Written By : Michelle Llamas
Edited By : Sophia Clifton
This page features 20 Cited Research Articles
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Why Are People Filing Zantac Lawsuits?

People are suing because they claim drugmakers knew that Zantac could form N–Nitrosodimethylamine (NDMA) and potentially cause cancer. Companies put profits before patient safety and failed to warn the public.

As far back as the early 1980s, drugmakers had access to scientific evidence showing that ranitidine contained a compound that could form NDMA when combined with other substances in the body. Zantac cases claim ranitidine is a defective drug because it contains ingredients that may form NDMA.

People diagnosed with cancer after taking Zantac made with ranitidine may be able to file a lawsuit for compensation including lost wages, medical expenses and pain and suffering. Family members who lost loved ones to cancer potentially caused by ranitidine can file wrongful death claims.

An experienced lawyer can help you gather your medical records and the necessary evidence to help prove your cancer was caused by ranitidine. They can help you put forth your strongest case for potential compensation.

Has Zantac Been Recalled?

In September 2019, ranitidine manufacturers voluntarily recalled their products after the FDA found NDMA in some batches of the drug. Then, in April 2020, FDA requested all Zantac and ranitidine manufacturers withdraw all products from the U.S. market after it found NDMA levels in ranitidine may increase over time at room temperature and when exposed to above average room temperatures.

Only manufacturers of brand name Zantac made with ranitidine — including Sanofi, Boehringer Ingelheim, Chattem, Pfizer and GlaxoSmithKline —are involved in lawsuits currently. Generic companies are protected from liability by preemption.

For a complete list of lot numbers and recalled products, please check the FDA’s ranitidine recall page.

Some of the first manufacturers to issue recalls for all Zantac and generic ranitidine products include:
  • Sanofi
  • Sandoz
  • Apotex
  • Perrigo
  • Dr. Reddy’s Laboratories
  • Lannett Company, Inc.
  • Novitium Pharma, LLC
  • Aurobindo Pharma ISA
  • American Health Packaging
  • Golden State Medical Supply
  • Precision Dose, Inc.
  • Amneal Pharmaceuticals
  • Glenmark Pharmaceutical, Inc.
  • Denton Pharma dbd Northwind Pharmaceuticals
  • Appco Pharmaceuticals LLC

Over-the-counter and prescription ranitidine products are no longer allowed to be sold in the U.S.

Sanofi re-released a new version of over-the-counter Zantac 360 made with famotidine, the same ingredient in Pepcid. Zantac 360 is available wherever over-the-counter medicines are sold.

Does Zantac Cause Cancer?

There aren’t enough studies to say without a doubt that the ranitidine in 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 published in January 2021 in the Journal of Clinical Medicine found no evidence that exposure to NDMA through ranitidine increases cancer risk. Two other 2021 studies also found no link between gastrointestinal or gastric cancer and ranitidine.

How Much NDMA Is in Zantac?

There is no NDMA in the new formula of Zantac made with famotidine, and only Zantac made with ranitidine was found to have NDMA. Levels of the toxic chemical vary across batches of recalled Zantac products. 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. In April 2020, FDA confirmed that its lab tests showed that time and temperature raise the level of NDMA in some ranitidine products above 96 ng.

Why Was NDMA Found in Ranitidine?

Unlike other drugs that were recalled for containing NDMA, such as valsartan, studies and lawsuits suggest that the NDMA in Zantac (ranitidine) is not a product of contamination during manufacturing. Rather, they suggest that ranitidine itself is capable of producing NDMA under certain conditions.

For example, FDA’s lab tests suggest that NDMA wasn’t formed in the stomach or the intestines, and that levels of NDMA in some ranitidine products increase over time at room temperature and increased temperatures.

An analysis published in January 2021 in JAMA suggests that NDMA in ranitidine increases under simulated conditions that mimic the stomach.

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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.

