Mutual Pharmaceutical Co. v. Bartlett

Whether federal law preempts state law design-defect claims against generic drug manufacturers.

The Hatch-Waxman Amendments to the federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301 et seq., and regulations promulgated under them by the Food and Drug Administration (FDA) govern the creation and marketing of generic drugs. In PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the United States Supreme Court held that the FDCA preempts state law failure-to-warn claims against generic drug manufacturers, because the FDA requires generic manufacturers to copy brand-name manufacturers' warnings and does not permit generic manufacturers to change those warnings.

Respondent ingested sulindac, a non-steroidal anti-inflammatory (NSAID) drug that is a generic for the brand name NSAID Clinoril, and as a result suffered painful and debilitating injuries. Respondent sued Petitioner—who manufactures generic sulindac—in state court for design defect among other causes of action. Petitioner removed the case to federal court, and Respondent ultimately proceeded to trial only on the design defect claim. The jury found for Respondent and awarded $21.06 million in compensatory damages. The trial court denied Petitioner's motion for judgment as a matter of law and motion for a new trial.

Petitioner appealed to the Court of Appeals for the First Circuit which upheld the jury award and held that: (1) a safer alternative is not a necessary element of a design defect claim, and (2) Respondent could choose not to make the drug at all if the risks outweigh the benefits, and Wyeth v. Levine's (129 S.Ct. 1187 (2009)) general rule against preemption would not prevent states from prohibiting manufacture of a dangerous drug. The First Circuit’s holding conflicts with decisions in the Fifth, Sixth, and Eighth circuits, and the Supreme Court granted certiorari to resolve the circuit split.