Tasigna Side Effects Led To Partial Leg Amputation, Lawsuit Claims

Lawsuit claims Novartis purposefully hid risks of narrowing and hardening arteries to increase profits.

According to allegations raised in a recently filed product liability lawsuit, side effects of Tasigna caused a North Carolina woman to experience a narrowing and hardening of the arteries, which resulted in a partial leg amputation after receiving the chemotherapy drug.

The complaint (PDF) was filed by Polly Harris in the U.S. District Court for the Western District of North Carolina on October 25, indicating that Novartis Pharmaceuticals Corporation failed to warn that the chronic myeloid leukemia treatment may cause a dangerous artery problems.

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 now faces a growing number of Tasigna lawsuits that allege inadequate information has been provided for consumers and the medical community about blood flow problems, which may lead to atherosclerosis, a stroke, heart attack, amputations or death.

According to Harris’s lawsuit, she was first diagnosed with CML in 2007, and was prescribed Tasigna from March 2008 through March 2018. As a direct result of the use of Tasigna, Harris indicates that she developed vascular disease, which led to a below-the-knee amputation of her left leg and a superficial femoral artery stent in her right leg.

The complaint accuses Novartis of knowing of the risks of Tasigna amputation side effects, but purposefully failing to warn patients in order to maximize profits.

“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,” the lawsuit states. “Novartis further knew that full disclosure of the true risks of Tasigna would limit the amount of money it would make selling the drug.”

Harris’s complaint will consolidated as part of a federal Tasigna MDL (multidistrict litigation), which was established before U.S. District Judge Roy Bale Dalton in the Middle District of Florida in August, since dozens of lawsuits filed nationwide raise similar questions of fact and law.

Following coordinated discovery and potential “bellwether” trials that will likely be scheduled in the MDL, if Novartis fails to reach Tasigna settlements to resolve claims, each individual claim may later be returned back to the U.S. District Court where it was originally filed for a separate trial in the future.

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