GSK is currently being sued by Valisure, an independent lab based in Connecticut, which claims that the company defrauded the US government by falsely informing that Zantac, its once-popular heartburn medication, contains cancer risks. The whistleblower stated in his complaint that GSK impeded the government from knowing that these solutions entailed severe dangers for almost four decades while billions of dollars were spent by federal health programs on prescriptions involving Zantac.
Valisure, a New Haven company, revealed that its labs in 2019 determined that Zantac, or ranitidine, could produce NDMA—a recognized carcinogen—and was unsafe for human consumption. The lab alleges that GSK hid similar findings from the FDA, which approved Zantac in 1983.
From a legal point of view, the lab filed the lawsuit in a Philadelphia court and demanded billions of dollars in compensation from GSK, including civil penalties of up to $11,000 per violation. Valisure also represents many clients in product liability cases against GSK and other manufacturers of ranitidine.
GSK has stated it will vigorously defend against Valisure’s claims, labeling the lawsuit as baseless. The company noted that the FDA has deemed Valisure’s testing techniques as inefficient and unsupported by scientific evidence, asserting that the proof of ranitidine being a carcinogen is inconclusive.
In the FCA (False Claims Act), whistleblowers are allowed to bring their cases to court in the name of the federal government and be provided with a cut for their service. Notably, Valisure first sued GSK in 2019 seeking class action status on behalf of the federal government and more than 20 states. Although the governments did not join in March, Valisure is proceeding solo.
Zantac, which in 1988 was the annual sales record holder as the world’s top-selling drug and one of the first to hit $1 billion in sales, was pulled from store shelves in April 2020 after the FDA received reports that NDMA was detected in samples following a test conducted by Valisure. More precisely, a federal judge dismissed approximately 50,000 Zantac cases in 2022, stating that the plaintiffs failed to present adequate scientific evidence. Some of these cases are already on appeal.
At this moment, approximately 70,000 private actions related to the product have been filed in US courts, a majority of which are still in the court of Delaware where a judge is yet to rule on whether the cases can proceed. Moreover, the first trial regarding possible cancer risks stemming from the product was recently launched in Chicago and is set to start soon.
