A popular heartburn drug with an active ingredient that degrades into a carcinogen so virulent “It’s the ‘Terminator’ of cancer.”
Or a safe and effective medication used by a woman whose colon cancer was caused by a host of other factors, including the woman ignoring for years a doctor’s advice to get a colonoscopy.
Those were the sharply different arguments lawyers made Wednesday in their dueling final pitches to a Cook County jury in a trial over whether Zantac caused an elderly Brookfield woman’s colon cancer.
The trial — the first of thousands of similar cases across the country to go to a jury — has lasted three weeks.
Attorneys representing 89-year-old Angela Valadez shared the “horrific” details of her life after her cancer diagnosis and alleged that the active ingredient in Zantac degraded into the potentially cancer-causing substance NDMA and was a culprit for her disease.
Valadez, who was back in the courtroom Wednesday for the first time since she testified two weeks ago, is seeking $640 million in damages.
“This case is really very simple,” said Mikal Watts, one of Valadez’s lawyers, during his closing statement to the jury. These companies “knew that people were being exposed to NDMA, but they hid that exposure to make money.”
The defense for the two drugmakers — GSK and Boehringer Ingelheim — poked holes in the science behind claims that Zantac caused her cancer and contended that other health issues contributed to Valadez’s disease. They also detailed how safe and effective the heartburn drug is.
“Mrs. Valadez has failed to meet her burden of proving Zantac caused her cancer,” said Andrew Bayman, representing Boehringer Ingelheim, during his closing statement.
The jury of nine women and three men deliberated for about three hours Wednesday before Cook County Circuit Judge Daniel Trevino sent them home for the night, asking them to resume on Thursday. Jurors must decide on three separate counts outlined in Valadez’s lawsuit: failure to warn, negligence and negligent misrepresentation.
The crux of the woman’s case is that Zantac’s active ingredient — called ranitidine — degrades into NDMA, a “probable human carcinogen.” Lawyers and experts debated its severity throughout the trial.
“This is a ruthless carcinogen,” Watts said. “It’s the Terminator of cancer … It’s highly efficient at causing cancer.”
During the trial, Watts referenced scientific organizations that call it a recognized carcinogen in lab animals and humans. He also discussed many studies, often focusing on one from 1982 that found ranitidine can turn into NDMA when it interacts with an acid similar to what’s found in the stomach.
Packages of Zantac sit on a shelf at a drugstore on Sept. 19, 2019 in New York City. In 2020, the FDA recalled ranitidine, including Zantac and its generics, after a lab found “exceedingly high levels of NDMA” in the drug. The regulatory agency later found there was no risk posed to consumers.
Drew Angerer/Getty
Earlier in the trial, Dr. Stephen Hobbiger, a British physician who worked for GSK for more than 20 years and specialized in drug safety and medical governance, testified about the safety of Zantac.
While acknowledging that ranitidine can degrade into NDMA, Hobbiger repeatedly pushed back on the claim that Zantac causes cancer. He pointed out that the 1982 study that found NDMA in ranitidine only happened under “very abnormal” conditions and at levels of NDMA that humans don’t encounter in everyday life.
Hobbiger also said no scientists at GSK, outside researchers or regulatory agencies have found a connection between Zantac and colon cancer. No medical society or science organization says Zantac causes cancer, he added.
Watts also argued, in his closing statement and throughout the trial, that ranitidine degraded into NDMA when it was exposed to hot and humid conditions. In order to keep the drug safe, it should have been constantly refrigerated, both in storage and in transportation, he said.
He focused on warehouses where the drug was stored in Spain off the Mediterranean Sea and Mexico City, emphasizing the warm climate of those areas.
Boehringer Ingelheim executive Maureen Oakes testified earlier in the trial about how Zantac was produced and stored.
Oakes repeatedly maintained that refrigeration was not necessary to keep the drug safe. The company therefore never required or recommended it to be refrigerated during storage and transportation or when it was sold in pharmacies and kept in customers’ homes.
Tarek Ismail, one of the lawyers representing GSK, discussed Valadez’s Zantac use and her medical history during his closing argument to the jury.
No one who testified in the trial corroborated Valadez’s 18 years of using Zantac, Ismail said. Of the 20,000 medical records submitted for the trial, Ismail reiterated that only one mentions that Valadez took ranitidine. A July 2011 doctor’s note says she tried taking the heartburn drug Mylanta, baking soda and ranitidine, but her acid reflux persisted.
Valadez was diagnosed with colon cancer in 2015 after she got her first colonoscopy. She ignored her doctors’ recommendations for years advising her to get the procedure.
Dr. Michael Vaezi, a gastrointestinal doctor, testified Tuesday that a colonoscopy is one of the best ways to prevent colon cancer. The procedure can identify polyps on the colon that could turn into cancerous tumors, he said.
Following her cancer diagnosis and surgery, Valadez testified she’s dealt with uncontrollable diarrhea, which has prevented her from living a normal life. She detailed multiple times when she lost control while in public.
She repeatedly told the jury how humiliating and embarrassing those incidents were and how she is still forced to stay at home most days out of fear of having an accident.
Toward the end of his client’s testimony, Watts asked Valadez why she pursued the lawsuit.
“Because I suffered a lot,” Valadez said. “Because if Zantac caused my cancer, I don’t think it’s right that they get away with it.”
In 2020, the FDA recalled ranitidine, including Zantac and its generics, after a lab found “exceedingly high levels of NDMA” in the drug. The regulatory agency later found there was no risk posed to consumers.
GSK developed Zantac and later sold the over-the-counter version 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.
