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According to allegations raised in a recently filed product liability lawsuit, Truvada side effects caused a woman to develop bone fractures and the need for hip replacement surgery, after the HIV drug’s harsh chemicals caused death of cells in her bones.
The complaint (PDF) was filed by Vanessa L. Naisha in Delaware Superior Court on July 11, naming the makers of Truvada, Gilead Sciences, as the defendant.
Truvada (emtricitabine/tenofovir disoproxil fumarate) was approved in 2004, for the treatment of HIV and it is also used as a PrEP HIV drug, to prevent the spread of the disease. Truvada belongs to a class of HIV drugs that contain the antiviral tenofovir disoproxil fumarate (TDF) drugs, which is also found in other blockbuster treatments sold by Gilead, including Viread, Atripla, Complera and Stribild, which have collectively generated tens of billions in profits for the drug maker.
According to allegations raised in the Truvada lawsuit, Naisha was prescribed the drug soon after it hit the market, for the treatment of HIV. However, in 2009 she began to suffer from loss of balance and excruciating hip pain, according to the complaint.
By 2010, both of Naisha’s hips had failed, and she underwent hip replacement surgery for both hips during 2011. She was diagnosed as suffering advanced avascular necrosis; meaning the tissue cells in her bones were dying. This usually only happens due to infection from tuberculosis, extreme temperatures, radiation or chemical exposure.
“In 2018, Plaintiff learned via television that Gilead Sciences failed to warn consumers that Truvada contained toxicity that caused bone injuries such as osteopenia, osteoporosis, and bone fractures,” the lawsuit states. “The FDA claimed the company sales representatives had violated the law by giving doctors and patients false and misleading information regarding TDF’s side effects.”
She presents claims of design defect, failure to warn, breach of warranty, failure to comply with the Federal Food, Drug, and Cosmetic Act, and deceptive marketing strategies.
Gilead faces a growing number of individual HIV drug lawsuits, which allege the drug maker knew or should have known that TDF drugs posed an increased risk of bone fractures and kidney problems, yet failed to warn consumers and the medical community.
The complaints also indicate that Gilead knew that an alternative antiviral, known as tenofovir enofovir alafenamide (‘TAF’), could result in much less toxic doses, while providing the same effectiveness. However, Gilead decided to shelve TAF in 2004, as part of a coordinated effort to increase profits by extending patent protection. Gilead began selling TAF-drugs in 2015, promoting it as a safer alternative as generic versions of Truvada and other TDF drugs were beginning to be introduced.
Several groups of plaintiffs have also filed Truvada class action lawsuits, alleging that Gilead and some other drug makers purposefully price-fixed TDF medications in the United States, capitalizing on the life-saving need for the HIV drugs to increase profits.