Potential Class Action Lawsuit Against Novartis, Makers of Tasigna

When pharmaceutical companies advertise a drug, they are required to inform the audience of the potential harmful side effects their drug could cause.

But what happens if the makers of the drug neglect to warn of its serious side effects?

What if people don’t know that the drug that may be helping them with one condition may actually be causing them more harm? What if it’s already caused them irreparable harm?

And what if the pharmaceutical company continues to neglect adding a warning to their drug’s labels and disclaimers in one country, while playing it safe in others?

This is why the Law Offices of James Scott Farrin is investigating Novartis-manufactured leukemia chemotherapy drug Tasigna. If you or someone you know took Tasigna, and then suffered atherosclerosis or other arterial issues, including cardiovascular issues, you may be eligible for compensation.

Please contact us immediately or call 1-866-900-7078 for a free case evaluation. Claims are subject to a strict statute of limitations in North Carolina, so please do not delay.

Tasigna Lawsuits and Settlements: Have You Been Harmed?

According to studies by the American Journal of Hematology, Tasigna may be linked with the development of atherosclerosis, and many other medical studies have been published linking Tasigna to a higher rate of atherosclerosis in users. Furthermore, many patients reportedly developed atherosclerosis during the clinical trials with the use of Tasigna.

A number of lawsuits have been filed by patients across the U.S. in recent years, accusing Tasigna of causing “severe, accelerated and irreversible atherosclerosis-related conditions.” Novartis issued warnings in Canada in 2013 once a report came out about Tasigna’s link to atherosclerosis, but for years — even up until now — Novartis failed to warn people in the United States of this serious side effect. With Tasigna’s popularity and effectiveness to treat Ph+ CML leukemia, it is likely thousands of people have been, or are, affected by Novartis’s negligence but don’t know it.

Atherosclerosis is the hardening of the arterial walls, which can restrict blood flow, and cause rupture or dangerous blood clots, which can then cause stroke or heart attack.

Atherosclerosis-related conditions include:

  • Heart attack
  • Stroke
  • Irregular heartbeat
  • High blood pressure
  • Angina (chest pain or pressure)
  • Aneurysm
  • Infections
  • Tissue decay
  • Necrosis requiring amputation
  • Peripheral arterial disease
  • Kidney failure
  • Death
Atherosclerosis and its life-threatening conditions were not, and still are not, listed on Tasignia's warning label in the U.S. If you took Tasigna, and suffered atherosclerosis or cardiovascular disease afterward, there may be a link.

The family of a Tasigna user who allegedly died from prolonged use of the drug filed a wrongful death lawsuit against Novartis in 2016. In this lawsuit, the decedent’s family alleges that since at least 2010–2011, Novartis has been aware that Tasigna can cause severe and irreversible atherosclerosis-related conditions.

While there have been many individual lawsuits brought by Tasigna users across the U.S., there have been no class action lawsuits brought against Novartis. However, Novartis did settle two individual lawsuits in 2018. The terms and amounts of the settlements have not been disclosed to the public.

2013: Novartis Lists Atherosclerosis on Tasigna’s Warning Label… in Canada Only

In 2013, Health Canada sent out an alert that revealed there were numerous reports of arteriosclerosis logged in the Novartis global safety database. At least 277 reported cases, in fact, in a clinical trial done between 2005 to 2013. In 2013, Novartis updated its warning label to include a warning that there is a risk of arteriosclerosis; however, the label was only updated in Canada.

Novartis did not —and still hasn’t —changed the warning label in the United States, which has left many people wondering why such an important addition didn’t make it to the U.S. And why do they continue to neglect to leave it out?

2015: After Issuing Atherosclerosis Warning in Canada, Novartis Continues Their Efforts to Push Tasigna in the U.S. Novartis Pays $390 Million to Settle Allegations of Paying Kickbacks

In 2015, Novartis was accused of paying kickbacks to specific pharmacies that promoted Tasigna and other products that Novartis owns. Novartis was allegedly giving certain pharmacies money to push Tasigna onto unsuspecting patients and ignoring its serious side effects. Novartis agreed to pay $390 million to different federal and state government agencies in order to settle these claims of illegal marketing.

Besides allegedly failing to warn American customers of life-threatening side effects, Novartis is also being accused of:

  • Aggressive and illegal marketing of the drug Tasigna
  • Fraud and negligence
  • Failing to warn about Tasigna’s risks for the sake of profit
  • Breach of its duty of care
  • Conscious disregard to the life, safety, and/or rights of people who were injured because of Tasigna

2017: FDA Adds a Black Box Warning to Tasigna

In December 2017, the FDA essentially forced Novartis to add a black box warning to Tasigna labels. A black box warning is the most serious medication warning required by the U.S. Food and Drug Administration (FDA). Any time after a drug is approved, the FDA can require the manufacturer to create a black box warning listed on the medication packaging.

The 2017 Tasigna black box update warns of the risk of serious cardiac side effects from a condition called “QTc prolongation,” which is a change in one’s heart rhythm that may cause sudden death. The Tasigna website also states this warning. However, it currently still does not include a warning that it may cause atherosclerosis in the United States.

More Tasigna Lawsuits on the Horizon

Despite additional warnings from researchers about the risk of atherosclerosis and peripheral arterial diseases from Tasigna, Novartis (the manufacturer) allegedly never notified doctors, patients, or the FDA in the United States of the dangers when their clinical studies indicated otherwise.

It is believed thousands of patients may be affected as a result, and many people may not know that they are affected. Many will continue to be uninformed until Novartis and Tasigna issue explicit warnings about the drug’s serious and irreversible side effects on their labels and disclaimers.

The Basics About the Drug Tasigna

Tasigna (nilotinib) is a capsule medication, manufactured by Novartis, and approved by the FDA in 2007. It is used to treat Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), a type of blood cell cancer that starts in the bone marrow.

Tasigna belongs to a class of drugs called tyrosine kinase inhibitors, or TKIs, that work by blocking an abnormal protein (called BCR-ABL) in order to stop the growth of cancerous cells.

According to the Tasigna website, its approved uses include medical prescriptions to treat:

  • Adults with newly diagnosed Ph+ CML in the chronic phase
  • Adults with Ph+ CML in chronic phase and accelerated phase who no longer benefit from, or did not tolerate, other treatment, including GLEEVEC® (imatinib)
  • Children (ages 1 year and older) with chronic phase Ph+ CML who:
    • Are newly diagnosed, or
    • Are no longer benefiting from treatment with a tyrosine kinase inhibitor medicine, or
    • Have taken another tyrosine kinase inhibitor medicine and cannot tolerate it

North Carolina Personal Injury Lawyer

We believe Novartis has neglected patient safety in failing to add these side effects to Tasigna’s warning labels and notify the public.

If you or someone you know has suffered atherosclerosis, amputation, stroke, or death resulting from the undisclosed side effects of Tasigna, you may be eligible for compensation for:

  • Medical expenses
  • Physical and mental distress
  • Lost wages
  • Other expenses related to injuries suffered

Contact us immediately or call 1-866-900-7078 for a free case evaluation. Claims are subject to a strict statute of limitations in North Carolina, so please do not delay.