Lawsuits Over Tasigna Heart Risks Centralized in Federal MDL For Pretrial Proceedings

Given common questions of fact and law raised in a growing number of Tasigna lawsuits being filed in U.S. District Courts nationwide, a federal multidistrict litigation (MDL) has been established to coordinate all discovery and pretrial proceedings.

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.

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Side effects of Tasigna may increase risk of heart attack, stroke, amputation and wrongful death.

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In April, a petition was filed with the the U.S. Judicial Panel on Multidistrict Litigation (JPML) calling for the creation of a Tasigna MDL in the U.S. District Court for the Southern District of Illinois, so that the claims can be overseen by one judge.

Such centralization is common in complex product liability litigation, where a large number of claims are being filed in courts nationwide over similar injuries caused by the same drugs or product defects. Coordinating the cases before one judge is meant to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and serve the convenience of common witnesses, parties, and the court.

At the time of the motion, there were at least 18 Tasigna lawsuits pending in 12 different U.S. District Courts, each raising similar claims and allegations. However, as Tasigna injury lawyers continue to review and file claims in the coming weeks and months, that number is expected to increase significantly.

In a Transfer Order (PDF) issued on August 10, the JPML agreed that the federal Tasigna litigation should be centralized, but assigned the cases to U.S. District Judge Roy Bale Dalton in the Middle District of Florida.

The panel noted that common issues of general causation and discovery about the labeling and regulatory history of Tasigna was sufficiently complex to justify the centralized management of the cases.

“After considering the argument of counsel, we find that centralization of these actions in the Middle District of Florida will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation,” the JPML wrote. “All actions can be expected to share factual questions arising from allegations that Novartis failed to appropriately warn of the risks that use of Tasigna may cause severe atherosclerotic injuries. Despite warning doctors and patients in Canada of the heightened risks of atherosclerotic-related conditions,3 plaintiffs contend that Novartis concealed its knowledge of Tasigna’s unreasonably dangerous risks from plaintiffs, other consumers, and the medical community in the U.S.”

Now that a Tasigna MDL is established, cases filed in U.S. District Courts nationwide will be transferred to Judge Dalton’s court for management during discovery and any early “bellwether” trials, which may be scheduled to help the parties gauge how juries are likely to respond to certain evidence that will be repeated throughout the litigation.

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.

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