Direct Filing of Zantac Class Action Lawsuits Permitted in Federal MDL

The U.S. District Judge presiding over all Zantac lawsuits has approved a process for the direct filing of class action complaints and pleadings directly in the federal multidistrict litigation (MDL), which was established last year to help manage the growing number of claims brought on behalf of former users of the recalled heartburn drug.

All versions of Zantac and generic ranitidine were removed from the market, after independent researchers discovered that the active pharmaceutical ingredient may convert to high levels of a potent human carcinogen, known as N-nitrosodimethylamine (NDMA), either when stored at high temperatures or as the pills pass through the body.

Over the past year, thousands of individuals nationwide have filed Zantac class action lawsuits or personal injury claims, alleging that years of exposure to the chemical placed them at an increased risk of developing breast cancer, prostate cancer, pancreatic cancer, stomach cancer or other injuries.

Given common allegations and claims raised in the complaints, the federal litigation is currently centralized before U.S. District Judge Robin L. Rosenberg in the Southern District of Florida, who is presiding over coordinated discovery and pretrial proceedings.

In a pretrial order (PDF) issued on March 22, Judge Rosenberg outlined procedures for the direct filing of all class action pleadings that otherwise would have been brought in U.S. District Courts nationwide.

“To eliminate potential delays associated with transfer to this Court of putative class action cases filed in or removed to other federal district courts, and to promote judicial efficiency, the Master Class Action Complaints identified in this Order, having been filed directly in this District as a member case of the MDL, may proceed subject to the provisions set forth below,” according to the order, which also directs the defendants to file a Master Answer, as opposed to filing responsive pleadings in each case.

Direct filing is intended to streamline the process for managing the litigation, and addressing motions that may be common to many different claims. Although all current and future claims can be brought in the Southern District of Florida, the order notes it will be the venue for pretrial purposes only, and the parties preserve their right to have each case remanded to the forum where it would have originally been filed for trial, if settlements are not reached during the MDL proceedings.

Zantac Cancer Risks

The Zantac litigation 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.

As part of the coordinated pretrial proceedings before Judge Rosenberg, it is expected that a “bellwether” program will be established, where a small group of representative claims will be prepared for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the claims.

While the outcome of such early trials will not be binding in other cases, they may help the parties reach Zantac settlements, avoiding the need for potentially hundreds or thousands of individual trials in courts throughout the U.S. federal court system.