Valsartan Lawsuit - Legal Claims by Cancer Victims

A Valsartan lawsuit is a legal claim for money damages brought by a consumer who took the drug and was subsequently diagnosed with cancer. The lawsuits allege that many batches of Valsartan from 2012 to 2018 were contaminated with NDMA, a probable carcinogen, causing widespread cancer among unwitting consumers. The FDA announced a recall of hundreds of products containing Valsartan that were made in China.

Shouse Law Group is assisting victims from across the United States to bring lawsuits against the drug manufacturers. We are seeking to collect financial compensation for serious side effects and complications.

The current litigation is not a class action. It is a mass tort where each individual sues separately. Because of the large number of claims, the litigation has been consolidated into a multidistrict litigation based in New Jersey.

Our law firm is currently accepting cases that meet the following criteria:

  1. The patient took Valsartan during the period 2014 or later, and
  2. After at least one year of using the drug, the patient was diagnosed with one of the following cancers:
    • Liver cancer,
    • Stomach cancer,
    • Intestinal cancer (including colon or rectal cancer),
    • Esophageal cancer,
    • Pancreatic cancer,
    • Leukemia,
    • Prostate cancer,
    • Non-Hodgkins lymphoma, or
    • Multiple myeloma

There is a limited timeframe in which to file a claim, so contact an attorney quickly.

In this article, our Valsartan lawyers will address:

Also learn about the FDA recalls of the related drug Amlopidine and Losartan.

drug recall
The chemical NDMA that contaminated some Valsartan drugs has been shown to cause cancer and liver damage.

1. What are the legal grounds for a Valsartan lawsuit?

Two common claims in the lawsuits are:

  1. The pills had a manufacturing defect; and
  2. The pills had improper labeling which failed to warn about the dangers

Plaintiffs do not need to prove that the manufacturers intended to cause harm or even that the manufacturers were negligent.

Instead, manufacturers are held "strictly liable" for their manufacturing defects and inadequate warning labels. This means that the plaintiff just needs to prove that the manufacturer made a major mistake that caused their illness.

Victims may have as little as one year to bring a lawsuit. So anyone affected by Valsartan should seek legal counsel right away. The statute of limitations varies by state, but can be as short as one year from the cancer diagnosis.

1.1 Manufacturing defect

A manufacturing defect occurs when a product that has a safe design becomes unsafe due to poor construction.

Valsartan is safe when it is compounded correctly. But several hundreds of lots became unsafe when they were contaminated during the manufacturing process with possible cancer-causing agents.

In order to win a manufacturing defect claim, the plaintiff would need to prove:

  • The drug had a manufacturing defect when it left the manufacturer's possession; and
  • This defect was a substantial factor in causing the plaintiff's harm

The FDA has made public which lots of Valsartan contain carcinogens. So plaintiffs would need to show that that the pills they ingested came from those affected lots. Old pill bottles could serve as evidence of this, as well as prescription records from the pharmacy.

In order to prove that the Valsartan caused the plaintiff's cancer, the plaintiffs' attorneys could present such evidence as:

  • medical records that show the plaintiff developed cancer after taking Valsartan, and
  • expert witness testimony and medical journal articles explaining the link between Valsartan and cancer

1.2 Improper labeling/ failure to warn

All medication including Valsartan carries risk. Therefore, the manufacturers are required to disclose these risks in the form of warning labels and instructions.

However, none of the contaminated Valsartan pill bottles warned that they may contain carcinogens. Had doctors and patients known of this risk, they likely would have chosen another medication instead.

Failure to warn is a straightforward claim to prove in court. The plaintiffs' attorneys would show how the pill packaging and instructions omitted important information. And the plaintiffs can testify that they would not have taken the pills but for this misinformation.1

1.3. What compensation can I get for getting sick from Valsartan?

The precise amount of available compensation is unknown since no Valsartan cases have been decided. In general, plaintiffs in dangerous drug lawsuits may recover compensation for:

  • Costs of the prescriptions and any incidental medical costs,
  • Costs of cancer treatment or other necessary treatment, including side effect management, follow-up appointments, and ongoing care,
  • Lost income due to illness, such as time off work or unemployment, including potential future income,
  • Pain and suffering from the disease,
  • Mental anguish and emotional distress, and/or
  • Punitive damages to punish the manufacturer for wrongful conduct.
Valsartan pills
Valsartan is a popular drug for high blood pressure and heart failure.

2. What is the link between Valsartan and cancer?

The chemical NDMA that contaminated more than one thousand lots of Valsartan drugs has been showed to cause cancer. NDMA is short for N-nitrosodimethylamine.

The US Environmental Protection Agency (EPA) classifies NDMA as a “probable human carcinogen." This means that it probably causes cancer in humans.

