The first jury trial to determine whether a popular heartburn drug causes cancer began Thursday in a packed Cook County courtroom, where an Illinois woman is arguing Zantac is responsible for the disease afflicting her colon.
An attorney for Angela Valadez argued in his opening statement that there’s a direct link between her cancer diagnosis and the over-the-counter heartburn drug she took for nearly 20 years. Defense attorneys said the drug has a proven safety record and blamed other health factors for her cancer.
Valadez, 89, is suing two pharmaceutical companies, GSK and Boehringer Ingelheim, that once manufactured Zantac. Her suit alleges that the drug’s active ingredient, called ranitidine, turns into a cancer-causing substance called NDMA as it ages.
GSK developed Zantac and later sold the over-the-counter version of the medication to Pfizer in 1998. In 2006, Boehringer Ingelheim bought the drug and owned it until 2017.
Valadez’s suit is one of thousands against the drugmakers. In December 2022, a federal judge in Florida dismissed roughly 50,000 claims because “no scientist outside this litigation” concluded the drug causes cancer.
Valadez regularly took Zantac and its generic versions from 1995 to 2014, according to the lawsuit. She was diagnosed with colon cancer in 2015 at 80 years old.
Reporters and other spectators missed a portion of the plaintiff’s opening statement because there wasn’t enough room in the courtroom in the Daley Center and Cook County Circuit Judge Daniel Trevino, who is presiding over the trial, did not make an overflow room available until an hour into the proceedings.
Mikal Watts, one of Valadez’s lawyers, portrayed the companies as profit-hungry with a disregard for patient safety. He specifically accused GSK of storing and transporting Zantac at unsafe temperatures and humidity levels. NDMA levels increase in hot and humid conditions, he said.
The drugmakers also didn’t tell customers such as Valadez or drug retailers to refrigerate the medication, Watts said.
“This product is sensitive to temperature. … You gotta protect this product, and they didn’t,” Watts said. “These are the ways that Zantac becomes cancer.”
The lawsuit alleges NDMA, or nitrosodimethylamine, is a carcinogen known to cause cancer in laboratory animals. In 2020, the FDA recalled ranitidine, including Zantac and its generics, after a lab found “exceedingly high levels of NDMA” in the drug.
But those findings distort the full picture, said Andrew Bayman, one of the lawyers representing Boehringer Ingelheim.
NDMA is a common impurity that pops up in medications, cosmetics, food, water and “even the air we breathe,” he said. It’s the amount that is ingested that can make it dangerous, and it has to be a lot, he added.
“We’re all exposed to NDMA every day. Exposure to NDMA doesn’t mean you get colon cancer or we’d all have colon cancer,” he said.
He also said both companies had rigorous testing in place for years to ensure the safety of the drug. It wasn’t until 2019 that NDMA was found in the medication, long after both companies sold the rights to it, he said. And before that, the FDA did not require manufacturers to test for NDMA, he said.
Tarek Ismail, one of the lawyers representing GSK, also said studies by independent scientists have found no risk for cancer associated with Zantac. No medical or scientific organization has said taking Zantac is a risk factor for colon cancer, he told the jury.
Ismail argued that Valadez had several other health factors that likely contributed to her colon cancer, including advanced age and that she is a woman, overweight, a former smoker and has Type 2 diabetes.
“Mrs. Valadez checks every single one of these boxes,” Ismail said. “It’s a textbook case of colon cancer.”
