Valsartan Lawsuits Overview - October 2024
Valsartan, a medication used to treat high blood pressure and heart failure, has been linked to severe health risks due to contamination with carcinogens.
Thousands of users have filed lawsuits seeking compensation for their developed health issues. This page provides the latest updates and essential information about Valsartan lawsuits.
Recent Increase in Valsartan Lawsuits
As of October 2024, over 1,300 active cases are pending in the Valsartan multidistrict litigation (MDL), with a total of 1,433 cases filed overall. These lawsuits are consolidated in the US District Court of New Jersey under Judge Renée M. Bumb. The litigation is based on claims that people who took contaminated valsartan, a blood pressure medication, developed cancer due to exposure to carcinogens like NDMA and NDEA.
Trials haven't started yet, but there have been some settlement negotiations, particularly with smaller defendants like Hetero. The larger defendants are still fighting the claims
The number of cases in the Valsartan MDL is expected to rise as more individuals learn about the potential cancer risk associated with the drug.
Valsartan users are starting to notice health issues linked to the medication during their medical check-ups, prompting an increase in legal actions.
Valsartan Lawsuit Updates – October 2024
As of August 2024, 1,248 Valsartan lawsuits were pending. The lawsuits target several companies, including Zhejiang Huahai Pharmaceutical and Hetero Labs, that produce and distribute contaminated Valsartan.
The federal cases are consolidated into multidistrict litigation in the U.S. District Court of New Jersey, overseen by Judge Renee M. Bumb.
The Valsartan litigation continues to evolve. Here are the latest updates:
October 6, 2024 - Bellwether Trial Set to Begin Next Month
The Valsartan lawsuit's first bellwether trial begins in November. These trials offer an idea of how a jury might respond to the evidence and arguments the plaintiffs present and could influence settlement talks. Around 1270 cases form this MDL as of October 2024. Lawyers will present oral arguments on October 8th to resolve any remaining questions about evidence and witness statements before the trial begins.
September 30, 2024 - Taking a Closer Look at the FDA Risk Assessment for Valsartan
Almost five years ago, the FDA conducted a comprehensive risk assessment concerning the possible contamination of valsartan with Nitroso Dimethylamine (NDMA), a recognized probable human carcinogen. We thought a look back at their key findings would be a nice refresher for those following along with the lawsuit and for those who are just learning about these lawsuits.
The presence of NDMA in valsartan was unexpected. It wasn't a very common circumstance, and the way the drug became a possible cancer-causing agent is odd, too. It's believed that valsartan's cancer-causing properties originated from changes in the manufacturing processes at certain facilities, particularly at Zhejiang Huahai Pharmaceuticals.
Once this was discovered, a study involving over 5,000 Danish patients looked at the long-term effects of NDMA exposure through contaminated valsartan. This study did not find a huge increase in cancer risk; however, the researchers cautioned that the long-term use of NDMA-containing Zantac was not clear and would likely increase your exposure to the carcinogen.
September 9, 2024 – Allocation of Sanction Fees in ZHP Case
The court awarded the plaintiffs a total of $309,130 in attorneys' fees and $41,399.20 in costs as sanctions against ZHP. These fees were granted for time spent dealing with the Baohua Chen deposition and missing document production. Importantly, the awarded funds are designated for common benefit time rather than any specific plaintiff’s case.
In response, plaintiffs’ counsel plans to file a motion seeking to classify the awarded fees and costs as common benefit reimbursement, which would be managed by the Plaintiffs' Executive Committee to benefit all plaintiffs.
September 8, 2024 – Concerns Over Trial Schedule Length
Plaintiffs' attorneys are raising concerns that the current 25-day trial schedule is insufficient, given the complexity of the case. They are pushing for an earlier start or an extension of the trial length to ensure enough time for witness testimonies and the defense's arguments to be properly addressed.
September 3, 2024 – 7 New Valsartan Cases Added
In the last month, 7 additional cases were filed in the Valsartan MDL, bringing the total number of pending cases to 1,264. Though the growth is modest, the litigation continues to expand.
