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Tasigna Lawsuit Update
Novartis is well accustomed to being in court, and that includes a huge $345 million fine handed down in 2020 to resolve issues relating to the Foreign Corrupt Practices Act. Lawsuits have been filed and settled in Tasigna legal cases too.
However, in the summer of 2022, we began to see an increase in the number of Tasigna compensation lawsuits. There are many reasons for this, including increased awareness of the issues and new studies linking Tasigna to serious health issues.
Nevertheless, by fall 2022, many of the Tasigna lawsuits have become consolidated in states like New Jersey and Florida. This means that judges order the individual lawsuits to be merged together, making it easier for rulings, shared testimony, and so on.
Reports claim that many more lawsuits against the drug manufacturer Novartis are inevitable. The current consolidated lawsuits are at the pretrial stage.
What is Tasigna?
Tasigna is used to treat a type of blood cancer known as Philadelphia chromosome positive chronic myeloid leukemia (CML). The drug works by interfering with the growth and spread of cancerous cells in the body.
Tasigna is manufactured by Novartis AG, and was approved by the U.S. Food and Drug Administration (FDA) in October 2007.
What’s the Problem?
Within 5 years of Tasigna entering the U.S. market, researchers began noting higher than expected number of reports of peripheral arterial disease (PAD) in adult patients taking Tasigna. These statistics were also observed in a 2013 clinical trial which found similarly higher rates of PAD among users of tyrosine kinase inhibitors.
Tasigna Side Effects
Serious side effects of Tasigna include:
- Atherosclerosis related conditions
- Peripheral artery disease (PAD)
- Coronary artery disease (CAD)
- Carotid artery disease
- Hardening / narrowing of the peripheral arteries
- Heart attack
- Carotid artery stenosis
- Other arterial diseases
- Limb amputations
- Blood disorders
- Blood clots
- And more
Less severe side effects:
- Skin rash
- High blood pressure
- Muscle weakness
- Joint pain
- Temporary hair loss
- General tired feeling (malaise)
- Cold symptoms
Tasigna Wrongful Death Lawsuit
In March 2016, California resident Kristi Lauris filed the first wrongful death Tasigna lawsuit against Novartis on behalf of her father, Dainis, who she claims died from a massive stroke after switching from Gleevec to Tasigna.
Considering the large number of people who are prescribed chemo meds like Tasigna each year in the U.S., it’s a safe bet there will be more than a few similar claims to be filed in the near future.
Tasigna Cardiac Complications
It is well known that taking Tasigna can cause heart problems. For example, a quote from the FDA’s website regarding Tasigna’s boxed warning: “the increased risk of abnormal heart rhythm (QT prolongation) and sudden death.”
Several other heart conditions, such as myocardial ischemia, have been linked to taking Tasigna. However, much of the worry – and one of the main reasons behind Tasigna lawsuits in 2022 – centers around the links with atherosclerosis.
This is a disease where the arteries become hard and clogged with plaque. It is relatively common in the United States – around 4.6 million people have atherosclerosis, but it is usually found in older people and is a “slow disease”, building up over the years.
The issue with Tasigna, however, is that it has been linked to causing “accelerated” atherosclerosis in patients taking Tasigna. Atherosclerosis can lead to chest pain, stroke, heart attack, and death.
What is Atherosclerosis?
Atherosclerosis is a hardening and narrowing of the arteries caused by cholesterol plaques lining the artery over time, according to the American Cancer Society. Taking Tasigna can put blood at risk as your arteries and bone marrow become blocked.
Atherosclerosis may also be referred to as arteriosclerosis or atherosclerotic cardiovascular disease. It’s the usual cause of heart attacks, strokes, and vascular disease -- what together are called cardiovascular disease.
- Chest pain or angina
- Pain in the leg, arm, or anywhere else that has a blocked artery
- Shortness of breath
- Muscle weakness in the legs
What is Peripheral Artery Disease?
Peripheral artery disease (PAD) is a common circulatory problem in which narrowed arteries reduce blood flow to your limbs.
When you develop PAD, your legs or arms don't receive enough blood flow to keep up with demand. This may cause symptoms, such as leg pain when walking (claudication).
PAD is also likely to be a sign of a buildup of fatty deposits in your arteries (atherosclerosis). This condition may narrow your arteries and reduce blood flow to your legs and, occasionally, your arms.
You often can successfully treat PAD by exercising, eating a healthy diet and quitting tobacco in any form.
How Do Leukemia Cancer Cells Affect Bone Marrow?
Chronic myelogenous leukemia may seem to come out of nowhere. After a routine blood test, your doctor tells you that your white blood cells count is sky high. Next thing you know, you’re hearing the word “leukemia.”
Your diagnosis may come as a shock. It also may come with a lot of terms that are likely to be unfamiliar to you.
What is Chronic Myeloid Leukemia (CML)?
