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Case Details

Case: Riegel, Charles, et ux. v. Medtronic, Inc.
Subject(s): preemption, torts, Medical Device Act, Medtronic, federalism
Appealed from: Second Circuit Court of Appeals

Docket No: 06-0179
Decision Rendered: No
Decision: None

Question(s) presented: Whether the federal scheme permitting the FDA to pre-approve some products insulates manufacturers from state tort suits.

Holding of appellate court: The plaintiff in the case is Charles Riegel, who suffered severe complications when a coronary artery catheter burst during his angioplasty. Riegel sued the manufacturer, Medtronic, for negligence in the design, manufacture, and labeling of the device. Medtronic argued that Riegel could not bring these state-law negligence claims because they were preempted by Section 360k(a) of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act. The District Court dismissed Riegel's claims as preempted by the MDA. The U.S. Court of Appeals for the Second Circuit agreed that the suits based on medical devices like the Evergreen Balloon Catheter are preempted by the MDA. The catheter had been through the exceptionally rigorous "premarket approval" (PMA) process, by which federal regulators ensured that it met federal requirements.

Date of Oral Arguments Your Prediction Your Prediction by Justice Update
Affirm Reverse Vacate Justice Affirm Reverse Vacate
Dec 04, 2007 Alito