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According to allegations raised in a recently filed product liability lawsuit, Gilead knew that side effects of Viread and Atripla may increase the risk of kidney and bone problems, but failed to warn users of the HIV drugs, or make safer alternatives available, which the drug maker had already developed.
After being served last month with a complaint brought by Philip Epstein in Florida state court, Gilead filed a notice of removal (PDF) on October 29, transferring the case to the U.S. District Court for the Southern District of Florida.
Epstein claims that Viread and Atripla were sold without adequate warning labels about kidney and bone risks, indicating that Gilead knew for years that it could have replaced one ingredient in either drug, which would have made them much safer. However, the drug maker allegedly refused to do so in order to continue to profit from the medications as long as possible, extending their essentially monopoly over the latest HIV treatments.
Viread and Atripla are antiretrovirals manufactured by Gilead, which are used to slow the progression of HIV, and allow individuals with the disease to lead healthy lives, with what are promoted as relatively manageable side effects. The drugs each contain tenofovir disoproxil fumarate (TDF), which is also found in the blockbuster HIV treatments Truvada, Complera and Stribild.
According to the original complaint (PDF), Epstein used Viread and Atripla under the belief that they were safe, due to Gilead’s label warnings and advertisements. However, he suffered kidney and bone injuries, which he indicates could have been avoided.
“Gilead… knew before it obtained approval to market Viread and its other TDF drugs, that it had discovered and tested a similar form of the drug that could be given in lower doses with reduced toxicity to the kidneys and bones,” the lawsuit states. “But, an improved form of the drug would have undercut Gilead’s sales of Viread and, Gilead was counting on Viread’s once-per day pill form to set it apart from the pack of antiretroviral medications already on the market.”
A safer form of tenofovir, known as tenofovir alafenamide fumarate (TAF) is able to be administered at a much lower dose than TDF, resulting in less toxicity and fewer side effects from the HIV treatment. However, Gilead allegedly stopped development of this safer alternative in 2004, as part of a coordinated effort to extend patent protection, according to the lawsuit.
It was not until Viread, Atripla and other TDF drugs were all nearing the end of patent protection, and would be facing generic competition, that Gilead began selling TAF drugs in 2015, and began marketing these newer treatments as safer alternatives.
The case joins a growing number of similar Gilead HIV drug lawsuits filed by individuals left with kidney injuries or bone problems following use of Viread, Atripla, Truvada, Complera and Stribild.