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GSK whistleblower claims drugmaker cheated US government over Zantac cancer risk

An independent laboratory in Connecticut has filed a lawsuit against GSK, alleging that the pharmaceutical company hid cancer risks associated with Zantac, a popular heartburn medication, which resulted in defrauding the U.S. government and taxpayers.

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A whistleblower complaint submitted on Monday by Valisure alleges that GSK breached federal law by concealing the dangers of its product for approximately 40 years, during which time government-funded healthcare programs, including Medicare and Medicaid, reimbursed billions of dollars in prescriptions.

A research facility in New Haven announced that its 2019 investigation discovered that Zantac, also referred to as ranitidine, has the potential to generate a cancer-inducing substance called NMDA, rendering it unsafe for human use.

GSK was accused of hiding the same information from the U.S. Food and Drug Administration, which granted Zantac in 1983.

Valisure is pursuing a massive damages claim against GSK, potentially amounting to billions of dollars. The claim includes penalties of up to $11,000 for each infringement, as outlined in a lawsuit filed in Philadelphia, a city where the UK-based pharmaceutical company maintains a significant presence.

The firm’s attorneys also advocate for numerous individuals who have filed personal injury claims against GSK and other companies involved in the sale of ranitidine.

GlaxoSmithKline has announced its intention to vigorously contest the lawsuit filed by Valisure, which the company believes lacks substance. Additionally, GSK pointed out that the FDA has deemed Valisure’s testing methods flawed and lacking in credibility. Furthermore, the company emphasized that there is still no conclusive or trustworthy data to suggest that ranitidine is linked to an increased risk of cancer.

Whistleblowers are allowed to file lawsuits on behalf of the federal government under the False Claims Act and are entitled to a portion of any funds recovered. In 2019, Valisure initiated legal action against GSK on behalf of the United States and multiple states, with the case initially kept confidential. The federal government chose not to participate in the lawsuit in March, which resulted in Valisure continuing with the legal proceedings independently.

In 1988, Zantac achieved great success as the most widely among the first medications to surpass $1 billion in yearly sales. Following the discovery of NDMA in samples by Valisure, the FDA requested drug manufacturers in April 2020 to remove Zantac and its generic versions from retail shelves.

Approximately 50,000 Zantac claims were thrown out by a federal judge two years later due to the rejection of the plaintiffs’ scientific experts. Some of these cases are currently under appeal. Over 70,000 private lawsuits related to Zantac are still awaiting resolution in U.S. courts. Most of these cases are in a Delaware state court, where a judge considers whether they can move forward.

A landmark court case examining the alleged connection between Zantac and cancer commenced in Chicago earlier this month and is expected to conclude within the next few days.

The lawsuit is U.S. ex-rel Valisure LLC against GlaxoSmithKline Pl, filed in the U.S. District Court for the Eastern case number 19-04239.

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