CML is considered chronic because the disease typically progresses slowly. The term myeloid has to do with, or is related to, white blood cells and bone marrow—a sponge-like tissue found in the center of most bones.
How many people in the United States have CML?
- Approximately 8,500 people are expected to be diagnosed with CML in 2020
- More than 58,000 people were living with CML as of 2017
Tasigna Lawsuit Timeline
- January 2, 2022 - Tasigna & other drug removals for clients with advanced control specialty formulary - State of West Virginia Public Employees Insurance Agency.
- December 1, 2022 - Tasigna linked to Parkinson disease - Tasigna works by blocking the activity of a protein called BCR-ABL that is known to support cancer development. But, this protein is also linked to few mechanisms in the brain, such as alpha-synuclein-induced neurodegeneration and oxidative stress, which play critical roles in Parkinson's disease.
- November 7, 2022 - Novartis published important safety information regarding its Tasigna (nilotinib) capsules:
- "TASIGNA can cause QTc prolongation, a possibly life-threatening heart problem. QTc prolongation causes an irregular heartbeat, which may lead to sudden death."
- November 1, 2022 - Mayo Clinic warns of the side effects of using Tasigna (Nilotinib). Some side effects may include: no blood pressure, no breathing, fast heartbeat and more.
- October 25, 2022 - Tasigna (Nilotinib) common and uncommon side effects from the National Center for Biotechnology Information (NCBI): Tasigna (Nilotinib) side effects are common and include: Abdominal discomfort, Anemia, Anorexia, Arthralgias, Cough, Diarrhea, Edema, Fatigue, Hand-foot syndrome, Headache, Muscle cramps, Pruritus, Rash and Skin discoloration.
- Tasigna (Nilotinib) uncommon side effects include: Heart failure, Pancreatitis, QT interval prolongation, Renal failure and Tumor lysis syndrome.
- October 24, 2022 - The U.S. Congress - Committee on Oversight and Reform one of the most broad investigations of drug price increase that U.S. Congress has ever conducted. The two companies involved are Novartis (Tasigna) & Gleevec (imatinib).
- October 15, 2022 - Roy B. Dalton, Jr (U.S. District Judge) MDL -3006 - Tasigna (Nilotinib) Products Liability Litigation - Pending MDL Dockets By District
- August 10, 2022 - United States Judicial Panel on Multidistrict Litigation - Tasigna (Nilotinib) Products Liability Litigation
- February 9, 2022 - Multicounty Litigation Application – New Jersey State Court Litigation Involving Tasigna
Related Article: Nuplazid Side Effects Lawsuit
What are Tasigna Lawsuits Alleging?
Even though the serious cardiovascular side effects have been well known by Health Canada and included on the warning label there for several years, patients in the U.S. were not as fortunate.
Subsequently, the family of a California man who died of atherosclerosis related symptoms decided to file a lawsuit against Novartis in March 2016, alleging that Novartis failed to warn patients about possible side effects.
The man was prescribed Tasigna in 2012, and by September of the following year, he allegedly showed signs of atherosclerosis. The condition caused him to develop peripheral artery disease, resulting in 90 to 100% artery blockages in his legs. Sadly, he died from complications associated with atherosclerosis in March 2014.
Novartis currently faces a wave of Tasigna lawsuits from those who believe the company knew of Tasigna’s atherosclerosis dangers but did nothing to warn Americans.
Claimants in the Novartis lawsuits are asking why Tasigna has carried warning labels for its links to cardiovascular conditions like atherosclerosis in Canada for several years, yet it was aggressively marketed to CML patients and medical professionals in the United States.
While Tasigna does carry a black box warning over its links to heart conditions like QT syndrome, the basis of these cases against Novartis is that the company, at best, did little to warn Americans of the dangers of Tasigna, and, at worst, fully knew their product could kill people and continued to aggressively market it to CML patients and health professionals.
Have There Been Any Settlements?
Novartis in 2015 agreed to pay a $390 million settlement  to the U.S. Department of Justice to resolve a civil fraud lawsuit which claimed the company paid kickbacks to specialty pharmacies in exchange for promoting two drugs, including Tasigna.
As stipulated in the agreement, Novartis was allowed to admit no wrongdoing in regards to the charges.
Is There a Class Action?
No class action lawsuit has been filed to date in the Tasigna litigation. However, that doesn’t mean you’re out of luck if you’ve been injured. Our lawyers are now filing individual lawsuits on behalf of injured parties and/or their loved ones. Contact our lawyers today to learn more about your legal rights.
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Get a Free Tasigna Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Tasigna lawsuits. We are handling individual litigation nationwide and currently accepting new Tasigna cases in all 50 states.
Again, if you were injured by the side effects of Tasigna, you should contact our law firm immediately for a free case evaluation. You may be entitled to a settlement by filing a suit for lost wages and we can help.