The FDA approved the oral chemotherapy drug Tasigna in 2007 for the treatment of a type of bone marrow and blood cancer known as Philadelphia chromosome-positive chronic myeloid leukemia. Tasigna is classified as a tyrosine kinase inhibitor drug, which works by blocking the BCR-ABL protein, which stops leukemia cells from growing. Thanks to these drugs, patients are now living longer than five years after diagnosis.
However, it wasn’t long before the first Tasigna lawsuit was filed against manufacturer Novartis AG Pharmaceutical, claiming the company failed to warn patients of serious side effects such as a hardening of the arteries (atherosclerosis) and potentially fatal complications like heart attack and stroke.
If you or a loved one have any questions about the ongoing litigation, contact a Tasigna lawyer at Showard Law Firm in Tucson, Arizona to find out if you have a claim and determine the next steps to ensure your rights are not compromised.
Tasigna and atherosclerosis
Atherosclerosis is one of the most serious side effects associated with Tasigna use. This life-threatening disease is marked by plaque buildup in the arteries, which causes them to narrow and harden to limit blood flow throughout the body. Early signs of atherosclerosis include: chest pain, pain in the leg or arm, shortness of breath, fatigue, confusion, and muscle weakness.
Arterial blockage caused by atherosclerosis may lead to life-threatening complications including:
- Carotid artery disease
- Chronic kidney disease
- Coronary artery disease
- Gangrene, tissue decay, and necrosis (leading to amputation)
- Heart attack
- Kidney failure
- Peripheral artery disease
One of the first major pieces of research linking Tasigna and atherosclerosis was published in 2011, which found 25 percent of patients taking the drug experienced cardiovascular events and 16 percent developed peripheral arterial disease.
Two years later, 11 more studies emerged, including a post-market review conducted by the FDA, which found a “strong association between nilotinib (Tasigna) and peripheral arterial occlusive disease.”
Subsequent reviews concluded that Tasigna was associated with accelerated atherosclerosis. Those risks are one of the main reasons why patients are filing Tasigna lawsuits against Novartis.
Tasigna and wrongful death
The first Tasigna and wrongful death claim was filed by a California widow in 2016. According to the complaint, decedent Dainis Lauris switched from Gleevec to Tasigna in October 2013 and took the drug for over a year before developing “severe, accelerated, and irreversible” conditions related to atherosclerosis. The first symptoms were pain and cramping in his legs while mowing the lawn, walking, or exercising. He could not walk short distances without having to stop due to extreme pain. The pain affected his quality of life and ability to sleep, and placed enormous amounts of stress on his family members who watched his slow deterioration.
Though he stopped taking the drug and underwent a painful peripheral artery bypass in his right leg to avoid amputation in November 2013, the damage was already done. Less than a year later, the patient suffered a fatal stroke in March 2014. An autopsy revealed that the patient’s coronary arteries narrowed 40-60 percent and cerebral arteries narrowed 70 percent. The lawsuit pointed to studies and warnings in Canada that indicated the manufacturer should have known of the risks associated with Tasigna as early as 2011, but did nothing. As of July 2018, a motion by the defendant to dismiss the case has been denied, but the lawsuit is still pending in court.
FDA Tasigna recall information
Tasigna carries a Black Box warning – the strongest FDA warning placed on a drug – notifying patients that Tasigna has the propensity to elongate part of the heart’s rhythm. Patients with history of hypokalemia, hypomagnesemia, long QT syndrome, or other heart issues should discuss with their doctors before taking the drug and undergo intensive monitoring if they decide on this course of therapy.
In 2013, Novartis and Health Canada released a public statement indicating that their global review conducted between 2005-2013 identified 277 cases of atherosclerosis found in Tasigna users. Though the safety information was added to the reference document for healthcare professionals and the consumer information leaflet in Canada, no changes were made in the United States.
Rather than issuing enhanced safety warnings for American patients, the FDA approved a label update stating that patients in remission may discontinue Tasigna use rather than staying on it indefinitely, and expanded Tasigna’s use to pediatric patients with leukemia who are at least one-year-old.
Once enough Tasigna lawsuits are filed, we will likely see them consolidated into streamlined Multidistrict Litigation (MDL) proceedings before one particular judge. Unlike a class action lawsuit which splits a settlement offer among participants, each Tasigna lawsuit will be heard individually after a series of bellwether trials that explore the strengths and weaknesses for both sides of the argument. Plaintiffs will have their cases examined based on their own unique merits, not on common group allegations. Compensation will be determined based on the degree of suffering for each plaintiff, which can be significant in some cases.
Tasigna lawsuit settlement amounts & verdicts
To date, patients have not received any jury verdicts or settlements related to Tasigna lawsuits. However, the U.S. Department of Justice ordered Novartis to pay $390 million to settle a civil fraud lawsuit accusing the company of paying illegal kickbacks to specialty pharmacies to promote Tasigna. Additionally, the company was accused of illegal marketing practices such as paid patient referrals and pharmacy rebates. “Novartis incentivized and pressured the pharmacies to emphasize benefits to patients, while understating the drug’s serious, potentially life-threatening side effects,” the Justice Department found.
Contact Tasigna lawyers at Showard Law Firm
We cannot rely on Novartis, nor the FDA, to protect cancer patients from irreversible harm like atherosclerosis and death, so we must take it upon ourselves to hold negligent parties accountable through the court of law. Contact a Tasigna lawyer at Showard Law Firm for a free, no-obligation consultation if you or a loved one has experienced pain in the arms and legs, itching, tingling, or other circulatory issues following the use of Tasigna. We are currently accepting and representing these types of claims against the manufacturer of Tasigna. Remember, all legal representation is FREE until we win the case for you, so there is nothing to lose!
- American Cancer Association – Survival Rates CML, https://www.cancer.org/cancer/chronic-myeloid-leukemia/detection-diagnosis-staging/survival-rates.html
- LEUKEMIA – Nilotinib treatment-associated accelerated atherosclerosis: when is the risk justified? https://www.nature.com/articles/leu2013112
- Leagle – Lauris vs. Novartis AG, https://www.leagle.com/decision/infdco20160725454
- Arentz Law – Lauris Wrongful Death Complaint, https://arentzlaw.com/wp-content/uploads/2017/11/Lauris-Wrongful-Death-Tasigna-Complaint.pdf?x25093
- Empr – FDA: Certain CML Patients on Nilotinib May Be Eligible to Stop Treatment, https://www.empr.com/news/tasigna-nilotinib-chronic-myeloid-leukemia-treatment-remission/article/720570/