Riegel v. Medtronic Inc.
Riegel sued Medtronic, a medical manufacturer, after a Medtronic catheter used during Riegel's angioplasty procedure malfunctioned. The district court dismissed Riegel's state law claims (strict liability, breach of implied warranty, and negligent design, testing, inspection, distribution, labeling, marketing, and sale) because the catheter had already been approved by the Food and Drug Administration (FDA). The 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act stipulate that state law cannot establish requirements for medical devices that are different from federal requirements. The district court found that since the FDA approval process established federal requirements, Riegel's state law tort claims were preempted.
The Second Circuit Court of Appeals affirmed. Riegel's claims were based on the alleged faulty design of the catheter, but the FDA had already approved the catheter's design through its stringent pre-market approval process. Since Medtronic's catheter design was already approved by the FDA, it could not still be subject to suits based on state law, because that would, in effect, be setting up different requirements than the federal ones.
Question Presented
Whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. ยง360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received pre-market approval from the Food and Drug Administration.
