Valsartan Side Effects: What Are the Legal Consequences?

by | Jun 5, 2024 | Product Liability, Medications

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What is Valsartan For?

The blood pressure medication Valsartan, also known by the brand name Diovan, is widely used by millions of people in the United States. Cardiovascular disease and excessive blood pressure are treated with Valsartan. Valsartan belongs to the class of medicine called angiotensin receptor blockers.

The American pharmaceutical company Novartis created Valsartan, which the FDA approved for use in 1996. Before its patent expired and it became generic as Valsartan, it was marketed under the brand name Diovan. Following its introduction, Valsartan immediately climbed to the top of the highly competitive blood pressure drug market as one of the most commonly prescribed drugs worldwide.

Our in-depth blog will cover everything from mild to severe valsartan side effects, as well as the legal implications that have arisen due to certain Valsartan-related complications. We aim to provide you with a clear understanding of the side effects and benefits of this medication so that you can make informed decisions about your health and well-being.

Valsartan with HCTZ

Hydrochlorothiazide is a waterpill (thiazide diuretic). Valsartan and Hydrochlorothiazide (HCTZ Valsartan) are used together or seperately to treat high blood pressure. This medication combines two pills into a single pill. Both Valsartan and Hydrochlorothiazide significantly reduce blood pressure.

Valsartan HCTZ side effects

  • Allergic reactions
  • Change in potassium level
  • Eye problems
  • Kidney problems
  • Low blood pressure

Valsartan Amlodipine

Amlodipine relaxes blood vessels as a “calcium channel blocker,” allowing blood to flow more freely. Amlodipine and Valsartan are sometimes prescribed together by doctors because they may be able to decrease blood pressure when other medications have gone wrong.

Amlodipine Valsartan side effects

  • Low blood pressure
  • Heart attack

What are the Serious Side Effects of Valsartan?

A chemical by-product of both natural and artificial chemical reactions is NDMA. It has been determined that NDMA is probably carcinogenic to humans. Therefore, in addition to causing other health issues, exposure to NDMA may increase a person’s chance of getting some forms of cancer.

NDMA exposure for a brief period can harm the liver. Lung, liver, and kidney tumor risks can increase with prolonged exposure. Other possible malignancies that Valsartan medication products may contribute to include:

  • Bladder cancer
  • Colorectal cancer
  • Intestinal cancer
  • Kidney cancer
  • Leukemia
  • Liver cancer
  • Pancreatic cancer
  • Prostate cancer
  • Stomach cancer

Numerous batches of generic Valsartan were discovered to have significant amounts of NDMA in 2018. 60 to 70% of the four million people who take Valsartan each year have contaminated tablets. Up to 20,000 nanograms of NDMA contamination were found in some of the samples.

NDMA can increase a person’s chance of developing cancer by 50% to 100%. As a result of people developing cancer after using Valsartan, people throughout the United States are filing Diovan side effects lawsuits against the drug’s producers, distributors, and other companies.

Zhejiang Huahai Pharmaceuticals Co., Ltd.

The Valsartan high blood pressure drug is produced by Zhejiang Huahai, a wholesale pharmaceutical production facility, and sold through its American subsidiaries, Prinston, Huahi, and Solco. China and India are the countries where 80% of generic pharmaceuticals supplied in the U.S. are produced.

The first Chinese business to receive FDA approval to produce and market generic medications in the U.S. was Zhejiang Huahai. NDMA (N-nitrosodimethylamine) has been found in some batches of Valsartan manufactured by the Indian company Hetero Labs Limited and the Chinese company Zhejiang Huahai Pharmaceuticals.

Zhejiang Huahai Pharmaceuticals is at the core of the Valsartan FDA recall that began in the summer of 2018 due to the discovery of NDMA contamination in its Valsartan. Most FDA-recalled Valsartan producers obtained the harmful component from Zhejiang Huahai Pharmaceuticals.

The Chinese Valsartan maker, Zhejiang Huahai, thinks the NDMA contamination happened after it altered its production procedure in 2012. Water, soil, and air may all contain trace quantities of NDMA. It has been labeled a potential human carcinogen.

Contaminated Valsartan medications from a supplier, Zhejiang Huahai Pharmaceuticals, had an average NDMA level of 60 parts per million (ppm). This is more than 1,000 times the average person’s daily water intake.

