Federal Pre-Emption Under The Food, Drug & Cosmetic Act From Medtronic, Inc. V. Lohr; Pliva, Inc. V. Mensing



Beginning in 1996, the United States Supreme Court took a series of cases related to Federal preemption of state law claims for products approved by the United States Food and Drug Administration (''FDA''). In some instances, these courts found federal law pre-empted state law claims. In other cases, the court found that no federal pre emption existed and allowed the state law claims to proceed. This article examines the reasoning in each of these five cases as well as two state court cases related to federal pre-emption. In doing so, this article describes the current landscape of federal pre-emption for products approved by the FDA.

Federal Pre-Emption The theory of federal pre-emption rests on the Supremacy Clause of the United States Constitution. The Supremacy Clause provides that federal law is ''the supreme law of the land; ... anything in the constitution or laws of any state to the contrary notwithstanding.'' Therefore, a state law that conflicts with federal law is pre-empted and has no effect.

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