HIV drugmaker Gilead Sciences has agreed to pay up to $40 million in a one-time payment to settle a lawsuit involving its HIV med Viread (tenofovir disoproxil fumarate, or TDF), a component of several treatment regimens. Adrian Holley, et al. V. Gilead Sciences, Inc. was filed in May 2019 in the Northern District of California.

The settlement will be awarded to about 2,625 eligible plaintiffs nationwide who are living with HIV and were taking the med.

The Food and Drug Administration (FDA) approved TDF as part of HIV treatment in 2001. The plaintiffs claim that Gilead was also developing a newer, safer version of the drug: tenofovir alafenamide fumarate, or TAF. Allegedly Gilead delayed work on TAF so the company could reap more profits from TDF, despite knowing that TDF could cause kidney and skeletal problems. Gilead eventually resumed work on TAF, which received FDA approval in 2015.

To learn more about the two blockbuster meds, read “TAF Versus TDF: What’s the Difference?” Both meds are also approved as pre-exposure prophylaxis, or PrEP, to prevent HIV. (This lawsuit did not involve PrEP.) 

On June 4, Gilead released a statement about the settlement. It reads in part:

“Gilead entered into this agreement to avoid the cost and distraction of litigating these cases, and in no way is this settlement an admission of liability or wrongdoing,.… Gilead expects that the settlement will resolve the claims of the overwhelming majority of plaintiffs in the federal TDF litigation. However, there may be some plaintiffs in the federal TDF litigation who do not elect to participate in the settlement and there are others who are not part of this agreement. As to those plaintiffs, Gilead will continue to vigorously defend itself. Gilead has never stopped working to improve the lives of people with HIV. The evidence shows that the long-term safety of TAF was unknown and impossible to predict in October 2004 when Gilead stopped TAF development in favor of further developing TDF medications. Today, both TDF- and TAF-containing medicines are approved by the FDA, are recommended in the U.S. Department of Health & Human Services HIV treatment guidelines, and successfully help treat and prevent HIV in millions of people.”

The settlement was reached after U.S. District Judge Jon Tigar of Oakland refused to dismiss the case last fall, notes the San Francisco Chronicle. The newspaper added that although Gilead insists it did nothing wrong, the fact that the company is willing to pay about $15,000 to each plaintiff means the drugmaker knew it was legally vulnerable.

Of note, this case is separate from a pending California state TDF case against Gilead.