Table of contents
- Latest Tasigna Lawsuit Updates
- August 10, 2021: Tasigna Cases Centralized as MDL No. 3006
- November 20, 2015: Novartis Finalizes $390 Million Government Settlement
- What Is Nilotinib (Tasigna)?
- Who May Be Affected?
- Reported Injuries or Damages
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- What Are the Main Allegations Against Novartis?
- What Did Pretrial Order No. 1 Do in the Tasigna Lawsuit?
- What Does the Research Say About Tasigna and Artery Problems?
- Has Tasigna Been Recalled?
Tasigna (nilotinib) is a leukemia drug made by Novartis Pharmaceuticals Corporation. Lawsuits allege Novartis failed to warn that Tasigna may cause severe atherosclerotic injuries and concealed what it knew about the drug’s risks. These are plaintiffs’ allegations, not court findings.
The cases are in MDL No. 3006 in the Middle District of Florida. Judge Roy B. Dalton, Jr. oversees the pretrial proceedings. No class action has been certified, and no settlement of the injury cases has been announced.
People who took Tasigna to treat chronic myeloid leukemia and later had an artery or heart problem may be affected.
Latest Tasigna Lawsuit Updates
August 10, 2021: Tasigna Cases Centralized as MDL No. 3006
The Judicial Panel on Multidistrict Litigation centralized the Tasigna cases as MDL No. 3006. It sent them to the Middle District of Florida, before Judge Roy B. “Skip” Dalton, Jr. [1].
No court has ruled on liability in the Novartis cases. The claims are plaintiffs’ allegations, and the cases are in pretrial proceedings.
November 20, 2015: Novartis Finalizes $390 Million Government Settlement
Novartis Pharmaceuticals Corporation finalized a settlement with the U.S. Attorney’s Office for the Southern District of New York, with total payments of $390 million. The case concerned kickbacks to specialty pharmacies for Exjade and Myfortic [2].
The U.S. Attorney announced a $370 million civil settlement plus a $20 million forfeiture [3]. The whistleblower suit also concerned TOBI, Tasigna and Gleevec. It did not settle Tasigna injury claims.
What Is Nilotinib (Tasigna)?
According to the FDA label, Tasigna (nilotinib) is a kinase inhibitor [4]. It treats adults with Philadelphia chromosome positive chronic myeloid leukemia. That includes newly diagnosed patients in chronic phase.
Novartis makes Tasigna as capsules for oral use. The lawsuits in MDL No. 3006 involve patients who took the drug for this type of leukemia.
Who May Be Affected?
People who took Tasigna (nilotinib) for chronic myeloid leukemia and later had an arterial vascular occlusive event may be affected.
You took Tasigna or nilotinib. A doctor later diagnosed an artery, heart or circulation problem. Examples include ischemic heart disease, an ischemic cerebrovascular event or peripheral arterial occlusive disease.
The FDA label lists two groups of adult users: newly diagnosed patients, and patients resistant or intolerant to prior imatinib therapy.
Only an individual legal review of your records, medical history and treatment dates can say whether your own situation qualifies for you.
Reported Injuries or Damages
The actions in MDL No. 3006 allege severe atherosclerotic injuries from Tasigna. The FDA label reports a different set of events. It does not say the drug caused atherosclerosis.
In a randomized trial of newly diagnosed patients, median time on therapy was 60 months. Cardiovascular events occurred in 9.3% of the Tasigna 300 mg arm, 15.2% of the 400 mg arm and 3.2% of the imatinib arm.
Peripheral arterial occlusive disease occurred in 3.6% and 2.9% of patients in the two Tasigna arms and in 0% of the imatinib arm.
The label also carries a boxed warning for QT prolongation and sudden deaths. It states that sudden deaths have been reported in patients receiving nilotinib. Trial rates and reports do not prove that the drug caused any one person’s injury.
Evidence to Preserve
Keep these records and items, because they may help show your treatment and any later diagnosis:
- Prescription and pharmacy records that show your Tasigna or nilotinib doses and the dates you took them
- Leukemia treatment records from your cancer doctor or clinic for the whole time you took the drug
- Medical records of any artery, heart or circulation diagnosis, along with imaging results
- Surgery or amputation records, if you had a procedure for a circulation problem
- Any pills you have left and the original bottles, kept just as you got them
- Bills and insurance statements that show the cost of your treatment and care
- A diary of your symptoms and treatments, with the date each one began
- Letters and messages with doctors, pharmacies or the maker about the drug
Filing Deadlines
Time limits for a Tasigna claim come from state law. They depend on where you live and on when the injury and its diagnosis happened.
Some states start the clock at diagnosis. If a deadline passes, a claim can end even when the facts behind it are strong.
A lawyer can check the dates that apply to your own situation. Ask as soon as you can, so you know where you stand.
Frequently Asked Questions
What Are the Main Allegations Against Novartis?
The main allegations against Novartis involve warnings and concealment. Plaintiffs allege it did not properly warn about severe atherosclerotic injuries. They also allege it hid what it knew about Tasigna’s risks from patients, other consumers and the U.S. medical community.
What Did Pretrial Order No. 1 Do in the Tasigna Lawsuit?
Pretrial Order No. 1 in the Tasigna lawsuit, filed August 31, 2021, consolidated the transferred actions into one action for pretrial purposes under Federal Rule of Civil Procedure 42(a). New cases are first filed in their home district, then transferred.
What Does the Research Say About Tasigna and Artery Problems?
Research on Tasigna and artery problems shows cardiovascular events, including arterial vascular occlusive events, in a randomized trial. The FDA label also describes them in postmarketing reports of patients receiving nilotinib, under its warnings on cardiovascular events.
Has Tasigna Been Recalled?
Tasigna has not been recalled, and no FDA recall has been announced. The FDA updated the Tasigna label on December 27, 2017 with discontinuation information. That update was not a recall.