Mutual Pharmaceutical Co. v. Bartlett

Background

A patient, Karen Bartlett, was prescribed the brand drug Clinoril but received a generic version of sulindac made by a generic drug maker, Mutual Pharmaceutical. She developed toxic epidermal necrolysis, suffered severe injuries, and sued in New Hampshire. A jury found the manufacturer liable on a design-defect theory and awarded more than $21 million. The First Circuit affirmed, and the case reached the Supreme Court.

Reasoning

The Court addressed whether federal drug law bars state design-defect claims that depend on whether a drug’s warnings are adequate. The Food, Drug, and Cosmetic Act and FDA rules require generics to match the brand drug in composition and labeling and forbid unilateral label changes. Because sulindac could not be redesigned—both by federal rules and because of its simple chemistry—the State’s law effectively required the manufacturer to change the label. The Court relied on its prior decision in PLIVA (Mensing) and the Supremacy Clause to hold it was impossible to comply with both duties, so New Hampshire’s warning-based design-defect claim was pre-empted and the First Circuit’s judgment was reversed.

Real world impact

The ruling holds that state design-defect claims that turn on warning adequacy are pre-empted for FDA-approved generic drugs sold in interstate commerce. That prevents many state suits that rest on the need to strengthen generic warnings. The Court rejected the idea that a manufacturer could avoid the conflict simply by stopping sales, saying that option does not defeat impossibility pre-emption.

Dissents or concurrances

Two dissenting opinions argued against broad pre-emption: one said the company could comply by leaving the market or paying damages and urged deference to the FDA’s views; another said the majority mischaracterized Bartlett’s claim and ignored Congress’ choice to preserve state law.