August 20, 2024: Upcoming Hearing
A hearing is scheduled for this Friday to address several disputes between the involved parties.
August 15, 2024: Focus on Upcoming Bellwether Trial
The litigation is now concentrated on preparing for the first bellwether trial, set to begin in November.
August 5, 2024: Zhejiang's Response to Sanctions
Zhejiang Huahai Pharmaceutical has filed a 31-page motion challenging the recent sanctions order, arguing that the jury should decide on the discovery violations. This contradicts the court’s prior rulings. They also claim that the sanctions could complicate proceedings and potentially lead to a mini-trial on settled matters, which could prolong the case. A hearing on this motion is scheduled for September 3, but the court is unlikely to reverse its decision, having carefully considered Zhejiang’s non-compliance before issuing the sanctions.
August 3, 2024: Clarifying Jury Instructions
Teva Pharmaceuticals, Actavis, and Torrent have requested a minor revision to the adverse inference jury instruction related to Zhejiang Huahai Pharmaceutical. This instruction, resulting from ZHP’s failure to produce their CEO for a deposition, allows the jury to infer that the missing testimony would have been unfavorable to ZHP. Teva and Torrent seek to change references from “defendants” to “ZHP” in the instruction, to avoid potential prejudice against them, as they were not involved in the discovery violations. This request is expected to be granted.
August 2, 2024: Valsartan MDL Case Count Update
The Valsartan, Losartan, and Irbesartan MDL-2875 saw a slight increase in active cases from July to August 2024, with the number now at 1,257. This mature litigation is not expected to see significant jumps in case counts moving forward.
July 24, 2024: Major Sanctions Against ZHP
The court issued a significant sanctions ruling against Zhejiang Huahai Pharmaceutical for violating discovery orders, including failing to produce documents and allowing the deposition of its CEO. The court will instruct the jury that they may infer that the missing testimony and documents would have been unfavorable to ZHP, which is a substantial advantage for the plaintiffs. Additionally, ZHP has been ordered to pay over $350,000 in attorneys’ fees and expenses. These sanctions put ZHP at a considerable disadvantage as they head into the first Valsartan trial.
July 17, 2024: New Valsartan Lawsuit Filed
A new lawsuit has been filed in the Valsartan MDL by a New Jersey man who is suing Zhejiang and Aurobindo, among others. The case involves colon cancer, one of the seven types of cancer linked to the contaminated drug.
July 14, 2024: Judge Stands Firm on Previous Rulings
Judge Bumb has reaffirmed the court’s decision to proceed with the TPP class trial, rejecting defense requests for reconsideration. The court also highlighted the importance of discussing the Mansouri study at the next conference, with the first Valsartan trial scheduled for November 2024.
July 7, 2024: Valsartan Settlement Talks
Plaintiffs have engaged in direct settlement talks with Teva and Torrent, but these discussions have not yet led to an agreement. Settlement negotiations with the ZHP defendants have been unproductive, making it likely that a few major verdicts will be necessary before any reasonable settlement is reached.
June 2024: Over 1,200 lawsuits are ongoing. Federal cases are consolidated into multidistrict litigation (MDL) in the U.S. District Court of New Jersey. There is growing speculation about potential settlements in the Valsartan litigation.
Recent developments include settlements with Hetero, a smaller Valsartan defendant that sold contaminated batches for only two months and had lower levels of NDMA contamination.
While this isn't a groundbreaking change, the question remains whether larger settlements with primary defendants will happen soon.
It's uncertain when a significant settlement might occur, but in cases like this, it often takes a few trial verdicts to push defendants toward offering fair settlement amounts.
May 2024: Judge Renee M. Bumb has taken over the litigation, and plaintiffs' attorneys have requested a status conference.
April 2024: There have been a few Valsartan settlements. Judge Kugler appointed two retired judges to mediate and resolve the remaining lawsuits.
