Gilead Knowingly Designed HIV Drugs To Be Unreasonably Dangerous, Lawsuit Claims

According to allegations raised in a product liability lawsuit recently filed by a group of 10 people, Gilead Sciences, Inc. allegedly sold inferior, potentially life-threatening HIV drugs knowing it had a safer formulation, in order to increase its profit margins at the expense of patients.

The complaint (PDF) was filed in the U.S. District Court for the Northern District of California on October 9, by users of Gilead’s tenofovir disoproxil fumarate (TDF) HIV drugs, including Truvada, Viread, Atripla, Complera and Stribild. The lawsuit indicates the company sold the drugs knowing they could cause kidney and bone damage when it had a safer version on the backburner for when patent protections ran out.

According to the HIV drug lawsuit, Gilead has known for years that a less toxic version of the medications could be developed, involving the antiviral tenofovir alafenamide fumarate (TAF), yet the drug maker continued to sell the more toxic versions without adequate warnings.

It was after the blockbuster drugs were about to face competition from generic TDF equivalents that the drug maker introduced TAF-based drugs, marketing them as safer than the toxic TDF-drugs they had sold for years without adequate warnings for consumers.

Plaintiffs allege the decision to withhold development of TAF-based drugs was part of a scheme intended to allow Gilead to maintain an essential monopoly on HIV treatments until at least 2032. However, as a result of this decision to place profits before consumer safety, thousands of individuals nationwide have been left with severe injuries that may have been avoided. The lawsuit indicates those drugs were “unreasonably dangerous” given its access to the TAF-based drugs.

“Falsely claiming that TAF was not different enough from TDF, Gilead abruptly shelved its TAF design in 2004. 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,” the lawsuit states. “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.”

The lawsuit joins a growing number of complaints filed by plaintiffs nationwide, who say they suffered Gilead HIV drug side effects. Most of the complaints are currently pending in California state court, but a number have also been filed in various federal district courts nationwide over the past year.