Sanofi has agreed in principle to settle 4,000 US lawsuits related to the discontinued heartburn drug Zantac and its link to cancer. The financial terms of the settlement were not disclosed, and it is not an admission of liability from Sanofi. The agreement aims to resolve most of the lawsuits against the company in US state courts, except for cases in Delaware where the majority are still pending. Sanofi stated that they are settling to avoid the expense and ongoing distraction of the litigation, but they will continue to vigorously defend against the Zantac lawsuits.
Despite the settlement, Sanofi is still facing around 20,000 lawsuits related to Zantac in Delaware state court. A judge in Delaware Superior Court is currently considering the fate of approximately 70,000 cases filed against Sanofi and other defendants, including GSK, Pfizer, and Boehringer Ingelheim. Plaintiffs and defendants are waiting for a ruling on whether there is enough scientific evidence to support the claim that Zantac causes cancer. In 2022, a judge dismissed about 50,000 lawsuits that were consolidated in federal court in Florida, stating that the expert opinions on Zantac causing cancer were not supported by sound science. Plaintiffs have appealed this ruling.
The drugmakers maintain that there is no evidence that Zantac exposed users to harmful levels of the carcinogenic chemical NDMA. Jennifer Moore and Brent Wisner, the lead plaintiffs’ attorneys in the Delaware and California litigation, expressed satisfaction with Sanofi’s settlement while the litigation continues against other defendants. They remain focused on moving forward with cases against GSK and Boehringer Ingelheim and preparing for multiple trials in California state court this year. Zantac was first approved in 1983 and became the world’s best-selling medicine in 1988, eventually being sold to Sanofi in 2019 after various ownership changes.
In 2019, some manufacturers and pharmacies stopped selling Zantac after traces of NDMA were found in some pills. Tests indicated that the active ingredient ranitidine in Zantac could degrade into NDMA over time or when exposed to heat. Lawsuits began to mount from individuals who claimed they developed cancer after taking Zantac. Plaintiffs alleged that the companies were aware or should have been aware of the cancer risk associated with ranitidine but failed to warn consumers. The US FDA requested the removal of Zantac from the market in 2020. Sanofi now sells Zantac360, a reformulated heartburn medicine with a different active ingredient, famotidine, as the company faces the legal challenges related to the original Zantac product.
