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According to allegations raised in a recently filed product liability lawsuit, side effects of Tasigna caused a narrowing and hardening of the arteries of a Utah man, which resulted in a loss of blood flow to his spleen and the need for surgery.
The complaint (PDF) was filed by Henry Wagner this month in New Jersey Superior Court, naming Novartis Pharmaceuticals as the defendant.
Tasigna (nilotinib) was approved by the FDA in 2007, and is part of a class of medications known as kinase inhibitors, which are prescribed for treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) among recently diagnosed adults. It is also approved for the treatment of chronic phase and accelerated phase Ph+ CML in adults who are resistant or intolerant to prior therapy.
The drug currently carries a black box warning about the risk of QT prolongation, which is a heart rhythm problem that can result in sudden death. However, the lawsuit alleges Novartis should have also provided strong warnings about the risk of Tasigna blood flow problems, which may lead to artherosclerosis, a stroke, heart attack, amputations or death.
Wagner was diagnosed with CML in 2014, and was prescribed Tasigna. He took the drug from about 2014 to 2018, but indicates he was never warned about the risks of atherosclerotic-related injuries. He was diagnosed with a splenic infarct, or loss of blood to the spleen, resulting in the need for a splenectomy, the lawsuit claims.
Novartis knew Tasigna could cause a narrowing and hardening of arteries no later than 2010, according to the lawsuit. However, instead of warning the public, Novartis aggressively marketed the drug as a new standard of leukemia care. Wagner claims the company’s own clinical investigators urged the company to warn doctors and patients of the risks, which Novartis refused to do.
“Novartis’ conduct as alleged herein was done with reckless disregard for human life, oppression, and malice,” the lawsuit states. “Novartis was fully aware of the safety risks of Tasigna.”
Wagner’s lawsuit joins dozens of other Tasigna lawsuits pending in the New Jersey state court system, each alleging plaintiffs suffered injuries after taking the chronic myeloid leukemia drug.
The complaints raise common questions of fact and law, indicating Novartis has intentionally concealed its knowledge about the drug’s risks, resulting in patients suffering heart attacks, strokes, peripheral vascular disease, and amputations.
Last month, plaintiffs petitioned the New Jersey Supreme Court to consolidate and centralize Tasigna litigation before one judge for pretrial proceedings, as part of a New Jersey multi-county litigation (MCL).
Similar to multidistrict litigations (MDLs) used at the federal level, consolidating the cases as part of a New Jersey MCL would transfer claims pending throughout the state to one judge for all pretrial proceedings. While each lawsuit remains an individual case, the Court will coordinate discovery into common issues in the claims and likely schedule a series of early “bellwether” trials to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.