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(Reuters) - Drugmakers including Sanofi SA lost a bid to dismiss proposed class actions by consumers who bought or used the heartburn drug Zantac and are seeking refunds or medical monitoring because the medication contains a probable carcinogen.
U.S. District Judge Robin Rosenberg in West Palm Beach, Florida, in separate rulings Wednesday allowed the proposed class actions to proceed against Sanofi, GlaxoSmithKline, Boehringer Ingelheim and Pfizer Inc, which sold Zantac products in the years before widespread recalls of the drug began in 2019.
The lead lawyers for the plaintiffs--Tracy Finken of Anapol Weiss, Robert Gilbert of Kopelowitz Ostrow Ferguson Weiselberg Gilbert, Michael McGlamry of Pope McGlamry, and Adam Pulaski of Pulaski Kherkher--hailed the rulings in a joint statement.
They 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).
"We look forward to holding them accountable," the lawyers said.
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.
GSK declined to comment, and the other defendants did not respond to requests for comment. They are being represented by lawyers at Arnold & Porter Kaye Scholer, Dechert and King & Spalding.
The lawsuits are part of the broader multidistrict litigation over Zantac and ranitidine after various drugmakers including the defendants launched recalls of their products in 2019.
More than 800 lawsuits are now pending before Rosenberg, including lawsuits by people who say they developed cancer after using the medication. A registry used to track filed and unfiled cases by law firms includes 110,000-plus claims.
The lawsuits were filed after the U.S. Food and Drug Administration announced it was investigating whether the drug causes levels of NDMA to rise in users' bodies. In April 2020, the FDA requested all manufacturers withdraw their products from the market.
The MDL also encompasses two proposed class actions by people who claimed they were deceived into buying brand-name ranitidine seeking refunds and by plaintiffs who sought to recover the costs of testing to detect if they developed cancer.
The medical monitoring claims, brought under various states' laws, would be pursued through several state- and defendant-specific classes.
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.
But Rosenberg said no threshold was needed. Noting the plaintiffs cited studies and the FDA's recall request to support their claims, she concluded the "allegations are sufficient to plead 'significantly increased risk' at this time."
The judge also allowed plaintiffs to keep pursuing in the other case claims they suffered economic losses under various state laws, such as violations of state consumer protection statutes, unjust enrichment and breach of quasi-contract.
Rosenberg rejected arguments by the brand-name companies that the state-law claims were preempted by federal law because they would impose labeling requirements inconsistent with FDA labeling rules.
Rosenberg said the plaintiffs' claims were not barred to the extent they were enforcing state laws requiring accurate, non-misleading labels that paralleled federal law.
The case is In re Zantac (Ranitidine) Products Liability Litigation, U.S. District Court for the Southern District of Florida, No. 9:20-md-02924.
For the plaintiffs: Tracy Finken of Anapol Weiss; Robert Gilbert of Kopelowitz Ostrow Ferguson Weiselberg Gilbert; Michael McGlamry of Pope McGlamry; and Adam Pulaski of Pulaski Kherkher
For Sanofi: Anand Agneshwar of Arnold & Porter Kaye Scholer
For GlaxoSmithKline: Marc Cheffo of Dechert
For Pfizer Inc: Joseph Petrosinelli of Williams & Connolly
For Boehringer Ingelheim: Andrew Bayman of King & Spalding