Valsartan Cancer Lawsuit

This widely prescribed blood pressure medication turned into a cancer risk thanks to contamination with NDMA, a chemical so toxic it’s classified as a probable human carcinogen. Millions of people unknowingly swallowed a threat disguised as a cure.

If Valsartan harmed you or someone you love, you’re not alone. Across the country, lawsuits are stacking up, demanding answers and accountability. 

At LitigationConnect, our network of experienced attorneys will match you with a legal professional who knows how to fight for justice. Reach out today at (833) 552-7274 or contact us online.

What Is Valsartan and How Does It Work?

Approved by the FDA in 1996 under the brand name Diovan, Valsartan belongs to the angiotensin II receptor blocker (ARB) class of drugs. Its job is to block angiotensin II, a hormone that tells blood vessels to tighten. By keeping those vessels relaxed, Valsartan lowers blood pressure, improves blood flow, and takes some of the burden off the heart.

When the patent held by Novartis expired in 2012, the floodgates opened for generic versions. Dozens of pharmaceutical companies entered the market, mass-producing generic Valsartan, much of it outsourced to overseas manufacturers. By 2019, however, many of those generic options were recalled due to contamination with carcinogenic impurities, throwing the supply chain into chaos. In response, the FDA fast-tracked approvals for newer versions to prevent a nationwide shortage.

How Valsartan Works

Valsartan is fast-acting and straightforward. Within two hours of taking the drug, blood pressure begins to drop. Over the next two to four weeks, it reaches full effectiveness, offering steady control for patients battling high blood pressure or heart failure. By blocking angiotensin II from binding to the AT1 receptor, it reduces vasoconstriction—a fancy way of saying it stops blood vessels from narrowing—and lowers aldosterone levels, which helps prevent water retention. The result? Easier blood flow and less strain on the heart.

What Is Valsartan Used For?

Valsartan’s versatility makes it a go-to for a range of cardiovascular and kidney issues. Doctors prescribe it not just to lower high blood pressure but to improve survival rates and quality of life for patients grappling with heart disease and diabetes-related kidney problems.

Here’s what it treats:

• Hypertension: Valsartan reduces high blood pressure, minimizing the risk of strokes, heart attacks, and kidney damage.
• Heart Failure: For those with heart failure, it alleviates symptoms and reduces hospitalizations.
• Post-Heart Attack Recovery: Patients recovering from heart attacks rely on Valsartan to lower their risk of subsequent cardiac events.
• Diabetic Kidney Disease: By decreasing protein loss in the urine and slowing the progression of kidney damage, it helps protect the kidneys in patients with diabetes.

Millions of people worldwide rely on Valsartan, especially its generic versions. It’s particularly effective for patients with heart or left ventricular failure following a heart attack, where its ability to ease the heart’s workload can mean the difference between recovery and decline.

Valsartan Contamination

The lawsuit hinges on the discovery that the medication was tainted with N-nitrosodimethylamine (NDMA), a chemical that the International Agency for Research on Cancer (IARC) classifies as a probable human carcinogen. 

NDMA causes cancer by damaging DNA at the cellular level. When NDMA enters the body—whether ingested, inhaled, or absorbed—it metabolizes in the liver and releases alkylating agents, which directly attack DNA. These agents create mutations by altering the genetic code, disrupting normal cellular processes, and impairing the mechanisms that repair damaged DNA. Over time, this damage accumulates, increasing the likelihood of cancer.

Manufacturing Lapses

The contamination traced back to manufacturing shortcuts at facilities in China and India, with Zhejiang Huahai Pharmaceutical taking the spotlight. To boost production speed, they altered the drug’s chemical synthesis process, introducing NDMA as an unintended byproduct.

Global Recalls

Once NDMA contamination came to light in 2018, the recalls were swift and massive. The European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and other regulatory bodies scrambled to pull Valsartan off the shelves. Tens of millions of prescriptions were impacted.

• In the U.S., the FDA issued detailed recall notices specifying batch numbers and manufacturers involved.
• Europe followed suit, with countries like Germany and the U.K. conducting their own investigations and halting distribution.
• Even after these recalls, concerns lingered, as many patients had already been exposed to the contaminated drug for years.

