Gilead Sciences must face consumer claims over older, lower-quality drugs, court rules

Gilead Sciences

Gilead Sciences must face consumer claims over older, lower-quality drugs, court rules

Published: Jan 10, 2024

By Connor Lynch


Gilead Sciences must face thousands of claimants in court who allege the company deliberately delayed development of safer drugs to maximize profits on older drugs, California’s First District Court of Appeal ruled Tuesday.

The claims allege that the drugmaker’s tenofovir, an antiretroviral used in Gilead’s older HIV drugs, caused kidney, tooth, or bone damage to patients, and that Gilead knew its tenofovir-based drugs which were still in development, were safer. They further allege that Gilead deliberately paused the development of those new, safer drugs in order to maximize its profits from both types.

“We conclude that the legal duty of a manufacturer to exercise reasonable care can, in appropriate circumstances, extend beyond the duty not to market a defective product,” Associate Justice Jeremy M. Goldman wrote in the court’s published opinion, according to reporting by Bloomberg Law. The court further noted that there does not appear to be precedent in California cases of express consideration of the relationship between “defect” and “negligence.”

The ruling reaffirms a lower court ruling denying Gilead’s motion for summary dismissal for negligence claims, but also reversed the lower court’s decision to deny Gilead’s motion for summary dismissal on the claims of fraudulent concealment. Similar litigation is also under review by a federal court in California, also involving thousands of claims. Separate litigation filed in 2019 by eight patients who took Gilead’s Truvada, a combination of emtricitabine and tenofovir disoproxil fumarate, makes similar claims to this lawsuit, alleging Gilead withheld safer HIV drugs in a “patent-timing scheme.” The company has yet to announce the outcome of that suit.

This isn’t the first round of litigation related to its HIV drugs the company has faced, though the last round was ultimately decided in Gilead’s favor. A court ruled in July 2023 that Gilead and Teva did not conspire to delay the release of generic versions of their drugs.

The 2019 lawsuit, filed by consumers as well as direct purchasers such as the Blue Cross Blue Shield Association, claimed Gilead had maintained a monopoly in the market by extending patent protection on its drugs as well as striking so-called “pay-to-delay” deals. In particular, the suit alleged Gilead struck a deal in 2014 to pay Teva $1 billion in a “reverse payment,” so that Teva would reshelve its generic versions of Truvada and another drug, according to reporting by Bloomberg Law.

The suit sought $3.6 billion in damages, but a jury decided that the 2014 deal did not violate antitrust law.

That ruling came just two months after a jury concluded that Truvada and another Gilead HIV prevention drug, Descovy, did not violate government patents and also found that those patents were invalid. The lawsuit, launched in 2012 by the Trump administration, alleged the two-drug regimen at the basis of Gilead’s offerings was invented and proposed for prophylaxis by Centers for Disease Control and Prevention researchers. Descovy netted Gilead over $1.6 billion in revenue in 2022, with Truvada bringing in $113 million.

Source: BioSpace