Gilead Class Action Lawsuit Over TDF-Based HIV Drugs Allowed to Move Forward

A federal judge has cleared the way for a lawsuit against Gilead to proceed which alleges the drug company engaged in deceptive practices with Truvada, Complera and other tenofovir disoproxil fumarate (TDF) based HIV drugs, which caused users to face a risk of side effects that may have been avoided if safer alternative designs had been introduced using the compound tenofovir alafenamide fumarate (TAF).

The complaint (PDF) was originally brought by Darren Johnson in Missouri state court in October 2020, seeking class action status to pursue damages on behalf of all similarly situated consumers who purchased the medications in Missouri. However, Gilead removed the lawsuit to the federal court system and filed a motion to dismiss for failure to state a claim.

Johnson indicates he began using Truvada in May 2012, and continued to take the HIV medication until he switched to Complera in May 2014. Both Truvada and Complera are TDF-based HIV drugs, which have generated billions in revenue for Gilead. However, the lawsuit claims that by the time those medications were introduced, Gilead had already discovered the potential for safer TAF-based HIV drugs, which would be less toxic and equally effective.

Rather than introducing these safer HIV treatments, Gilead allegedly sat on development of the new drugs and continued to market Truvada, Complera and older TDF drugs, which placed users at risk of suffering kidney and liver side effects. It was only after patent protection for the TDF-based HIV drugs expired, and Gilead began to face generic competition, that it introduced new versions that contained the TAF compound, including Descovy, Odefsey, Genvoya and others, which it then marketed as safer than the generic TDF drugs sold by other companies.

Johnson switched to the TAF version of Complera marketed as Odefsey when it became available in March 2016. However, he now indicates that he never would have taken Truvada or Complera if the safer versions had been available earlier.

“Plaintiff would not have paid what he paid for Truvada and Complera had he known that they were less effective and more dangerous than they needed to be, had he known of Gilead’s deceptive and misleading conduct, or had he known of any of the other facts [outlined in the complain],” according to the lawsuit. “Plaintiff believes it is unjust for Gilead to have reaped profits on the TDF-based drugs given Gilead’s deceptive, unlawful and unfair conduct described.”

Once the Gilead class action lawsuit over the TDF-based HIV drugs was removed to the federal court system, the drug maker filed a motion to dismiss, arguing that the claims are pre-empted by federal law.

In a memorandum and order (PDF) issued on September 28, U.S. District Judge Matthew T. Schelp, of the Eastern District of Missouri, rejected that argument and allowed the case to proceed.

“The Court concludes that Plaintiff’s claims as alleged are not preempted because Defendant could have independently complied with both state and federal law prior to submitting the TDF drugs for FDA approval,” Judge Schelp ruled.

The decision comes as Gilead faces thousands of similar HIV drug lawsuits brought by former users of the TDF-based medications who have been left with severe and often life-threatening injuries, which they argue could have been avoided if the safer TAF-based HIV drugs had been introduced earlier.