Many medications using the ingredient valsartan have been the subject of voluntary recalls since 2018 due to an NDMA contamination at the manufacturing level that started in 2012.
The SadakaFirm is available to represent those who believe they’ve purchased or used drugs tainted by this negligence and want just and fair compensation.
Read more to learn about valsartan, the massive litigation against its manufacturers, and how SadakaFirm can help you.
What Is Valsartan?
Valsartan is an oral medication most commonly used as a central component for drugs prescribed to treat diabetes-related kidney diseases, high blood pressure, and heart failure. It can be sold under a variety of trade names and is also available in generic forms.
Valsartan was introduced to the market in the mid-90s and has been sold consistently since then.
Valsartan is what’s known as an angiotensin II receptor blocker, or ARB. It functions by blocking the hormone responsible for constricting blood vessels throughout the body. Doing so prevents blood pressure from rising, alongside other benefits.
This function makes valsartan a popular ingredient in blood pressure medications. According to the Center for Disease Control, 30 million adults take blood pressure medication. It’s safe to assume that most of them are regularly consuming valsartan as a result.
Dosages vary based on intended treatment as well as age. It’s currently manufactured in tablet form, in four sizes: 40 mg, 80 mg, 160 mg, and 320 mg. It’s rare for doctors to prescribe 320 mg doses because valsartan poses an overdose risk.
Valsartan and NDMA
In 2018 the European Medicines Agency discovered impurities in certain drugs using valsartan and began a recall. Initially, they found batches of valsartan contaminated with NDMA shipped to European countries and Canada.
As the EMA tested valsartan products, they found the active ingredient, manufactured by Zhejiang Huahai Pharmaceuticals of China, contaminated by NDMA, an organic compound known to be carcinogenic.
The American Food and Drug Administration followed in the EMA’s footsteps almost immediately. During extensive laboratory testing and research, the FDA confirmed valsartan shipped to the United States had been contaminated as well, not only with NDMA but NDEA (a weaker carcinogenic compound) as well. As the FDA began naming specific manufacturers selling medication that tested positive for NDMA, recalls began.
Currently, the FDA believes contamination to have begun in 2012 when Zhejiang Huahau Pharmaceuticals altered their manufacturing process.
As one of the largest valsartan manufacturers globally, their valsartan has been purchased by over thirty companies and used in many more medications under different brand names and generic forms. With blood pressure medications being commonplace, especially in North America, it’s believed that exposure to NDMA is potentially widespread.
At present, the FDA has not issued a recall notice for drugs containing valsartan. However, many companies have participated in a voluntary recall of their products that include the compound. It’s not currently known if the FDA will mandate a recall, but their research and testing are ongoing.
While not requiring drug companies to recall medications with valsartan, the FDA maintains and regularly updates a list of recalled products. You can view that list on the FDA’s website here. The administration also posts updates, including other manufacturers creating valsartan with impurities, here.
Valsartan Injuries and Side Effects
Under ordinary circumstances, valsartan has potential side effects that patients need to monitor for their wellbeing. These side effects vary depending on the medication prescribed to them. The dosage could also be a factor. As with all drugs, valsartan can have harmful interactions with other medicines you take.
When used as a heart failure treatment, side effects include dizziness, diarrhea, joint and back pain, and low blood pressure. Of these side effects, dizziness is the most common and affects less than 17% of patients. The other side-effects occur much less frequently and aren’t as severe.
As a treatment for hypertension and high blood pressure, many of the same side effects are present. In addition to these, flu-like symptoms, such as abdominal pain, may be present. However, all of these are incredibly uncommon when compared to their presence in other treatments.
Lastly, valsartan and other ARBs used to treat kidney failure can worsen renal failure and heart failure symptoms. A dosage that’s too high or taken too frequently can cause a bodily response to constrict blood flow in an attempt to direct more blood to the kidneys. These are the most severe complications valsartan can produce and require close monitoring by both the patient and their healthcare professional.
Valsartan is one of many drugs to come with a black box warning. A black box warning establishes when drugs pose a serious threat to a fetus. This threat is a natural consequence of the drug, so pregnant women should never take it.
The NDMA contamination has added much more severe risks. Nitrosodimethylamine NDMA sometimes causes liver damage, including tumors and cirrhosis, in laboratory rats. Based on this, scientists believe NDMA is a human carcinogen as well.
NDMA can occur naturally in low doses, but higher doses pose a health risk. NDMA appears as part of the water treatment process. The Environmental Protection Agency has established an acceptable level of concentration, and local authorities constantly analyze their water to ensure it’s within safe limits.
