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Gilead faces a product liability lawsuit filed by dozens of plaintiffs in California, who allege that side effects of HIV drugs like Truvada, Atripla, Stribild and other tenofovir-based medications resulted in severe kidney and bone injuries.
The complaint (PDF) was filed last month in the Superior Court of the State of California by 41 individuals who experienced problems after using HIV drugs that contain tenofovir disoproxil fumarate (TDF), which is used to prevent the spread of the disease.
Each of the drugs are antiretrovirals manufactured by Gilead, which include HIV drug cocktails widely used in recent years, such as Truvada, Viread, Atripla, Complera and Stribild. Collectively these drugs have generated billions in profits for the drug maker, yet they have been linked to toxic side effects, which plaintiffs allege could have been avoided if safer HIV treatments had been used, known as tenofovir enofovir alafenamide (TAF).
In this recently filed lawsuit, some of the plaintiffs indicate they were using TDF-based drugs to combat HIV, while others used Truvada as a pre-exposure prophylactic (PrEP) to prevent contracting the disease. Each indicates they have been left with severe side effects from the tenovir, including kidney failure, chronic kidney disease, bone fractures, tooth loss and other problems.
Plaintiffs allege Gilead had a safer alternative to tenofovir available which provided the antiviral treatment with much less toxic doses. However, the drug maker withheld development of TAF in 2004, as part of a coordinated effort to increase profits by extending patent protection, according to the lawsuit.
Gilead began selling TAF-drugs in 2015, promoting it as a safer alternative as generic versions of Truvada, Atripla, Stribild and other TDF drugs were beginning to be introduced.
“This is a straightforward case of a corporation’s greed, involving the decision of a pharmaceutical company to withhold for more than a decade, a prodrug for the treatment of HIV that it knew was safer and more effective than the prodrug it had already put into the market,” the lawsuit states. “Beginning in 2001, Gilead manufactured and sold a prodrug form of tenofovir called TDF. All the while, it had developed another prodrug form of tenofovir called TAF, which it knew to be less toxic to kidneys and bones.”
The lawsuit indicates Gilead failed to alert patients that it had a safer alternative to TDF drugs, which would have prevented or eliminated the side effects of tenofovir associated with Truvada, Atripla, Stribild, Complera and Viread. They present claims of negligence, strict product liability, breach of warranties, fraud and concealment.
The case joins a growing number of similar claims, as well as Gilead HIV drug class action lawsuits that allege the drug makers purposefully price-fixed TDF medications in the United States, capitalizing on the life-saving need for the HIV drugs to increase profits.