In first Zantac trial, GSK and Boehringer Ingelheim gain key victory

In the first personal injury case that has gone to trial over Zantac, GSK and Boehringer Ingelheim have emerged with an important victory as a Chicago jury has rejected the claim of Angela Valadez that the heartburn drug caused her colon cancer.

Valadez, 89, who said she used the drug every day from 1995 to 2014, was seeking $640 million for her suffering. Earlier in the trial, a Cook County circuit judge denied her attempt to also collect punitive damages.

Valadez argued that GSK and Boehringer knew that Zantac’s main ingredient, ranitidine, could transform into a possible carcinogen called NMDA over time or when exposed to high temperatures and that the companies failed to warn customers.

Early in the trial, Valadez’s lawyer Mikal Watts told the jury that Zantac pills changed color as they degraded, requiring the companies to “put a paint job on it.”

The result could have broad implications as thousands of lawsuits have yet to be decided. Until Thursday, all cases previously set for trial had been settled or dropped, including another in Illinois which was set to begin Thursday but was recently dismissed.

“This outcome is consistent with the scientific consensus that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer, supported by 16 epidemiological studies looking at human data regarding the use of ranitidine,” GSK said in a statement after the Valadez decision. “GSK will continue to vigorously defend itself against all other claims.”

During the three-week trial, GSK countered that Valadez had several risk factors that could have led to her developing colon cancer.

GSK gained approval for Zantac in 1983, and, five years later, it was a blockbuster and the world’s bestselling drug. After GSK lost its patent protection for the treatment in 1997, Pfizer, Sanofi, Boehringer Ingelheim and others began selling generic versions until the FDA instructed all companies to stop its manufacture in 2020. Zantac has since returned to the market with a new formulation that does not include ranitidine.

In April, Sanofi agreed to pay $100 million—or roughly $25,000 per claimant—to resolve roughly 4,000 cases. Pfizer then settled more than 10,000 complaints, resolving litigation in several state courts.

Zantac manufacturers notched a massive win in court in 2022 when a Florida district judge rejected the science backing the claims that it could cause cancer. The ruling freed the drugmakers from defending against approximately 50,000 cases that had been consolidated in the Florida federal court.

Over the last year, GSK has hammered out settlements with individual plaintiffs in California, resolving cases before they could go to court. With a longer history with Zantac, GSK faces more claims than the other companies, with Reuters reporting 79,000 outstanding cases in October of last year.