A wrongful death lawsuit has been filed by a California man, alleging that his father was killed by the side effects of Tasigna, a chronic myeloid leukemia (CML) drug linked to a narrowing and hardening of the arteries.
The complaint (PDF) was brought by Jason Adams in New Jersey Superior Court on August 26, pursuing damages on behalf of himself and the estate of his father, Lionel Adams, who died of stroke-related injuries in February 2018.
Novartis Pharmaceuticals Corporation is named as the sole defendant in the lawsuit, alleging the fatal stroke was the result of an atheroscleritic-related condition the drug makers knew or should have known may result from use of Tasigna, yet warnings were never provided for users or medical providers in the U.S.
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.
According to the lawsuit, Lionel Adams was diagnosed with CML in 1995 and was prescribed Tasigna from about March 2010 until 2015, when he suffered a stroke, which caused confusion, hearing and vision loss. Adams died of a stroke-related complications on February 8, 2018.
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.
“At no time since Tasigna was approved has Novartis proposed to FDA that language similar to the warning provided to doctors in Canada about the atherosclerotic-related risks caused by Tasigna should be added to the label in the United States. Likewise, at no time since Tasigna was approved has Novartis sent a Dear Health Care Professional letter to doctors in the United States warning of atherosclerotic-related risks caused by Tasigna,” the lawsuit states. “To this day, the Tasigna label remains inadequate as it has not been updated to include a warning similar to the one provided in Canada and fails to warn of the atheroscleroticrelated risks associated with Tasigna.”
In July, 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.
A similar request for consolidation was made at the federal level in April, with the U.S. Judicial Panel on Multidistrict Litigation approving consolidation of the cases at the federal level last month.
Following the MDL proceedings, if Tasigna settlements or another resolution is not reached, each individual case may later be returned to the U.S. District Court where it was originally filed for a separate trial in the future.