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Direct Filing of Zantac Recall Cases in Federal MDL Proposed By Parties

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To streamline the filing of new Zantac lawsuits by former users of the recalled heartburn drug who have developed cancer, a proposal has been submitted that would allow claims to be brought directly in the federal multidistrict litigation (MDL), which has been centralized in the Southern District of Florida for coordinated pretrial proceedings.

Over the past few months, more than 140 product liability lawsuits and class action cases have been 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 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 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.

Last month, 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, centralizing the pretrial proceedings 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 March 16, the plaintiffs and defendants filed a joint statement (PDF) on the submission of several proposed orders, including a plan that would allow the direct filing of Zantac recall cases directly in the Southern District of Florida.

Direct filing would help avoid the delay associated with transferring cases from different U.S. District Court nationwide, while every case still retains an “originating” venue, where it can be sent for trial after the pretrial procedures are complete.

“In any complaint directly filed in the Southern District of Florida pursuant to this Order, Plaintiff shall identify his or her federal district of residence in which the action otherwise would have been filed absent the direct filing procedure,” the proposed order states. “Upon completion of all pretrial proceedings applicable to a case directly filed in this Court…this Court will transfer each case to the identified federal district of residence unless the parties jointly advise the Court that a case should be transferred to another district in which venue is proper.”

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.

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.

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