Daubert Hearings for Zantac Cancer Lawsuits To Be Held in September 2022

MDL Judge will decide at a series of Daubert hearings which expert testimony about the link between Zantac and cancer will be admissible at trial

The U.S. District Judge presiding over all Zantac cancer lawsuits filed by former users of the recalled heart burn drug will hold a series of hearings in September, to consider challenges to proposed expert witnesses that each side intends to use at trial.

Zantac (ranitidine) was used by millions of Americans for treatment of heartburn and acid reflux, 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.

In a Pretrial Order (PDF) published on May 12, Judge Rosenberg established the schedule for the court to hear Daubert challenges and Summary judgment motions.

At the Zantac Daubert hearings, to Court will conisder challenges presented by each side over the admissibility of different expert testimony about whether Zantac causes can cancer and which types of cancer may result from exposure to NDMA. The court will consider the qualifications and basis for each proposed experts opinions, to asses whether they are based on scientifically valid reasoning.

Named for a U.S. Supreme Court decision that established the standards, Daubert v. Merrell Dow Pharmaceuticals, Inc., the hearings are intended to allow the Judge to act as a “gatekeeper” to weigh whether the opinions are sufficiently sound and reliable. If the defendants are able to convince the court to exclude expert testimony proposed by the plaintiffs, it may leave former users unable to establish that their cancer was caused by Zantac. Similarly, if the Court excludes defense experts, it could prevent the drug makers from challenging key elements of the plaintiffs’ claims.

Judge Rosenberg’s schedule places a June 13 deadline for the defendants to file any Daubert and summary judgment motions, and a July 6 deadline for plaintiffs’ Daubert and summary judgment motions to be brought. Any plaintiffs’ opposition to the defendants’ motions must be filed by August 1, and defense responses to plaintiffs’ motions are due by August 24. The Court will then hold a hearing to consider the defendants’ Daubert motions and summary judgments on September 20, and consider the plaintiffs’ Daubert motions and summary judgments on September 28.

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.

Following the Daubert hearings, it is expected that the Court will hold a series of early bellwether trials in the Zantac litigation, which may have a significant impact on any negotiations to resolve claims.

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.