Pharmaceutical giant GSK has agreed to pay up to $2.2 billion to resolve tens of thousands of product liability lawsuits in the United States. These cases allege that the company’s now-banned heartburn medication, Zantac, was responsible for causing cancer. The settlement, announced on 9 October 2024, will cover more than 80,000 lawsuits that have been filed against the company. The agreements were reached with 10 law firms representing 93% of all plaintiffs involved in the litigation over GSK’s sale of Zantac. These firms are reportedly advising their clients to accept the terms of the settlement, which remain confidential.
Additionally, GSK has tentatively resolved a lawsuit brought by Valisure, an independent laboratory based in Connecticut. The company has agreed to pay $70 million to settle the whistleblower case, which was originally filed in 2019. Valisure’s claim followed routine testing that linked Zantac to NDMA, a known carcinogen. The lawsuit accused GSK of violating the federal False Claims Act by concealing the drug’s risks for over 40 years.
In its statement, GSK made clear that the settlements do not imply any admission of liability. The company emphasized that it “strongly believes” settling is the best long-term option for both GSK and its shareholders. It also highlighted that 16 studies have failed to show any reliable link between Zantac and cancer.
Zantac, or ranitidine, was initially developed by GSK’s predecessors in the 1970s and was first approved by U.S. regulators in 1983. The drug quickly became a top-selling medication worldwide, reaching over $1 billion in annual sales within five years. However, in 2019, Valisure’s testing raised concerns that the active ingredient in Zantac could break down into NDMA, especially when exposed to heat. As a result, the U.S. Food and Drug Administration (FDA) ordered the drug to be pulled from shelves in April 2020. Shortly thereafter, GSK faced a flood of lawsuits from patients who had taken the drug and later developed cancer. The UK also took similar actions in 2019, recalling four versions of Zantac as a precaution.
In February 2020, the Southern District of Florida established a Judicial Panel on Multidistrict Litigation (MDL) to manage the growing number of Zantac-related cases, which by that time had reached 50,000. However, in December 2022, a federal judge in Florida ruled that there was insufficient scientific evidence to prove a direct link between Zantac and cancer, leading to the dismissal of many of those cases. While around 14,000 cases remain under appeal and are excluded from GSK’s current settlement, the company has resolved the majority of claims.
Other pharmaceutical companies have also been impacted by the Zantac recall. Since GSK’s patent expired in 1997, companies such as Pfizer, Boehringer Ingelheim, and Sanofi have sold Zantac in the U.S. As a result, over 130,000 lawsuits have been filed against these firms. Pfizer has recently agreed to settle about 10,000 cases in state court, while Sanofi settled roughly 4,000 cases earlier in 2024.
Zantac is not the only instance of large-scale pharmaceutical litigation in the U.S. Johnson & Johnson, for example, continues to face tens of thousands of lawsuits over claims that its talcum powder caused cancer. As of October 2024, the company is still dealing with more than 58,000 cases consolidated in MDL. Similarly, Danish pharmaceutical company Novo Nordisk is currently defending against over 1,000 cases alleging its Ozempic drug causes stomach paralysis.
