Zantac Settlement Agreement Reached in 4,000 Lawsuits Filed in U.S. State Courts

Sanofi has announced it has reached a Zantac settlement agreement to resolve about 4,000 cancer lawsuits filed in state courts nationwide, but the drug maker continues to face tens of thousands of other claims over the recalled heartburn drug that are still pending Delaware.

Zantac (ranitidine) was used by millions of Americans for treatment of heartburn and acid reflux, before a Zantac recall was announced in late 2019, due to ranitidine being inherently unstable, which can result in the creation of high levels of a chemical byproduct known as N-Nitrosodimethylamine (NDMA), which is a potent human carcinogen.

Despite the settlement, GlaxoSmithKline, Boehringer Ingelheim Pfizer, Sanofi and various other manufacturers, distributors, and retailers, continue to fight more than 70,000 Zantac lawsuits in various state courts nationwide, with most filed in Delaware. About 20,000 of those Delaware claims name Sanofi as a defendant, involving allegations that former users have been diagnosed with bladder cancer, liver cancer, pancreatic cancer, stomach cancer and other injuries after taking Zantac.

Sanofi announced it reached an agreement in principal on Wednesday, to resolve thousands of claims pending outside of Delaware state courts. However, the drug maker has not released settlement details, according to a report by Reuters, and the company indicates it still intends to fight the remaining litigation.

The Zantac  litigation was originally focused in the federal court system, where all Zantac cancer lawsuits were centralized before Judge Robin L. Rosenberg in the U.S. District Court for the Southern District of Florida, for coordinated discovery and pretrial proceedings. However, in 2022 Judge Rosenberg issued a controversial ruling that excluded all of the plaintiffs’ expert witnesses from testifying at trial under federal evidentiary rules.

While appeals have been filed to challenge Judge Rosenberg’s ruling, the decision has left federal plaintiffs without any means of proving the recalled Zantac pills caused their cancer, and all Zantac lawsuits pending in the federal court system have been dismissed. However, the federal ruling did not have any impact on lawsuits filed in California, Delaware and various other state courts, where different standards for the admissibility of expert witness testimony apply.

Delaware Superior Court Judge Vivian Medinilla is currently weighing whether Zantac cases in that state should be dismissed on similar grounds as the federal cases, following hearings held in January. Her decision could determine whether the bulk of Zantac lawsuits filed in that state move forward. Much like the federal cases, if manufacturers can convince Judge Medinilla to exclude all of the plaintiffs’ expert witnesses, it would effectively kill the litigation in that venue, where most claims have been filed since the federal MDL was dismissed.

Judge Medinilla is likely using the same legal standards that were applied at the federal level, however, that does not mean she will reach a similar conclusion. The Delaware state court Zantac cases are using a different set of expert witnesses than those used in the federal lawsuits. It is unclear when she will make her final determination.

April 2024 Zantac Lawsuits Update

Sanofi’s Zantac settlement announcement comes after GlaxoSmithKline settled several Zantac lawsuits before they went to trial in California state court.

GlaxoSmithKline announced two Zantac settlements in February, and another last November. Like Sanofi, the company has claimed it still plans to defend itself against the remaining lawsuits. However, it also made those statements after previous settlements, and the drug maker faces several additional Zantac lawsuits that are scheduled for trial in California in the coming months.

While the results of those trials will have no binding impact on other Zantac cancer lawsuits pending nationwide, they are likely to be closely watched to see how the jury would have responded to evidence and testimony which could be repeated in tens of thousands of trials nationwide.