Imagine trusting a medication to manage your high blood pressure, only to find out it contains a substance that could cause cancer.
This is the devastating reality for thousands who took valsartan, a popular medication now linked to severe health risks.
Valsartan, a medication used to treat high blood pressure and heart failure, has been found contaminated with harmful substances.
This discovery has led to numerous lawsuits as affected individuals seek justice for their health issues.
At Dolman Law Group, we understand the fear and frustration of such a betrayal of trust. Our dedicated team is here to help you navigate this challenging time and fight for the compensation and justice you deserve.
If Valsartan has harmed you, contact Dolman Law Group to find out how they can help you. Call 833-552-7274 to speak with an attorney about your case today.
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 of people relied on valsartan to manage their heart conditions. Its role in preventing heart attacks and strokes made it a staple in many households, underscoring the shock and betrayal felt when the contamination news broke.
In 2018, the FDA announced valsartan recalls after detecting N-nitroso dimethylamine (NDMA) and N-nitroso diethylamine (NDEA) in several batches of an FDA laboratory analysis. These substances are classified as probable human carcinogens.
The recall affected several drugs containing Valsartan due to the cancer risk associated with NDMA and NDEA contamination.
The recalls primarily targeted generic versions of Valsartan and certain combinations containing Valsartan.
The following is a list of the affected drugs:
- Diovan (Valsartan). While the brand name Diovan was not directly implicated in the recalls, some generic versions of Valsartan were contaminated.
- Exforge (Valsartan and Amlodipine). Some batches of the generic versions of this combination were recalled.
- Diovan HCT (Valsartan and Hydrochlorothiazide). The recalls affected the standalone and combination versions of generic Valsartan with hydrochlorothiazide.
- Entresto (Valsartan and Sacubitril). There were no recalls specific to Entresto, as it did not appear to be affected by the contamination issues.
- Valturna (Valsartan and Aliskiren). The contamination issues did not mention specific recalls for Valturna, but it is important to verify the safety of each combination drug individually.
Why is Valsartan Potentially Causing Cancer?
NDMA (N-nitrosodimethylamine)
NDMA is a chemical classified as a probable human carcinogen by the U.S. Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC).
It causes cancer in laboratory animals and is used in research to induce cancer for study purposes.
NDMA was historically used in producing rocket fuel and other industrial processes, but its production is now limited to research applications.
In the case of valsartan, NDMA contamination was detected due to changes in the manufacturing process. These changes led to conditions where NDMA could form as an unintended byproduct.
Specifically, the presence of specific amine and nitrite molecules during manufacturing can combine to create NDMA.
Additionally, cross-contamination of manufacturing equipment and fluids may have contributed to the spread of NDMA across different batches of valsartan.
The FDA has set a daily intake limit of 96 nanograms for NDMA in drugs. Contaminated valsartan batches contained levels significantly higher than this limit, leading to recalls and increased cancer risk estimates for users of these medications.
NDEA (N-nitrosodiethylamine)
NDEA, another contaminant found in valsartan, is also classified by the EPA and IARC as a probable human carcinogen.
Gasoline and lubricant additives contain NDEA. Like NDMA, it can form during the drug manufacturing process under specific conditions.
NDEA in valsartan is particularly concerning because it has been linked to various cancers, including liver cancer and other digestive tract cancers.
The FDA's estimates suggest that the cancer risk from NDEA contamination, while lower than NDMA, is still significant enough to warrant recalls and legal actions.
The FDA and other health agencies have estimated the potential cancer risk based on high-dose exposure scenarios. For instance, if 8,000 people took the highest daily dose of valsartan (320 mg) containing NDMA for four years, there would likely be one additional case of cancer among them.
For NDEA, the risk estimate is one additional cancer case for every 18,000 people taking the same high dose for four years.
The contamination of valsartan with NDMA and NDEA has raised serious health concerns and led to widespread recalls.
These carcinogens, formed during specific manufacturing processes, pose significant cancer risks to users of the contaminated medication.
The ongoing investigations and legal actions aim to address these risks and provide justice for affected individuals.
