The Federal Food, Drug, and Cosmetic Act (FDCA) requires manufacturers to gain Food and Drug Administration (FDA) approval before marketing
The Federal Food, Drug, and Cosmetic Act (FDCA) requires manufacturers to gain Food and Drug Administration (FDA) approval before marketing any brand-name or generic drug in interstate commerce. Once a drug is approved, a manufacturer is prohibited from making any major changes to the "qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application." Generic manufacturers are also prohibited from making any unilateral changes to a drug's label. Respondent patient brought an action against petitioner pharmaceutical manufacturer alleging that the label on the manufacturer's generic drug failed to warn of a severely disabling disease which the patient contracted after taking the drug. The pharmaceutical manufacturer contended that the simple composition of its generic drug precluded altering the drug to make it safer, and that federal drug-labeling laws precluded compliance with the state-law duty to provide the additional warning. Respondent sued the pharmaceutical manufacturer and a jury found the pharmaceutical manufacturer liable on respondent's design-defect claim, awarding her over $21 million.
The case was appealed to the U.S. Supreme Court to determine whether federal drug-labeling regulations preempt the state-law duty to provide additional warning. How do you think the Supreme Court ruled? Give a rationale for your decision. [Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013).]
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