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The manufacturers of recalled generic valsartan pills, which were tainted with cancer-causing impurities during the manufacturing process, face a product liability lawsuit brought by a California man, who indicates he was diagnosed with stomach cancer following years of exposure to the contaminated blood pressure drug.
The complaint (PDF) was filed by Kevork Avedikian in the U.S. District Court for the Eastern District of California on February 12, naming Zhejiang Pharmaceutical Co., Ltd., Prinston Pharmaceutical and Solco Healthcare as defendants.
Avedikian indicates that he starting using generic valsartan for treatment of high blood pressure in October 2015, and continued to receive pills manufactured by the defendants until June 2018, when it was discovered that much of the generic valsartan supply in the United States has been contaminated with chemical by-products for years, known as N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), which are known to increase the risk of cancer among humans.
At least some of the tainted valsartan pills Avedikian took were included in those recalls, according to the lawsuit, which indicates that he was diagnosed with stomach cancer about a month before the first public reports about the problems.
The lawsuit notes that generic drugs are supposed to be pharmacologically identical to the brand name drug they are based off; in this case, Diovan. However, the recalled generic valsartan he received was not identical to Diovan, which has never been shown to contain NDMA or NDEA.
“NDMA and NDEA both have the ability to cause cancer by triggering genetic mutations in humans. This mutation affects the structure of the human body, and thus, NDMA and NDEA are, by definition, active ingredients in a drug,” the lawsuit states. “FDA further requires that whenever a new, active ingredient is added to a drug, then the drug becomes an entirely new drug, necessitating a submission of a New Drug Application by the manufacturer. Absent such an application, followed by a review and approval by the FDA, this new drug remains a distinct, unapproved product.”
Since July 2018, a number of different generic valsartan recalls have been issued due to the presence of NDMA and NDEA, impacting a large portion of the pills distributed throughout the United States in recent years.
The FDA has assigned a group of pharmacists and nurses to answer consumer’s questions about the recalls. Since the first recalls, the agency indicates it has received more than 6,000 inquiries from patients, doctors, nurses, pharmacists and academics. Inquiries can be made by calling 855-543-3784 or by sending an email to email@example.com.
While this lawsuit was an individual claim, there are also a number of valsartan class action lawsuits pursuing damages for users of the medications who have not been diagnosed with cancer, seeking reimbursement for the cost of what were essentially worthless drugs, and funding for medical monitoring they may require for the rest of their lives due to their exposure to cancer-causing agents.
For individuals like Avedikian diagnosed with stomach cancer, liver cancer, kidney cancer, bladder cancer, colorectal cancer and other cancers, valsartan lawsuits are also being reviewed by product liability lawyers.