FDA Preemption
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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.[1]
Relevant Cases
- Riegel v. Medtronic, Inc. (2008) The U.S. Supreme Court ruled that manufacturers of FDA-approved devices are protected from liability under state laws.
- Wyeth v. Levine (2009) The U.S. Supreme Court ruled that Vermont tort law was not preempted in this case.
References
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- [1] The Pharmaceutical Research and Manufacturers of America's official statement in support of FDA preemption.
- [2] A statement against FDA preemption.
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- ↑ When and How to Defer to the FDA: Learning from Michigan's Regulatory Compliance Defense Michigan Telecommunications and Technology Law Review, Vol. 15, p. 565, 2009.
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