GSK Gets Expert Witness Excluded in Zantac Cancer Lawsuit in Florida Before Trial

Florida ruling does not directly impact other Zantac lawsuits filed against GlaxoSmithKline in other state courts, each involving claims that former users were not adequately warned about the cancer risks that led to a 2020 recall.

GlaxoSmithKline (GSK) is seeking the dismissal of a Zantac lawsuit filed in Florida, after it convinced the state court judge presiding over the claim to exclude the plaintiff’s expert witness from testifying that the recalled heartburn drug increased risk of cancer for users.

The ruling was announced in a GSK press release late last week, and is one of a string of recent victories for the drug maker, which continues to face tens of thousands of Zantac cancer lawsuits that are pending in various different state courts nationwide.

Zantac (ranitidine) was a widely used over-the-counter drug approved for treatment of heartburn and acid reflux, which was sold at different times by GSK, Pfizer, Sanofi, Boehringer Ingelheim and various generic manufacturers, until all versions of Zantac were removed from the market more than four years ago.

The Zantac recalls were required by the FDA after it was discovered that the active ingredient in the pills is inherently unstable, and produces high levels of the chemical byproduct N-Nitrosodimethylamine (NDMA), which is a known human carcinogen.

As a result of the drug makers’ failure to disclose this risk for years, nearly 100,000 Zantac lawsuits have been presented by former users who developed bladder cancer, liver cancer, pancreatic cancer, stomach cancer and other injuries.

The Zantac litigation was initially focused in the federal court system, where claims brought in U.S. District Courts nationwide were centralized before U.S. District Judge Robin L. Rosenberg for coordinated discovery and pretrial proceedings. However, before the first federal case ever reached trial, Judge Rosenberg issued a controversial ruling excluding all of the plaintiffs’ expert witness testimony, which was needed to establish that Zantac causes cancer.

Judge Rosenberg’s decision was based on an interpretation of the federal rules regarding the admissibility of expert testimony, resulting in the dismissal of all federal Zantac lawsuits in late 2022. However, the ruling had no impact on tens of claims brought in various different state court systems, which each have slightly different standards for the admissibility of expert witness testimony.

“Today’s decision echoes the December 2022 ruling by Judge Rosenberg in the federal multidistrict litigation, which rejected all expert evidence put forward by the plaintiffs and dismissed all MDL cases alleging bladder, esophageal, gastric, liver, or pancreatic cancer,” the GSK press release states. “Both the MDL and Florida courts have determined that the methodology used by plaintiffs’ experts is unreliable and fails to meet the Daubert standard for scientific evidence.”

The trial involved claims that Zantac caused prostate cancer. It was scheduled to go before a jury in late September and is now likely to be dismissed. However, the ruling will not have any impact on claims pending in other state courts nationwide.

GSK faces more than 70,000 lawsuits in Delaware, where a state court judge cleared Zantac lawsuits to move forward to trial in late May 2024.

The drug maker has also faced several Zantac trials in Illinois state court, where the first two cases to go before a jury ended in a defense verdict, but GSK is expected to face a steady stream of future trials, after plaintiffs’ expert witness testimony was cleared.

Additional trials over the Zantac cancer risk are currently expected to begin later this year in Texas state court, with at least one Nevada trial slated for September 2026 and three cases set to go before juries in Pennsylvania state court next year.

Following extensive discovery and pretrial proceedings, Pfizer and Sanofi have already agreed to pay hundreds of millions in Zantac settlements to resolve their role in the development and marketing of the heartburn drug. However, GSK has not participated in those agreements, and probably faces the largest liability in the litigation.

While GSK continues to deny that there is scientific evidence establishing that Zantac causes cancer, the drug maker has reached a few settlements to resolve individual claims just before trial was set to begin.