Gilead Faces Bone Demineralization Lawsuit Over Truvada, Other TDF-Based HIV Drugs

Plaintiffs say they suffered bone demineralization, resulting in bone density loss and permanent injuries due to Gilead’s marketing of a less safe formulation of the drugs in order to make more money.

Two plaintiffs have filed a bone demineralization lawsuit against Gilead, indicating that the HIV drug manufacturer knew the side effects of Truvada and similar TDF-based anti-viral drugs could cause bone loss and other serious health risks, but chose to continue selling the older drugs in order to increase profits, before introducing new safer variations.

The complaint (PDF) was filed late last month in the U.S. District Court for the Central District of California by Darren Johnson and Rosyln Rochester, naming Gilead Sciences, Inc. as the defendant. The lawsuit indicates the plaintiffs suffered various bone injuries after taking versions of Gilead HIV drugs that contained the compound tenofovir disoproxil fumarate (TDF), including Truvada, Atripla and Complera, among others.

Gilead developed and manufactured each of the medications, 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 warning about the risk of bone demineralization, bone fractures and other side effects, plaintiffs indicate Gilead continued to sell the older drugs, and delayed development of the safer alternative, until patent protections expired, further extending its monopoly of the HIV treatment market.

Darren Johnson, of Missouri, indicates he was prescribed Truvada, Atripla and Complera over the course of several years, beginning with Truvada in 2012. According to the lawsuit, taking the drugs led to Johnson suffering bone demineralization in his right hip, which led to bone density loss.

As a result, Johnson has extreme difficulty walking and had to undergo hip replacement surgery, and required extensive treatment, rehabilitation and physical therapy.

Similarly, Rochester, of Massachusetts, began taking Viread, Truvada and Atripla in 2005, indicating that the drugs caused bone demineralization and kidney failure, leading to a diagnosis of chronic kidney disease and osteoporosis.

The claims join a growing number similar Truvada 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, lawsuits allege that 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.

“In addition to withholding safer designs, Gilead failed to adequately warn physicians and patients about the risks and safe use of TDF,” the lawsuit states. “Gilead provided only the weakest, inadequate warnings to doctors and patients about the need for frequent monitoring of all patients for TDF-associated kidney and bone damage—preventing doctors from detecting early signs of TDF toxicity.”

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.