{"id":423428,"date":"2026-08-04T08:34:14","date_gmt":"2026-08-04T08:34:14","guid":{"rendered":"https:\/\/www.newsbeep.com\/us-ca\/423428\/"},"modified":"2026-08-04T08:34:14","modified_gmt":"2026-08-04T08:34:14","slug":"california-supreme-court-rules-gilead-not-liable-for-defective-hiv-drug-claims","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us-ca\/423428\/","title":{"rendered":"California Supreme Court rules Gilead not liable for defective HIV drug claims"},"content":{"rendered":"

(CN) \u2014 The California Supreme Court on Monday reversed<\/a> a lower court\u2019s decision denying summary judgment to Gilead in a class action accusing the pharmaceutical giant of deliberately delaying development of a new HIV treatment drug to maximize the value of the drug it was currently selling.<\/p>\n

The ruling overturns a state appellate court\u2019s conclusion<\/a> that the plaintiffs did not have to claim the product was defective to bring a negligence claim.<\/p>\n

\u201cWhat today\u2019s decision declines to do is recognize, for the first time anywhere, sweeping liability for injuries caused by a concededly nondefective drug because the manufacturer allegedly failed to make a different drug available sooner,\u201d Justice Joshua P. Groban wrote for the majority.<\/p>\n

\u201cImposing such liability would create substantial burdens and would risk adverse consequences for pharmaceutical innovation, public health, and patient safety. For these reasons, we conclude 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.\u201d<\/p>\n

The case stems from claims by people living with HIV\/AIDS who say they suffered unnecessary kidney, bone and tooth damage after taking Gilead\u2019s HIV drug tenofovir disoproxil fumarate, or TDF, which the Food and Drug Administration (FDA) approved in 2001.<\/p>\n

While clinically testing TDF, Gilead also began developing a backup drug, tenofovir alafenamide fumarate (TAF). In 2004, the company said<\/a> it stopped developing TAF because it \u201chad not distinguished itself from TDF.\u201d Gilead resumed work on TAF in 2010, and the Food and Drug Administration approved TAF-based medicines in 2015.<\/p>\n

The plaintiffs do not claim TDF is defective. Instead, they contend Gilead knew TAF posed fewer side effects but deliberately delayed its development to maximize profits from TDF. They also say Gilead resumed work on TAF only as its TDF patent neared expiration in 2017 to preserve its competitive advantage over generic versions.<\/p>\n

The trial court denied Gilead\u2019s motion for summary judgment on negligence and fraudulent concealment claims. The appellate court upheld the negligence ruling, finding a manufacturer\u2019s duty of reasonable care may extend beyond marketing a nondefective product. However, the appeals court reversed the denial of the fraudulent concealment claim, concluding Gilead had no duty to disclose information about TAF because it was not available to patients.<\/p>\n

In Monday\u2019s opinion, Groban agreed the lower court correctly recognized that California Civil Code\u00a0Section 1714<\/a>\u00a0imposes a general duty of reasonable care; however, precedent limits a drug manufacturer\u2019s duty to design, manufacture and market products free of defects.<\/p>\n

Groban added that even if manufacturers owed a broader duty of care, the foreseeability and policy factors outlined in Rowland v. Christian would create an exception under California products liability law.<\/p>\n

\u201cWhere, as here, the allegedly safer drug has not yet undergone large-scale clinical testing in humans or received approval from the federal Food and Drug Administration (FDA), any harm resulting from a drug manufacturer\u2019s delay in commercializing that drug would arise, if at all, only through a chain of uncertain scientific outcomes and discretionary decisions by actors beyond the manufacturer\u2019s control,\u201d he said.<\/p>\n

\u201cImposing a duty of care in these circumstances would place extraordinary burdens on drug manufacturers by effectively requiring them to commit substantial time, expenses, and resources to conduct the later-stage clinical trials necessary to obtain FDA approval. It would also risk distorting research priorities and chilling pharmaceutical innovation in ways that may ultimately undermine, rather than advance, public health and safety,\u201d he continued.<\/p>\n

Associate Justices Carol A. Corrigan, Goodwin H. Liu, Leondra R. Kruger and Associate Justice Tara M. Desautels, sitting by designation, concurred.<\/p>\n

Chief Justice Patricia Guerrero separately concurred, finding that plaintiffs must have claimed a defect in the product in order to bring a negligence claim.<\/p>\n

\u201cPlaintiffs contend that Civil Code section 1714 authorizes a negligence cause of action without proof of a defective product.\u00a0 Plaintiffs are incorrect. Their contention interprets section 1714 in a vacuum, and it ignores the entire history of negligence law in California,\u201d she said.<\/p>\n

Kruger additionally filed an additional concurring opinion, joined by Corrigan and Desautels.<\/p>\n

Associate Justice Kelli M. Evans dissented, writing that the majority opinion grants drug manufacturers \u201csweeping immunity from negligence liability.\u201d The justice said manufacturers should not be granted an exception to negligence law that requires everyone to exercise ordinary care.<\/p>\n

\u201c Like other entities, drug manufacturers should be held liable for injuries caused when they act negligently or engage in willful misconduct,\u201d she said.<\/p>\n

\u201cThe default duty of care should attach when drug manufacturers make decisions about whether and when to commercialize a drug known to be significantly safer than and as effective as an existing one. This conclusion aligns with traditional tort law principles, our precedent, and the realities of the pharmaceutical industry. I therefore respectfully dissent.\u201d<\/p>\n

Gilead celebrated the ruling in a press release, calling it a \u201cvictory for all those working to develop improved medical treatments and new medicine.\u201d<\/p>\n

\u201cThe California Supreme Court\u2019s decision supports American innovation, allowing companies to continue pursuing breakthroughs for patients and consumers,\u201d the company said. \u201cGilead is proud to have developed innovative, life-saving medicines that continue to be used by millions worldwide to prevent and treat HIV. We remain committed to ending the HIV epidemic through scientific innovation and a focus on the needs of people with HIV.\u201d<\/p>\n

A representative for the plaintiffs did not immediately respond to a request for comment.<\/p>\n


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