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Valsartan Recall Lawsuit

The FDA recalled Valsartan in July 2018 after finding the probable human carcinogen N-nitrosodimethylamine (NDMA) had contaminated the drug in a supplier’s facility. This carcinogenic substance has been linked to serious injuries such as an increased risk of the following cancers:

  • Liver Cancer
  • Colon Cancer
  • Intestinal Cancer
  • Stomach Cancer
  • Lower Esophageal Cancer
  • Prostate Cancer
  • Pancreatic Cancer
  • Non-Hodgkin’s Lymphoma
  • Leukemia
  • Multiple Myeloma

 

If you or a loved one took Valsartan and contracted cancer, contact our dangerous drug attorneys at GoldenbergLaw.

Did you receive a Valsartan recall letter?

Many pharmacies and clinics have sent out letters notifying their patients of this recall. If you received a letter or are taking this drug, you should contact your doctor immediately to understand your treatment options.

GoldenbergLaw Partner Marlene Goldenberg Appointed to Valsartan MDL Leadership

New Jersey Federal District Court Judge Robert Kugler appointed GoldenbergLaw Partner Marlene Goldenberg to the Executive Committee within the leadership team for the Valsartan Multidistrict Litigation (MDL) on May 6, 2019.

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Information about the MDL

On February 14, 2019, the class action and personal injury cases pertaining to Valsartan-containing drugs were consolidated into a multidistrict-litigation (MDL) under Judge Kugler in the District of New Jersey. The Judicial Panel on Multidistrict Litigation (JPML) chose New Jersey as the location since many of the defendants are headquartered there. Many documents and witnesses relevant to the litigation are also located in New Jersey. 

Litigation Update

The litigation is in the process of discovery. Plaintiff leadership has made it through core discovery productions with the API (active pharmaceutical ingredient) and finished dose manufacturers.  Leadership is now receiving custodial productions and hopes to start depositions shortly after the first of the year.

The Valsartan Lawsuit: Case Quick Facts

The Problem: Valsartan and Cancer

Valsartan is an angiotensin receptor blocker (ARB) that is used to treat high blood pressure and congestive heart failure. It was approved by the FDA in 1996. In 2018, investigators found that certain lots of Valsartan were contaminated with N-nitrosodimethylamine (NDMA), a probable human carcinogen. NDMA was found in Valsartan tablets produced by three different facilities:  Zhejiang Huahai Pharmaceuticals in China, Hetero Labs Limited, in India, and Zhejiang Tianyu, in China.

According to the Environmental Protection Agency, N-nitrosodimethylamine was formerly used in the production of rocket fuel, antioxidants, additives for lubricants, and softeners for copolymers.

The Injuries: Side Effects of Valsartan

Long-term exposure to NDMA can lead to:

  • Liver Cancer
  • Stomach Cancer
  • Colon Cancer
  • Intestinal Cancer
  • Prostate Cancer
  • Lower Esophageal Cancer
  • Non-Hodgkin’s Lymphoma
  • Multiple Myeloma
  • Leukemia
  • Pancreatic Cancer
The Defendant(s)

The recalled Valsartan was manufactured by the following companies:

  • Major Pharmaceuticals
  • Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
  • Teva Pharmaceuticals USA
  • Camber Pharmaceuticals, Inc.
  • Torrent Pharmaceuticals
  • Torrent Pharmaceuticals Limited

Certain lots of Valsartan have been recalled, and the list continues to grow. If you are concerned that your medication was contaminated, you can compare your prescription with this list to determine if it was recalled.

What Is NDMA and Why Is It Dangerous?

N-nitrosodimethylamine (NDMA) is a known animal carcinogen and has been classified as a probable human carcinogen. NDMA is a chemical that can be formed either naturally or unintentionally through industrial processes. NDMA exposure can occur through contaminated drinking water or food. However, NDMA exposure can also occur through medications that have been contaminated with the probable human carcinogen. 

Exposure to NDMA in Valsartan is linked to

  • Prostate cancer 
  • Lower esophageal cancer 
  • Non-Hodgkin’s lymphoma 
  • Leukemia 
  • Multiple myeloma 
  • Colon cancer 
  • Stomach cancer
  • Intestinal cancer
  • Pancreatic cancer
  • Liver damage

The Environmental Protection Agency (EPA) has classified NDMA as a B2 carcinogen, which means that it is a probable human carcinogen. This means that there is not enough human data at this time to definitively state that it is carcinogenic to humans; however, there is sufficient animal data to show that exposure to NDMA would probably be carcinogenic to humans. The U.S. Department of Health and Human Services agrees and states that NDMA is “reasonably anticipated to be a human carcinogen.” 

