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The FDA thinks that ranitidine can turn carcinogenic in three different ways

Plaintiffs contend that Sanofi either knew or had an obligation to know of the spikes in NDMA regardless of the source of contamination

Monday, November 22, 2021 - Regulators at the Food and Drug Administration have been studying and testing ranitidine for about three years now and have come to some interesting conclusions. Their findings are sure to be focused on when a federal judge decides on which scientific experts will be allowed to testify at bellwether trials coming up in 2023, and which ones are merely inflammatory and not based on hard science. The FDA's ranitidine test results may run contrary to those of online prescription drug testing pharmacy Valisure which ignited a firestorm of controversy several years back about ranitidine being inherently unstable and degrading to become carcinogenic. More than 70.000 heartburn medicine cancer lawsuits have been registered in multidistrict litigation by people with stomach, bladder, esophagus, colon, prostate, breast, or another form of terminal cancer. 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 reported that the agency thinks that carcinogenic levels of NDMA is not due to the inherent instability of the ranitidine molecule only, but can develop in any of three different ways. According to the Regulatory Affairs Professional Society, "Nitrosamine impurities can be introduced in three ways, with contamination occurring during the manufacturing process or via the supply chain; impurities may also develop because of problems with the drug's stability." Plaintiffs suing Sanofi allege think that the company either knew or had an obligation to know of the spikes in NDMA regardless of the source of contamination. Sanofi is under investigation by the Department of Justice (DOJ) for allegedly lying to government regulators about their knowledge of NDMA levels.

Legal experts think that there is a likelihood that Sanofi will make a settlement offer due to overwhelming scientific evidence against them and the sheer number of potential plaintiffs. Over 15 million Americans were using Zantac at the time of the April 1, 2020, FDA ranitidine recall that set the heartburn medicine world back to the stone ages. According to attorneys, the settlement offer may mirror the $12 billion settlement of 90,000 cancer cases by Bayer over allegations that plaintiffs developed non-Hodgkin's lymphoma (NHL) from ingesting Roundup herbicide by inhaling the fumes or repeatedly coming into direct skin contact. If that happens, plaintiffs may be divided into three groups according to the magnitude of their injuries and the amount and regularity of taking Zantac. Settlements amounts could range from $20,000 to $400,000 or more according to Lawyers for those who have filed antacid cancer lawsuits are required to have them pre-screened by filling out an extensive questionnaire about their and their family's medical and employment history, their history of taking Zantac, and the doctor's certification of their cancer diagnosis so that only the best-qualified plaintiffs are accepted into the MDL.

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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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