Riegel v. Medtronic
- Case Date: 10/19/2007
- Project Name: Health Care Project
On February 19. 2008, the U.S. Supreme Court ruled that federal law preempts state-law product liability suits challenging the design or labeling of medical devices that have been determined to be safe and effective by FDA. The 8-1 decision was a victory for the WLF, which filed a brief in the case, urging preemption of such suits. The Court agreed with WLF that Congress mandated preemption when it adopted the Medical Device Amendments of 1976 (MDA), which established a rigorous Premarket Approval process for all new medical devices. The Court held that allowing state court judgments against a device manufacturer that are based on a determination that the device is either defectively designed or deficiently labeled would undermine the approval process by calling into question FDA's decisions mandating specific product designs and labels. The Court held that Congress's intent to preempt such suits is spelled out in a federal statute, 21 U.S.C. § 360k(a).
More Information and Downloads:
10/19/2007: Download the Brief
Litigation Update: Court Upholds Preemption of Suits Involving Medical Devices