The United States Supreme Court granted certification to review Riegel v. Medtronic, 451 F3d 104 (2nd Cir. 2006), to determine whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. §360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval (PMA) from the Food and Drug Administration.
As Bloomberg.com reports, the federal law says preemption applies when the U.S. government imposes a "requirement,'' though it doesn't specify whether that term includes FDA approval.
Court case: 06-179, Riegel v. Medtronic, Inc.
Applicable law:
21 U.S.C. §360k
(a) General rule
Except as provided in subsection (b) of this section, no State or political subdivision of a State may 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 this chapter 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 this chapter.
