Sanofi Settles Zantac Litigation in U.S. State Courts
April 4, 2024
Sanofi has reached a settlement to resolve around 4,000 personal injury lawsuits linked to its heartburn medication, Zantac, in all U.S. state courts except for Delaware. This move comes after the medication faced allegations that it could cause cancer, leading to widespread litigation. The specifics of the settlement, finalized last month, are under wraps and pending approval from individual plaintiffs, a process Sanofi anticipates will be lengthy.
The litigation’s resolution is expected to have no significant financial impact on Sanofi. It suggests the company managed a favorable settlement, reflecting its limited involvement in marketing Zantac and its robust legal defenses. Initially developed by GSK and approved in 1983, Zantac was acquired by Sanofi in 2016 from Boehringer Ingelheim. The drug was voluntarily withdrawn from the market in 2019 following reports from an online pharmacy about the potential carcinogenic effects of its main ingredient, ranitidine. Subsequent FDA directives in 2020 led to the removal of ranitidine-containing Zantac products nationwide, though Zantac has since reemerged with a new, ranitidine-free formula.
While Sanofi and other companies also faced federal lawsuits, a significant ruling in Florida in 2022 dismissed the scientific basis of claims linking Zantac to cancer, effectively releasing them from some 50,000 federal cases. However, state-level claims remain ongoing, particularly in Delaware, with about 75,000 cases.
GSK, with a more extended association with Zantac, continued to settle individual cases to avoid jury trials and reported facing 79,000 outstanding cases as of last year. Despite these legal challenges, Sanofi and other involved companies have consistently denied any causal link between Zantac and cancer, attributing their decision to settle not to the merits of the claims but to the desire to avoid further litigation expenses and distractions. This settlement strategy underscores a complex landscape of legal, scientific, and regulatory considerations surrounding pharmaceutical product safety and litigation.
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[Source: Fierce Pharma, April 4th, 2024]
