Millions of people have taken Zantac® or ranitidine (the generic counterpart to or active ingredient in Zantac®) to treat ulcers, acid reflux, and the occasional bout of heartburn. Traditionally viewed as an extremely safe medication, ranitidine has been available with a prescription or over-the-counter for years. But recent testing has revealed a potential link between the use of these medications and the development of cancer.
Hundreds of civil lawsuits have been filed against the manufacturers of ranitidine products, and in April of 2020, the U.S. Food and Drug Administration (FDA) announced a request that manufacturers withdraw all ranitidine drugs (whether prescription or over-the-counter) from the market.
Let's take a look at health and legal issues related to Zantac® and ranitidine, and the current state of litigation involving this popular medication.
In 2019, Valisure (which bills itself as an "online analytical pharmacy") conducted tests of commonly-available medications containing ranitidine. They found that taking these medications could create high levels of N-Nitrosodimethylamine (NDMA) in the body. NDMA is a substance that the FDA treats as a "probable carcinogen."
NDMA is probably safe in small amounts. After all, it’s found in a number of foods many of us eat, including smoked meats. However, in high enough doses, there’s a chance NDMA causes cancer in people. The crux of the debate hinges on how much NDMA the body receives when taking a typical dose of Zantac®/ranitidine.
Depending on the testing method, a typical over-the-counter dose of Zantac® could potentially expose an individual to anywhere between 200 and 20,000 times the amount of NDMA that the FDA says is safe. However, in its own earlier testing, the FDA announced that "the levels of NDMA in ranitidine and nizatidine are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats."
Then came the FDA's April 2020 request that all ranitidine products be pulled from the market, which was accompanied by the agency's finding 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 this impurity." Prior to that FDA announcement, a number of manufacturers of these drugs had voluntarily recalled their products, and some stores (including pharmacies like CVS) had taken ranitidine products off their shelves.
The connection between ranitidine and potentially unsafe levels of NDMA in people is a relatively new development. So lawsuits over diagnosed health problems possibly linked to use of Zantac®/ranitidine are just beginning.
The initial wave of lawsuits began in late 2019. However, the majority of these early cases did not involve allegations that Zantac® or a generic ranitidine drug caused cancer. Instead, the plaintiffs made legal arguments based on consumer protection laws. For example, a common argument was that manufacturers of ranitidine medication are liable for not properly warning consumers of the risks associated with their products. Some of these cases seek class-action status.
Lately, lawsuits alleging that ranitidine causes cancer have begun to gather steam. For example, in a Colorado federal court case called Blake v. Boehringer Ingelheim Pharmaceuticals, Inc., et al., the plaintiff claims that the Zantac® he took for decades caused his bladder cancer.
The Blake case and other ranitidine-related lawsuits are just getting started. These types of lawsuits can last for a number of years.
What may happen is that many or most Zantac® and ranitidine lawsuits will consolidate into MDL, or multi-district litigation. This is a special procedure in federal civil court, in which a single judge handles the pretrial matters of lawsuits that share similar facts and defendants.
The goal of MDL is to allow more efficient litigation and make it easier for all of the cases to settle. But before a settlement takes place, a few "test" trials will occur, commonly known as "bellwether" trials. The judge overseeing an MDL will choose a small number of cases that provide a broad representation of all lawsuits in the MDL. How each bellwether case turns out will then serve as an indicator of what all parties involved in the MDL can expect should they go to trial. For instance, if all the bellwether cases result in defense verdicts, the defendants may be more inclined to go to trial, or to not budge off of a low settlement offer. But if many or most of these bellwether trials result in massive jury verdicts in favor of the plaintiffs, then claimants know they have the upper hand in settlement talks.
Medications containing ranitidine are still available for sale in the United States. But as awareness of the potential cancer risks spread, it's safe to expect the number of ranitidine and Zantac® lawsuits to rise. If you're experiencing health problems that could be linked to your use of these medications, it might make sense to discuss your situation with a Zantac/ranitidine lawyer.