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According to allegations raised in a recently filed product liability lawsuit, side effects of tenofovir-based HIV drugs sold by Gilead in recent years caused former users to experience various kidney and bone injuries, which could have been avoided if safer formulations had not been withheld by the drug maker.
A group of nearly 20 plaintiffs have joined together in a complaint (PDF) filed last week in the U.S. District Court for the Northern District of California, indicating that each of them suffered kidney damage, kidney failure, chronic kidney disease, bone density loss and other complications after injesting various tenofovir disoproxil fumarate (TDF) drugs, including Truvada, Stribild, Viread, Atripla and Complera.
According to allegations raised in the tenofovir lawsuit, Gilead Sciences, Inc. intentionally kept safer versions of the drug off the market, so that they could maximize profits from the sale of the older, more toxic, HIV drugs before patent protection expired.
Plaintiffs indicate Gilead has known for years that a less toxic version of the HIV drugs could have been developed, involving the antiviral tenofovir alafenamide fumarate (TAF). However, the drug maker did not introduce the safer alternatives until after it was about to face competition from generic equivalents of the older tenofovir drugs.
The actions represent a decision by the drug maker to place profits before consumer safety, according to the lawsuit, which indicates plaintiffs may have avoided bone and kidney damage if information had been disclosed.
“Gilead failed to include any warning about the need to monitor bone effects until October 14, 2003, and that warning was limited to patients with certain risk factors. Since then, Gilead has only suggested that doctors monitor, and only informs patients that monitoring may be necessary, for patients with certain risk factors for bone adverse effects,” the lawsuit states. “Gilead’s inadequate kidney monitoring warnings also prevented doctors from detecting early signs of kidney damage that can lead to bone density loss. Gilead failed to warn about the need for universal monitoring even though it knew that all patients taking TDF are at risk for renal and bone adverse effects.”
The lawsuit joins a growing number of tenofovir lawsuits being pursued by former users of the older, TDF-based versions of the HIV drugs. Most of the complaints are currently pending in California state court, but a number have also been filed in various federal district courts nationwide over the past year.