Valsartan lawsuit plaintiffs say batches of the blood pressure medication were contaminated with NDMA, leading them to develop cancer. In July 2024, more than 1,200 lawsuits were ongoing. The federal cases are consolidated into multidistrict litigation in New Jersey.
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Valsartan Lawsuit Facts
Defendants
Zhejiang Huahai Pharmaceutical Co., Ltd., Hetero Labs, Ltd. and several other companies
Injuries in Lawsuits
Certain cancers and liver injuries that require hospitalization
Status
Active. No jury trials or official court-approved settlements yet, but settlement talks have started.
Number of Cases
1,254 pending cases in multidistrict litigation
Latest Valsartan Cancer Lawsuit Updates
As of July 2024, 1,254 valsartan lawsuits were pending and 1,421 total cases had been filed. So far there are no jury verdicts or known settlements of any legal claims.
Cases are consolidated into multidistrict litigation (MDL) in the U.S. District Court of New Jersey and are ongoing. Multiple other drugs are included in this MDL, including losartan and irbesartan.
Chief U.S. District Judge Renee M. Bumb presides over the MDL. She took over from the original judge overseeing the litigation, Judge Robert B. Kugler, after his retirement.
We’ve done the research and talked to lawyers who are litigating these cases, and we provided our findings on the latest updates below. Check back here regularly for our latest updates.
Recent Valsartan Lawsuit Updates
June 2024
At the end of May, Judge Bumb issued an order to defendants and plaintiffs to finalize the terms of the valsartan settlement, according to court documents we researched. The parties would have until June 30 to finalize the terms. According to our legal partners, the settlement terms were specifically for claims involving the defendant Hetero. Lawyers were working toward final approval of Hetero’s class action and personal injury settlements.
But, as our partners have informed us, Hetero only makes up a small percentage (about 5%) of valsartan cases. Litigation was proceeding against the other defendants, though some defendants may settle before others.
Magistrate Judge Joel Schneider was also involved in settlement negotiations, and he reported in May that the losartan settlement negotiations were at an impasse. Judge Bumb told the parties to meet and hopefully resolve the impasse. Plaintiffs’ lawyers remained hopeful that a valsartan trial date would be reset so litigation could proceed.
May 2024
Judge Renee M. Bumb was appointed to preside over the litigation, and plaintiffs' attorneys requested a status conference. Judge Bumb seemed to have pushed the litigation forward since she took over, according to court documents. She met with legal counsel and issued several key orders regarding valsartan and the other drugs in the MDL.
At the end of May, she issued an order for plaintiffs and defendants to finalize the settlement terms for all three classes of valsartan plaintiffs: personal injury, economic loss and medical monitoring. This could indicate a global settlement on the horizon for personal injury plaintiffs.
Previously, defendants and plaintiffs wrote to the judge advising her that they intended to file a motion for preliminary approval of the valsartan economic loss settlement. The economic loss settlement would include plaintiffs in class actions, but not personal injury claims.
February 2024
Plaintiffs and defendants filed motions to exclude certain experts from depositions and plaintiffs' fact sheets. From our research, this is a standard step in discovery. Each side wants experts that will benefit them.
A judge may exclude key experts in some instances, potentially damaging plaintiffs’ cases if they feel the expert can’t establish a link between the product and the harm plaintiffs claim the product caused.
December 2023
The court certified three classes of plaintiffs including consumer economic loss, medical monitoring and third-party payor ("TPP") classes, as well as some subclasses in the litigation. No decisions had been made regarding the defendants' wrongdoing or the plaintiffs' personal injury claims.
February 2023
Judge Kugler certified consumer and insurance companies’ claims against manufacturers and distributors of tainted valsartan. MDL plaintiffs requested medical monitoring of valsartan’s adverse effects.
December 2022
Judge Kugler rejected valsartan drug makers' and distributors’ motion to exclude expert testimony linking the contaminated drug to cancer. His ruling allowed valsartan trials to proceed with scientific study findings usable as evidence against the implicated parties.
March 2022
Judge Kugler appointed retired judges Gregory M. Sleet and Lawrence F. Stengel to manage valsartan MDL settlement negotiations.
Millions of Americans take valsartan-containing drugs for blood pressure and congestive heart failure annually. The U.S. Food and Drug Administration joined 21 other global agencies that recalled certain drugs containing valsartan in July 2018, leading to investigations of harmful side effects and eventual lawsuits. The tainted valsartan was taken off the market because of its potential to cause certain cancers.
Why Are People Filing Valsartan Lawsuits?
People filing valsartan lawsuits claim they developed cancer or liver damage after taking valsartan drugs contaminated with N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA). The FDA classifies NDMA and NDEA as probable human carcinogens, which means they can potentially cause cancer.
Plaintiffs allege that certain drugmakers manufactured defective valsartan and say that, even if the defendants knew of the potential for contaminated valsartan to cause cancer and liver damage, they did not warn the public.
In addition to valsartan personal injury claims, others filed valsartan lawsuits to get refunds for the cost of medication, according to court documents we reviewed. These were filed as class action claims rather than injury claims. These claimants don’t get to negotiate settlements or have individual representation.
If you were diagnosed with cancer after taking valsartan, you may qualify to file a valsartan cancer lawsuit. You may also file a lawsuit on behalf of a deceased loved one.
Only a licensed lawyer working in valsartan litigation can tell you if you qualify. However, our valsartan legal partners have given us certain qualifying factors that we can provide.
