Numerous lawsuits have emerged in recent years alleging that generic valsartan, a widely used blood pressure medication, contains dangerous impurities linked to various forms of cancer, including bladder cancer, kidney cancer, colorectal cancer, and stomach cancer. With more than 1,200 lawsuits being pursued by former users who have been diagnosed with cancer, a federal judge has selected five claims for the second round of bellwether trials in case the parties fail to reach a valsartan settlement following the first round of trials, which are slated to begin later this year.
What is Valsartan?
Valsartan is an angiotensin II receptor blocker (ARB) commonly used to manage high blood pressure and heart failure in patients. It works by relaxing blood vessels, making it easier for the heart to pump blood. While valsartan has been effective for many patients, significant concerns arose in mid-2018 when the FDA announced recalls of several medications containing the active ingredient valsartan, due to contamination with N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA)—two chemicals classified as probable human carcinogens.
NDMA and NDEA Impurities Found in Valsartan Products
A byproduct of various industrial processes, NDMA is known to cause cancer in laboratory animals and is suspected to pose similar risks to humans. The compound NDEA is also linked to cancer and was found in numerous batches of valsartan manufactured by various companies. The contamination of valsartan reportedly occurred due to changes in the manufacturing processes of generic versions of the blood pressure medication. According to reports, the contamination of valsartan has allegedly been occurring since 2012 when Zhejiang Huahai Pharmaceuticals (ZHP) in China began manufacturing generic valsartan pills.
Valsartan Lawsuits Consolidated in MDL
As of now, over 1,200 product liability lawsuits have been filed in federal courts across the country against manufacturers of the blood pressure drugs valsartan, losartan, and irbesartan, with plaintiffs alleging that the contaminated medications led to serious health issues, including various types of cancer. These lawsuits have been consolidated into a multidistrict litigation (MDL) in the U.S. District Court for the District of New Jersey, overseen by Judge Renee M. Bumb.
The Valsartan Bellwether Trial Process
To facilitate the resolution of these claims, the court has initiated a series of valsartan bellwether trials. These trials are designed to gauge how juries may respond to the evidence presented in the valsartan lawsuits, potentially influencing settlement negotiations. The first round of bellwether trials is set to commence in September 2025, with the possibility of additional trials if necessary. The claims that have been selected for the second round of bellwether trials include:
- Lana Dufrene’s Kidney Cancer Lawsuit: Filed in July 2019 after her kidney was removed due to cancer, allegedly linked to her valsartan use.
- Robert Garcia’s Colorectal Cancer Claim: A Texas resident who developed colorectal cancer after using valsartan, with his lawsuit filed in June 2020.
- Evon Smalls’ Stomach Cancer Lawsuit: Another claimant from South Carolina who alleges that her stomach cancer is a result of taking valsartan.
- Sandra Meeks’ Wrongful Death Claim: Filed on behalf of her deceased husband, claiming that valsartan use contributed to his esophageal cancer and subsequent death.
- James and Cynthia Suits’ Colon Cancer Lawsuit: Alleges that long-term use of valsartan led to colon cancer, resulting in permanent injuries.
Health Risks Allegedly Associated with Valsartan Use
Plaintiffs pursuing compensation from the manufacturers of contaminated valsartan allege that the pills caused them to develop serious and potentially life-threatening health problems, including cancer. Valsartan products contaminated with NDMA or NDEA have been linked to a range of cancer types, including the following:
- Liver Cancer
- Colorectal Cancer
- Stomach Cancer
- Prostate Cancer
- Bladder Cancer
- Esophageal Cancer
Those who successfully prove their valsartan claims in court may be entitled to recover compensation for:
- Medical expenses
- Lost wages
- Pain and suffering
- Emotional distress
The Future of the Valsartan Litigation
As the valsartan bellwether trials approach, the outcome of these initial lawsuits could set a precedent for future claims. If the trials reveal a strong correlation between valsartan and the health risks alleged by plaintiffs, it may lead to increased settlements and a more streamlined process for victims seeking compensation. The ongoing litigation could also have broader implications for pharmaceutical companies, particularly in terms of regulatory scrutiny and manufacturing practices. Companies may face increased pressure to ensure the safety and purity of their products, as well as to provide transparent information to healthcare professionals and patients.
Valsartan Lawsuit Information
Laboratory analysis of valsartan products, FDA
Valsartan Cancer Lawsuit, Leading Justice