March 2024: The MDL judge ruled before the bellwether trial that Valsartan-supplied drug labels implied a promise of safety for these generic blood pressure medications.
Whether this promise was breached due to the alleged contamination with a carcinogenic substance is still disputed.
February 2024: Plaintiffs and defendants file motions to exclude specific experts from depositions and plaintiffs' fact sheets.
January 2024: The court issued a significant ruling on the admissibility of expert testimony at trial. Instead of a broad approach, the court carefully dissected the expert reports, allowing some opinions while excluding others.
December 2023: The MDL judge certified three classes of plaintiffs, including Consumer Economic Loss, Medical Monitoring, and Third Party Payor ("TPP") Class, as well as some subclasses. The Court has not yet decided on the Defendants' wrongdoing or the Plaintiffs' personal injury claims.
August 2023: 1,230 cases are pending in the MDL.
July 2023: 1,223 cases were pending in MDL 2875.
February 2023: Federal judge Robert Kugler in New Jersey certified consumer and insurance companies’ claims against manufacturers and distributors of tainted Valsartan. MDL plaintiffs requested medical monitoring of Valsartan’s adverse effects.
January 2023: There were an estimated 1,072 ongoing Valsartan lawsuits.
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.
What is Valsartan?
Valsartan is an angiotensin II receptor blocker (ARB) used to treat high blood pressure and heart failure. It helps relax blood vessels, making it easier for the heart to pump blood.
Millions relied on Valsartan to manage their heart conditions until contamination concerns arose.
Why is Valsartan Potentially Causing Cancer?
The contamination of Valsartan involves two carcinogenic substances: NDMA (N-nitrosodimethylamine) and NDEA (N-nitrosodiethylamine). Both chemicals are classified as probable human carcinogens and have been detected in several batches of Valsartan.
NDMA and NDEA Contamination in Valsartan
NDMA is a chemical that has been shown to cause cancer in laboratory animals and is used in research to induce cancer.
Changes in the manufacturing process detected it in Valsartan, leading to conditions where NDMA could form as an unintended byproduct.
NDEA is another contaminant found in Valsartan and classified as a probable human carcinogen. It has been linked to various cancers, including liver and other digestive tract cancers.
How Did the Contamination Happen?
The contamination was traced to specific manufacturing processes, particularly those at Zhejiang Huahai Pharmaceutical in China.
Changes in solvent use and lapses in quality control contributed to the formation of NDMA and NDEA in Valsartan.
FDA's Response to Valsartan Recalls
In 2018, the FDA announced a significant recall of prescription drugs containing the active ingredient valsartan for blood pressure and heart conditions.
Valsartan is commonly found in various brand-name and generic medications (such as Diofan and Exforge) used to treat hypertension and heart failure.
It was recently discovered that Valsartan when manufactured in a specific way, can cause a harmful impurity known as N-nitroso dimethylamine (NDMA).
NDMA is recognized as a human carcinogen. The contaminated valsartan drugs containing this dangerous impurity were traced to a pharmaceutical ingredient supplied by Zhejiang Huahai Pharmaceuticals, a Chinese company.
It is believed Zhejiang Huahai produced the tainted valsartan component and distributed it to multiple U.S. pharmaceutical companies, including Teva Pharmaceuticals Ltd. and Solco Healthcare.
The detection of NDMA impurities in Zhejiang Huahai’s products ultimately led to the FDA recall.
All valsartan products made with ingredients from Zhejiang Huahai were immediately recalled for safety reasons.
According to the FDA, the NDMA impurities in these drugs were “completely unexpected” and were thought to result from changes in the Chinese company's manufacturing process.
The FDA thoroughly investigated the recalled products and the NDMA contamination. This investigation revealed that the NDMA contamination was more extensive than initially suspected.
At least one pharmaceutical ingredient manufacturer in India was also identified as a potential source of NDMA contamination.
Which Valsartan Drugs Have Been Recalled?
