People are suing because they claim drugmakers knew that Zantac could form N–Nitrosodimethylamine (NDMA) and potentially cause cancer. Companies failed to warn the public and put profits before patient safety.
Shortly after Zantac hit the market, it made $1 billion dollars in 1986, and sales remain strong. In 2018, Zantac was in the top 10 for antacid brands in the United States and sales of Zantac 150 totaled $128.9 million, according to lawsuits.
But people who filed lawsuits claimed that before the drug hit the market in 1983, there was already scientific evidence showing that drugs like ranitidine contained a compound that could form NDMA when combined with other substances in the body.
Lawyers have filed proposed class actions on behalf of people who purchased Zantac in different states, but these lawsuits request refunds for purchased drugs and don’t address cancer potentially caused by the drug.
Lawyers have filed hundreds of individual Zantac cancer lawsuits on behalf of people all over the country, and these are consolidated in federal court in Florida.
NDMA and Zantac
In September 2019, the FDA found unacceptable levels of NDMA in samples of ranitidine, prompting voluntary recalls from several manufacturers.
Then, in April 2020, the FDA found that levels of ranitidine continued to increase over time and in higher than room temperatures. This prompted the agency to request that manufacturers withdraw all ranitidine from the market.
Zantac isn’t the first drug involved in lawsuits because of NDMA contamination. People who took the blood pressure drug valsartan have filed similar lawsuits for NDMA contamination from manufacturing processes.
However, Zantac cases claim ranitidine is a defective drug because it contains ingredients that may form NDMA. According to the FDA, levels of ranitidine may continue to rise when the drug is stored.
How Much NDMA Is in Zantac?
Levels of NDMA vary across batches of Zantac. These can increase over time during storage, especially if exposed to above normal room temperatures.
In September 2019, the pharmacy Valisure tested samples of ranitidine and found as much as 3,000,000 ng of NDMA per tablet, far above the U.S. Food and Drug Administration’s acceptable limit of 96 ng.
The FDA has said that Valisure’s high-temperature testing may have caused levels to increase. Even so, the agency acknowledged that its own testing found unacceptable levels using a low-heat method.
In November 2019, the FDA released the results of its initial NDMA testing of 18 samples. It used parts per million or ppm to measure NDMA content. The agency said that 0.32 ppm is the daily acceptable limit, but several samples reached levels above 0.32 ppm. One sample showed levels of 2.85 ppm.
Does Zantac Cause Cancer?
There aren’t enough studies to say without a doubt that Zantac causes cancer, but the possibility can’t be ruled out.
The International Agency for Research on Cancer (IARC) classifies NDMA as a probable human carcinogen. While it has been shown to cause cancer in animals, there aren’t enough studies to prove it causes cancer in humans.
A 2016 study by Teng Zeng and William A. Mitch of Stanford University and a 2004 study by the National Cancer Institute found potential links between ranitidine and bladder cancer, but they didn’t find proof of causation.
Researchers at Memorial Sloan Kettering Cancer Center who surveyed 24,000 center patients found an increased chance of presenting with breast, testicular, thyroid and kidney cancer among people who used ranitidine, according to an article by Richard H. Adamson, PhD, and Dr. Bruce A. Chabner in The Oncologist.
But a study by Dr. Nabeeha Mohyuddin and colleagues presented data that showed people who took ranitidine had a lower cancer rate than those who took famotidine, another H2 blocker not contaminated with NDMA.
Who Qualifies for a Lawsuit?
People who took Zantac and developed cancer may qualify for a Zantac lawsuit.
Some lawyers say that potential claimants should have taken Zantac for at least a year. Taking higher doses of the drug may also make the connection to cancer stronger.
Potential claimants have to prove they took the drug with receipts or medical records. They must also have been diagnosed with a cancer potentially linked to Zantac.
According to lawyers, doctors told several people diagnosed with cancer after taking Zantac that they had no family history or genetic markers for the disease.
- Bladder cancer and bladder removal
- Breast cancer
- Colon cancer
- Esophageal cancer
- Kidney cancer and kidney removal
- Liver cancer
- Ovarian cancer
- Prostate cancer
- Stomach cancer
Status of Lawsuits
As of Oct. 15, 2020, there were 539 Zantac cancer lawsuits pending in federal court in Florida. Because millions of people may have taken Zantac, lawyers expect many more cases.
The litigation is in the initial stages, and so far there have been no settlements or trials scheduled. The judge has mapped out the procedures for picking bellwether trials, and that may happen in late 2021 or early 2022, according to a pretrial order filed on May 28, 2020. But the COVID-19 pandemic may delay the process.
How Much Is a Zantac Lawsuit Worth?
How much a Zantac lawsuit is worth varies depending on the type of cancer and amount of damages a person incurred because of it. Damages include loss of income, medical bills and other expenses.
Typically, jury awards from bellwether cases help determine how much a case is worth. But Zantac manufacturers can choose to offer a settlement before then.
14 Cited Research Articles
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- Adamson, R.H. & Chabner, B.A. (2020). The Finding of N‐Nitrosodimethylamine in Common Medicines. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7288647/#onco13312-bib-0017
- In Re: Zantac (Ranitidine) Products Liability Litigation. (2020, May 28). Pretrial Order #24. Retrieved from https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2020-05-28-Order.pdf
- Lewis, T. (2019, October 28). What We Know about the Possible Carcinogen Found in Zantac. Retrieved from https://www.scientificamerican.com/article/what-we-know-about-the-possible-carcinogen-found-in-zantac/
- Michaud, D.A. et al. (2004). Peptic ulcer disease and the risk of bladder cancer in a prospective study of male health professionals. Retrieved from https://pubmed.ncbi.nlm.nih.gov/14973090/
- O’Neal v. Boehringer Ingelheim Pharmaceuticals et al. (2020, January 10). Complaint and Demand for Jury Trial. Retrieved from https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2020-1-10-zantac-oneal-complaint.pdf
- U.S. Food and Drug Administration. (2019, November 1). Laboratory Tests|Ranitidine. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-tests-ranitidine
- U.S. Food and Drug Administration. (2020, April 1). FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
- U.S. Food and Drug Administration. (2020, April 1). Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac
- United States Judicial Panel on Multidistrict Litigation. (2020, October 15). MDL Statistics Report - Distribution of Pending MDL Dockets by District. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-October-15-2020.pdf
- Valisure. (2019). Ranitidine Investigation Summary. Retrieved from https://www.valisure.com/wp-content/uploads/SUMMARY-of-Ranitidine-investigation-v1.8.pdf
- Valisure. (2019, September 9). Valisure Citizen Petition on Ranitidine. Retrieved from https://www.valisure.com/wp-content/uploads/Valisure-Ranitidine-FDA-Citizen-Petition-v4.12.pdf
- Valisure. (n.d.). Valisure Detects NDMA in Ranitidine. Retrieved from https://www.valisure.com/blog/valisure-news/detection-of-ndma-in-raniditine/
- Young, K.D. (2020, May 12). Ranitidine did not show higher cancer risk than famotidine in study. Retrieved from https://www.mdedge.com/clinicianreviews/article/222118/gastroenterology/ranitidine-did-not-show-higher-cancer-risk
- Zeng, T. & Mitch, W.A. (2016, March 18). Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine. Retrieved from https://academic.oup.com/carcin/article/37/6/625/1744630