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Valisure LLC's Motivations And Ranitidine Testing Methods May Not Be Scrutinized Before Trial

MDL Judge Reinhart has refused to allow advanced discovery by Glaxo into Valisure's manipulation of ranitidine testing results

Thursday, February 24, 2022 - Glaxo Smith Kline(GSK), one of the makers of Zantac heartburn and acid reflux medicine, has accused Valisure LLC of fraudulently testing ranitidine. Valisure allegedly discovered that the ranitidine molecule was inherently unstable and broke down naturally to become N-nitrosodimethylamine (NDMA), a carcinogen known to cause cancer in humans. GSK thinks that Valisure Inc., a start-up online prescription drug testing pharmacy falsified ranitidine testing results and has conflicts of interests and relationships with attorneys and the FDA. According to MedTruth, "GSK alleges that Valisure LLC, an independent pharmacy that detected that Zantac heartburn medication broke down into the carcinogenic chemical N-Nitrosodimethylamine (NDMA), has engaged in concerted efforts to generate false lab results to further its financial interests and the financial interests of potential litigants, their lawyers, and their litigation funders." former Zantac users have filed Zantac lawsuits thinking that taking ranitidine caused their cancer.

GSK was attempting to prove their allegations against Valisure through discovery when MDL Judge Bruce E. Reinhart stopped the inquiries. The basis of the action was that only third-party tests would be cited as testimony, not Valisure's ranitidine tests. The discovery that the MDL judge blocked pertained to the following questions according to MT. "To attempt to prove this theory, they subpoenaed evidence across 23 distinct categories regarding four inquiries. Those inquiries were: "What are the origins and development processes of the Valisure study that found NDMA in Zantac that led to their Citizen's Petition? How is Valisure funded and by whom? What is Valisure's relationship with the attorney Mr. Bretholz and how do they communicate? What is the extent of Valisure's lobbying efforts in Congress and with the U.S. Food and Drug Administration (FDA)?"

Judge Reinhart thinks that it is irrelevant that Valisure may have had financial motivation to make their heartburn medicine cancer claims to have found levels of NDMA that were orders of magnitude greater than the levels that the FDA thought to be safe. The official Valisure story as to why they tested Zantac ranitidine in the first place was because it was recommended to be given to one of the company's founder's daughters as medicine. The Valisure ranitidine testing method is believed to be the same as the one that the FDA uses, with the modification of possibly excessively overheating the ranitidine sample to produce a high amount of NDMA poison. In an article published recently by the Regulatory Affairs Professional Society (RAPS), Jason Rodriguez, director of the division of complex drug analysis at the US Food and Drug Administration's (FDA's) Office of Testing and Research in St. Louis was astonished when FDA testing showed little acceleration in NDMA in ranitidine samples they tested. What they did find, however, was that Valisure's testing method using gas chromatography/mass spectrometry (GC/MS) to gauge nitrosamine impurity levels so overheated the testing sample that there was little left of it. "After testing the samples, FDA staff discovered black material in the sample headspace that proved to be the "charred remains" of the tested tablets. "This was not something that we usually see for headspace, so we began to think, 'What is going on here?'" said Rodriguez. "Is ranitidine undergoing some thermal degradations to form NDMA?"

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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.

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