GlaxoSmithKline LLC (GSK) recently requested from a Florida federal judge more information from the pharmacy, Valisure, so it can better prepare for Zantac trials that are consolidated in multidistrict litigation (MDL) and are scheduled to start in 2023.
The request for more information for pre-trial discovery to U.S. Magistrate Judge Bruce E. Reinhart was conducted via Zoom on Jan. 19, and relates to the alleged links between the heartburn drug and cancer, Law360.com reported.
In 2019, independent laboratory testing by Valisure revealed that ranitidine, the active, generic ingredient in Zantac, had the proclivity to mutate into a cancer-causing compound, N-nitrosodimethylamine (NDMA). Valisure then filed a citizen petition, requesting that the U.S. Food & Drug Administration (FDA) issue a recall for all ranitidine products.
The following year, the FDA issued a recall on ranitidine. All Zantac products—both prescription and over the counter—were removed from the market.
As of Feb. 1, 2022, 1,753 Zantac lawsuits have been assigned to the MDL. According to a law firm representing Zantac plaintiffs, tens of thousands of Zantac lawsuits have been filed without yet joining the MDL. In addition, Zantac lawsuits have been filed at the state level. Zantac trials held in state court may begin before the federal MDL, most likely in California.
GSK alleges that Valisure’s research was flawed yet nonetheless filed the 2019 citizen petition. Furthermore, GSK’s legal defense added that it was Valisure’s CEO, David Light, who filed the first Zantac suit. Light, GSK alleged, may have influenced Congressional, regulatory and public opinion on Zantac since he conducted interviews with major media outlets.
An attorney for GSK who urged the judge to have Valisure release information for discovery said that the pharmacy’s testing is “critical to the plaintiffs’ case” and the drugmakers should be able to issue subpoenas and request documents from the pharmacy, despite plaintiffs’ assurances that Valisure is not an expert in the case and its research and citizen petition will not be used,” per Law360.com.
The attorney for GSK added, “It’s almost like a bait and switch. It’s still in the master complaint, and it’s across the country referenced in the state cases as well. Our defenses include that this is ginned up litigation and the underlying science is almost a bait and switch at this point.”
Other Zantac makers named as defendants in the MDL include Sanofi, Pfizer, and Boehringer Ingelheim Pharmaceuticals, as well as generic-drug makers, retailers, distributors and active pharmaceutical ingredient makers.
According to Law360.com, the first Zantac trials in the MDL will be held in July 2023. Tens of thousands of Zantac claims have already been filed.
