GSK says $2.2bn settlement resolves most Zantac litigation

GSK has reached an agreement that it says will resolve 93% of the outstanding lawsuits brought against the company claiming that its gastrointestinal drug Zantac caused cancer.

The company has agreed to pay $2.2 billion to settle around 80,000 state court product liability cases alleging injury from Zantac (ranitidine), most of which had been consolidated in a Delaware action.

Law firms representing the plaintiffs are "unanimously recommending" to their clients that they accept the terms of the settlement, said GSK, which hopes to complete the deal in the first half of 2025.

A separate $70 million settlement has been agreed to settle a whistleblower complaint brought by Valisure, an independent Connecticut laboratory that alleged that GSK violated the federal False Claims Act by hiding the risks of Zantac for nearly 40 years while Medicare and other health programmes covered billions of dollars of prescriptions. That deal is subject to approval by the Department of Justice.

The common claim in the lawsuits is that a contaminant in Zantac (ranitidine) called N-nitrosodimethylamine (NDMA) – as well as other ranitidine products sold by other companies – increased the risk of cancer.

GSK has steadfastly denied that Zantac causes cancer, pointing to the lack of any reliable evidence in 16 epidemiological studies investigating a link, and stressed that the settlements have been agreed "with no admission of liability."

If pushed over the line, the settlements substantially resolve an issue that has been hanging over GSK for more than two years and at the outset had been estimated to put the company at risk of several billion dollars in liability.

Zantac was originated by GSK and launched by the company in the early 1980s, which sold it as a prescription and over-the-counter (OTC) product for indications like heartburn and acid indigestion over many years. It has also been sold in generic form by several other producers, some of which have also been named in litigation, including Boehringer Ingelheim, Pfizer, and Johnson & Johnson.

GSK's settlement follows a $100 million deal by Sanofi earlier this year, reported by Bloomberg, which settled around 4,000 claims. The French drugmaker had rights to the OTC version of the drug that was recalled in 2019 over possible contamination with the suspected carcinogen N-nitrosodimethylamine (NDMA). The FDA banned ranitidine sales altogether in 2020.

Pfizer, meanwhile, has also said it settled around 10,000 claims without revealing financial terms.

GSK said it expects to take a charge of £1.8 billion ($2.3 billion) in its third-quarter results in relation to the settlements, which will be funded through "existing resources," and said there will be "no changes to GSK's growth agenda or investment plans for R&D as a result."

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