A Florida magistrate judge has ruled that Zantac (ranitidine) drugmakers are not entitled to receive discovery from Valisure. The independent pharmacy found high levels of the toxic NDMA – N-nitrosodimethylamine – in Zantac. Valisure’s alarming findings alerted FDA to the problem.Last week, the judge denied GlaxoSmithKline’s subpoenas which sought more information from Valisure LLC. In the multidistrict litigation set in Florida over the heartburn drug Zantac, the judge found that the information GSK sought in the subpoenas has limited importance to the litigation.
U.S. Magistrate Judge Bruce E. Reinhart said he had “serious questions” about whether the evidence GSK sought in its subpoenas against Valisure and investor/attorney Michael Bretholz is relevant to the claims. The Zantac MDL court was set up to explore the cancer link between Zantac and its generic equivalent ranitidine.
GSK sought information about Valisure’s testing of ranitidine and the citizen petition Valisure filed in 2019. That petition requested that the U.S. FDA recall all products containing ranitidine. The petition claimed the drug had a propensity to form the cancer-causing chemical N-nitrosodimethylamine, or NDMA.
A GSK attorney had argued that Valisure’s testing is “critical to the plaintiffs’ case” and the drugmakers should be able to get additional documents form the pharmacy.
Judge notes Valisure not Expert in the Case
Judge Reinhart’s order noted that the plaintiffs assured the court that Valisure is not an expert witness in the case, that the plaintiffs 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,” said Judge Reinhart; “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.”
He said 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. The agency pulled all prescription and OTC ranitidine drugs from the market in April 2020.
Zantac Lawsuits
The lawsuits in the MDL accuse Sanofi SA, Pfizer Inc., Boehringer Ingelheim Pharmaceuticals Inc. and GSK – along with generic-drug makers, retailers, distributors, and active drug ingredient makers – of false advertising, failure to warn, and other claims associated with NDMA in the medication.
The FDA pulled Zantac amid concerns that when stored in higher than room temperature, ranitidine can degrade and result in exposure to unacceptable levels of NDMA. While the FDA has set an allowable daily limit of 96 nanograms of NDMA, researchers have found more than 3 million nanograms in a single dose of Zantac.
Zantac Trial Dates
Initial bellwether trials in the MDL are scheduled to begin in July 2023.
A lawyer who represents Zantac clients said, “Judge Reinhart attentively engaged with all parties during oral argument, keenly teased out the nuances, and upheld the limits of Rule 45 (which limits discovery to relevant issues). 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 from Law 360 for comment.
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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by Matthews & Associates