Manufacturers Named in the Recall

The recall list was a pharmaceutical roll call, implicating more than a dozen manufacturers across the industry. These companies were responsible for producing Valsartan-containing drugs tainted with unacceptable levels of NDMA:

• A-S Medication Solutions LLC
• Aurobindo Pharma
• AvKARE Inc.
• Bryant Ranch Prepack Inc.
• Hetero Labs
• Major Pharmaceuticals
• Mylan Pharmaceuticals
• Northwind Pharmaceuticals
• NuCare Pharmaceuticals
• Preferred Pharmaceuticals
• RemedyRepack Inc.
• Rising Pharmaceuticals
• Solco Healthcare LLC
• Teva Pharmaceuticals
• Torrent Pharmaceuticals

Patient and Consumer Responses

For patients, the recall created a two-pronged crisis: on one side, the long-term risks of NDMA exposure; on the other, the immediate danger of stopping treatment abruptly. This left patients with few options beyond navigating the system for a replacement.

Some manufacturers, like Solco Healthcare LLC, offered reimbursement programs to offset the financial burden of purchasing alternative medications. While helpful, these measures didn’t undo the anxiety and uncertainty caused by the widespread contamination. Patients with recalled prescriptions faced delays in finding safe replacements, further compounding the impact.

The Legal Avalanche

The recall wasn’t limited to a single misstep by one manufacturer—it exposed systemic failures across multiple companies and international supply chains. These manufacturers relied on raw materials from suppliers like Zhejiang Huahai Pharmaceutical, where lax oversight and cost-cutting measures created the conditions for contamination.

Multidistrict Litigation (MDL)

The legal response to the Valsartan contamination consolidated into multidistrict litigation (MDL) in the U.S. District Court of New Jersey. MDLs exist to make complex cases involving large groups of plaintiffs more efficient by centralizing pretrial proceedings. In this instance, over 1,200 lawsuits claiming harm from NDMA-laced Valsartan joined forces under MDL No. 2875.

This MDL highlights the scope of the damage. Plaintiffs allege the contaminated drug caused serious health issues, particularly cancer, after prolonged exposure. Attorneys argue manufacturers knew—or should have known—about the contamination and failed to act. The legal framework relies heavily on statutes like the Federal Food, Drug, and Cosmetic Act (FDCA), which requires manufacturers to ensure the safety and purity of their products.

Bellwether Trials

Bellwether trials within the MDL are set to begin late 2025. These trials act as legal test cases, providing insight into how juries might respond to the evidence and arguments. A strong outcome for plaintiffs could pressure manufacturers into settlements to avoid protracted litigation.

Here’s what’s at stake in these trials:

• Establishing whether manufacturers violated FDA regulations or deviated from industry standards in their production practices.
• Proving causation between NDMA exposure and specific cancers linked to Valsartan use.
• Assessing damages, including medical expenses, lost wages, and emotional distress.

Settlements and Legal Strategies

Some manufacturers, like Hetero Labs, have entered preliminary settlement negotiations, signaling a willingness to resolve claims outside of court. Others, including Zhejiang Huahai Pharmaceutical, appear intent on fighting the allegations, potentially dragging these cases through years of legal wrangling.

Eligibility to File a Valsartan Lawsuit

For individuals impacted by NDMA-contaminated Valsartan, the path to legal action starts with proving a connection between the drug and their illness.

Who Qualifies for a Valsartan Lawsuit?

Not everyone exposed to contaminated Valsartan can file a lawsuit. Attorneys evaluate cases based on specific criteria to ensure claims meet the legal and evidentiary thresholds. To qualify, you typically need to demonstrate the following:

• Long-Term Valsartan Use: Proof of at least six months of consistent Valsartan use between 2015 and 2019, whether as a standalone drug or in combination with hydrochlorothiazide (HCTZ) or amlodipine.
• Cancer Diagnosis Post-2017: A diagnosis must have occurred after 2017 and fall within the types of cancer linked to NDMA exposure.
• Specific Cancer Types: Only certain cancers are eligible, including:
  • Colorectal cancer
  • Stomach or intestinal cancer
  • Liver cancer
  • Esophageal cancer
  • Prostate cancer
  • Blood cancers
  • Bladder cancer
  • Lung cancer
• No Existing Legal Representation: You cannot already have an attorney actively handling your claim.

