BREAKING NEWS: Gilead to pay $40 million to over 2,600 plaintiffs

Is this their escape hatch?

This will be a quick post, but I need to alert you to a major—and very disturbing—update on the Truvada disaster and the litigation surrounding TDF. This is an ongoing story and will be updated as appropriate.

From Gilead’s website (emphasis mine throughout):

Gilead Statement on Agreement in Principle to Resolve Federal TDF Litigation

Gilead Sciences has reached an agreement in principle with counsel representing the overwhelming majority of plaintiffs in the federal TDF litigation pending in the U.S. District Court for the Northern District of California (ADRIAN HOLLEY, et al.).

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. In general terms, the agreement provides that Gilead will make a one-time payment of up to $40 million to the group of eligible plaintiffs (approximately 2,625 plaintiffs). The agreement is subject to certain conditions, including that at least 98% of these eligible plaintiffs elect to participate in the settlement.

This has been picked up by both Poz, BMJ, and Fierce Pharma. It is important to note that this is not the class action lawsuit. From Poz:

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.

$15,000 per patient? That seems wildly inadequate—recall that Gilead had previously been asked to set up a $10 billion slush fund for its 26,000 class action litigants; a payout of over $350,000 per litigant. This smells like they’re taking an escape hatch, and I’m alarmed at what this spells for the future of these patients, as well as for those that have been harmed by Truvada for PrEP. (The Poz piece specifically indicates that this lawsuit involves Viread, which is not indicated for PrEP.)

From the Fierce Pharma piece:

As Gilead Sciences awaits the progression of California state litigation over its alleged delay of safer HIV drugs, the company is biding its time with a proposed $40 million settlement to quell the claims of more than 2,000 plaintiffs.

Exactly—the company is biding its time. I’m sure they’re hoping that this pathetic payout, which is certainly a drop in the bucket for Gilead compared with the $10 billion they were asked to pay, will make this case disappear. As the piece states, “The one-time payment of $40 million is meant to “avoid the cost and distraction of litigating these cases” and is “in no way” an admission of wrongdoing or liability, the company said in a June 4 statement.” So they want to avoid the “cost and distraction” of litigation and, worse, they refuse to admit wrongdoing! Amazing. Again from Fierce Pharma:

“Gilead has never stopped working to improve the lives of people with HIV,” it added in its statement. “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.”

This is a spin I haven’t heard yet—“good Truvada” had an unknown safety profile, so Gilead chose to go with a compound that had a known profile of being manifestly unsafe to the kidneys and bones. Of course, we know that “good Truvada” isn’t so good, given its potential to cause cardiovascular events, but I doubt that was the motivation behind Gilead’s actions.

In order for it to go through, 98% of plaintiffs must agree to the deal.

The recent action is separate from the California state litigation, which is currently pending in the California Supreme Court with Gilead’s initial briefing due on July 15 following the court’s decision to review of a recent appeals court's decision.

Let’s hope they don’t hit the 98% goal. These plaintiffs ought to be holding out for much greater compensation. Regardless, this is a very concerning development; Gilead and the activists lurking behind the scenes will do everything in their power to make this case, and the atrocities surrounding it, disappear. And, predictably, it will be the unwitting patients—including those on PrEP who are taking a drug that they have no indication of a need for—that suffer the consequences.

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