Tasigna is a life-extending leukemia drug — but a group of lawsuits says Novartis let U.S. patients take it without the atherosclerosis warning it gave patients in Canada. Here is what the cases allege, who may qualify, and why "still pending" does not mean "settled."
Allegations Only · No Settlement Yet
This page describes ongoing litigation. The statements below are unproven allegations. Novartis has not been found liable, there is no certified class, and there is no settlement or claim form at this time. The cases are consolidated for pretrial proceedings and remain contested. This page is informational and is not legal or medical advice; do not stop taking any prescribed medication without consulting your doctor.
What Is This About?
Tasigna (nilotinib) is a Novartis prescription drug used to treat chronic myeloid leukemia (CML), a cancer of the blood and bone marrow. It belongs to a class of medicines called tyrosine kinase inhibitors, which can control CML for years. A group of plaintiffs alleges that Tasigna also carries a serious cardiovascular risk — that it can cause atherosclerosis, a hardening and narrowing of the arteries — and that Novartis did not adequately warn U.S. patients and their doctors about it.The federal cases are consolidated in multidistrict litigation known as MDL 3006, In re: Tasigna (Nilotinib) Products Liability Litigation, in the U.S. District Court for the Middle District of Florida before Judge Roy B. Dalton, Jr. The U.S. Judicial Panel on Multidistrict Litigation centralized the cases there in August 2021. It is a relatively small MDL — on the order of three dozen actions pending as of the panel's 2026 reports — but the questions it raises about drug labeling and a differing warning abroad have kept it closely watched.
The claims are allegations that have not been proven, and there is no settlement.
What Do the Lawsuits Allege?
Plaintiffs allege that nilotinib can promote atherosclerosis — the buildup of plaque that hardens and narrows arteries — and that this can lead to atherosclerosis-related conditions such as coronary artery disease and peripheral arterial disease, along with downstream events like heart attack, stroke, and reduced blood flow to the limbs. In the most serious cases, plaintiffs allege, the resulting circulatory problems contributed to amputations or death.The core legal theory is failure to warn. Plaintiffs allege that Novartis knew, or should have known, of the atherosclerosis risk and did not provide an adequate warning to U.S. patients and prescribers, which they say deprived doctors and patients of information they needed to weigh the drug's risks and monitor for cardiovascular problems. Novartis disputes these claims and contests both the science and its legal responsibility. No liability has been established.
The U.S.–Canada Warning Gap
Much of the story centers on a difference between how Tasigna was labeled in different countries. In 2013, Health Canada announced that a review of Novartis's global safety data had linked Tasigna to atherosclerosis-related conditions and required the company to update its Canadian product information to reflect that risk. Plaintiffs allege that no equivalent atherosclerosis warning appeared on the U.S. label at that time — so American patients and doctors, they say, were not given the same safety information as patients elsewhere.That contrast is central to the failure-to-warn theory: plaintiffs argue that a company that added an atherosclerosis-related warning in one country had the knowledge to warn U.S. patients too. Novartis, for its part, has defended its U.S. labeling and raised legal defenses including federal preemption — the argument that FDA regulation of drug labels limits state-law failure-to-warn claims. Whether the U.S. warning was adequate is one of the questions the litigation is contesting, and it has not been resolved.
Where the Case Stands
The Tasigna cases have moved through several rounds of pretrial litigation rather than toward a quick resolution. Two developments give a sense of the posture:• Novartis pressed a federal-preemption defense, and an attempt to take that issue up on an interlocutory appeal was rejected, leaving the failure-to-warn claims to proceed.
• In a January 2025 order, Judge Dalton denied Novartis's motion for summary judgment after declining to exclude the plaintiffs' general-causation expert, finding the expert's methodology reliable enough to link Tasigna to irreversible atherosclerotic conditions — while also limiting that expert from testifying that the drug causes atherosclerosis characterized as "severe," "rapidly progressive," or "treatment-resistant."
