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Valsartan Lawsuits Quick Facts

  • Associated Products

    Valsartan-based drugs

  • Companies Involved

    Zhejiang Huahai Pharmaceuticals, Hetero Labs Ltd, and Others

  • Common Uses

    To lower blood pressure, treat heart failure, and reduce mortality after heart attack

  • How Many Lawsuits

    11+

  • Major Side Effects

    Potentially Contributes to Cancer

  • Settlement Details

    No Settlements

  • Lawsuit Locations

    Federal: District of New Jersey, Northern District of Illinois, and Others

Valsartan lawsuits are filed by patients who developed various forms of cancer after taking the generic blood pressure drug. Manufacturers have found cancer-causing nitrosodimethylamine (NDMA) in valsartan products, possibly paving the way for many more valsartan lawsuits.

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Why People Are Looking to File Valsartan Lawsuits

Valsartan is an active ingredient in a number of medications used to treat hypertension (high blood pressure) and related medical conditions. Like all prescription drugs, valsartan has a number of side effects on its own, but the concerns that have been leading to discussion about lawsuits are primarily around the discovery that batches of valsartan have been contaminated with a chemical known as N-nitrosodimethylamine (NDMA). In September 2018, the FDA discovered that three batches of valsartan manufactured by Torrent Pharmaceuticals also contained traces of a second impurity, N-nitrosodiethylamine (NDEA).

NDMA is classified by the U.S. Environmental Protection Agency (EPA) as a probable human carcinogen. It was primarily used in the past in the production of rocket fuel, antioxidants, and other industrial uses. Because of its carcinogenic properties, NDMA has been used by some scientists to induce cancer in rats for research.

Valsartan and Cancer Risks

The FDA has estimated that the risk of developing cancer after taking NDEA- or NDMA-contaminated valsartan is very low (about 1 additional diagnosis of cancer for every 8000 people). However, individuals who have developed certain types of cancer may still have a legal case if they have taken valsartan-based medications that were contaminated. The cancer cases currently being investigated by law firms include:

  • Colorectal cancer
  • Intestinal cancer
  • Liver cancer (or other liver injury)
  • Stomach cancer

If you developed any of these cancers after taking potentially contaminated medications containing valsartan, you should discuss your case with an attorney right away.

Valsartan Recalls and FDA Actions

In July 2018, the FDA and at least 22 health and safety agencies in other countries, including Health Canada and the European Medicines Agency, issued recalls for valsartan after discovering the presence of NDMA in the drug. The FDA has stated that the contamination likely was caused by changes to the drug’s manufacturing process, and that some valsartan products may have contained NDMA for as long as four years.

Since the initial announcement, the valsartan recall has been expanded to include valsartan-containing products (including valsartan/hydrochlorothiazide) from these affected companies:

  • A-S Medication Solutions LLC
  • Aurobindo Pharma USA
  • AvKARE
  • Bryant Ranch Prepack Inc.
  • Camber Pharmaceuticals (Hetero Labs)
  • H J Harkins Company Inc. (Pharma Pac)
  • Mylan Pharmaceuticals
  • Northwind Pharmaceuticals
  • NuCare Pharmaceuticals
  • Preferred Pharmaceuticals
  • Prinston Pharmaceutical Inc., including its subsidiary Solco Healthcare LLC
  • Proficient Rx LP
  • RemedyRepack Inc.
  • Teva Pharmaceuticals, including its subsidiaries Major Pharmaceuticals and Actavis
  • Torrent Pharmaceuticals Limited

See the FDA’s updated list of recalled products

Not all valsartan medications are included in the recall, only those supplied by the Chinese company Zhejiang Huahai Pharmaceuticals and the Indian company Hetero Labs Limited (Camber Pharmaceuticals). As a result, Diovan lawsuits and legal actions against other valsartan-containing drugs produced by Novartis are not currently being filed. In September 2018, the FDA imports from Huahai’s Chuannan factory due to the contaminated valsartan.

