Product News and Recalls

Update: Consolidation Sought in Valsartan Lawsuits

valsartan plaintiffs seek consolidation of lawsuitsPlaintiffs involved in lawsuits over contamination of a key ingredient in generic heart medications have moved to have their cases consolidated before a federal judge.

Shipments of valsartan, an ingredient in medications used to treat high blood pressure and heart failure, were found to be tainted with a chemical known as NDMA. According to the EPA, NDMA is a possible human carcinogen and is used in everything from rocket fuel to the processing of fish. A voluntary recall of valsartan was issued as a result and patients were encouraged to work with their medical providers to find a suitable replacement medication or to identify whether their medications had been made from the tainted lots in the first place. However, they were also encouraged to continue taking their medications while taking these steps.

Additional valsartan impurities were discovered as a result of subsequent testing and an additional chemical known as NDEA was also found. In this case, those lots were tied to a Chinese manufacturer and led to punitive and protective actions taken by both the United States and Canada. As a result, medications manufactured by Zhejiang Huahai are not currently allowed into the US.

A series of federal lawsuits filed by affected patients followed and a group of those patients in Illinois would like to see their lawsuits consolidated with other similar cases and to have the matter tried as a multidistrict litigation. The plaintiffs filed their motion in late October and have asked the Judicial Panel on Multidistrict Litigation to move their cases to New Jersey to be tried by Judge Freda L. Wolfson.

Additional valsartan lawsuits are expected as more patients learn the potential ramifications and extent of NDEA and NDMA contamination and the potential failures that took place that may have allowed the medications they depended on to become agents of possible harm. While the number of affected valsartan lots may be low, the number of patients taking heart medication in the United States reaches well into the millions. Given such a large number, even a small percentage is enough to warrant concern.