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The U.S. District Judge presiding over all federal Zantac cases, has ordered parties involved in the litigation to conduct a two-stage census to provide more information about all filed and unfiled claims involving former users of the recalled heartburn drug who have developed cancer.
There are current about 140 product liability lawsuits and class action cases filed throughout the federal court system, each involving allegations that Zantac exposed users to high levels of cancer-causing chemicals. However, as Zantac recall lawyers continue to bring additional cases in the coming months and years, it is ultimately expected that tens of 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 N-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.
In February, 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, for centralized the pretrial proceedings that are designed 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.
On April 2, Judge Rosenberg issued a pretrial order (PDF) approving plans for a two-step census process. It will include an initial census designed to give the court information about the nature of the “full inventory of retained clients” represented by lawyers involved in the litigation, and help the court select a leadership team that is most effective and represents the interests of plaintiffs.
The order calls for the use of an “Initial Census Form” to get a count and information on all cases filed in the MDL to date, as well as some unfiled cases. In addition, the order calls for a second phase, which will involve the use of “Census Plus Form” for all personal injury and medical monitoring claims. The order also calls for the creation of a voluntary Census Registry for potential unfiled cases.
“The parties contemplate that this census process will enable the parties and Court to have better information to target their resources toward an efficient management of this litigation,” the order states. “In order to accomplish this objective, both parties have negotiated in good faith and made concessions for the benefit of the litigation as a whole.”
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.