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More than 70 plaintiffs have joined together in a lawsuit filed against Gilead, alleging that they suffered unnecessary bone and kidney injuries due to the side effects of Truvada, Viread, and other combination HIV drugs, because the manufacturer withheld a safer formulation in order to maximize profits.
The complaint (PDF) was filed in the U.S. District Court for the Northern District of California on June 5, including 73 plaintiffs who used Gilead’s tenofovir disoproxil fumarate (TDF)-based HIV drugs, such as Viread, Truvada, Atripla, Complera and Stribild, and suffered kidney and bone injuries as a result.
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.
The lawsuit notes that John Milligan, the company’s president and CEO, once admitted to investment analysts that TAF would have hurt TDF sales by revealing that the TDF-based products were unreasonably and unnecessarily safe.
“Before Gilead began selling its first TDF Drug, Viread, in 2001, Gilead knew that TDF posed a safety risk to patients’ kidneys and bones,” the lawsuit states. “Gilead’s knowledge of the toxic effects of TDF only grew as patients began treatment with and were injured by each successive TDF product. By the time Gilead designed Stribild, it had ten years’ worth of cumulative evidence that TDF injured patients’ kidneys and bones.”
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.