The French pharmaceutical company Sanofi says it has reached an agreement to resolve 4,000 cases in the U.S., in which plaintiffs are linking the discontinued heartburn drug Zantac — and its active ingredient ranitidine — to cancer. Sanofi has long denied these claims.
The company said in a statement: “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.”
Sanofi adds that medical experts “have found the allegations of the plaintiffs to be without merit.” And in 2022, in a lawsuit brought by other plaintiffs in another Zantac case, a U.S. federal court judge ruled “the plaintiffs had no reliable evidence.”
Sanofi acquired Zantac in 2017. Before that, other companies owned the drug.
Peter Pitts, the former associate commissioner of the FDA, says these types of lawsuits are concerning for the industry.
“I think when people see ‘settlement,’ they hear 'guilty.' And that is not true," said Pitts. "When people hear 'settlement,' they hear the drug is dangerous and it isn’t effective."
Pitts adds that it has a negative impact on innovation, which could hurt patients in the long run.
"What concerns me is that companies are driven to spend money that can otherwise be used for additional research and development," said Pitts. "These companies have deep pockets. They’re cash-rich, and they’re viewed as targets.”
Sanofi discontinued the ranitidine formulation of Zantac, and the new formulation, Zantac 360, is made with famotidine, a different active ingredient.
Sanofi’s agreement still needs to be finalized with the consent of individual plaintiffs, and the company notes that “will still take some time to conclude.” Those settlements don’t include cases in Delaware, where the company is still facing 20,000 lawsuits.
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