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Valsartan Lawsuit FAQ

For years, drug manufacturers have known contaminated medication batches formulated with Valsartan (Diovan) yet never warned consumers of their dangerous products. The product was contaminated with NDMA (N-nitrosodimethylamine), a probable human carcinogen that causes liver damage with short-term exposure.

Valsartan (Diovan) is classified as an angiotensin II receptor blocker (ARB). Doctors have long prescribed valsartan (Diovan) to treat high blood pressure (hypotension) and heart issues. A personal injury attorney specializing in defective valsartan lawsuits answered valsartan lawsuit FAQs (frequently asked questions) below.

Valsartan Lawsuit FAQ

What is Valsartan?

What is valsartan (Diovan) is an antihypertensive medication regulating high blood pressure to prevent heart failure. Doctors also prescribed the medication to lower the potential risk of dying after a heart attack.

The medication is classified as an angiotensin receptor blocker (ARB) that relaxes blood vessels allowing less restrictive blood flow and lowering high blood pressure to prevent kidney problems, heart attacks, and strokes.

The product label cautions pregnant mothers of taking valsartan due to the possible fatal or severe harm it can cause an unborn baby. Pregnant women and those planning pregnancy should avoid taking the medication without discussing the drug use with their doctor.

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Has the Food and Drug Administration (FDA) Recalled Valsartan?

In August 2018, the FDA (Food and Drug Administration) announced that the product manufacturers voluntarily recalled medications formulated with valsartan (Diovan) due to impurity contamination. An FDA statement said that the voluntary valsartan recall would pull half of the valsartan (Diovan) supply off pharmacy shelves in the United States.

The recall involved Hetero Labs Limited of India, Zhejiang Tianyu, and Zhejiang Huahai in China. The following month, the U.S. Food and Drug Administration (FDA) identified the second batch of tainted Hetero Labs products containing other toxic chemicals, including N-nitrosodiethylamine (NDEA).

Since then, many other medications formulated with the angiotensin II receptor blocker (ARB) were also recalled after the drugmaker found NMBA (N-Nitroso-N-methyl-4-aminobutyric acid) unexpectedly and some of their medications in March 2019.

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Who Are The Defendants in the Valsartan Class Action Lawsuit?

The first valsartan class action lawsuit was filed in August 2018 against four drug manufacturers as defendants, including Teva Pharmaceuticals, Solco Healthcare, Prinston Pharmaceutical Inc., and Huahai US. The plaintiffs filed a complaint claiming that the four defendants knew, or should have known, of valsartan's carcinogenic properties back in 2012.

The lawsuit states that the four drugmakers continued to manufacture, distribute, and sell the generic medication even with this knowledge. The lawsuit claims that their fraudulent activity deceived consumers.

A class-action lawsuit was filed in the United States District Court in the District of New Jersey that was eventually included in the state's MDL (multidistrict litigation) in October 2018. Initially, there were eleven cases involved in numerous valsartan class-action lawsuits.
By 2019, the valsartan cases were included in the Judicial Panel on Multidistrict Litigation (JPML). Since then, other companies have been added to the list of plaintiffs filing against drugmakers.

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How Long Does It Take To Collect on a Blood Pressure Medication Valsartan Lawsuit?

The length of time it takes to resolve a valsartan lawsuit depends on specific circumstances, available evidence, and the extent of the plaintiff's injuries. That said, drug injury lawsuits commonly take up to three years to resolve successfully.

Nearly all harmful drug cases are resolved through a negotiated settlement. Only a small number of severe injury or wrongful death lawsuits are heard in open court or included in MDL (multi-District litigation) or class-action lawsuits.

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How Do I Know Which Valsartan Lawsuit To Take Part?

Personal injury and trial lawyers can evaluate the extent of your injuries and the scope of your damages to determine which valsartan lawsuit ensures you receive maximum compensation.

While plaintiffs have participated in numerous class-action lawsuits and multidistrict litigation (MDL) cases, some injured parties have filed separate valsartan claims directly with the drug manufacturer.

