Zantac not cause of woman’s cancer, jury rules in first drug trial – 05/23/2024 at 8:22 p.m.


((Automated translation by Reuters, please see disclaimer https://bit.ly/rtrsauto))

(Added GSK and Boehringer comments to paragraph 6) by Diana Novak Jones

A Chicago jury on Thursday rejected an Illinois woman’s claim that Zantac, a now-withdrawn heartburn drug, caused her colon cancer, in the first lawsuit among thousands of lawsuits making similar allegations.

The Cook County, Illinois, circuit court jury accepted arguments from drugmakers GSK GSK.L and Boehringer Ingelheim that the plaintiff, Angela Valadez, 89, an Illinois resident, had not proven that his colon cancer was caused, at least in part, by the use of Zantac.

Ms. Valadez had claimed that her cancer was the result of taking over-the-counter Zantac and its generic versions between 1995 and 2014. Lawsuits against the drug claim that its active ingredient, ranitidine, turns into a carcinogen under certain conditions. called NDMA.

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

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

Both GSK and Boehringer said in statements that the verdict was consistent with scientific evidence that Zantac does not cause cancer, and that they would vigorously defend against any future claims.

British company GSK, whose predecessor developed the drug before selling the brand to other companies, and German manufacturer Boehringer Ingelheim, which sold the drug from 2006 to 2017, were the only defendants in the lawsuit after the other companies settled the dispute.

At the trial which opened on May 2, Mr Watts said the companies knew ranitidine would turn into NDMA when aged or exposed to extreme temperatures, but failed to ensure this. that it is properly handled by carriers, distributors and stores.

Lawyers for GSK and Boehringer countered that Zantac has repeatedly been shown 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 Ms. Valadez’s claim that she had taken Zantac for 18 years and that she had a series of risk factors that made her made them more likely to develop colon cancer.

The jury found that Ms. Valadez had proven that she had taken Zantac, but not that the drug caused her cancer.

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

In 2020, the U.S. Food and Drug Administration asked drugmakers to remove 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 major victory in 2022, when a judge dismissed about 50,000 centralized complaints in federal court in Florida. This judge concluded that the opinions of the plaintiffs’ expert witnesses that Zantac can cause cancer were not supported by sound scientific data.

Some of the plaintiffs appealed the decision to the 11th United States Circuit Court of Appeals, based in Atlanta, Georgia.

A Delaware state court judge is weighing the fate of about 72,000 cases, the bulk of the remaining cases, in which drugmakers also argue that plaintiffs’ expert testimony should not be taken into account.

Other cases have been settled previously, including several individual cases just before trial, and approximately 4,000 lawsuits in state courts outside of Delaware against Sanofi SASY.PA, which owns the right to sell Zantac on sale free since 2017.

Earlier this month, the Financial Times reported that Pfizer

PFE.N 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 medication with the active ingredient famotidine.



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