Valsartan Cancer Lawsuit
Attorneys Prosecuting Valsartan Contaminated with Nitrosodimethylamine (NDMA)
The personal injury lawyers at Rosenfeld Injury Lawyers LLC are committed to holding the corporations responsible for manufacturing defective lots accountable for people who have developed cancer after taking the popular medication to treat hypertension, Valsartan.
Generic Valsartan (brand name Diovan) is a popular medication to treat hypertension and congestive heart failure (CHF) prescribed by doctors.
Valsartan is an angiotensin ARB (angiotensin II receptor blocker). It is used to increase a patient’s longevity after suffering a heart attack because it is known to relax blood vessels and improve blood flow.
The medication also helps lower blood pressure, prevent stroke, and prevent kidney malfunction in diabetes patients. Millions of Americans have taken the medication for high blood pressure, Valsartan for these conditions.
Blood Pressure Medications: Valsartan, Losartan and Irbesartan
For decades, pharmaceutical companies have developed and manufactured angiotensin II receptor blockers (ARBs) to regulate blood pressure or hypertension.
Due to the active ingredient, Valsartan and other blood pressure medications, such as Losartan and Irbesartan, were manufactured and widely prescribed by doctors to patients dealing with hypertension.
The medications work by blocking the hormone angiotensin II, making blood vessels narrow and tightening them up. The drugs relax these arteries allowing blood to flow more freely.
It increases blood pressure as a result of more blood flowing through the body, which is why these drugs are ideal for patients suffering from hypertension, congestive heart failure, and other conditions.
Valsartan was one of the most widely preferred pharmaceuticals to treat hypertension in America. It became popular when it was released by Novartis Pharmaceuticals Corporation in 1996.
The medication was manufactured in pill form to be taken orally once a day for hypertension, heart failure, kidney malfunction in diabetes patients, and other conditions.
FDA Drug Approval
The FDA approved the drug because it had been stated that it “may reduce patient’s risk of having a heart attack or stroke,” making it a popular choice among doctors and patients.
The angiotensin II receptor blocker (ARB) was a replacement treatment for similar medications, including Captopril and Enalapril, that were known to cause side effects such as dizziness, hypotension, kidney disease, and heart failure.
While the ARB appeared to be less dangerous, it was not as effective as the original medications. Despite this, Valsartan pills were still widely used and prescribed by doctors because it offered a safer alternative to help patients who were suffering from hypertension and other heart conditions live longer lives.
Valsartan contamination of the generic medication manufactured in China led to an increase in cancer cases due to the n nitrosodimethylamine (NDMA) exposure.
At the same time, the Food and Drug Administration (FDA) announced a recall, the EMA (European Medicines Agency began reviewing the medication due to increasing Valsartan claims of adverse effects like hepatic or renal impairment, hyperkalemia, and mitral valve/aortic stenosis.
Food and Drug Administration Recall of Valsartan High Blood Pressure Medication Due to NDMA Contamination
In July 2018, the U.S. FDA recalled some Valsartan products after it was discovered the drug had been contaminated with NDMA linked to cancer during the manufacturing process.
The federal agency said that traces of the carcinogenic compound N-nitrosodimethylamine (NDMA) were found in Valsartan during the manufacturing process.
For decades, NDMA had been used in rocket fuel, among other things, before being used in dangerous drugs, including Diovan (valsartan).
This recall is the subject of "mass tort" federal Valsartan cancer lawsuits currently working their way through in federal court as MDL (multi-district litigation).
Exposure to elevated levels of NDMA can seriously damage the liver and increase the risk of developing cancer of the liver, gastrointestinal tract, stomach, kidneys, and colon, even in relatively small amounts.
The organic chemical is known to cause cancer in research animals and is considered a "probable" human cancer-causing agent by the medical community.
Other potential cancers that might be caused by Valsartan drug products (Diovan) include intestinal cancer, pancreatic cancer, esophageal cancer, kidney cancer, prostate cancer, multiple myeloma, non-Hodgkin's lymphoma, and leukemia.
Valsartan Lawsuits: Allegations Against Zhejiang Huahai Pharmaceuticals with a Probable Human Carcinogen
There are legal grounds to file a Valsartan lawsuit against the pharmaceutical company.
The basis of a legal argument might include the pharmaceutical company's manufacturing defect of Valsartan pills or tablets, improper Black box labeling of the drug to identify life-threatening side effects, and a failure to warn the consumer about the potential dangers of severe harm or death.
