Zantac Science Day Presentations About Heartburn Drug Cancer Risks Underway in MDL

The non-adversarial presentations involving the science behind the heartburn drug’s cancer risks will be held today and tomorrow in southern Florida.

As thousands of Zantac lawsuits move forward in the federal court system, the U.S. District Judge presiding over the federal litigation is holding a “Science Day” today, where a series of presentations will be made to educate the court about cancers caused by the heartburn drug, and other scientific issues that will come up during the consolidated MDL proceedings.

Zantac (ranitidine) was one of the most widely used brand-name medications in the United States before the heartburn drug was recalled in 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 involved in the sale of Zantac pills now face more than 100,000 product liability claims brought by former users diagnosed with bladder cancer, colorectal cancer, esophageal cancer, and other injuries they indicate were caused by exposure to NDMA. Plaintiffs maintain that the drug makers knew, or should have known, about the heartburn drug cancer risks, yet continued to aggressively market and sell the drug for years.

Given common questions of fact and law raised in the litigation, all cases brought throughout the federal court system are centralized before U.S. District Judge Robin L. Rosenberg in the Southern District of Florida as part of a Zantac MDL, or multidistrict litigation, where the parties are preparing for a series of early “bellwether” trials, which are designed to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the claims.

Throughout the pretrial proceedings, Judge Rosenberg will be asked to rule on a number of matters which will require background knowledge about science related to the heartburn drug’s cancer risks and other side effects of NDMA. Therefore, the Court scheduled a Zantac science day for December 2 and 3, at which time the parties will be given an opportunity to make non-adversarial, educational presentations about the potential side effects of the heartburn drug, including details about the scientific terminology and statistical analysis concepts.

The Zantac presentations are not part of the official record in the case, and information presented by either side will not be subject to cross examination.

Heartburn Drug Cancer Concerns Emerged in Late 2019

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 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.

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.