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FDA preemption

FDA preemption is the legal theory in the United States that products licensed or otherwise approved for use by the Food and Drug Administration (FDA) are exempt from various state efforts to preclude their use. It has been raised as a counter to both direct efforts to ban such products, and as a defense against tort claims regarding such products. The doctrine hinges on the assertion of Congressional intent to designate FDA as the national clearinghouse for determinations of the safety of pharmaceutical products, and the Supremacy Clause of the Constitution of the United States placing federal law over state law.

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. • Mutual Pharmaceutical Co. v. Bartlett (2013): The U.S. Supreme Court ruled that generic drug manufactures cannot be held liable under state law for not adequately labeling medication when federal law prohibits them from changing the label from the original brand name drug. ==See also==
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