((Automated translation by Reuters, please see disclaimer https://bit.ly/rtrsauto))
(Added comment from plaintiff’s attorney and background in paragraphs 6-18) by Dietrich Knauth
Sanofi SASY.PA has reached a tentative agreement to settle 4,000 U.S. lawsuits that link Zantac, a discontinued heartburn drug, to cancer, the company said Wednesday.
Sanofi did not disclose the financial terms of the deal. The agreement, which has yet to be finalized, will end most lawsuits against the French pharmaceutical company in US state courts, with the exception of Delaware where the majority of cases are pending.
Sanofi admitted no liability under the settlement and said it was to avoid the expense and ongoing distraction of the litigation.
“Sanofi has vigorously defended the Zantac litigation from the beginning and will continue to do so,” the company said in a statement.
Sanofi still faces approximately 20,000 Zantac-related lawsuits in Delaware state courts. A Delaware Superior Court judge in Wilmington is weighing the fate of about 70,000 complaints filed against Sanofi and other defendants, including GSK GSK.L , Pfizer PFE.N and Boehringer Ingelheim.
GSK, Boehringer Ingelheim and Pfizer did not immediately respond to requests for comment.
The plaintiffs and defendants are awaiting a ruling from the judge on whether there is sufficient scientific evidence to support the plaintiffs’ claims that Zantac causes cancer.
Drugmakers scored a major victory in 2022, when another judge threw out about 50,000 lawsuits making similar claims that had been consolidated in federal court in Florida.
This judge concluded that the opinions of the plaintiffs’ expert witnesses that Zantac can cause cancer were not supported by sound scientific data. The plaintiffs appealed this decision.
Drugmakers have maintained that there is no evidence that Zantac exposes users to harmful levels of NDMA, a cancer-causing chemical.
Jennifer Moore and Brent Wisner, who are lead plaintiffs’ attorneys in the Delaware and California litigation, said Wednesday they were pleased that Sanofi reached a settlement while litigation continues against other defendants.
“We are aggressively continuing our efforts against GSK and Boehringer Ingelheim and are preparing for multiple trials in California state court this year,” Mr. Moore said.
First approved in 1983, Zantac became the world’s best-selling drug in 1988 and one of the first drugs to exceed $1 billion in annual sales. Originally marketed by a precursor to GSK, it was then sold successively to Pfizer, Boehringer and finally Sanofi.
In 2019, some manufacturers and pharmacies halted sales of Zantac after NDMA was detected in some pills. Some tests have shown that Zantac’s active ingredient, ranitidine, can break down into NDMA over time or when exposed to heat.
Lawsuits began piling up from people claiming they developed cancer after taking Zantac. The plaintiffs said the companies knew, or should have known, that ranitidine posed a cancer risk and failed to warn consumers.
The Food and Drug Administration (FDA) asked manufacturers to remove the drug from the market in 2020.
Sanofi now sells Zantac360, a reformulated heartburn medication with the active ingredient famotidine.