“If [people] have consumed valsartan they should contact us. We’ll look at the prescription records to see if it’s the contaminated medication. Oftentimes, it is. If they consumed contaminated valsartan and they had cancer or were diagnosed with cancer after consuming that medication, they would be eligible for a valsartan claim.”
Injuries accepted in lawsuits:
Bladder cancer
Colorectal cancer
Kidney cancer
Liver cancer
Liver injury
Pancreatic cancer
Stomach cancer
Valsartan can cause other serious side effects as well, but these are not included in lawsuits, according to our research. Life-threatening complications from taking the hypertension drug include low blood pressure, difficulty breathing and swelling of body parts (eyes, lower legs, tongue and throat).
Certain batches of valsartan medications were manufactured with NDMA.
How a Lawyer Can Help With Your Valsartan Claim
Your lawyer will review your case, properly present the science in your case and gather medical records to show that your valsartan was part of the contaminated batch, according to our legal partners.
Our partners say that it’s a good idea to keep your bottle of contaminated valsartan, if possible. Your remaining valsartan pills may be tested for NDMA. If you received a valsartan-related cancer diagnosis after using the drug, your attorney can review your medical records for use in the case.
Attorney Daniel Nigh tells people why they should speak to an attorney about valsartan lawsuits.
In our experience and from our talks with legal partners, eligibility to file a valsartan claim also depends on your state’s applicable statute of limitations. That’s the period between your cancer diagnosis and filing the complaint in court.
You can discuss any applicable potential exceptions to statutes of limitations in your case with your lawyer. Only a qualified attorney can properly determine your time limit to file.
Valsartan Lawsuit Q&A With Attorney Daniel Nigh
Daniel Nigh, an award-winning attorney and partner at Nigh Goldenberg Raso & Vaughn, is on the MDL leadership committee for valsartan litigation. He answered a few of our questions.
What is the most important thing to know about valsartan lawsuits?
If you’ve been taking valsartan and you were diagnosed with cancer, you should speak to an attorney. We’re going to be able to look at those pharmaceutical records. We’re going to be able to see if you qualify for a claim and if we need to file a lawsuit on your behalf.
How do I know if the valsartan I took was contaminated?
We will be able to look at [your] medical records and see if you were taking contaminated valsartan.
How do lawsuits claim valsartan causes cancer?
Contaminated valsartan has a carcinogen in it known as NDMA, and that causes cancer. It actually attacks the DNA inside the body and destroys the DNA and creates cancer as a result.
Companies Named in Valsartan Litigation
Plaintiffs in valsartan lawsuits have filed suits against multiple local and overseas companies involved in producing or distributing the generic version of the blood pressure drug Diovan. China-based Zhejiang Huahai Pharmaceutical Co., Ltd. and India-based Hetero Labs manufactured contaminated batches of valsartan.
These companies are the primary defendants. Patients are suing them because of an alleged failure to test for, detect and prevent toxic contamination in their products.
Some U.S.-based distributors and re-packagers of tainted valsartan are also named in suits. The degree of liability for cancer-related personal injuries will depend on the role each defendant is determined to have played in the valsartan supply chain.
Defendants in valsartan lawsuits include:
Actavis, LLC
A-S Medication Solutions LLC
AvKARE Inc.
Bryant Ranch Prepack Inc.
Camber Pharmaceuticals Inc.
Hetero Labs Ltd.
H.J. Harkins Company Inc. (Pharma Pac)
Major Pharmaceuticals
Northwind Pharmaceuticals
NuCare Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.
Prinston Pharmaceutical Inc.
RemedyRepack Inc.
Solco Healthcare U.S., LLC
Teva Pharmaceutical Industries Ltd.
Teva Pharmaceuticals USA Inc.
Torrent Pharmaceuticals Limited
Zhejiang Huahai Pharmaceutical Co., Ltd.
Valsartan isn’t naturally carcinogenic. Not all batches of the medication were contaminated with NDMA during manufacture. The non-tainted brands of the drug weren’t recalled in the U.S. and their manufacturers aren’t involved in the ongoing valsartan litigation.
For example, the FDA’s 2018 recalls in the U.S. didn’t include Diovan. Novartis, the patent owner, said the recalls didn’t affect its valsartan or Sandoz valsartan medications. Sandoz’s valsartan is a combination medication that treats high blood pressure.
In July 2018, the FDA recalled several lots of valsartan after investigators found contamination with the cancer-causing chemical NDMA. To find out if your drug was part of the valsartan recall, locate the name of the drug's manufacturer and the lot number on the prescription bottle or warning label and compare this information to the FDA's recall list. If you aren’t sure, your lawyer will be able to check your medical records and find this out.
People filing valsartan lawsuits have typically been diagnosed with liver, kidney, intestinal or stomach cancer. Liver damage with hospitalization is also an injury in lawsuits. Your lawyer can review your medical records to confirm your diagnosis.
There are various ways to treat cancer, including surgery, chemotherapy and radiation. Your attorney will want to know about your cancer treatment plan as well as how effective it’s been for you.
Please seek the advice of a medical professional before making health care decisions.
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“If [people] have consumed valsartan they should contact us. We’ll look at the prescription records to see if it’s the contaminated medication. Oftentimes, it is. If they consumed contaminated valsartan and they had cancer or were diagnosed with cancer after consuming that medication, they would be eligible for a valsartan claim.”
