Gilead forks over $40M to settle thousands of claims in web of litigation over alleged delay of safer HIV meds

As Gilead Sciences awaits the progression of California state litigation over its alleged delay of safer HIV drugs, the company is biding its time with a proposed $40 million settlement to quell the claims of more than 2,000 plaintiffs.

The concurrent cases revolve around Gilead’s older tenofovir disoproxil fumarate (TDF) based medicine, or Viread, Truvada and others, and its newer product made with tenofovir alafenamide fumarate (TAF), Vemlidy.  

In California federal court, a group of some 2,625 plaintiffs contended that the TDF-based drugs resulted in unnecessary kidney and bone damage “caused by Gilead's failure to provide adequate warnings and its profit-driven decision” to wait on the TAF meds, a 2023 filing notes.   

The purpose of the lawsuits is not to blame Gilead for the injuries, but for the alleged negligence of waiting to launch the newer, safer products, according to the plaintiffs.

The one-time payment of $40 million is meant to “avoid the cost and distraction of litigating these cases” and is “in no way” an admission of wrongdoing or liability, the company said in a June 4 statement.

It should resolve the claims of the “overwhelming majority” of the plaintiffs but may not cover some who opt not to participate, as well as the others who are not included in the agreement. In those cases, Gilead will “continue to vigorously defend itself,” the drugmaker noted.

“Gilead has never stopped working to improve the lives of people with HIV,” it added in its statement. “The evidence shows that the long-term safety of TAF was unknown and impossible to predict in October 2004 when Gilead stopped TAF development in favor of further developing TDF medications.”

In order for it to go through, 98% of plaintiffs must agree to the deal.

The recent action is separate from the California state litigation, which is currently pending in the California Supreme Court with Gilead’s initial briefing due on July 15 following the court’s decision to review of a recent appeals court's decision.

That appeals ruling came in January when the appeals court moved to permit a unique negligence claim on the plaintiffs' side.

Around 24,000 TDF users linked up in the legal action and argued that Gilead’s early TAF testing suggested the med may pose fewer risks while delivering the same benefits, meaning the California-based drugmaker allegedly purposely chose to hold off on further development to maximize its TDF profits.

Crucially, those plaintiffs note that TDF isn’t faulty on its own, but that Gilead’s actions fall outside of its duty of reasonable care.

Gilead, for its part, argues that one cannot seek compensation for harm caused by a product that is not proven defective.

The appeal’s court ruling “upended established California law,” a company spokesperson previously said, marking the first time the state’s appellate courts have ever held that a manufacturer could be held liable for a non-defective product that “will have widespread, negative consequences across all fields of innovation and manufacturing.”

Gilead has been battling similar accusations since 2016 when it prevailed in a case surrounding its alleged efforts to keep TDF prices high and prevent generic entries by delaying TAF.