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A product liability lawsuit filed by more than 40 plaintiffs claims that side effects of Gilead’s HIV combination therapy drugs, such as Truvada, Viread, Atripla, Complera and Stribild, exposed users to an unnecessary risk of serious kidney and bone injuries.
The complaint (PDF) was filed in the U.S. District Court for the Northern District of California on July 1, alleging that Gilead, Inc. knew about the toxic risks associated with the medications, yet withheld safer and less toxic versions as part of a scheme to continue profiting from the sale of the high-priced HIV drugs until generic competitors were introduced.
Each of the medications contain the compound tenofovir disoproxil fumarate (TDF), which is known to be toxic to the bones and kidneys. However, the lawsuit alleges that Gilead had already discovered a safer compound, tenofovir alafenamide fumarate (TAF), which is just as effective, but far less toxic since it can be taken at much smaller doses.
Instead of developing and releasing the safer products, the lawsuit alleges that Gilead engaged in a plan to maximize products by delaying the new drugs until the original products faced generic competition. The drug maker then marketed the TAF-based HIV drugs, which include Descovy, Genvoya and others, which are still under patent protection.
Gilead now markets the newer treatments as safer, and has extended its monopoly over HIV treatments in the United States. However, the scheme came at the expense of thousands of users of the drug, who have been left with devastating bone problems and kidney injuries.
“In addition to withholding safer designs, Gilead failed to adequately warn physicians and patients about the risks and safe use of TDF. Gilead provided only the weakest, inadequate warnings to doctors and patients about the need for frequent monitoring of all patients for TDF-associated kidney and bone damage—preventing doctors from detecting early signs of TDF toxicity,” the lawsuit states. “Gilead provides stronger monitoring warnings to physicians and patients in the European Union (EU) than it does in the United States for the exact same TDF products.”
The lawsuit presents claims of design defect, failure to warn, negligence, gross negligence, fraud by omission, breach of warranty, and violation of state consumer protection and product liability laws in New Jersey, Ohio, Arizona, Colorado, Maryland and Massachusetts. The plaintiffs seek compensatory and punitive damages.