Lawsuit Against Truvada, Viread Maker Alleges TDF-Based HIV Drugs Toxic to Users Kidneys, Bones

Gilead failed adequately to warn users that its TDF-based HIV drugs could lead to bone demineralization, kidney disease and kidney damage, plaintiffs say.

A group of 19 plaintiffs from a dozen different states have joined together to file a lawsuit against Gilead, the makers of Truvada, Viread, Atripla, Complera and Stribild, alleging that the the drug maker failed to adequately disclose that it’s TDF-based HIV drugs are toxic to bones and kidneys, and withheld the development of a safer alternative in order to maximize profits.

The complaint (PDF) was filed in the U.S. District Court for the Northern District of California on May 25, indicating that each of the plaintiffs took one or more of the medications which contain the compound tenofovir disoproxil fumarate (TDF), and subsequently experienced bone fractures, chronic kidney disease or other kidney damage.

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 indicate 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.

In the lawsuit against the Truvada manufacturer, plaintiffs indicate Gilead misled patients and the medical community about the TDF-based drugs, leaving them no way to anticipate their resulting injuries and thus avoid them, noting the company’s use of stronger label warnings on its drugs in the European Union.

“No reasonable person would have suspected that Gilead provided stronger warnings to patients and doctors in the EU than it did in the U.S. for the exact same TDF products,” the lawsuit states. “Gilead’s misrepresentations and omissions would lead a reasonable person to believe that he or she did not have a claim for relief.”

Gilead HIV Drug Lawsuits

The claims join a growing number similar Gilead HIV drug lawsuits filed over the past few years, each raising similar allegations that Gilead 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 lawsuits over Gilead’s HIV drugs are pending in the California state court system.

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.