Lawsuits Over TDF Drug Injuries Dismissed After California Supreme Court Ruling

Ruling effectively ends the long-running litigation, finding that Gilead did not have a duty to develop and sell safer HIV drugs.

California’s highest court has issued a ruling that resulted in the dismissal of about 24,000 HIV drug lawsuits being pursued against Gilead, which were brought by former users who developed kidney damage or bone problems after using the treatments.

The litigation involves product liability lawsuits over side effects associated with various Gilead combination HIV treatments that contain the compound tenofovir disoproxil fumarate (TDF), such as Truvada, Viread, Atripla, Complera and Stribild.

Over the past five years, tens of thousands of individuals have filed their lawsuits in California state courts, each raising similar allegations that the drug manufacturer intentionally sold toxic and dangerous versions of the drugs while sitting on a safer formulation for years.

The alternative, a compound known as tenofovir alafenamide fumarate (TAF) is believed to reduce the risks of bone problems, kidney damage and other side effects linked to the older TDF formulations. However, Gilead allegedly delayed development of TAF-based HIV drugs until the existing TDF-based drugs neared the end of patent protections, extending the drug maker’s monopoly over the market by avoiding competition from generic competitors.

HIV Drug Lawsuit Settlement

In 2024, Gilead announced a $40 million HIV drug lawsuit settlement, resolving more than 2,600 claims pending in the federal court system, while leaving the California claims unresolved.

Gilead sought summary judgment in the California cases, arguing that plaintiffs never identified TDF drugs as having any kind of actual defect, but instead claimed the company had a duty to develop other treatment options. A California court of appeals rejected the company’s arguments, resulting in the case making its way to the California Supreme Court.

In a 6-to-1 opinion (PDF) issued on August 3, the California Supreme Court agreed with Gilead that the cases should be dismissed. The justices defended the company’s freedom to stop investing in a potential drug product, even if it showed the potential to be a better treatment.

“Imposing 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.”

– Associate Justice Joshua Groban writing for the majority, California Supreme Court

According to the majority opinion, plaintiffs failed to meet essential elements of negligence claims under California law. The court determined a company’s existing duties under law, while encompassing a broad area of reasonable care, do not extend to owing its customers the development of a safer alternative product.

The decision effectively ends the litigation at the California state level.

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