Tasigna Heart Attack Lawsuit Filed Over Side Effects of Chemotherapy Drug

A recently filed product liability lawsuit alleges Novartis Pharmaceuticals failed to adequately warn about the link between Tasigna and heart problems, claiming the side effects of the chemotherapy drug caused a Florida woman to suffer a heart attack and undergo a procedure to implant a cardiac stent.

Emily Riley filed the complaint (PDF) late last month in the U.S. District Court for the Middle District of Florida, claiming the drug makers knew or should have known about the heart attack risks associated with the medication used to treat adults with chronic myeloid leukemia (CML).

Tasigna (nilotinib) was approved by the FDA in 2007, and is part of a class of chemotherapy medications known as kinase inhibitors, and 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 Tasigna heart attack lawsuit, Riley was diagnosed with CML in 2011, and received Tasigna from August 2011 through August 2012. However, after just one year of using the drug, she suffered a myocardial infarction, which required a heart stent. In addition, she also suffered severe lower extremity vascular disease. This resulted in Riley needing a left femoral popliteal artery bypass, a right artery stent, a repeat stent, and an angioplasty, the lawsuit indicates.

Riley alleges that Novartis withheld information from users and U.S. medical professionals abou the problems with Tasigna, refusing to warn about the risk of narrowing and hardening arteries, which can lead to a heart attack. However, the same drug did contain such warnings in Canada.

“Novartis failed to warn United States doctors like it did Canadian doctors because of the feared impact that such a warning would have on sales,” Riley’s lawsuit states. “Indeed, in late 2012 and early 2013, after the issuance of 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 it had done substantial ‘damage’ to Novartis’ ‘billion dollar asset.’ For this reason, these same personnel decided to reverse a prior decision to warn of atherosclerotic-related risks in the United States.”

Riley’s complaint joins dozens of other Tasigna lawsuits pending in courts nationwide, each alleging plaintiffs suffered injuries after taking the chronic myeloid leukemia drug.

The complaints 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.

Most of the cases, however, have been filed in New Jersey state courts. In February, 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 which will be repeated throughout the litigation.