One of the key players involved in the ongoing valsartan NDMA litigation has agreed to a settlement of valsartan lawsuits, providing some relief to individuals impacted by the contaminated blood pressure medication. The U.S. District Judge presiding over the valsartan lawsuits has been informed that a preliminary settlement agreement has been reached with Hetero Drugs, Ltd. and Hetero Labs Ltd., the India-based generic valsartan drug makers. This settlement resolves personal injury, economic loss, and medical monitoring claims brought against the companies.
What is the Valsartan Litigation?
Hetero is one of several pharmaceutical firms embroiled in the valsartan litigation, which emerged after it was discovered in late 2018 that changes to the generic drug manufacturing process had led to the development of toxic chemicals in many versions of the blood pressure medication distributed across the United States.
Valsartan Recalls and NDMA Contamination
The valsartan recalls were initiated after it was confirmed that certain pills contained high levels of N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), and other harmful byproducts. These impurities have been linked to an increased risk of various cancers, including stomach, liver, esophageal, prostate, and pancreatic cancer, among others.
The contamination issue can be traced back to as early as 2012, when Zhejiang Huahai Pharmaceuticals in China began manufacturing the generic valsartan ingredients. This resulted in the potential exposure of numerous individuals to the cancer-causing impurities over an extended period.
Consolidation of Valsartan Lawsuits
In response to the growing number of valsartan-related product liability lawsuits filed across the country, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized the litigation in the District of New Jersey in 2019. This allowed for more efficient pretrial proceedings, such as coordinating discovery and motion practice, as well as promoting consistency in rulings. The valsartan, losartan, and irbesartan product liability MDL currently involves more than 1,200 active cases, with plaintiffs alleging that their use of the contaminated medications led to the development of various forms of cancer.
Hetero’s Valsartan Settlement
The settlement agreement with Hetero is a significant development in the valsartan litigation, as it marks the first resolution of claims against one of the manufacturers involved in the controversy. While the specific details of the Hetero settlement have not been publicly disclosed, the agreement is expected to resolve most of the personal injury, economic loss, and medical monitoring claims filed against the company. The only valsartan-related lawsuits that would remain unresolved are those associated with economic loss claims linked to losartan, a similar hypertension drug from the same class of medications.
Approval Process and Remaining Litigation
Judge Renee M. Bumb, who recently took over the valsartan MDL from the retiring Judge Robert B. Kugler, has ordered the parties to finalize the terms of the Hetero settlement agreement by June 30, 2024. The judge has also arranged for a mediation session within the next 90 days to attempt to resolve the outstanding losartan economic loss claims.
If the Hetero settlement is finalized, it will still leave hundreds of valsartan lawsuits pending against other manufacturers. These remaining cases will likely face future bellwether trials to help the parties gauge the potential payout juries may award for individuals diagnosed with cancer allegedly linked to the drug.
Potential for Additional Valsartan Settlements
The Hetero valartan settlement settlement provides a glimmer of hope for those affected by the contaminated medication. However, there are numerous other defendants still facing a substantial number of claims. Still, the Hetero settlement may pave the way for other manufacturers to follow suit and explore potential resolutions to the valsartan claims. As the litigation progresses, the outcomes of upcoming bellwether trials could further incentivize the remaining defendants to engage in meaningful settlement negotiations.
Ongoing Medical Monitoring and Compensation
For individuals who have used the recalled valsartan products, the settlement with Hetero may provide some financial relief to cover medical expenses, lost wages, and other damages associated with their exposure to the NDMA-contaminated medication. Additionally, the medical monitoring component of the settlement could ensure that affected individuals receive the necessary screening and surveillance to detect any long-term health consequences.