Truvada Lawsuit Over Failure to Warn About HIV Drug Risks Allowed To Move Forward

A federal judge has rejected a motion filed by Gilead Sciences, which sought to dismiss a Truvada lawsuit which alleges the company should have used safer active ingredients in its HIV drugs, allowing failure to warn claims to move forward.

The decision came in one of a growing number of HIV drug lawsuits filed against Gilead, each raising similar allegations that the active ingredient tenofovir disoproxil fumarate (TDF) in the blockbuster mediations Truvada, Viread, Atripla, Complera and Stribild is excessively toxic and threatens kidneys and bones, yet consumers and the medical community were not adequately warned about the risk.

Plaintiffs allege Gilead had already discovered an alternative ingredient, tenofovir alafenamide fumarate (TAF), which is equally as effective at smaller doses, making it less toxic and safer for patients. However, instead of developing and marketing TAF-based HIV drugs, Gilead decided to continue promoting the more toxic TDF drugs until its patent protection ran out, only then ramping up sales and marketing for the TAF versions of the drugs.

The recent ruling came in a case filed Anthony Gaetano, who filed his lawsuit against Gilead in New Jersey state court in July 2020, which was then removed by Gilead (PDF) to federal court just days later. Once it was transferred to the U.S. District Court for the District of New Jersey, Gilead filed a motion to dismiss, arguing that Gaetano’s state law claims over failure to warn about the Truvada risks are preempted by federal law.

In an opinion (PDF) issued on March 26, U.S. District Judge Kevin McNulty rejected Gilead’s position and allowed the case to move forward. McNulty pointed out the lawsuit alleges Gilead acquired new information about the side effects of its HIV drugs, which the company did not pass on to federal regulators.

“Dismissal is thus appropriate only if it is manifest from the face of the Complaint that the risks Gilead allegedly failed to warn about did not meet the definition of newly acquired information,” McNulty wrote. “This Gilead cannot show, because some of Gaetano’s allegations, interpreted in the light most favorable to him, do seem to concern newly acquired information.”

That information, according to the lawsuit, came in the form of Gilead’s own studies, conducted from October 2001 through May 2007, which indicated otherwise healthy individuals were experiencing adverse kidney events while taking Truvada. However, Gilead allegedly failed to warn doctors to monitor patients for kidney problems after this new information became available.

It was only after the blockbuster drugs were about to face competition from generic equivalents of Truvada and other TDF drugs that Gilead introduced safer TAF-based versions, marketing them as safer than the toxic drugs they had sold for years without adequate warnings for consumers.

Gaetano and other plaintiffs allege the decision to withhold development of TAF-based drugs was part of a scheme intended to allow Gilead to maintain an essential monopoly on HIV treatments until at least 2032. However, as a result of this decision to place profits before consumer safety, thousands of individuals nationwide have been left with severe injuries that may have been avoided.