Valsartan Lawsuit (2024 Update)

Valsartan is the name of a medication that is used alone or in combination with other drugs to treat hypertension. In the U.S., it is typically sold under the brand names Diovan or Prexxartan, though several legal generic versions exist. Like other ARBs, it blocks a substance formed by the body that can cause blood vessels to tighten.

High blood pressure is a concern because it forces the heart, arteries and other organs to work harder. This can result in risks like:

• Heart failure or heart attacks
• Stroke
• Kidney failure
• Pooling of blood in the lungs

When blood pressure is decreased using a drug like Valsartan, blood moves more freely to the heart, brain and other organs. This increases the supply of oxygen those organs receive, reducing the danger of them failing.

Like all drugs, Valsartan may have side effects. Common side effects of Valsartan include:

• Fatigue and dizziness
• Fever
• Body aches
• Abdominal pain
• Headaches
• Diarrhea
• Back or joint pain
• Rashes

The most serious side effects can occur in patients who have kidney disease before taking this drug. Valsartan can worsen the effects of kidney disease and typically should not be prescribed to anyone with this condition.

Valsartan lawsuits have been filed because hundreds (and possibly thousands) of people taking Valsartan-based drugs have been diagnosed with several types of cancer in recent years. These individuals might not have suffered cancer if they hadn’t taken contaminated drugs.

The contamination was first identified in 2018. This was when the FDA discovered that some batches of Valsartan had been contaminated with two carcinogenic substances, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA).

The contaminated batches were created in China and India by Zhejiang Huahai Pharmaceutical Co. Ltd. and Hetero Labs, respectively. These batches were created exclusively for use in the U.S. and had likely been produced since 2012, when the patent expired. This is when companies started making generic versions of the drug, which have been available in the U.S. market since 2014.

The FDA estimates that roughly 1 in 8,000 people who took the highest dose of NDMA-contaminated medications for four years might develop cancer due to these drugs.

When individuals who had taken the drug and were later diagnosed with one of several types of cancer learned about the contamination, they began filing lawsuits.

Affected patients are filing lawsuits for compensation from the manufacturers for their medical bills, suffering and loss of quality of life. Some third-party payors are also suing to recover money spent on an unsafe product.

The first Valsartan lawsuits were filed after it became public knowledge that some batches of Valsartan were contaminated with carcinogenic substances.

The number of lawsuits grew until February 2019, when a federal court in New Jersey combined all pending lawsuits into multi-district litigation (MDL). At that time, a few hundred lawsuits had been filed. As of 2024, over 1,400 cases had been filed.

Initially, the first bellwether trial was scheduled for 2022. However, that trial has not yet occurred. The first bellwether trial has not been scheduled. This trial will represent third-party payors who are seeking compensation for helping to distribute the tainted drugs.

The evidence during this trial could potentially help consumers reach settlements with the manufacturers or support their trials.

Since the various lawsuits were consolidated into an MDL, the case has had several notable developments.

• Retired judges appointed to assist with settlement negotiations (March 2022). These negotiations have not yet concluded.
• The judge rejected the manufacturer’s attempt to exclude expert testimony (December 2022). Several manufacturers tried to prevent scientific studies that connect the contaminated drug to cancer from being included as evidence.
• Three classes of plaintiffs were certified (December 2023). The three certified classes are Consumer Economic Loss, Medical Monitoring and Third Party Payor (TPP).
• A status conference was held in March 2024. No information is available about the meeting.

An MDL is not like a class action lawsuit. In an MDL, all pre-trial motions and court procedures are combined. However, lawsuits are still pursued independently. This means that while the results of the first lawsuit will affect other lawsuits, a win for the litigants or the defendants in the initial lawsuit does not ensure similar results in later trials.

Roughly 20 companies are currently defendants in the Valsartan lawsuit. While Hetero Labs and Zhejiang Huahai Pharmaceutical Co., Ltd. are the primary defendants in most lawsuits, other companies in the supply chain have also been named.

For example, Prinston Pharmaceutical Inc. has been named in some lawsuits despite being the company that first identified the contamination and notified the FDA. Those actions may mitigate its liability, but a judge and jury will determine whether any other liability exists for which it must compensate victims.

Companies that created Valsartan drugs that weren’t contaminated have gotten ahead of this lawsuit as quickly as possible. For example, Novartis, the original Valsartan patent owner, never contracted with the manufacturers creating the contaminated product. Their drug, Diovan, has been determined not to be contaminated.

Other companies also create drugs using generic Valsartan that never produced contaminated products. Those companies were quick to prove their products were never contaminated and have thus far avoided being named in the lawsuit.

The other main response by companies named in Valsartan lawsuits is attacking expert testimony. These companies have attempted to exclude experts and their dispositions repeatedly throughout the pre-trial process. Expert testimony can be a powerful addition to a product liability case, so defendants may be motivated to exclude it.

The most meaningful recent development in the Valsartan lawsuits is the rapid growth of the size of the lawsuit. It has added over 1,000 cases in just a few years. This is a relatively small percentage of the estimated 1 million people who may have taken these contaminated drugs.

While the rate of new claims has been slowing down in recent months, there are still potentially hundreds of thousands of eligible litigants.

The other meaningful development might occur after the bellwether trial concludes. If litigants are successful, the rate of new cases could increase, as could the rate of settlements. However, if the defendants prevail, many litigants may end their claims rather than continue in the face of an existing precedent in the defendants’ favor.

One of the significant advantages of an MDL is that individual lawsuits are tried separately. This means, unlike a class action lawsuit, you won’t lose your ability to file a lawsuit just because a single trial has been resolved. However, there are other limitations.

