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Valisure's Ranitidine Testing Method May Not Matter As Sanofi Could Be Held Responsible For Failing To Warn Customers

No one is questioning if ranitidine becomes NDMA when heated to high temperatures, but who was responsible for telling consumers

Tuesday, February 1, 2022 - Valisure Inc., an unknown internet startup company just a couple of years ago, sent shockwaves through the medical community when it announced they had tested Zantac heartburn and acid reflux medicine and found quantities of a deadly carcinogen far above the amount that the Food and Drug Administration deemed safe for human consumption. Valisure sent a notice to Sanofi that they immediately recall the product voluntarily and the company complied. A citizen’s petition also went to the FDA requesting that the government health watchdog agency recall all forms of ranitidine, Zantac being the best-known and best-selling in the world. What is now in question, nearly three years later, is the type of testing Valisure used on ranitidine and there are questions if the testing itself did not cause the contamination. There were more than 100,000 people that have filed Zantac lawsuits to become included in the heartburn medicine cancer multidistrict litigation against Sanofi, claiming that they had taken Zantac regularly and developed cancer. The types of cancer eligible for inclusion in the MDL are bladder cancer, esophageal cancer, gastric cancer, liver cancer, and pancreatic cancer. Notably excluded is oral and breast cancer.

It may seem that Valisure is on trial as plaintiffs expert Valisure's CEO David Light tells his story. Sanofi could look to 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, who reported that the FDA team tested and found levels of NDMA in Zantac that were only slightly elevated and not a reason for panic. The FDA recall was more due to exercising an abundance of caution because the agency had no way to monitor the handling of the tablets during transportation and storage where high temperatures may cause ranitidine to break down to become NDMA. N-nitrosodimethylamine (NDMA) is a deadly carcinogen that is found in low levels in the air, water, and land. At issue at trial will certainly be whether Sanofi, the maker of Zantac, knew or had an obligation to know that ranitidine was, as David Light claims, is an inherent molecule that could degenerate under high temperatures during transport or storage. There is an ongoing investigation of Sanofi by the US Department of Justice that alleges the company may have lied to FDA regulators about what they knew about ranitidine and NDMA. Blood pressure medications Valsartan and Losartan had been recalled previously. Valisure tells us that the quality and professionalism of their ranitidine testing lab are unparalleled and that they are accredited through international standards organizations. The company says that they hold themselves to the highest standards in management, data tracking, document tracking, and pride themselves in providing the highest standard of testing, according to a video published by the company on YouTube titled "How Valisure's Lab Detected NDMA in Ranitidine."">

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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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