An elderly American woman’s claim that the new discontinued heartburn drug Zantac was the cause of her colon cancer has been rejected by a Chicago jury – in the first trial out of thousands of lawsuits making similar allegations.
The jury agreed with pharmaceutical companies GSK and Boehringer Ingelheim that the plaintiff, Angela Valadez (89) had not proven her colon cancer was at least partly caused by taking over-the-counter Zantac and generic versions of it from 1995 to 2014, reports Reuters.
The lawsuits are claiming the drug’s active ingredient, ranitidine, under some conditions, turns into a cancer-causing substance called NDMA, with attorneys for Valadez asking the jury to award $640m for her suffering.
The judge rejected her request to seek punitive damages during the trial, according to her attorneys.
Both GSK and Boehringer have said the verdict was consistent with scientific evidence that Zantac does not cause cancer, and that they would continue to defend themselves against future claims.
Britain-based GSK, whose predecessor developed the drug but later sold the brand to other companies, and German drugmaker Boehringer Ingelheim, which sold the medicine from 2006 until 2017, were the only defendants in the trial after the other companies settled.
One of the attorneys for Valdez said at the trial that the companies knew ranitidine would turn into NDMA as it aged or were exposed to extreme temperatures, but did not ensure it was properly handled by transporters, distributors and stores.
However, attorneys for GSK and Boehringer countered that Zantac has been repeatedly proven to be safe and effective and that no scientific or medical study has connected it to cancer.
The companies’ attorneys also argued that there was no evidence to support Valadez’s claim that she had taken Zantac for 18 years. They pointed out that she had a host of risk factors making her more likely to develop colon cancer.
The jury found that Valadez had proved she had taken Zantac but not that it was a cause of her cancer.
First approved in 1983, Zantac became the world’s best selling medicine in 1988 and one of the first-ever to top $1bn in annual sales.
In 2020, the US Food and Drug Administration asked pharmaceutical companies to withdraw the medication and its generic versions from the market after NDMA was found in samples of the drug. Thousands of lawsuits began piling up in federal and state courts.
The defendants notched a significant win in 2022, when a judge dismissed about 50 000 claims centralised in federal court in Florida. That judge concluded that the opinions of the plaintiffs’ expert witnesses that Zantac can cause cancer were not supported by sound science.
Some of the claimants in those cases are appealing the ruling.
A judge in Delaware state court is weighing the fate of about 72 000 cases, the bulk of those remaining, where the drugmakers similarly argue that plaintiffs’ expert testimony should be kept out.
Some other cases were previously settled, including several individual cases just before trial, and about 4 000 state court lawsuits outside Delaware against Sanofi, which has owned the right to sell Zantac over the counter since 2017.
Earlier this month, Pfizer had struck a deal to pay up to $250m to settle more than 10 000 Zantac lawsuits.
Sanofi now sells Zantac360, a reformulated heartburn medicine whose active ingredient is famotidine.
See more from MedicalBrief archives:
GSK coughs up again in another Zantac settlement
GSK settles another lawsuit on heartburn drug Zantac
Judge dismisses thousands of lawsuits claiming Zantac cancer link
More countries and companies recall heartburn drug Zantac