The Valsartan lawsuits claim that numerous batches of Valsartan have been found to be contaminated with the cancer-causing substances N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and/or N-Methylnitrosobutyric acid (NMBA).
Our law firm is accepting clients who took valsartan and have been diagnosed with liver, kidney, stomach, or intestinal cancer.
What Do We Know About the Valsartan Lawsuits?
Several drug companies have voluntarily recalled their blood pressure and heart medication that contains valsartan after it was discovered that the medication might have become contaminated in the Chinese and India manufacturing plants it was being produced.
The companies involved include Actavis; A-S Medication Solutions; AvKARE; Bryant Rank Prepack; Camber Pharmaceuticals; Hetero Labs, Inc.; HJ Harkins Company; Major Pharmaceuticals; Mylan Pharmaceuticals; Northwind Pharmaceuticals; NuCare Pharmaceuticals; Preferred Pharmaceuticals; Prinston Pharmaceutical; RemedyRepack Inc.; Solco Healthcare; Teva Pharmaceuticals; and Torrent Pharmaceuticals Limited.
A complete list of the recalled products can be found at angiotensin II receptor blockers recall list.
What are the Main Legal Issues Involving Valsartan?
The primary legal issue is that Valsartan (a generic version of Diovan) might have become contaminated with the chemicals N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and/or N-Methylnitrosobutyric acid (NMBA) if produced by Zhejiang Huahai Pharmaceuticals or Hetero Labs Limited. Potential injuries include liver damage, tumors, and cancer.
What Injuries & Side Effects Result from Valsartan?
Valsartan is an angiotensin II receptor blocker (ARB) used to treat hypertension (high blood pressure), recent heart attacks, and heart failure.
Certain batches of valsartan produced by the Chinese company Zhejiang Huahai Pharmaceuticals and the India company Hetero Labs Limited have been contaminated with N-nitrosodimethylamine (NDMA). This chemical is a known carcinogen.
Short-term exposure to NDMA can cause liver damage (such as liver fibrosis and scarring). Long-term exposure can increase the risk of liver, kidney, and lung tumors.
According to the Environmental Protection Agency (EPA), NDMA is not currently produced in pure form or commercially used in the United States, except for research purposes.
It was formerly used in production of liquid rocket fuel, antioxidants, additives for lubricants, and softeners for copolymers.
Symptoms of NDMA Overexposure
What Compensation is Recoverable in a Valsartan Lawsuit?
If you were taking any of the valsartan medications contaminated with N-nitrosodimethylamine, and have experienced liver, kidney, stomach, or intestinal cancer, we will be seeking the following damages for you:
- Past and future medical expenses to treat your injuries.
- Past and future pain and suffering that results from your injuries, both from a physical and mental standpoint.
- Wage loss, if any.
- Other economic losses experienced because of your injuries.
- Punitive damages, if appropriate.
Have there been Financial Settlements Involving Valsartan?
As of this time, there have been no large groups of mass torts settlements involving Valsartan and the link to cancer. However, litigation likes this generally takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented.
Large groups of settlements do not generally occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk. The first step in this process is usually having large groups of cases combined in federal court for discovery purposes. This process is known as Multi-District Litigation (known as an MDL).
In February 2019, an MDL was established for Valsartan in federal court in New Jersey. Our law firm is serving as co-lead counsel for the MDL. As of February 17, 2021, more than 700 lawsuits were pending in the MDL.
Attorneys Mike Papantonio and Madeline Pendley Discuss the Valsartan Lawsuits
Have there been any Valsartan Recalls or Warnings?
In May 2018, the European Medicines Agency (EMA) began reviewing medicines containing valsartan that was supplied by Zhejiang Huahai Pharmaceuticals. The review started after the company detected NDMA in the valsartan it was supplying to manufacturers in the European Union.
In July 2018, the FDA announced that three companies were voluntarily recalling their medications containing valsartan that was supplied by the Chinese company Zhejiang Huahai Pharmaceuticals. The recall occurred after the company determined the presence of NDMA in the valsartan. The FDA also provided guidance to manufacturers regarding how to properly test their valsartan for possible NDMA contamination.
