Valsartan Lawsuit Overview

Valsartan cancer lawsuits were filed against multiple pharmaceutical companies after it was discovered that numerous generic versions of the widely used blood pressure medication were contaminated with N-nitrosodimethylamine (NDMA), a probable human carcinogen linked to an increased risk of liver, colorectal, stomach, and other cancers.

Concerns over valsartan cancer side effects first emerged in 2018, when the U.S. Food and Drug Administration (FDA) announced a series of valsartan recalls due to impurities identified in the drug’s manufacturing process. Although the issue was not made public until 2018, potentially contaminated products had been distributed since as early as 2012, exposing many long-term users to unsafe levels of NDMA.

The discovery prompted a wave of litigation, with individuals filing personal injury and class action lawsuits alleging that contaminated valsartan medications contributed to cancer diagnoses. These lawsuits sought compensation for medical expenses, drug purchase reimbursements and the following injuries:

• Bladder Cancer
• Colon Cancer
• Colorectal Cancer
• Esophageal Cancer
• Intestinal Cancer
• Liver Cancer
• Lung Cancer
• Leukemia
• Multiple Myeloma
• Non-Hodgkin’s Lymphoma
• Prostate Cancer
• Rectal Cancer
• Small Intestine Cancer
• Stomach or Gastric Cancer

At this time, the valsartan litigation has largely been resolved and new cases are no longer being investigated. The information on this page is provided for historical reference and informational purposes.

