The valsartan recall litigation could be massive, as legal experts anticipate that thousands of plaintiffs will seek compensation for personal injuries and other damages allegedly related to their use of contaminated medications.
Valsartan was the first of several generic heart failure and blood pressure drugs recalled last year, after NDMA was discovered in active pharmaceutical ingredients manufactured by China-based Zhejiang Huahai Pharmaceutical Co.
NDMA occurs in bacon and other cured meats, and has long been designated a known carcinogen. Some research suggests the compound may cause cancers of the gastrointestinal tract, including colon cancer, stomach cancer, and esophageal cancer. Other studies have linked NDMA to liver cancer, kidney cancer, and pancreatic cancer.
Tests have since detected NDMA and other potentially cancer-causing nitrosamines in active ingredient used to manufacture generic losartan and irbesartan tablets. A second overseas supplier, Hetero Labs of India, was also caught up in the controversy, but so far, Zhejiang Huahai’s products have had the highest carcinogen levels.
Contaminated valsartan tablets circulated for at least four year before the problems surfaced. The recalls are ongoing, and the U.S. Food & Drug Administration continues to update its lists of affected valsartan, losartan and irbesartan products.
So far, the valsartan recall litigation underway in New Jersey federal court houses fewer than four dozen cases. More than half of the filings assert personal injury claims for cancer, while the remaining consist of class action lawsuits that seek economic damages and medical monitoring on behalf of consumers who purchased contaminated medications.
According to Bloomberg News, a plaintiffs’ attorney told the Court last month that 1.8 million Americans had taken adulterated drugs and suggested that his firm could file at least 2,000 valsartan lawsuits within the next two years. A lawyer for MSP Recovery, a Florida-based service representing health insurance companies that covered 73,311 valsartan patients, estimated those claims totaled more than $91 million.
Plaintiffs involved in the valsartan recall litigation allege that the tainted pills contained somewhere between 3.1 and 177 times the level of NDMA deemed safe for human consumption. According to at least one complaint, the amount of contaminant in a single valsartan tablet is the equivalent of 30 pounds of bacon.
Plaintiffs have already sued over 40 defendants, including Zehjiang Huahai, Teva Pharmaceutical Industries Ltd., Mylan NV, and CVS Health Corp. So far, the proceeding does not include any irbesartan or losartan lawsuits.