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Dozens of individuals nationwide are pursuing product liability claims against Gilead, alleging that side effects of HIV drugs like Truvada, Stribild and other medications that contain tenofovir disoproxil fumarate (TDF) are unreasonably dangerous and increase the risk of kidney problems, bone fractures and other injuries.
A complaint (PDF) filed last month in the in the U.S. District Court for the Northern District of California presents claims for 86 different plaintiffs, each of whom allege that they may have avoided severe and debilitating injuries if the manufacturer had released safer alternatives that contain a different antiviral, which was available years earlier.
Each of the plaintiffs indicate that they suffered renal failure, kidney injury, bone loss, fractures or other complications associated with boen deterioration following exposure to TDF-based HIV drugs sold by Gilead in recent years, including Viread, Truvada, Atripla, Complera and Stribild.
“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 also knew that the relatively high dose of TDF created a greater risk of toxic effects, and that bone and kidney toxicities were even more likely to be seen with long-term use of TDF for the treatment of a virus that, for the foreseeable future, has no cure.”
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 withheld the safer alternative for years, continuing to sell the more toxic versions on the market until patent protections expired and generic equivalents were introduced.
It was not until the company faced eroding sales from generic competition that it began introducing TAF-based drugs in 2015, Plaintiffs point out that this was part of scheme intended to allow Gilead to maintain an essential monopoly on HIV treatments until 2032, as patent protection on the safer alternatives would have expired years earlier if they had not withheld the TAF drugs. 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.
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.