Chantix Black Box Warning is Adequate as Matter of Law: Judge

A “black box” warning added to the smoking cessation drug Chantix in July 2009 is strong enough to alert people about the potential psychological side effects of the medication, including a potential risk of suicide, attempted suicide and other unusual behavior, according to a ruling issued by a federal judge this week. 

On July 24, U.S. District Judge Inge Johnson issued an order (PDF) partially granting and partially denying a motion for summary judgment filed by Pfizer, who faces thousands of Chantix lawsuits filed on behalf of individuals who suffered serious or fatal injuries from a suicide attempt or sudden aggressive behavior.

Chantix (varenicline) was approved in the United States in 2006, as a prescription medication to help people quit smoking.  The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine.

Within months after the medication was introduced, reports began to surface about individuals committing suicide or engaging in other unusual behavior, which was allegedly caused by the neuropsychological effects of the medication on the brain.

Following a series of weaker label updates, the FDA announced in July 2009 that Pfizer would add a “black box” warning to Chantix about the risk of psychological problems while taking the drug. Placed prominently on the drug label, such boxed warnings are considered the strongest that can be provided with prescription medications.

In May 2012, Pfizer filed a Motion for Summary Judgment (PDF) as to the adequacy of that warning provided on July 1, 2009. The drug maker also asked the Court to dismiss all cases where the plaintiffs were first precribed Chantix after that warning was added, or where the applicable statute of limitations expired based on the warning constituting adequate notice that any psychological problems experienced prior to that date may have been caused by the medication.

While Judge Johnson granted the motion to the extent that the court found the July 1, 2009 black box warning adequate as a matter of law regarding the risk of neuropsychiatric complications among users of Chantix, the remainder of the motion was denied. Judge Johnson indicated that Pfizer has the right to file individual motions for summary judgment in each case regarding the running or expiration of the statute of limitations.

All federal lawsuits over Chantix are currently consolidated before Judge Johnson for pretrial proceedings as part of an MDL, or multidistrict litigation, in the U.S. District Court for the Northern District of Alabama.

The complaints all involve similar allegations that Pfizer failed to adequately research the side effects of Chantix or warn users about the increased risk of suicidal thoughts or unusual behavior.

At a status conference held before Judge Johnson on July 24, the parties informed the court that there are currently 2,627 Chantix cases pending in the MDL. The vast majority of those cases involve claims where the plaintiffs started using Chantix prior to the date when Pfizer placed the black box warning on the medication, and plaintiffs allege that Pfizer knew or should have known prior to introducing the drug in 2006 that the warnings were inadequate.

According to a pretrial order issued earlier this year, the first Chantix trial date in the federal MDL is expected to begin on October 22, 2012, with a second trial scheduled to begin on January 22, 2013.