Pfizer, GSK, Sanofi and Boehringer Ingelheim are now able to wash their hands of thousands of Zantac-related lawsuits after a federal judge in Florida ruled that the claims against the companies weren't sound.
U.S. District Judge Robin Rosenberg’s ruling in the federal multidistrict litigation took about 50,000 claims off the drugmakers' plates. While the decision does not impact the thousands of cases in state courts, it chalks up a major win for the companies in the litigation, which has been looming since 2020. That’s when the FDA first asked all Zantac and its generic manufacturers to voluntarily recall their products. That followed a 2019 recall spree, after online pharmacy Valisure discovered high levels of a likely carcinogen in the drug and its generics.
Now, the district court is rejecting the science used to back up claims that Zantac and its generics cause cancer. Judge Rosenberg’s ruling consists of more than 300 pages detailing how the plaintiff’s experts utilized “unreliable methodologies” to reach their conclusions.
The court pointed out that no scientist not involved in the litigation has concluded that Zantac causes cancer, and the plaintiff’s scientists in the 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,” the summary judgment said.
GSK welcomed the ruling, which ensures that “unreliable and litigation-driven science did not enter the federal courtroom,” the company said in a statement.
Sanofi as well is “pleased with the federal court’s determination” and remains committed to its defense, a company spokesperson told Fierce Pharma in an email. “This ruling significantly decreases the scope of the litigation potentially by over 50%,” the Sanofi spokesperson noted.
Boehringer Ingelheim “appreciates the court’s thorough and detailed analysis,” and looks forward to continuing its defense in state courts, a spokesperson said in an email. “The scientific evidence including numerous recently conducted epidemiological studies points to only one conclusion: Zantac does not cause any type of cancer.”
As for Pfizer, the company is also “pleased” with the judgment, a spokesperson told Fierce Pharma in an email, noting that the company has not sold a Zantac product in more than 15 years.
Thousands of state cases are still in play. The first one, which was supposed to go to trial in Illinois, ended in a settlement in August after the plaintiff’s counsel filed for voluntary dismissal due to “personal health reasons.” At the time, GSK, which did not pay a settlement in that particular case, noted that the next trials are set to begin in Illinois and California in February 2023.