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Valsartan Lawsuits

Valsartan lawsuits claim blood pressure medications containing valsartan were contaminated by a suspected cancer-causing chemical called N-nitrosodimethylamine, or NDMA. Lawyers are accepting cases on behalf of people who took valsartan and have been diagnosed with liver damage, tumors or cancer. The lawsuits follow a large-scale recall in summer 2018 affecting generic valsartan medications.

Suffering from cancer or liver damage after taking Valsartan?

If you or a loved one suffered from adverse events like liver damage or cancer after Valsartan use, you may be eligible for compensation.

Valsartan
Valsartan Lawsuit Facts
  1. Injuries Liver damage, tumors, cancer
  2. Manufacturers More than 30 different companies
  3. Top Settlement None yet
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In August 2018, two people filed what they hope will be a valsartan class-action lawsuit in federal court in New York.

People who were harmed by contaminated valsartan blood pressure medications are filing lawsuits to obtain compensation for liver damage, tumors, cancer and other injuries.

A large-scale recall of certain generic valsartan blood pressure medications is leading people to sue the manufacturers.

Drugwatch’s legal partners are accepting cases from people who took the drug and developed certain valsartan side effects.

The U.S. Food and Drug Administration estimates that between 3 million and 3.7 million patients have been prescribed valsartan-containing medications each year for three years ending in 2018.

Why Are People Filing Valsartan Lawsuits?

People are filing lawsuits after they took contaminated valsartan and were diagnosed with liver damage, tumors or cancer. The lawsuits follow a massive recall and an FDA announcement that batches of valsartan have been contaminated with NDMA for years.

Conveyor belt with valsartan medicine
Expand
Certain batches of valsartan medications were manufactured with NDMA.
Valsartan injuries you can sue for include:
  • Liver Damage
  • Tumors
  • Cancer

What Is NDMA?

NDMA is a chemical once used to make rocket fuel. Its full name is N-nitrosodimethylamine. Today, it’s mainly used as a research chemical.

NDMA Dangers

The Environmental Protection Agency says NDMA is a probable human carcinogen, or cancer-causing substance. The agency says research has shown that exposure to high levels may cause liver damage in humans.

Fact
NDMA has been used to intentionally poison people.
Source: National Library of Medicine

So far, research has been limited to animal studies. The basis for its designation as a probable human carcinogen is the discovery of tumors in studies involving rodents and other mammals.

The National Library of Medicine has reports of people who were killed by deliberate NDMA poisoning. In one case, it was added to the victim’s lemonade. In another case, it was put in a dish of raspberries.

What Are the Signs of NDMA Exposure?

Short-term exposure to NDMA can cause liver damage. Longer-term exposure may also reduce platelet counts.

Long-term ingestion and inhalation of NDMA may lead to an increase in tumors, including in the liver, kidneys and lungs, according to the results of animal studies cited by the EPA.

Potential symptoms of NDMA over-exposure include
  • Headache
  • Fever
  • Nausea
  • Jaundice
  • Vomiting
  • Abdominal Cramps
  • Enlarged Liver
  • Dizziness
  • Reduced function of liver, kidneys and lungs

Valsartan Recall

On July 13, 2018, the FDA announced that some pharmaceutical companies were recalling certain batches of valsartan. The recalled valsartan medications were tainted with NDMA.

The FDA’s announcement came after recalls were launched in other parts of the world, including Europe, Asia and Canada.

The agency expanded the recall in August 2018 to include a total of 11 U.S. pharmaceutical companies. It said it would continue to investigate.

Recalled Valsartan Products – Manufacturers Involved

Zhejiang Huahai Pharmaceuticals manufactured batches from 10 of the 11 companies involved in the U.S. recall. It made the drugs in Linhai, China.

Zhejiang Huahai said NDMA was introduced when it changed its manufacturing process. The company made about 44 percent of the active ingredient for valsartan drugs sold between January and August 2018.

