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Nearly 150 individuals have joined together in a product liability lawsuit filed last week against Gilead, alleging that they suffered bone fractures, kidney problems and other injuries caused by side effects of HIV drugs like Truvada and Atripla.
The complaint (PDF) was filed in the U.S. District Court for the Northern District of California on on March 17, indicating that Gilead knew that the drugs were toxic to kidneys and bones, yet failed to provide adequate warnings for consumers and the medical community. The drug maker is also accused of withholding safer alternative treatments, waiting years to introduce less toxic versions of the HIV drugs, until patent protections were set to expire, which would impact sales of the blockbuster treatments.
Each of the plaintiffs indicate that they suffered renal failure, kidney injury, bone loss, fractures or other complications associated with bone deterioration following exposure to tenofovir disoproxil fumarate (TDF) based HIV drugs sold by Gilead in recent years, including Viread, Truvada, Atripla, Complera and Stribild.
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 generic equivalents were about to diminish sales that the drug maker introduced TAF-based drugs, marketing them as safer than the toxic TDF-drugs they had sold for years.
Plaintiffs allege that 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.
“In addition to withholding safer designs, Gilead failed to adequately warn physicians and patients about the risks and safe use of TDF,” the lawsuit states. “Gilead provided only the weakest, inadequate warnings to doctors and patients about the need for frequent monitoring of all patients for TDF associated kidney and bone damage—preventing doctors from detecting early signs of TDF toxicity.”
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 growing number have also been filed in various federal district courts nationwide over the past year.