WILMINGTON, Del. (Legal Newsline) - A commercial laboratory that the judge overseeing thousands of Zantac lawsuits acknowledges is at the core of the scientific debate over whether the heartburn medicine causes cancer was paid $2 million for its work, court filings show.
Emery Pharma, an Alameda, Calif., contract research lab run by Ph.D chemist Ron Najafi, subjected Zantac to a variety of tests including simulated cooking in an overheated car to conclude the drug, with the generic name ranitidine, can decompose into carcinogenic NDMA. Defendants say Emery was motivated to find results that would push litigation that could lead to millions in attorney fees.
Following similar results from Valisure, another lab that works closely with plaintiff lawyers, the Food and Drug Administration ordered Zantac off store shelves and lawyers filed tens of thousands of lawsuits by plaintiffs claiming they got cancer from the drug.
Defense attorneys have attacked Emery’s methodology, saying the lab only found dangerous levels of NDMA in ranitidine after being retained for litigation. In a 2020 filing in federal court in Florida, GSK and other defendants said plaintiff lawyers hired Emery after the FDA and regulators around the world failed to find high enough levels of NDMA to sue over.
Plaintiff attorneys have paid Emery $2.2 million so far, the defendants said.
“The significant financial incentives to design a methodology that would drive up NDMA levels, coupled with the fact that Emery’s analysts were able to exercise uncontrolled discretion during testing (something Plaintiffs do not dispute), cast serious doubt on the reliability of Emery’s testing,” the defendants said.
A federal judge in Florida dismissed 75,000 federal cases after finding expert opinions, including the core claim by Valisure that ranitidine can degrade into NDMA, unreliable. A state court judge in Delaware ruled the opposite way on June 3, however, allowing in experts including Emery despite objections to their methodology.
In her ruling, Delaware Superior Court Judge Vivian L. Medinilla observed “the somewhat more aggressive and pejorative rhetoric in the briefs suggests the Emery opinion lies at the heart of the Daubert debate, for both sides.”
Under the U.S. Supreme Court’s Daubert ruling, judges are instructed to act as gatekeepers to prevent juries from hearing unsupported scientific evidence. Judge Medinilla largely abstained from playing gatekeeper, however, instead ruling that jurors must decide which version of the science is more believable.
GSK has filed for interlocutory appeal of the judge’s ruling, which defense lawyers say could drive more mass-tort litigation in Delaware, home to many of the world’s largest corporations.
In its attack on Emery, GSK said the lab has no written protocols or standard operating procedures and produces unverifiable results. NDMA is a common substance found widely in the environment and in foods including bacon, beer and cheese.
To find higher levels of the substance, Valisure and Emery heated ranitidine to simulate its passing through the human gut or being stored in hot shipping containers and cars.
"Using this unreliable method, Dr. Najafi reported NDMA levels that are significantly higher than levels reported by FDA and every other independent researcher," GSK wrote.
"Tellingly, these levels are also significantly higher than Dr. Najafi’s own pre-litigation testing data for ranitidine, which he brushes aside in favor of his litigation-motivated opinion."
Defense lawyers say those tests produced results that can’t be verified and haven’t been peer reviewed. Judge Medinilla said verification isn’t necessary, calling any dispute over methodology “appropriate grist for the jury’s mill.”