Ten of the plaintiff-chosen experts expected to testify in litigation over whether the heartburn drug Zantac caused cancer will be reviewed by the Delaware Supreme Court, raising the possibility that none of them might be allowed to participate in trial.
The decision could impact nearly 75,000 cases alleging that Zantac (ranitidine) contained a carcinogen called N-nitrosodimethylamine (NDMA) and caused a range of cancers. GSK, the original maker of Zantac, has maintained that “there is no consistent or reliable evidence” that Zantac increases the risk of cancer. Pfizer, Sanofi and Boehringer Ingelheim also marketed ranitidine products and are named as defendants.
Earlier this year, a Delaware Superior Court denied the drugmakers’ attempt to exclude plaintiff’s expert testimony. But the Delaware Supreme Court agreed to take up the question, and Justice Christopher Griffiths said in an order that a ruling in favor of defendants could lead to a resolution “for some or all of the almost 75,0000 claims filed in Delaware.”
“We are pleased the Delaware Supreme Court has granted permission for the companies to immediately appeal the trial court’s ruling and look forward to presenting our argument that the opinions of all of plaintiffs’ causation experts must be excluded as they do not meet the standards required for expert testimony under Delaware law,” a Pfizer spokesperson said Wednesday.
The spokesperson added that Pfizer “has not sold a Zantac product in more than 15 years and did so only for a limited period of time.”
Zantac was first approved as a prescription medicine for heartburn in 1983, leading to record sales and eventually several over-the-counter versions. However, the FDA requested its removal from the market in 2020 over NDMA contamination. The agency said at the time that it didn’t observe unacceptable NDMA levels in many of the samples that were tested, but levels in some products may increase over time and when stored at higher temperatures.
The Delaware Supreme Court will conduct its review as the Zantac cases proceed in lower court. GSK said in a statement on Tuesday that it “will press additional defenses in the litigation, including failure to provide proof of use and proof of diagnosis requirements recently ordered by the Court.”