A Miami man alleges in his Zantac lawsuit that the popular heartburn and acid reflux treatment caused him to develop breast cancer, a disease not commonly diagnosed in men. The complaint attributes the diagnosis to the drug being tainted with N-Nitrososdimethylamine (NDMA), a compound that has been identified as a probable human carcinogen. Named as defendants in the Zantac lawsuit are Sanofi US Services LLC and related companies as well as Publix Super Markets Inc., NBC Miami reports.

According to the lawsuit, the chance of a man developing breast cancer is extremely low and amounts to about one diagnosis out of every 833 men. The plaintiff, Joseph G., believes the NDMA — which under laboratory testing conditions was found to have in excess of 3 million ng per tablet—wreaked havoc on his anatomy and gave rise to the rare cancer which is expected to affect 2,670 men in 2019.

The Zantac lawsuit indicated the U.S. Food and Drug Administration (FDA) set a limit beyond which the body could not handle or eliminate. This limit was identified as 96ng daily. Since 2009, Joseph G. had been regularly taking the reflux medicine under assurances that it was safe and without any warnings to the contrary by the manufacturers.

Joseph’s Story

Zantac had been approved by the FDA as early as 1983 and became a bestseller within four years. Joseph G. says he started taking Zantac in 2009 for frequent heartburn and acid reflux and continued to use it through 2018 and possibly into 2019. In the winter of 2013, he was diagnosed with male breast cancer and underwent a mastectomy followed by rounds of chemotherapy.

FDA Warns of NDMA

According to a Sept. 16, 2019, Law360 article, the timing of this legal filing follows an FDA warning about low levels of NDMA in Zantac, known generically as ranitidine. Although not technically a class action, plaintiff’s counsel indicated that he expects ‘tens of thousands’ of people to join the case in the coming weeks.

What is NDMA?

As indicated by the lawsuit, NDMA is a ‘volatile, combustible, yellow, oily liquid nitrosamine.’ It is allegedly used in laboratory research to induce cancerous tumors. A World Health Organization (WHO) report says that NDMA can be a powerful carcinogen in laboratory animals when ingested in a variety of ways including drinking water.

Other Sources

According to the Minnesota Department of Health, NDMA is often found in the environment as a byproduct of industrial processes. It has been found helpful, however, in preventing waterborne illnesses and is used in small amounts to disinfect water. NDMA is also found in many processed foods and drinks such as bacon, sausage, cheeses, whiskey, and beer.

The Sanofi US Services et al. Lawsuit is Case No. 95707176 in the Circuit Court of the 11th Judicial Circuit In and For Miami-Dade County, Florida.