The thought of pursuing a lawsuit against “Big Pharma” may be overwhelming, but if you have suffered physical harm due to taking prescribed or over-the-counter (OTC) medications, it is essential to hold the rich and powerful drug companies accountable for the negligence that caused your health issue.  A legal expert with experience in Valsartan lawsuits can assist you and make you feel comfortable with the process.  You may be entitled to monetary compensation if you have been diagnosed with cancer after using Valsartan.

Sections in this article include:

• What is Valsartan?
• Valsartan Lawsuits
• When to Contact an Attorney
• What to Do if You Have Taken Valsartan
• Valsartan and Recalls
• Legal Grounds for Valsartan Lawsuits
• Valsartan, NDMA and Cancer
• Damages Sought in Valsartan Lawsuits
• When Will the Valsartan Lawsuits Settle
• Look for an Experienced Attorney

Valsartan is a medication for treating high blood pressure and congestive heart failure. It is taken orally and is within a class of drugs called angiotensin receptor blockers (ARBs).

The brand-name formulation of Valsartan is manufactured by Novartis and is called Diovan. Entresto, with the same active ingredient, is also made by Novartis. Novartis’s patent expired in 2012, and that is when generics entered the market.

A Valsartan lawsuit is a legal claim for damages initiated by a consumer who took the medication and, thereafter, was diagnosed with cancer. Valsartan lawsuits allege that numerous batches of the drug manufactured from 2012 to 2018 were contaminated with N-Nitrosodimethylamine (NDMA), a known carcinogen.  NDMA is the same chemical that was found in high levels within some Zantac formulations and has since become the subject of lawsuits related to that medication. Similarly, NDMA has contaminated some Valsartan drugs.

The Valsartan lawsuits are multi-district litigation (MDL) filed in a New Jersey federal court.  It is not a class-action suit.  Each plaintiff (the consumer who was harmed by the drug) will receive a separate amount of money based on the facts specific to his or her case.  

The MDL is entitled: Valsartan NDMA Products Liability Litigation. MDL # 2875. Federal Court, District of New Jersey. The judges assigned to the MDL are the Honorable Robert B Kugler and the Honorable Joel Schneider.

Of all the cases within the MDL, the judges will appoint four or five to continue to trial.  The verdicts reached in these “bellwether’ trials will determine whether the rest of the cases receive big settlements or more modest amounts.

Please reach out to our firm if you fall into the following categories:

You took Valsartan in 2014 or later, and you took Valsartan for at least one year, after which you were diagnosed with one of the following conditions:

• Intestinal cancer (which includes colon/rectal)
• Stomach cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer
• Leukemia
• Esophageal cancer
• Multiple myeloma
• Non-Hodgkins lymphoma

• Review the Food & Drug Administration (FDA) website for updates on recalls.
• Call your physician to discuss an alternative medication or treatment option.
• Order your medical and pharmacy records.
• Retain any supplies of Valsartan you have in your home.
• Seek advice from an attorney experienced in Valsartan litigation.

Because each state has a time limit in which you must act to preserve your rights, it is important to talk with a lawyer as soon as possible if you suspect you have sustained harm due to your use of Valsartan.

The FDA has not recalled Valsartan, however, starting in July 2018, many of the drug companies that were manufacturing the drug have voluntarily recalled their supplies.  The FDA has a page here that provides regular updates regarding the voluntary recalls:

Some of the drug manufacturers that have voluntarily recalled Valsartan are:

• Camber
• Acetris
• Hetero
• Aurobindo
• Mylan
• Major
• Teva/Actavis
• Prinston/Solco
• Torrent

The FDA has announced that the Valsartan product manufactured by Alkem Laboratories Ltd. is safe.  

There are a couple of common claims in the filed lawsuits:

1. There was a manufacturing defect; and 
2. There was a failure to warn of the danger due to improper labeling.

Drugmakers are “strictly liable” for defects in manufacturing and inadequate or improper warning labels. This means that the plaintiff does not need to prove negligence on the part of the drug maker, just that a mistake was made by the manufacturer, and that mistake caused the plaintiff harm.