Scientists have already confirmed that NDMA causes cancer in animals. Scientists often use NDMA to cause cancer in rats for research. Animal studies have associated NDMA with the following diseases:

  • Colorectal cancer,
  • Gastric cancer,
  • Liver cancer, and
  • Kidney cancer2

In the past, people have even used NDMA as poison in murders:

  • In 1978, a German court convicted a chemistry teacher who attempted to murder his wife by mixing NDMA into her blackberry jam.
  • Also in 1978, a court sentenced a man in Omaha, Nebraska, to death for killing a baby and a 24-year-old man by putting NDMA into their lemonade.
  • In 2013, a student in China put NDMA into a water cooler and poisoned his roommate. He died 15 days later.3

In addition, the World Health Organization lists NDMA as “probably carcinogenic to humans.” Federal regulations list NDMA as a “priority toxic pollutant.”4 And the U.S. National Library of Medicine says NDMA is “reasonably anticipated” to cause cancer in humans.

Short-term exposure to NDMA can also cause liver damage. Long-term exposure can increase the risk of liver, kidney, and lung tumors. Symptoms of NDMA overexposure include:

  • Headaches,
  • Fever,
  • Nausea,
  • Jaundice,
  • Vomiting,
  • Abdominal cramps,
  • Enlarged liver,
  • Reduced function of the liver, kidneys, and lungs, and
  • Dizziness5

A 2018 Danish study showed that NDMA exposure can cause cancer of the liver, stomach, colon, rectum, and pancreas. The EPA also reports that NDMA exposure may cause liver damage.

Patients who took Valsartan are advised to take the following five steps:

  1. Check here for FDA updates and to see if their particular medicine is on the recall list,
  2. Talk to their doctor about an alternative drug or treatment,
  3. Gather their medical and insurance records,
  4. Keep any recalled Valsartan they still have as evidence, and
  5. Talk to a Valsartan lawsuit attorney

2.1. What is Valsartan used for?

Valsartan is the generic component of commonly prescribed drugs used to treat high blood pressure and heart failure. Doctors sometimes prescribe it to people who have had a heart attack or stroke, or are at risk for one. It can also treat type II diabetes by slowing the development of kidney disease.

Valsartan is an “angiotensin II receptor blocker" (ARB). This means that it prevents the action of the hormone that causes blood vessels to constrict. People with high blood pressure typically take one pill daily, and heart failure patients take two.6

More than 100 million adults in America have high blood pressure. In 2017, more than 10 billion pills containing Valsartan were sold worldwide.

Valsartan is the generic name for Diovan, built by drug company Novartis into a $6 billion-a-year pharmaceutical brand. The patent for Diovan expired in 2012.

The drug company Zhejiang Huahai Pharmaceutical Co. (ZHP) of China has manufactured most of the Valsartan in the world since 2012. ZHP sold $50 million worth of Valsartan in 2017.

Generic drugs are supposed to be of equal quality and safety to their brand-name counterparts. This means Valsartan is supposed to be “bioequivalent” to Diovan.

2.2. What are the carcinogens in Valsartan?

The first chemical impurity found in some Valsartan is called N-nitrosodimethylamine (NDMA). It can be unintentionally produced through certain chemical reactions.

NDMA has been used to make liquid rocket fuel, softeners, lubricants, and other industrial products. NDMA is a byproduct of some pesticide and rubber tire manufacturing. The WHO states NDMA is a byproduct from municipal wastewater treatment facilities and some industrial manufacturing facilities.7

Authorities believe that Valsartan contamination is an unexpected byproduct of changes in how the drug is manufactured. The contamination has apparently been taking place since 2012, when ZHP of China started manufacturing the generic pills.

The FDA ran further tests on Valsartan batches that contained NDMA and found a second carcinogen in some of the drugs. This second carcinogen is called N-nitrosodiethylamine (NDEA).

NDEA causes cancer in animals and is used to induce liver tumors for research. It is also “reasonably anticipated” to cause cancer in humans.

Learn more about NDMA contamination in our article Valsartan versus Losartan.

cancer cells
People who have taken contaminated Valsartan pills may be at greater risk of developing cancer.

3. Has the FDA issued recalls and warnings?

Several U.S. drug companies have voluntarily recalled their contaminated Valsartan pills that were made in China or India. The FDA maintains an updated list of recalled Valsartan lots.

The FDA's announced the first batch of Valsartan recalls on July 13, 2018. Since then the FDA has been publishing regular updates about the latest recalls on its dedicated website.

Authorities in over 20 countries have recalled contaminated Valsartan. Not all Valsartan has been recalled. The brand-name Diovan has not been recalled.

Since the 2018 recall, the FDA has banned imports into the US of any medicines or drug ingredients made by ZHP.

4. Who makes and manufactures Valsartan?

Drug manufacturers who have issued Valsartan recalls include:

The FDA has announced that the Valsartan generic drug produced by Alkem Laboratories Ltd. is safe.

5. In what court would a Valsartan lawsuit be filed?

There is a "multi-district litigation lawsuit" (MDL) out of the federal District of New Jersey. But Valsartan victims from all around the U.S. may be eligible to join this MDL.

Plaintiffs may file lawsuits in their home state and have the case consolidated into this New Jersey MDL. Or to save time, they can file their lawsuit directly into the MDL.

