Key facts
- California's Supreme Court ruled 6-1 in favor of Gilead Sciences.
- The decision dismisses negligence claims from approximately 24,000 patients using an HIV drug.
- The case concerned Gilead's decision to stop developing an alternative drug with fewer side effects.
- The court stated that imposing a 'duty to innovate' could create substantial burdens and risk adverse consequences for pharmaceutical innovation, public health, and patient safety.
- Gilead's HIV drugs accounted for 70% of its $29.4 billion in 2025 revenue.
California's highest court has ruled in favor of Gilead Sciences in a significant case that addressed whether manufacturers of drugs deemed safe have an obligation to develop potentially safer alternatives. In a 6-1 decision, the California Supreme Court ordered the dismissal of negligence claims brought by an estimated 24,000 patients who used a Gilead HIV drug. The patients alleged that Gilead was negligent for stopping the development of an alternative drug with fewer side effects more than 20 years ago.
Justice Joshua Groban, writing for the majority, stated that recognizing such liability for injuries caused by a concededly non-defective drug would create substantial burdens and risk adverse consequences for pharmaceutical innovation, public health, and patient safety. Gilead, in a statement, called the decision a victory for medical treatment development and American innovation.
The case, closely watched by the pharmaceutical industry, centered on the concept of a 'duty to innovate,' which critics argued would make drug development too costly and punish successful products. The patients involved took Gilead drugs containing tenofovir disoprofil fumarate (TDF), which were approved in 2001 despite potential side effects like kidney dysfunction and bone problems. Gilead had begun testing tenofovir alafenamide fumarate (TAF), which had fewer side effects, but stopped its development in 2004, concluding its benefits were not sufficiently different to justify the expense. Patients argued that TDF's side effects necessitated a better alternative and accused Gilead of delaying TAF's commercialization to maximize profits until TDF's patent exclusivity expired in 2017. Justice Kelli Evans dissented, calling Gilead's conduct 'morally blameworthy.'