Forum
U.S. Supreme Court
Case Status
Docket Number
06-179
Term
2007 Term
Oral Argument Date
December 04, 2007
Questions Presented
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 from the Food and Drug Administration.
Case Updates
Supreme Court affirms federal preemption of state tort law
February 20, 2008
The Supreme Court concluded that the Medical Device Amendments to the Food, Drug and Cosmetic Act preempts state law personal injury lawsuits where the device in question received premarket approval.
U.S. Chamber files amicus brief on the merits
October 19, 2007
NCLC urged the Supreme Court to find that the Medical Device Amendments to the Food, Drug and Cosmetic Act preempts state law personal injury lawsuits where the device in question received premarket approval. In this case, the plaintiff’s husband died after a balloon catheter manufactured by the defendant ruptured during an angioplasty. Because the catheter had been approved by the Food and Drug Administration (“FDA”) pursuant to a rigorous premarket approval process, NCLC contended that personal injury lawsuits, which impose regulatory-like burdens of their own, conflicted with the considered judgment of the FDA and should be preempted.