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Tasigna Stroke Lawsuit Filed Over Side Effects of CML Treatment

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According to allegations raised in a recently filed product liability lawsuit, a Georgia woman suffered a narrowing and hardening of her arteries that led to a stroke caused by Tasigna, a Novartis chemotherapy drug prescribed for treatment of chronic myeloid leukemia (CML).

Lucille Bresette filed the complaint (PDF) in New Jersey Superior Court on July 6, indicating that Novartis failed to adequately disclose the side effects of Tasigna or warn about the risks of sever forms of severe, accelerated and irreversible atherosclerotic-related conditions.

According to the lawsuit, Bresette was diagnosed with chronic myeloid leukemia (CML) in 2010, and was given Tasigna from about September 2013 until November 2013, and then again from November 2017 until May 2018. As a result of the treatment, Bresette indicates she suffered a left-sided cerebrovascular accident, or stroke, which caused by occlusion to the left internal carotid artery that was a direct result of her Tasigna use.

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 marketed by Novartis for treatment of chronic phase and accelerated phase Ph+ CML in adults who are resistant or intolerant to prior therapy.

While the drug carries a “black box” warning about the risk of QT prolongation, which is a heart rhythm problem that can result in sudden death, Novartis faces product liability lawsuits for failing to adequately warn about the risk of Tasigna blood flow problems, which may lead to atherosclerosis, a stroke, heart attack, amputations or death.

The lawsuit notes Novartis warned doctors in Canada about the potential risks to arteries in April 2013, but made no effort to give U.S. citizens similar warnings.

“Novartis failed to warn United States doctors like it did Canadian doctors because of the feared impact that such warning would have on sales. Indeed, in late 2012 and early 2013, after the issuance of the warnings in Canada, Novartis, including senior leadership responsible for safety and global regulatory affairs, analyzed the impact that the warning had on Tasigna sales and found that it had done substantial “damage” to Novartis’ ‘billion dollar asset’,” the lawsuit states. “For this reason, these same personnel decided to reverse a prior decision to warn of atherosclerotic-related risks in the United States.”

Late last month, all Tasigna lawsuits filed throughout the New Jersey state court system 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.

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. Oral arguments on that request will be heard by the JPML next week.

 

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