The FDA said the chemical was in the drugs for as long as four years leading up to the recall. The European Medicines Agency traced the change in manufacturing back to 2012.

The eleventh company’s contaminated valsartan batches were manufactured by Hetero Labs in India.

U.S. manufacturers implicated in the valsartan recall were:
  • Bryant Ranch Prepack Inc.
  • H. J. Harkins Company Inc. 
  • Proficient Rx
  • NuCare Pharmaceuticals Inc.
  • Northwind Pharmaceuticals
  • Torrent Pharmaceuticals Ltd.
  • Lake Erie Medical, doing business as Quality Care Products LLC
  • Major Pharmaceuticals (Teva Pharmaceuticals USA)
  • Solco Healthcare (Prinson Pharmaceuticals
  • Actavis (Teva Pharmaceuticals Industries Ltd.)
  • Camber Pharmaceuticals Inc.

How to Know If You Took Recalled Valsartan

The FDA provides a list of recalled valsartan drugs. Valsartan drugs made by Torrent that were involved in the recall are available separately.

You can compare these lists with your prescriptions or talk to your pharmacist about whether your medications were recalled.

The FDA also offers a list of valsartan medications not recalled. For example, Novartis, the maker of the original valsartan drug, Diovan, was not affected by the recall.

Companies not involved in the recall included:
  • Alembic Pharmaceuticals Limited
  • Allergan, Inc.
  • American Health Packaging
  • Amneal Pharmaceuticals LLC
  • Aphena Pharma Solutions
  • Apotex Corp.
  • Aurobindo Pharma Limited
  • AvPAK
  • Cardinal Health
  • Carilion Materials Management
  • Gavis Pharmaceuticals, LLC
  • Lucid Pharma
  • Jubilant Cadista Pharmaceuticals Inc. labeled as Cadista
  • Lupin
  • Macleods Pharmaceuticals USA
  • Mylan
  • Northwind Pharmaceuticals
  • Novartis Pharmaceuticals Corporation
  • Novel Laboratories, Inc.
  • Ohm Laboratories Inc.
  • Par Pharmaceutical, Inc.
  • PD-Rx Pharmaceuticals, Inc.
  • Preferred Pharmaceuticals Inc.
  • Proficient Rx LP
  • Sandoz Inc
  • Unichem Pharmaceuticals (USA), Inc.

What to Do If You Took Recalled Valsartan

If you took recalled valsartan, the FDA says you should continue taking your medication until you are able to get a replacement from your doctor or pharmacist.

You may also consider contacting a lawyer to find out if you are eligible for compensation through a lawsuit.

How to File a Valsartan Lawsuit

If you were harmed by valsartan medication and think you may have a legal claim, you should consult with an experienced valsartan lawyer. The right product liability lawyer is the key to increasing your chances of succeeding in holding the drug maker accountable.

Suffering from liver damage or cancer after taking Valsartan? Get a Free Case Review

The lawyer will be able to evaluate your case and tell you what to expect. Once you enter into an agreement, the attorney can prepare and file your valsartan lawsuit.

Compensation in a Valsartan Lawsuit

Valsartan lawsuits likely will seek compensation for medical expenses, pain and suffering, lost wages and other economic losses because of valsartan injuries. The amount of compensation a person may receive depends on a number of factors.

For example, people who suffer more serious injuries are generally entitled to receive higher awards and settlements. People who lost high-paying jobs or had their lives drastically altered are also generally likely to receive higher amounts of money when their cases succeed.

Cases settled more quickly may involve lower payments than cases that are resolved through drawn-out litigation.

Valsartan Lawsuit Settlement Amounts

Valsartan litigation is at its early stages. Few, if any, lawsuits have been filed.

There have been no jury trials or large-scale settlements announced. Typically, it can take years for injured parties to get legal compensation.

