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District Judge Renee M. Bumb, who is currently overseeing the centralized Valsartan litigation in the District of New Jersey, recently received a motion from plaintiffs to establish a qualified settlement fund for certain cases subject to settlement and appoint a settlement administrator and custodian for the funds. If approved, the funds will be used to pay damages to claimants.

A small group of lawsuits against Hetero Drugs, Ltd.—an India-based generic drug maker and one of the several companies involved in the valsartan litigation—was resolved with a partial settlement in 2024. The fund under consideration now is related to this settlement and would help distribute payouts from drug makers who have reached agreements with plaintiffs.

Many other cases, however, are still pending. Preparations for early trial dates continue, with the first scheduled to begin in September 2025. Judge Bumb has identified six bellwether lawsuits that will be tried first. Two involve plaintiffs who claim the drug caused their stomach cancer, two more involve colorectal cancer claims, and the remaining two involve claims of prostate and liver cancer.

Valsartan Found to Contain a Cancer-Causing Impurity

On February 14, 2019, the U.S. Judicial Panel for Multidistrict Litigation (JPML) ordered all federally filed valsartan lawsuits to be centralized in the District of New Jersey. Valsartan is a medication used to treat high blood pressure and congestive heart failure and to reduce the risk of heart attack and stroke. Many medications include valsartan, including generic versions sold by Major Pharmaceuticals, Teva Pharmaceuticals, and Solco Healthcare.

In July 2018, the U.S. Food and Drug Administration (FDA) issued a recall of several drug products containing the active ingredient valsartan due to an impurity called Nitroso Dimethylamine (NDMA). Based on animal studies, the Environmental Protection Agency (EPA) has classified NDMA as a probable human carcinogen.

The contamination was believed to have been caused by a change in the manufacturing process. It was first discovered in 2018, but potentially contaminated valsartan medications have been on the market since 2012 when the manufacturing change took place.

Now, more than 1,200 cases are pending in the court, with plaintiffs claiming that the medication, because of the NDMA impurity, caused former users to develop a variety of different types of cancer. Though last year’s settlement resolved a small portion of these, the remaining cases remain on track for early trials to begin in September.

Plaintiffs Seeking Compensation for Medical Costs and Future Medical Monitoring

Shortly after the FDA recall, individuals began to come forward to file valsartan lawsuits. The numbers increased with time.

The plaintiffs seek compensation for medical costs, lost wages, pain and suffering, and economic losses for buying potentially harmful medications.

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