How Did the Contamination Happen?
The contamination affected multiple manufacturers and led to the recall of hundreds of batches, impacting millions of patients worldwide.
The Valsartan contamination was linked to specific manufacturing processes.
Manufacturing Process Changes
The contamination was traced to changes in some companies producing generic Valsartan manufacturing processes.
Notably, Zhejiang Huahai Pharmaceutical in China was identified as a key manufacturer whose processes led to the formation of these impurities.
The following are the main factors involved.
- The Use of Solvents. Changes in the use of solvents during the production process contributed to the formation of NDMA and NDEA. Under certain conditions, these chemicals can form as byproducts during the synthesis of the active pharmaceutical ingredient (API).
- Insufficient Quality Control. Lapses in quality control and inadequate impurity testing allowed these carcinogens to go undetected in the final product. Manufacturers failed to detect and prevent the contamination before distributing the medications to the public.
- Global Supply Chain Issues. The complex global supply chain for generic drugs involves various companies, including manufacturers, distributors, and repackagers. This complexity made it difficult to trace and address the contamination issues promptly.
What Is the Government Doing About Valsartan Recalls?
In response to the discovery, the FDA and other regulatory bodies issued recalls for the affected batches of valsartan.
The recalls highlighted the need for stricter oversight and improved manufacturing practices to prevent such incidents in the future.
The contamination has had severe health impacts, leading to numerous lawsuits from individuals who developed cancer or other health issues after taking the contaminated medication.
The ongoing litigation seeks to hold the responsible parties accountable and compensate those affected.
What Are the Health Impacts of Contaminated Valsartan?
Types of Cancer Linked to Valsartan
Exposure to NDMA and NDEA has been linked to several types of cancer, including:
- Liver cancer
- Colorectal cancer
- Stomach cancer
- Kidney cancer
Other Health Issues From Taking Losartan
Beyond cancer, contaminated valsartan has been associated with liver damage and other serious health complications. Symptoms of exposure include headaches, dizziness, jaundice, and liver fibrosis.
Following the recalls, numerous lawsuits were filed against valsartan manufacturers and distributors. In 2018, these cases were consolidated into multidistrict litigation (MDL) to streamline the legal process.
What’s the Current Legal Status of Valsartan Lawsuits?
As of early 2024, over a thousand cases are pending. Courts have allowed these cases to proceed, recognizing the validity of the scientific studies linking NDMA exposure to cancer.
The lawsuits target several companies producing and distributing contaminated valsartan, including Zhejiang Huahai Pharmaceutical and Hetero Labs.
Why Choose Dolman Law Group for Your Losartan Case?
- Proven Settlement Record. Dolman Law Group has a solid history of achieving significant settlements and verdicts for our clients. Our attorneys have successfully managed complex mass tort cases, securing over $400 million in settlements. Matthew Dolman has consistently held negligent companies accountable, helping clients obtain the compensation needed to recover from the harm caused by contaminated medications.
- Respected Legal Authority. Dolman Law Group is recognized as a leading voice in the legal community. Our attorneys are frequently interviewed and quoted in prominent legal publications, providing insights on new laws, significant lawsuits, and major legal updates. Our commitment to protecting consumer rights is often highlighted in the media, and we are invited to join podcasts to discuss important legal issues. Our involvement in high-profile cases and dedication to justice have established us as a trusted source of information and advice in the legal world.
- Comprehensive Resources and Commitment. Taking on powerful corporations requires determination and substantial resources. At Dolman Law Group, we pursue justice relentlessly, making it difficult and costly for insurers and large companies to continue their defense. We have the financial and legal resources to challenge these giants effectively, ensuring they understand the actual cost of their actions. Testimonials from past clients show our unwavering commitment, which means we aim for victory, and you only pay if we succeed, guaranteeing that your interests are always our top priority.
3 Steps to Take if Valsartan Contamination Damaged You
- Medical Attention. If you suspect you’ve been harmed by contaminated valsartan, seek medical attention immediately and document all health issues and treatments.
