Sanofi has reached an agreement in principle to settle 4,000 lawsuits in the US linking the discontinued heartburn drug Zantac to cancer. The financial terms of the deal were not disclosed, but it will resolve most of the lawsuits against the French pharmaceutical company in US state courts, with the exception of cases in Delaware. Sanofi did not admit any liability in the settlement and stated that it is settling to avoid the expense and ongoing distraction of the litigation. The company has vigorously defended the Zantac litigation from the beginning and will continue to do so.
However, Sanofi still faces around 20,000 lawsuits over Zantac in Delaware state court. A judge in Delaware is currently considering about 70,000 cases filed against Sanofi and other defendants, including GSK, Pfizer, and Boehringer Ingelheim. The plaintiffs and defendants are awaiting a ruling from the judge on whether there is sufficient scientific evidence to support the claims that Zantac causes cancer. In 2022, the drugmakers won a significant victory when a judge dismissed about 50,000 lawsuits in federal court in Florida, stating that the plaintiffs’ expert opinions were not supported by sound science. Plaintiffs are currently appealing that ruling.
The drugmakers, including Sanofi, GSK, Pfizer, and Boehringer Ingelheim, have consistently denied that Zantac exposes users to harmful levels of the carcinogenic chemical NDMA. Lead plaintiffs’ attorneys in the Delaware and California litigation expressed their satisfaction with Sanofi’s settlement while continuing the litigation against other defendants. They are preparing for multiple trials in California state court this year against GSK and Boehringer Ingelheim, while also pursuing legal action against other defendants.
Zantac was first approved in 1983 and became the best-selling medicine in 1988, reaching over $1 billion in annual sales. The drug was originally marketed by a predecessor of GSK and was later sold to Pfizer, Boehringer, and finally Sanofi. In 2019, some manufacturers and pharmacies stopped Zantac sales after NDMA was detected in some pills. Lawsuits started piling up from individuals who claimed they developed cancer after taking Zantac, alleging that the companies knew or should have known about the cancer risk posed by ranitidine, Zantac’s active ingredient. The US FDA requested manufacturers to remove the drug from the market in 2020.
Sanofi now sells Zantac360, a reformulated heartburn medicine with famotidine as the active ingredient. The lawsuits surrounding Zantac and its alleged link to cancer have been a major legal battle for the drugmakers involved, with thousands of cases being contested in various courts. The outcome of the litigation will depend on the judges’ rulings on the scientific evidence supporting the claims of harm caused by Zantac. Despite the settlement between Sanofi and some plaintiffs, the legal battle against other defendants, including GSK and Boehringer Ingelheim, is still ongoing.