Once NDMA is present in a water source, you must treat it differently as it isn’t easy to filter out. There are also increasing concerns with NDMA entering our environment in other ways. For example, burning rocket fuel at test sites leads to the compound developing in groundwater.
Why Was Valsartan Recalled?
Recalls worldwide have taken place because the FDA, the EMA, and other medical bodies have discovered NDMA in valsartan manufactured by the world’s largest supplier. As authorities continued investigating the contamination, they found other pharmaceutical companies producing ARBs like valsartan with the same contamination.
The voluntary recalls are happening in the United States and worldwide because NDMA can cause cancer in humans based on animal testing. Officially, the EPA classifies the compound as a possible carcinogen based on laboratory tests. NDMA has even been used to intentionally poison people in the past.
Zhejiang Huahai Pharmaceuticals, the first identified source of the contamination, was the leading producer of valsartan in the world. The FDA believes that when ZHP changed their manufacturing process in 2012, they accidentally created NDMA as a by-product, adding it to the drug. This mistake appears to have gone unnoticed until EMA and FDA testing confirmed the contamination.
In wanting to produce valsartan in more significant quantities faster, ZHP changed some of the process’s chemicals. However, the new combination had the side-effect of creating NDMA.
Dangerous methods like these were found in another manufacturer, Hetero Labs in India, and have renewed the FDA’s focus on drugs made outside of the United States. Unfortunately, they don’t have much control over how foreign companies do business.
Since tracing valsartan back to ZHP and Hetero Labs and connecting them with companies worldwide, the FDA has worked to identify which products are likely contaminated and pose a danger to the public. Over fifty companies have since recalled affected products from the market.
Similar NDMA contaminations appeared in other drugs since 2012. The popular over-the-counter heartburn treatment Zantac underwent a recall in 2019 when independent testing revealed contamination. Some valsartan products sold by Teva Pharmaceutical, Solco Healthcare, and other companies have suffered from flawed production.
Consumers should note that while the recalls for specific drugs aim to remove them from the market entirely, only portions of the drugs produced starting in 2012 are known to be affected.
Similarly, not all medicines containing valsartan have been subject to recall. Those that secured their ingredients from sources that tested safe remain for sale.
Status of Valsartan Litigation
Lawsuits against the tainted drug manufacturers and sellers started shortly after the FDA announced the faultiness in 2018. Some of the litigants had developed ill-health during the time the manufacturing took place. Others don’t show signs of illness. But because they took the tainted medicine, users believe they were at risk.
As of this writing, all of these valsartan lawsuits have been joined together into a multi-district lawsuit. It is similar to a class-action lawsuit in that all of the plaintiffs are collectively suing the defendants. However, the case each person brings is resolved individually on a case-by-case basis rather than as one judgment or settlement.
A few individual suits from the multi-district lawsuit will be allowed to go forward with their trials first (these initial trials in multi-district litigation are sometimes called bellwether trials). This trial will play out as any ordinary trial would and follow the same processes. The results from these cases cause both sides to either settle or litigate the remainder of the lawsuit.
The bizarre nature of the contamination and its discovery has given litigants various reasons to file a valsartan recall lawsuit. The most common so far appears to be personal injuries, where plaintiffs suffered physical harm resulting from taking the defective products. Others are suing for monetary damages stemming from the loss of work or medical bills and wrongful death.
Whether or not any specific case will succeed can’t be known beforehand. However, the nature of multi-district lawsuits means that individual litigants aren’t bound to each other’s success as a group.
Given the widespread use of medications with valsartan and how long it takes for litigation to move forward, the number of plaintiffs will likely grow.
While many litigants have come forward with their complaints, the underlying thread they have in common is that the involved pharmaceutical companies ignored the risky procedures used by ZHP and Hetero Labs.
Those two manufacturers stand accused of ignoring warnings from the FDA regarding their manufacturing practices. This litigation’s ultimate goal is to resolve these issues and compensate consumers harmed by this negligence.
What To Expect When Filing a Lawsuit
If you intend to file and join the valsartan recall lawsuit against manufacturers and sellers of valsartan, the first thing you should know is that you have a limited time to do so. Each state has a statute of limitations that establishes how long you have to file a lawsuit, regardless of the reason for the suit. It’s always best to file your case as soon as possible to ensure it falls within the legal time limit.
Before filing, your lawyer will ask you a series of questions to determine whether or not they think you have a case and how strong it is. They’ll need to know how long you’ve been taking the medication and what medical problems it has caused you. You’ll need to present evidence supporting each claim, so be prepared with relevant records.
