Common heartburn pill caused my colon cancer, claims Illinois woman, 89, in landmark lawsuit
READ MORE: Zantac maker settles 4,000 lawsuits
An Illinois woman could be awarded $640million in damages from the makers of heartburn drug Zantac — as she claims the pill she took for 18 years caused her deadly colon cancer.
In a landmark court case, Angela Valadez, 89, from Brookfield, Illinois, has accused the firm of failing to disclose risks of the disease, which she was diagnosed with in 2015.
The case is one of more than 10,000 lawsuits brought against manufacturers of the drug that alleges it caused cancer, but this is the first that has made it to trial.
It is thought that the active ingredient in the drug, ranitidine, contains a 'probable carcinogen' called NDMA, which is a 'forever chemical' which accumulates in our body over time.
Such was the concern about the drug's safety, that the FDA ordered all products with rantidine including Zantac be removed from shelves in 2020 and urged patients to stop taking any medications containing the ingredient.
Ms Valadez's case is one of tens of thousands against GSK, Boehringer Ingelheim, and other pharmaceutical companies, which link Zantac's active ingredient - ranitidine - to cancer
Sanofi, drugmaker behind discontinued heartburn medication Zantac, agreed to settle 4,000 lawsuits alleging that the drug's active ingredient created cancer-causing chemicals
Speaking to the jury, Ms Valadez she has dealt with uncontrollable diarrhea and suffered multiple humiliating incidents as a result of her cancer.
She is forced to stay at home the majority of the time out of fear of having an accident.
'I suffered a lot,' Ms Valadez said, adding that she pursued the lawsuit because 'if Zantac caused my cancer, I don't think it's right that they get away with it.'
She started taking Zantac during a stressful time of her life in late 1996 after seeing an ad for Zantac on TV.
'I got heartburn real bad,' she said. 'I was suffering all the time.'
She took the Zantac every day 'because it worked, and it was the only thing that worked for me.'
To begin with, Ms Valadez took the branded version but then started taking the generic version instead because it was cheaper.
At 80 years old, Ms Valadez was diagnosed with colon cancer after receiving her first colonoscopy. She had surgery to get rid the cancer and has remained cancer-free ever since.
In the years after her diagnosis and surgery, she suffered with debilitating diarrhea and often had to wear adult diapers, as well as taking medication for it.
The above graph shows colon cancer cases among under 50s by year. There is a drop in 2020 because the Covid pandemic led to fewer people coming forward for screenings
In 2020, only 0.6 children ages 10 to 14 per 100,000 population were diagnosed with colorectal cancer compared to 0.1 per 100,000 in 1999 - a 500 percent increase. Escalations were also found in older adults, with rates rising by 71 percent to 6.5 per 100,000 people in aged 30 to 34 and by 58 percent to 11.7 per 100,000 in ages 35 to 39 in 2020
Ms Valadez's attorney, Mikal Watts, said the companies knew that ranitidine would turn into a cancer-causing substance called NDMA as it aged or was exposed to extreme temperatures, but did not ensure it was properly handled by transporters, distributors and stores.
Attorneys 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 until 2017, countered that Zantac has been repeatedly proven to be safe and effective.
Zantac, an over-the-counter pill for heartburn and indigestion, was pulled from shelves after animal studies found that ranitidine released 'probable human carcinogens' linked to esophageal, kidney, and colorectal cancer.
Concerns relate to the compound NDMAN-Nitrosodimethylamine (NDMA, which) is a chemical byproduct of industrial manufacturing processes, including the production of rocket fuel.
It's also common in low quantities in many foods, such as cured or smoked meats, fish and beer as well as tobacco smoke.
NDMA is a 'forever chemical,' meaning that it doesn't degrade, or break down, naturally in the environment or our bodies. Over time, it accumulates, and our exposures build up.
A number of theories have been put forward to explain how the toxic chemical ended up in the supply of some heartburn medications, as well as in the blood pressure drugs, valsartan and losartan, in recent years.
Some have suggested it's due to poor manufacturing, while others have initially suggested that the way the body metabolizes the drug could make levels of NDMA surge in the stomach. However, the latter theory was debunked in 2019.
Animal studies have shown that NDMA can increase the risk of cancers in the esophagus, kidneys, and stomach. They have also been linked to colorectal cancer, which is on the rise among young Americans.
There have been no cancer cases officially linked to Zantac, the WHO states, though thousands of patients have alleged otherwise.
GSK's attorney Tarek Ismail told the jury there is 'no objective evidence linking Ms. Valadez’s cancer to Zantac.'
'No genetic test, lab report, imaging study… nothing whatsoever.'
Mr Ismail also said Ms Valadez had a host of risk factors that made her more likely to develop colon cancer.
Read More
FDA says ALL Zantac must be pulled from shelves months after officials warned the popular heartburn drug is contaminated with cancer-causing chemicals
First approved in 1983, Zantac became the world's best selling medicine in 1988 and one of the first-ever drugs to top $1 billion in annual sales.
It was originally marketed by a forerunner of GSK and later sold successively to other companies.
In 2020, the US Food and Drug Administration asked drugmakers to pull Zantac and its generic versions off 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 now on the market has a different active ingredient and does not contain ranitidine.
The companies notched a significant win in 2022 when a judge dismissed about 50,000 claims centralized in federal court in Florida.
That judge concluded that claims brought by plaintiffs' expert witnesses linking Zantac to cancer were not supported by sound science.
More than 70,000 Zantac cases remain pending in the US, many of them in Delaware state court where a judge is considering similar arguments.
Some other cases were previously settled, including several individual cases just before trial, and about 4,000 state court lawsuits outside of Delaware against French drugmaker Sanofi SA.