A whistleblower lab has filed a lawsuit against GSK, claiming that the drugmaker concealed the cancer risk in Zantac heartburn pills for decades.
The lab claims that 2019 testing showed that Zantac, which is also known as ranitidine, could end up forming NMDA, a cancer-causing carcinogen. This ultimately made the drug unfit for humans to consume.
Concealed Cancer Risks in Zantac?
This whistleblower lawsuit may potentially cost GSK Plc up to billions of dollars. It was filed by the laboratory that showed that probable carcinogens could be present in Zantac, which is a heartburn medication that had become a blockbuster.
In the recently filed whistleblower complaint, Valisure said that GSK went against the federal False Claims Act by disclosing the risks of the drug for almost 40 years. This may have come while billions of dollars worth of prescriptions were covered by Medicaid, Medicare, and other programs.
The lab, based in New Haven, claimed that 2019 testing revealed the possible formation of the cancer-causing carcinogen. It also said that GSK hid the same results from the US Food and Drug Administration, which granted approval to Zantac back in 1983.
With this, Valisure seeks billions of dollars worth of damages from the drugmaker. This amount includes civil fines that go up to $11,000 for each violation. The lawyers of the lab also represent up to thousands of plaintiffs within personal injury lawsuits against the drugmaker and other firms that have distributed the medication.
GSK shared in a statement that it will defend against the "meritless lawsuit" filed by Valisure. They also said that the FDA has found the tests scientifically unreliable and flawed.
The drugmaker also maintains that there is no reliable or consistent proof that Zanatac could heighten cancer risk.
The first lawsuit filed by Valisure against GSK was in 2019. This was done on behalf of the US and over 24 states. Such a case was filed under seal.
However, in March, the federal government declined participating in the lawsuit. This left Valisure to independently sue.
In April 2020, the FDA instructed drugmakers to recall Zantac and their genetic variants after the discovery of NDMA in samples.
However, after two years, roughly 50,000 Zantac claims were dismissed by a federal judge. This came after the rejection of the scientific experts of the plaintiffs.
In US courts this month, over 70,000 private lawsuits regarding Zantac are still pending.
Zantac Heartburn Pills
Zantac is mainly a prevention and treatment for heartburn and other symptoms that are due to excessive stomach acid. It works to reduce acid amounts within the stomach.
In 1988, Zantac heartburn pills became the best-selling medicine in the world. It also became one of the first drugs to reach $1 billion worth of annual sales.
The first trial regarding the potential cancer link in Zantac started this month in Chicago. It may be finished by this week.
Earlier this month, Pfizer agreed to pay as much as $250 million to resolve thousands of lawsuits related to Zantac.
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