In New Jersey, on Friday, January 29, 2021, U.S. District Judge Robert Kugler permitted numerous fraud allegations to move forward against a group of generic blood pressure drugmakers that consumers claim consciously sold their valsartan medications with the presence of possible carcinogen N-nitrosodimethylamine (NDMA). The companies in question include but are not limited to: China’s Zhejiang Huahai Pharmaceutical, Prinston Pharmaceutical, Hetero Drugs, Mylan, Aurobindo Pharma, Teva, Arrow Pharm Malta, and Actavis Pharma.
In 2018, the FDA discovered that NDMA and the similar N-nitrosodiethylamine (NDEA) could be created during the manufacturing of certain drugs. The results led to a global recall of hundreds of lots of blood pressure drugs valsartan, irbesartan, and losartan. The FDA then launched a thorough investigation into how the contamination may have occurred as well as the risk it could present for U.S. consumers.
Buyers hope to hold the companies responsible for the recall of drugs containing valsartan, which is the active ingredient in Novartis’ Diovan, due to a failure to mention the potential presence of NDMA. According to the lawsuit, the plaintiffs believe that the drugmakers would have found the NDMA impurities sooner had they followed FDA guidelines, suggesting that the manufacturers “either knew of or recklessly disregarded the contamination,” according to Ruben Honik, an attorney for the consumers.
Judge Kugler simultaneously threw out claims against distributors of the generic drugs, claiming that wholesalers Cardinal Health, McKesson, and AmerisourceBergen as well as pharmacies including CVS Health, Walgreens Boots Alliance, and Rite Aid couldn’t have known that they were stocking tainted products.
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.