dispute arose when Charles R. Riegel underwent a medical procedure involving a balloon catheter manufactured by Medtronic, Inc. Following the procedure, Riegel experienced severe complications, which he attributed to the catheter. Subsequently, Donna S. Riegel, both individually and as the administrator of her husband's estate, filed a lawsuit against Medtronic, claiming that the catheter was defectively designed and unreasonably dangerous, thus seeking damages under state tort law. The procedural history of the case began in the United States District Court for the Southern District of New York, where Medtronic moved to dismiss the claims based on the argument that they were preempted by the Medical Device Amendments of 1976 (MDA). The district court ruled in favor of Medtronic, leading the Riegels to appeal to the United States Court of Appeals for the Second Circuit. The appellate court upheld the district court's decision, confirming that the MDA's preemption clause barred the Riegels' common-law claims. The case was then brought before the Supreme Court of the United States on a writ of certiorari. The relevant background context includes the legislative changes surrounding medical device regulation in the United States. Prior to the MDA, the introduction and regulation of medical devices were primarily managed at the state level, which led to significant inconsistencies and safety concerns, particularly highlighted by the failures of devices like the Dalkon Shield. The MDA was enacted to establish a comprehensive federal regulatory framework for medical devices, including a preemption clause that prevents states from imposing additional requirements on devices that have received premarket approval from the FDA. This case ultimately tested the boundaries of that preemption clause and its implications for state tort claims against manufacturers of approved medical devices.

Whether the pre-emption clause enacted in the Medical Device Amendments of 1976, 21 U.S.C. §360k, bars common-law claims challenging the safety and effectiveness of a medical device given premarket approval by the Food and Drug Administration (FDA).

The judgment of the Court of Appeals is affirmed.