Gilead TDF Lawsuit Alleges Toxic Effects of HIV Drugs on Bones, Kidneys Was Known For Years

This and similar lawsuits claim Gilead sat on a safer formulation of its HIV drug for years in order to maximize its profits from the older, more toxic version.

About 80 plaintiffs from across the country have joined together to file a lawsuit against Gilead over tenofovir disoproxil fumarate (TDF) based HIV drugs which exposed users to the toxic side effects on bones and kidneys, even though the drug maker was aware of safer formulations.

The complaint (PDF) was filed in the U.S. District Court for the Northern District of California on December 27, involving various injuries allegedly caused by TDF-based drugs, including the blockbuster treatments Truvada, Atripla, Stribild and Viread.

Gilead developed and manufactured each of the medications, promoting them as safe and effective for years, while creating an essential monopoly over HIV treatments in the U.S. However, plaintiffs allege the TDF-based medications were more toxic than they had to be, since Gilead was already aware of a safer alternative, using the HIV drug compound tenofovir alafenamide fumarate (TAF), which could be taken at lower doses and be equally as effective.

The case joins a growing number of Gilead TDF lawsuits filed by plaintiffs nationwide, each raising similar allegations that bone fractures, kidney failure and other severe injuries could have been avoided.

Rather than introducing the safer HIV drugs, the drug maker decided to sit on the development and continued to market the Gilead TDF drugs for years. However, once it started to face competition from generic equivalents for Truvada, Atripla, Stribild, Viread and other TDF drugs, Gilead introduced and began aggressively marketing versions of the medications with the HIV drug compound TAF.

“Falsely claiming that TAF was not different enough from TDF, Gilead abruptly shelved its TAF design in 2004,” the Gilead TDF lawsuit states. “However, as John Milligan, Gilead’s President and Chief Executive Officer, later admitted to investment analysts, the real reason Gilead abandoned the TAF design was that TAF was too different from TDF. Once Gilead’s first TDF product, Viread, was on the market, Gilead did not want to hurt TDF sales by admitting that its TDF-based products are unreasonably and unnecessarily unsafe.”

As a result of the apparent decision to place profits before consumer safety, plaintiffs allege they suffered various injuries from toxic effects from the TDF HIV drugs, including low kidney function, bone demineralization, osteoporosis, and bone fractures.

The complaint presents claims of design defect, failure to warn, negligence, gross negligence, fraud by omission, breach of warranty, and violation of multiple states’ consumer protection laws. The plaintiffs seek both punitive and compensatory damages and disgorgement of Gilead’s allegedly ill-gotten profits.