Zantac MDL Judge To Consider Motion to Dismiss Amended Medical Monitoring Class Action

The U.S. District Judge presiding over all federal Zantac lawsuits will hold a hearing early next month to decide whether certain class action claims filed by plaintiffs, which seek to to force makers of the recalled heartburn drug to pay medical monitoring costs to watch for potential future cancer cases, can move forward or will be dismissed.

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 carcinogen.

Over the past year, thousands of individuals have filed lawsuits alleging they developed cancer from Zantac side effects, but the drug makers also face a number of class action complaints seeking damages on behalf of 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.

After Judge Rosenberg issued pretrial rulings granting the manufacturers’ motion to dismiss certain Zantac class action claims earlier this year, the door was left open for the plaintiffs to amend and refile certain pleadings.

Plaintiffs amended two of the class action complaints seeking medical monitoring and refiled. However, last month, defendants filed a motion to dismiss (PDF) the complaints yet again, on a number of different grounds. The main thrust of the motion claims the state-law failure to warn lawsuits are preempted by federal law, since the FDA approved ranitidine and its label warnings.

In a response (PDF) filed in opposition to the motion on September 9, plaintiffs pointed out that Zantac was recalled due to levels of NDMA that exceed the FDA’s Acceptable Daily Intake threshold, which they argue should prevent the manufacturers from hiding behind the FDA’s prior decision to approve the drug.

In an order (PDF) issued on September 27, Judge Rosenberg announced the court will hold a hearing on the motions to dismiss on October 4 via Zoom conference due to the ongoing pandemic. Each side will be allowed 15 minutes to make arguments on each motion, and are not allowed to raise new arguments at that time.

The order calls for the parties to submit a list of presenters for the hearing by October 1.

Zantac Cancer Risks

The litigation over Zantac 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 Zantac cancer risk 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.

If the parties fail to reach Zantac settlements or another resolution for the cases following discovery and bellwether trials held before Judge Rosenberg, thousands of individual cases may end up remanded back to U.S. District Courts nationwide for individual trial dates in the coming years.