Tasigna Lawsuit Moves Forward, After Interlocutory Appeal of Preemption Ruling Denied

A federal judge determined the lawsuit was not barred due to preemption laws, after plaintiff brought evidence suggesting Novartis had new information which could have led to updated label warnings.

After a federal judge denied a motion filed by Novartis to dismiss a lawsuit over Tasigna heart risks on pre-emption grounds, the Court rejected the drug maker’s request to allow an immediate appeal of the issue, allowing the case to move forward in the trial court.

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.

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 patients and doctors were not adequately warned that the medication may cause blood flow problems, which may lead to atherosclerosis, a stroke, heart attack, amputations or death.

In an early complaint (PDF) filed in the U.S. District Court for the District of Connecticut in March 2020, Novartis filed a motion to dismiss, arguing that the claim filed by Sheila Colella should be pre-empted by federal law, since the FDA approved the medication and warning label. While the motion only applied to the one case, the filing was closely watched as a potential signal for how other judges may rule on similar motions.

In October, U.S. District Judge Roy B. Dalton, Jr., who is overseeing centralized Tasigna lawsuits filed in federal courts nationwide for pretrial proceedings in the U.S. District Court for the Middle District of Florida, denied the motion and pointed out in a pretrial order (PDF) that Colella’s lawsuit “specifically alleges—and the Court accepts as true— that Defendant had newly acquired information not only permitting it, but in fact requiring it, to change the label via the CBE regulation without prior FDA approval.”

Following the ruling, Novartis sought an immediate appeal of that decision, known as an interlocutory appeal, which would allow the appellate court to consider the issue before a final judgments is issued in the case. However, in a court order (PDF) issued on January 4, Judge Dalton rejected the request, finding that Novartis failed to meet the burden necessary to warrant a “rare exception” to the policy against piecemeal appeals.

As part of the coordinated pretrial proceedings, it is expected that a series of early trial dates will be scheduled, which may help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation, and potentially facilitate Tasigna settlements without the need for each individual case to go to trial.