Zantac Lawsuit

Federal health regulators recently warned that prescription and over-the-counter versions of Zantac (ranitidine) had tested positive for the presence of N-nitrosodimethylamine (NDMA), a known human carcinogen. You may be eligible to file a Zantac lawsuit if you or someone you love developed cancer that could be related to the use of a contaminated ranitidine product.

Contact a Contaminated Zantac Lawyer Today          

The nationwide law firm of Bernstein Liebhard LLP is investigating potential legal claims involving contaminated Zantac. We would like to hear from anyone who used Zantac or its generic equivalents and was later diagnosed with cancer, including

  • Esophageal Cancer
  • Colon Cancer
  • Intestinal Cancer
  • Kidney Cancer
  • Liver Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • Stomach Cancer
  • Testicular Cancer

To contact a Zantac lawyer for your free, no-obligation legal review, please fill out the form on this page, or contact our office today at (888) 994-5118.

What is Zantac?

Zantac is an acid-reducing H2 (histamine) blocker that contains the active ingredient ranitidine.

More than 15 million people are prescribed Zantac or a generic equivalent every year to treat GERD, peptic ulcers, and other digestive disorders related to the excess production of stomach acid. Millions more use over-the-counter versions of Zantac or ranitidine to control heartburn.

Sanofi-Aventis currently holds the license to market name-brand Zantac in the United States. However, Boehringer Ingelheim Pharmaceuticals held the license from October 2006 through January 2017.

Various generic drug makers also market prescription and over-the-counter versions of ranitidine.

FDA Zantac Warning

On September 9, 2019, the online pharmacy company Valisure informed the U.S. Food & Drug Administration (FDA) that every sample of Zantac and ranitidine it had tested contained NDMA. While the agency’s daily intake limit for NDMA is 96 ng, Valisure  detected as much as  3,000,000 ng per tablet. That’s more than 26,000 times higher than the limit set by the FDA!

Four days later, the FDA issued a public warning for contaminated Zantac. While the agency insisted the levels of NDMA detected in the samples posed little risk, it also urged consumers using over-the-counter versions of Zantac or ranitidine to consider switching to another heartburn medication.  Those taking prescription versions should speak with their doctor before stopping treatment, as doing so could worsen their condition.

Zantac Recalls

The FDA did not order a Zantac recall, despite urgings from Valisure that it do so.

However, just days later, Novartis’ Sandoz unit halted worldwide distribution of its generic ranitidine products as a precautionary measure. According to a statement from Health Canada, the company was also recalling its prescription oral version of ranitidine after testing found it contained NDMA levels “above what is considered acceptable.”

The Canadian regulator also asked every company making brand-name and generic ranitidine products to stop distribution in that country. However, a spokesperson for Sanofi-Aventis told Bloomberg News that it wouldn’t be halting distribution of Zantac or other ranitidine-containing drugs in any country outside of Canada.

Several countries in the European Union also recalled generic Zantac products manufactured by India-based Saraca Laboratories Ltd. Germany’s Federal Institute for Drugs further indicated the contamination problems could impact other pharmaceutical manufacturers.

What is NDMA?

NDMA is a semi-volatile organic chemical compound that was once used to manufacture rocket fuel. It forms as a byproduct of certain production processes, while low levels are found in drinking water and some foods.

The U.S. Environmental Protection Agency (EPA) classifies NDMA as a probable human carcinogen, as animal studies have linked exposure to various cancers, including tumors of the liver, kidneys, and gastrointestinal tract. Research also suggests exposure to NDMA may result in non-cancerous liver damage or internal bleeding and death.

In June 2018, the discovery of NDMA in active pharmaceutical ingredients used to manufacture generic versions of valsartan and other angiotensin II receptor blockers led to dozens of drug recalls in the United States and 22 other countries. The ingredient that triggered the valsartan recalls was supplied by overseas manufacturers based in China and India. The FDA later determined that NDMA was a byproduct of the manufacturing process that occurred when the companies altered their production methods four years earlier.

Zantac Lawsuit Filings

Within days of the FDA’s warning, Zantac lawsuit filings began to mount in courts around the United States.

Among other things, the complaints claim that ranitidine actually metabolizes into NDMA when ingested, and suggests the risks associated with the medication remained hidden for over 40 years. Although Sanofi-Aventis and Boehringer Ingelheim were allegedly aware of these dangers, they failed to warn the public out of a desire to protect the profits derived from sales of Zantac.

“Had Defendants disclosed that Zantac results in unsafe levels of NDMA in the human body, no person, let alone a reasonable person, would have purchased and consumed Zantac,” one such complaint states.

Learn More About Filing a Zantac Lawsuit

While no amount of money can make up for a cancer diagnosis, compensation from a Zantac lawsuit would ensure you have the financial resources to cover all of your injury-related damages, including:

  • Past and future medical bills
  • Past and future lost wages
  • Pain and suffering
  • Emotional distress
  • Loss of enjoyment of life
  • Loss of consortium (for spouse)
  • Wrongful death (if you lost a loved one to cancer)

To learn if you qualify to file a Zantac cancer lawsuit, give us a call today (888) 994-5118.

The consultation is free and because we represent all of our clients on contingency, you won’t owe any legal fees unless your case is successful and our Zantac lawyers win compensation on your behalf.

  1. FDA (April 2009) “Zantac: Prescribing Information” https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf
  2. Sanofi-Aventis (2017) “Zantac OTC” https://www.zantacotc.com/heartburn-treatments.html?gclid=CjwKCAjwq4fsBRBnEiwANTahcCj-XOCSNE4ZaLbsEoBEU6aLBiY78NZ8hrx06r6RAqv1LeQC3w492BoCdWkQAvD_BwE
  3. Valisure (September 2019) “Valisure Citizen Petition on Ranitidine”  https://www.valisure.com/wp-content/uploads/Valisure-Ranitidine-FDA-Citizen-Petition-v4.12.pdf
  4. FDA (September 2019) “Zantac (ranitidine): Safety Information – NDMA Found in Samples of Some Ranitidine Medicines” https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/zantac-ranitidine-safety-information-ndma-found-samples-some-ranitidine-medicines
  5. Bloomberg (September 2017) “Carcinogen Scare Sets Off Global Race to Contain Tainted Zantac” https://www.bloomberg.com/news/articles/2019-09-18/sandoz-halts-distribution-of-zantac-after-carcinogen-concerns
  6. Health Canada (September 2017) “Health Canada requests that companies stop distributing ranitidine drugs in Canada while it assesses NDMA; some products being recalled”  https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/71029a-eng.php
  7. EPA (January 2014) “Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA)” https://www.epa.gov/sites/production/files/2014-03/documents/ffrrofactsheet_contaminant_ndma_january2014_final.pdf
Last Modified: September 24, 2019

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