Tasigna Lawsuit (Novartis Lawsuit) - June 2024

Tasigna is the brand name for nilotinib, which is a drug used to treat certain types of leukemia. Produced by Novartis International AG – one of the world’s largest pharmaceutical companies – it has been approved by the FDA in the United States, and many Americans have used Tasigna to treat CML (chronic myelogenous leukemia). But a growing number of people have been reporting severe side effects after taking Tasigna. Moreover, after the discovery that Tasigna can lead to acute atherosclerosis and other cardiovascular side effects, Novartis has been accused of misleading America’s CML patients.

The company now 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.

• August 1, 2024 - There are over 35 active cases in the Tasigna MDL. Plaintiffs allege that Novartis, the manufacturer, failed to warn about the risks of accelerated atherosclerosis associated with the drug. While Tasigna carries a black box warning for QT prolongation, it lacks specific warnings about atherosclerosis in the U.S.
• June 1, 2024 - Tasigna Nilotinib (Oral Route) Side Effects - Updated
• March 1, 2024 - Novartis (NVS) Q4 Earnings: How Key Metrics Compare to Wall Street Estimates.
• February 1, 2024 - Tasigna (Nilotinib Oral Route) Side Effects 2024 Update.
• January 1, 2024 - Cost Shifting in the Tasigna MDL
• February 1, 2023 - FDA approves Tasigna for newly diagnosed chronic myeloid leukemia patients.
• January 1, 2023 - FDA approves Tasigna in the treatment of newly diagnosed patients with chronic myeloidleukemia. Data show significant improvements over Glivec.
• December 1, 2022 - United States District Court - Middle District of Florida: Tasigna (Nilotinib) Products Liability Litigation, MDL No. 3006
• November 22, 2022 -Novartis grants Tasigna rights to Medicines Patent Pool for generics in low or middle-income countries.
• April 13, 2022 - National Library of Medicine updated the warning page of TASIGNA- nilotinib capsule -Warning: QT prolongation & sudden deaths.
• January 2, 2022 - Tasigna & other drug removals for clients with advanced control specialty formulary - State of West Virginia Public Employees Insurance Agency.
• December 1, 2021 - Tasigna link 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, 2021 - 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, 2021 - 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, 2021 - 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, 2021 - 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, 2021 - Roy B. Dalton, Jr (U.S. District Judge) MDL -3006 - Tasigna (Nilotinib) Products Liability Litigation - Pending MDL Dockets By District
• August 10, 2021 - United States Judicial Panel on Multidistrict Litigation - Tasigna (Nilotinib) Products Liability Litigation
• February 9, 2021 - Multicounty Litigation Application – New Jersey State Court Litigation Involving Tasigna

Tasigna is a medication used to treat a type of leukemia called Philadelphia chromosome (PH+)-positive chronic myelogenous leukemia (CML). CML accounts for around one in six leukemia cases in adults (around one in seven for minors). It is the brand name of nilotinib, which was developed by Novartis in the 2000s and later marketed worldwide by the pharmaceutical giant.

Following is a plaintiffs list in MDL NO. 3006 - Tasigna (Nilotinib) Products Liability Litigation:

• Allen Garland
• Annette Schimming
• Billy Miller
• Bruce Becker
• Charlotte Dean
• Curtis Pederson
• Debra Craig
• Douglas Isaacson
• Emily Riley
• Estate Of Gerald Mielke
• Jeffrey Giancaspro
• Lisa Pinson
• Pamela Gustin
• Randy Poitra
• Robert Merced
• Robert Witt
• Robin Davis
• Roger Burke
• Ronald Hurd
• Ronald Tonge
• Sheila Colella
• Stephen Lally
• Teresa Gustin

Source: USCourts.gov

Tasigna is part of a class of drugs called TKIs (tyrosine kinase inhibitors), which are used to treat leukemia. CML, as well as other types of leukemia, causes rapid production and growth of cells in the bone marrow. Eventually, these cancerous cells can dominate the bone marrow (pushing out healthy cells) and sometimes spread to the rest of the body through the bloodstream. Tasigna and other TKIs interfere with the signaling from the proteins that cause these cancerous cells. While TKIs don’t cure CML, they can help patients live longer and improve their quality of life.

The basis of the Tasigna leukemia drug lawsuits is the accusation that Novartis put profit before patient safety by marketing Tasigna but failing to warn Americans over all of its potential side effects. There are dozens of reported side effects of Tasigna. Below, we will list some of them, separating them into groups of short-term and long-term Tasigna side effects.

Please note: People who take Tasigna have reported different side effects for varying lengths of time. The list below is only a broad guide and not exhaustive. If you have any side effects from Tasigna, you should contact your doctor for further advice.

Short-Term Side Effects of Tasigna

• Headaches
• Nausea
• Vomiting
• Cough
• Aches and muscle pains
• Rashes/Dry Skin/Itchiness
• Fatigue
• Acne
• Bowel problems, including constipation and diarrhea
• High temperature and fever
• Insomnia and night sweats

Long-Term Side Effects of Tasigna

• Hypertension/high blood pressure
• Atherosclerosis/arteriosclerosis
• Heart attack and stroke risk
• Narrowing of arteries (peripheral artery disease, myocardial ischemia, carotid artery stenosis)
• Blood clots and blood vessel blockages
• Pneumonia
• Myelosuppression (neutropenia, leukopenia, thrombocytopenia)
• Bleeding on the brain (Intracranial hemorrhage)
• QT prolongation
• Sudden death

It is well known that Tasigna can cause heart problems. For example, a quote from the FDA’s website regarding Tasigna’s boxed warning: “the risk of abnormal heart rhythm (QT prolongation) and sudden death.” Several other heart conditions, such as myocardial ischemia, have been cited as Tasigna side effects. However, much of the worry – and one of the main reasons behind Tasigna lawsuits in 2021 – 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 CML patients. Atherosclerosis can lead to chest pain, stroke, heart attack, and death.

