((Automated translation by Reuters, please see disclaimer https://bit.ly/rtrsauto))
(Added update on study timeline to paragraph 2, and statement from Boehringer Ingelheim to paragraph 9) by Brendan Pierson
The first trial over allegations that the blockbuster heartburn drug Zantac, once sold by GSK GSK.L and other companies, causes cancer, is expected to begin this week in Chicago.
Jury selection began Tuesday before Cook County Circuit Court Judge Daniel Trevino and is expected to continue Wednesday morning. The attorneys will deliver opening statements once the jury has been selected.
GSK and Boehringer Ingelheim are the only defendants in the lawsuit, after other companies reached a settlement.
The plaintiff, Angela Valadez, 89, an Illinois resident, alleges in her lawsuit that she developed colorectal cancer as a result of taking over-the-counter Zantac and its generic versions between 1995 and 2014. As d Other plaintiffs claim that the drug’s active ingredient, ranitidine, turns into a carcinogen called NDMA as it ages.
“We are happy that she is being heard by the courts,” said Ashley Keller, Ms. Valadez’s lawyer.
His case is one of tens of thousands against GSK, Boehringer Ingelheim and other companies, including Pfizer PFE.N and Sanofi SASY.PA , that have worried investors in recent years. It will be the first test of whether the cancer allegations will convince a jury, given that all cases previously scheduled to go to trial have been settled or dropped.
Drugmakers have maintained that Zantac does not cause cancer and does not contain significant amounts of NDMA under normal conditions.
“We are confident in our position based on facts and science and look forward to presenting our arguments at trial,” GSK said in a statement.
“The body of scientific evidence, which includes numerous recent epidemiological studies, leads to only one conclusion: Zantac does not cause any type of cancer,” Boehringer Ingelheim said in a statement.
First approved 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 first marketed by a precursor to GSK, whose potential liability is the greatest, before being sold successively to the 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.
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, but not all, of the plaintiffs appealed that decision to the 11th U.S. Circuit Court of Appeals, based in Atlanta, Georgia.
Another judge is currently considering the fate of about 72,000 cases in Delaware state court, where drugmakers also argue that plaintiffs’ expert testimony should not be considered.
Other cases have already been settled, including several individual cases just before trial, and approximately 4,000 lawsuits in state courts outside of Delaware against Sanofi. Pfizer and Boehringer Ingelheim have not announced large-scale settlements.
A new version of Zantac currently on the market contains a different active ingredient and does not contain ranitidine.