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Also, products with expiration dates prior to July 2018 were not included in the recall, meaning that any expired drugs which have not been properly disposed of could still be problematic if somebody takes them. Future products that contain the active pharmaceutical ingredient valsartan may also be added to the recall, if they are discovered to contain NDMA.

The risk of developing cancer from the traces of NDMA found in contaminated valsartan is still unknown. Anyone who takes valsartan should talk to their pharmacist or health care professional to see if their prescription is included in the recall and to receive a different medication, if necessary.

Valsartan Side Effects

  • Dizziness
  • Headache
  • Viral infection
  • Fatigue
  • Abdominal pain
  • Hypotension (low blood pressure)
  • Diarrhea
  • Arthralgia (joint pain)
  • Back pain
  • Hyperkalemia
  • Coughing
  • Increased blood creatinine
  • Jaundice

Current Valsartan Lawsuits

Since the initial valsartan recall were announced, several class action lawsuits and individual lawsuits have been filed. Additional lawsuits are expected to be filed as awareness of the potential NDMA and NDEA contaminations increases.

Early Valsartan Class Action Lawsuits

In August 2018, Eric J. Erwin filed a class action lawsuit against Prinston Pharmaceutical Inc., Solco, Huahai US, and Teva. Erwin, who took valsartan to manage his blood pressure, filed individually and on behalf of those who have been affected by valsartan recalls. In the complaint, he alleges that the defendants were aware of the cancer-causing ingredient in valsartan as early as 2012, but continued to distribute the drug, and he raises claims of fraud and deception against the manufacturers and companies. Erwin’s lawsuit was filed in the United States District Court in the District of New Jersey.

Valsartan Multidistrict Litigation

In October 2018, a motion was filed to consolidate 11 outstanding valsartan lawsuits (including the Erwin lawsuit) into a multidistrict litigation (MDL) overseen by the U.S. District Court for the District of New Jersey. Movant Robert Kruk had filed his own lawsuit in the U.S. District Court for the Northern District of Illinois, and he argued that the 11 valsartan lawsuits in question all shared common questions of fact, potentially overlapping class definitions, and likely have duplicative discovery requirements. Several of the plaintiffs in other cases filed a motion in November 2018 agreeing with Kruk’s motion. As of December 2018, the Judicial Panel on Multidistrict Litigation has not yet ruled on whether to consolidate these lawsuits into an MDL.

Frequently Asked Questions About Valsartan Lawsuits

Litigation around valsartan contaminated with NDMA or NDEA is still developing. However, below are some answers to common questions people have about potential valsartan lawsuits.

Am I Eligible for a Valsartan Lawsuit?

If you or a loved one has been diagnosed after taking a prescription that contains valsartan contaminated with NDMA or NDEA, you could be eligible to file a lawsuit. You may have a viable case if you have developed any of the following cancers:

  • Colorectal cancer
  • Liver cancer (or other liver injury)
  • Intestinal cancer
  • Stomach cancer

If you have been diagnosed with any of these cancers after taking valsartan, you should talk to a drug lawyer to understand your legal rights.

What Compensation Can I Get for a Valsartan Lawsuit?

No valsartan settlements or verdicts have occurred yet, so the range of compensation that may be available is still unclear. In general, legal claims like these tend to seek compensation for the following:

  • Costs of cancer treatment, including side effect management, follow-up appointments, and ongoing care
  • Lost income due to the illness, such as time off work or unemployment, including potential future income
  • Pain and suffering from the disease
  • Mental anguish and emotional distress
  • Punitive damages to punish the manufacturer for wrongful conduct (if applicable)

You should talk to a lawyer to see what compensation may be available in your case.

How Much Do Valsartan Lawsuits Cost?

Valsartan lawsuits are most commonly accepted by law firms on a contingency basis, meaning that they only get paid if they help you receive compensation. The payment is usually a percentage of the recovered amount.

During your free case evaluation, you will have a chance to discuss what costs will be paid to your lawyer if they help you receive a settlement or favorable verdict.

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