Drugmakers Won’t Get Discovery From Valisure In Zantac MDL

Drugmakers Won’t Get Discovery From Valisure In Zantac MDL

Magistrate judge on Friday quashed GlaxoSmithKline’s subpoenas for more information from pharmacy Valisure LLC in multidistrict litigation over heartburn drug Zantac after finding the information sought in the subpoenas has limited importance to the litigation. U.S. Magistrate Judge Bruce E. Reinhart said he had “serious questions” as to whether the evidence covered by the subpoenas against Valisure and Michael Bretholz, a business owner who is also a Valisure investor, is relevant to the claims in the MDL that link Zantac and its generic equivalent ranitidine to various cancers. GSK sought information about Valisure’s testing of the drug and the citizen petition the pharmacy filed in 2019 requesting that the U.S. Food and Drug Administration recall all products containing ranitidine. Valisure said in the petition that the drug had a propensity to form the cancer-causing chemical N-nitrosodimethylamine, or NDMA. At a hearing earlier this month, GSK’s attorney Patrick Oot said Valisure’s testing is “critical to the plaintiffs’ case” and the drugmakers should be able to get additional documents form the pharmacy. But Judge Reinhart pointed out in his order that the plaintiffs assured the court that Valisure is not an expert witness in the case and that they are not relying on Valisure’s testing. “It is not clear that plaintiffs will rely on Valisure testing, directly or indirectly, to prove their claims,” the judge said. “Therefore, the additional requested evidence has limited, if any, importance to the issues at stake in this MDL.” The judge added that even if the subpoenaed evidence were relevant, it is “disproportionate to the needs of the case.” The drugmakers already have enough evidence that would allow them to make an adequate circumstantial case about their theory that Valisure waged a campaign to influence public opinion and the FDA, which pulled all prescription and over-the-counter ranitidine drugs from the market in April 2020. The suits in the MDL accuse Sanofi SA, Pfizer Inc., Boehringer Ingelheim Pharmaceuticals Inc. and GSK — as well as generic-drug makers, retailers, distributors and active pharmaceutical ingredient makers — of false advertising, failure to warn and other claims associated with the alleged discovery of NDMA in the medication. The FDA pulled the drug over concerns that when stored at temperatures higher than room temperature, ranitidine could degrade and result in exposure to unacceptable levels of NDMA. The FDA has set an allowable daily limit of 96 nanograms of NDMA, but researchers have found more than 3 million nanograms in a dose of Zantac. Initial bellwether trials in the MDL are slated to start in July 2023. Sean Burstyn, who represents Bretholz, said he and his client are “grateful that the defendants’ ‘everything under the sun’ approach to discovery was rejected in its entirety.” “Judge Reinhart attentively engaged with all parties during oral argument, keenly teased out the nuances, and upheld the limits of Rule 45,” Burstyn said. “Had the defendants been willing to engage in reasonable compromise at the outset, we would have avoided the significant costs, fees and expenses for which we shall promptly seek reimbursement.” Attorneys for GSK and Valisure did not respond to requests for comment. The plaintiffs are represented by Tracy A. Finken of Anapol Weiss, Robert C. Gilbert of Kopelowitz Ostrow Ferguson Weiselberg Gilbert, Michael L. McGlamry of Pope McGlamry PC and Adam Pulaski of Pulaski Kherkher PLLC. Valisure is represented by William Egan of Robinson & Cole LLP. Bretholz is represented by Sean A. Burstyn of Burstyn Law PLLC. GlaxoSmithKline is represented by Patrick Oot of Shook Hardy & Bacon LLP and Mark Cheffo, Judy Leone, Will Sachse and Lindsey Cohan of Dechert LLP. Sanofi is represented by Anand Agneshwar, Daniel S. Pariser and Paige H. Sharpe of Arnold & Porter and Loren Brown, Ilana H. Eisenstein, Rachel A.H. Horton and Matthew A. Holian of DLA Piper. Boehringer Ingelheim Pharmaceuticals Inc. is represented by Andrew T. Bayman of King & Spalding LLP. Pfizer is represented by Joseph G. Petrosinelli, M. Elaine Horn and Jessica B. Rydstrom of Williams & Connolly LLP. The case is In re: Zantac (Ranitidine) Products Liability Litigation, case number 9:20-md-02924, in the U.S. District Court for the Southern District of Florida.

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