A Florida state court last month handed the manufacturers of the heartburn drug Zantac another legal victory by dismissing a plaintiff’s claim that Zantac caused his prostate cancer and finding that the plaintiff’s expert testimony was unreliable.
On Aug. 19, Florida’s 13th Judicial Circuit Court in Hillsborough County issued the order dismissing the lawsuit brought by Edward Wilson against a number of pharmaceutical companies, including GlaxoSmithKline Holdings (GSK) and Boehringer Ingelheim Pharmaceuticals Inc.
The dismissal followed the court’s decision days earlier to exclude the plaintiff’s expert witness testimony, which attempted to link ranitidine, the stomach acid reducer in Zantac, to an increased risk of prostate cancer. In a statement provided to the Florida Record, GSK welcomed the decision written by Judge Darren Farfante.
“(The) decision echoes the December 2022 ruling by Judge (Robin) Rosenberg in the federal multidistrict litigation (MDL), which rejected all expert evidence put forward by the plaintiffs and dismissed all MDL cases alleging bladder, esophageal, gastric, liver or pancreatic cancer,” the statement by GSK says. “Both the MDL and Florida courts have determined that the methodology used by plaintiffs’ experts is unreliable and fails to meet the Daubert standard for scientific evidence.”
Both Florida and federal courts rely on the Daubert standard, which was established by a U.S. Supreme Court case in 1993. Under that standard, judges must make sure that expert witness methodology has been tested or can be tested, has been peer-reviewed, provides a potential error rate and has general acceptance among scientists.
The pharmaceutical companies argued that plaintiff attorneys lacked evidence that ranitidine caused Wilson’s cancer or any reliable data on what amount of the drug could cause the plaintiff’s cancer. Farfante agreed with the defendants’ position.
“... The court concludes that (the) plaintiff lacks admissible expert evidence that ranitidine can cause prostate cancer or that ranitidine caused plaintiff’s prostate cancer,” the court’s order states.
Federal Judge Rosenberg’s decision two years ago found that some of the evidence plaintiffs relied upon was based on conditions that didn’t resemble what could happen in the human body. Zantac was voluntarily pulled from store shelves in 2020 because of concerns it could degrade into a carcinogen, N-Nitrosodimethylamine (NDMA).
A private laboratory testing firm called Valisure found Zantac could generate amounts of NDMA exceeding Food and Drug Administration’s consumer limits on the substance, but Rosenberg concluded those findings were based on lab conditions that were not relevant to real-world conditions.
In a similar Zantac decision last month in Illinois, a jury in state court concluded that GSK was not responsible for a plaintiff’s colorectal cancer. And previously, a Chicago jury found GSK and Boehringer Ingelheim not liable for a plaintiff’s colon cancer in a personal-injury case.
GSK maintains that after conducting 16 epidemiological studies on the risks of using ranitidine, scientists have come to a general conclusion that the drug does not elevate the risk of any cancer.
“(The Aug. 15) ruling reflects the state of that science and ensures that unreliable and litigation-driven science does not enter the courtroom,” GSK said in a statement.