Cancers linked to Zantac in lawsuits include:
  • Bladder cancer or bladder removal
  • Breast cancer
  • Colon cancer
  • Esophageal cancer
  • Kidney cancer and kidney removal
  • Liver cancer
  • Melanoma
  • Ovarian cancer
  • Prostate cancer
  • Stomach cancer

Status of Zantac Litigation

As of Aug. 13, 2021, there were 716 Zantac cancer lawsuits pending in federal court in Florida. Because millions of people may have taken Zantac, lawyers expect many more cases.

COVID-19 delayed the original trial schedule, and the first bellwether trials may begin in early 2023, according to a June 2021 order.

Zantac Lawsuits Consolidated Into MDL

In February 2020, the United States on Multidistrict Litigation consolidated all Zantac (ranitidine) lawsuits into multidistrict litigation (MDL) in the Southern District of Florida.

At the time, there were 15 lawsuits in nine districts across the country that alleged ranitidine could break down and form NDMA. Six of those cases were looking for refunds for their Zanatc purchases and nine claimed injury claims.

According to judges, creating the MDL would streamline the process and allow the cases to share all documents produced for discovery, prevent inconsistent rulings and conserve resources. This potentially translates to a quicker litigation resolution and lower costs, especially when there are hundreds of plaintiffs involved in Zantac litigation.

Zantac Lawsuit Settlements

The litigation is in the initial stages, and so far there have been no settlements or trials scheduled. It’s difficult to say how much an individual case is worth because the amount 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.

Please seek the advice of a qualified professional before making decisions about your health or finances.
Last Modified: September 20, 2021

20 Cited Research Articles

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  1. 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
  2. Braunstein, L.Z. et al. (2021, January 29). Analysis of Ranitidine-Associated N-Nitrosodimethylamine Production Under Simulated Physiologic Conditions. Retrieved from https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2775727
  3. Cardwell, C. et al. (2021, August). Exposure to Ranitidine and Risk of Bladder Cancer: A Nested Case-Control Study. Retrieved from https://journals.lww.com/ajg/Citation/2021/08000/Exposure_to_Ranitidine_and_Risk_of_Bladder_Cancer_.14.aspx
  4. In Re: Zantac (Ranitidine) Products Liability Litigation. (2020, February 06). Transfer Order. Retrieved from https://www.flsd.uscourts.gov/sites/flsd/files/TransferOrder-20md2924.pdf
  5. In Re: Zantac (Ranitidine) Products Liability Litigation. (2021, June 14). Pretrial Order #65. Retrieved from https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2021-06-14-Order.pdf
  6. Kim, Y.D. et al. (2021, July 12). No association between chronic use of ranitidine, compared with omeprazole or famotidine, and gastrointestinal malignancies. Retrieved from https://onlinelibrary.wiley.com/doi/10.1111/apt.16464
  7. Kumar, S. (2021, April 15). Ranitidine Use and Gastric Cancer Among Persons with Helicobacter pylori. Retrieved from https://link.springer.com/article/10.1007/s10620-021-06972-w
  8. 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/
  9. 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/
  10. 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
  11. 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
  12. 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
  13. 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
  14. United States Judicial Panel on Multidistrict Litigation. (2021, August 13). 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
  15. Valisure. (2019). Ranitidine Investigation Summary. Retrieved from https://www.valisure.com/wp-content/uploads/SUMMARY-of-Ranitidine-investigation-v1.8.pdf
  16. 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
  17. Valisure. (n.d.). Valisure Detects NDMA in Ranitidine. Retrieved from https://www.valisure.com/blog/valisure-news/detection-of-ndma-in-raniditine/
  18. Yoon, H.J. et al. (2021, January 5). Risk of Cancer Following the Use of N-Nitrosodimethylamine (NDMA) Contaminated Ranitidine Products: A Nationwide Cohort Study in South Korea. Retrieved from https://pubmed.ncbi.nlm.nih.gov/33466237/
  19. 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
  20. 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