(Gilead logo)

Pharmaceutical giant Gilead was hit with a lawsuit filed by 41 people from 12 states on April 11 who allege they suffered bone and/or kidney damage after taking Gilead’s tenofovir disoproxil fumarate, (TDF). The personal injury suit, filed in California Superior Court in Los Angeles, alleges the pharmaceutical company knew in 2001 that TDF was “highly toxic in the doses prescribed and risked permanent and possibly fatal damage to the kidneys and bones” —and that there was a safer alternative.

“More and more plaintiffs are coming forward to tell their stories of how they have been harmed by Gilead’s practice of putting profits over patient health,” said Liza Brereton with HIV Litigation Attorneys.

The suit is part of an ongoing effort to hold Gilead accountable for its alleged failure to rectify a known defect in the drug formulation of TDF, knowing that a safer alternate existed—tenofovir alafenamide (TAF). Additionally, AIDS Healthcare Foundation spokesperson Ged Kenslea told the Los Angeles Blade, the suit also includes Gilead’s failure to warn patients of TDF’s damaging side effects and its active misrepresentation of TDF’s efficacy and substantial risks. AHF is paying for the litigation and only seeks legal costs in return.

“Gilead had their safer alternative available and suppressed it in a malicious deliberate way for over 15 years just so they could maximize and extend the profits on TDF,” Kenslea said.

The suit also asserts that Gilead deliberately and maliciously kept information about TAF quiet to extend its patent, FDA exclusivity, and sales of its existing medications, including TDF. Gilead netted over $18 billion in profit in 2015.

The lawsuit alleges that “thousands and thousands of HIV/AIDS patients may have been unwittingly exposed to significant kidney and bone damage from TDF” during their antiretroviral drug regimens. Additionally, “many HIV-negative individuals seeking to prevent HIV acquisition may have suffered similar harm to their kidneys or bones from taking Truvada as part of their PrEP (pre-exposure prophylaxis) protocol.”

Gilead sells TDF under the brand name Viread. TDF is also a component of Gilead’s Truvada.

“Gilead knowingly continued selling a drug that had debilitating side effects while keeping a safer version in the wings until the patent on the first, more dangerous version had been exhausted. In other words, Gilead allowed serious injuries to occur so they could make a few more bucks before releasing a safer version,” prominent AIDS activist and “My Fabulous Disease” blogger Mark S. King told the Los Angeles Blade. “Meanwhile, Gilead continues to own our governmental and community-based HIV response lock, stock, and barrel by throwing endless cash at national organizations that should have our best interests at heart. Gilead’s behavior has been truly vile.”

King added: “I have been critical of AHF in the past for the quickness to sue, primarily other HIV organizations with which they differed. But this lawsuit is righteous and I hope they win, big time.”