Zantac® Lawsuits: Here’s What You Need to Know

At their worst, defective drugs can be lethal; at their best, they can cause adverse health effects that can leave the victim injured or permanently disabled. That’s why drug manufacturers of both prescription and over-the-counter drugs have a legal obligation towards the consumers, known as their duty of care. Thus, pharmaceutical companies must ensure that their products are safe and will not produce dangerous, unexpected side effects.

Time and again, however, pharmaceutical companies fail to live up to this standard. Through negligent or willful lack of appropriate care and caution, some drug manufacturers release medicines that are defective and potentially harmful. Unfortunately, such incidents are not isolated. According to statistics, between 2012 and 2019, there was a yearly average of more than 1,400 drug recalls as a result of regulatory activities taken by the Food and Drug Administration (FDA) to protect the public from potentially dangerous drugs.

Sadly, some drugs and their harmful side effects only come to the attention of lawmakers and regulatory agencies after years or decades of circulating the market. In many such circumstances, action is taken only after concerns are raised by people whose life and health have been irreversibly altered due to the long-term use of a defective drug.

Recently, these concerns have been raised about a popular heartburn drug, Zantac®, and many of its generic versions. This has led to a large number of market recalls and lawsuits against the drug manufacturer. Read on to learn more about this developing story and discover how you might be affected.

What is Zantac®?

Zantac® is a heartburn medication based on a substance called ranitidine. It was first approved by the FDA in 1983 and achieved great popularity with both doctors and patients in a relatively short time. By 1988, it became the world’s best-selling drug and one of the first medicines to surpass $1 billion in annual sales. 

Over time, this popularity turned into a decades-long trend. In the past decade, Zantac® was on the list of the 100 most-prescribed drugs every year. In 2019, it was estimated to have been prescribed more than 15 million times per year in the US alone. It is expected, though, that sales of the over-the-counter versions of this Zantac® and similar drugs greatly surpass that number as heartburn is an ailment experienced by more than 60 million Americans at least once a month.

Even though all drugs have some undesirable side effects, Zantac® was generally considered to be a very safe drug. For example, one study that reviewed the effects of a drug based on 189 clinical trials conducted over a decade with the combined sample of more than 26,000 patients concluded that the drug had an “excellent safety profile.” That perception, however, began to shift dramatically in September of last year.

The Controversy

The controversy began in September 2019, when the FDA issued a warning concerning Zantac® and other drugs based on ranitidine. The reason for the warning was that the drugs were found to contain nitrosamine impurity called N-nitrosodimethylamine (NDMA). This was concerning as NDMA is a known human carcinogen or, in other words, a substance that can cause cancer. While NDMA is often present in food products such as meat, dairy, and vegetables, a daily intake of NDMA surpassing 96 nanograms over long periods is considered to be dangerous.

Some of the ranitidine drugs tested by the FDA were found to contain dangerous levels of NDMA which led to both mandatory and voluntary recalls of Zantac® and similar medicines. Although the FDA initially ordered a recall of only a few brands of the drug, on April 1, 2020, the agency ordered the removal of all ranitidine products from the market. The decision was taken after an ongoing investigation had shown that “the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels” of NDMA.

The Lawsuits

The action taken by the FDA raised serious concerns among many Americans who had been taking Zantac® and similar drugs for years or even decades. Based on the FDA’s findings, some individuals now believe that they have developed cancer due to long-term use of ranitidine. 

As of early May, this led to about 230 lawsuits filed in the federal court system with allegations of negligence or recklessness on the part of Zantac® manufacturers. Specifically, plaintiffs “allege that the companies that made and sold Zantac® knew its active ingredient, ranitidine, metabolized in the human body to form a carcinogen known as N-nitrosodimethylamine, or NDMA.”

The number of lawsuits related to Zantac® cancer claims is rapidly growing and individual cases are being consolidated into class actions. Many personal injury law firms are still accepting new cases from people who might have developed cancer due to ranitidine use. In addition, US District Judge Robin Rosenberg, who is currently overseeing the consolidated litigation, decided that the proceedings will continue despite the COVID-19 pandemic. 

The outcome of this litigation remains to be seen. Yet, if you or a family member suffered injuries or disability due to cancer that might have been caused by Zantac® or a similar ranitidine drug, please visit our dedicated Zantac® page.

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