Truvada, Viread and Other HIV Drugs Were Toxic to Kidneys and Bones, Lawsuit Alleges

A joint product liability lawsuit has been filed against Gilead Sciences on behalf of a dozen former users of Truvada, Viread, Atripla, Complera and Stribild, alleging that side effects of the HIV drugs caused kidney damage, bone fractures and other injuries.

The complaint (PDF) was filed in the U.S. District Court for the Northern District of California on August 10, indicating the drug maker failed to adequately warn about the risks associated with tenofovir disoproxil fumarate (TDF) HIV drugs, and withheld development of safer formulations of the drugs as part of a scheme to increase profits.

“Before Gilead began selling its first TDF Drug, Viread, in 2001, Gilead knew that TDF posed a safety risk to patients’ kidneys and bones. Gilead knew that two of its other antiviral drugs with structures similar to tenofovir, cidofovir and adefovir dipivoxil, had been highly nephrotoxic (i.e., toxic to kidneys) and that preclinical data for TDF showed that it could cause significant kidney and bone damage,” the lawsuit states. “Gilead’s knowledge of the toxic effects of TDF only grew as patients began treatment with and were injured by each successive TDF product. By the time Gilead designed Stribild, it had ten years’ worth of cumulative evidence that TDF injured patients’ kidneys and bones.”

According to the lawsuit, Gilead has known for years that a less toxic version of the drugs could be developed, involving the antiviral tenofovir alafenamide fumarate (TAF), yet the drug maker continued to sell the more toxic versions without adequate warnings.

It was after the blockbuster drugs were about to face competition from generic equivalents that the drug maker introduced TAF-based drugs, marketing them as safer than the toxic TDF-drugs they had sold for years without adequate warnings for consumers.

Plaintiffs allege the decision to withhold development of TAF-based drugs was part of a scheme intended to allow Gilead to maintain an essential monopoly on HIV treatments until at least 2032. However, as a result of this decision to place profits before consumer safety, thousands of individuals nationwide have been left with severe injuries that may have been avoided.

The plaintiffs, including Lawrence Nitz, Stephen Kosiorek, George Colter, Ronald Kimsey, Barbara Egli, Louis Rodriguez, Ian Au, Darius Williams, Timothy Stewart, Michael Holland, James Weiss and Vincent Cleveland, are presenting claims against Gilead that include design defect, failure to warn, negligence, gross negligence, fraud by omission, breach of warranty and violation of various state consumer protection laws.

The lawsuit joins a growing number of complaints filed by plaintiffs nationwide, who say they suffered Gilead HIV drug side effects. 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.