2025 Valsartan Lawsuit Updates

• October 2, 2025 Update: Plaintiffs in the federal Valsartan litigation are seeking sanctions against generic drugmaker ZHP, accusing it of concealing and destroying key documents related to cancer-causing contaminants in recalled blood pressure pills.
• July 7, 2025 Update: With the first Valsartan cancer bellwether trial set for September, U.S. District Judge Renee Bumb has directed lawyers to prepare a second wave of test cases for trial by January 2026. The litigation involves claims that contaminated batches of Valsartan caused bladder, stomach, prostate, and other cancers. While the outcome of these early trials will not be binding, they could shape future Valsartan settlement negotiations if large jury awards are returned.
• June 3, 2025 Update: The U.S. District Judge presiding over the Valsartan MDL has selected four cases for a second wave of bellwether trials, to follow the first case currently set for September 2025. These Wave 2 cases involve plaintiffs who developed cancer after taking recalled Valsartan and will proceed through discovery this summer, with potential trial dates in mid-2026. If no global settlements are reached after these trials, the Court may begin remanding cases for individual trials nationwide.
• May 1, 2025 Update: The Valsartan MDL continues to move toward its first bellwether trial in September 2025, with the Court now requiring plaintiffs to provide specific product identification linking their cancer diagnoses to recalled versions of the drug made by each manufacturer named in their lawsuit. U.S. District Judge Renee M. Bumb has approved a procedure that allows defendants to challenge cases lacking proof of product use, potentially leading to dismissals if plaintiffs cannot establish manufacturer-specific exposure. This effort to streamline the litigation comes as over 1,300 Valsartan cancer lawsuits remain pending, with parties preparing to test key claims involving NDMA and other carcinogen contamination.
• March 4, 2025 Update: A Special Master overseeing hundreds of Valsartan cancer lawsuits has issued an order laying out the schedule for the first bellwether trial, setting a series of deadlines between now and when the case is slated to go before a federal jury on September 8, 2025.
• January 1, 2025 Update: The Valsartan litigation is set to make significant progress in 2025, with the first bellwether trials scheduled to begin later this year. In October 2024, the Court selected six bellwether lawsuits to move forward, including cases involving stomach cancer, colorectal cancer, prostate cancer, and liver cancer. The liver cancer lawsuit filed by Gaston is the first scheduled trial, set to begin on September 8, 2025.Per a court order issued on November 27, the parties must complete expert discovery in the Gaston case by April 28, 2025, and submit a proposed pretrial order by August 11, 2025. A final pretrial conference will take place on August 28, just days before evidence is presented in open court. These bellwether trials are expected to provide critical insights into how juries may respond to claims and evidence in the broader litigation.
• November 1, 2024 Update: Discussions were held to select a valsartan injury lawsuit for the initial bellwether trial, following the cancellation of a trial involving a third party payor’s claims for reimbursement due to contaminated blood pressure medication. Retired Judge Thomas Vanaskie, acting as the Special Master, confirmed in a case management order that a Valsartan liver cancer lawsuit by Gaston Roberts, Jr. will lead, with five other randomly chosen cases scheduled for subsequent trials, involving stomach cancer and colorectal cancer linked to the drug.
• October 14, 2024 Update: The first bellwether trial in the Valsartan multi-district litigation (MDL) is set to begin next month, providing vital insights that could prompt Valsartan settlement discussions. As of October 1, 2024, there are 1,270 pending lawsuits.
• July 26, 2024 Update: In a order issued on July 22, Special Master Judge Thomas I. Vanaskie, who has been assigned to oversee discovery issues between plaintiffs and defendants determined that ZHP had violated Valsartan court orders which compelled the company to produce documents and make its CEO, Baohua Chen, available for deposition. As a result, the court as fined the company nearly $310,000 in attorney fees and $41,400 in plaintiffs’ expenses.
• July 16, 2024 Update: Ahead of the next scheduled conference on July 23, the parties filed a Valsartan joint status report on July 9, indicating that there are currently more than 1,200 personal injury claims pending in the MDL, involving plaintiffs who developed cancers after using valsartan or similar blood pressure drugs, such as losartan, irbesartan or combination therapies. The report also details developments in the litigation, key rulings that have occurred in the past, and a number of matters still actively pending.
• June 5, 2024 Update: The U.S. District Judge handling all valsartan lawsuits has been informed of a tentative valsartan settlement agreement involving Hetero Drugs, Ltd. and Hetero Labs Ltd., which covers claims for personal injury, economic losses, and the need for ongoing medical monitoring caused by the drug. However, this settlement does not resolve lawsuits concerning economic losses from losartan, a drug similar to valsartan. Judge Bumb has ordered that the details of this settlement be finalized by June 30, 2024, and has further arranged for a mediation session within the next 90 days to try to settle the outstanding losartan claims, stating that she will not approve the valsartan settlement until the losartan cases are either settled or declared unsolvable.
• April 2, 2024 Update: Judge Kugler issued an order denying the manufacturers’ request for summary judgment, allowing claims for breach of express warranty, violation of consumer protection laws, and fraud to move forward. He also declined to remove the option for plaintiffs to seek punitive damages from the manufacturers and distributors. This decision opens the possibility for the jury to impose significantly larger damages as punishment for the manufacturers’ negligent disregard for consumer health and safety.
• February 2024 Update: The U.S. JPML released its latest MDL docket report, revealing 1,226 active valsartan lawsuits within the Valsartan, Losartan, and Irbesartan Products Liability Litigation as of February 1, 2024. The potential for hundreds more claims emerging throughout 2024 remains.
• December 2023 Update: The federal judge overseeing the Valsartan MDL approved three plaintiff classes—Consumer Economic Loss, Medical Monitoring, and Third Party Payor (“TPP”) Class—along with certain subclasses within the valsartan litigation.
• December 2022 Update: Despite a recent order dismissing Zantac lawsuits involving the same cancer-causing contaminant, the U.S. District Judge handling valsartan NDMA lawsuits rejected defendants’ renewed request to exclude plaintiffs’ expert witnesses. Defendants sought reconsideration, citing flaws highlighted in a related case, but Judge Kugler swiftly denied the motion, emphasizing the undeniable presence of nitrosamines in valsartan-containing drugs.
• March 2022 Update: Judge Kugler appointed retired U.S. District Judges Gregory M. Sleet and Lawrence F. Stengel as settlement special masters in the valsartan litigation. Their task is to lead advanced settlement negotiations, aiming to resolve the litigation without resorting to numerous trials.
• December 2020 Update: The judge overseeing the valsartan MDL denied several motions to dismiss from defendant drug manufacturers, signaling the court’s determination to proceed with the litigation despite arguments claiming federal preemption.
• December 2019 Update: A federal panel issued a transfer order on December 18, 2029, consolidating all losartan and irbesartan lawsuits from U.S. District Courts with the ongoing valsartan litigation due to the similar allegations involving contamination of generic blood pressure drugs with cancer-causing chemicals.
• February 2019 Update: The U.S. JPML centralized all valsartan cancer lawsuits filed in federal courts nationwide before U.S. District Judge Robert B. Kugler in the District of New Jersey for pretrial proceedings through a transfer order issued on February 14, 2019.