Ultimately, generic Valsartan was produced by more than 30 different firms. According to reports, this contamination was not discovered until random testing.

Why is Valsartan Being Recalled?

The European Medicines Agency (EMA), the FDA’s equivalent in Europe, initiated a review of Valsartan on July 5, 2018, after some batches of the medication were discovered to contain the carcinogen NDMA. As a result, European nations started recalling tainted batches of the drug.

The FDA announced the voluntary recall pharmaceutical products containing the active component of carcinogen N-nitrosodimethylamine (NDMA) found in Valsartan on July 17, 2018.

The FDA identified Hetero Labs Limited, an Indian pharmaceutical company that sells products under the Camber Pharmaceuticals brand, as another source of the contamination on August 9, 2018. The FDA observed that Zhejiang Huahai Pharmaceuticals, which produced further batches of tainted Valsartan, used a similar manufacturing technique to Hetero.

Retesting the recalled Zhejiang Huahai products sold in the U.S. under the Torrent Pharmaceuticals (India) brand showed N-Nitrosodiethylamine (NDEA), a second known carcinogen, according to a statement released by the FDA on September 13, 2018.

The FDA prohibited the Chinese pharmaceutical company Zhejiang Huahai from bringing additional Valsartan or other medications into the US on September 28, 2018. The FDA claimed that the prohibition is in place to safeguard patients and that the business must determine how to ensure the safety of its production process.

More than 1.5 million Americans used Valsartan daily during the recall. According to the FDA, if the chemical processes utilized to create the medicine are not thoroughly regulated and monitored, the material may develop defects during manufacturing.

Since the recall, hundreds of plaintiffs from across the nation have brought side effects of Diovan lawsuits against the pharmaceutical companies and drugstore retailers Walgreens and Walmart.

The following are the carcinogens connected to Valsartan:

  • N-nitrosodimethylamine (NDMA)
  • N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)
  • N-nitrosodiethylamine (NDEA)

Which Drugs are Recalled?

Several generic medications with Valsartan as the active component are included in the Valsartan recall, although not all of them. The following medication combinations that contain Valsartan have been recalled:

  • Amlodipine and Valsartan
  • Amlodipine, Valsartan and hydrochlorothiazide (HCTZ)
  • Valsartan and hydrochlorothiazide (HCTZ)

How was NDMA Included in Valsartan?

The synthesis procedure employed by generic manufacturers of Valsartan is thought to have undergone an update in 2012. This modification caused a side reaction, leading to higher quantities of NDMA. Valsartan was created by Novartis, which also has a patent on it.

Additionally, they got FDA permission for their procedures. Other businesses can produce generic copies of medicine once its patent expires. Recent research in connection with the Zantac Class Action Lawsuit shows how the body can make NDMA due to the dissolving of specific drugs or chemicals in the stomach.

Is there a lawsuit against valsartan? In the United States, more than 1,000 Valsartan lawsuits have been brought against pharmaceutical companies, merchants, pharmacies, and other parties involved in the medicine’s production, distribution, and sale.

Every year, almost 3 million Americans use drugs containing Valsartan. Valsartan recall lawyers have looked into accusations and filed Valsartan side effect lawsuits for people who took the contaminated medication due to a widespread recall of specific generic Valsartan blood pressure drugs that started in July 2018.

Valsartan Class Action Lawsuit

The NDMA in Valsartan led to a boost in product liability claims. Approximately 1,100 Valsartan side effect lawsuits have been submitted since the 2018 recall. A district of New Jersey class action MDL finally merged most of the Valsartan lawsuits, which had been filed in federal courts before.

Plaintiffs in these side effects of Valsartan cases include people who used prescription medications containing Valsartan to treat high blood pressure for a long time before receiving a cancer diagnosis associated with NDMA.

Plaintiffs in the Valsartan litigation allege that the NDMA in Valsartan was directly responsible for their valsartan side effects and cancer. Significant and trustworthy scientific data connects NDMA use to too many illnesses.

Federal “mass tort” Valsartan cancer lawsuits related to this recall are now being heard in federal court as MDL cases (multi-district litigation). The U.S. federal courts combined the ongoing lawsuits into multi-district litigation or MDL.

The Diovan class action lawsuit MDL in New Jersey has only added 120 new cases in the past six months towards the end of October 2022.

