Class Action Claims to Monitor For Zantac Cancer Diagnosis Cleared To Proceed

The U.S. District Judge presiding over all federal Zantac lawsuits has cleared the way for certain class action claims to move forward, which seek to force the manufacturers of the recalled heartburn drug to cover the costs of medical monitoring for cancer and other injuries that may result from the exposure to chemical contaminants found in pills.

Zantac (ranitidine) was a popular heartburn treatment used by millions of Americans before it was removed from the market in late 2019, following the discovery that the active pharmaceutical ingredient is inherently unstable, and produces high levels of the chemical byproduct N-Nitrosodimethylamine (NDMA), which is a known human carcinogen.

Over the past year, thousands of individuals have filed individual injury lawsuits alleging they developed cancer from Zantac side effects. However, the drug makers also face a number of Zantac class action complaints that seek damages for certain groups of individuals who were exposed to the medications, but have not yet been diagnosed with an injury.

Given common questions of fact and law raised in the litigation, cases filed throughout the federal court system have been centralized before U.S. District Judge Robin Rosenberg in the Southern District of Florida, as part of an MDL or multidistrict litigation.

Following a ruling earlier this year by Judge Rosenberg, which granted the manufacturers’ motion to dismiss certain Zantac class action claims, plaintiffs amended the complaints regarding medical monitoring and other causes of action, which led to the drug makers to file another motion to dismiss on several different grounds; primarily claiming failure to warn lawsuits filed under state laws were preempted by federal law, since the FDA approved ranitidine and its label warnings.

However, after a hearing on the renewed motion to dismiss was held on October 4, Judge Rosenberg issued an order (PDF) rejecting the defendants’ arguments, indicating class action lawsuits calling for Zantac cancer monitoring are now sufficiently pled to move forward in the litigation. On the same day, the Court issued another order (PDF) allowing class action claims over economic losses stemming from the recall to also proceed forward.

The drug makers attempted to argue that the amended class action complaints failed to establish that the Zantac pills contained high enough levels of NDMA to be a health risk that justifies a medical monitoring claim. However, the judge recognized that the FDA’s push for the Zantac recall counted as a counterargument that the claims should be pre-empted.

“Although the Plaintiffs acknowledge that the FDA initially concluded that the levels of NDMA detected in ranitidine were relatively low, at the motion to dismiss stage, they are entitled to the inference that the FDA subsequently changed its mind about the levels of NDMA in ranitidine (and corresponding risk of cancer) because the FDA called for a voluntary nationwide recall of ranitidine,” Judge Rosenberg concluded. “The Court must accept all of these allegations as true and view all reasonable inferences in favor of the Plaintiffs. The Plaintiffs’ allegations are sufficient to plead ‘significantly increased risk’ at this time.”

Zantac Cancer Risks

The litigation over Zantac cancer risks may become one of the largest active mass tort claims over the next few years, given the widespread use of the heartburn and acid reflux drug for decades before it was removed from the market late last year.

Public concerns about the link between Zantac and cancer diagnosis first emerged in September 2019, when an online pharmacy discovered that each pill may expose users to levels of NDMA that are drastically higher than the permissible and safe. The FDA has previously found that the daily safe limit for NDMA exposure is only 96 nanograms (ng). However, pills tested by the independent pharmacy found that users may be exposed to more than 3 million nanograms from each Zantac pill.

Investigations have confirmed the problems were not caused by contamination or changes in the manufacturing process, but appear to be part of the inherent molecular structure of the active pharmaceutical ingredient in Zantac, ranitidine.

Plaintiffs allege the manufacturers of Zantac knew or should have known about these problems for decades, yet aggressively marketed and sold brand-name prescription, generic and over-the-counter versions of Zantac for years, without warning users that it may cause them to develop cancer.

Following coordinated pretrial proceedings before Judge Rosenberg, if the parties fail to reach Zantac settlements or another resolution for the claims, thousands of individual cases may end up remanded back to U.S. District Courts nationwide for individual trial dates in the coming years.