Gathering Evidence for a Valsartan Lawsuit

The foundation of any successful lawsuit lies in the evidence. Claims against Valsartan manufacturers hinge on proving that contaminated drugs directly caused—or significantly contributed to—a cancer diagnosis. The stronger your evidence, the better your chances of building a solid case.

What Evidence Do You Need?

If you’re considering legal action, start assembling documentation as soon as possible. Essential pieces of evidence include:

• Medical Records: These confirm your cancer diagnosis, detailing the type of cancer, date of diagnosis, and any treatment history. Medical records also establish whether you had pre-existing conditions or other risk factors.
• Proof of Valsartan Usage: Prescription records, pharmacy receipts, or even pill bottles can demonstrate your consistent use of Valsartan or related drugs during the contamination period.
• Cancer Diagnosis Details: Pathology reports, imaging scans, and oncologist evaluations are critical to connecting your diagnosis to NDMA exposure.
• Additional Documentation: This might include employment records showing lost wages, bills for out-of-pocket medical expenses, or personal statements describing how the diagnosis has impacted your life.

The Role of Attorneys

Lawyers experienced in pharmaceutical litigation understand what documentation courts require and how to obtain it. They’ll request records from your healthcare providers, investigate the manufacturing and distribution chain for the drugs you used, and ensure your case meets all filing deadlines.

By starting the process early and working with a legal professional, you set yourself up for the best chance of success.

Recoverable Damages in the Valsartan Lawsuit

When NDMA-contaminated Valsartan leads to cancer, the consequences ripple far beyond the diagnosis. Physical suffering, financial strain, and emotional distress all take a toll, and recoverable damages aim to address these losses.

Economic Damages

Economic damages represent the tangible financial losses caused by the harm Valsartan inflicted. These are measurable costs, backed by bills, receipts, and records. Plaintiffs may recover compensation for:

• Medical Expenses: This includes past and future costs related to cancer treatments such as surgeries, chemotherapy, radiation, medications, and hospital stays.
• Lost Wages: If cancer or its treatment has kept you from working, you may recover income lost during that time.
• Future Loss of Earning Capacity: For those unable to return to work or forced to switch to lower-paying jobs due to their health, damages can account for the long-term impact on earning potential.
• Out-of-Pocket Costs: Expenses like transportation to treatment facilities, hiring in-home care, or purchasing medical devices may also qualify for reimbursement.

Non-Economic Damages

While economic losses can be tallied on a spreadsheet, non-economic damages deal with the intangible impact of cancer on a person’s life:

• Physical Pain and Suffering: The discomfort and physical challenges caused by cancer treatments and related health complications.
• Mental Anguish: Anxiety, depression, and emotional distress caused by the diagnosis and its aftermath.
• Diminished Quality of Life: The loss of independence, mobility, or ability to enjoy life as you once did.

Courts evaluate these damages on a case-by-case basis, taking into account the severity of the illness, the duration of suffering, and its impact on daily living.

Wrongful Death Damages

When NDMA contamination leads to the death of a loved one, surviving family members may pursue wrongful death claims. These lawsuits compensate families for the emotional and financial void left behind, including:

• Funeral and Burial Expenses
• Loss of Companionship: For spouses, children, or other dependents, the emotional loss is immeasurable but legally recognized.
• Loss of Financial Support: Families can recover income their loved one would have contributed had they survived.

Get Justice for the Harm Valsartan Caused

The pharmaceutical companies behind Valsartan let greed override responsibility, leaving patients to suffer the consequences. You don’t have to face this fight alone. Our network of experienced attorneys will work to hold them accountable and secure the compensation you deserve.

Call LitigationConnect, LLC at (833) 552-7274 or contact us online today and connect with a lawyer who knows how to take on the pharmaceutical giants. Justice is waiting—take the first step.