Valsartan Class Action Lawsuit

A New York man and woman filed what they propose to be a valsartan class-action lawsuit in the federal Southern District of New York on Aug. 16, 2018. Elizabeth and John Duffy named Solco Healthcare, Prinston Pharmaceutical Inc., Walgreens and Throggs Neck Pharmacy as defendants in their complaint.

In a class action, a single lawsuit represents the interest of a large group of people, known as a class. The complaint asked the court to certify the class as all people in the U.S. who purchased valsartan contaminated with NDMA, except for people who purchased the medication to resell it.

Among other things, the lawsuit alleges fraud, gross negligence and battery.

A proposed class action has also been filed in Canada, where valsartan has also been recalled. That case names five pharmaceutical companies that sold contaminated valsartan to Canadians.

The companies are accused of negligence and failing to implement adequate quality control testing when they received the active ingredient from their Chinese supplier.

Diovan Lawsuit

Diovan is not currently involved in lawsuits over valsartan contamination.

Novartis says none of its valsartan medications sold in the U.S. has been subject to the ongoing recall. Among Novartis’ valsartan drugs are Diovan and Exforge.

Fact
Novartis, the maker of Diovan, says none of its valsartan products in the U.S. is affected by the recall.

In 2010, the company settled criminal and civil allegations from the Justice Department. The company agreed to pay more than $420 million to resolve charges it promoted its drugs for unapproved uses and paid kickbacks to health care professionals.

The allegations involved Diovan, Exforge and four other drugs.

Please seek the advice of a medical professional before making health care decisions.

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11 Cited Research Articles

  1. U.S. Environmental Protection Agency. (2000, January). N-Nitrosodimethylamine. Retrieved from https://www.epa.gov/sites/production/files/2016-09/documents/n-nitrosodimethylamine.pdf
  2. Cision. (2018, July13). Valsartan Class Action. Retrieved from https://www.newswire.ca/news-releases/valsartan-class-action-688128691.html
  3. U.S. Department of Justice. (2010, September 30). Novartis Pharmaceuticals Corp. to Pay More Than $420 Million to Resolve Off-Label Promotion and Kickback Allegations. Retrieved from https://www.justice.gov/opa/pr/novartis-pharmaceuticals-corp-pay-more-420-million-resolve-label-promotion-and-kickback
  4. U.S. Food and Drug Administration. (2018, August 9). FDA updates recalled valsartan-containing product information. Retrieved from  https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm?utm_campaign=FDA%20MedWatch%20Recall%20Notice%20-%20Valsartan-Containing%20Product%20by%3A%20Hetero%20Labs&utm_medium=email&utm_source=Eloqua
  5. U.S. Food and Drug Administration. (2018, August 2). FDA updates on valsartan recalls. Retrieved from  https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm
  6. U.S. Food and Drug Administration. (2018, July 17). FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. Retrieved from  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM613532.htm?utm_campaign=07132018_PR_FDA%20announces%20recall%20of%20several%20valsartan%20medicines&utm_medium=email&utm_source=Eloqua
  7. U.S. Food and Drug Administration. (2018, July 18). FDA updates health care professionals and patients on recent valsartan recalls. Retrieved from  https://www.fda.gov/drugs/drugsafety/ucm613916.htm
  8. U.S. Food and Drug Administration. (2018, August 8). Email with Drugwatch.com.
  9. Watts, G. (2019, August. 7). Two more Chinese pharma groups hit by drugs scandal. Retrieved from  http://www.atimes.com/article/two-more-chinese-pharma-groups-hit-by-drugs-scandal/
  10. Novartis. (2018). Novartis Pharmaceuticals Corporation (Novartis) Statement on Recall Outside the United States of Sandoz Generic Valsartan and Sandoz Valsartan and Hydrochlorothiazide Film-Coated Tablets. Retrieved from  https://www.pharma.us.novartis.com/news/statements#ui-id-1=1
  11. European Medicines Agency. (2018, August 2). Update on review of recalled valsartan medicines. Retrieved from  http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/08/news_detail_003000.jsp&mid=WC0b01ac058004d5c1
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