Zantac MDL Judge Indicates “Time Has Come” To Finalize Registry Data for Pending Claims

The U.S. District Judge presiding over all Zantac cancer lawsuits filed throughout the federal court system is calling for parties to finalize the registry data submitted for each case, indicating that two years after the heartburn drug was recalled, the litigation is advanced enough that the parties and the Court need to know with some degree of certainty who the Claimants are, and what claims they intend to pursue.

Zantac (ranitidine) was a popular heartburn treatment used by millions of Americans before it was recalled from the market in late 2019, following a discovery that the active pharmaceutical ingredient is inherently unstable, and produces high levels of the chemical byproduct N-Nitrosodimethylamine (NDMA), which is a potent human carcinogen.

GlaxoSmithKline, Boehringer Ingelheim, Pfizer, Sanofi and various other manufacturers, distributors and retailers involved in the sale of brand name Zantac or generic ranitidine pills now face more than 100,000 product liability claims brought by former users who allege Zantac caused cancer as NDMA moved through the body, following years of exposure.

Given common questions of fact and law raised in the litigation, all Zantac cases brought throughout the federal court system are centralized before U.S. District Judge Robin L. Rosenberg in the Southern District of Florida, who is presiding over coordinated discovery and pretrial proceedings, including a series of early “bellwether” trials that are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the claims.

Early in the litigation, the parties agreed to set up a Zantac claim registry, which allowed plaintiffs to preserve their claim without filing a lawsuit. This prevented the statute of limitations in registered case from expiring, while also helping the potential claimants avoid costs associated with filing a lawsuit while the cases were investigated.

For the drug makers and distributors, this process was intended to provide a more accurate tally of the number of claims they were likely to face, as well as the types of injuries, while reducing the number of cases they need to defend against in various different jurisdictions, thus saving considerable money and resources.

In a pretrial order (PDF) issued on February 28, Judge Rosenberg indicated she believed the registry had served its purpose, and was outliving its usefulness. Therefore, the parties have been directed to finalize the registry information.

“Now, almost two years after the inception of this MDL, the time has come for the data in the Registry to be finalized; the pleadings have closed, the Plaintiffs’ Leadership has designated the specific cancers it will pursue, the parties have begun the process of preparing Daubert challenges on the issue of general causation, and the bellwether trial selection process has begun,” Rosenberg wrote. “For this MDL to proceed in an orderly fashion, both parties and the Court need to know with some degree of certainty who the Claimants are, what claims they intend to file, and where the Claimants will file their claims.”

The order calls for Defendants to turn over the data from the registry, and for each Plaintiff to answer key questions about the state of their claim no later than June 30.

Zantac Cancer Risks

Public concerns about the link between Zantac and cancer first emerged in September 2019, when an online pharmacy discovered that each pill may expose users to high levels of NDMA, which is a known carcinogen often used to cause cancer in laboratory animals.

While the FDA has found that the daily safe limit for NDMA exposure in pharmaceutical drugs is only 96 nanograms (NG), 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 NDMA may may develop as the pills sit in storage or travel through the body, increasing the long-term risk of cancer from Zantac.

It is expected that the Court will schedule a series of early bellwether trial dates in the Zantac MDL.

While the outcome of the individual test trials will not be binding on other cases, they will be closely followed and could have a significant impact on settlement negotiations.

Following coordinated pretrial proceedings before Judge Rosenberg, if the parties fail to reach Zantac settlements or another resolution for the claims, thousands of individual cases may end up remanded back to U.S. District Courts nationwide for individual trial dates in the coming years.