Surviving summary judgment means the plaintiffs' claims can move forward; it is not a finding that Tasigna caused any particular plaintiff's injury or that Novartis is liable. The litigation remains active, and no settlement has been announced. As with any MDL, the ultimate outcome — whether the cases proceed to bellwether trials, resolve through a settlement, or are decided some other way — has not been determined.
Who May Qualify?
You may qualify to speak with counsel if you:• Took Tasigna (nilotinib), typically for chronic myeloid leukemia, and
• Were later diagnosed with atherosclerosis or an atherosclerosis-related condition — such as coronary artery disease, peripheral arterial disease, or a related cardiovascular event.
The families of people who took Tasigna and died from an atherosclerosis-related condition may also be able to speak with an attorney. Eligibility depends on your medical history, the timing and length of Tasigna use, and the facts of your case. Helpful evidence includes pharmacy and prescription records, cardiology and vascular records, and imaging documenting the arterial disease. Statutes of limitations vary by state and can be short, so anyone considering a claim should consult an attorney promptly. Do not stop taking Tasigna or any prescribed medication without talking to your doctor.
Is There a Settlement?
No. There is no settlement of the Tasigna atherosclerosis claims and no claim form or deadline on this page. MDL 3006 is an active, contested litigation. If a settlement or a claim process is ever established, the terms — including who is eligible and any deadlines — would come from the court and the parties, and this page would be updated to reflect them.Frequently Asked Questions
What do the Tasigna lawsuits allege?
Plaintiffs allege that Novartis's leukemia drug Tasigna (nilotinib) can cause atherosclerosis and related cardiovascular conditions — such as coronary artery disease and peripheral arterial disease — and that Novartis failed to adequately warn U.S. patients and doctors of that risk even though it disclosed an atherosclerosis-related warning in other countries. These are unproven allegations; liability has not been decided.
What is the difference between the U.S. and Canadian Tasigna warnings?
Plaintiffs point out that in 2013 Health Canada announced Tasigna was associated with atherosclerosis-related conditions and required Novartis to update the Canadian product information, while, they allege, the U.S. label did not carry an equivalent atherosclerosis warning at that time. Novartis disputes the failure-to-warn claims, and this warning-history comparison is part of what the litigation is contesting.
Is there a Tasigna settlement?
No. There is no settlement of the Tasigna atherosclerosis claims in MDL 3006, and no claim form or deadline. The cases are consolidated for pretrial proceedings and remain active; in a January 2025 ruling the court denied Novartis's motion for summary judgment, but that is a procedural step, not a finding of liability or a settlement.
Who may qualify to speak with a Tasigna attorney?
Generally, people who took Tasigna (nilotinib) for chronic myeloid leukemia and were later diagnosed with atherosclerosis or an atherosclerosis-related condition — such as coronary artery disease, peripheral arterial disease, or a related cardiovascular event — and the families of people who died from such conditions. Eligibility depends on the facts of each case and state deadlines, and should be reviewed with an attorney.
Related Mass Torts & Sources
• Taxotere eye injury lawsuit (MDL 3023) — another failure-to-warn MDL over a cancer treatment.• Fosamax femur fracture lawsuit (MDL 2243) — a pharmaceutical MDL that turned on the same federal-preemption question.
• PPI kidney injury lawsuit (MDL 2789) — a drug MDL that resolved through settlements.
Primary sources: the U.S. District Court for the Middle District of Florida MDL 3006 case information and docket (No. 6:21-md-03006-RBD-DAB); the U.S. Judicial Panel on Multidistrict Litigation (JPML) pending-MDL statistics; Health Canada's 2013 advisory regarding Tasigna and atherosclerosis-related conditions; the FDA-approved Tasigna prescribing information; and legal trade-press reporting on the court's summary-judgment and expert rulings.
Important Disclosures
This page is for general informational purposes and does not constitute medical or legal advice. You should consult a qualified attorney about your individual situation and your doctor about any medication. OpenClassActions.com is not a law firm and is not a claims administrator, and this page does not create an attorney-client relationship.Free settlement alerts
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