Tasigna Stroke Lawsuit Not Preempted By Federal Law, Judge Rules

A federal judge has determined that Novartis cannot avoid a Tasigna lawsuit, finding that a case filed by a former user who suffered a stroke should not be dismissed based on pre-emption. However, the Court has barred the plaintiff from pursuing punitive damages in at least one claim. 

The ruling allows a product liability claim filed by Dennis and Lori McWilliams to proceed, involving allegations that drug maker failed to adequately warn that the side effects of Tasigna may result in constricting and hardening of arteries, which plaintiffs claim caused Dennis McWilliams to suffer a stroke.

Tasigna (nilotinib) was approved by the FDA in 2007, and is part of a class of drugs 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 lawsuits allege 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.

The case raises allegations similar to those presented in a number of Tasigna lawsuits being pursued by individuals nationwide, indicating that users and the medical community were not adequately warned about the risk of heart attacks, strokes, the need for amputations and death.

The McWilliams and other plaintiffs maintain that Novartis was aware of the Tasigna stroke risk since at least 2010, following reports by clinical investigators who identified side effects in patients that included hardening and narrowing of arteries that supply blood to the legs and arms, heart and brain.

In April 2013, Novartis issued a warning to Canadian health professionals and the Canadian public following an investigation by Health Canada; that nations drug regulatory agency. However, no similar notification or warning was provided to doctors and patients in the U.S., the lawsuit claims.

Tasigna Case Allowed To Proceed

U.S. District Judge Robin Rosenberg, of the Southern District of Florida, issued an order (PDF) on July 9 granting in part and denying in part a motion for summary judgment filed by Novartis. The ruling grants summary judgment denying the McWilliams the ability to pursue punitive damages against Novartis. However, the ruling refused to dismiss the case based on claims of preemption by Novartis.

To prove a preemption claim, defendants have to show that state failure-to-warn laws conflict with the drug’s federal approval. To do that, they must show that the FDA would not have approved a change to the label that would have met state law requirements.

Judge Rosenberg’s ruling indicates that Novartis failed to prove the FDA would have rejected a stronger label warning had the manufacturer proposed one. However, the ruling sides with Novartis’ claim that the plaintiffs are not entitled to punitive damages, due to New Jersey law, where Novartis is headquartered, which indicates that you cannot award punitive damages when the drug was approved by the FDA. Plaintiffs argued that Florida law, where the plaintiffs are from, should apply instead.

On July 13, plaintiffs filed a motion for partial reconsideration (PDF) of the summary judgment, seeking to be allowed to pursue punitive damages. The motion indicates that the Court mistakenly assumed plaintiffs’ arguments did not take New Jersey state laws into consideration.

“As argued in Plaintiffs’ opposition brief, Plaintiffs have demonstrated a triable issue of fact on punitive damages under New Jersey law,” the motion states. “Under New Jersey law, punitive damages are available ‘where the product manufacturer knowingly withheld or misrepresented [material and relevant] information required to be submitted under the agency’s regulation.’ Plaintiffs have shown that Novartis not only withheld from the FDA material information related to atherosclerosis-related conditions associated with Tasigna, but that it knowingly made material misrepresentations to the FDA.”

The Court has set a trial date for September 17, with a status conference scheduled for August 15.