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A New Contaminant Found In Popular Blood Pressure Medication

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A Valsartan lawsuit is a legal claim filed against valsartan manufacturers by people who took the blood pressure drug and were later diagnosed with cancer. Valsartan lawsuits allege that hundreds of Valsartan batches were contaminated with N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), potentially potent carcinogenic substances.

These Valsartan lawsuits claim contamination with toxic chemicals, including NDMA and N-NDEA, caused health problems while others demand compensation for the tainted medicine they bought and used. After being given Valsartan, which is reported to contain high levels of NDMA, various cancers have developed in people and animals.

Status of Lawsuits

In February 2019, a federal panel combined 10 Valsartan lawsuits from around the United States into a Multi-District Litigation (“MDL”) suit in New Jersey federal court. In a MDL case, the cases are not tried in class action, but instead each is brought individually. The panel identified at least 30 other related lawsuits that could join the lawsuit, naming 20 other manufacturers as defendants in the suit. 

As of October 2022, there were 1,155 lawsuits in the litigation, following some voluntary dismissals. No bellwether trial dates have been set, and there have not yet been any settlements or verdicts.

The first 10 cases combined in the mass litigation were consumer class action lawsuits seeking reimbursement for people who had purchased tainted Valsartan for as long as six years. But the federal panel also identified 17 individual personal injury lawsuits that claimed the tainted valsartan caused cancer or liver damage. It opened the litigation to personal injury cases as well.

Valsartan is a widely used blood pressure medicine, commonly sold under the brand names Diofan and Exforge. An estimated 1.5 million people may have taken tainted valsartan in 2018. Extensive recalls of the tainted batches of the medicine lasted several months and affected hundreds of batches of valsartan and related blood pressure medicine. 

Being so widely used, attorneys handling Valsartan lawsuits expect “approximately 2,000” Valsartan lawsuits to arise within the next two years. 

Are All Batches of Valsartan Part of the Litigation?

Not all batches of Valsartan were contaminated. The brand name version of Valsartan, called Diovan, was not affected by the contamination of NDMA. 

On July 13, 2018, the FDA announced that some companies were voluntarily issuing Valsartan recalls because manufacturers found NDMA in the medications, the agency further expanded the recall in August 2018 to include 11 other U.S. based pharmaceutical companies.

The European Medicines Agency suspects the NDMA contamination stemmed from manufacturing changes made at Zhejiang Huahai Pharmaceutical’s plant in China, which supplies nearly half of all valsartan to the United States.

In September 2018, the FDA announced that Zhejiang Huahai had found another toxic chemical in the recalled medications — a cancer-causing chemical called N-nitrosodiethylamine (NDEA).

A total of 1,114 lots of angiotensin II receptor blockers, including valsartan, losartan and irbesartan, had been recalled as of June 11, 2019, according to the FDA.

Manufacturers in Lawsuits

Because Valsartan is a generic medication, named for the active pharmaceutical ingredient (API), different companies are part of the supply chain: manufacturers, distributors and repackagers.

Zhejiang Huahai Pharmaceutical Co. Ltd. in China and India-based Hetero Labs were among the first companies identified to have manufactured the contaminated Valsartan that made its way to the U.S. market, and they are two of the main defendants in the litigation, along with 16 other companies. Large companies such as Walgreens and Throggs Neck Pharmacy have also been implicated in several complaints regarding Valsartan.

Filing a Suit for Valsartan

If you think your medication was included in the Valsartan recall, you can check online. You should also keep your medication bottles and pills for testing. You should then contact an experienced product-liability attorney for guidance on next steps in your case, including information on wether you qualify, as Valsartan litigation can be very complicated. Additionally, some states may enforce a statute of limitations on claims, and so an attorney can properly determine time limits on filing. 

Remember that only certain injuries can be linked to Valsartan contamination, and thus only those injuries are eligible for a lawsuit. 

These injuries include: cancer of the gastrointestinal tract and supplementary digestive organs, including the stomach, colon, rectum, liver, and pancreas. People diagnosed with liver, kidney, colorectal, stomach, bladder or pancreatic cancer may have a viable case if they had been taking Valsartan for at least a year before diagnosis. 

Further, people injured by the drug must have been taking the drug, alone or in combination with another drug, for at least 30 days between 2014 and 2022.

Complaints Filed for Tainted Valsartan

The first complaint filed was by Elizabeth and John Duffy, proposed to be a class action, in the federal Southern District of New York on August 16, 2018, naming Solco Healthcare, Priston Pharmaceuticaal Inc., Walgreens and Throggs Neck Pharmacy as defendants. This was followed by a complaint filed by Eric J Erwin on August 31, 2018 in the district of New Jersey Trenton Vicinsge, naming Priston Pharmaceutical, Solco Healthcare, Huahai US Inc., Teva Pharmaceutical and Teva USA.

The third complaint was filed on September 11, 2018, by James Jones, a class action in the Eastern District of Missouri Eastern Division, naming Zhejiang Huahai Pharmaceutical co. Ltd, Priston Pharmaceutical, Inc., Solco Healthcare U.S. LLC and Huahai US Inc. as defendants. The fourth was filed on September 26, 2018 in the U.S. district Court of New Jersey by Dominic Stimma, Margot Strand, and Jynoona Gail Lee against Torrent Pharma inc., Hetero USA, Camber Phamaceuticals, Kroger, Quality Food Centers and CVS. 

Necessary Information in Filing a Valsartan Lawsuit

Was your Valsartan part of the recall?

You can find out if your Valsartan was a part of the recall by locating the name of the drugs manufacturer and the lot number on the prescription bottle or the warning label that comes with it, and search the FDA’s recall list using that number. 

What have you been diagnosed with?

Because people wishing to file a Valsartan Lawsuit must have one of certain injuries, it is important to make sure you qualify by contacting an attorney and having them review your medical records. 

When did you begin to experience side effects?

There is a statute of limitations on Valsartan lawsuits, that indicate how long you have to file a lawsuit from the time you started experiencing side effects. An attorney can properly help you to establish your eligibility based on your timeline.

How have the side effects affected your daily life?

Be sure to note the physical, mental, and emotional effects your diagnosis and side effects have had on you, as well as all that you have done to combat and counteract these effects. Sharing this information with your attorney may be helpful in pursuing your case. 

What treatments are you undergoing/have you undergone?

Your attorney will want to know which form of cancer treatment you have been using and how effective it has been for you, as this will be utilized in your case as well. 


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