Valsartan Lawsuit
A valsartan lawsuit may be an option for people who have experienced serious complications associated with the drug, including liver damage and cancer. Valsartan is the active ingredient in a number of prescription medications used primarily to treat high blood pressure (hypertension), and in some cases, heart failure.
Along with a comprehensive treatment program, medications such as valsartan may be able to help patients regulate high blood pressure. However, valsartan has been linked to serious side effects and risks associated with the liver as well as a possible link to a carcinogen present in certain drugs containing the ingredient. Affected patients and their families may be able to pursue a claim and recover compensation with the help of a dangerous drug attorney.
If you or a loved one have been adversely affected by a potentially dangerous drug, contact Attorney Group to learn about your options. We offer free, no obligation consultations. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
Have You Seen a Valsartan Lawsuit Commercial?
You may have seen a valsartan lawsuit commercial on television and wondered whether you or a loved one have been affected by it and similar drugs and, if so, whether you are eligible to pursue a claim against the drug manufacturer or distributor. The purpose of this article is to provide you with additional information about lawsuits and other litigation involving dangerous drugs so that you have a better understanding of your options.
What is Valsartan?
Valsartan, commonly known as Diovan, is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to lower high blood (hypertension) in adults and children (6 to 16 years of age), to treat heart failure in adults, and to improve the chance of living longer after a heart attack (myocardial infarction) in adults. Valsartan is not for children under 6 years of age or children with certain kidney problems.
Valsartan is a type of cardiovascular medicine known as an angiotensin II receptor antagonist (ARB, or angiotensin receptor blocker). Valsartan is manufactured and distributed by several pharmaceutical companies, including Major Pharmaceuticals, Novartis Pharmaceuticals Corporation (Diovan) and Teva Pharmaceuticals Industries Ltd.
Valsartan Side Effects
According to the drug’s prescribing information, the most common adverse side effects of Valsartan to treat people with high blood pressure include:
- Headache
- Dizziness
- Flu symptoms
- Tiredness
- Stomach (abdominal) pain
The most common side effects of Valsartan used to treat people with heart failure include:
- Dizziness
- Low blood pressure
- Diarrhea
- Joint and back pain
- Tiredness
- High blood potassium
Common side effects of Valsartan used to treat people after a heart attack which caused them to stop taking the drug include low blood pressure, cough, high blood creatinine (decreased kidney function) and rash.
Valsartan Risks
Serious side effects associated with the use of Valsartan for the treatment of high blood pressure and heart failure may include:
- Injury or death to an unborn baby: Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
- Low Blood Pressure (Hypotension): Low blood pressure is most likely to happen if you also take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea. Lie down, if you feel faint or dizzy. Call your doctor right away.
- Impaired Renal Function: Kidney problems may get worse if you already have kidney disease. Some patients will have changes on blood tests for kidney function and may need a lower dose of Valsartan. Call your doctor if you get swelling in your feet, ankles, or hands, or unexplained weight gain. If you have heart failure, your doctor should check your kidney function before prescribing Valsartan.
- Hyperkalemia: Some patients with heart failure have developed increases in potassium. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment.
Other risks may be associated with the use of Valsartan, including liver damage as well as a possible connection to cancer-causing ingredients.
Valsartan and Liver Damage
Valsartan has been reportedly linked with a low rate of elevations in some liver enzymes. According to LiverTox, a website published by the National Institutes of Health, “[r]are instances of clinically apparent acute liver injury have been reported in association with valsartan therapy.” Postmarketing experience also indicate that very rare reports of hepatitis in addition to elevated liver enzymes.
Symptoms of liver damage may include jaundice, abdominal pain and swelling, swelling in the legs and ankles, itchy skin, dark urine color, irregular stool color, chronic fatigue, nausea or vomiting, loss of appetite, or tendency to bruise easily.