As you might expect, many CML patients who take Tasigna and get atherosclerosis have died. Families of those victims have taken lawsuits for wrongful death against Novartis. For example, back in 2016, the family of a CML patient who died after being treated with Tasigna took out a wrongful death lawsuit against Novartis. The company paid an out of court settlement for an undisclosed fee.

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 2021, 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 showing Tasigna health issues.

Nevertheless, by fall 2021, 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 Novartis are inevitable. The current consolidated lawsuits are at the pretrial stage.

Some individuals have already brought cases against Novartis for wrongful death, and the company agreed to settle for undisclosed amounts of money. At the moment, it is only speculation as to how much money claimants can get from the Novartis CML lawsuits. It will likely depend on individual circumstances and the extent of negligence proven on the part of Novartis.

So, what are the accusations against Novartis? The company has not made it a secret that Tasigna can cause certain side effects. Indeed, it lists many of them on the official Tasigna website. However, Novartis was made aware of studies linking Tasigna use to atherosclerosis (sometimes called arteriosclerosis) and has not taken the necessary steps to warn US patients. Studies going back almost a decade (in both the US and Canada) have determined the link between nilotinib (Tasigna) and atherosclerosis. However, there is a warning of atherosclerosis in Canada and not the US.

The Tasigna accusations from the current lawsuits look at these six broad areas:

• That Novartis breached its duty of care by not warning of the Tasigna atherosclerosis risk.
• That Novartis knowingly – and aggressively – marketed a drug that was known to be dangerous.
• That Novartis put profit before patient safety.
• That Novartis behavior was fraudulent and negligent.
• That Novartis behaved recklessly when charged with the care of patients.
• That Novartis showed no regard for the safety of CML patients, many of whom died after taking Tasigna.

Despite warnings on the links with atherosclerosis, Tasigna has not been recalled by the FDA. The drug is still prescribed by medical professionals in the United States, and it is still being marketed by Novartis to Americans with CML.

Tasigna does carry a black box warning in the United States. These black box warnings – sometimes called boxed warnings – are required by the FDA for medications with serious safety risks. However, while Tasigna’s black box carries information about risks like QT prolongation, there is no mention of other risks like atherosclerosis. The fact that such warnings apply in other countries like Canada – meaning Novartis is aware of the issue – is at the heart of the current Tasigna court cases.

Class action lawsuits and mass tort lawsuits are similar in structure but have some important differences. Most notably, there is a difference in how the plaintiffs (those filing the claim) are treated. In a class-action lawsuit, the plaintiffs are grouped together as one with the same grievance. As such, compensation is shared equally if the lawsuit is successful. In the Tasigna cases, some claimants will be accusing Novartis of causing wrongful death, whereas others might claim minor injuries have been caused by Tasigna and want compensation for medical expenses. As such, it doesn’t make sense for the lawsuits to become a class action.

A mass tort lawsuit is similar in terms of structure to a class action. However, each plaintiff is treated individually when it comes to the outcome. It is much more likely that the Tasigna lawsuits will be consolidated into mass tort cases – or MDLs (multi-district litigation) – as they are more commonly used for injuries caused by defective drugs. A mass tort – or MDL – will allow a more streamlined process in the courts, while also ensuring victims are paid relative to the injuries – and, if applicable, wrongful death – caused by Tasigna.

There is understandable anger among Americans who believe that Novartis willfully hid the links between Tasigna and atherosclerosis from them. Tasigna injury law firms are asking for people to come forward and join the lawsuits against Novartis to secure compensation. If you or a loved one has had CML and believe injury has been caused by taking Tasigna, then fill out our free Tasigna lawsuit evaluation form and let us connect you with an expert personal injury lawyer to begin your Tasigna compensation claim.

What is the Tasigna Lawsuit about?

The 2021 Tasigna Novartis lawsuits allege that the maker of the drug failed to warn Americans about the risks of atherosclerosis when taking Tasigna for CML. Dozens of lawsuits have been filed so far, and Tasigna attorneys are calling for more claimants to come forward.

Does Tasigna cause neuropathy?

There have been studies linking nilotinib (Tasigna) with peripheral neuropathy – a type of nerve damage that can cause numbness, pain and weakness in the hands, arms and feet.

Does Tasigna cause night sweats?

Many CML patients have reported night sweats as one of the common side effects of taking Tasigna.

Does Tasigna cause stomach problems?

The Mayo Clinic lists stomach pain, as well as nausea and vomiting, among the most common Tasigna side effects.

Can Tasigna cause high blood pressure?

Yes. Several studies have shown that patients who take Tasigna are more likely to have hypertension (high blood pressure).

Why did it take so long to warn about Tasigna side effects?

Tasigna is a relatively new drug (approved for use in the United States since 2007). However, reports of dangerous side effects emerged not long after it first came on the market. Novartis is accused of ignoring some of the more dangerous side effects, particularly atherosclerosis, in the Tasigna lawsuits.

What is chronic myelogenous leukemia?

Chronic myelogenous leukemia (CML) is a type of cancer that affects white blood cells. It is most common among adults in their 60s. Tasigna is used to treat CML by interfering with the proteins that cause the rapid production of cancerous cells.

What are the side effects of Tasigna?

There’s a huge number of side effects reported by people who take Tasigna. These can range from hair loss to long QT syndrome. However, one of the main claims in the Tasigna lawsuits is that its manufacturer, Novartis, failed to warn Americans about the links between Tasigna and atherosclerosis.