Did you Receive a Valsartan Recall Letter? GoldenbergLaw Can Help

If you or a loved one received a Valsartan recall letter and was diagnosed with cancer, contact us.

Do I Qualify?

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Valsartan Recalls

July 2018: 

The first Valsartan recalls were instituted by the Food and Drug Administration (FDA) after the probable human carcinogen N-nitrosodimethylamine (NDMA) was discovered to have contaminated the popular blood pressure medication. The recalled Valsartan was supplied by the Chinese company, Zhejiang Huahai Pharmaceuticals. The NDMA contamination was found in the company’s manufacturing facility and it is believed that NDMA had been contaminating Zhejiang’s Valsartan products since 2012 when NDMA was produced as a by-product of changes in manufacturing processes. 

The FDA sent an update to health care professionals and patients after discovering companies that repackage drug products were also recalling valsartan-containing products. There were three additional repackagers of products containing Valsartan made by Teva Pharmaceuticals and Prinston Pharmaceuticals Inc that recalled products due to NDMA contamination. The products were labeled as A-S Medication Solutions LLC, AvKARE and RemedyRepack. 

August 2018 

The FDA released an updated list of recalled Valsartan products after the announcement that manufacturer Hetero Labs Limited (located in India and labeled as Camber Pharmaceuticals Inc) was recalling certain Valsartan tablets due to the discovery of the NDMA in their active pharmaceutical ingredient (API). Test results from the Hetero Labs showed that the levels of NDMA found in the Valsartan API exceeded the threshold deemed safe by the FDA.

November 2018 

The FDA issued an alert regarding Mylan Pharmaceuticals’ voluntary recall of 15 lots of Valsartan-containing products due to the presence of NDEA. Not all of Mylan’s Valsartan-containing products in the U.S. were recalled; only those that tested for NDEA above the levels deemed acceptable by the FDA were included in the recall. 

The FDA issued an alert regarding Teva Pharmaceuticals’ voluntary recall of products containing Valsartan. Teva recalled all lots of amlodipine and Valsartan combination tablets and amlodipine, Valsartan, and hydrochlorothiazide (HCTZ) combination tablets due to NDEA contamination. 

December 2018: 

The Valsartan recall was expanded through pharmaceutical company Mylan’s voluntary recall of over 100 lots of Valsartan medications, including Amlodipine and Valsartan Tablets, Valsartan Tablets, and Hydrochlorothiazide Tablets. 

January 2019: 

The FDA alerted patients and health care professionals to Aurobindo Pharma USA’s voluntary recall of two lots of Valsartan tablets–26 lots of amlodipine and Valsartan combination tablets, and 52 lots of Valsartan and hydrochlorothiazide (HCTZ) combination tablets. The recall was due to the amount of NDEA found in the API. 

March 2019 

The FDA announced AurobindoPharma USA’s voluntary recall expansion to patients and health care providers. Aurobindo expanded the recall to include 38 additional lots of Valsartan and amlodipine/Valsartan combination tablets due to the presence of NDEA.

Valsartan Lawsuit FAQs

What is Valsartan?

Approved by the FDA in 1996, Valsartan, the generic version of Diovan, is an angiotensin receptor blocker (ARB) that is used to treat high blood pressure and congestive heart failure.

Why is Valsartan being recalled?

Manufacturers recalled Valsartan in July of 2018 after finding unsafe levels of the probable human carcinogen N-nitrosodimethylamine (NDMA) in the pills. This carcinogenic substance has been linked to digestive tract cancers, among others.

Do I have a Valsartan case?

If you have contracted cancer after taking Valstartan, you may have a case. GoldenbergLaw is helping to lead this litigation nationally and will work with you to not only seek the compensation you deserve, but also to deliver some measure of justice. Contact us today for a free consultation.

Why Choose GoldenbergLaw?

If you find yourself wanting to pursue a Valsartan lawsuit, GoldenbergLaw has the people and resources to help you out. Our team of Valsartan lawyers has experience in related cases and will fight to bring you justice.

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