TDF Lawsuit Filed Against Gilead Over Toxic Side Effects of Truvada, Atripla, Other HIV Drugs

In addition to claims filed in federal court, Gilead faces about 24,000 TDF lawsuits in California state court, each raising similar allegations that the drug maker withheld a safer version of its HIV drugs.

Two dozen plaintiffs have filed a lawsuit over Gilead’s product line of tenofovir disoproxil fumarate (TDF) HIV drugs, saying they suffered kidney and bone problems because the company sat on a safer formulation in order to maximize profits.

The complaint (PDF) was filed last week in the U.S. District Court for the Northern District of California, naming Gilead Sciences, Inc. as the defendant.

Gilead developed and manufactured Truvada, Viread, Atripla, Complera and Stribild, and promoted them as safe and effective HIV treatments, while creating an essential monopoly in the U.S. market. However, plaintiffs allege that the drug maker knew 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.

Rather than fully warning about the risk of bone demineralization, bone fractures and other kidney side effects, plaintiffs have filed TDF lawsuits nationwide, indicating Gilead continued to sell the older drugs without accurate risk information, and delayed development of the safer alternative, until patent protections expired, further extending its monopoly of the HIV treatment market.

As a result of Gilead’s actions, the plaintiffs indicate they suffered numerous, severe, life-altering injuries. Some plaintiffs, like Dillon Davis of Arkansas, indicate they suffered kidney failure and End Stage Renal Disease as a result of TDF drug use. Others, like Christine Baskin of Florida, not only suffered chronic kidney disease, but also suffered bone demineralization and osteopenia.

All of this could have been avoided if Gilead had released its TAF drugs when the company knew they were safer than Truvada, Atripla and other HIV drugs, the TDF lawsuit states.

“Before Gilead began selling its first TDF Drug, Viread, in 2001, Gilead knew that TDF posed a safety risk to patients’ kidneys and bones,’” plaintiffs say. “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 plaintiffs present claims of strict product liability, design defect, failure to warn, negligence, gross negligence, fraud by omission, breach of implied warranty, and violations of several states’ consumer protection laws.

April 2024 TDF Lawsuit Update

This recent complaint joins a growing number similar TDF lawsuits filed against Gilead over the past few years, each raising similar allegations that the drug maker placed its desire for profits before consumer safety, by continuing to sell and promote more toxic formulations.

As the end of patent protections for the blockbuster drugs approached, allowing competition from generic equivalents for Truvada, Atripla, Stribild, Viread and other TDF-based drugs, the lawsuits allege Gilead began to introduce and aggressively market TAF-based versions of the medications, promoting their newer drugs as the safer alternatives to the toxic drugs they sold for years.

While this complaint was filed in federal court, most of the TDF lawsuits over Gilead drugs are pending in the California state court system, where about 24,000 claims have been filed and Courts cleared lawsuits over Truvada and other TDF-based HIV drugs to move forward toward trial earlier this year.

Given common questions of fact and law, the litigation is being coordinated in California state court during discovery and a series of early “bellwether” trials will be scheduled to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout hundreds of claims.

While the outcome of these bellwether trials will not be binding on plaintiffs involved in other claims, the average TDF lawsuit payout amounts may influence the amounts of any settlements Gilead may be required to pay to avoid each individual claim being set to go before a jury.