AIDS Healthcare Foundation Files Additional Lawsuits Against Gilead over TDF Toxicity Concerns


Gilead Sciences is facing another round of lawsuits regarding its HIV treatments. This morning the AIDS Healthcare Foundation announced two sets of California-based patients filed a personal injury lawsuit against the Bay Area company regarding safety concerns surrounding its TDF treatment.

The lawsuits claim that the company has failed to “rectify a known defect” in the formulation of tenofovir disoproxil fumarate, despite knowing there is a safer alternative drug, tenofovir alafenamide (TAF). Additionally, the lawsuits charge Gilead with a failure to warn patients of “damaging side effects” from TDF, as well as “active misrepresentation of TDF’s efficacy and risks.”

The AIDS Healthcare Foundation and Gilead are no strangers to litigious engagements. Two years ago the foundation filed a lawsuit challenging the patents on Tenofovir, a component in Genvoya, Gilead’s four-in-one fixed-dose combination to treat HIV/AIDS patients as well as Gilead’s combination drug, Stribild. The foundation alleges that Gilead “manipulated the patent system and engaged in anticompetitive practices to prevent economical access” to TAF, a prodrug of the Tenofovir compound. That lawsuit is currently pending in the Federal Circuit Court of Appeals in Washington D.C

The latest filings claim that Gilead is more concerned about its profit level than the wellbeing of its patients. The plaintiffs claim that TDF is “highly toxic in the doses prescribed and risked permanent and possibly fatal damage to the kidneys and bones.” In addition to the safety concerns, the lawsuits reiterate the previous claims AHF made regarding patents. The plaintiffs assert that Gilead “deliberately and maliciously suppressed from the market its alternate and newer formulation of the drug, TAF, in order to extend the patent life—and sales—of its existing medications that included TDF.”

Michael Lujano, one of the plaintiffs, said Gilead “shelved” the safer drug TAF in order to “increase its long-term profits.”

“I’m bringing this lawsuit to try to hold Gilead responsible for their reckless focus on profits over patient safety,” Lujano said in a statement.

The lawsuit says that the U.S. Food and Drug Administration (FDA) issued warning letters to Gilead two times over its TDF marketing practices. The plaintiffs said the FDA claimed company “sales representatives had violated the law by giving doctors and patients false and misleading information regarding TDF’s side effects.”

The plaintiffs claim that Gilead knew that use of TDF “risked permanent and possibly fatal damage to the kidneys and bones in patients prescribed and taking the drug.” The lawsuit also claims Gilead knew TAF reduced the risk of toxicity and damage to kidney and bones.

“Plaintiffs bring these lawsuits today because Gilead should be accountable for making misrepresentations about the significant side effects of its key HIV drug, TDF, while it shelved a safer alternative in TAF for many years simply to increase profits,” plaintiff’s attorney Michelle M. Rutherford of Rutherford Law said in a statement.

In addition to the TFF lawsuits, a class action lawsuit against Gilead has been filed on behalf of California HIV patients who used Viread, Truvada, or Atripla from Oct. 26, 2001 through the present over toxicity concerns.

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