A Waterloo woman claims she developed bladder cancer after years of using generic Zantac medication, which allegedly contains increased levels of carcinogens when stored for an extended period of time in heat and humidity.
Debra and Richard Garretson filed the complaint on Sept. 23 in the Madison County Circuit Court against Dr. Reddy’s Laboratories, Walmart, Sam’s West, Walgreens Boots Alliance, Walgreen Co., and Bond Drug Company of Illinois, doing business as Walgreens. The lawsuit was filed through attorney Eric Holland of Holland Law Firm LLC in St. Louis.
According to the complaint, the plaintiffs claim Debra Garretson developed cancer after taking the generic version of Zantac, or ranitidine, to treat heartburn and acid indigestion. She alleges she was unaware that a “potent carcinogen” in the medication increased over time in hot and humid conditions.
“Plaintiff Debra Garretson was denied the right to make an informed decision about whether to purchase and use ranitidine-containing products, knowing the full risks attendant to that use,” Holland wrote. “Such conduct was done with conscious disregard of plaintiffs’ rights.”
The Garretsons claim the Food and Drug Administration (FDA) asked all manufacturers to withdraw prescription and over-the-counter ranitidine drugs from the market in April 2020.
“The FDA and others have determined that NDMA in ranitidine products increases over time but increases significantly with exposure to heat and humidity,” the suit states. “Once consumed, ranitidine further metabolizes to even more dangerous levels of NDMA in the body.”
The plaintiffs allege that as a result of the FDA’s request for removal, ranitidine products are no longer available in the U.S.
Debra Garretson purchased and regularly ingested ranitidine tablets manufactured by Dr. Reddy’s Laboratories from about November 2017 to October 2019, the suit states. Then on Sept. 23, 2019, Garretson was diagnosed with bladder cancer. The plaintiffs claim that according to scientific evidence, exposure to NDMA in ranitidine drugs can cause bladder cancer.
The plaintiffs claim they did not learn about the link between Debra Garretson’s cancer and ranitidine exposure until June 2020. They claim Debra Garretson’s physicians were also unaware of the increased risk of cancer associated with the drugs.
According to the complaint, NDMA is a semi-volatile organic chemical that is part of N-nitrosamines, which is described as a “family of potent carcinogens.”
The suit states that brand-name medications undergo a rigorous review before being approved. After a brand-name medication has been approved, generic manufacturers may submit their medication for approval without the rigorous review as long as the drugs are bioequivalent. The two medications must also have the same approved labeling. However, generic manufacturers may include a difference in “expiration dates, formulation, bioavailability or pharmacokinetics.”
“Despite the FDA requirement of bioequivalency, the FDA recognizes that no two manufacturers’ drugs will be exactly the same,” Holland wrote. “For that reason, brand and generic manufacturers are responsible for conducting their own, independent stability testing, which must be ‘designed to assess the stability characteristics of drug products’ and which ‘shall be used in determining appropriate storage and conditions and expiration dates.’”
The plaintiffs claim the defendants knew or should have known that the level of NDMA in ranitidine drugs increases depending on age of the product, heat and humidity.
The defendants are accused of failing to adjust expiration dates and failing to advise consumers to store the product under refrigerated conditions and low humidity.
“Manufacturer defendants knew, or should have known, that ranitidine is highly sensitive to heat and humidity and that it degrades more rapidly into significantly higher levels of NDMA when subjected to either condition,” Holland wrote.
The plaintiffs also allege the defendants concealed ranitidine’s link to NDMA by failing to report it to the FDA.
The Garretsons seek punitive damages “sufficient to punish and deter defendants and others from future wrongful practices,” arguing that their conduct was “done with reckless disregard for human life, oppression, and malice.”
“Defendants were fully aware of the safety risks of ranitidine, particularly the carcinogenic potential of ranitidine as it transforms into NDMA within the chemical environment of the human body and/or during transport and/or storage,” Holland wrote. “Nonetheless, defendants deliberately crafted their label and marketing to mislead consumers.”
“This was not done by accident or through some justifiable negligence,” he added. “Rather, defendants knew they could profit by convincing consumers that ranitidine was harmless to humans, and that full disclosure of the true risks of ranitidine would limit the amount of money defendants would make selling the drugs.”
The plaintiffs also seek more than $50,000 for each count of the complaint, plus costs, and all other relief the court deems just.
Madison County Circuit Court case number 21-L-1154