Zantac Lawsuits in Delaware State Court Cleared To Move Forward

A Delaware judge has ruled that GlaxoSmithKline, Boehringer Ingelheim, Sanofi and other drug makers must face tens of thousands of Zantac cancer lawsuits in that state’s courts, after rejecting the drug makers’ efforts to have plaintiffs’ expert witnesses barred from testifying at trial.

The decision follows three days of hearings, where parties presented arguments to Delaware Judge Vivian L. Medinilla over whether the expert testimony needed to establish that each plaintiff’s cancer diagnosis was caused by Zantac is sufficiently reliable for a jury to consider.

Judge Medinilla is overseeing all lawsuits pending in Delaware state court that stem from a massive Zantac recall issued in 2019, after it was discovered that the active pharmaceutical ingredient, ranitidine, is inherently unstable and produces high levels of the chemical byproduct N-Nitrosodimethylamine (NDMA), which is a potent human carcinogen.

Plaintiffs allege that the drug makers knew or should have known about the Zantac cancer risks, yet continued to market and sell the drug without any warnings. The lawsuits include claims for individuals who developed bladder cancer, liver cancer, colon cancer, pancreatic cancer, stomach cancer and other injuries long-term use of the heartburn drug.

For several years most of the litigation was focused in the federal court system, where all Zantac 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, determining that all of the plaintiffs’ expert witnesses were excluded 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 various state courts, where different standards for the admissibility of expert witness testimony apply.

Although Zantac manufacturers like Pfizer and Sanofi have already agreed to pay hundreds of millions to settle claims over their role in the development and sale of the drug, nearly 75,000 Zantac lawsuits remain unresolved, most of which are currently pending in Delaware state court.

Judge Rejects Motion to Dismiss Plaintiffs’ Expert Witnesses

Following three days of Daubert hearings, meant to test whether expert testimony is scientifically sound and relevant to the litigation, Judge Medinilla issued an omnibus order (PDF) rejecting defendants’ efforts to have plaintiffs’ witnesses excluded. Had she dismissed the expert witnesses, plaintiffs would have had no way to prove causation, effectively killing the litigation, which is what occurred at the federal level.

“Plaintiffs in this litigation were not before the federal MDL Court. Nor are the experts the same,” Judge Medinilla wrote. “Plaintiffs here are pursuing ten cancers—bladder, esophageal, gastric, liver, pancreatic, breast, colorectal, kidney, lung and prostate. Thus, five of the cancer claims here were not before the MDL Court.”

She notes that defendants rely on an FDA study released in July 2021, which did not support that ranitidine converted to NDMA in a “general, healthy population.”

“This does little to advance their arguments. If that were the only issue here, that study might have some utility,” the Judge determined. “Zantac was not marketed to serve a generally healthy population.”

She indicated that GSK’s marketing efforts appear to have focused on off-label promotion of long-term use for Zantac at the very start, even though it was only approved for short-term use.

Both GlaxoSmithKline and Sanofi have issued statements indicating they disagree with the decision. GlaxoSmithKline indicates it plans to appeal the ruling.

Zantac Lawsuit Settlements

The decision means that the tens of thousands of Zantac lawsuits filed in Delaware can continue to move forward toward trial, unless they are resolved through settlement agreements or other means.

In early April 2024, Sanofi announced a Zantac settlement that resolves about 4,000 claims pending outside of Delaware state court, for an estimated payment of about $100 million. Weeks later, a massive Pfizer Zantac settlement was announced to resolve another 10,000 claims for $250 million.

However, GlaxoSmithKline and Boehringer Ingelheim continue to face the majority of the remaining claims. Since the drug makers failed to convince Judge Medinilla to exclude all of the plaintiffs’ expert witnesses, it is expected that a steady stream of additional claims will go before juries in the coming years unless those drug makers agree to voluntarily make Zantac cancer payouts to settle claims.