((Automated translation by Reuters, please see disclaimer https://bit.ly/rtrsauto)) by Diana Novak Jones
U.S. lawyers for a woman who claims her colon cancer was caused by Zantac, a now-discontinued heartburn drug, told a Chicago jury Thursday that pharmaceutical companies GSK and Boehringer Ingelheim knew that the product could cause cancer if not handled properly, but failed to warn the public.
Mikal Watts, who represents Angela Valadez, 89, said the companies knew that Zantac’s active ingredient, ranitidine, would turn into a cancer-causing substance called NDMA as it aged or was exposed to extreme temperatures, but that they had failed to ensure that the product was properly handled by carriers, distributors and stores.
Valadez’s case is one of tens of thousands of cases against GSK, Boehringer Ingelheim and other pharmaceutical companies that have worried investors in recent years. It will be the first test of whether the cancer allegations in the long-running litigation will convince a jury, given that all of the cases scheduled to go to trial have been settled or dropped.
GSK and Boehringer Ingelheim are the only defendants in the lawsuit, after other companies reached a settlement.
Watts told the jury the pills changed color as they degraded, but the companies covered it up.
“They know we won’t accept a product that looks bad, so they paint it,” Mr Watts said.
Lawyers for GSK, which developed the active ingredient in Zantac but later sold the brand to other companies, and Boehringer Ingelheim, which sold the drug from 2006 to 2017, countered that Zantac was found to be safe and effective on several occasions and that no scientific or medical studies had established a link between Zantac and cancer.
There is “no objective evidence linking Ms. Valadez’s cancer to Zantac,” GSK lawyer Tarek Ismail told the jury. “No genetic testing, no lab reports, no imaging studies…nothing at all”
Ms. Valadez, who said she had taken Zantac every day for at least 18 years, had a series of risk factors that made her more likely to develop colon cancer, Mr. Ismail said.
First authorized in 1983, Zantac became the world’s best-selling drug in 1988 and one of the first drugs to exceed $1 billion in annual sales. It was originally marketed by a precursor to GSK and then sold successively to other companies.
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.
A new version of Zantac, currently on the market, contains a different active ingredient and does not contain ranitidine.
The companies won a major victory in 2022, when a judge threw out 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.
More than 70,000 Zantac cases remain pending in the United States, including many in Delaware state court, where a judge is weighing similar arguments from drugmakers 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 French drugmaker Sanofi SA
SASY.PA.