Mutual Pharmaceutical Co. v. Bartlett

570 U.S. 472 (2013)

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Mutual Pharmaceutical Co. v. Bartlett

United States Supreme Court
570 U.S. 472 (2013)

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Facts

Karen Bartlett (plaintiff) was prescribed Clinoril, the brand-name version of sulindac, for pain. Her pharmacist dispensed a generic version of sulindac manufactured by Mutual Pharmaceutical Co. (Mutual) (defendant). The drug caused toxic epidermal necrolysis, leaving Bartlett disfigured, almost blind, and physically disabled. Bartlett sued Mutual, asserting a New Hampshire design-defect claim premised on the drug’s dangerousness and the label’s failure to warn of toxic epidermal necrolysis. The Federal Food, Drug, and Cosmetic Act (FDCA) prevented all drug manufacturers from making major changes to drugs approved by the Food and Drug Administration (FDA) and prohibited generic manufacturers from making changes to a drug’s label. The label for Clinoril did not warn of toxic epidermal necrolysis. Mutual argued that it could not be liable under state law because federal law prevented Mutual from altering the drug’s design or from adding warnings to its labels. The district court held in Bartlett’s favor, awarding substantial damages. The court of appeals affirmed. Mutual appealed to the Supreme Court.

Rule of Law

Issue

Holding and Reasoning (Alito, J.)

Dissent (Breyer, J.)

Dissent (Sotomayor, J.)

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