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A group of 20 different plaintiffs have joined together in a lawsuit against Gilead, over failure to warn that side effects of HIV drugs may cause users to suffer bone fractures, kidney problems and other complications that may have been avoided if a safer version had not been withheld by the drug maker.
The complaint (PDF) was filed in the U.S. District Court for the Northern District of California on June 18, presenting claims for injuries suffered by plaintiffs residing throughout the country, from Oregon to New York.
Each of the plaintiffs allege they suffered injuries after ingesting various tenofovir disoproxil fumarate (TDF) drugs manufactured by Gilead, including Truvada, Atripla, Viread, Complera and Stribild. These injuries include kidney damage, kidney failure, chronic kidney disease and bone density loss.
According to the lawsuit, Gilead has known for years that a less toxic version of the drugs could be developed, involving the antiviral tenofovir alafenamide fumarate (TAF), yet the drug maker continued to sell the more toxic versions without adequate warnings. It was only when the blockbuster drugs were about to face competition from generic equivalents that the drug maker introduced TAF-based drugs, marketing them as safer than the toxic TDF-drugs they had sold for years without adequate warnings for consumers.
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.
The lawsuit notes Gilead tipped its hand when it sought FDA approval for its first TAF drug, Genvoya.
“In seeking FDA approval of its first TAF-based antiviral drug product, Genvoya, Gilead told the FDA that TAF has better entry and concentration in HIV-target cells than TDF, thereby allowing the administration of smaller doses and reducing systemic tenofovir exposure, renal toxicity and bone effects, without sacrificing efficacy,” the lawsuit states. “In seeking FDA approval of Genvoya in 2014, Gilead relied on TAF data obtained by Gilead more than a decade earlier—before the company abruptly shelved its TAF design in pursuit of more money.”
The lawsuit joins a growing number of complaints filed by plaintiffs nationwide, who say they suffered Gilead HIV drug side effects. Most of the complaints are currently pending in California state court, but a number have also been filed in various federal district courts nationwide over the past year.