The main limitation to filing a Valsartan lawsuit is the statute of limitations in your state. You can only file a lawsuit if the deadline to file has not passed in the state you live in (not in New Jersey, where the MDL is being tried).

Every state has a different statute of limitations for product liability cases. Many states give you two years from when you were injured to file a lawsuit. However, those numbers vary significantly, with some states only giving you one year and others giving three or more.

Furthermore, different states have different standards for when the clock on the time limit begins. Typically, the clock starts ticking either when you become aware of the harm caused by the product or should have become aware.

However, not all states use that standard, and some states place a hard deadline on how long you have to file, even if you weren’t immediately aware of the harm you suffered.

Since deadlines and standards of knowledge are different in every state, you should contact an experienced product liability or Valsartan lawyer to determine whether you still have time to file a lawsuit.

NDMA and NDEA are carcinogens. That means they increase the likelihood of getting cancer when ingested. Unsurprisingly, the majority of Valsartan claims and lawsuits have been made by people who were diagnosed with one of several types of cancer that are associated with these carcinogens.

Bladder Cancer Claims

A study in the National Library of Medicine found that exposure to NMAs (including NDMA and NDEA) increased the likelihood of tumors in the bladders of rats and hamsters. This type of cancer can appear in men or women, though it is more likely to develop in men.

It is highly treatable if discovered early. However, if not treated, like any type of cancer, it can metastasize and spread throughout the body. Common symptoms of bladder cancer are painful and frequent urination (possibly with blood) and back pain.

Colorectal Cancer Claims

More commonly known as colon cancer, colorectal cancer starts as polyps forming inside the colon. Unfortunately, the polyps don’t usually cause symptoms, which means people might not be aware they have them until they have evolved into cancer.

Once these polyps become cancerous, patients may experience:

• Rectal bleeding
• Gas, pain or belly discomfort
• Fatigue
• Significant weight loss
• Frequent diarrhea

These symptoms can have a significant impact on the quality of life of the victim and will often require a lifetime of medical care.

Liver Cancer Claims

According to Mayo Clinic, liver cancer often forms in another part of the body and spreads to the liver after it metastasizes. However, liver cancer can also form due to carcinogens like those found in the contaminated Valsartan.

People suffering from liver cancer are at greater risk of cirrhosis and several types of hepatitis infections. Even when this type of cancer isn’t fatal, it can have severe side effects like nausea and vomiting, and treatment may require partial removal of the liver.

Stomach Cancer Claims

The good news for stomach cancer is that it is relatively likely to respond to treatment if it is discovered early before it has spread to other organs. The bad news is that it is often found after it has advanced and become much more resistant to a cure. Claims involving stomach cancer could require years, if not a lifetime, of treatment.

Liver Injury Claims

There is one type of non-cancerous condition associated with NMAs. Some claimants have suffered liver failure that may be associated with these contaminated drugs. While not all liver injuries make people eligible to file a lawsuit, individuals who require surgery because of these injuries have been added to the Consumer Economic Loss class.

Filing a Valsartan lawsuit is relatively simple. If you were prescribed a drug that included Valsartan, you may be eligible to join the lawsuit. You should contact a lawyer as soon as possible.

The lawyer will attempt to determine whether you qualify by investigating the following questions:

• Were you taking a contaminated dose of the drug? About three million people took Valsartan in 2014 to 2018, but only one million were exposed to contamination.
• Were you diagnosed with a relevant condition? The carcinogenic substance is only associated with certain types of cancer and some liver injuries which appear at least one year after taking the drug for at least 30 days.
• When did you take the drug, and when were you diagnosed? You must file your claim within your state’s statute of limitations. An attorney can help evaluate your eligibility.

In 2024, some deadlines have passed, and your lawyer will have to determine whether you are eligible due to state time limits.

Assuming you qualify to file a lawsuit, your attorney would file a lawsuit in your home state and then petition to have it join the MDL. The MDL offers several advantages. Your attorney won’t have to independently file pre-trial motions or fight to get certain evidence included. Those efforts are all part of the MDL.

Because no cases have concluded in a verdict or settlement yet, there are no concrete figures for what compensation may be coming from these lawsuits. Compensation for product liability claims depends on how much harm the litigant suffered.

Assuming the evidence supports the claimant, cases involving cancer that have metastasized or moved onto later stages may get the most compensation. They could receive compensation for medical treatments, which can easily cost hundreds of thousands of dollars, lost wages, other expenses and loss of quality of life.

Of course, this assumes that the manufacturers or other defendants are eventually found liable after a trial or agree to a settlement with the claimants. If they aren’t found liable or the case is dismissed for some reason, claimants will receive nothing from these claims.

Yes. The FDA issued a recall of all NDMA and NDEA-contaminated drugs in 2018. The recall does not include Diovan or any other product that was manufactured with non-contaminated Valsartan.

The FDA maintains a list of all medications that were recalled. Anyone using these medications can search online to find the lot numbers of all affected products. The website that lists these recalled products also provides information on how to identify the lot number of medication.

Taking any drug can be dangerous under the wrong conditions. Valsartan is known to have life-threatening complications, especially in people who have kidney disease. Other life-threatening complications include difficulty breathing or dangerous swelling.

However, these are known side effects of the drug, which are considered reasonable dangers given the potentially life-saving benefits it offers. The presence of a carcinogen is different, especially since the drug can be manufactured without that carcinogen being present.

This is the main reason that the Valsartan lawsuits exist and why there are over 1,000 active cases in the U.S. Whether these claims are legitimate has yet to be determined, though that question will likely be answered within a few months as the first case goes to trial.

Current and potential claimants will probably have a lot more answers to their questions before the end of 2024.