French Drugmaker Sanofi Agrees to Settle 4,000 Lawsuits Linked To Zantac heartburn Medication

French drugmaker Sanofi has reached an agreement to settle about 4,000 U.S. lawsuits that linked the company’s heartburn drug Zantac to cancer. The company announced the agreement on Wednesday, April 3, 2024, but stopped short of announcing the financial terms of the deal. Also, the drugmaker did not accept any liability in the settlement. Instead, the French drugmaker said the settlement was to help it avoid the expenses and distractions of the litigation.  

The agreement which is yet to be finalized will see the drugmaker settle most of the lawsuits filed against the company in U.S. state courts. The only exception is in Delaware where the majority of the cases are still pending.

“Sanofi has vigorously defended the Zantac litigation since the outset and will continue to do so,” the French drugmaker said in a statement.

There are still around 20,000 lawsuits filed against Zantac in Delaware state court. Delaware Superior Court judge in Wilmington is still considering the fate of nearly 70,000 cases filed against Sanofi and other drugmakers, including Boehringer Ingelheim, Pfizer, and GSK, as defendants. Both the plaintiff and the defendants are waiting on the ruling from the judge on whether there is significant scientific evidence that links Zantac to cancer.

“While the financial terms of Sanofi’s agreement are confidential, 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 company said in the statement.

Sanofi has faced a similar mass lawsuit in the past

Back in 2022, Sanofi won a similar mass lawsuit when a judge dismissed 50,000 cases filed against the French drugmaker by plaintiffs making similar claims that had been consolidated in the federal court of Florida. 

In the ruling, the judge concluded that the opinions of the expert witnesses by the plaintiffs that the use of Zantac can lead to cancer were not supported by sound science. The plaintiffs are appealing that ruling. The defendants continue to insist that there is no evidence that Zantac exposed users to harmful levels of NDMA, a carcinogenic chemical.

Zantac was first approved in 1983 and became the best-selling medicine in the world in 1988. It was also one of the first-ever drugs to cross over $1 billion in annual sales. It was first marketed by GSK's forerunner before being sold to Pfizer, Boehringer, and Sanofi acquired it in 2017.

After NDMA was detected in some Zantac pills in 2019, some pharmacies stopped its sale. Further tests showed that the active ingredient in Zantac, ranitidine, could degrade to NDMA when exposed to heat or over time.

Sanofi recalled the drug in 2019, a month after the discovery of NDMA by independent lab Valisure. In April 2020, the US Food and Drug Administration confirmed the findings and ordered the recall of the medication from the market.

Eventually, lawsuits started to mount from people who claimed that they developed cancer after taking the drug. According to the plaintiffs, the companies either knew or should have known about the carcinogenic risk posed by ranitidine and failed to warn consumers. Sanofi now sells a reformulated heartburn medication called Zantac360 which has ranitidine removed as the active ingredient and replaced with famotidine.