Lawsuit Claims Gilead’s Controversial HIV Drugs are Unnecessarily Toxic

Gilead Sciences has come under fire recently in light of claims that the company intentionally delayed the production of its safer, next-gen HIV drugs in order to gain as much revenue as possible from the older generation drugs before the new medications hit the market. Now, hundreds of HIV patients who took Gilead’s older drugs are suing the company, alleging that they needlessly suffered serious kidney and bone problems because of Gilead’s delay in introducing its newer version of the HIV medications, which the company later touted as posing a lower risk of kidney and bone toxicity. In one recently filed lawsuit, several plaintiffs allege that the Gilead HIV drugs Truvada, Atripla, Viread, Complera and Stribild are unnecessarily toxic and that side effects of the drugs caused them to suffer a number of kidney- and bone-related injuries that could have been avoided had they had access to the new, safer HIV drugs.

What are Gilead’s TDF-Based HIV Drugs?

Tenofovir disoproxil fumarate (TDF), sold under the brand names Truvada, Viread, Atripla, Complera and Stribild, is an antiretroviral medication used to treat chronic hepatitis B and to prevent and treat HIV and AIDS. TDF was patented in 1996 and became available for use in the United States beginning in 2001. Gilead won approval from the FDA for Viread in 2001, Truvada in 2004, Atripla in 2006, Complera in 2011 and Stribild in 2012. According to reports, Gilead had the opportunity to pursue a less toxic antiviral tenofovir alafenamide fumarate (TAF)-based HIV regimen more than a decade ago, which could have protected users from the devastating side effects that have been linked to Gilead’s TDF medications, but instead the company withheld the safer treatment from the market. The potential side effects of the TDF drugs Truvada, Viread, Atripla, Complera and Stribild include the following:

  • Kidney failure
  • Chronic kidney disease
  • Acute kidney injuries
  • Bone fractures
  • Dental injuries
  • Bone density loss

Kidney and Bone Injuries from TDF Drugs

In this latest lawsuit against Gilead, filed in California Superior Court on December 30, on behalf of Glen Roske, Anna Eversole, Richard Wollschleager and Johnene Barras, the plaintiffs claim that they suffered side effects from the company’s older HIV medications, which Gilead allegedly knew posed a risk of kidney and bone injuries for users. According to the lawsuit, Gilead was aware that a less toxic TAF version of the medications existed, yet made the decision to withhold the safer alternative from the market until the patent protections on its TDF-based drugs expired and generic versions were introduced. In doing so, Gilead is accused of putting profits before patient safety and exposing people living with HIV to severe side effects from the TDF drugs, which require a much higher dose than the TAF-based regimens do.

“Beginning in 2001, Gilead manufactured and sold a prodrug form of tenofovir called tenofovir disoproxil fumarate, or TDF. Unbeknownst to Plaintiffs and the general public, Gilead had also developed another prodrug form of tenofovir called tenofovir alafenamide fumarate, or TAF, which it knew to be more efficacious and less toxic to kidneys and bones,” the lawsuit states. “Yet, despite knowing of the disparity in safety between TAF and TDF, Gilead shelved the TAF project in 2004 to artificially and unreasonably maximize profits on the existing TDF patent.” It wasn’t until 2015 that the company started manufacturing its new TAF-based drugs, marketing the medications as safer than and superior to the generic TDF-based drugs that had been introduced since Gilead’s brand-name drug patents had begun to expire. By doing so, Gilead extended what is essentially a monopoly on HIV treatments and protected the profits generated from its brand-name medications.

TDF Drug Injury Lawsuits Against Gilead

Plaintiffs involved in the ongoing litigation against Gilead Sciences allege that they have suffered serious injuries to their kidneys, bones and teeth, which could have been avoided had the company introduced the safer TAF versions of the HIV drug earlier. Additionally, the lawsuits allege that Gilead failed to adequately warn consumers and the medical community about the potential side effects of the toxic TDF-based medications used to treat HIV. If you took a Gilead HIV drug like Truvada, Viread, Atripla, Complera or Stribild and you have suffered a serious complication like kidney disease, bone fractures or dental injuries, you may qualify for compensation from Gilead Sciences. Contact an experienced product liability lawyer as soon as possible to discuss the possibility of filing a TDF drug injury lawsuit against Gilead Sciences.