by Jonathan Stempel
LONDON: GSK has been sued by an independent Connecticut laboratory, which accuses the drugmaker of defrauding the US government and taxpayers by hiding secrets. risk of cancer In Zantac, once a blockbuster heartburn drug.
In a whistleblower complaint filed on Monday, Valisure said GSK violated federal False Claims Act By hiding the risk for nearly four decades from Medicare, Medicaid and others health program Billions of dollars worth of prescriptions covered.
The New Haven-based lab said its testing in 2019 showed that Zantac, also known as ranitidine, can form a cancer-causing carcinogen called NMDA and is therefore “unsuitable for human consumption.”
It said GSK hid the same results from the US Food and Drug Administration, which approved Zantac in 1983.
In a complaint filed in Philadelphia, Valizure is seeking billions of dollars in damages from GSK, including a civil penalty of up to $11,000 per violation, where some of the British drugmaker’s operations are based.
Its lawyers also represent thousands of plaintiffs personal injury lawsuits Against GSK and other companies that sold ranitidine.
In a statement, GSK said it would defend against Valisure’s meritless lawsuit, and that the FDA had found the laboratory’s tests “scientifically flawed and unreliable.”
GSK also said that there is no consistent or reliable evidence that ranitidine increases the risk of cancer.
The False Claims Act allows whistleblowers to sue on behalf of the federal government and share in the recovery.
In a case filed under seal, Valizer first sued GSK in 2019 on behalf of the United States and more than two dozen states.
The federal government declined to join the suit in March, leaving Valisure to sue on its own.
Zantac became the world’s best-selling drug in 1988, and was one of the first drugs to top $1 billion in annual sales.
The FDA asked drugmakers in April 2020 to remove Zantac and generic counterparts from store shelves after NDMA was found in samples, which Valizer said was its testing.
Two years later, a federal judge dismissed nearly 50,000 Zantac claims after overhearing the plaintiffs’ scientific experts. Some of those cases are being appealed.
More than 70,000 private lawsuits over Zantac remained pending in US courts this month. Most are in Delaware state court, where a judge is considering whether the cases can proceed.
The first trial into Zantac’s link to cancer began this month in Chicago, and may end this week.
The case is US ex rel Valisure LLC v. GlaxoSmithKline PLC et al, US District Court, Eastern District of Pennsylvania, No. 19-04239.
(Reporting by Jonathan Stempel and Brendan Pearson in New York; Editing by Marguerita Choy and Stephen Coates)
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