Key Takeaway: California court holds that drug manufacturers do not have a duty to commercialize a safer drug to replace a nondefective one.
In the Gilead Tenofovir Cases, a group of unnamed plaintiffs alleged that Gilead was negligent by unreasonably delaying the release of a new HIV drug to maximize profits of an older, less safe drug. Specifically, the plaintiffs claimed they would have switched to the new drug, which presented fewer side effects to kidneys and bones, had Gilead not delayed in bringing the new drug to market. Importantly, however, the plaintiffs conceded that Gilead’s older drug was not defective. The California Court of Appeal held that liability could nonetheless exist under those circumstances.
On August 3, 2026, in a 6-1 decision, the Supreme Court of California reversed. The majority described a defective product as “an essential element of any products liability claim” and worried that adopting the plaintiffs’ negligence theory could “upend current products liability law.” The majority expressed concern that imposing a duty on drugmakers to develop and commercialize a safer product “risks inviting fact finders to second-guess complex resource-allocation decisions about whether and when to pursue potential alternative products while a concededly nondefective product remains on the market.” Thus, the Court “conclude[d] 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.”
Editor: Brenden S. Gingrich, Ph.D.
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