Valsartan Side Effects Lawsuit 2022 Update

Since April 2022, the MDL has received 40 additional Valsartan side effects cases. Around six Valsartan cases have been voluntarily dismissed throughout that period. As of June 15, there were 1,110 active Valsartan class action cases.

In Valsartan side effects lawsuits, plaintiffs allege the drug’s contamination with hazardous substances, including N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), led to their health issues and want damages for the tainted medication they purchased. Cancer has appeared in humans and animals exposed to NDMA, even though it is not a common Valsartan adverse effect.

According to the claims, several Valsartan batches produced between 2012 and 2018 were tainted with NDMA, possibly carcinogenic to humans. China-made Valsartan products numbering in the hundreds have been recalled. The same carcinogen is the subject of ongoing Zantac litigation.

In the class action lawsuit Valsartan, the plaintiffs said that they had purchased contaminated medicine and demanded a return of their money. Lawyers for Valsartan soon started bringing personal injury claims against Valsartan defendants.

In a district court, a few Valsartan side effects lawsuits will go to trial in 2022 and 2023. These Valsartan bellwether trials’ findings are quite important. They assist plaintiffs’ attorneys in determining how to bargain and how much they may seek.

Valsartan Lawsuit Update 2023

As of February 2023, all federal court procedures connected with these lawsuits have been combined into the Valsartan MDL class action, which is currently taking place in New Jersey. As of May 2023, there are 1211 cases pending in federal court.

After millions of people were exposed to cancer-causing chemicals, sufferers of the drug Valsartan now have the go-ahead to join a class action lawsuit against numerous producers of generic valsartan, according to a Federal court in New Jersey.

August 2023 Update

Over the past month, only five new cases were added to the Valsartan class-action lawsuit. A few cases were also dropped, so right now, there are 1,230 cases still pending. The first Valsartan bellwether trial for this lawsuit is scheduled for early next year.

Valsartan Lawsuit Updates 2024

Valsartan Lawsuit March 2024 Update

The first Valsartan trial scheduled for March 2024, got postponed. Over 100 pre-trial motions are pending, so the delay gives more time for rulings. As of March 2024, there were 1,231 Valsartan, Losartan, and Irbesartan cases were pending in the MDL.

Valsartan Lawsuit June 2024 Update

1,248 Valsartan, Losartan, and Irbesartan cases are still pending as of june 2024, in MDL No. 2875 under Judge Robert B. Kugler.

Allegations Against Valsartan

Patients who used recalled blood pressure medications and later experienced liver damage, or cancer may have a case against the pharmaceutical manufacturer.

The Valsartan side effect cases raise several different allegations of product responsibility, such as:

  • Fraud
  • Manufacturing defects
  • Failure to warn people
  • Improper Black Box warning labels
  • Negligence

Drug manufacturers may afford a huge Valsartan lawsuit settlement. More than 10 billion blood pressure medications Valsartan were purchased globally in 2017. There is a time limit to file class action lawsuits against Valsartan. Therefore, seeking legal counsel as soon as you believe that using Valsartan may have caused you to experience side effects is essential.

Which Damages Can Be Recovered in Valsartan Recall Lawsuits?

People who have had cancer after taking Valsartan contaminated with NDMA for at least one year may be entitled to bring a product liability and negligence claim against the pharmaceutical firm. Plaintiffs may be entitled to the following compensatory damages, depending on the circumstances of their case:

Additionally, the careless mistake that sparked this Valsartan cancer lawsuit may be justifiable for punitive damages. Personal injury attorneys will fight for your case’s highest Valsartan settlement possible.

Medical records show the seriousness of your condition and how it affects your life.

How Should You Proceed If You Have a Claim?

If you took the blood pressure medication Valsartan and later developed cancer, you may file a legal claim for financial settlement in a Diovan recall lawsuit.

Contact an accomplished and committed Valsartan lawyer to get started. An experienced Valsartan lawsuit attorney will carefully review your claim. There is a limited amount of time in which you may file a personal injury lawsuit before the statute of limitations expires.

To wrap up, plaintiffs who take the initiative and file drug injury cases can obtain reasonable Valsartan lawsuit payout and make a company liable for its careless deeds. A critical factor in consumer safety is ensuring businesses adhere to the law and moral standards.

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MedLegal360 is a specialized author in medical-legal matters, providing clear, authoritative insights on healthcare legislation and personal injury litigation for professionals and the curious.

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