Zantac does not cause women’s cancer, jury says in first drug trial

By Diana Novak Jones

CHICAGO (Reuters) – A Chicago jury on Thursday rejected an Illinois woman’s claim that the now-discontinued heartburn drug Zantac caused her colon cancer, in the first of thousands of lawsuits making similar claims. .

A jury in the Cook County, Illinois district court agreed with drug makers GSK and Boehringer Ingelheim’s arguments that the plaintiff, 89-year-old Illinois resident Angela Valadez, had failed to prove that her colon cancer was at least partly caused by her Zantac use.

Valadez had claimed her cancer was the result of taking over-the-counter Zantac and its generic versions from 1995 to 2014. The lawsuits over the drug say its active ingredient, ranitidine, under certain conditions turns into a cancer-causing substance. called NDMA.

Valadez’s lawyers had asked the jury to award her $640 million for her suffering. The judge rejected Valadez’s request for damages during the trial, according to her lawyers.

Mikal Watts, one of Valadez’s attorneys, said he respected the jury’s verdict but was confident the companies would be held accountable in future Zantac trials. “This is a marathon, not a sprint,” he said.

GSK and Boehringer did not immediately respond to requests for comment.

Britain-based GSK, whose predecessor developed the drug but later sold the brand to other companies, and German drugmaker Boehringer Ingelheim, which sold the drug from 2006 to 2017, were the only defendants in the lawsuit after other companies settled.

Watts said in the trial that began May 2 that the companies knew ranitidine would convert to NDMA as it aged or was exposed to extreme temperatures, but failed to make sure it was handled properly by shippers, distributors and stores.

Lawyers for GSK and Boehringer countered that Zantac has been repeatedly proven to be safe and effective and that no scientific or medical studies have linked Zantac to cancer.

Lawyers for the companies also argued at trial that there was no evidence to support Valadez’s claim that she had been taking Zantac for 18 years and that she had a host of risk factors that made her more likely to develop colon cancer.

The jury found that Valadez proved that she had taken Zantac, but not that it was the cause of her cancer.

First approved in 1983, Zantac became the world’s best-selling drug in 1988 and one of the first to reach $1 billion in annual sales.

In 2020, the US Food and Drug Administration asked drugmakers to pull Zantac 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 scored a landmark victory in 2022, when a judge threw out nearly 50,000 centralized claims in federal court in Florida. That judge concluded that the plaintiffs’ experts’ opinions that Zantac could cause cancer were not supported by sound science.

Some of the plaintiffs in those cases are appealing the ruling to the 11th U.S. Circuit Court of Appeals based in Atlanta, Georgia.

A Delaware state court judge is weighing the fate of about 72,000 cases, most of which remain, where drugmakers similarly argue that plaintiffs’ expert testimony should be excluded.

Several other cases had previously been settled, including several individual cases just before trial, and about 4,000 state lawsuits outside Delaware against Sanofi, which has owned the right to sell Zantac over the counter since 2017.

Earlier this month, the Financial Times reported that Pfizer had reached an agreement to pay up to $250 million to settle more than 10,000 Zantac lawsuits.

Sanofi now sells Zantac360, a reformulated heartburn drug whose active ingredient is famotidine.

(Reporting By Diana Novak Jones in Chicago, Brendan Pierson in New York; Editing by Bill Berkrot and Alexia Garamfalvi)