Zantac Study Finding Increased Risk of Cancer Results in Supplemental Expert Reports Being Filed in MDL

Following the publication of a new study that provides evidence about the Zantac cancer risks, plaintiffs have submitted supplemental expert reports for the U.S. District Judge presiding over the litigation to evaluate, as the Court evaluates whether there is sufficiently reliable scientific support for thousands of lawsuits to move forward involving claims that the recalled heartburn drug caused cancer.

Zantac (ranitidine) was used by millions of Americans for treatment of heartburn and acid reflux, before it was removed 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 or generic ranitidine pills now face more than 100,000 Zantac cancer lawsuits brought by former users who indicate they have been diagnosed with bladder cancer, esophageal cancer, liver cancer, pancreatic cancer, stomach cancer or other injuries, as NDMA moved through their body.

Given common questions of fact and law raised in Zantac lawsuits filed throughout the federal court system, centralized pretrial proceedings have been established in a federal MDL before U.S. District Judge Robin L. Rosenberg in the Southern District of Florida, who has been presiding over coordinated discovery and a “bellwether” process where a small group of cases are being prepared for early trial dates.

Before clearing the first Zantac trials to begin, Judge Rosenberg has held a series of Zantac “Daubert” hearings over the past several weeks, to evaluate the qualifications of different experts who will testify at trial, and confirm that the opinions are sufficiently sound and reliable to allow juries to consider the evidence under the evidence standards in the federal court system. However, a study published in the middle of these hearings has added further support for plaintiffs.

Study Links Zantac to Liver, Lung, Gastric and Pancreatic Cancers

In late September, researchers from Taiwan published a study in the International Journal of Environmental Research and Public Health, which provide further evidence about a link between several different types of cancer and Zantac use, including liver, lung, gastric and pancreatic cancers.

Researchers conducted a population-based cohort study which included more than 55,000 participants who had used Zantac between January 2000 and December 2018. They compared cancer rates among Zantac users with users of other heartburn drugs, including proton pump inhibitors (PPIs), like Nexium and Prilosec, and Pepcid AC (famotidine).

According to the findings, Zantac use was linked to a 22% increased risk of liver cancer, a 17% increased risk of lung cancer, a 26% increased risk of gastric cancer, and a 35% increased risk of pancreatic cancer.

“(T)he clinically meaningful results of this large-scale, longitudinal population-based cohort study using an excellent prescription and cancer database provide concrete evidence with very convincing long-term follow-up information for exploring the causative role of ranitidine in increasing the risk of carcinogenic effects on the liver, which was primarily caused by increasingly heavier ranitidine usage,” the researchers concluded. “However, to elucidate the underlying mechanisms of its causal association, further studies are necessary.”

Plaintiffs Submitting Supplemental Expert Reports on Zantac Study

Earlier this month, plaintiffs in Zantac litigation filed an expedited motion to submit supplemental expert reports (PDF) with Judge Rosenberg. The motion notes that the study links directly with the Zantac litigation, as it provides additional proof that Zantac could have caused many of the cancers suffered by potentially thousands of plaintiffs.

“The study is highly relevant for this Court to consider for many reasons, of which four stand out. First, it provides ranitidine-specific epidemiological evidence of increased risk for each designated cancer (including dose-response analyses for some cancers),” the motion states. “Second, it includes subanalyses using famotidine and PPIs as active comparators, a form of analysis Defendants have emphasized. Third, it discusses multiple other ranitidine-specific epidemiological studies, identifying particular limitations in those studies that are similar to the limitations MDL Plaintiffs’ experts have identified (short follow-up, low exposure, young age, and so forth). Fourth, it analyzes scientific literature on NDMA, which Defendants claim no scientist outside this litigation has ever done.”

On October 7 as part of ongoing Daubert hearings, Judge Rosenberg issued an order (PDF) granting plaintiffs permission to submit supplemental briefs by five different expert witnesses who have analyzed the study’s findings. Those briefs were submitted on October 11.

November 2022 Zantac Lawsuit Update

In the federal court system, the outcome of the Zantac MDL Daubert hearings will be closely watched throughout the month of November 2022, to evaluate whether plaintiffs will be permitted to introduce the proposed expert witness testimony involving the five supported cancers.

Based on the strength of the available studies linking Zantac to bladder cancer, esophageal cancer, gastric cancer, liver cancer and pancreatic cancer, it is widely anticipated that the cases will be cleared to move forward. However, if the drug makers are successful convincing the judge to exclude expert testimony linking Zantac to specific cancers, it may leave plaintiffs unable to establish their claims in the federal court system.

In California state court, a series of four Zantac lawsuits have been scheduled for trial next year, with cases scheduled to go before different juries on February 13, 2023, May 1, 2023, August 7, 2023 and October 23, 2023.

These trials will be closely watched by parties involved in the litigation, and may provide a “bellwether” to help gauge how juries will respond to certain evidence and testimony that will be repeated throughout the litigation. If plaintiffs are successful, it is likely to drive up the cost of any Zantac settlements the drug makers will offer to avoid tens of thousands of individual cases going to trial nationwide in the coming years.