Pharmaceutical Products and Suicide Risks

Federal Preemption Poses A Major Sticking Point

Suits charging that someone became suicidal because of a prescription medication's use are generally based on a claim that the drug's manufacturer failed to warn users through adequate labeling of a known potential side effect. Such suits often fail to get past the summary judgment phase. The primary reason is that the plaintiffs' state law claims run afoul of the doctrine of federal preemption, embodied in the Supremacy Clause to the U.S. Constitution, which provides that the 'Laws of the United States … shall be the supreme Law of the Land.' U.S. Const. Art. VI, cl. 2. Therefore, 'any state law that conflicts with federal law is 'without effect.” Cipollone v. Ligget Group Inc., 505 U.S. 504 (1992) (citation omitted). The Medical Device Amendments (MDA) to the Food Drug and Cosmetics Act (FDCA) 21 U.S.C. ' 301 et seq., contain an express preemption provision, namely ' 360k(a), which prohibits states from imposing requirements different from, or in addition to, the specific federal requirements imposed on medical devices by FDA regulations. However, the rules on drugs are not so clear.