## Facts

- Karen Bartlett was prescribed the brand-name NSAID Clinoril (sulindac) for shoulder pain, but her pharmacist dispensed a generic sulindac product manufactured by Mutual Pharmaceutical Co.
- After taking the drug, Bartlett developed Stevens–Johnson syndrome and toxic epidermal necrolysis, suffering severe and permanent injuries, including extensive skin loss, disfigurement, disabilities, and near blindness.
- At the time, the FDA-approved sulindac label warned generally about serious skin reactions and fatalities but did not specifically name toxic epidermal necrolysis; the FDA later recommended more explicit warnings for NSAIDs.
- Bartlett sued in New Hampshire; by trial, only a state-law design-defect claim remained.
- New Hampshire prescription-drug design-defect law evaluated risk–utility by considering both the drug’s chemical properties and its warning label.
- A federal jury found Mutual liable and awarded Bartlett over $21 million in compensatory damages; the district court denied a new trial.
- The First Circuit affirmed, rejecting federal preemption; the Supreme Court granted review.

## Issues

1. Whether federal generic-drug requirements preempt a state-law design-defect claim that effectively requires stronger warnings or a different drug design.
2. Whether a generic manufacturer can avoid impossibility preemption by choosing to stop selling the drug.

## Decision

- The Supreme Court reversed the First Circuit in a 5–4 decision (Justice Alito).
- The Court held that federal law preempted Bartlett’s New Hampshire design-defect claim as applied to a generic drug.
- Because federal law barred Mutual from unilaterally changing sulindac’s labeling and from making major formulation changes, it was impossible to comply with both federal duties and the state-law duty as construed at trial.
- The Court rejected the argument that Mutual could comply by withdrawing the drug from the market (“stop-selling” theory).

## Legal Principles

- Under the Supremacy Clause, a state requirement is preempted where it is impossible for a private party to comply with both state and federal law (impossibility preemption).
- Federal generic-drug law requires “sameness” between generic and brand-name drugs, including labeling; generic manufacturers generally may not unilaterally strengthen warnings.
- Federal law also restricts major changes to an approved drug’s qualitative or quantitative formulation, limiting redesign options for generic manufacturers.
- State-law design-defect claims that turn on the adequacy of a generic drug’s warnings are preempted when the only routes to avoid liability would be label changes or design changes forbidden by federal law.
- An actor is not required to cease selling a product to avoid impossibility; permitting “stop-selling” as a solution would largely eliminate impossibility preemption.

## Conclusion

The Court held that federal generic-drug requirements preempt state-law design-defect liability when the claim would require a generic manufacturer to alter the drug’s labeling or composition, and it refused to treat withdrawal from the market as a permissible way to avoid the federal–state conflict.


Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013)