Valsartan Recalls Over NDMA Contamination

Diovan (valsartan) was first introduced by Novartis in 1996, as a drug to treat hypertension or blood pressure. It belongs to a class of drugs known as angiotensin II receptor blockers (ARBs), which help to relax blood vessels and improve blood flow. However, a number of blood pressure medications containing the active ingredient valsartan have entered the market since 2012 by various drug manufacturers.

Concerns regarding Valsartan NDMA cancer risks arose on July 5, 2018, when the European Medicines Agency (EMA) initiated a recall of various valsartan products following the detection of NDMA in batches sourced from Zhejiang Huahai Pharmaceuticals in China.

The FDA issued a valsartan recall days later on July 13, 2018, impacting valsartan drugs manufactured by several major manufacturers including Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals, and Prinston Pharmaceuticals. In the following months, the FDA expanded these recalls and subsequently announced additional valsartan drug recalls for drugs distributed by specific repackagers, including;

• NuCare Pharmaceuticals
• AvKARE
• Bryant Ranch Prepack Inc.
• A-S Medication Solutions LLC
• RemedyRepack
• Proficient Rx
• Lake Erie Medical, doing business as Quality Care Products LLC
• H.J. Harkins Company, Inc.

The FDA ultimately stopped all imports of drug ingredients and medicines made by Zhejiang Huahai Pharmaceuticals, after an inspection report outlined a number of serious manufacturing problems at the company’s facility in late August.

FDA investigators indicated that NDMA in valsartan is likely a byproduct and impurity resulting from the manufacturing process. Evidence indicates that contaminated versions of valsartan drugs have been in circulation for years, and the risk of cancer associated with valsartan may persist for years to come following the discontinuation of the recalled pills.

Can Recalled Valsartan Medications Cause Cancer?

According to the FDA, valsartan contaminated with NDMA consumed at the highest doses between 2015 and late 2018 may have increased cancer risks among users due to prolonged exposure. Furthermore, at elevated doses, NDMA in Valsartan can lead to severe liver damage, bleeding, and even death.

NDMA stands for N-nitrosodimethylamine. It is a chemical compound that is primarily used in laboratory research to induce cancer in animals for study purposes and is a known environmental contaminant and has been found in certain food items and water supplies. Additionally, it has been identified as a byproduct of certain industrial processes and is considered a probable human carcinogen by the U.S. Environmental Protection Agency (EPA), the World Health Organization (WHO) and the International Agency for Research on Cancer (IARC).

The U.S. has legal limits of how much NDMA can be in drinking water. It has been linked to an increased risk of liver cancer, and is suspected of increasing the risks of kidney cancer and lung cancer as well. EPA determined that consuming up to 96 nanograms of NDMA per day is considered reasonably safe for human ingestion. However, recalled valsartan drugs were found to far exceed that level, according to FDA investigators.

How could NDMA in Generic Valsartan cause cancer?

Valsartan’s contamination with NDMA presented a significant cancer risk due to NDMA’s carcinogenic properties, which have been observed to stimulate tumor development in various organs such as the gastrointestinal tract, liver, lungs, kidneys, and more.

Exposure to NDMA from recalled Valsartan can instigate cancer through multiple pathways. One of such ways is that NDMA has been shown to turn on genes in the body called oncogenes, like RAS, which help control how cells grow and divide. When these genes are overactive, it can increase the risk of cancer.

NDMA has also been shown to change in the body and create a harmful substance called methyldiazonium. This substance can damage the cells’ DNA, which controls how they work. When the DNA is damaged, cells can begin growing out of control, which is a hallmark of cancer.

Studies Linking Valsartan NDMA Exposure to Cancer Risks

Research has found patterns of increased cancer risks among individuals who were exposed to NDMA in valsartan medications when compared to individuals who were been exposed.

Valsartan NDMA Exposure Increases Cancer Risks: Study

In December 2022, a study published in the Journal of the American Heart Association aimed to evaluate the link between exposure to NDMA in generic valsartan and cancer occurrence. Utilizing data from the Système National des Données de Santé, a comprehensive French national health database, researchers analyzed consumers of valsartan aged 40 to 80 between January 1, 2013, and December 31, 2017, with no prior cancer history.