Not every Valsartan drug has been recalled—only those produced with ingredients from Zhejiang Huahai. Below is a list of all the recalled drugs:
Drug Name
Manufacturer
Valsartan
Major Pharmaceuticals
Valsartan
Solco Healthcare
Valsartan T
eva Pharmaceuticals Industries Ltd.
Valsartan/Hydrochlorothiazide (HCTZ)
Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ)
Teva Pharmaceuticals Industries Ltd.
Health Impacts of Contaminated Valsartan
Exposure to NDMA and NDEA has been linked to several types of cancer, including liver, colorectal, stomach, and kidney cancer.
Beyond cancer, contaminated Valsartan has been associated with other serious health complications.
Types of Cancer Linked to Valsartan
- Bladder cancer
- Colorectal cancer
- Non-Hodgkin’s lymphoma
- Kidney cancer
- Prostate cancer
- Liver cancer
- Liver injury
- Pancreatic cancer
- Stomach cancer
- Blood cancer
- Multiple Myeloma
- Leukemia
- Lung cancer
- Throat cancer
When Will the Valsartan Lawsuit Be Settled?
One of the more minor defendants in the Valsartan lawsuit has already settled. However, as of June 2024, there have not been any significant settlement negotiations. A Valsartan trial is expected to occur in the MDL sometime in 2024.
How to Qualify for a Valsartan Lawsuit
To qualify for a Valsartan lawsuit, you must have:
- Taken Valsartan and developed cancer or other serious health issues.
- Medical records linking your health issues to Valsartan.
How Much is a Valsartan Case Worth?
The value of a Valsartan lawsuit settlement largely depends on the severity of the injuries and the extent of financial losses incurred. More severe injuries and more significant financial impact result in higher compensation amounts.
Key factors that influence settlement amounts include:
Medical Expenses. Costs associated with cancer treatment and other related medical care.
Lost Wages. Compensation for income lost during treatment and recovery periods.
For cases involving long-term or permanent disability that affects the ability to work and earn a living, settlements often account for the loss of future earnings.
Additionally, compensation may cover non-economic damages such as physical pain and emotional distress caused by severe side effects.
Questions Valsartan Lawyers May Ask You During a Consultation
Was Your Valsartan Medication Recalled?
In July 2018, the FDA issued a recall for several lots of Valsartan after discovering contamination with the carcinogenic chemical NDMA. To determine if your medication was part of the recall, check the manufacturer’s name and the lot number on your prescription bottle or warning label and compare it to the FDA's recall list.
Has A Doctor diagnosed you?
Individuals filing Valsartan lawsuits are often diagnosed with cancers such as liver, kidney, intestinal, or stomach cancer. Your lawyer will review your medical records to verify your diagnosis and establish a connection to the contaminated Valsartan.
How has an illness impacted your daily life after taking Valsartan?
Cancer can significantly impact your daily life. Inform your attorney about the physical, mental, and emotional effects your diagnosis has had on you to help build your case.
What Treatments Are You Undergoing?
Cancer treatment can involve various methods, such as surgery, chemotherapy, and radiation. Your lawyer will need details about your treatment plan and its effectiveness to support your compensation claim.
To Learn More About a Valsartan Cancer Lawsuit, Contact Lawsuit Legal News
If you have been injured by taking contaminated Valsartan, it's in your best interests to contact a dedicated Valsartan lawyer with experience in dangerous drug lawsuits as soon as possible.
Partnering with a skilled legal team at Lawsuit Legal News will help you gather the necessary evidence to prepare your Valsartan cancer lawsuit effectively and create a solid legal claim. Contact our experienced Valsartan lawyers today.
We remain ready, willing, and able to help you file a lawsuit and seek compensation for the harm and losses you sustained from taking contaminated Valsartan.
We are working on claims against every manufacturer and distributor involved, including Zhejiang Huahai Pharmaceutical, Hetero Labs, and other companies responsible for the contamination. To learn if you can bring a Valsartan lawsuit, reach out today.