Tasigna Side Effects Cause Narrowing and Hardening of Arteries, Stroke: Lawsuit

According to allegations raised in a recently filed product liability lawsuit, side effects of Tasigna caused a Virginia man to suffer a narrowing and hardening of his arteries, which ultimately causied a stroke.

The complaint (PDF) was filed by Robert Erlich in New Jersey Superior Court on February 17, alleging that Novartis Pharmaceuticals Corporation failed to provide adequate warning about the risks associated with the leukemia drug.

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 Tasigna lawsuit alleges that Novartis should have also provided strong warnings about the potential artherosclerosis side effects, which may lead to a stroke, heart attack, amputations or death.

Erlich was diagnosed with CML in 2006, and took Tasigna from August 2008 through January 2016. According to his lawsuit, his use of Tasigna resulted in peripheral vascular disease, coronary artery disease, and a stroke.

“Novartis failed to warn of risks that Tasigna caused several forms of severe, accelerated, and irreversible atherosclerotic-related conditions—i.e., the narrowing and hardening of arteries delivering blood to the arms, legs, heart, and brain,” Erlich states in his lawsuit. “Despite warning doctors and patients in Canada of the risks of atherosclerotic-related conditions, Novartis concealed, and continues to conceal, their knowledge of Tasigna’s unreasonably dangerous risks from Plaintiff, other consumers, and the medical community.”

Erlich’s lawsuit joins at least 64 other Tasigna lawsuits pending in New Jersey Superior Courts, each alleging plaintiffs suffered injuries after taking the chronic myeloid leukemia drug.

The lawsuits 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.

Earlier this 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.