A New Jersey man who claims taking Zantac three times a week for five-plus years caused him to get prostate cancer has filed a lawsuit against the drug’s manufacturers, Boehringer Ingelheim Pharmaceuticals Inc., Chattem Inc., Sanofi-Aventis US LLC, and Sanofi US Services Inc.

William M. filed his Zantac cancer lawsuit in New Jersey federal court on Dec. 2. He alleges that Zantac produces N-Nitrosodimethylamine (NDMA), an impurity that the U.S. Food and Drug Administration (FDA) has classified as a probable human carcinogen. William M. claims that the manufacturer and related companies were well aware of this fact yet continued to commercially push the medication. According to the suit, NDMA levels in each Zantac dose are thousands of times higher than what the FDA has set as a maximum daily limit.

The Zantac cancer lawsuit also states that the way the body metabolizes NDMA can damage the DNA and initiate mutations into the DNA sequence, causing chromosomes to split.

Why is Zantac Taken?

As indicated by WebMD, Zantac—known generically as ranitidine—is an over-the-counter medication often used to treat heartburn or acid reflux. Physicians also prescribe Zantac for conditions such as stomach and intestinal ulcers, and prevention of their return, as well as gastroesophageal reflux disease (GERD) and esophagitis.

According to Everydayhealth.com, Zantac is part of a drug class known as H2 blockers which halt the production of stomach acid. It has some additional preventative uses such as keeping the stomach from being damaged by the regular ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) and keeping a patient from aspirating stomach acid in an anesthetized state.

The lawsuit notes news reports from September stating that Zantac, on the market since 1984, exposes consumers to massive doses of NDMA. Health regulators around the world sounded a unified alarm regarding the warning which purportedly should not have been new to the drugmaker but was eye-opening to the medical community and the public. A number of countries have pulled ranitidine products from shelves. In the U.S, manufacturers have done the same or recalled the medication altogether. The FDA has allegedly downplayed the seriousness of the revelation by claiming the exposure to ranitidine is low.

The FDA has set the acceptable level of NDMA to 96 ng daily or 35,040 ng annually. According to recent testing, the exposure level of a patient taking a daily 150 mg dose of Zantac would be 889,000,000 ng over the course of a year.

The complainant accuses the defendants of violating the New Jersey Products Liability Act and engaging in battery and fraud by omission. He is seeking both compensatory and punitive damages.