Federal Judge Denies Preemption Dismissal of Tasigna Lawsuit

Federal Judge Denies Preemption Dismissal of Tasigna Lawsuit

Introduction

U.S. District Judge Robin Rosenberg, of the Southern District of Florida, issued an order on July 9, granting part permission to the plaintiffs in the Tasigna lawsuit to pursue claims against Novartis; however, he barred them from pursuing punitive damages in one claim.

The ruling allows a product liability case filed by a couple to proceed, involving allegations that the Tasigna manufacturer failed to provide adequate warning about the drug’s side effects like constricting and hardening of arteries, which caused the plaintiff to develop a stroke. Judge Rosenberg refused to dismiss the case based on preemption. To prove a preemption claim, the defendants are supposed to present that the state failure-to-warn laws conflict with the drug's federal approval. The Court ruling indicates that Novartis failed to prove that the FDA would have disapproved of a stronger label warning for Tasigna. However, the Court supports the defendant in denying punitive damages to the plaintiffs due to the New Jersey law which prohibits awarding punitive damages if the drug is approved by the FDA.

Plaintiffs filed a motion on July 13 to allow partial reconsideration of the summary judgment requesting to allow pursuing punitive damages. The motion stated, “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.”

A Court trial is scheduled for September 17, 2018, and a status conference for August 15, 2018. Growing number of Tasigna lawsuits claim it causes atherosclerosis (hardening of the arteries), which can develop a stroke, heart attack, or can even lead to death.