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According to allegations raised in a recent product liability lawsuit, Novartis has failed to adequately warn about serious health problems that may result from Tasigna, indicating that side effects of the leukemia drug caused a Kentucky woman to experience a buildup of plaque on artery walls, known as atherosclerosis, which resulted in the need for multiple toe amputations and other complications.
The complaint (PDF) was filed by Linda Trudeau in the Superior Court of New Jersey on February 24, indicating that the drug maker knew about the risk that users may experience a narrowing and hardening of arteries, but withheld information from consumers and the medical community in the United States.
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 that Novartis should have also provided strong warnings about the risk of Tasigna artherosclerosis problems, which may lead to a stroke, heart attack, amputations or death.
Trudeau states that she was diagnosed with CML in 1999, and was prescribed Tasigna from about June 2011 through 2017. The lawsuit indicates Trudea suffered severe atherosclerosis of the brain and severe peripheral vascular disease, which were caused by side effects of Tasigna. As a result of the complications, Trudea has undergone multiple toe amputations and lower extremity grafts, which may have been avoided if warnings had been provided by the drug maker.
The lawsuit notes that versions of Tasigna sold in Canada have carried label warnings about the risks of the narrowing and hardening of arteries, but for years the manufacturer refused to give its patients in the United States the same warning.
“Novartis was fully aware of the safety risks of Tasigna. Nonetheless, Novartis deliberately crafted their label, marketing, and promotion to mislead consumers,” Trudeau’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.”
Trudeau’s lawsuit joins nearly 70 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.