A group of plaintiffs pursuing lawsuits in connect with recent valsartan recalls have proposed that all such federal claims be centralized in a single U.S. District Court for the purpose of coordinated discovery and other pretrial proceedings.
In a motion filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on October 22nd, the plaintiffs suggest that the U.S. District Court, District of New Jersey, would serve as an ideal venue for the federal valsartan litigation.
Valsartan is a generic medication used to treat high blood pressure and heart failure.
In June, a Chinese manufacturer — Zhejiang Huahai Pharmaceuticals – disclosed that its valsartan API (active pharmaceutical ingredient) had been contaminated with a potentially cancer-causing chemical called N-nitrosodimethylamine (NDMA).
The announcement prompted numerous generic drug makers in the United States, Europe, and Canada to announce valsartan recalls.
At least 11 valsartan lawsuits are now pending in various federal courts throughout the United States. The majority are class action lawsuits that seek compensation on behalf of consumers who purchased contaminated valsartan. In addition to Zhejiang Huahai Pharmaceuticals, the claims name various generic drug makers, distributors, and retailers as defendants.
The motion filed with the JPML predicts that the federal valsartan docket will grow considerably in the near future.
“Significantly, these filed cases represent only a small sample of the cases that will eventually be filed, as the Recall and other government investigations of the scope of NDMA contamination are still in their infancy,” plaintiffs state. “It is reasonable to expect that more cases will be filed as the public becomes increasingly aware that a generic drug meant to treat heart disease — the leading cause of death for Americans — has been contaminated with a carcinogen.”
Plaintiffs further point out that all of the pending claims put forth many common allegations of fact, including:
The motion asserts that centralization before a single federal judge in the District of New Jersey – where 5 of the currently pending valsartan lawsuits were filed – would serve the best interests of the parties, parties’ counsel, and the judiciary by conserving economic resources and equitably preventing inconsistent rulings.
The U.S. Environmental Protection Agency (EPA) has declared NDMA a probable human carcinogen. Animal studies have linked NDMA exposure to tumors of the liver, respiratory tract, kidneys and blood vessels.
According to the U.S. Food & Drug Administration (FDA), NDMA-contaminated valsartan appears to have resulted from a change in Zhejiang Huahai Pharmaceuticals’ production methods that occurred in 2014. Thus, tainted drugs may have been in circulation for the past 4 years.
The FDA’s scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there might be one additional case of cancer over the lifetimes of those 8,000 people.
Valsartan patients should contact their pharmacy to determine if their medication has been recalled. Alternatively, consumers can check the FDA’s regularly-updated lists of medications included in the valsartan recall, as well as those not included in the recall.
Those with recalled valsartan should continue taking their medication until they have obtained a replacement, as stopping could result in serious adverse health consequences.
Consumers with questions about the valsartan recalls can also contact the pharmacists and nurses staffing the FDA’s dedicated hotline at (855-543-3784).