Sanofi has agreed to settle approximately 4,000 personal injury claims from users of its heartburn drug Zantac, resolving litigation in all U.S. state courts besides Delaware, the company confirmed on Thursday.
The agreement, which was completed last month, requires the approval of individual plaintiffs and “will take some time to conclude,” a company spokesperson wrote in an email. Sanofi did not reveal terms of the deal, which was first reported by Bloomberg.
“The amount that would be paid reflects the limited time during which Sanofi marketed Zantac and the strong defenses available to Sanofi in these cases. The resolution of these cases will have no material financial impact,” the French company added.
Sanofi is among several companies facing lawsuits that claim Zantac—which was developed by GSK and approved in 1983—can cause cancer. Sanofi acquired the then-over-the-counter treatment in a 2016 asset swap with Boehringer Ingelheim and then pulled Zantac off the market in 2019 when on online pharmacy, Valisure, raised questions about its contents.
In 2020, the FDA instructed all companies to take Zantac off the market after it confirmed that the compound’s main ingredient ranitidine can transform into a possible carcinogen over time or when exposed to high temperatures. Zantac has since returned to the market with a new formulation that does not include ranitidine.
Companies facing federal litigation, including Pfizer, gained a huge win in 2022 when a Florida district judge rejected the science backing the claims that Zantac can cause cancer. The ruling freed the drugmakers from approximately 50,000 cases that had been consolidated in the Florida court.
The state claims remain, with roughly 75,000 consolidated in Delaware, including approximately 20,000 against Sanofi.
Over the last 10 months, GSK has settled individual Zantac cases in California to avoid jury trials. With a longer history with Zantac, GSK faces more claims than the other companies, with Reuters reporting 79,000 outstanding cases in October of last year.
Throughout the ordeal, the companies have maintained that Zantac can not cause cancer.
“Consistent with the federal court’s ruling that plaintiffs had insufficient evidence that ranitidine can cause plaintiffs’ alleged cancers, the medical, scientific, and regulatory communities have extensively evaluated and have found the allegations of the plaintiffs that Zantac causes cancer to be without merit,” Sanofi's spokesperson said. “Sanofi is settling these cases, not because we believe the claims have any merit, but rather to avoid the expense and ongoing distraction of the litigation. No concessions of liability have been made.”
Last year, an International Chamber of Commerce arbitration tribunal sided with Sanofi when Boehringer claimed that the Paris drugmaker agreed to indemnify it from future liabilities on cancer claims against Zantac.