Tasigna Wrongful Death Lawsuit Filed Over Atherosclerotic-Related Injuries

A wrongful death lawsuit has been filed against the makers of Tasigna, over failure to warn that the chemotherapy drug may cause a dangerous narrowing and hardening of arteries, which caused a New Jersey woman to suffer a stroke, heart attack and die.

The complaint (PDF) was brought by Gary Novack in New Jersey state court on June 24, on behalf of himself and the estate of his mother, Susan Blatt.

Novack claims that Novartis Pharmaceuticals Corporation knew about the heart attack and stroke side effects of Tasigna, yet refused to provide meaningful label warnings for users receiving the chronic myeloid leukemia drug, or doctors administering the chemotherapy.

Tasigna (nilotinib) was approved by the FDA in 2007, and is part of a class of chemotherapy medications known as kinase inhibitors, which 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.

According to the lawsuit, Blatt was diagnosed with CML in 2002, and was prescribed Tasigna from 2011 to 2018. However, Gary Novak indicates that Tasigna caused his mother to suffer peripheral vascular disease and coronary artery disease.

“As a result, Plaintiff-Decedent underwent numerous procedures to treat her conditions including a coronary artery bypass graft, tibial bypass procedures, angioplasties, stent placements, and more. Plaintiff-Decedent also suffered a stroke that left her permanently wheel-chair bound,” the lawsuit states. “As a result of the injuries caused by her use of Tasigna, Plaintiff-Decedent passed away from a heart attack on May 1, 2019.”

The lawsuit claims Novartis acted with “reckless disregard for human life, oppression, and malice” by deliberately misleading the medical community and patients by failing to add adequate label warnings to Tasigna in order to protect its profits.

The complaint presents claims of failure to warn, negligence, strict liability, and wrongful death. Novack is seeking both compensatory and punitive damages.

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.

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.