Valsartan Lawsuit

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Researcher: Ariana Arce​

Researcher: Ariana Arce​

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Journalist: Aaron Vivanco

Journalist: Aaron Vivanco

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Editor: Daniela Polo

Editor: Daniela Polo

d.polo@legalhelpadvisor.com

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Valsartan Lawsuit

Valsartan lawsuits involve legal claims made by individuals who took this blood pressure medication and later developed cancer. These lawsuits allege that certain batches of valsartan were contaminated with substances, such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), which are very dangerous due to their involvement in the increased risk of cancer.

Valsartan is a commonly prescribed medication used to manage hypertension and other heart-related conditions. The presence of contaminated valsartan pills resulted in worldwide Valsartan recalls initiated by the United States Food and Drug Administration (FDA) and European health officials.

If you believe that your valsartan medication may have been contaminated, you may be eligible to obtain legal representation. Please contact us for free legal advice to determine the appropriate course of action.

How does Valsartan work?

Valsartan is a generic blood pressure medication for the treatment of hypertension and heart attacks. In individuals with heart failure, this medication reduces the likelihood of hospitalization. The drug is classified as an angiotensin receptor blocker (ARB).

The drug works by relaxing the blood vessels, which helps improve blood flow and lower blood pressure.

Doctors prescribed this drug to adults and children aged 6 years and older. Occasionally, it is administered alongside other blood pressure medications.

Possible side effects related to Valsartan

Valsartan and other ARB medications can cause various mild to moderate, temporary, and manageable side effects such as dizziness and liver damage. However, there are also more severe effects including renal function impairment, high potassium levels, and decreased blood pressure.

According to The Mayo Clinic, valsartan users may experience the following side effects:

  • Dizziness
  • Head congestion
  • Drowsiness
  • Nausea
  • Vomiting
  • Diarrhea
  • Cough

Medications like valsartan have been linked to birth defects and should be avoided by pregnant women. However, these effects typically do not necessitate discontinuation of the medication and have not caused harm.

Is Valsartan related to increased cancer risk?

Batches of valsartan produced by Zhejiang Huahai Pharmaceuticals and Hetero Labs Limited have been found to contain NDMA, a known carcinogen.

The presence of NDMA was not anticipated. This contamination resulted from a modification in the drug synthesis method that Zhejiang Huahai had implemented several years ago.

The discovery raised safety concerns due to the dangers of these chemicals. NDMA is classified as a carcinogen because it causes cancer in humans. Animal research has demonstrated that even minimal quantities of NDMA can lead to liver and gastrointestinal cancer and kidney failure.

NDMA was previously utilized in the production of rocket fuel; however, its use was discontinued due to concerns regarding environmental contamination. The Environmental Protection Agency categorizes NDMA as a potential human carcinogen and recognizes it as a priority toxic pollutant in federal regulations.

Valsartan recall for possible contamination

The EMA started investigating tainted drugs from Zhejiang Huahai Pharmaceuticals in May 2018 due to the presence of NDMA in the valsartan it supplied to manufacturers in the European Union.

In July 2018, the FDA announced that three drug makers were recalling their medications containing valsartan due to the presence of this toxic component. The NDMA was found in the medication supplied by this Chinese company. The FDA has also given drug companies guidance on testing their products for possible NDMA contamination.

Many valsartan/amlodipine/HCTZ tablets have been recalled since November 2018 due to contamination with NDMA, NDEA, and/or NMBA.

What are the Valsartan lawsuits?

Multiple pharmaceutical companies have issued voluntary recalls for their blood pressure and heart medications containing valsartan due to concerns of potential contamination in their manufacturing plants in China and India.

The potential issue with valsartan, the generic version of Diovan, is the possibility of contamination with specific chemicals if manufactured by Zhejiang Huahai Pharmaceuticals or Hetero Labs Limited. Potential health risks include liver damage, tumors, and cancer.

The initial lawsuits were filed on behalf of individuals who consumed the contaminated drugs.

Elizabeth and John Duffy filed a valsartan class-action lawsuit in the federal Southern District of New York on August 16, 2018, naming Solco Healthcare, Prinston Pharmaceutical Inc., Walgreens, and Throggs Neck Pharmacy as defendants in their complaint.

Companies involved in the litigation

Zhejiang Huahai Pharmaceutical Co. Limited. Hetero Labs, based in China, and India, were among the first companies identified that manufactured contaminated medications distributed in the US market.

According to legal professionals, two API manufacturers are the main defendants in this legal dispute. Because both companies supply multiple manufacturers, distributors, and repackagers with several valsartan, the liability levels can vary.

Companies involved in valsartan lawsuits include:

  • Zhejiang Huahai Pharmaceutical Co. Ltd.
  • Hetero Labs Ltd.
  • Prinston Pharmaceutical Inc.
  • Teva Pharmaceutical Industries Inc.
  • Teva Pharmaceuticals USA Inc.
  • Torrent Pharmaceuticals
  • Solco Healthcare, U.S. LLC
  • Actavis LLC
  • Major Pharmaceuticals
  • Camber Pharmaceuticals Inc.
  • A-S Medication Solutions LLC
  • NuCare Pharmaceuticals Inc.
  • H.J. Harkins Company Inc. (Pharma Pac)
  • Bryant Ranch Prepack Inc.
  • Northwind Pharmaceuticals
  • AvKARE Inc.
  • RemedyRepack Inc.
  • Preferred Pharmaceuticals

Walgreens, Throggs Neck Pharmacy, and drug manufacturers are all involved in the complaints.

Is there multidistrict litigation (MDL) regarding Valsartan?

An MDL related to tainted valsartan medication, including a consumer, and insurer economic loss class and a medical monitoring class, has been certified by US District Judge Robert Kugler. The defendants in the lawsuit include manufacturers, retail pharmacies, and wholesalers.

The MDL focuses on recalls that took place in 2018 and 2019 for generic versions of valsartan, which were originally sold as Diovan and Exforge. These recalls were necessary due to contamination with high carcinogen levels.

Are you eligible for compensation with a valsartan lawsuit?

Legal professionals are currently accepting cases related to the potential harm caused by contaminated valsartan. Compensation may be available for individuals who have experienced harm, including liver, colorectal, stomach, pancreatic, and kidney cancers, which may be associated with exposure to NDMA.

To meet the requirements for a feasible case, the complainant should have taken valsartan for a minimum of one year before being diagnosed with cancer or liver disease. Additionally, the drug must have been taken for at least 30 days from 2014 to present.

It is advisable to promptly seek legal counsel as numerous states have statutes of limitations that set a designated timeframe for pursuing legal action.

If you believe you have been affected by valsartan, you should keep your prescription bottles and pills as evidence for further testing.

Is there a possible settlement for the valsartan case?

Determining potential settlement amounts for the valsartan MDL is challenging as our valsartan lawyers are still uncertain about the specific types of cancer that will be associated with valsartan by the federal court judge.

The settlements for valsartan lawsuits will be categorized into different tiers on a point-based system. This system considers factors such as the severity of the plaintiff’s injuries, the dosage of valsartan, age, and type of cancer.

A successful valsartan lawsuit could result in substantial compensation. To obtain an understanding of the monetary value of cancer cases, one can refer to the provided sample settlements and verdicts categorized by the specific type of cancer.Think your valsartan medication got contaminated? Get in touch for free legal advice from our experienced attorneys.