More than five years after the initial valsartan recalls, the U.S. District Judge overseeing the valsartan litigation has greenlit the first trial against manufacturers and distributors of the tainted generic blood pressure drug. Over 1,200 valsartan lawsuits have been filed, with individuals alleging that changes to the manufacturing process resulted in the distribution of valsartan pills contaminated with N-nitrosodimethylamine (NDMA) and other harmful chemicals. These contaminants have been linked to various types of cancer, including stomach cancer, liver cancer, esophageal cancer, prostate cancer, and other injuries.

What is Valsartan?

Valsartan, an angiotensin II receptor blocker (ARB), is a widely prescribed medication used to treat high blood pressure and heart conditions such as heart failure and post-myocardial infarction. It was initially developed by Novartis and gained FDA approval in 1996. Valsartan works by blocking angiotensin II, a hormone that constricts blood vessels and raises blood pressure. With its effectiveness in managing hypertension and heart failure, valsartan quickly became a popular choice among physicians and patients alike.

NDMA Contamination and Valsartan Recall

In July 2018, it was discovered that the raw valsartan produced by one of the leading manufacturers of generic valsartan, China’s Zhejiang Huahai Pharmaceuticals (ZHP), was contaminated with NDMA. NDMA, also known as N-nitrosodimethylamine, is a well-known carcinogen that is believed to cause cancer in humans. In a valsartan recall announcement issued on July 13, 2018, the FDA stated that “The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance [valsartan] was manufactured.” The presence of NDMA in valsartan raised serious safety concerns due to the popularity of the blood pressure drug and NDMA’s potential link to cancer. 

The Link Between Valsartan and Cancer

Numerous research studies have established a potential connection between long-term NDMA exposure and an increased risk of cancer. Furthermore, NDMA is classified as a probable human carcinogen by the U.S. Environmental Protection Agency (EPA). This classification is based on the evidence showing that NDMA causes cancer in animals and is reasonably anticipated to have the same effect on humans. Cancer types associated with NDMA exposure from valsartan include:

• Colorectal cancer
• Intestinal cancer
• Stomach cancer
• Liver cancer
• Esophageal cancer
• Prostate cancer
• Blood cancers
• Non-Hodgkin’s lymphoma
• Multiple myeloma
• Leukemia
• Bladder cancer
• Lung cancer

MDL Judge Clears Valsartan Cancer Lawsuit to Move Forward

Given the common fact patterns and legal questions raised in valsartan lawsuits filed across different U.S. District Courts, the litigation has been centralized before U.S. District Judge Robert B. Kugler in the District of New Jersey since 2019. This consolidation, known as multidistrict litigation (MDL), allows for more efficient handling of the valsartan claims and facilitates the coordination of pretrial proceedings.

After years of preparation and legal proceedings, the U.S. District Judge overseeing the valsartan lawsuits has cleared the first claim to go before a jury. This significant milestone marks a crucial step towards seeking justice for individuals who developed cancer and other injuries after using tainted versions of the generic blood pressure drug. With over 1,200 lawsuits filed against valsartan manufacturers and distributors, this trial will serve as a bellwether trial, providing insights into how juries may respond to the evidence and testimony presented throughout the litigation.

Seeking Compensation for Damages

Individuals who have been harmed by NDMA-contaminated valsartan are seeking financial compensation for their injuries. Valsartan lawsuits allege that changes to the manufacturing process resulted in the distribution of valsartan pills with high levels of NDMA, exposing individuals to the risk of developing cancer and other related injuries. By holding the manufacturers and distributors accountable, plaintiffs aim to recover damages for medical expenses, pain and suffering, lost wages, and other losses allegedly caused by their exposure to the contaminated medication.

The Future of Valsartan Cancer Litigation

With the first valsartan trial cleared to move forward, the valsartan litigation is at a critical juncture. If a global settlement is not reached, the court may proceed with a series of bellwether trials. These trials serve as test trials, allowing both plaintiffs and defendants to assess how juries are likely to respond to the evidence presented. Depending on the outcomes of these bellwether trials, the court may consider remanding individual claims back to U.S. District Courts nationwide for separate trial dates.

However, there is still room for settlement negotiations. The court has appointed special masters to facilitate potential settlements between the parties involved. A global settlement, if reached, could provide compensation to affected individuals without the need for each claim to go to trial. This approach would expedite the resolution of the litigation and ensure that individuals receive the compensation they deserve for the harm allegedly caused by the contaminated valsartan.