U.S. District Judge Robin L. Rosenberg, appointed to preside over the coordinated discovery and pretrial proceedings of Zantac lawsuits, issued a pretrial order on February 14, indicating an Initial Conference to be scheduled at 9:00 a.m. on March 20, to discuss the status of the litigation.
Since it was discovered late last year that the popular heartburn drug puts users at high levels of cancer-causing chemicals, more than 140 product patents and allegations made in stages by Zantac have been included in the entire court system. However, as Zantac's lawyers continue to review and apply for former users who are diagnosed with various forms of cancer, thousands of lawsuits are expected to be filed in the coming weeks and months.
Each claim raises similar allegations, indicating that the active ingredient in Zantac, ranitidine, produces high levels of a carcinogen known as Nitrosodimethylamine (NDMA). After prolonged exposure to chemicals, the plaintiffs claimed that Zantac's adverse effects had led to bladder cancer, kidney cancer, colon cancer, stomach cancer, and other cancers in the digestive tract.
The Initial Conference agenda includes a proposed discovery plan, amendments of pleadings, consideration of any class action allegations and motion, and discussion of the mode of trial. Also, parties can file any proposed case management orders or additional agenda items by March 6. Finally, the parties are allowed to identify two expert witnesses who would be available within the next several months to participate in a "Science Day."
Earlier this month, the U.S Judicial Panel on Multidistrict Litigation (JPML) decided to consolidate and centralize the growing number of Zantac lawsuits before Judge Rosenberg in Florida.
The Zantac litigation may become one of the largest active mass tort claims over the next few years, given the widespread use of the acid reflux and heartburn 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.
Last year, the popular heartburn drug was voluntarily recalled by many drug makers, due to rising allegations, which indicates the active ingredient in Zantac, ranitidine, produces high levels of the known human carcinogen Nitrosodimethylamine (NDMA). More than 140 product liability and class action lawsuits over Zantac are filed throughout the federal court system.
