Boehringer loses bid to be shielded from Zantac litigation
Sanofi says it has won an arbitration dispute with Boehringer Ingelheim, in which the latter had tried to protect itself from liabilities that may arise from ongoing litigation over Zantac in the US.
The case stems from claims emerging in 2019 that Zantac (ranitidine) or generic versions caused cancer and other illnesses as a result of contamination with a carcinogen called NDMA.
Zantac was originally developed by GSK for gastrointestinal disorders in the early 1980s, but over the years around a dozen other companies were involved in the sale of the drug – including Sanofi, Boehringer, and Pfizer – both as a prescription-only therapy and an over-the-counter (OTC) medicine.
Boehringer came into the frame of the litigation after it bought rights to the OTC version of Zantac in the US in 2006, which were then transferred to Sanofi in 2017 as a result of an exchange deal in which Boehringer’s consumer health business was swapped with Sanofi’s animal health division.
According to Sanofi, Boehringer raised a dispute in the International Chamber of Commerce (ICC), seeking indemnification for potential liabilities, but this was rejected and the decision is final and cannot be appealed.
When news of the Zantac litigation first emerged, there was speculation that the defendant companies may end up negotiating settlements that could end up costing billions of dollars.
Since then, some key legal judgments have gone their way, including a US federal court ruling in December 2022 that found no reliable evidence that Zantac causes the alleged injuries, in line with the conclusions of regulators including the FDA and EMA.
That was followed in May by a supreme court ruling in Canada that concluded that there was clear evidence that neither ranitidine nor NDMA is associated with cancer risk. There has, however, been a small victory for the other side in California, where a judge recently denied GSK’s attempt to keep experts called by the plaintiffs out of the proceedings of a jury trial due to start next month.
According to Sanofi’s statement, “tens of thousands of claimants” have already abandoned their claims or withdrawn from the class-action suits, either filing in state court or not re-filing at all.
While the US federal court ruling is open to appeal, Sanofi maintains this would have a low probability of success and overall recent events have “significantly decreased the potential scope of the litigation.”
“There is no evidence of consumer harm from real-world use of Zantac as a result of any NDMA contamination,” insisted the drugmaker.
