Sanofi May Challenge Valisure's Ranitidine NDMA Findings And Say Their Testing Methods Caused NDMA To Spike

Both sides must present a pool of experts they want to testify on their behalf to the MDL judge by November 1, 2021.

Thursday, September 16, 2021 - U.S. District Judge Robin Rosenberg of the Southern District of Florida has told the pool of lawyers representing Zantac cancer lawsuits, and also Sanofi defense lawyers that they have until April 25, 2022, to decide which medical experts to present their scientific evidence that Zantac ranitidine causes cancer. Both sides have until May 9 to present challenges to the court against any of their opponent's experts, according to New York Injury Law News. Both sides must present a pool of experts they want to testify on their behalf by November 1, 2021. The judge's decision may rest on the credibility of the type of drug testing method used by a novel online startup company. Deciding which scientific experts to allow and which to discard is a daunting task for Judge Rosenberg. The judge's decision could affect over 70,000 Zantac lawsuits against Sanofi, the maker of Zantac heartburn and acid reflux medicine. Expert testimony will range from the chemistry underlying the ranitidine molecule and how it transforms into N-nitrosodimethylamine, a deadly carcinogen, to the efficacy of the testing method that some say caused the NDMA spike. Both sides agree that the ranitidine molecule becomes NDMA when exposed to high temperatures. Plaintiff attorneys will argue that transportation and storage temperatures are high enough to cause Zantac to develop more than the 96 nanograms per capsule of NDMA the FDA deems safe. The defense will argue that transportation and storage temperatures are not high enough to cause the ranitidine molecule to break down. They will also say that it was Valisure's high heat testing methods that caused the NDMA spike.

The US Food and Drug Administration (FDA) has weighed in on ranitidine and stated "FDA has found N-nitrosodimethylamine (NDMA) levels in some ranitidine products increase with time and temperature posing a risk to consumers." Perhaps the most eye-opening piece of evidence the defense will argue is that the levels of NDMA that the FDA found are in line and often much less than in foods like processed meats and others preserved with nitrates. "Dr. Janet Woodcock, research director for FDA's Centers for Drug Evaluation and Research, explained that NDMA levels in Zantac are nothing in which to be alarmed. "NDMA can cause harm in large amounts, but the levels the FDA found in preliminary tests of ranitidine "barely exceed amounts you might expect to find in common foods," she wrote. Valisure scientists made modifications to the FDA's Liquid Chromatography High-Resolution Mass Spectrometry (LC-HRMS) Method for the Determination of NDMA that made it more sensitive. Reuter wrote, "The FDA, which checked the over-the-counter drugs using a low-heat method of testing, said it found much lower levels of the impurity - N-nitrosodimethylamine (NDMA) - than was discovered with a higher temperature test employed by Valisure."

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Lawyers for Zantac Heartburn Medicine Lawsuits

OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.