GSK announced on Thursday that it will pay as much as $2.2bn (£1.68bn) to settle approximately 80,000 U.S. lawsuits over claims that a discontinued form of its popular heartburn medication Zantac was linked to cancer. This settlement covers 93% of all cases filed in U.S. courts and is part of the company’s broader effort to resolve lingering legal disputes.
The company’s decision to settle follows extensive legal proceedings, though GSK maintained that there is "no consistent or reliable evidence" that Zantac’s active ingredient, ranitidine, directly causes cancer. The heartburn drug, once a top seller worldwide, was pulled from shelves in 2020 after regulators raised concerns that ranitidine could degrade into a cancer-causing substance when exposed to high temperatures.
As part of the settlements, GSK will also pay $70 million to settle a whistleblower lawsuit in which a laboratory accused the pharmaceutical company of defrauding the U.S. government by concealing Zantac's potential cancer risks.
GSK, however, did not admit any liability in the settlements and stated that its decision was aimed at removing "significant financial uncertainty" for the company and its investors. This legal resolution will allow the firm to refocus on its broader portfolio and future growth prospects.
Zantac, originally launched in 1983, quickly became one of the world’s best-selling drugs, with annual sales exceeding $1bn at its peak. It was marketed by several major pharmaceutical companies, including Pfizer, Sanofi, and Boehringer Ingelheim, all of whom have faced legal challenges related to the drug. Both Pfizer and Sanofi have agreed to settle their respective claims, while Boehringer Ingelheim has yet to announce any significant settlement.
In 2020, the U.S. Food and Drug Administration (FDA) removed Zantac from the market after studies showed the drug could form a substance called N-nitrosodimethylamine (NDMA), which is considered a probable human carcinogen. This move triggered a wave of lawsuits from individuals who claimed they developed cancer as a result of using the drug.
Despite Zantac's removal from the market, a new version of the drug, branded as Zantac 360, which contains no ranitidine, continues to be sold.
