Pfizer Settles 10,000 Zantac Lawsuits for Up to $250 Million
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Pfizer has agreed to settle lawsuits related to its Zantac heartburn treatment, which claim the over-the-counter medication caused cancer.
The pharmaceutical giant will pay up to $250 million to resolve 10,000 lawsuits brought on by former users of the now-recalled drug, according to the Financial Times.
Routine batch testing in 2019 revealed that Zantac, containing the active ingredient ranitidine, had carcinogenic N-nitrosodimethylamine (NDMA). In response, the U.S. Food & Drug Administration (FDA) asked drug manufacturers to pull products containing ranitidine from the market.
New York-based Pfizer sold Zantac between 1998 and 2006. According to a 2022 statement from Pfizer, “the withdrawal of Zantac products from the market in 2019 and 2020 did not involve any Pfizer products.”
Pfizer recently told the Financial Times (FT) that it continues to “vigorously defend” against the Zantac lawsuits.
“The company is confident that its Zantac products, which were reviewed and approved by the [US Food and Drug Administration], did not cause cancer when used as directed,” Pfizer added.
Lawsuits Affected Numerous Drug Makers
Tens of thousands of individuals have filed personal injury lawsuits against drugmakers involved with Zantac cancer allegations. The majority are in a Delaware MDL, but there are a few cases in California, Illinois and Pennsylvania, FT reported.
Pfizer’s settlement announcement comes on the heels of French drugmaker Sanofi’s decision to settle about 4,000 Zantac lawsuits, Fierce Pharma reported in April. Sanofi did not disclose the specifics of its settlement, but reports from Bloomberg suggest it would pay $100 million, which is about $25,000 to each claimant.
“The amount that would be paid reflects the limited time during which Sanofi marketed Zantac and the strong defenses available to Sanofi in these cases,” the company told Fierce Pharma in an email. “The resolution of these cases will have no material financial impact.”
While some Zantac lawsuits have reached settlements, a significant number remain in the legal process. This includes claims against GlaxoSmithKline (GSK), the first company that brought Zantac to market in 1983.
Zantac Whistleblower Lawsuit
The latest blow to the Zantac lawsuits involves a whistleblower lawsuit from Valisure.
Valisure, a quality assurance lab that first raised concerns about Zantac in 2019, accuses GSK of a decades-long cover-up. The lawsuit alleges that GSK knew about the potential presence of NDMA in Zantac but withheld this information to secure the drug’s approval in 1983. Valisure claims GSK used “false data” and concealed the connection with prior studies.
GSK denies the accusation.
A GSK spokesperson told Fierce Pharma that the lawsuit was meritless and highlighted how the FDA and a federal judge had determined that Valisure’s testing methods were unreliable. They emphasize that no scientific consensus links Zantac to an increased cancer risk. This contradicts Valisure’s claims, raising the stakes in the ongoing legal battle.