GSK has agreed to pay up to $2.2 billion to resolve approximately 80,000 lawsuits brought by users of Zantac who claimed the heartburn drug caused their cancer.
The agreement frees the British pharma giant from litigating 93% of the state court cases it faced in the U.S., most of which had been consolidated in Delaware. The settlement was reached with 10 plaintiff firms with the agreement that GSK does not admit liability, the company said.
With the deal, lawyers representing the plaintiffs are unanimously recommending that clients accept terms of the settlement, which is expected to be complete by the end of the first half of 2025, GSK said.
The agreement is in line with a similar settlement Sanofi reportedly made earlier this year. The French pharma consented to pay $100 million to resolve roughly 4,000 Zantac claims, Bloomberg reported in April. That deal paid plaintiffs roughly $25,000 each. The GSK settlement comes to approximately $27,500 per claimant.
In May of this year, Pfizer also settled approximately 10,000 Zantac lawsuits for an undisclosed figure. Pfizer had the rights to sell the antacid from 1998 to 2006.
In addition to the $2.2 billion deal, GSK also said on Wednesday that it will pay $70 million to resolve a qui tam complaint filed by Connecticut-based laboratory Valisure, which first raised alarm bells about Zantac’s risks in 2019 during routine batch testing.
Along with alerting the FDA about the link between Zantac and the probable carcinogen N-nitrosodimethylamine (NDMA), Valisure also filed a complaint on behalf of U.S. taxpayers and 25 states, arguing that GSK “knowingly and deliberately lied to the FDA” to secure Zantac’s 1983 approval.
The resolution with Valisure is subject to approval from the U.S. Department of Justice, GSK said.
To account for the settlement payments, GSK said it will log an incremental charge of 1.8 billion pounds sterling ($2.3 billion) in its third-quarter earnings statement.
“The costs of these settlements will be funded through existing resources,” GSK explained. “There are no changes to GSK’s growth agenda or investment plans for R&D as a result of these settlements.”
Another company facing Zantac litigation is Boehringer Ingelheim. GSK gained approval for Zantac (ranitidine) in 1983 and lost its patent protection for the treatment in 1997. Boehringer acquired the U.S. OTC rights for Zantac later in 2006. Sanofi and Pfizer also had Zantac OTC rights at different time points.
In 2020, the FDA instructed all companies to take Zantac off the market after it confirmed that the medicine’s main ingredient can transform into a possible carcinogen over time or when exposed to high temperatures. Zantac has since returned to the market with a new formulation that does not include ranitidine.
Companies facing federal litigation gained a huge win in 2022 when a Florida district judge rejected the science backing the claims that Zantac can cause cancer. The ruling freed the drugmakers from defending against approximately 50,000 cases that had been consolidated in the Florida federal court.
GSK’s settlements come weeks after the company gained a key victory, with the Delaware Supreme Court upholding a GSK appeal, deciding to review the state’s Superior Court decision to allow expert testimony that would support the consolidated lawsuits the company faced in the state.