By reviewing your medical records, let us determine if you or a loved one qualify for a Valsartan lawsuit. As a plaintiff in a Valsartan lawsuit, you will not be required to prove that the pharmaceutical company intended to cause you harm.
Your attorney will only need to show that the pharmaceutical company negligently acted when designing, manufacturing, distributing, or marketing the product.
Your attorney will likely hold the drug manufacturer accountable under strict liability laws and prove that there were manufacturing defects that the pharmaceutical company knew or did not know. They failed to provide adequate warning labels.
Showing that the manufacturer caused illness due to a significant mistake is the first step to associating the drug maker's negligence and their responsibility for compensating you for your damages.
If you take Valsartan (Diovan or generic Valsartan), you are probably understandably alarmed and confused. In this article, we will try to address some of your concerns.
The Status of Valsartan Litigation
Since the recall, thousands of plaintiffs around the country have filed Valsartan lawsuits against the drug makers mentioned earlier (including China's Zhejiang Huahai) and drug store retailers, including Walgreens and Wal-Mart.
The Valsartan lawsuits allege negligence, strict liability, failure to warn, fraud, and breach of express and implied warranty of merchantability, among other causes of action. Many of these personal injury cases remain unresolved.
Because of that, the Valsartan class action lawsuit has been consolidated in New Jersey federal court in what is known as Multidistrict Litigation (MDL).
The Valsartan MDL (Valsartan MDL 2875) is currently pending before Judge Robert B. Kugler, U.S.D.J., and Judge Joel Schneider, U.S.M.J. The defendants are being sued by plaintiffs who took the recalled Valsartan, who claim it put them at risk for cancer.
The plaintiffs' claim in one argument that the drug companies should have been aware of safety problems involving Zhejiang that predate the Valsartan recall.
The litigation is still in its early stages, and there have been no valsartan lawsuit settlements or verdicts related to contaminated Valsartan products announced yet.
Our law firm will update this webpage as litigation progresses on opened Valsartan cases. Check back for ongoing updates on Valsartan cancer lawsuits involving NDMA contamination.
Valsartan Related Cancers of the Digestive System
More than any other organ, it seems NDMA wreaks the most havoc on the liver more than any other organ. It has been known to cause severe and non-cancerous liver conditions in humans and is used by cancer researchers to induce liver tumors in rodents.
Cancer of the liver: Generally, it has a poor prognosis because the liver is a vital organ essential to bodily function. Most cancers of the liver are the secondary cause, meaning that cancer originated in another organ or bodily system and spread or metastasized to the liver.
Alternatively, primary cancer of the liver originates in the organ and accounts for only two percent of cancers in the U.S. Its causes include hepatitis, alcohol abuse, smoking, and possibly obesity. Primary liver cancer strikes twice as many men as women, at an average age of sixty-seven.
A few benign and cancerous tumors can develop in the liver. Because of that, the symptoms of cancerous and non-cancerous could be similar.
Symptoms of cancer of the liver include:
- Unexplained weight loss
- Loss of appetite
- Upper abdominal pain
- Nausea and vomiting
- Jaundice of the skin or eyes
- White, chalky stools
Cancer in the liver is generally treated through surgical removal of tumors and chemotherapy.
Stomach Cancers: Cancer of the stomach (adenocarcinoma) is generally more treatable than cancer in the liver, with a higher survival rate, especially when caught at an early stage. GERD and Acid Reflux are often precursors of liver cancer.
Researchers also believe there is a correlation between stomach cancer and obesity, smoking, and an unhealthy diet. Some symptoms of stomach cancers can be like cancer in the liver and include:
- Feeling bloated after eating
- Feeling full after eating small amounts of food
- Persistent heartburn
- Nausea or vomiting
- Stomach pain
- Weight loss
Doctors usually recommend treatments for cancer of the stomach depending on how the disease has progressed and the need for surgery (including removal of the stomach), radiation, and chemotherapy.
Colorectal Cancer: Colon (intestinal) cancer is among the most common types of cancer in the U.S. It is treatable and even curable if diagnosed early. This form of cancer is most common among older adults but can strike anyone at any age.
Most cancer of the colon starts as polyps, or growths, on the inner lining of the colon or rectum. If precancerous polyps are not removed, they can degrade into cancer.
Colon and rectal cancer risk factors include a diet high in fat or red meat, family history, and being over age fifty. Doctors advise men and women over fifty years of age to undergo colonoscopies every five years to find polyps and remove them.