Typically, class-action lawsuits take many years to resolve, long after bellwether cases have helped the courts determine the value of each plaintiff's case. Alternatively, individuals filing separate valsartan lawsuits in state and federal courts create different opportunities where a negotiated settlement can occur in one to two years.

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What Are the Side Effects of Valsartan?

The most common side effects associated with taking valsartan include

  • Back pain,
  • Blurry vision
  • Chest pain,
  • Diarrhea,
  • Dizziness,
  • Fainting,
  • Flu-like symptoms,
  • Headaches,
  • Joint pain,
  • Lightheadedness,
  • Palpitations,
  • Shortness of breath,
  • Sinusitis,
  • Skin rash or itching,
  • Stomach pain,
  • Swelling,
  • Swollen eyes or lips,
  • Tiredness (fatigue),
  • Unexpected weight loss,
  • Upper respiratory infections,
  • Vomiting,
  • Common symptoms associated with the cold including sore throat, sneezing, stuffy or runny nose, and coughing

The dangers of short-term exposure to N-nitrosodimethylamine (NDMA) could cause liver fibrosis, scarring, and liver damage. Long-term exposure could increase the potential risk of tumors in the lungs, kidneys, and liver, or being diagnosed with cancer.

While the chemical was once manufactured in the United States for commercial use, it is now made in America only for research purposes. Decades ago, NDMA was manufactured as lubricant additives, antioxidants, liquid rocket fuel, and copolymer softeners.

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Is There a Recall on Losartan?

Losartan manufactured by companies other than Zhejiang Huahai Pharmaceutical, Prinston Pharmaceutical, and Teva Pharmaceuticals Industries is not part of the FDA recall.

The voluntary recall does not claim that any products containing valsartan are unsafe to patients. Instead, the FDA states that there are problems with some drugmakers' manufacturing processes after detecting unacceptable ingredients, including potential human carcinogenic chemicals, including NDMA and NDEA.

Drug manufacturers that are not part of the valsartan recalled include:

  • Anuh Pharma LTD
  • CPhI India Attending
  • CPhI Worldwide Attending
  • Darou Pakhsh Pharma Chem Co
  • DEAFARMA
  • Enaltec Labs Private Limited
  • Fareva
  • Granules India Limited
  • Hengdian Group
  • Hetero Drugs Limited
  • Hoventa Pharma
  • Jubilant Life Sciences Limited
  • Nishchem International Pvt. Ltd
  • Saneca Pharmaceuticals
  • Smilax Laboratories Limited
  • SynerGene 10
  • Tenatra Chemie
  • Vasudha Pharma Chem Limited
  • Vijayasri Organics Limited
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Is the FDA the Overseer Recalling Valsartan Contaminated with N-nitrosodimethylamine (NDMA)?

By the time the Food and Drug Administration recalled generic valsartan products from the medical marketplace, twenty-two other countries had already identified NDMA contamination problems with valsartan medications manufactured by Zhejiang Huahai Pharmaceuticals, a Chinese drug manufacturing company, and removed the medicines from their pharmacy shelves.

Early in 2018, the European Medicines Agency (EMA) released reports of issues with valsartan products after finding impurities of NDMA in numerous drugs. The EMA stated that the chemical was a "probable human carcinogen" known to cause cancer in humans.

United Kingdom health authorities also recalled valsartan drugs and urged pharmacies across the nation to pull the contaminated products from patient use.

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How Long Does it Take for Valsartan to Get Out of Your System?

Testing shows that generic valsartan (Diovan, Prexxartan, Exforge, ENTRESTO, Byvalson, Amlodipine, Cozaar, losartan) has an elimination half-life of approximately six hours based on about 5.5 x elimination half-life. Using this formula would take about 33 hours (six hours times 5.5) for the body to clear valsartan from the system.

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How Does Valsartan Work in the Body?

Doctors prescribe valsartan (Diovan, Cozaar, losartan) to manage high blood pressure and heart failure complications. The ARB (angiotensin II receptor blocker) medication works by blocking blood vessels' tightening caused by a substance in the body.

The drug lowers blood pressure by relaxing the blood vessel while increasing oxygenated-rich blood supply to the heart.

