Valsartan lawsuits have been brought against numerous manufacturers of the blood pressure medication. Many batches of generic versions of the drug sold between 2015 and 2018 were contaminated with potentially carcinogenic impurities. In this article, we will discuss the current status of the valsartan lawsuits and how you may be able to pursue a claim for damages.
What Is Valsartan?
Valsartan is a prescription angiotensin-II receptor blocker (ARB). It allows blood vessels to relax, lowering blood pressure and increasing the supply of blood and oxygen to the heart. It is highly effective in managing chronic high blood pressure (hypertension), which in turn helps prevent heart attacks and strokes.
Novartis began manufacturing valsartan under the brand name Diovan in 1996. When Novartis' patent expired in 2012, dozens of manufacturers began producing generic valsartan for the U.S. market. Many obtained the active pharmaceutical ingredient (API) in valsartan from Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), a major Chinese pharmaceutical manufacturer.
Discovery of Contaminated Valsartan
In June 2018, ZHP and its New Jersey-based subsidiary Prinston Pharmaceuticals reported a potentially dangerous impurity in several batches of its generic valsartan to the Food and Drug Administration (FDA).
The following month, the FDA announced a voluntary recall of valsartan products distributed by Prinston, Solco Healthcare, Major Pharmaceuticals and Teva Pharmaceuticals Industries Ltd. Further testing uncovered contaminated batches from many other manufacturers.
By the end of 2018, millions of bottles of valsartan (and other ARBs, including losartan and irbesartan) had been recalled in the U.S. and more than 30 countries.
The recalled valsartan drugs showed traces of N-nitroso dimethylamine (NDMA) and N-nitroso diethylamine (NDEA), chemicals the EPA considers probable human carcinogens. Subsequent investigations revealed that the contamination likely occurred during ZHP's manufacture of the API in its Chinese plant.
Why Are There Valsartan Medication Lawsuits?
While the FDA recalls helped prevent injuries after 2018, more than a million patients had already taken valsartan, some for many years. Many of these patients have filed lawsuits against manufacturers that used ZHP's contaminated API in their generic formulations of valsartan.
The primary allegations in these lawsuits include:
- Product Liability. Manufacturers and distributors of dangerous or defective products, including pharmaceuticals, can face product liability lawsuits. Plaintiffs argue that the manufacturers failed to ensure the safety and purity of their valsartan products.
- Negligence. Many lawsuits allege that pharmaceutical companies and manufacturers were negligent in their quality control processes, allowing dangerous contaminants to enter the medication supply.
- Failure to Warn. Manufacturers must disclose any known side effects or risks related to the use of their products to potential consumers. Failing to take adequate steps to do so is a "marketing defect" that can impose liability. Plaintiffs argue that manufacturers and distributors of valsartan failed to provide adequate warnings about the potential risks for patients who had taken contaminated drugs.
- Breach of Warranty. Patients claim that the sale of contaminated Valsartan constituted a breach of the warranty of merchantability and fitness for a particular purpose, a standard commercial sellers must meet.
Multiple scientific studies and government findings have confirmed that much of the generic valsartan sold between 2015 and 2018 was contaminated. Some lawsuits include allegations that drug manufacturers covered up or delayed reporting known contamination and prioritized profit over patients. If proven, these claims could lead to significant punitive damages awards.
Valsartan Lawsuits in MDL
Thousands of product liability cases are filed in the U.S. every year. When many cases are filed about a particular drug or product, federal courts use the "multidistrict litigation" (MDL) system to consolidate them for pre-trial preparation. The MDL judge rules on questions of fact common to all cases, decides procedural issues and oversees discovery (exchanging evidence and taking depositions).
In an MDL, a few cases that best represent the others are set for trial before the others. The outcome of these "bellwether" trials sets the tone for resolving the remaining cases. If their juries return high verdicts, defendants may be more inclined to settle.
Over 1200 valsartan cases are consolidated in MDL No. 2875 in the District of New Jersey federal court. The trial schedule has been delayed because the MDL was recently reassigned to a different judge. Scheduling conferences are set for late June 2024.
Additionally, ZHP failed to produce its CEO for a deposition (interview under oath) despite being ordered to do so. The plaintiffs have requested the court sanction (penalize) the company for this and for failing to turn over all requested documents. These types of discovery disputes can cause significant delays in litigation. In June 2024, the new MDL judge appointed a "special master" to oversee complex discovery issues.
In March 2024, the MDL judge ruled that the defendants’ affirmations, statements and labeling of the generic Valsartan they produce was an "express warranty." This decision is helpful to plaintiffs' breach of warranty claims.
Is There a Class Action Lawsuit Against Valsartan?
One of the cases in the MDL is a class action lawsuit, which was certified by the NJ District Court in December 2023. There are three classes of plaintiffs in the valsartan class action lawsuit:
- The first class claims economic damages related to purchasing contaminated drugs.
- The second class seeks compensation for the cost of ongoing medical monitoring due to their increased risk of cancer.
- The third-party payor class seeks reimbursement on behalf of insurers and other agencies for claims related to tainted valsartan.
The valsartan class action lawsuit seeks damages on behalf of everyone who suffered these types of economic damages. It is separate from the many personal injury claims brought by patients who allege they developed cancer or suffered other damages as a result of contaminated generic valsartan. These cases seek compensation for economic damages like medical expenses along with non-economic damages like pain and suffering.
When Will the Valsartan Lawsuit Be Settled?
Although there are no current reports of individual valsartan lawsuit settlements, MDLs often use global settlement agreements to resolve all cases in the consolidated litigation simultaneously. The MDL judge may encourage mediation or alternative dispute resolution tools to help the parties resolve these cases quickly.
