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Mutual Pharmaceutical Co. v. Bartlett

Supreme Court of the United States · 2013 · Constitutional Law

Constitutional LawFederal PreemptionGeneric DrugsSupremacy ClauseSupremacy Clauseimpossibility preemptiongeneric drug labelingdesign defect

Facts

Mutual manufactured sulindac, a generic NSAID that Bartlett's pharmacist dispensed after her doctor prescribed Clinoril. Bartlett developed toxic epidermal necrolysis and suffered catastrophic injuries. At the time, sulindac's label warned of severe skin reactions and fatalities, and the package insert listed Stevens-Johnson Syndrome and toxic epidermal necrolysis as potential adverse reactions; later, after the FDA reviewed NSAID risks, it recommended stronger warnings. Under New Hampshire design-defect law, a product's unreasonable danger is evaluated in part by the adequacy of its warnings, and sulindac could not be redesigned because federal law required generic sameness and the drug was chemically a one-molecule drug.

Issue

Whether federal law preempts a New Hampshire design-defect claim against a generic drug manufacturer when, as applied, the claim turns on the adequacy of the drug's warnings and the manufacturer cannot independently change either the drug's composition or its label.

Rule

State-law design-defect claims that turn on the adequacy of a drug's warnings are preempted by federal law when brought against FDA-approved generic drugs sold in interstate commerce, because federal law prohibits generic manufacturers from independently changing the drug's composition or labeling and it is therefore impossible to comply with both state and federal law. A manufacturer is not required to avoid preemption by ceasing to sell the product altogether.

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One of 10 multiple-choice questions for this case. Pick an answer to see why.

In Vermont, Lena Ortiz sues North River Labs, a manufacturer of an FDA-approved generic migraine drug sold nationwide. Vermont design-defect law asks whether the drug was unreasonably dangerous by balancing its utility against its risks, and expressly treats the adequacy of warnings as part of that inquiry; the generic's chemical composition cannot be changed without making it a different drug, and federal law requires the generic label to match the brand-name label.

If Vermont liability would be avoided only by strengthening the drug's warning, is the design-defect claim most likely preempted?

Explanation. The majority held that state-law design-defect claims are preempted when, as applied, they turn on the adequacy of a generic drug's warnings and the manufacturer cannot independently change either the drug's composition or labeling. Here, Vermont's risk-utility test incorporates warning adequacy, redesign is unavailable, and the only way to avoid liability would be a stronger warning. That creates an impossibility conflict with federal law requiring generic-label sameness. (Derived from Mutual Pharmaceutical Co. v. Bartlett (2013).)