Symptoms of colon cancer include:
- Changes in bowel habits
- Unexplained weight loss
- Rectal bleeding or blood in stool
- Persistent abdominal discomfort
Treatment for colorectal cancer is relatively similar to stomach cancers and includes removal of cancerous tumors and, if necessary, parts of the colon (colostomy) or rectum, and chemotherapy.
July 2018 Valsartan Voluntarily Recall
Drug Company Recalled Medicine Major Pharmaceuticals
- Valsartan 80 mg and 160 mg tablets
- Solco Valsartan 40 mg, 80 mg, 160 mg, 320 mg
- Actavis – Teva Pharmaceuticals USA Valsartan 40 mg, 80 mg, 160 mg, 320 mg
- A-S Medication Solutions LLC Valsartan 80 mg, 160 mg
- Bryant Ranch Prepack Inc. Valsartan 80 mg, 320 mg
- H J Harkins Co. Valsartan 160 mg
- Northwind Pharmaceuticals Valsartan 80 mg, 160 mg, 320 mg
- Care Products LLC (Lake Erie Medical) Valsartan all doses NuCare
- Pharmaceuticals Valsartan all doses Proficient Rx Valsartan all doses
- Actavis – Teva Pharmaceuticals USA
- Valsartan w/ hydrochlorothiazide (HCTZ) 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, 320 mg/25 mg
- AvKARE Valsartan w/ hydrochlorothiazide (HCTZ) 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, 320 mg/25 mg
- A-S Medication Solutions LLC Valsartan 80 mg, 160 mg & Valsartan w/ hydrochlorothiazide (HCTZ) 160 mg/12.5 mg, 320 mg/25 mg
Were You Diagnosed with Cancer After Taking Valsartan or Generic Valsartan? Contact Our Attorneys.
If you consumed the Valsartan drug between 2015 and 2019, you should speak to your doctor right away.
If you took Valsartan and were diagnosed with cancer, you should consider taking immediate legal action against the drug makers who manufactured, marketed, and sold the defective drug.
However, time is of the essence because you must follow statutes of limitations to file a Valsartan lawsuit at both the federal and state levels.
The product liability attorneys at Rosenfeld Injury Lawyers LLC are monitoring potential Valsartan lawsuits across the United States.
Our law firm is centrally located in Chicago, Illinois, and we are here to provide you with the latest information on recalls and pending litigation involving monetary damages.
Our Valsartan lawyers invite you to discuss your experience and your legal options with us for a free case evaluation. Let us review your medical records.
If you meet the following criteria, our Valsartan recall attorneys would like to review your case with you:
- You used Valsartan between 2015 and the present
- Live in the United States
- You have been diagnosed with pancreatic cancer or cancer of the liver, colon, or stomach, OR you experienced liver damage that required hospitalization
- You used Valsartan for at least one year before your diagnosis
If you or a loved one meets all of the above criteria, our law firm urges you to contact our office today for a free case consultation.
If you have been prescribed Valsartan and experience a minimal or severe reaction, you are likely alarmed by the recall. Our legal team provides answers below to many of the questions posed by concerned patients just like you, including:
Valsartan Cancer Litigation FAQs
If you have been prescribed the high blood pressure medication Valsartan and experience minimal or severe side effects, you are likely alarmed by the recall.
Our legal team provides answers below to many of the questions posed by concerned patients just like you, including:
What Are the Side Effects of Valsartan?
Many patients who have been given Valsartan and used the medication for weeks or months know that significant side effects range from mild headaches to low blood pressure.
The U.S. Food and Drug Administration included a Black box warning with each prescription warning patients of associated fetal toxicity when taking the drug.
The most common effects experienced by patients tend to be brief and mild. They include:
- Low blood pressure
- High blood potassium (hyperkalemia)
- Weight gain
- Possible hair loss
- Allergic reaction
- Reduced renal function (kidneys)
- Fetal toxicity
- Acute liver injury
Liver damage is a significant problem when taking valsartan, though reports are rare. During clinical trials, some participants who were given Diovan, the generic form of Valsartan, displayed elevated liver chemistries on occasion.
These individuals were dropped from the study and stopped taking the medication due precisely to their elevated liver chemistries to ensure their safety.
What is NDMA?
N nitrosodimethylamine NDMA is an organic compound classified as a waste product of industrial processes, including the making of lubricants and pesticides. It is part of the N-nitrosamine family of potent carcinogens.
The yellowish liquid is often present at supposedly safe micro levels in some food products—particularly cured meats—and water supplies, even beer. The toxic chemical is known to damage the liver and other organs in humans and cause cancer in laboratory rats.
