FDA Preemption
Encyclopedia
FDA Preemption is the legal theory in the United States
that exempts product manufacturers from tort
claims regarding Food and Drug Administration
approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA (at least under the Bush Administration) and pharmaceutical manufacturers are in favor of it, arguing that the FDA should set both the floor and the ceiling for drug regulation. Michigan is the only state that voluntarily applies FDA Preemption to its own state tort law through a regulatory compliance defense, although Michigan's law has been controversial and efforts to repeal it are underway.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
that exempts product manufacturers from tort
Tort
A tort, in common law jurisdictions, is a wrong that involves a breach of a civil duty owed to someone else. It is differentiated from a crime, which involves a breach of a duty owed to society in general...
claims regarding Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA (at least under the Bush Administration) and pharmaceutical manufacturers are in favor of it, arguing that the FDA should set both the floor and the ceiling for drug regulation. Michigan is the only state that voluntarily applies FDA Preemption to its own state tort law through a regulatory compliance defense, although Michigan's law has been controversial and efforts to repeal it are underway.
Relevant cases
- Riegel v. Medtronic, Inc.Riegel v. Medtronic, Inc.Riegel v. Medtronic, Inc., 552 U.S. 312 , is a decision by the Supreme Court of the United States holding that the pre-emption clause of the Medical Device Amendment bars state common-law claims that challenges the effectiveness or safety of a medical device marketed in a form that received...
(2008) The U.S. Supreme Court ruled that manufacturers of FDA-approved devices are protected from liability under state laws. - Wyeth v. LevineWyeth v. LevineWyeth v. Levine, 555 U.S. 555 , is a United States Supreme Court case holding that Federal regulatory approval of a medication does not shield the manufacturer from liability under state law.-Vermont jury trial:...
(2009) The U.S. Supreme Court ruled that Vermont tort law was not preempted in this case.
External links
- Pharmaceutical Research and Manufacturers of AmericaPharmaceutical Research and Manufacturers of AmericaPharmaceutical Research and Manufacturers of America , founded in 1958, is a trade group representing the pharmaceutical research and biopharmaceutical companies in the United States. PhRMA's stated mission is advocacy for public policies that encourage the discovery of new medicines for patients...
's official statement in support of FDA preemption. - A statement against FDA preemption