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What is the Difference Between Valsartan and Valsartan Hydrochlorothiazide?

Doctors prescribe valsartan to patients to regulate elevated blood pressure levels and to treat heart failure. Valsartan HCT works primarily the same but contains an additional ingredient, hydrochlorothiazide, an effective diuretic prescribed to lower blood pressure by assisting the body when excreting excess amounts of sodium (salt) and water.

Diovan HCT is the brand-name form of valsartan with hydrochlorothiazide that combines the popular angiotensin receptor blocker (ARB) with a potent diuretic.

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How Long Does it Take Valsartan to Work?

Patients prescribed valsartan typically see noticeable reductions in their high blood pressure approximately 4 to 6 hours after taking the drug. However, the full effect of managing elevated pressure levels in treating heart failure problems often takes up to two to four weeks to provide the most benefits.

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Are There any Potential Interactions Using Valsartan With Other Medications?

A doctor should review every patient's medical history and known medical problems before prescribing any medication that might affect using valsartan-based drugs, primarily if the patient is known to have:

  • Angioedema that can react with another blood pressure drug including benazepril, enalapril, Lotrel, lisinopril, Zestril, Zestoretic, and Vasotec,
  • Severe congestive heart failure (CHF) could lead to severe kidney issues,
  • Diabetic conditions in patients taking Tekturna (Aliskiren),
  • An electrolyte imbalance where there are insufficient sodium levels in the body,
  • A fluid imbalance due to diarrhea, vomiting, or dehydration,
  • Severe kidney disease that when taking the drug could make the condition significantly worse.

Certain medications can interact with valsartan-based products, including NSAIDs (nonsteroidal anti-inflammatory drugs), including naproxen, ibuprofen, aspirin, meloxicam, indomethacin, and diclofenac.

Other medications that might interact with valsartan or valsartan HCT include Rifampin, Cyclosporine, diuretics, and Ritonavir.

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What are the Potential Cancer Risks of Taking Valsartan Medications?

In 2018, the Food and Drug Administration announced specific concerns about medications tainted with N-nitrosodimethylamine (NDMA) and N‐nitrosodiethylamine (NDEA) carcinogenic, mutagenic organic compounds known to cause cancer, including stomach cancer, pancreatic cancer, and intestinal cancer in humans and animals.

The FDA Director of the Center for Drug Evaluation and Research, Dr. Janet Woodcock, stated that "we have carefully assessed the valsartan-containing medication sold in the United States, and we have found that the valsartan sold by these specific companies does not meet our safety standards. This is why we have asked these companies to take immediate action to protect patients."

Statistics found on the Online Adverse Event Reporting System managed by the U.S. Food and Drug Administration (FDA) announced over 19,000 severe reports that involved over 2800 valsartan-related deaths that date as far back as 2009.

Most patients filing formal complaints to treat elevated blood pressure levels and heart failure concerns complained that taking the drug increased their blood pressure or caused liver injury and liver cancer metastasis.

The U.S. Environmental Protection Agency (EPA) released a fact sheet showing that the contaminant NDMA "is reasonably anticipated to be a human carcinogen."

Studies on animals revealed that N-nitrosodimethylamine can be toxic to humans and might lead to the development of tumors of the respiratory tract, kidney, and liver. Elevated exposure levels of the toxic chemical could cause liver damage.

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Is There a Risk for Liver Damage When Taking Valsartan?

By early 2017, numerous patients were suffering severe complications after they had taken tainted valsartan products. Some reports exposed a correlation between taking the blood pressure regulating medication and the development of liver damage.

Some of the reported symptoms associated with taking valsartan-based medications and developing liver damage include:

  • Abdominal pain
  • Jaundice
  • Liver enlargement (hepatomegaly)
  • Nausea
  • Pruritic erythematous (patchy, dry) skin rashes
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How Many Patients Could be Affected by Valsartan?

Statistics maintained by the National Center for Health Statistics show that approximately one-third of adults in the United States suffer from elevated blood pressure levels. Of these individuals, three-quarter likely takes some medication to regulate their blood pressure or treat heart failure problems.

