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Mut. Pharm. Co. v. Bartlett - 570 U.S. 472, 133 S. Ct. 2466 (2013)

Rule:

Under the Supremacy Clause, U. S. Const. art. VI, cl. 2, state laws that require a private party to violate federal law are preempted and, thus, are without effect.

Facts:

The Federal Food, Drug, and Cosmetic Act (FDCA) required manufacturers to gain Food and Drug Administration (FDA) approval before marketing any brand-name or generic drug in interstate commerce. Once a drug was approved, a manufacturer was 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 were also prohibited from making any unilateral changes to a drug's label. In 2004, respondent Karen Bartlett was prescribed Clinoril, the brand-name version of the nonsteroidal anti-inflammatory drug (NSAID) sulindac, for shoulder pain. Her pharmacist dispensed a generic form of sulindac manufactured by petitioner Mutual Pharmaceutical. Bartlett soon developed an acute case of toxic epidermal necrolysis. She was now severely disfigured, has physical disabilities, and is nearly blind. At the time of the prescription, sulindac's label did not specifically refer to toxic epidermal necrolysis. By 2005, however, the FDA had recommended changing all NSAID labeling to contain a more explicit toxic epidermal necrolysis warning. Bartlett sued Mutual Pharmaceutical in a New Hampshire state court, and Mutual Pharmaceuticalremoved the case to federal court. A jury found Mutual Pharmaceutical liable on Bartlett's design-defect claim and awarded her over $21 million. The Court of Appeals for the First Circuit affirmed. As relevant, it found that neither the FDCA nor the FDA's regulations pre-empted Bartlett's design-defect claim. It distinguished PLIVA, Inc. v. Mensing, 564 U. S. 604, 131 S. Ct. 2567, 180 L. Ed. 2d 580 in which the United States Supreme Court held that failure-to-warn claims against generic pharmaceutical manufacturers were pre-empted by the FDCA's prohibition on changes to generic drug labels--by arguing that generic manufacturers facing design-defect claims could comply with both federal and state law simply by choosing not to make the drug at all. The United State Supreme Court granted certiorari review.

Issue:

Was the state-law tort claim based on an inadequate warning of the drug’s dangers preempted by federal law?

Answer:

Yes.

Conclusion:

The U.S. Supreme Court held that the patient's state-law tort claim based on an inadequate warning of the drug's dangers was preempted by federal law, since it was impossible for the manufacturer to comply with both the state-law requirement to strengthen its warning label and the federal-law prohibition of a unilateral alteration of the label on the drug. According to the Court, to avoid liability, state design-defect law required the manufacturer to either redesign the drug, which was not possible based on the drug's composition, or to strengthen the warning on its label, which was also impossible under federal law, and the manufacturer was not required to stop selling the drug as a viable means of complying with both federal and state law.

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