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The U.S. District Judge presiding over all federal Zantac recall lawsuits is holding a series of virtual hearings today and tomorrow, to consider a number of motions to dismiss filed by makers of the heartburn drug, which has been linked to thousands of reports involving former users diagnosed with cancer.
Sanofi, GlaxoSmithKline, Boehringer Ingelheim and other drug manufacturers, distributors and retailers face more than 70,000 potential product liability lawsuits brought over the past two years, following the discovery that the active ingredient in Zantac converts to high levels of a potent human carcinogen as it passes through the body or while it is being stored at higher temperatures.
The litigation emerged in late 2019, after independent researchers found that nearly all versions of Zantac and generic ranitidine contained dangerous levels of the chemical byproduct N-nitrosodimethylamine (NDMA), which is actually used during laboratory studies to induce tumors in test rats.
Lawsuits are now being pursued by former Zantac users diagnosed with various cancers, including breast cancer, prostate cancer, pancreastic cancer, esophageal cancer, stomach cancer, bladder cancer, liver cancer and other injuries that may have been avoided if the drug makers had provided adequate warnings for users and the medical community.
Given common questions of fact and law raised in lawsuit filed throughout the federal court system, the Zantac litigation is currently centralized before U.S. District Judge Robin L. Rosenberg in the Southern District of Florida, who is presiding over the coordinated discovery and plans for a small group of “bellwether” cases to go to trial next year, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the claims.
The Defendants have filed a number of early motions to dismiss, arguing that the claims should be tossed out on a number of different grounds; chief among them claiming that the state-law failure to warn lawsuits should be preempted by federal law, since the FDA approved ranitidine and its label warnings.
According to an order (PDF) issued by Judge Rosenberg, a series of arguments will be presented over Zoom teleconference starting today and tomorrow at 10am, including motions to dismiss for failure to state a claim, to dismiss brand-name manufacturer innovator liability claims, to dismiss retailer and pharmacy defendants, to dismiss drug distributors, to dismiss medical monitoring class action complaints and other claims.
On Monday, the Court will hold a separate hearing over Zoom teleconference at 3p, to address a separate motion filed by Plaintiffs to modify a prior pretrial schedule, arguing that Defendants have caused widespread delays in production of critical documents relevant to the litigation, including deleting emails related to the Zantac recalls, which has “handicapped” their ability to prepare key witnesses and general causation expert reports.
Zantac Cancer Risks
The litigation over Zantac 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.
If the parties fail to reach Zantac settlements or another resolution for the cases following discovery and bellwether trials held before Judge Rosenberg, thousands of individual cases may end up remanded back to U.S. District Courts nationwide for individual trial dates in the coming years.