GlaxoSmithKline (GSK) Plc, the UK-based pharmaceutical giant, is embroiled in a whistleblower lawsuit that could potentially cost the company billions of dollars.
The lawsuit, filed by Connecticut-based independent laboratory Valisure, alleges that GSK concealed the cancer risks associated with Zantac, its blockbuster heartburn medication, for decades while US government health programs, including Medicare and Medicaid, covered prescriptions for the antacid.
Valisure, the laboratory that first raised concerns about Zantac’s cancer risks in 2019, amended its complaint on Monday, claiming that GSK engaged in potential fraud by hiding the presence of NDMA, a probable carcinogen, in the drug.
If successful, the lawsuit would seek repayment of billions of dollars the government paid for Zantac, along with fines.
“Our argument is that every dollar the government — state or federal — paid for Zantac, was fraud,” said Brent Wisner of Wisner Baum in Los Angeles, one of Valisure’s attorneys in the case. Wisner added that the lawsuit “may rise to the level of posing an existential threat to GSK.”
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This whistleblower lawsuit is separate from the approximately 80,000 state suits brought by Zantac users who claim their cancers were caused by the drug contaminated with NDMA.
In response to the allegations, GSK stated that it will “vigorously defend itself” against what it considers a “lawsuit with no merit.”
GSK whistleblower claims drugmaker cheated US government over Zantac cancer risk https://t.co/RMaElMCOsu pic.twitter.com/8ic0gb4TVq
— Reuters U.S. News (@ReutersUS) May 21, 2024
The company further claimed that Valisure’s 2019 Zantac tests were “determined scientifically flawed and unreliable” by both the US Food and Drug Administration (FDA) and a federal judge in Florida.
However, it is important to note that Valisure used the FDA’s test method for detecting NDMA at the time of its initial findings. The agency later revised its method and did find elevated levels of the carcinogen in Zantac.
Valisure’s whistleblower case is unique in that it was not brought by company employees or insiders, but rather by the laboratory itself, which had non-public information about GSK when it discovered NDMA in Zantac.
The lab also provided its findings to the FDA several months before making them public.
Attorneys Brent Wisner and Jennifer Moore of Moore Law Group in Louisville, Kentucky, recently took on Valisure’s case.
The pair are well-known for their large verdicts against Bayer AG on behalf of individuals who claimed the company’s herbicide Roundup caused their cancers.
The litigation against Bayer has led to a significant decline in the German company’s share value and the departure of former CEO Werner Baumann.
As the whistleblower lawsuit against GSK unfolds, the pharmaceutical industry and the public will be closely watching the potential implications for the company and the future of Zantac, a drug that was once a blockbuster for the UK-based drugmaker.
