California Supreme Court Limits Negligence Liability for Drug Manufacturers

The California Supreme Court held in Gilead Tenofovir Cases, No. S283862, slip op. at 56 (Cal. Aug. 3, 2026), “that drug manufacturers do not owe a duty of care to users of a nondefective drug when making decisions about whether and when to commercialize an allegedly safer alternative drug.”

The plaintiffs there had alleged that they suffered injuries from a prescription drug manufactured by Gilead Sciences, Inc., though they conceded that the drug was not defective. Their theory was that Gilead unreasonably “delayed bringing to market another drug it had invented that was equally effective and less toxic.” Id. at 1. The Court of Appeal found that the plaintiffs’ allegations gave rise to a negligence claim “pursuant to Civil Code section 1714, . . . which establishes a default duty requiring all persons and entities to exercise reasonable care to avoid causing harm to others.” Id. at 1-2. The Supreme Court of California reversed. 

The majority expressed “substantial doubt that California law recognizes a general negligence duty requiring drug manufacturers to act reasonably in making drug development and commercialization decisions apart from their established duty to design, manufacture, and market products free from defects.”  Id. at 20. It nevertheless assumed for purposes of its analysis that such a duty could exist and concluded that foreseeability and public policy considerations justify a categorical exception for decisions about whether and when to develop and commercialize an allegedly safer alternative drug. Id.  20-23. 

Although the California Supreme Court’s holding is limited to decisions about whether and when to commercialize an alternative drug, the majority’s broader skepticism toward negligence liability for injuries caused by a nondefective drug may prove significant in future cases involving novel theories of manufacturer liability.

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