Judge Robin Rosenberg, U.S. District Court for the Southern District of Florida

A federal judge tossed all the plaintiffs' general causation experts in thousands of cases filed over heartburn medication Zantac.

Tuesday's opinion, by U.S. District Judge Robin Rosenberg in West Palm Beach, Florida, effectively dismissed the Zantac multidistrict litigation, which involves about 50,000 claims. In 2020, the U.S. Food and Drug Administration announced an involuntary recall of heartburn medication ranitidine, including Zantac, after discovering the presence of a possible carcinogen.

But Rosenberg found plaintiffs' experts made "analytical leaps" from existing data to reach unreliable opinions that differed from established science.

"Here, there is no scientist outside this litigation who concluded ranitidine causes cancer, and the plaintiffs' scientists within this litigation systemically utilized unreliable methodologies with a lack of documentation on how experiments were conducted, a lack of substantiation for analytical leaps, a lack of statistically significant data, and a lack of internally consistent, objective, science-based standards for the evenhanded evaluation of data," she wrote in a 341-page opinion granting summary judgment after tossing 10 plaintiffs experts under the U.S. Supreme Court's standard in its 1993 decision, Daubert v. Merrell Dow Pharmaceuticals Inc.

The ruling is a big win for the four drug companies named as defendants: GlaxoSmithKline, Pfizer, Sanovi-Aventis and Boehringer Ingelheim. GlaxoSmithKline, in a statement on Wednesday, said the ruling demonstrates there is no scientific consensus that ranitidine increases the risk of cancer.

"Following the 12 epidemiological studies conducted looking at human data regarding the use of ranitidine, the scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer," a spokesman said in a statement. "Yesterday's ruling reflects the state of that science and ensured that unreliable and litigation-driven science did not enter the federal courtroom."

Boehringer Ingelheim spokeswoman Belinda Martin, in an email, praised the judge's "thorough and detailed analysis."

"The scientific evidence, including numerous recently conducted epidemiological studies, points to only one conclusion: Zantac does not cause any type of cancer," she wrote.

In a statement, Pfizer said: "The order dismisses all claims in the federal MDL, which comprise a substantial percentage of the pending Zantac claims nationally."

A representative of Sanofi-Aventis did not respond.

'Extremely Surprised'

Lead plaintiffs lawyers said they were "extremely surprised" by the decision and intend to appeal the ruling to the U.S. Court of Appeals for the Eleventh Circuit.

Michael L. McGlamry, Pope, McGlamry, Atlanta Michael L. McGlamry, Pope, McGlamry, Atlanta. (Courtesy photo)

"Our experts clearly met the Daubert standard, and we're extremely confident we will prevail on appeal as we prosecute these cases on behalf of the tens of thousands of innocent Americans diagnosed with cancer after taking this dangerous drug," they wrote in an emailed statement.

The lead plaintiffs attorneys include Tracy Finken of Philadelphia's Anapol Weiss; Robert "Bobby" Gilbert of Kopelowitz Ostrow Ferguson Weiselberg Gilbert in Coral Gables, Florida; Michael McGlamry of Atlanta's Pope McGlamry; and Adam Pulaski of Pulaski Kherkher in Houston.

In Tuesday's order, Rosenberg, who heard oral arguments on Sept. 21 and 22, and Oct. 7, found that the methods of one expert, for instance, were unreliable because they were "based upon facts that are not fit for this case" and, among other things, lacked protocols and documentation. Other experts made "analytical leaps" from the available data that departed from the findings of other scientists, who generally found no link between ranitidine and cancer.

"Even if there is some evidence of an association in some of the ranitidine studies, there is no widespread acceptance in the scientific community of an observable, statistically significant association between ranitidine and cancer," she wrote.

The plaintiffs experts all focused on five specific types of cancer: bladder, gastric, esophageal, liver and pancreatic.

Read the opinion here:

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The multidistrict litigation has been pared down since the FDA's recall. Last year, Rosenberg granted dismissal of several claims and defendants.

Ahead of a filing deadline this year, many plaintiffs attorneys opted to avoid the multidistrict litigation and pursue tens of thousands of Zantac cases, many involving other types of cancer, in state courts in Delaware, California, Illinois, Pennsylvania and New York.

On Tuesday, one of them, R. Brent Wisner, of Los Angeles-based Baum Hedlund Aristei & Goldman, said he is confident about his experts in the California state court cases involving Zantac. The first trial is set for Feb. 13 in Oakland.

"I learned early on that the direction of this MDL was not looking out for the best interests of the victims," he wrote in an email following Rosenberg's ruling. "I am glad my firm realized this and focused on filing in state court."

Amanda Bronstad

Amanda Bronstad

Amanda Bronstad is the ALM staff reporter covering class actions and mass torts nationwide. She writes the email dispatch Law.com Class Actions: Critical Mass. She is based in Los Angeles.

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