You should also expect a lot of waiting while the lawsuit goes forward. It’s rare for a case to quickly work its way through the courts, let alone one with so many plaintiffs and defendants. It can take years for a suit to start and reach a conclusion.
Throughout this waiting period, your lawyer will be in contact with you with updates. Likewise, you should reach out to them if your condition changes. Constant communication between you and your legal team is essential to staying abreast of the situation as it unfolds.
After the bellwether trials conclude, the remainder of the multi-district litigation begins. The plaintiffs serve as one group and all the defendants as another. Usually, the initial trials’ results will promote defendants to settle rather than continue expensive litigation, but that’s not always the case.
Who Can File a Lawsuit
There are standards in place that you have to meet to be eligible to sue in this case. Simply taking valsartan alone is enough to qualify your case. The currently established standards require that those with injuries need to have taken a drug containing valsartan manufactured or sold from one of the named defendants for at least a year with a specific illness or damage resulting from use.
Though studies have shown that NDMA can cause cancer in laboratory mice, confirmed studies on the impact it has on humans are few and far between. The studies that do exist point towards the compound impacting the liver, gastrointestinal tract, and digestive organs. If you were diagnosed with cancer of the liver, stomach, bladder, colon, rectum, liver, pancreas, or kidneys, you might qualify.
However, your diagnosis has to have come one year after you started taking valsartan for your claim to be valid. It doesn’t matter if you medicated consistently during this time so long as you took it for at least thirty days. The dosage and frequency of use are non-factors in determining your eligibility.
Finally, the medication you took must have been sold or made by one of the identified companies and been part of one of the affected lots. These requirements are in place to prevent people from lawsuits against pharmaceutical companies that didn’t use contaminated valsartan.
All of this needs to have occurred from 2014 onward. Other forms of injury may qualify, but it is on a case-by-case basis. Speak with your lawyer if you’re unsure you are eligible, and they’ll assist you.
Compensation for Valsartan Injury Lawsuits
All the law firms representing the numerous plaintiffs in the valsartan lawsuit are working together for their clients’ shared goals. They ultimately seek the defendants to cover all medical costs, compensation for pain, suffering, lost wages, and out-of-pocket costs related to taking the drug, injuries, and legal expenses.
Should settlements be reached, awards are delegated on an individual case-by-case basis.
That said, litigation is still in the very early stages, and anything could happen. Usually, the bellwether trials’ results allow attorneys to gauge the likelihood of different outcomes, including settlement negotiations, but that isn’t always the case.
Even though the defendants are successful pharmaceutical companies, that isn’t indicative of what they are willing to pay in a settlement, should a settlement be reached.
How SadakaFirm Can Help
SadakaFirm is a national law firm working in defective products (including pharmaceuticals and medical devices), chemical exposure, and vaccine-related injuries.
Our team uses a mixture of unique skills to represent our clients, with so much of our work focusing on medical and health issues. We believe in building the most concrete cases we can using science-based evidence to support our claims.
As our client, you can expect our personal and caring team to give your lawsuit our undivided attention. Even in the case of multi-district litigation, we focus on your experience as an individual. We believe strongly in holding corporations accountable for their mistakes and how they affect you personally.
In the case of the valsartan cancer lawsuit, you can expect SadakaFirm to prepare you for the process to the fullest extent. Not only do we help you determine if you are eligible to sue, we provide you with all the ways you can prove the defective drug has made you suffer.
Our lawyers will also prepare you for all the questions the defense is likely to ask, so there are no surprises.
With so many defendants named in this lawsuit, and with some of them located in other countries, holding the appropriate parties responsible will be complex.
SadakaFirm will ensure that everything is filed correctly on your behalf, even when dealing with foreign corporations. We also help you identify each party responsible for your harm based on the specific product you took.
Our attorneys do so much to help you because we’re not just a legal team: we’re also advocates for our clients. We go beyond arguing your case because our underlying philosophy is holding people accountable. You can see the results of some of our past court cases here.
FAQ About Valsartan Recall Lawsuits
The two primary defendants are Zhejiang Huahai Pharmaceutical (located in China) and Hetero Labs (located in India). These two companies are the largest valsartan manufacturers believed to have used flawed processes, leading to contamination of the drug with NDMA. As large suppliers, they provided valsartan to over thirty companies for use in their drugs.
Other defendants include those companies that sold drugs with NDMA and some retailers. Their suits allege that they share some responsibility for selling a defective product, not recalling their products sooner, or both. New defendants could be named if more drugs test positive for containment.
