A lawsuit claims the use of Zantac (ranitidine) caused a man to develop bladder cancer and need three surgeries.
The lawsuit claims that Zantac caused the man to develop cancer because Zantac becomes N-Nitrosodimethylamine (NDMA), a probable human carcinogen, inside the body as the digestive system breaks it down.
The complaint claims that ranitidine molecules contain a dimethylamine group and a nitrite group, and that these are “well known” to form NDMA by combining. The complaint claims that ranitidine produces NDMA by reacting with itself, meaning Zantac users are exposed to NDMA by every form and dosage of the drug. The complaint claims testing has found NDMA levels in ranitidine which were so high that the ranitidine molecule itself being the source of the NDMA is the only explanation.
The complaint notes that NDMA in drinking water was linked to ranitidine in 2003, and that a 2016 Stanford University study found that healthy subjects who took ranitidine produced startlingly high amounts of NDMA in their urine in the next 24 hours.
The complaint claims that while the U.S. Food and Drug Administration has set a daily limit of 92 ng for NDMA, researchers have found over 3 million ng per day in a single dose of Zantac.
The complaint claims that Zantac makers knew or should have known that their products posed a cancer risk, yet failed to warn the public about it. The complaint claims that research going back as far as 1981 showed elevated rates of NDMA.
The complaint claims that a 1979 news article noted that NDMA caused cancer in lab animals, that the mechanism behind NDMA causing cancer in animals is not known, and that when a mechanism is not known one must assume what causes cancer in animals might cause cancer in humans.
The complaint also claims that NDMA breaks down into derivatives which are also associated with cancer.
The complaint claims that GlaxoSmithKline intentionally produced flawed studies in 1981 and 1987 to hide the presence of NDMA in Zantac.
The complaint accuses Zantac makers of malice, oppression and reckless disregard for human life, stating they intentionally misled consumers through their promotion, marketing and labeling in order to profit.
The complaint seeks to recover damages based on multiple causes of action, including strict liability – design defect, strict liability – failure to warn, negligence, and breach of express and implied warranties.
The FDA requested in April that all drugs containing ranitidine be removed from the market because of NDMA contamination.