It’s believed that the Chinese company’s production of valsartan could have become contaminated with NDMA starting in 2012 after the company changed its manufacturing process.
In August 2018 , the FDA announced that certain batches of valsartan produced by India company Hetero Labs Limited and sold under the label Camber Pharmaceuticals also will be recalled because of the presence of NDMA.
In August 2018, Torrent Pharmaceuticals announced the voluntary recall of 14 lots of Valsartan/Amlodipine/HCTZ tablets due to the presence of NDMA.
In November 2018, Teva Pharmaceuticals voluntarily recalled all lots of amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets after NDEA was detected in an active pharmaceutical ingredient manufactured by Mylan India.
Since November 2018, numerous lots of Valsartan/Amlodipine/HCTZ tablets have been recalled for various forms of contamination with NDMA, NDEA, and/or NMBA.
What is the Purpose of Valsartan?
Valsartan is an angiotensin II receptor blocker (ARB) used to treat hypertension (high blood pressure), recent heart attacks, and heart failure. The medication is usually available in tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg.
The drug was created by pharmaceutical company Novartis and approved by the FDA in 1996. Today, the drug is produced by numerous companies.
Valsartan should be discontinued upon pregnancy as it can result in fetal toxicity, and cause injury and death to the developing fetus.
Additionally, Valsartan should be used with caution when a patient shows signs of hereditary angioedema, volume depletion, severe congestive heart failure (CHF), hyperkalemia, hepatic or renal impairment, aortic or mitral valve stenosis.
Valsartan Lawsuit News
Popular Heart Drugs Tainted With Carcinogens Face a Wave of Lawsuits
“My best estimate sitting here today is I expect that we will have approximately 2,000 personal-injury cases on file in the next two years,” Daniel Nigh, who has filed 12 such lawsuits so far, told judges at a conference in the U.S. District Court in New Jersey last month, according to a transcript. To read more, click Bloomberg Drug Lawsuits
Tainted drugs: Ex-FDA inspector warns of dangers in U.S. meds made in China, India
The valsartan recall came as little surprise to Massoud Motamed, a former inspector with the U.S. Food and Drug Administration (FDA). More than a year before the notices went out, Motamed had tried to sound the alarm on what he flagged as potential systemic problems at two facilities in China and India that produce the active ingredients in generic valsartan and other blood pressure medications. To read more, click NBC Tainted Drugs
Recall of heart drug valsartan continues to expand
The US Food and Drug Administration has again expanded the list of recalled medications that contain valsartan, used as a component in a set of drugs to treat heart failure and blood pressure. To read more, click CNN Continued Recall
Valsartan recall: 4 things patients should know
The FDA action came after 22 other countries issued recalls involving 2,300 valsartan batches sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta. To read more, click CNN Recall Knowledge
Blood Pressure Medicine Is Recalled
Three companies that sell the generic drug, valsartan, in the United States agreed to recall it after the F.D.A. said it might be tainted by N-nitrosodimethylamine (NDMA), considered a probable human carcinogen. To read more, click New York Times
FDA and Scientific Studies Regarding Valsartan
FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)
This website is a comprehensive list of the various announcements by the FDA regarding the Valsartan contamination issues. To read more, click FDA Updated Valsartan Recall
FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. To read more, click FDA Safety Announcement
FDA Finds NDEA in Torrent Pharmaceuticals Valsartan Products
The FDA’s latest testing of products shows an additional unexpected impurity in three lots of Torrent Pharmaceuticals’ recalled valsartan drug products. This second impurity, N-Nitrosodiethylamine (NDEA) is a known animal and suspected human carcinogen. To read more, click FDA Valsartan Update
Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer
The results of this study do not imply a markedly increased short term overall risk of cancer in users of valsartan contaminated with NDMA. However, uncertainty persists about single cancer outcomes, and studies with longer follow-up are needed to assess long term cancer risk. To read more, click British Medical Journal