Lauren A. on May 16, 2016
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Valsartan and Cancer
The FDA has indicated that trace amounts of N-nitrosodimethylamine (NDMA) in several products containing valsartan in a voluntary recall announcement issued in July 2018. NDMA is classified as a probable human carcinogen.
Exposure to NDMA at high levels may include headaches, fever, nausea, jaundice, vomiting, in addition to reduced function of the kidneys, liver and lungs.
The presence of NDMA in certain products containing valsartan was reportedly “unexpected” and believed to have occurred when changes were made in the way the active ingredient was manufactured.
Has There Been a Valsartan Recall?
On July 13, 2018, the FDA announced a voluntary recall of several medications containing valsartan following the “detection of an impurity.” According to the FDA, the impurity found in recalled products containing valsartan known as NDMA “is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.”
According to the FDA’s announcement, the companies listed in the table below are recalling all lots of non-expired products that contain the ingredient valsartan supplied to them by Zhejiang Huahai Pharmaceuticals, Linhai, China. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company.
| Medicine | Company |
|---|---|
| Valsartan | Major Pharmaceuticals |
| Valsartan | Solco Healthcare |
| Valsartan | Teva Pharmaceuticals Industries Ltd. |
| Valsartan/Hydrochlorothiazide (HCTZ) | Solco Healthcare |
| Valsartan/Hydrochlorothiazide (HCTZ) | Teva Pharmaceuticals Industries Ltd. |
Drug recalls may be conducted by the drug manufacturer, by FDA request, or by FDA order. The FDA plans to continue to investigate the issue and provide information as it becomes available. The recall announced by the FDA follows a previous recall of about 2,300 batches sent to countries in Europe including 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, according to report by CNN.
Potential litigation could possibly claim that the drug makers failed to disclose known side effects of the drug and that patients suffered damages as a result. Failure to warn of side effects of a drug can be a basis of drug company liability, regardless of whether the drug has been recalled.
Is There a Valsartan Class Action Lawsuit?
At the time of this article’s publication, a valsartan class action lawsuit action has not been filed on behalf of patients who suffered serious complications. Valsartan lawsuit attorneys are doubtful that a class action will be certified for patients who are adversely affected by the device.
Instead, if multiple lawsuits are filed against the manufacturers, alleging injuries and other damages caused by adjustable valves, shunts and similar medical devices, it is anticipated that these potential lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called multidistrict litigation (MDL), and on a state level it is known as a state court consolidated proceeding.
MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims arising from injuries caused by defective medical devices.
In most cases that proceed in an MDL or state court consolidated proceedings, after a certain period of time initial trials, also known as bellwether trials, take place. The purpose of these trials is for the parties to get an idea of the types of evidence and arguments that will made, as well as to see how juries will respond to the evidence and arguments.
After a certain number of cases have been tried, the parties are in a better position to determine whether a case can be settled.
Have There Been Any Valsartan Lawsuit Settlements?
Some dangerous drug lawsuits may settle early in the claims process. However, it is not expected that there will be any valsartan lawsuit settlements at this time. Instead, it is expected that valsartan lawsuits will be consolidated in federal court through an MDL. Valsartan lawsuit attorneys note that the outcome of any case is never guaranteed, and past results are not necessarily predictive of future outcomes.
Valsartan Lawsuit News
- July 2018FDA announces a voluntary recall of several medications containing valsartan following the “detection of an impurity” known as N-nitrosodimethylamine (NDMA) in several products containing valsartan supplied to them by Zhejiang Huahai Pharmaceuticals.
- July 2018The European Medicines Agency indicates that it is reviewing medications containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, and that while the review is underway, European authorities are recalling those medicines.
- August 2002FDA approves valsartan for heart failure in patients who are tolerant of ACE inhibitors.
- January 1997FDA approves valsartan in the United States to treat hypertension.
How a Valsartan Lawsuit Attorney Can Help
Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by valsartan, or other similar drugs containing the active ingredient to treat high blood pressure or heart failure, may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.
