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Science Day For Zantac Discovery Could Take Months

Getting to the bottom of what caused ranitidine to become NDMA will be the focus of MDL scientific testimony

Sunday, October 31, 2021 - Science day for thousands of Zantac cancer lawsuits organized into multidistrict litigation is scheduled for December 2, 2021, in a West Palm Beach Florida courtroom. Starting then, experts from both sides will give a presentation of their scientific studies pertaining to ranitidine, the active ingredient in Zantac heartburn and acid reflux medicine. Ten experts from each side will be heard during a procedure that could take months to analyze, and give testimony about their research that will link ranitidine with developing numerous types of cancer or refute the connection.

The first expert to testify may be David Light, the CEO of Valisure, the online prescription drug testing pharmacy that first discovered highly elevated N-nitrosodimethylamine (NDMA), and suspected it could cause heartburn medicine cancer. Valisure stumbled on ranitidine NDMA contamination when one of the company founders tested ranitidine because he wanted his daughter to take it for a condition she had developed. Valisure discovered more than 3 million nanograms of NDMA in a Zantac tablet they tested, far exceeding the 96 nanogram limit set by the FDA. A nanogram is equivalent to one billionth of a gram. A grain of salt weighs more than 50,000 nanograms in comparison. Valisure immediately notified Sanofi, the maker of Zantac, and the US Food and Drug Administration of their finding more than the acceptable limit of NDMA in each tablet they tested. The petition they filed urged Sanofi to voluntarily withdraw Zantac from the market, which they did. They also urged the FDA to recall all forms of ranitidine, which complied about a month later.

Valisure's finding on ranitidine went beyond finding mere NDMA contamination, and targeted the ranitidine molecule as being inherently unstable and degrading into carcinogenic NDMA when heated to higher temperatures, much like red meats may become carcinogenic when grilled to well-done. The FDA recalled ranitidine, not because of the elevated levels of NDMA which their tests determined were only slightly elevated and not a cause of concern, but because there was no way to monitor the temperatures in which ranitidine was being transported or stored. Heating a drug capsule during transportation and storage may also have affected other medicines that have been tested and found to contain worrisome levels of NDMA. Blood pressure medicine, diabetes medicine, and smoking cessation drugs have all tested positive for alarmingly high amounts of NDMA and all have been recalled to one degree or another.

The results of the scientific element of the Zantac MDL could determine whether the issue of ranitidine being carcinogenic expands into the largest mass tort lawsuit of our time, or fizzles out to be nothing more than a false alarm on the part of an overeager internet startup company. The defense of ranitidine will no doubt highlight the way Valisure manipulated the FDA testing process and may have heated their samples of all drugs to temperatures that are unrealistic to expect in transportation or storage.

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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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