No one can say with certainty who will be held responsible by this lawsuit. Part of litigation’s purpose is to make arguments that the defendants are liable to some degree. The success of this will depend on the evidence presented during the trial.
Not all valsartan sold since 2012 comes from contaminated sources, and thus some drugs still on the market are safe. The FDA maintains a list of companies that have voluntarily recalled their products here. You can also ask your prescriber or primary care professional if your valsartan is safe to use.
If you find that your medication is among the contaminated valsartan batches, you should not stop taking it immediately. Instead, the FDA recommends consulting your doctor about stopping first. Depending on why you take the medication, they may need to switch you to something else to ensure you don’t encounter additional health problems.
The NDMA valsartan first class-action lawsuit came to light in 2018. More quickly followed, and in early 2019 these were all combined into a single multi-district litigation case. In doing so, there are established eligibility requirements in place for plaintiffs.
As long as you were taking medication contaminated with NDMA after 2012, and your diagnosis came a year after you started taking it, it doesn’t matter how recent the diagnosis was. You can still file a valsartan cancer lawsuit and join the multi-district litigation. However, you will need to prove that your medication was traced back to a contaminated source, which your doctor and our law firm can help you determine.
In 2019, as part of the multi-district litigation procedure, all of the lawsuits were grouped into three over-arching master complaints. The first alleges that their medication was contaminated and caused them to develop cancer or liver damage. Because of the cancer risks of NDMA, this complaint is the most publicized but isn’t the only one.
Plaintiffs who took contaminated valsartan since 2012 but haven’t been diagnosed with ill-health effects fall under the second complaint. They allege that manufacturers put them at risk by selling the product and were negligent by not performing quality tests. They are seeking compensation for the negligence of these manufacturers.
Finally, the third complaint represents people who bought valsartan at any time since 2012 but did not take it. They allege that they were sold a faulty and dangerous product and want to hold the manufacturers responsible. People in this group did not suffer damage. But despite not taking the medication, they were still at risk had they chosen to take it.
So long as your lawsuit falls under one of these three complaints, you can join the valsartan lawsuit. SadakaFirm can help you build a strong case regardless of your situation. However, you need to file soon before your state’s statute of limitations passes.
It’s a common misconception among the public that plaintiffs need to prove that the defendants acted intentionally or with malice for lawsuits like this to succeed. This belief isn’t the case for faulty product litigation. Even accidental contamination and defects open the way for lawsuits.
Product liability guidelines hold manufacturers accountable for selling products without adequate safety labels and information. Given that the FDA and EMA only discovered the contaminated valsartan by random testing, none of the manufacturers had adequately warned the public about their products beforehand. Whether they knew about the contamination before selling their products isn’t relevant to the litigation.
The plaintiffs in this case only need to prove that the manufacturers sold harmful products without safety labels. Those suing over injuries and health effects must also prove that they were caused by taking the medication. Other than that, plaintiffs have no further responsibility in regards to proof.
The Environmental Protection Agency recognizes NDMA as carcinogenic at specific concentrations. Under certain levels, it is “acceptable.” At these levels, the EPA doesn’t believe it to pose a severe health risk. It’s when you go above those levels where concerns come into play.
NDMA is encountered by people every day in small, safe amounts. For example, it’s not uncommon to find trace amounts of the compound in cured meats. The valsartan contamination is different. Many of the drugs tested have shown to contain levels the EPA and the FDA find unacceptable and dangerous.
If you choose to join the valsartan recall lawsuit against manufacturers and pharmaceutical companies that sold contaminated NDMA, you do not need to know your specific exposure levels. Lawyers don’t expect consumers to understand how to test their medications for impurities. You need to prove that your medicine came from a seller using contaminated NDMA as identified by the FDA, which the SadakaFirm can help you do.
This concept is problematic in the world of faulty product litigation. In the other parts of the supply chain, it’s reasonable to expect that manufacturers and resellers know what is in the products they sell. However, that same burden doesn’t always fall on retailers who choose to sell the products.
Some pharmacies are defendants in the case. However, some have cited what are called innocent seller statutes in a bid to have themselves removed. Whether the court will remove them remains to be seen but would have no impact on lawsuits against manufacturers and pharmaceutical groups.
Hire SadakaFirm To Represent You
If you believe you are eligible to join the valsartan recall lawsuit, let the team at SadakaFirm handle your case. We have offices in New York and New Jersey, but we are a national firm that has represented thousands of people harmed by various medical and chemical products and devices.
Our dedication to holding corporations accountable and getting justice for consumers has earned us a reputation for being compassionate and detail-oriented. Call us at 1-800-810-3457 or visit us online to discuss a potential case today.