Carl Williams has been taking Zantac for 30 years to relieve antacid discomfort.  The drug, otherwise known by its chemical name, ranitidine, is a popular antacid medication. Unfortunately, it also can cause cancer. Williams did not know this to be true of Zantac, but he claims that the drug’s manufacturers were aware of the drug’s cancer risks, and they intentionally hid this information from consumers. He now has bladder cancer.

Williams is suing Zantac manufacturers for their negligence and failure to warn him about the risks he was taking by using their drug.

How Zantac Causes Cancer

When ranitidine is consumed and digested by the human body, it generates startling quantities of N- Nitrosodimethylamine (NDMA) by “reacting with itself,” according to Williams’ complaint, Civil Action No:  9:20cv80737. NDMA has been classified as a probable human carcinogen by both the Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC).

According to a public health statement issued by the U.S. Centers for Disease Control & Prevention (CDC), NDMA was at one time intentionally produced to manufacture rocket fuel. This application of the substance was halted upon discovery that large traces of the compound were discovered in soil samples, water, and air surrounding the rocket fuel plant. The compound also forms as an unintentional by-product in other industrial processes.

The CDC further reports that animals’ exposure to even lower levels of NDMA over a period of more than a few weeks, resulted in liver cancer and lung cancer, as well non-cancerous liver damage occurred, adding its conclusion that “…it is reasonable to expect that exposure to NDMA by eating, drinking, or breathing could cause cancer in humans.”

Starting in 1980, manufacturers of products with unsafe levels of NDMA were recalled, sometimes voluntarily and sometimes involuntarily, as ordered by the FDA.

FDA Involvement

The U.S. Food and Drug Administration (FDA) found that ranitidine products, like Zantac, experience levels of NDMA that increase over time when exposed to heated environments for at least five days—a common condition of shipping and warehousing the drug.  Later research revealed that NDMA could result from normal temperatures and storage conditions.

According to the claim filed against Zantac manufacturers, the FDA’s allowable daily limit of NDMA is 92 ng (nanograms). The complaint asserts that a single dose of Zantac can contain over 3 million ng of the deadly compound.

The FDA issued a warning about NDMA in ranitidine in September 2019. Various pharmacies and drug stores removed the product from their shelves. This was the first time Williams heard anything about Zantac’s connection to cancer.

The following month, the agency ordered all ranitidine product manufacturers to test their products for NDMA.

In April 2020, the FDA officially requested the removal of all ranitidine products from the market. The agency went on to advise consumers to cease taking any over-the-counter ranitidine, dispose of the products they had on hand, and refrain from purchasing any more of this drug in the future.

The Lawsuit

This information came much too late to help Williams. He had been ingesting ranitidine for three decades with no knowledge of its harmful outcomes. He is now suing the following defendants for their negligence:

  • Boehringer Ingelheim Pharmaceuticals, Inc. (“BI”)
  • Defendant Sanofi US Services Inc.
  • Chattem, Inc
  • Pfizer, Inc.
  • GlaxoSmithKline, LLC

Williams’ complaint reinforces that while the defendants were making and selling Zantac in the U.S., scientific evidence had already pointed to the product’s unsafe NDMA levels. The lawsuit calls the defendants out for failing to disclose this vital information to the public—whether via product labeling or some other means—and for not reporting the risks to the FDA.

The plaintiff is seeking punitive damages against the defendants, claiming their actions were born, not of “justifiable negligence,” but rather greed and “conscious disregard of Plaintiff’s rights.”

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Sara Stephens is a freelance writer who has developed a hefty portfolio of work across several industries, with a strong emphasis on law, technology, and marketing. Her work has appeared in the New York Times, as well as various technology and consumer publications, both print and online. Sara also works as a freelance book editor, having developed and edited manuscripts for bestselling and novice authors alike, and as a verbal strategist for a Miami branding consultancy.