As a federal judge in Florida considers which expert testimony to admit in the Zantac multidistrict litigation (MDL), plaintiffs have filed an expedited motion, seeking permission to file a supplemental report that includes data from a recently-published study that suggests ranitidine, the H2-blocking drug known by the brand name Zantac, is associated with four different types of cancer, Law360 reported.
If granted, the study would allow five expert witnesses who weighed in on the study to file supplemental reports in Daubert hearings, which weighs the admissibility of evidence in the pretrial phase.
The study, published Sept. 30 in the International Journal of Environmental Research and Public Health, links ranitidine to an increased risk of lung, liver, pancreatic and stomach cancer.
Plaintiffs' attorneys described the study as "highly relevant" because it offers a “high-quality nationwide and population-based database with a long follow-up period to assess the relationship between the cumulative individual cancer incidence and long-term ranitidine use,” according to the motion.
Beginning in September 2019, the FDA alerted consumers that Zantac contained high levels of N-Nitrosodimethylamine (NDMA). The FDA’s safe limit for daily exposure to NDMA is 96 nanograms. Laboratory testing by the FDA and the independent online pharmacy, Valisure, revealed that Zantac contained as high as 3 million nanograms of NDMA. High levels of the compound have been associated with a higher risk of cancer.
The FDA issued a full recall of ranitidine-based products on April 1, 2020.
The plaintiffs in the Zantac MDL, all of whom claim they developed one of five specific types of cancer—bladder, esophageal, gastric, liver or pancreatic—allege that taking Zantac for several years caused them to develop cancer. Other plaintiffs who filed personal injury claims for other types of cancer have sued makers, distributors and retailers of Zantac/ranitidine in state court.
Attorneys representing cancer patients in the Zantac MDL who filed the expedited motion have sued GlaxoSmithKline. Other named defendants include Sanofi, Pfizer and Boehringer Ingelheim. The Zantac MDL was formed in 2020 in the Southern District of Florida and is being presided over by Judge Robin L. Rosenberg.