Valsartan Settlements Reached To Resolve Personal Injury, Class Action and Medical Monitoring Claims Against Hetero

Lawyers will seek preliminary approval for a settlement of valsartan lawsuits against the generic drug maker Hetero, but claims involving other manufacturers of contaminated valsartan pills remain unresolved

The U.S. District Judge presiding over all valsartan lawsuits has been told that a preliminary settlement agreement has been reached with one of the generic drug makers involved in the litigation, resolving personal injury, economic loss and medical monitoring claims brought against Hetero Drugs, Ltd. and Hetero Labs Ltd.

The India-based generic drug maker is one of several pharmaceutical companies involved in the valsartan litigation, which emerged after it was discovered in late 2018 that changes to the generic drug manufacturing process caused the development of toxic chemicals in most versions of the blood pressure medication distributed throughout the United States.

Hetero is one of several manufacturers who issued valsartan recalls, after it was confirmed that their pills contained high levels of N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) and other chemical byproducts, which have been linked to an increased risk of stomach cancer, liver cancer, esophageal cancer, prostate cancer, pancreatic cancer, and other injuries.

The valsartan settlement agreement with Hetero comes after more than 5 years of litigation, which currently involves more than 1,200 product liability lawsuits filed throughout the federal court system against various drug makers. However, given the long latency period for several types of cancer caused by NDMA in valsartan, new lawsuits continue to be filed.

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Side effects of recalled valsartan may increase the risk of cancer, due to an impurity discovered in certain generic versions of the hypertension drug.

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As a result of common questions of fact and law raised in complaints filed in U.S. District Courts nationwide, the litigation has been centralized for pretrial proceedings before U.S. District Judge Robert B. Kugler in the District of New Jersey since 2019, where the parties have been preparing groups of cases for early “bellwether” trials, which are designed to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout hundreds of claims.

However, Kugler recently announced his retirement, and the litigation was handed over to U.S. District Judge Renee M. Bumb, whom valsartan lawyers met with for the first time last week. At that time, Judge Bumb was advised of a pending settlement for valsartan lawsuits specifically filed against Hetero, which should effectively end their role in the litigation.

2024 Valsartan Settlement Update

Before the meeting, plaintiffs’ attorneys and the Hetero defendants sent a letter (PDF) to Judge Bumb, indicating their intent to file a motion for preliminary approval of a Valsartan settlement in the “near future”, which would resolve most personal injury, economic loss and medical monitoring lawsuits filed against the company.

Details on the proposed settlement have not been released, but lawyers indicate the only Hetero Valsartan lawsuits that would remain unresolved are those associated with economic loss lawsuits linked to losartan, a similar hypertension drug from the same class of medications. Hetero is the only manufacturer involved in the settlement agreement.

After meeting with the parties, Judge Bumb issued a court order (PDF) on May 31, calling for the parties to finalize the terms of the settlement agreement for all three classes of lawsuits by June 30, 2024. The order also calls for the parties to meet with retired Magistrate Judge Joel Schneider within the next 90 days to attempt to resolve the remaining losartan economic loss lawsuits.

Judge Bumb indicated that she will not grant any preliminary approval for the Valsartan settlement without the losartan lawsuits being resolved as well, unless Magistrate Schneider indicates the parties have reached an “irresolvable impasse” in settling the losartan lawsuits.

If the settlement agreement is finalized, it would still leave hundreds of valsartan lawsuits pending against other manufacturers, which will likely face future bellwether trials to help the parties gauge the average payout juries may award for individuals diagnosed with various forms of cancer. However, if those remaining drug makers fail to settle the remaining valsartan claims or otherwise resolve the litigation, dozens of individual cases may later be remanded back to different U.S. District Courts nationwide for separate trial dates in the future.

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