GlaxoSmithKline (GSK) is embroiled in a lawsuit filed by an independent Connecticut laboratory, Valisure, which accuses the drugmaker of defrauding the U.S. government and taxpayers by concealing cancer risks associated with Zantac, a once-popular heartburn drug.

In the whistleblower complaint filed on Monday, Valisure alleges that GSK violated the federal False Claims Act by hiding the risks of Zantac for nearly four decades, while Medicare, Medicaid, and other health programs covered billions of dollars of prescriptions.

According to Valisure, its testing in 2019 revealed that Zantac, also known as ranitidine, could form a cancer-causing carcinogen called NMDA, rendering it "unfit for human consumption." The lab claims that GSK concealed this information from the U.S. Food and Drug Administration (FDA), which approved Zantac in 1983.

Valisure is seeking billions of dollars in damages from GSK, including civil fines of up to $11,000 per violation, in a complaint filed in Philadelphia, where some of the British drugmaker's operations are based. The lab's lawyers also represent thousands of plaintiffs in personal injury lawsuits against GSK and other companies that have sold ranitidine.

In response, GSK stated that it would defend against Valisure's "meritless" lawsuit, emphasizing that the FDA has found the lab's tests "scientifically flawed and unreliable." GSK maintains that there is no consistent or reliable evidence that ranitidine increases cancer risks.

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