The makers of the HIV drugs Truvada and Viread face a new product liability lawsuit filed by a group of 20 plaintiffs over injuries ranging from bone density loss to kidney damage, kidney failure and chronic kidney disease. The lawsuit alleges that Gilead Sciences withheld a safer version of its tenofovir disoproxil fumarate (TDF) HIV drugs, despite knowing for years that the drugs posed a risk of bone fractures and kidney problems for users. If you or someone you love has suffered serious side effects after using a TDF-based HIV drug like Truvada, Viread, Complera, Atripla or Stribild, you may be eligible for compensation from Gilead through a product liability lawsuit.
Tenofovir disoproxil fumarate (TDF), sold under the brand names Truvada, Viread and others, is a prescription oral antiretroviral medication used to treat HIV/AIDS and chronic hepatitis B. TDF can’t cure HIV or AIDS, but it has been approved by the U.S. Food and Drug Administration (FDA) to help patients with HIV live longer, healthier lives. Since 2001, Gilead has marketed TDF as a safe and effective treatment for patients with HIV, all the while knowing that an alternative tenofovir alafenamide fumarate (TAF) formula could offer patients the same therapeutic benefits as TDF at a fraction of the dose, thereby posing a much lower risk of side effects. Despite the fact that Gilead first tested its new TAF formula (later sold under the brand names Genvoya and Odefsey) in 2002, the company delayed the drug’s release for more than a decade, waiting until its patent on TDF ran out to develop the less toxic version of the drug. As HIV patients taking TDF-based drugs begin to realize that their kidney and bone injuries may be related to their treatment, the number of lawsuits filed against Gilead over injuries stemming from the use of Truvada, Viread, Complera, Stribild and Atripla continues to grow.
This latest Gilead lawsuit was filed last month in the U.S. District Court for the Northern District of California, presenting claims for injuries sustained by 20 different plaintiffs who took TDF drugs manufactured by Gilead, including Truvada, Atripla, Viread, Stribild and Complera. According to allegations raised in the lawsuit, Gilead was aware that a less toxic version of the HIV medications existed, a version that contains the antiretroviral tenofovir alafenamide fumarate (TAF), yet continued to sell the TDF-based drugs for years without adequately warning about the potential risk of kidney damage, bone fractures and other serious side effects. It was only after Gilead’s blockbuster TDF drugs were about to face competition from generic equivalents that Gilead introduced the TAF-based drugs, marketing them as safer than the toxic version the company had sold for years.
Plaintiffs in this new Gilead lawsuit allege that the drug maker’s decision to delay the introduction of the safer TAF-based HIV drugs was a deliberate move intended to help the company protect its bottom line. “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 Gilead 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.”
Compared to tenofovir alafenamide fumarate, tenofovir disoproxil fumarate requires a much higher dose, which exposes users to an increased risk of serious kidney problems, including chronic kidney disease. TDF has also been linked to bone fractures, bone density loss and bone necrosis, among other severe complications. According to reports, Gilead originally developed both delivery systems for tenofovir – TDF and TAF – years ago, but the company announced in 2004 that it was discontinuing its TAF development program, despite evidence that the newer version of the drug was safer and more effective. Ten years later, when Gilead’s patent on TDF was nearing its expiration and the drug maker faced an impending decline in profits due to competition from generics, the company finally released the TAF data from 2001.
A growing number of lawsuits filed on behalf of HIV patients taking Truvada and other TDF-based medications accuse Gilead of failing to warn about the potential risk of side effects associated with its TDF drug formula. The lawsuits also blame Gilead for failing to pursue development of the more effective version of the drug the company knew posed a lower risk of damage to patients’ kidneys and bones. If you or a loved one has suffered from side effects like kidney damage or bone fractures and you believe an HIV drug made by Gilead is to blame, do not hesitate to seek legal guidance. An experienced product liability lawyer can review your case and determine whether you are eligible to file a claim against Gilead for your injuries.