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Valsartan Lawsuits

Trustwell Law is now accepting cases on behalf of persons who have been diagnosed with certain cancers after having taken valsartan1 for at least a year beginning in 2015 or later.

The valsartan lawsuits are based on evidence that many batches of valsartan1 were contaminated with one or more of the cancer-causing chemicals N-nitrosodimethylamine (NDMA)2 or N-Nitrosodiethylamine (NDEA)3.

On July 5, 2018, the European Medicines Agency (EMA) announced it would review all medicines containing valsartan after tests had shown NDMA in batches of the drug manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd (ZHP), a major supplier of generic valsartan.

On July 13, 2018, the Food and Drug Administration (FDA) announced a “voluntary recall of several drug products” containing valsartan due to the presence of NDMA in those products. According to the FDA “[t]he presence of NDMA was unexpected and is thought to be related to changes in the way the active substance [valsartan] was manufactured”.

As the FDA, the EMA, and other agencies investigated, more recalls of generic valsartan followed, valsartan from another supplier (Hetero Labs Ltd.) was found to contain NDMA, and tests found NDEA in some valsartan products.

Long-term exposure to NDMA and NDEA has been linked to many types of cancer, including:

  • stomach cancer
  • liver cancer
  • cancers of the intestines (including colorectal cancer)
  • cancer of the esophagus
  • pancreatic cancer
  • prostate cancer
  • bladder cancer
  • kidney cancer
  • non-Hodgkin’s lymphoma, and
  • other cancers of the blood

If you or a loved one have been diagnosed with one or more of these cancers after taking valsartan, call us at 202-914-1454 or submit your case details online. A member of our legal team will contact you shortly. You may be entitled to compensation.

Our attorneys have years of experience and a reputation for personalized, compassionate partnering with our clients. We also have access to the expertise, resources, and manpower to fully investigate your circumstances, file a lawsuit if appropriate, and help you seek the justice you deserve.

Valsartan and How it Works

The FDA first approved valsartan in 1996 under the brand name Diovan® to treat hypertension (high blood pressure) and in 2001 extended that approval to treat heart failure in certain classes of patients. Since the manufacturer Novartis’ patent protection expired in 2012, many generic competitors have entered the market. Valsartan is available by prescription both alone and in combination products.

Valsartan belongs to the class of drugs known as angiotensin II receptor blockers (ARBs), and it treats hypertension by occupying the same receptors on cells lining the blood vessel walls targeted by the hormone angiotensin II. Angiotensin II is a hormone the body produces that binds with receptors on cells lining the blood vessel walls (a bit like plugging into a tiny socket) and causes the blood vessels to constrict and blood pressure to increase. When valsartan molecules beat angiotension II molecules to those receptors, they block the hormone from attaching to the cells, prevent the blood vessels from constricting (or relax the vessels), and lower blood pressure or keep it low.

Safety Concerns — The Dangers of NDMA and NDEA

NDMA and NDEA are very dangerous chemicals. According to the FDA, these “genotoxic” chemicals “are of special concern to global regulators because…they have the potential to cause harm at very low levels.”

NDMA and NDEA are hepatotoxins (chemicals that cause liver damage) and mutagens (chemicals that cause birth defects). They are classified as “probable human carcinogen[s]” by the Environmental Protection Agency (EPA) and the World Health Organization. The EPA lists NDMA as an “extremely hazardous substance” for which facilities are legally required to provide state and local authorities information for emergency response plans and emergency notification of chemical releases4.

Valsartan Recalls Due to NDMA/NDEA Contamination

Before June 2018, regulators had not identified NDMA and NDEA as possible valsartan contaminants, so the required tests did not look for those carcinogens. But on June 19, 2018, a U.S. manufacturer informed the FDA that the company selling it valsartan had found NDMA in its product. The supplier, Zhejiang Huahai Pharmaceutical Co., Ltd (ZHP), was a major source of generic valsartan.

In early July 2018, the EMA announced it would review all medicines containing valsartan because of the reports of NDMA in valsartan manufactured by ZHP. A few days later, the FDA announced its first “voluntary recall” of several drug products containing valsartan due to NDMA.

