MDL Judge Dismisses Zantac Litigation, After Excluding Expert Testimony on Cancer Risk

The U.S. District Judge presiding over the federal Zantac litigation has issued an order that will result in the dismissal of thousands of claims brought by individuals diagnosed with cancer, after the Court granted the drug makers’ motion to exclude expert testimony that plaintiffs’ maintain establishes toxic chemicals in the recalled heartburn drug caused their diagnosis.

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 have faced 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 litigation, complaints filed throughout the federal court system have centralized as part of an MDL before U.S. District Judge Robin L. Rosenberg in the Southern District of Florida, who has been presiding over coordinated pretrial proceedings over the past two and a half years. However, thousands of claims are also pending in various state courts nationwide, which will not be impacted by this new ruling.

Zantac Cancer Risk Raised by Valisure Pharmacy Led to Massive Recall

Public concerns about Zantac cancer risks first emerged in September 2019, when the online pharmacy Valisure conducted testing on pills, and found alarming levels of NDMA that were drastically higher than what is considered permissible and safe.

The FDA has previously found the daily safe limit for NDMA exposure is only 96 nanograms (ng). However, testing conducted by the independent lab found that users may be exposed to more than 3 million ng from each Zantac pill.

Following this discovery, Valisure filed an FDA petition calling for a Zantac recall, and months later the federal regulatory agency required manufacturers of all Zantac and generic ranitidine drugs to remove their products from the market, after determining that there was no way to confirm which pills may contain NDMA.

Federal Zantac Litigation Dismissal

In a 300 page omnibus order (PDF) issued on December 6, Judge Rosenberg granted a motion filed by the drug makers to exclude plaintiffs’ expert witnesses and dismiss all federal cases, indicating that the testing procedures of Valisure, and then plaintiffs’ experts who followed the laboratory’s work, used questionable science and failed to show Zantac had high enough levels of NDMA to create a cancer risk.

Judge Rosenberg said that to get the high amounts of NDMA that Valisure found in its testing of Zantac, the pharmacy had to heat the active ingredient, ranitidine, well above temperatures that would be found inside the human body. Valisure also tested some of the Zantac in combination with salt to replicate what is experienced inside the body, but Judge Rosenberg indicates that some of the salt levels were high enough to almost kill a human.

While plaintiffs did not use Valisure’s testing as a basis of their claims and instead used their own experts and chemists, the judge said they used similar testing techniques as Valisure.

“For the reasons outlined in this Order, the methods used by the Plaintiffs’ chemist were unreliable and resembled (in many respects) the testing conducted by Valisure,” Judge Rosenberg concluded. “As the Court’s ruling reflects, the only reliable testing of ranitidine puts the average amount of NDMA in ranitidine at roughly equivalent or slightly higher than the FDA’s daily limit which, as discussed, equates to an infinitesimal, unprovable risk of cancer.”

As a result of the ruling, all Zantac lawsuits pending in the federal court system will be dismissed, since Plaintiffs are left without expert witness testimony to establish that their cancer diagnosis was caused by the recalled heartburn drug. However, the decision will not have any impact on lawsuits pending in various state courts, where different standards for the admissibility of expert witness testimony apply. In addition, plaintiffs have vowed to appeal the ruling.

Zantac Appeal Will Extend Litigation For Years

Judge Rosenberg’s decision immediately drew criticism from Plaintiffs attorneys and legal experts, who indicate that the Court widely overstepped its limited role as “gatekeeper” for evidence that should be considered by a jury, and committed significant errors applying the legal standard established by the U.S. Supreme Court for evaluating medical and scientific expert testimony.

In recent years, several mass tort litigations have been dismissed at the trial court level, only to be overturned on appeal by the U.S. Court of Appeals or U.S. Supreme Court.

For example, 3M Company faces more than 5,000 product liability lawsuits over surgical infections allegedly caused by the Bair Hugger forced-air warming blanket, which has been commonly used during hip and knee replacements.

In 2019, following several years of litigation, federal Bair Hugger litigation was dismissed, after the judge ruled that plaintiffs’ expert witnesses were precluded from testifying at trial. However, the U.S. Court of Appeals for the Eighth Circuit overturned that decision in August 2021, returning each of the individual Bair Hugger infection lawsuits back to the trial court for further proceedings.

Similarly, in 2014, U.S. District Judge Joel Pisano granted Merck’s motion for summary judgment, dismissing all Fosamax fracture claims involving injuries linked to the bone drug that occurred before an FDA label update, finding that the claims were pre-empted by federal law.

During a lengthy appeals process, the Third Circuit Court of Appeals vacated that order in March 2017, and Merck pursued the claim to the U.S. Supreme Court. However, the Fosamax lawsuits were dismissed again earlier this year after a judge determined Merck had provided clear evidence that the FDA would have rejected the warning plaintiffs say was missing from the Fosamax label.

One thing that is guaranteed from the decision is a lengthy delay for plaintiffs who sought damages in the federal court system for cancer caused by Zantac, many of whom may not survive the lengthy Zantac appeals process.

Zantac Litigation Continues in State Courts

Despite the dismissal of all cases pending in the Zantac MDL, manufacturers GlaxoSmithKline, Merck, Pfizer and Boehringer Ingelheim, all of whom manufactured versions of ranitidine pills at various times, still face thousands of Zantac cancer lawsuits in state courts nationwide. Attorneys estimate that another 50,000 Zantac lawsuits have been, or will be, filed in state courts including California, Illinois and Delaware.

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 state cases. If plaintiffs can establish that they can succeed with their claims before juries, it will increase pressure on the drug makers to negotiate Zantac settlements, including potential resolutions for claims that are pending on appeal and may later be reinstated and returned back to the trial court.