Why is the case important?
Patient brings common law claims against manufacturer of faulty medical device which was FDA pre-approved.
Facts of the case
“During Charles Riegel’s angioplasty, his surgeon used an Evergreen Balloon Catheter to dilate his coronary artery. The catheter burst, causing extreme complications. 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 MDA establishes a federal regulatory process for ensuring the safety of medical devices, and it provides that no state may set requirements that differ from or add to the federal ones. 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. To allow state common-law suits for PMA-approved devices, the court ruled, would be to add a state requirement to the regulatory process despite the MDA’s preemption clause.”
Whether the preemption clause in the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act (FDCA) bars common law claims challenging the safety and effectiveness of a medical device given premarket approved by the FDA?
Yes, such claims are preempted.
“The federal government had established “”requirements applicable to”” respondent’s catheter within the meaning of the Medical Device Amendments of 1976, 21 U.S.C.S. § 360k(a)(1). Premarket approval imposed “”requirements”” under the MDA because the FDA required devices that received premarket approval to be made with almost no deviations from the specifications in the approval application. Further, New York’s tort duties constituted “”requirements”” under the MDA. Thus, petitioners’ negligence and strict liability claims that related to safety and effectiveness were based on New York “”requirements”” with respect to the catheter that were “”different from, or in addition to”” the federal requirements.”
- Case Brief: 2008
- Petitioner: Donna S. Riegel, individually and as administrator of the Estate of Charles R. Riegel
- Respondent: Medtronic, Inc.
- Decided by: Roberts Court
Citation: 552 US 312 (2008)
Granted Jun 25, 2007
Argued: Dec 4, 2007
Decided: Feb 20, 2008