The analysis encompassed 1.4 million subjects, with 986,126 exposed to NDMA-contaminated valsartan and 670,388 exposed to uncontaminated valsartan during the specified period. The findings indicated an elevated cancer risk among valsartan users compared to the unexposed group, revealing:

• Any Malignancy: 55,690 cases among Valsartan users versus 33,174 cases among the unexposed.
• Breast Cancer: 8,085 cases among Valsartan users versus 4,376 cases among the unexposed.
• Prostate Cancer: 10,358 cases among Valsartan users versus 6,734 cases among the unexposed.
• Colon Cancer: 4,866 cases among Valsartan users versus 2,815 cases among the unexposed.
• Rectal Cancer: 1,303 cases among Valsartan users versus 758 cases among the unexposed.
• Liver Cancer: 1,473 cases among Valsartan users versus 789 cases among the unexposed.
• Melanoma: 2,410 cases among Valsartan users versus 1,297 cases among the unexposed.

Valsartan Recalls Increase User Cancer Diagnosis: Report

In a letter published in the July 2019 edition of Circulation: Cardiovascular Quality and Outcomes, researchers from Case Western Reserve University in Ohio reported that adverse event reports involving abnormal tissue growth linked to valsartan use increased nearly seven-fold after the FDA began recalling generic valsartan drugs, finding;

“Percentage of all reported AEs (valsartan to other ARBs) increased from 5.3% pre-recall to 23.4% post-recall,” the researchers determined. “Reporting odds ratio (ROR) for neoplasm AEs increased from 1.7 pre-recall to 7.1 post-recall.”

The researchers point out that those increases were likely the result of widespread alarm among both consumers and medical professionals. However, others have indicated that many of the adverse event reports are the result of consumers learning that their diagnosis was actually the result of valsartan, which they previously had no reason to suspect as a cause of their cancer.

Valsartan NDMA Exposure Cancer Study: 2018

A 2018 Danish study conducted a thorough examination involving 5,150 individuals who started taking valsartan between January 1, 2012, and June 30, 2017, and had no prior history of cancer. Within this cohort, researchers observed a noteworthy discrepancy in cancer occurrence between those exposed to NDMA-contaminated valsartan and those who were not.

Specifically, among individuals exposed to tainted valsartan, 198 cases of cancer were identified, whereas only 104 cases were found in the non-exposed group. This finding suggests a potential association between NDMA exposure through valsartan usage and an increased short-term risk of cancer.

Valsartan Lawsuits Over Cancer Side Effects

Due to the large number of valsartan cancer side effect lawsuits that were filed in various U.S. district courts nationwide wide, each raising similar allegations against the drug manufacturers, a valsartan multidistrict litigation was formed at the direction of the U.S. Judicial Panel on Multidistrict Litigation (JPML) in October 2018.

In a transfer order (PDF), the JPML ordered all claims filed throughout federal courts nationwide to be centralized in the District of New Jersey before U.S. District Judge Robert B. Kugler for more efficient pretrial proceedings, such as discovery and motion practice, as well as promoting consistency in rulings.

As part of the pretrial proceedings, Judge Robert B. Kugler has coordinated a “bellwether” process to prepare a small group of cases for early trial dates, 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.

Valsartan Class Action Lawsuit

Multiple valsartan class action lawsuits were also filed in the Valsartan, Losartan and Irbesartan Products Liability Litigation, which sought economic losses for money spent on the tainted drugs, as well as medical monitoring for cancer screenings for individuals who have not yet been diagnosed with cancer.

Despite objections from the companies responsible for the tainted valsartan pills, who argued that these class action suits were overly intricate and challenging to handle, the court sided against them and established three descriptions of class members involved in the valsartan class action lawsuits, which included a consumer economic loss class, medical monitoring class, and a third party payer class.

Valsartan Consumer Economic Loss Class

This class covered individuals across the U.S. and its territories who bought valsartan-containing medication from any defendant between January 1, 2012, and the final recall date of November 10, 2021.

Valsartan Medical Monitoring Class

This class included individuals in the U.S. (excluding Mississippi, New Hampshire, North Carolina, and North Dakota) who ingested high cumulative levels of NDMA or NDEA from generic valsartan-containing medications made by any defendant since January 1, 2012.

Valsartan Third Party Payer Class

This class included organizations that paid for contaminated valsartan medications in the U.S. between January 1, 2012, and November 10, 2021, from specific manufacturers or sellers.

Valsartan Lawyers

Valsartan injury lawyers previously reviewed potential claims involving individuals who developed cancer after taking contaminated batches of valsartan and related blood pressure medications. These lawsuits alleged that manufacturers failed to adequately ensure the purity of their products or warn consumers about the potential risks associated with NDMA contamination.