Zantac Litigation Moving Forward With Interim Leadership Team, Amid Coronavirus Outbreak

The U.S. District Judge presiding over the federal Zantac recall litigation has decided to leave the current interim attorney leadership team in place for the time being, as the coronavirus pandemic prevents courts nationwide from holding in-person hearings.

Over the past few months, more than 140 product liability lawsuits and class action cases have been filed throughout the federal court system, each involving allegations that Zantac exposed users to high levels of cancer-causing chemicals. However, as Zantac lawyers continue to bring additional cases in the coming months and years, it is ultimately expected that thousands of lawsuits will be filed nationwide.

Each of the complaints raise similar allegations, indicating the active ingredient in Zantac, ranitidine, produces high levels of the known human carcinogen Nitrosodimethylamine (NDMA). Following exposure to the chemical for extended periods of time, plaintiffs claim side effects of Zantac caused them to develop bladder cancer, kidney cancer, colorectal cancer, stomach cancer and other forms of cancer along the digestive tract.

Last month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to transfer all claims filed throughout the federal court system to U.S. District Judge Robin L. Rosenberg in the Southern District of Florida, centralizing the pretrial proceedings to reduce duplicative discovery into common issues raised in the lawsuits, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and judicial system.

Originally, the Court planned to hold an initial status conference this week, and interview attorneys seeking leadership positions in the litigation. However, due to the coronavirus outbreak, those will have to be postponed until an undetermined future date.

In a pretrial order (PDF) issued on March 20, Judge Rosenberg announced that the interim leadership teams appointed several weeks ago will remain in place to keep the Zantac litigation moving forward, until the initial conference can be held and presentations for permanent leadership appointments can take place.

“As the Court continues to monitor the health crisis and act in accordance with national, local and court directives and guidance, the Court is not in a position currently to give any greater specificity as to when and how the conference and interviews will occur,” Judge Rosenberg wrote. “But the parties should be assured that the Court is working diligently to ensure that, at the soonest feasible time, the Court will give clear direction to the parties on these and all other matters governing this case.”

The order means that the current Initial Census Team, Practices and Procedures Team and Interim Defense Leadership Team will continue in their current positions, and the court advises them to confer with other counsel involved in the litigation to ensure that everyone’s interests and concerns are being heard.

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 independent pharmacy discovered that each pill may expose users to levels of NDMA that are drastically higher than the permissible daily intake limits set by the FDA.

The online pharmacy Valisure found that some 150 mg pills contained more than 3,000,000 nanograms (ng) of NDMA, yet the daily limit deemed safe by the FDA is only 96 ng.

These 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, which may produce high levels of NDMA during storage at high temperatures or as it breaks down inside the human body.

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.