Gilead Sciences, the company behind widely used HIV drugs like Truvada and Atripla, faces a drug injury lawsuit filed on behalf of nearly 150 plaintiffs who allege that they suffered bone fractures, kidney damage and other serious injuries caused by the medications. The plaintiffs filed a joint lawsuit against Gilead in federal court, seeking damages for pain and suffering, mental anguish, lost earnings and loss of earning capacity, loss of enjoyment of life and other injuries. The lawsuit states that “Gilead designed each of the [tenofovir disoproxil fumarate] drugs to contain a form of the compound tenofovir that Gilead knew was toxic to patients’ kidneys and bones.” In doing so, the company put users at risk for serious bone and kidney injuries without providing them with adequate warnings.
Tenofovir belongs to a class of drugs known as nucleotide analogue reverse transcriptase inhibitors (NRTIs), which are antiretroviral drugs used to treat HIV. Tenofovir disoproxil fumarate, or TDF, is a form of tenofovir developed by Gilead Sciences that can be taken orally. TDF is the active ingredient in five drugs that have been approved to treat HIV. The first drug, Viread, was approved by the FDA in 2001, followed by Truvada in 2004, Atripla in 2006, Complera in 2011 and Stribild in 2012. Unfortunately, in order to achieve the desired therapeutic effect, a high dose of TDF (300 mg) is typically required, which increases the risk of toxic side effects in users.
According to reports, even before Gilead obtained approval to market Viread, its first TDF-based drug, the drug maker knew that TDF posed a risk to patients’ bones and kidneys. Gilead also allegedly knew at that time that a safer version of tenofovir called tenofovir alafenamide fumarate (TAF) existed, which could be administered at a much lower dose with the same or better results. In fact, a 25 mg dose of TAF has been shown to achieve the same therapeutic effect as a 300 mg dose of TDF, with a lower risk of side effects. Despite knowing that TAF could be administered to patients at a lower, safer dose than TDF, Gilead continued marketing TDF as a safe and effective HIV treatment for years.
This new lawsuit against Gilead Sciences was filed in the U.S. District Court for the Northern District of California on March 17, and alleges that Gilead knew its TDF-based HIV drugs exposed users to serious kidney and bone injuries, yet failed to provide adequate warnings about these risks to patients and healthcare providers. The drug manufacturer is also accused of deliberately withholding a less toxic version of its blockbuster TDF treatment until patent protections were set to expire, in order to maximize its profits from the older drugs. The lawsuit was filed on behalf of nearly 150 plaintiffs who claim that they suffered bone loss, kidney injury, renal failure and other serious complications following exposure to TDF-based drugs like Truvada, Atripla, Viread, Stribild and Complera.
The lawsuit joins a growing number of complaints brought on behalf of patients who claim that Gilead knew for years that a safer, less toxic version of tenofovir disoproxil fumarate (TDF) existed, called tenofovir alafenamide fumarate (TAF), but knew that introducing TAF too soon would impact sales of its blockbuster TDF-based HIV drugs. Instead, the drug maker allowed patients to continue taking Truvada, Viread and other TDF-based medications, knowing that the drugs could expose them to serious bone- and kidney-related injuries, and put off introducing TAF-based treatments until generic equivalents to TDF were about to enter the market and diminish sales. Once Gilead’s TAF-based drugs were introduced, the company began marketing them as a safer alternative to the toxic TDF drugs it had sold for years.
Plaintiffs in the ongoing tenofovir disoproxil fumarate litigation allege that Gilead’s strategic decision to keep safer, less toxic TAF-based drugs off the market for years was part of a scheme designed to allow the drug maker to maintain a monopoly on HIV treatments for the next decade. As a result of this alleged scheme, patients taking the older TDF-based HIV drugs were unnecessarily exposed to serious side effects that could have been avoided had Gilead not decided to put profits ahead of consumer safety. “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.”