Mut. Pharma. Co. v. Bartlett

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The Food, Drug, and Cosmetic Act requires Food and Drug Administration (FDA) approval before marketing any brand-name or generic drug in interstate commerce, 21 U.S.C. 355(a). The manufacturer of an approved drug is prohibited from making any major change 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 change to a drug’s label. In 2004, a patient was prescribed Clinoril, a brand-name nonsteroidal anti-inflammatory drug (NSAID) sulindac, for shoulder pain. Her pharmacist dispensed a generic form of sulindac manufactured by Mutual. The patient developed an acute case of toxic epidermal necrolysis and is 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, the FDA had recommended changing all NSAID labeling to contain a more explicit toxic epidermal necrolysis warning. A jury found Mutual liable on a design-defect claim and awarded the patient more than $21 million. The First Circuit affirmed. The Supreme Court reversed. State-law design-defect claims based on the adequacy of a drug’s warnings are preempted by federal law under a 2011 Supreme Court decision, PLIVA, Inc. v. Mensing. It is impossible for Mutual to comply with both its federal-law duty not to alter sulindac’s label or composition and its state-law duty to either strengthen the warnings on the label or change sulindac’s design. Redesign was not possible because the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as its brand-name drug equivalent and, due to sulindac’s simple composition, the drug is chemically incapable of being redesigned. Mutual could only ameliorate sulindac’s "risk-utility" profile, therefore, by strengthening its warnings, an action forbidden by federal law. View "Mut. Pharma. Co. v. Bartlett" on Justia Law