Press Officer Sandy Walsh of the FDA announced that "valsartan-containing drug products with active pharmaceutical ingredients supplied by the affected manufacturer make up nearly 43% of the United States market share of valsartan-containing drug products since January 2018.

The FDA states that doctors have likely prescribed valsartan-based drugs to more than 3.7 million patients up through 2018.

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What are the Legal Options for Patients Injured by Valsartan?

Any patient who suffered harm after taking tainted valsartan drugs - especially if they have been diagnosed with cancer - can file a valsartan lawsuit to recover damages for liver cancer and problems, stomach cancer, intestinal cancer, tumors, or other injuries associated with taking the medication. Many injured parties are suing the drug makers involved in the large-scale recall of contaminated valsartan.

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What are the Latest FDA Updates Involving the Valsartan Recall?

On August 20, 2018, the FDA updated their recall information to alert patients and healthcare professionals that Torrent Pharmaceuticals Limited will begin voluntarily recalling specific lots of valsartan/amlodipine/hydrochlorothiazide (HCTZ) medications.

The federal agency stated that "not all Torrent [pharmaceuticals] valsartan products distributed in the United States are being recalled." The drug monitoring agency was recently informed that some torrent pharmaceutical products were formulated with an active ingredient manufactured by Zhejiang Huahai Pharmaceuticals."

Testing by the Food and Drug Administration confirmed that some torrent products contained N-nitrosodimethylamine (NDMA).

By April 22, 2018, Torrent Pharmaceuticals expanded their voluntary recall to include many unexpired drug product lots containing valsartan after NDMA was detected in some of their products. The federal government released its method for detecting levels of NDMA in manufactured valsartan products.

The agency stated that they are "using this method to test potential NDMA-containing APIs [active pharmaceutical ingredients] and drug products. This method should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission."

On August 9, 2018, Camber Pharmaceuticals, Inc. released a report after initiating a Consumer Level Recall of valsartan tablets. The company issued a recall after detecting trace amounts of N-nitrosodimethylamine (NDMA) and multiple batches of their medication.

The recall was in response to a concern about the possible impurities and contaminants found in the API (active pharmaceutical ingredient) used to formulate their drugs.

Just a week earlier, while working together with medication pharmaceutical manufacturers, the FDA updated their list of recalled products to ensure that all future drugs containing Valsartan will not contain any amounts of NDMA that could harm patients.

The FDA reminded drug makers to evaluate their manufacturing processes using active pharmaceutical ingredients thoroughly and make any changes that are necessary to ensure a safe process void of any impurities.

The agency states that if the manufacturer detects any unacceptable impurities levels, they must take immediate action to ensure consumer safety.
During the initial voluntary recall beginning in July 2018, the Food and Drug Administration Press Release stated that:

"The presence of NDMA was unexpected and is thought to be related to changes in [how] the active substance was manufactured.

The manufacturer does not encourage consumers to discontinue the use of the recalled product. The manufacturer is notifying its distributors and customers, including doctors, pharmacies, wholesalers, and other customers in the supply chain by letter, fax, email, and phone calls.

Consumers may return the unused portion of the medication to the pharmacy from which it was obtained. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product."

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How Do I Find a Lawyer That Can Handle My Valsartan Lawsuit?

Some reputable personal injury attorneys have years of experience in successfully resolving personal injury cases involving patients who experienced severe complications and side effects.

Nearly every established law firm will accept personal injury cases through contingency fee agreements, avoiding the need to make any upfront payments until the case is resolved.

The lawyer will have a comprehensive understanding of how to resolve a product liability or wrongful death case by showing that:

  • The medication had a manufacturing defect, and
  • The drug was improperly labeled and did not warn consumers about the dangerous product

Trial lawyers from your law firm do not need to prove that the drug maker intended to cause you harm or that their manufacturing or design process was negligent. Instead, your lawyer will build a strict liability case under the premises liability tort law to show that the product was manufactured with defects and contained inadequate warning labels.

Valsartan has been proven highly effective as an angiotensin II receptor blocker when the manufacturer correctly compounds the formula. However, using contaminated ingredients has proven dangerous or deadly to some patients prescribed the drug.

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