In Heart Burn Drug Zantac's Litigation Saga, Sanofi Nears Settlement in Major Lawsuit Cluster

Sanofi SA SASY has announced an agreement in principle to settle approximately 4,000 lawsuits in the United States linked to the discontinued heartburn drug Zantac. 

The company stated that the settlement encompasses many pending cases across various U.S. state courts, excluding Delaware. The financial terms remain confidential.

The settlement arises amidst allegations that Zantac, manufactured by Sanofi and other companies, may have caused cancer due to the presence of NDMA, a possible carcinogen found in the drug. 

Sanofi clarified that they have not admitted any liability while settling these cases, maintaining their stance against the claims. 

The company emphasized its commitment to defending against such litigations.

The settlement with plaintiffs' lawyers aims to conclude most pending cases, allowing Sanofi to avoid the costs and distractions associated with prolonged litigation, the Wall Street Journal noted. 

Despite this development, the company still faces many lawsuits in Delaware state court.

In December 2022, U.S. District Judge Robin Rosenberg in Florida dismissed about 50,000 claims associated with GSK Plc GSK, Pfizer Inc PFE, Sanofi, and Boehringer Ingelheim, that claimed that the heartburn drug Zantac caused cancer, as a judge found the claims were not backed by solid science.

In 2019, Sanofi recalled Zantac following tests by an independent lab, Valisure, which found the likely carcinogen NDMA in the drug and its generics. 

The lab discovered that the active ingredient ranitidine could form NDMA over time or in high temperatures. 

The FDA confirmed these findings in April 2020 and ordered the removal of the medicine from the market. 

Bloomberg noted that Sanofi reintroduced Zantac without ranitidine and is now using famotidine. Now, with a new active ingredient, famotidine, Zantac has returned to store shelves. 

Despite resolving individual Zantac cases, companies like GSK and Pfizer have not agreed to broader settlement efforts.

Price Action: SNY shares are up 1.02% at $48.45 during the premarket session on the last check Thursday.

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