Zantac Litigation Continuing to Move Forward Through Video Conferences

As the nationwide COVID-19 pandemic continues to disrupt cases through the federal judicial system, the U.S. District Judge recently appointed to preside over the consolidated pretrial proceedings in all Zantac recall lawsuits has indicated that the litigation will continue to move forward, scheduling an initial status conference and interviews for attorneys seeking leadership positions that will be conducted through video conferencing.

There are current about 140 product liability lawsuits and class action cases filed throughout the federal court system, each involving allegations that ranitidine contained in Zantac produces high levels of the cancer-causing chemical Nitrosodimethylamine (NDMA), which has been linked to reports of stomach cancer, bladder cancer, colorectal cancer, kidney cancer and other injuries as the chemical moves long the digestive tract.

Due to the risk that NDMA may be produced as the heartburn pills are sitting on store shelves or in storage, the FDA recommended last week that all versions of Zantac be recalled, and a growing number of consumers are new learning that cancer diagnosed in prior years may have been caused by the carcinogenic chemical byproduct that has contaminated Zantac pills for decades.

Given the widespread use of the drug, as Zantac injury lawyers continue to investigate and file cases in the coming months and years, it is ultimately expected that tens of thousands of lawsuits may be involved in the litigation.

Prior to the emergence of the coronavirus outbreak in the United States, a panel of federal judges decided to centralize the litigation for coordinated pretrial proceedings, and transferred cases pending nationwide to U.S. District Judge Robin L. Rosenberg in the Southern District of Florida in February 2020.

The process is designed to facilitate the management of the growing litigation, avoid duplicative discovery into common issues in the cases and avoid conflicting pretrial rulings from different judges. However, just as the Zantac litigation was getting underway, it was been delayed by shutdowns in travel and the federal court system, requiring the Court to cancel an initial status conference initially set for March 20.

In a pretrial order (PDF) issued on April 3, Judge Rosenberg recognized the importance of keeping the litigation moving forward amid the constantly evolving situation with COVID-19.

While the Court will not schedule in-person proceedings, the initial conference has been rescheduled for May 12, and virtual interviews will be held for lawyers seeking leadership roles in the litigation.

“This conference will be held by videoconference; no persons, including the parties and counsel, will be permitted to attend in person,” the order states. “As this case proceeds into its next phase, it remains increasingly important that counsel continue to work cooperatively and in good faith to resolve issues through virtual meetings and conferrals.”

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.

On April 1, the FDA ordered a nationwide Zantac recall affecting all products currently left on the market. The recall came after the agency revealed that ongoing investigations, testing and evaluation by it and third-party laboratories confirmed the increase of NDMA levels over time, even under normal storage conditions. The agency’s experts and third-party labs found the older a Zantac product was, the higher the levels of NDMA.

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.