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The side effects of Tasigna, a chronic myeloid leukemia (CML) drug, hardened arteries leading to a woman’s limbs, resulting in arterial occlusive disease and severe health problems, according to a recently filed lawsuit.
The complaint (PDF) was filed by Patricia Savel in New Jersey Superior Court in Bergen County on June 10, indicating that Novartis Pharmaceuticals failed to adequately warn consumers and the medical community.
Tasigna (nilotinib) was approved by the FDA in 2007, and is part of a class of chemotherapy medications known as kinase inhibitors, whichy is specifically approved 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, heart attacks, strokes, amputations and death.
Savel, of Ohio, was diagnosed with CML in 2004, and was prescribed Tasigna from 2012 to 2018, according to the complaint. She was diagnosed with severe bilateral lower extremity arterial occlusive disease caused by Tasigna, which has led to the need for a number of procedures, including a femoral endatrectomy and femoral angioplasty.
The lawsuit indicates Novartis knew about the risks, but failed to provide adequate warning to Savel, her doctors, and the medical community at large.
“Novartis was fully aware of the safety risks of Tasigna. Nonetheless, Novartis deliberately crafted their label, marketing, and promotion to mislead consumers,” Savel’s lawsuit states. “This was not done by accident. Rather, Novartis knew that it could turn a profit by convincing physicians and consumers that Tasigna came without certain, harmful risks. Novartis further knew that full disclosure of the true risks of Tasigna would limit the amount of money it would make selling the drug.”
Savel’s complaint joins dozens of other Tasigna lawsuits pending in courts nationwide, 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.
Late last month, all Tasigna lawsuits filed in New Jersey courts were consolidated before Superior Court Judge Rachelle Harz in Bergen County as part of a multicounty litigation (MCL).
Similar to multidistrict litigations (MDLs) used at the federal level, consolidating the cases as part of a New Jersey MCL involves transfer of 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.
A similar request for consolidation was made at the federal level in April, with plaintiffs calling for the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all claims brought in the federal court system before one judge in the U.S. District Court for the Southern District of Illinois.