defective drug claims

Senator Tom Harkin and Representative Henry A. Waxman have filed a brief of amici curiae in support of Karen L. Bartlett over the Supreme Court of the United State’s decision in the case of Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett. The brief concerns pharmaceutical regulation and federal preemption under the Food, Drug, and Cosmetic Act (FDCA) and the Hatch-Waxman Amendments, of which Representative Waxman was co-sponsor during its creation in 1984. Under preemption, federal law overrides state law. In regard to issues of defective drugs or product liability, preemption would mean that plaintiffs can’t file claims in state court if a federal agency such as the U.S. Food and Drug Administration (FDA) has already approved the product in question.

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