Valsartan Lawsuit

Valsartan Lawsuit Overview

Individuals are now filing valsartan cancer lawsuits and valsartan class action lawsuits against several drug makers after it found that numerous generic versions of Valsartan, a widely-used blood pressure medication, were tainted with N-nitrosodimethylamine (NDMA), a known carcinogen that can increase the risk of liver, colorectal, stomach, and other forms of cancer.

The concerns over valsartan cancer side effects first emerged in 2018 when the U.S. Food and Drug Administration (FDA) initiated several valsartan recalls due to NDMA contamination resulting from alterations in the drug’s manufacturing processes. Although the impurity was identified in 2018, potentially contaminated Valsartan products had been available since as early as 2012, exposing numerous individuals to the cancer-causing impurity.

Consequently, individuals who took recalled valsartan pills are filing lawsuits against pharmaceutical companies, alleging that their use of toxic valsartan medications contributed to the development of cancer. This has led to the filing of both individual valsartan cancer lawsuits and valsartan class action lawsuits for medical monitoring and drug expense reimbursements.

Who is Eligible for a Valsartan Lawsuit?

Financial compensation may be available through a valsartan lawsuit for individuals who used the recalled drugs and received any of the following cancer diagnosis;

• 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

To determine if you or a loved one qualify for a valsartan cancer lawsuit, submit information for review by a valsartan lawyer, who will evaluate the circumstances of your potential claim.

Valsartan lawyers handle all cases on a contingency fee basis, which means that there are no fees or expenses paid unless a settlement or lawsuit payout is received.

2024 Valsartan Lawsuit Updates

• 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 presents 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

Recent 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 rising number of valsartan cancer side effect lawsuits and valsartan class action lawsuits being 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.

It is expected that the first valsartan bellwether trial will go before juries in March 2024, which will help parties gauge how juries may respond to evidence and testimony which will be repeated throughout the litigation, and facilitate potential valsartan cancer settlements with the manufacturers and distributors of the contaminated pills.

Valsartan Class Action Lawsuit

Multiple valsartan class action lawsuits have been filed in the Valsartan, Losartan and Irbesartan Products Liability Litigation, seeking 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 includes a consumer economic loss class, medical monitoring class, and a third party payer class.

Valsartan Consumer Economic Loss Class

This class covers 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 includes 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 includes 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 Lawsuit Settlements

If you have taken recalled valsartan, losartan or irbesartan, you may be eligible to receive multiple forms of settlement benefits depending on extent of your exposure and the injuries such as medical expenses, pain and suffering, lost income, medical monitoring.

• Medical Expenses: Individuals could receive compensation for for past, current, and future medical expenses associated with medical treatments, doctor visits, hospital stays, diagnostic tests, surgeries, and prescription medications to address health issues related to NDMA exposure.
• Pain and Suffering: Compensation for the reduction in the individual’s quality of life, including pain and suffering, emotional distress, and limitations on daily activities due to health complications from NDMA exposure.
• Lost Income: If your exposure to NDMA from valsartan forced you to miss work, or stop working altogether, individuals could be compensated for those losses.
• Medical Monitoring: Individuals may require ongoing medical monitoring, such as regular check-ups, screenings, and tests, to detect and manage any potential long-term health effects resulting from NDMA exposure.

Contact a Valsartan Lawyer

FIND OUT IF YOU MAY QUALIFY FOR A VALSARTAN CANCER LAWSUIT: As a result of the drug manufacturers’ failure to adequately ensure the purity of their products or warn about the risks associated with their medications, valsartan injury lawyers are evaluating whether users may be entitled to compensation through a product liability lawsuit.

To request a free consultation and claim evaluation to determine whether you, a friend or family member may be entitled to financial compensation through a lawsuit, submit information about a potential valsartan lawsuit for review by a lawyer.