Source – Sanofi
On 20 June 2023 in Paris, Sanofi reports that the International Chamber of Commerce tribunal has rejected Boehringer Ingelheim’s demand for indemnity against the pharmaceutical company and has ruled that Sanofi is not responsible for covering Boehringer Ingelheim’s possible damages resulting from the continuing Zantac case in the United States. This judgment is final and not subject to review.
This is significant because Sanofi continues to believe that the defense of the underlying US Zantac case is highly solid. The claims made against GSK, Pfizer, Boehringer Ingelheim, Sanofi, and other defendants in the US action are not supported by any credible scientific proof that Zantac causes the purported ailments. The active component of Zantac, ranitidine, has not been linked to any cases of cancer, according to analyses of the data conducted by the European Medicines Agency and the Food and Drug Administration.
This was significantly reaffirmed in December 2022, when a US federal court designated to oversee all federal lawsuits in the United States (“MDL”) concluded that plaintiffs lacked solid scientific proof that ranitidine can result in any of the plaintiffs’ claimed ailments. The exhaustive decision supported Sanofi’s scientific defenses, proving that there is no solid proof of causation for any cancer kinds, despite what the plaintiffs claimed to be the strongest cases. Sanofi thinks there is a slim chance that plaintiffs will be successful in their appeal of the MDL decision. Tens of thousands of claimants who were once involved in this MDL case made the decision to drop their lawsuits or to withdraw from the MDL early, either by filing in state court or by not filing at all.
GSK introduced Zantac as a prescription drug in the United States in 1983 (GSK marketed the Rx version until 2017). GSK introduced an over-the-counter version of their 75 mg Zantac composition in 1995. Ranitidine went generic and on the market in 1997. Pfizer purchased the OTC rights in 1998, and in 2004 it also introduced a 150mg version of the medicine. The OTC rights for Zantac in the United States were purchased by BI in 2006, then Sanofi bought them in January 2017.
Despite the lack of scientific support, lawsuits alleging that Zantac caused numerous malignancies were filed in US courts within days of the FDA’s September 2019 pronouncement. These cases included Sanofi as well as GSK, Pfizer, Boehringer Ingelheim, and several generic drug producers, merchants, and distributors.
As part of the January 2017 trade of Sanofi’s Animal Health division for Boehringer Ingelheim’s Consumer Health Care business, contractual indemnity obligations were made between Sanofi and BI that gave rise to the arbitration dispute. There is no proof that Zantac usage in the real world caused any NDMA contamination to damage consumers.