Sanofi SA, the maker of the drug Zantac, has lost an attempt to dismiss proposed class actions by those who used its heartburn medication and are seeking compensation or medical monitoring because it contains a known carcinogen, NDMA.  U.S. Food and Drug Administration (FDA) announced it was investigating whether Zantac causes “levels of NDMA to rise in users’ bodies, leading to cancer.”  This announcement triggered the sequential lawsuits.U.S. District Judge Robin Rosenberg, nominated by former President Barack Obama, in West Palm Beach, Florida, allowed separately the proposed class actions to proceed against Sanofi, GlaxoSmithKline, Boehringer Ingelheim and Pfizer Inc, all of which sold Zantac before the sweeping recalls that begin in fall 2019.“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested.  However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research stated of the initial recall.

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The lawsuits are part of the multidistrict litigation (MDL) over Zantac and ranitidine.  More than 800 suits are currently pending and include plaintiffs who say that developed cancer a result of use.  There are, in totally, more than 110,000 claims against the drugmakers that are seeking compensation and/or damages.The plaintiffs’ attorneys include Tracy Finken of Anapol Weiss, Robert Gilbert of Kopelowitz Ostrow Ferguson Weiselberg Gilbert, Michael McGlamry of Pope McGlamry, and Adam Pulaski of Pulaski Kherkher, all of whom submitted a joint statement applauding Judge Rosenberg’s rulings.The plaintiffs and their attorneys essentially accused the drugmakers of “engaging in a decades-long scheme to conceal the dangers and risks associated with Zantac use, despite research that linked ranitidine, the generic name of the drug, to a probable carcinogen, N-nitrosodimethylamine (NDMA).”  The statement also said, “We look forward to holding them accountable.”Pfizer, represented by Joseph Petrosinelli of Williams & Connolly, said it “believed the plaintiffs had not adequately pleaded their claims and will continue to defend itself against them.”  The others did not comment.The MDL also includes two proposed class actions by individuals who claimed they were duped into buying brand-name “ranitidine” seeking refunds for their purchases and by plaintiffs who sought to recover the costs of testing to detect cancer.  The medical monitoring claims, brought under state laws, will be pursued through the states in which the plaintiffs reside.Drugmakers including GSK and Sanofi had argued that the plaintiffs “had failed to allege a threshold level of NDMA exposure that would create a significantly increased risk of cancer that would warrant monitoring or specify how frequently they used the drugs.”However, in supporting her decision, the judge wrote, “The allegations are sufficient to plead ‘significantly increased risk’ at this time,” and she rejected assertions that the state law claims were preempted by federal law because state labeling requirements would be different than FDA (federal) requirements.  Rosenberg wrote, “The plaintiffs’ claims were not barred to the extent they were enforcing state laws requiring accurate, non-misleading labels that paralleled federal law.”

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Sanofi, GSK can't escape Zantac proposed class actions, judge rulesZantac RecallSanofi, GSK, Pfizer and Boehringer must face Zantac class-action lawsuits, court rules