In early December, a federal judge tossed plaintiffs’ expert evidence and dismissed some 2,450 lawsuits in the sprawling litigation involving the heartburn medication Zantac. U.S. District Judge Robin L. Rosenberg’s December 6, 2022 ruling brought attention not only for the welcome rejection of junk science in the courtroom, but her undressing of the small Connecticut laboratory behind it: Valisure Laboratories.
Valisure generated headlines a few years ago when it purportedly found astronomical levels of the cancer-causing chemical NDMA in Zantac (ranitidine). As noted by the Wall Street Journal, the Food and Drug Administration’s daily limit for NDMA is 96 nanograms, and Valisure claimed to have found levels exceeding 3,000,000 ng. The same day it published its findings, Valisure announced a “Citizen’s Petition” with FDA urging a recall of ranitidine. The FDA investigated and initiated a recall after finding NDMA in some pills that exceeded 96 ng. Thousands of lawsuits were filed, which were consolidated in multidistrict litigation before Judge Rosenberg.
In throwing out the claims, the Court said that plaintiffs’ experts lacked documentation on how experiments were conducted, substantiation for “analytical leaps”, statistically significant data and “internally consistent, objective, science-based standards for the evenhanded evaluation of data.” Worse yet, the Court noted that Valisure’s lab equipment effectively created NDMA by heating the ranitidine to 266 degrees Fahrenheit – well above the 98 degrees Fahrenheit found in the human body – to achieve its test result of 3,000,000 ng.
Trouble for Valisure goes beyond the Zantac ruling. On December 5, 2022, the FDA sent a letter to Valisure alleging violations of drug supply chain security requirements and “methodological deficiencies” in the company’s analytical testing laboratory. As the WSJ editorial noted, Valisure’s seeming coordination with plaintiffs’ lawyers, and its now-questionable reports that high NDMA levels persist in the diabetes drug metformin, and that high benzene levels are present in sunscreens and dry shampoos, deserve more scrutiny.