The FDA, EMA, and other agencies have continued to investigate the causes of the contamination and look for solutions. Tests have found NDMA in valsartan from another generic supplier (Hetero Labs, Ltd). Tests have also revealed other valsartan products contaminated with NDMA and some contaminated with NDEA. Many more recalls have followed.

NDMA’s properties “make it hard to detect in standard laboratory testing,” but the FDA has developed new test methods specifically designed to identify and quantify NDMA and NDEA in valsartan products. The FDA also says it has identified how the contamination most likely happened, beginning several years ago when certain suppliers changed their manufacturing process and reused certain chemicals.

The first round of voluntary recalls announced in July 2018 included valsartan products manufactured by Prinston Pharmaceuticals (labeled as Solo Healthcare), Teva Pharmaceuticals (labeled as Actavis LLC), and Teva Pharmaceuticals (labeled as Major Pharmaceuticals). These products were recalled for NDMA contamination and were made using valsartan from ZHP.

  • In August 2018, A-S Medication Solutions LLC, Camber Pharmaceuticals and Torrent Pharmaceuticals recalled valsartan products due to NDMA contamination. The Camber Pharmaceuticals products were made using valsartan from a different supplier, Hetero Labs Limited.
  • In September 2018, Teva Pharmaceuticals expanded its recall to include other valsartan-containing products due to NDMA contamination.
  • In November 2018, Mylan Pharmaceuticals and Teva Pharmaceuticals recalled some of their valsartan products due to NDEA contamination.
  • In December 2018, Mylan expanded its recall for NDEA contamination to include all its valsartan products.
  • In January 2019, Aurobindo Pharma USA recalled certain valsartan products due to NDEA contamination.
  • In March 2019, Aurobindo Pharma expanded its January recall.

The FDA maintains a searchable list for consumers and healthcare professionals of all valsartan products and other ARB drugs recalled due to NDMA or NDEA contamination.

Valsartan Litigation

Patients who have been diagnosed with cancer after taking contaminated valsartan have sued the manufacturers to seek compensation for their injuries. These cases are in their early stages, and there have been no outcomes announced (verdicts or settlements) in any lawsuit based on contaminated valsartan.

The first step in this process typically involves large groups of cases being combined in federal court for discovery and other pre-trial purposes in what is called a Multidistrict Litigation (MDL).

In February 2019, a federal court in the District of New Jersey established an MDL for valsartan. By October 2019, more than 100 lawsuits were pending in the MDL.

Generally, groups of tort cases do not settle until after several “bellwether” cases have been tried to a jury. The results of those trials allow the manufacturer and plaintiffs to better understand the impact of the available evidence and the gauge the risks of continued litigation.

 Consult your doctor before stopping any prescribed medication.
  

End Notes

  • Valsartan is the generic name for a complex molecule chemically described as N-(1-oxopentyl)-N-[[2’–(1H-tetrazol-5-yl) [1, 1’ -biphenyl]-4-yl)methyl]-L-valine. Valsartan has the chemical formula C24H29N5O3, and takes the form of a fine white powder.
  • “NDMA” is the abbreviation for the chemical N-nitrosodimethylamine (chemical formula:  C2H6N2O). NDMA is an organic (carbon-based) chemical that can form naturally and during industrial processes. NDMA was once used to help make liquid rocket fuel, antioxidants, additives for lubricants, and softeners for plastics. NDMA is no longer commercially used in the United States. The EPA has identified NDMA as “a drinking water contaminant of concern because of its miscibility with water [fully soluble in all proportions] as well as its carcinogenicity and toxicity.” The EPA also includes NDMA on the list of “extremely hazardous substances” it created as required by federal law.
  • “NDEA” is the abbreviation for the chemical N-Nitrosodiethylamine (chemical formula: C4H10N2O). NDEA is an organic compound related to NDMA (both are N-nitrosamines). Like NDMA, NDEA has no commercial use in the United States and is considered both a carcinogen and a mutagen.
  • The Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) was passed by Congress to encourage and support emergency planning efforts at the state and local levels and to provide the public and local governments with information concerning potential chemical hazards present in their communities.

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