By Susan Barfield /
September 10, 2020

Zantac Litigation: What you need to know

Prior to being recalled in early 2020, Zantac was one of the most widely used medications for the treatment of heartburn, acid reflux and acid related digestive issues. Chemically known as ranitidine hydrochloride, Zantac (or ranitidine) is a class of drugs called histamine H2-receptor antagonists (H2 blockers), which decrease the body’s production of stomach acid, providing temporary relief from acid related conditions. Zantac has been on the market since the early 1980s and was available over the counter and by prescription.

Over the years, numerous scientific studies have linked Zantac with a known carcinogen, N-nitrosodimethylamine, more commonly known as NDMA. NDMA is an extremely toxic substance and was formerly used as a key ingredient in rocket fuel. NDMA is so toxic that its used by scientists to induce cancer in lab rats when necessary for research purposes.

FDA takes action against Zantac

On September 13, 2019, the U.S. Food and Drug Administration (FDA) announced that it was investigating the link between Zantac and cancer. In the summer prior to the September announcement, the FDA became aware of independent laboratory testing that found NDMA in ranitidine. Researchers reported finding that Zantac tablets contain NDMA at levels up to 3,000 times greater than the FDA’s daily intake limit. Some experts believe there is no safe level of NDMA in the human body.

On April 1, 2020, the FDA issued an immediate market withdrawal request of all ranitidine-based medications including Zantac. Further FDA testing confirmed that NDMA levels increase in ranitidine even under normal storage conditions. NDMA was found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. FDA testing also revealed the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA the product may contain.

Types of cancer linked to Zantac

Lawsuits have been filed that claim the side effects of and range of potential injuries from ingesting NDMA are significant. Zantac use has been allegedly linked to the following type of cancer.

  • Liver cancer
  • Bladder cancer
  • Stomach cancer
  • Uterine cancer
  • Intestinal cancer
  • Ovarian cancer
  • Kidney cancer
  • Lung cancer
  • Prostate cancer
  • Colon cancer
  • Pancreatic cancer
  • Esophageal cancer

Every year, doctors wrote more than 15 million prescriptions for Zantac. Countless additional patients buy it over the counter in the non-prescription form. In February 2020, the Judicial Panel on Multidistrict Litigation created MDL 2924 to consolidate pretrial discovery for the flood of expected Zantac cancer cases.

Science Timeline for Zantac / Rantidine

  • 1980: As early as 1980 there was evidence that ranitidine could react with nitrate in the stomach to form NDMA.
  • 2000s: Studies show instability of ranitidine and its DMA group is linked to forming NDMA in oxidative conditions.
  • 2000s: Urination of ranitidine into wastewater suspected as source of NDMA in municipal drinking water supply.
  • 2004: National Cancer Institute study links antacids, ranitidine and cimetidine to bladder cancer.
  • 2016: Stanford University conducts clinical study with 10 healthy volunteers taking 150 mg of ranitidine daily. More than 40,000 ng of NDMA detected in urine linking Zantac to bladder cancer.
    • Levels of NDMA detected in urine were more than 15,000 times higher than the California drinking water limit.
    • The FDA maximum permissible daily exposure to NDMA in pharmaceuticals is 96 ng.
  • 2019: Valisure study shows ranitidine forms millions of ng of NDMA and can react with itself as both DMA and nitrate (N) are present in rantidine.
  • 2019: Valisure and Memorial Sloan Kettering Cancer Center begin epidemiological studies on ranitidine.

Case Works Zantac Expertise

The Zantac Team at Case Works is here to help your firm get Zantac cases proven up and ready to file into the recently created MDL. Our staff of case managers and medical review professionals works as a seamless extension of your law firm to provide exceptional service to your firm’s clients. Get in touch with us today to get your Zantac claims moving forward towards settlement.