Federal Judge Refuses to Nix Lawsuit Over Gilead HIV Drugs

Published on May 17, 2019 by Sandy Liebhard

A federal judge has refused to dismiss a lawsuit that claims Gilead Sciences, Inc. purposely delayed development of a safer HIV drug for years, merely to protect profits from sales of tenofovir disoproxil fumarate, or TDF.

History of Gilead HIV Drugs

Gilead Sciences obtained U.S. Food and Drug Administration approval for Viread, the first of its TDF franchise, in October 2011. By 2012, the company had launched four additional TDF-HIV treatments: Truvada, Atripla, Complera, and Stribild.

Gilead introduced Genvoya, the first HIV/AIDS drug to contain tenofovir alafenamide fumarate (TAF) in 2015. Just a year later, the company expanded that franchise with the launch of Odefsey and Descovy.

With sales that exceed $11 billion annually, Gilead HIV drugs currently dominate the market. Although the company’s TDF patents are set to expire in in 2021, it will maintain exclusivity over TAF until 2032.

Why Did Gilead Shelve Safer HIV Treatment?

The TDF HIV drug lawsuit was filed last year in the U.S. District Court, Northern District of California, and involves some 140 patients from more than 30 states.

According to the complaint, Gilead shelved TAF back in 2004, even though the drug had proven to be safer than TDF. At the time, the company maintained the medications were too similar to proceed with TAF development. However, plaintiffs claim that Gilead was actually motivated by a desire to maintain TDF’s profitablity for as long as possible.

Once Gilead finally launched Genvoya, it cynically hyped TAF’s superior safety profile to convince doctors and patients to abandon the older HIV treatments before its TDF patents expired. That campaign depended on “the very benefits that Gilead could have and should have incorporated into its prior product designs but withheld from doctors and patients for over a decade,” the lawsuit charges.

As a result of these alleged machinations, plaintiffs needlessly endured serious TDF side effects, including bone problems and kidney issues.

Gilead Wanted HIV Drug Lawsuit Dismissed on Preemption Grounds

The company’s Motion to Dismiss argued that the lawsuit was federally preempted, and asserted that the plaintiffs hadn’t provided sufficient evidence to back allegations that the older Gilead HIV drugs caused their injuries.  It also noted that the Court had previously dismissed a similar lawsuit brought on anticompetitive grounds.

U.S. District Judge Jon S. Tigar ultimately decided 10 of the lawsuit’s 12 claims should be allowed to move forward.

“Gilead lead could have independently complied with both state and federal law prior to submitting the TDF drugs for FDA approval,” he wrote in an Order dated May 10th.  “Because Gilead has not presented ‘clear evidence’ that the [U.S. Food and Drug Administration] would not have approved the allegedly safer versions of the drugs that plaintiffs contend would have complied with state law, plaintiffs’ pre-approval design-defect claims are not preempted.”

Judge Tigar did agree to dismiss failure-to-warn claims based on post-approval, post-2008 labeling changes, as well as fraud and consumer protection claims to the extent they are based on misrepresentations and not omissions. However, he also granted plaintiffs’ leave to amend the complaint, so long as they do so by May 31^st.