The Delaware Supreme Court rejected the legitimacy of expert testimony linking the heartburn drug Zantac to cancer, in a major win for makers of the product.
In a unanimous ruling Thursday, the state’s highest court agreed with the argument of companies including GSK Plc, Pfizer Inc. and Boehringer Ingelheim Pharmaceuticals that Superior Court Judge Vivian Medinilla erred in allowing the testimony and letting the cases proceed to trial.
“A trial judge must act as the gatekeeper of expert testimony and should not dismiss challenges to the sufficiency or reliability of an expert opinion by viewing the disputes as questions for the jury to weigh,” the state’s highest court said in a 46-page ruling.
Last year, GSK offered more than $2 billion to settle its Zantac liability, while Pfizer and French drugmaker Sanofi have pushed to resolve thousands of suits. Boehringer’s pharmaceuticals unit has settled only a small share of the cases against it.
Representatives of GSK, Pfizer, Sanofi and Boehringer did not immediately respond to requests for comment on the ruling.
The drugmakers had challenged a decision by Medinilla, who found the plaintiff’s expert witnesses appropriately reviewed evidence about whether Zantac can cause cancer. The supreme court sent the case back to Medinilla for her to take another look at the expert testimony.
While judges in other states including California and Illinois had signed off similar expert testimony, the drugmakers said Medinilla should have followed the lead of a federal judge in Florida, who in 2022 rejected the cancer evidence as unreliable.
Ex-Zantac users have sued branded and generic drugmakers that made the heartburn medicine alleging the product caused breast, stomach and colon cancer, among others. Plaintiffs contend the companies knew ranitidine — the drug’s active ingredient — turned into the potential carcinogen NDMA if not kept cool. In 2020, the US Food and Drug Administration asked companies to remove all ranitidine-based products.
The case is IN RE Zantac Litigation, No. 255, 2024, Delaware Supreme Court (Dover).
Photo: Photographer: Drew Angerer/Getty Images
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