The MDL began with about forty separate cases on March 27, 2019. But thousands of other cases are expected to join.

The Valsartan MDL number is 2875. The presiding judge is the Honorable Robert B. Kugler.

5.1. Notable current Valsartan cases

Patients Elizabeth Duffy and John Duffy who took contaminated Valsartan filed a lawsuit in New York. They sued Solco Healthcare, Prinston Pharmaceutical, Walgreens, and Throggs Neck Pharmacy. These defendants comprise Valsartan manufacturers, distributors, and retailers who sold prescriptions to the patients. The lawsuit alleges that:

  • Patients were misled and would not have bought the drugs if they knew they were contaminated,
  • Valsartan-tainted drugs are worthless because they are contaminated with a carcinogen and are not fit for human consumption,
  • Patients should receive money for injuries from consuming high levels of an acutely toxic substance,
  • The drug companies, distributors, and pharmacies breached their warranties including express warranty and the implied warranty of merchantability,
  • The companies lied about the drug's safety,
  • The companies engaged in false advertising,
  • The companies engaged in fraud,
  • Strict liability applies for a manufacturing defect,
  • The companies were negligent, and
  • Patients suffered battery through physical harm.

Patient Eric Erwin filed a similar lawsuit in New Jersey against Prinston Pharmaceutical Inc., Solco Healthcare, Huahai US Inc., and Teva Pharmaceuticals. This lawsuit also claims that drugmaker ZHP failed to meet FDA standards in other situations in 2007 and 2017:

The FDA sent ZHP a warning letter in 2015 about its drug-making facility in China. This letter stated that ZHP used improper data collection methods and deviated from good manufacturing practice.

Another New Jersey lawsuit involves patient Dominic Stimma suing Torrent Pharma, Hetero USA, Camber Pharmaceuticals, Kroger, Quality Food Centers, CVS, and Wal-Mart. The lawsuit states that the FDA found that Camber and Hetero committed other violations in 2016.

This lawsuit also alleges that Torrent failed to recall contaminated Valsartan for a month after the FDA announced that the drugs were contaminated. Some of the Torrent drugs contained both NDMA and NDEA.

In one more example, patient James Jones filed in Missouri against Zhejiang Huahai Pharmaceutical, Prinston Pharmaceutical, Solco Healthcare, and Huahai US. The lawsuit alleges:

  • Improper merchandising,
  • Strict liability,
  • Breach of contract,
  • Breach of warranties,
  • Unjust enrichment,
  • Fraud,
  • Negligence,
  • And other claims
Some patients who took contaminated Valsartan are suing the drug companies and pharmacies in mass tort lawsuits.

6. When are the Valsartan claims likely to be settled?

It is hard to predict. There will probably be no settlement talks until after a few Valsartan cases go to trial. The result of these "bellwether" trials will help victims gauge how much money they can demand.

The Valsartan recalls began only in 2018. And every day new victims are filing lawsuits. Since no trials have been scheduled yet, a settlement may still be at least a year or two away.

7. Is the litigation a class action or individual lawsuits?

Individual lawsuits, but these lawsuits get temporarily consolidated into an MDL -- short for "multi-district litigation."

Currently, there is a Valsartan MDL out of New Jersey's federal court. The purpose of this MDL is to streamline the pretrial proceedings for all of the Valsartan cases.

The MDL judge will eventually allow of few of these individual cases to go to trial. Depending on how these "bellwether" trials turn out, settlement negotiations will begin.

MDLs are similar to class actions: Both involve plaintiffs with similar injuries joining forces to sue the same defendants.

But whereas class actions combine all the plaintiffs' cases into one case, MDLs keep these cases separate. This leaves more bargaining power in the hands of the individual plaintiffs.

8. How should I select a lawyer?

Victims should select a personal injury attorney committed to the following two goals:

  1. Fighting for the maximum possible settlement for your case; and
  2. Staying in contact with you so you remain informed about your case status.

Furthermore, steer clear of any attorney who asks for payment upfront. You should not have to pay any expenses out of pocket unless your attorney wins your case.

Finally, look for an attorney with a successful track record against Big Pharma. The faceless law firms that drug companies hire will do everything to try to intimidate victims and delay proceedings.

But experienced personal injury attorneys know how to stay the course with a singular focus: Recovering the largest financial reward available.

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Call us for help at (855) LAW-FIRM.


Legal References

  1. See, e.g., Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 481-483 (2013)

  2. See Public Health Statement, CDC.
  3. See Chase Purdy, A common blood-pressure medicine is being recalled because of a toxic ingredient, Quartz (July 18, 2018).
  4. 40 CFR §131.36.
  5. Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA), EPA (January 2014).
  6. Valsartan, WebMD.
  7. Muhammad Junaid Farrukh, Muhammad Haseeb Tariq, Obaidullah Malik, and Tahir Mehmood Khan, Valsartan recall: global regulatory overview and future challenges, Ther Adv Drug Saf. (January 18, 2019)

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