British pharmaceutical company GSK has agreed to pay up to $2.2bn to settle 80 000 lawsuits in US courts claiming a discontinued version of heartburn drug Zantac caused cancer – the agreement with 10 plaintiffs’ law firms resolving about 93% of cases pending against the company nationwide.
It also said it would pay $70m to settle a related whistle-blower lawsuit filed by a Connecticut laboratory.
Reuters reports that GSK did not admit wrongdoing as part of the deal, as there was “no consistent or reliable evidence” that ranitidine, the drug’s active ingredient, increased the risk of cancer. However, it said the settlements were in the best long-term interest of the company to avoid the risk of continuing litigation.
First approved by US regulators in 1983, Zantac became the world’s best-selling medicine in 1988 and one of the first to top $1bn in annual sales.
The drug was sold at different times by GSK, Pfizer, Sanofi and Boehringer Ingelheim.
Lawsuits against the companies began piling up in both state and federal courts after the FDA, in 2020, asked manufacturers to pull Zantac off the market. The agency cited concerns that ranitidine could degrade into NDMA, a carcinogen, over time or when exposed to heat
Pfizer has agreed to settle most of the Zantac cases against it in state court, and Sanofi in April announced that it was settling about 4 000 cases.
Boehringer Ingelheim has not announced any major settlements, but is currently facing a trial over the drug in a Californian state court. The company has denied wrongdoing.
A majority of the remaining state court cases are in Delaware, where a judge in June allowed plaintiffs to present crucial expert testimony that Zantac caused cancer. The drug companies had sought to keep that testimony out, saying it was not based on sound scientific evidence, which would have ended the lawsuits, and are appealing the judge’s ruling to the Delaware Supreme Court.
The companies won a major victory in 2022 when a Florida federal court judge ruled that about 50 000 cases centralised there could not go forward because the plaintiffs’ expert testimony was not supported by reliable science.
About 14 000 of those cases are being appealed, and are not part of this recent settlement.
A drug currently sold under the name Zantac 360 uses a different active ingredient and contains no ranitidine.
Reuters article – GSK agrees to settle about 80,000 Zantac lawsuits for up to $2.2 bn (Open access)
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GSK wins latest case over Zantac cancer claims
GSK coughs up again in another Zantac settlement