The U.S. Environmental Protection Agency (EPA) concluded that NDMA is a “probable human carcinogen" that can increase a person&'s risk of developing cancer. Most of what is currently known about NDMA&'s carcinogenic qualities comes from animal-based studies.
However, the World Health Organization (WHO) reported that several case-control studies and one cohort study of dietary intake of NDMA by humans showed results “supportive of the assumption that NDMA consumption is positively associated with either gastric cancer or colorectal cancer."
The WHO has categorized NDMA as a probable carcinogen.
What Are the Dangers of Valsartan?
According to the Food and Drug Administration (FDA), the presence of NDMA in Valsartan was “unexpected" and related to “changes in the way the active substance was manufactured."
Since about 2012, when generic drugs by pharmaceutical companies became available, the China-based Zhejiang Huahai Pharmaceuticals Co. had manufactured most of the wholesale Valsartan sold to drug companies worldwide.
Zhejiang Huahai Pharmaceuticals company generated $50 million from the drug in 2017.
In 2018, Zhejiang notified regulators that NDMA residue had been discovered in many of its products, including batches of Valsartan. The Valsartan contamination was extensive.
What&'s more, lots of Valsartan-contaminated tablets containing NDMA were found in products made by several other wholesale pharmaceutical drug manufacturers located in China and India.
In July 2018, the FDA announced a safety warning to alert patients, healthcare professionals, and the public of a voluntary recall of Valsartan because of the chemical&'s probable carcinogenic effects because it was contaminated with NDMA.
Only Valsartan, sold exclusively by U.S. companies, was affected, and the FDA asked those companies to take immediate action to protect patients.
Companies found to have contaminated Valsartan Solco Healthcare, Teva Pharmaceuticals, and Major Pharmaceuticals. Later, however, other companies would be added to the NDMA contamination list.
Before the FDA pulled the dangerous products with severe side effects from the marketplace, twenty-two other countries had already recalled Valsartan products, including Canada, Taiwan, Hong Kong, and China.
The FDA discovered NDMA carcinogen in some of the recalled products: N-nitrosodiethylamine (NDMA), which cancer researchers use to induce tumors of the liver in laboratory animals.
Which Blood Pressure Medicine is Linked to Kidney Cancer?
The U.S. company Torrent Pharmaceuticals produced Valsartan drug products that were contaminated by toxic chemicals.
Torrent and several other pharma companies later issued a voluntary recall of some of their Losartan potassium products due to problems during the manufacturing processes.
The product was pulled due to "unacceptable" levels of NDMA as an active ingredient manufactured by Hetero Labs Ltd. Losartan is a generic drug similar to Valsartan, which is used to treat high blood pressure and heart failure.
What Kind of Cancer Can Valsartan Cause?
In 2018, a Danish paper revealed the risk of developing cancer after being exposed to NDMA found in contaminated batches of Valsartan medications.
A study had been done involving over 5100 Danish patients without any historical familiar or individual cases of cancer. The study lasted nearly 5.5 years.
The results of the study did not show an increased overall risk of developing cancer in the short term when exposed to products containing NDMA-contaminated Valsartan.
However, there was uncertainty "about single cancer outcomes, and studies with longer follow-up are needed to assess long-term cancer risk."
Is All Valsartan Affected by a Recall?
The FDA recommends that patients contact their health care providers to determine if the medication they are currently taking has been recalled.
However, it is imperative not to discontinue taking it until their doctor has prescribed a replacement because the drug may be treating a severe medical condition that could worsen if stopped.
The government administration releases and updates the list of recalled drugs (see below) that contain NDMA. Find the manufacturer&'s name on your prescription bottle to determine if your medication was recalled.
If you can&'t locate it, contact your pharmacist, who can assist you in identifying the drug manufacturer. If your Valsartan medication has been recalled, contact your doctor and discuss alternative treatment options.
Your physician might prescribe another drug or a brand of Valsartan or Losartan that is not part of the recall.
Contact an Attorney if You Have Developed Cancer After Taking Valsartan or Losartan
Were you or a loved one prescribed a recalled Losartan or Valsartan medication made by Solco Healthcare, Torrent Pharmaceuticals Limited, or Teva Pharmaceuticals and developed health problems associated with the liver, kidneys, colon, or stomach?
If so, contact the experienced defective drug injury attorneys at Rosenfeld Injury Lawyers LLC today at (888) 424-5757. All confidential or sensitive information you share with our Valsartan lawyers remains private through an attorney-client relationship.
We accept all personal injury cases and federal lawsuits on contingency fee agreements, meaning no upfront fees are required until the case is resolved.