Manufacturing Defect

A product that is normally safe can become dangerous due to a defect in the manufacturing process.  In this instance, the drug Valsartan is safe when correctly manufactured.  Numerous lots (several hundred) were made unsafe due to contamination with NDMA.

Proving a Manufacturing Defect

To have a valid claim in a Valsartan lawsuit based on a manufacturing defect, the plaintiff has to prove that the drug was defective upon leaving the possession of the drugmaker and that the defect was a substantial factor in the harm caused to the plaintiff.  

The FDA has published the Valsartan lots that were contaminated, so that information is public knowledge.  The plaintiffs need to have evidence that the medication they took came from the contaminated lots.  This could be proven by retained pill bottles, and records of prescriptions obtained from the plaintiff’s pharmacy.

Next, it must be proven that the contaminated Valsartan was the cause of the consumer’s cancer.  This could be supported by the plaintiff’s medical history through his or her records, as well as medical expert testimony and medical journal information documenting the link between NDMA and cancer.

Failure to Warn

As we all know, medications come with instructions and warning labels on the box, label, and/or with the packaging.  The manufacturers are required to disclose any risks associated with the use of the medication on the box, label, and/or instruction sheet.

Concerning the Valsartan lawsuits, the contaminated lots did not warn consumers that they may contain NDMA, a recognized carcinogen.  If they had included this information, physicians and patients very likely would have decided to use an alternate medication. 

Proving a Failure to Warn

The failure to warn in this circumstance is fairly easy to prove by simply showing the medication’s packaging and instruction materials.  The plaintiffs will need to confirm through testimony that if they had been made aware of the risks, they would have opted not to take Valsartan.

More than 1,000 lots of Valsartan based medications have been contaminated with NDMA.  

NDMA was a chemical produced in the United States.  It is a component of rocket fuel and presents an odorless liquid.  U.S. production of NDMA was ceased after excessive levels of the chemical were found in water, soil, and air in areas near a rocket fuel manufacturing plant.  NDMA is also produced in other manufacturing processes.

Animal experiments have resulted in inconclusive evidence that NDMA is a carcinogen, and the U.S. Agency for Toxic Substances and Disease Registry (ATSDR) states it is reasonable to expect that human exposure to NDMA by eating, breathing, or drinking could cause cancer. 

The animal studies have found NDMA to be associated with the following diseases: 

• Bladder cancer
• Colon cancer
• Liver cancer
• Kidney cancer
• Gastric cancer
• Pancreatic cancer

This list is not exhaustive, and health conditions linked to NDMA are not even limited to certain cancers.  It has also been linked to scarring of the liver, and reduced function of the kidneys, liver, and lungs.

Some of the categories for which monetary compensation (damages) will be sought in such a lawsuit are:

• Medical expenses already incurred
• Any future medical expenses based on physician recommendations & estimates
• Loss of income from inability to work – including in the future
• Out-of-Pocket expenses
• Pain and suffering

If you are married, your spouse may also have a claim for the negative effects your illness has had on the marital relationship.  These damages are known as “loss of consortium.”

It will be at least a couple of years before the MDL cases settle.  As discussed above, the results of the first cases to go to trial will set the tone for settlement negotiations for the other cases.

There are many complexities involved in litigation against dangerous drug manufacturers.  The big pharmaceutical companies have very deep pockets to defend lawsuits.  If you or a loved one has been diagnosed with cancer after taking Valsartan, it is important for you to seek legal counsel with experience in lawsuits against pharmaceutical manufacturers.

Below is a news clip discussing the contaminants found in Valsartan.

I’m Ed Smith, a Sacramento Drug Products Liability Lawyer. If Valsartan-related cancer has affected you or someone you love, do not hesitate to call me for free and friendly advice at 916-921-6400 or 800-404-5400. 

DISCLAIMER: This article is presented solely for informational purposes.  It does not constitute a Retainer/Agreement for Services. There exists no attorney-client relationship between you and our law firm unless/until a Retainer/Services Agreement is executed. The information presented at this site is not medical or legal advice, nor is it intended to be. Never stop taking any medication without first consulting your doctor.

Image by Steve Buissinne from Pixabay

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