USA — An arbitration tribunal of the International Chamber of Commerce has ruled in favor of Sanofi, dismissing a claim filed by Boehringer Ingelheim in relation to legal responsibilities concerning the ranitidine-based product Zantac.
The announcement was made by the French multinational company on Tuesday, marking a significant development in the ongoing Zantac litigation.
The controversy surrounding Zantac emerged in 2019 when online pharmacy Valisure detected elevated levels of the potentially carcinogenic compound N-nitrosodimethylamine (NDMA) in the medication, leading to a product recall.
Subsequently, in 2020, the FDA requested all manufacturers of the drug to voluntarily recall their Zantac products.
Since the initial FDA announcement, multiple lawsuits have been filed by individuals who used Zantac, targeting various companies involved in the production and distribution of the heartburn medication, including Sanofi and Boehringer.
Zantac manufacturers, including GSK, Pfizer, and other generic drugmakers, have been fortifying their legal defenses.
Last year, a Florida federal judge deemed claims against these companies to be unfounded, resulting in the dismissal of approximately 50,000 federal multidistrict claims.
However, numerous cases remain pending in state courts, awaiting resolution.
In 2017, Paris-based Sanofi acquired the over-the-counter rights to Zantac from Germany-based Boehringer as part of an exchange agreement.
Boehringer subsequently sought indemnification from Sanofi for potential losses related to the ongoing Zantac litigation in the United States.
Sanofi’s statement confirms that the claims made by Boehringer for indemnification have been rejected by the International Chamber of Commerce tribunal, and the decision is final and non-appealable.
Boehringer, on the other hand, has chosen not to provide further comments due to confidentiality provisions surrounding the arbitration process.
The announcement of the legal victory had a positive impact on Sanofi’s shares, which rose more than 3% on Tuesday.
Despite the extensive assessments conducted since 2019, both the FDA and the European Medicine Agency (EMA) have not found conclusive evidence linking Zantac to cancer, as stated in Sanofi’s press release.
The FDA’s concerns regarding the drug stem from the detection of increasing levels of the impurity NDMA in some ranitidine products over time and under specific storage conditions.
However, the FDA also acknowledged that many of the tested samples did not contain unacceptable levels of NDMA.
In December 2022, a federal judge in Florida ruled that there was no reliable scientific evidence supporting the alleged injuries caused by ranitidine, clearing Sanofi, Boehringer, and other drugmakers from approximately 50,000 federal cases.
Following this ruling, Boehringer expressed appreciation for the court’s detailed analysis and stated its intention to continue its defense in state courts, where numerous cases are still awaiting resolution.
Additionally, last month, the Supreme Court of Canada also dismissed cancer claims related to ranitidine-based products.
In its statement on Tuesday, Sanofi reiterated its confidence in the safety of Zantac and expressed full confidence in its defenses against the ongoing litigation, given the lack of scientific support for the plaintiffs’ claims.
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