- Documentation. Keep all medication bottles, medical records, and any other relevant documents. These will be crucial for your case.
- Get a Free Consultation. Contact Dolman Law Group for a free case evaluation. Our Valsartan lawyers will assess your situation and guide you to the best action.
What to Expect in a Valsartan Lawsuit
Case Review
Our mass tort lawyers will review your medical history, documentation, and the specifics of your case to determine its viability.
Legal Process
We will guide you through each step of the legal process, from filing the lawsuit to potential settlement or trial. Our goal is to make this process as smooth and stress-free as possible.
Potential Compensation
You may be entitled to compensation for past and future medical expenses, past and present lost income, past and future pain and suffering, wrongful death claims for family members, and possibly punitive damages.
Learn Whether You Qualify for a Valsartan Lawsuit
If you have had cancer or other serious health issues after taking contaminated valsartan, seek legal help.
Valsartan contamination has led to severe health complications due to the presence of harmful substances like NDMA and NDEA in the medication.
Our experienced product liability lawyers at Dolman Law Group are here to help you pursue justice and secure the compensation you deserve.
With the assistance of our experienced legal team, your Valsartan case will be meticulously prepared to seek the highest possible compensation for your damages.
We are committed to fighting for the maximum value available through a settlement or court award.
Our Valsartan lawsuit attorneys are ready to assist you on a national level. We handle Valsartan cases with the utmost dedication, ensuring each client receives the personalized attention they need.
If you believe you have a case, contact our Valsartan lawyers at 833-552-7274 or by using our online form.
Let us help you determine whether you qualify to file a Valsartan lawsuit. If you or a loved one took Valsartan and suffered severe health issues, we want to hear from you today.
Frequently Asked Questions about Valsartan Litigation
What is multidistrict litigation (MDL)?
MDL is a legal procedure consolidating multiple related lawsuits to streamline the pretrial and discovery processes.
This approach benefits complex cases like the Valsartan litigation, where many plaintiffs nationwide have similar claims. MDL allows for the more efficient handling of these cases by combining them under one court and judge.
This consolidation helps reduce the burden on the court system and ensures consistent rulings on pretrial matters. The U.S. District Court oversees the Valsartan MDL for the District of New Jersey.
How do I know if my Valsartan medication was contaminated?
You can check if your Valsartan medication was part of the recall by looking up the batch number on the FDA’s recall list or by contacting an attorney handling Valsartan cases.
This information is typically found on the medication bottle or packaging. If your medication is listed, it means it was found to contain NDMA or NDEA above the acceptable limits.
If you’ve been prescribed Valsartan, consult your pharmacist or healthcare provider for a replacement medication.
What should I do if I’ve been taking contaminated Valsartan?
If you suspect you have taken contaminated Valsartan, immediately contact your healthcare provider.
They can help you switch to a safe alternative and monitor your health for any signs of adverse effects.
Document any health issues and keep records of your medication and medical visits, as this information will be crucial if you decide to pursue legal action.
How long do I have to file a Valsartan lawsuit?
The statute of limitations, which governs the time limit for filing a Valsartan lawsuit, varies by state.
The filing date ranges from one to six years from the date of injury or discovery of the injury.
Consult a mass tort lawyer as soon as possible to ensure you file within the appropriate timeframe and preserve your right to compensation.
Can I file a Valsartan lawsuit if I haven’t developed cancer but have other health issues?
You may still be eligible to file a lawsuit if you have experienced other significant health issues linked to contaminated Valsartan.
This can include liver damage, severe headaches, dizziness, jaundice, or other related complications.
It’s important to discuss your specific health concerns with a qualified attorney to determine your eligibility.
How does Dolman Law Group handle Valsartan cases?
Dolman Law Group takes a comprehensive approach to handling Valsartan cases.
Our process includes thoroughly reviewing your medical history and documentation, expert consultation, and personalized legal strategies.
We handle all aspects of your case, from filing the lawsuit to negotiating settlements or taking it to trial if necessary.
We aim to secure the maximum compensation for your suffering and ensure justice is served.