GSK has reached a $2.2-billion settlement agreement with regard to pending product liability litigation in US state courts over Zantac (ranitidine), an antacid.  

The litigation stemmed from plaintiffs’ claims that the use of Zantac contributed to cancer. In 2020, the US Food and Drug Administration requested that manufacturers withdraw all prescription and OTC ranitidine drugs in the US as part of an investigation of nitrosamine impurities in the drug, specifically N-nitrosodimethylamine (NDMA), a probable human carcinogen, according to FDA. 

The issue of nitrosamine impurities first arose in the industry in 2018, when the FDA and the European Medicines Agency initiated investigations of nitrosamine impurities in certain “sartan”-containing active pharmaceutical ingredients (APIs), used in anti-hypertensive and cardiovascular drugs, such as valsartan, candesartan, irbesartan, losartan, and olmesartan. They later broadened those investigations into prescription and OTC forms of ranitidine and later expanded the investigation to include metformin extended-release products, used to treat Type II diabetes. As part of their investigations, the regulatory agencies issued guidelines for testing of products to detect nitrosamine impurities, acceptable daily intake levels, and risk-evaluation and risk-assessment measures.

GSK reached an agreement with 10 plaintiff firms, who together represent 93% (approximately 80,000) of the Zantac state court product liability cases pending against GSK in the US. Under these agreements, GSK will make an aggregate payment of up to $2.2 billion to resolve all US state court product liability cases handled by those plaintiff firms that meet agreed eligibility and participation criteria (the State Courts Settlement). GSK says that the participating plaintiff firms are unanimously recommending to their clients that they accept the terms of the State Courts Settlement, which is expected to be fully implemented by the end of the first half of 2025. 

GSK also confirmed that it has reached an agreement in principle to pay a total of $70 million to resolve the Zantac qui tam complaint previously filed by Valisure, a New Haven, Connecticut-based independent testing laboratory. In 2019, Valisure filed a citizens’ petition with FDA asking the agency to recall all products containing ranitidine following testing by the firm that found NDMA impurities in certain batches of ranitidine. The agreement in principle is subject to final approval from the US Department of Justice.  

In reaching the settlement agreement, GSK said that the company “has not admitted any liability in the State Courts Settlement or in the agreement in principle for the Qui Tam Settlement,” in an October 10, 2024, statement. “ While the scientific consensus remains that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer, GSK strongly believes that these settlements are in the best long-term interests of the company and its shareholders as they remove significant financial uncertainty, risk and distraction associated with protracted litigation.” 

GSK says it expects to recognize an incremental charge in its third-quarter 2024 results of £1.8 billion ($2.3 billion) in relation to the State Courts Settlement, the Qui Tam Settlement, and the remaining 7% of pending state court product liability cases, partially offset by expected reduced future legal costs. The company says that the costs of these settlements will be funded through existing resources and that there are no changes to GSK’s growth agenda or investment plans for R&D as a result of these settlements. 

Source: GSK