GSK has been sued for defrauding taxpayers and the U.S. Government by hiding Zantac Cancer risk.. Zantac was once a popular heartburn medication.
Valisure, in a whistleblower report filed on Monday by Valisure, said GSK had violated the federal False Claims Act, hiding the drug’s risks for almost four decades, while Medicare, Medicaid, and other health programs paid billions of dollars to cover prescriptions.
New Haven’s lab reported that its tests in 2019 showed Zantac (also known as ranitidine) could form a carcinogen known as NMDA and, therefore, was “unfit for consumption by humans.”
The report said GSK hid the same results from the U.S. Food and Drug Administration (FDA), which approved Zantac in 1983.
In a lawsuit filed in Philadelphia, where some of GSK’s operations are located, Valisure has sought billions in damages, including civil penalties of up to $11,000 for each violation.
The firm’s attorneys also represent thousands in lawsuits for personal injuries against GSK and other companies that have sold ranitidine.
GSK stated that it would defend itself against Valisure’s unjustified lawsuit and that the FDA had found the lab’s tests to be “scientifically flawed” and “unreliable.” GSK said that there is no evidence to support the claim that ranitidine causes cancer.
False Claims Act allows whistleblowers to sue the federal government on their behalf and share in any recoveries. In 2019, Valisure filed a lawsuit under seal for more than two dozen U.S. states and the United States.
In March, the federal government refused to join Valisure’s lawsuit. In 1988, Zantac was the best-selling medicine in the world and one of the first to reach $1 billion in sales.
In April 2020, the FDA requested that drugmakers remove Zantac and its generic equivalents from store shelves after Valisure claimed to have tested positive for NDMA.
Two years later, a federal judge rejected the plaintiffs’ scientific experts. Some of these cases are currently being appealed.
At the end of this month, more than 70,000 Zantac lawsuits were pending in private courts in the U.S. Most lawsuits are filed in Delaware state courts, where a judge decides whether to allow them to proceed.
The first trial in Chicago on Zantac and cancer may conclude this week. U.S. ex. rel Valisure LLC v GlaxoSmithKline Plc et al., U.S. District Court for the Eastern District of Pennsylvania, 19-04239.
