Pfizer Attempting to Dismiss Chantix Lawsuits After July 2009 Warning

Pfizer is asking a federal judge to throw out Chantix lawsuits filed by individuals who experienced psychiatric side effects while using the stop-smoking medication after a “black box” warning was added to the medication in July 2009. The drug maker also argues that they are entitled to summary judgment in many cases that were filed after the statute of limitations based on that warning update. 

Several hundred lawsuits over Chantix have been filed against Pfizer on behalf of individuals who committed suicide, attempted suicide, engaged in unusually agressive behavior or were otherwise injured as a result of neuropsychiatric events while taking the medication to help them quit smoking.

On May 18, Pfizer filed a Motion for Summary Judgment (PDF) in the U.S. District Court for the Northern District of Alabama, where all federal cases have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, before U.S. District Judge Inge Johnson.

The motion seeks the dismissal of all cases in which plaintiffs were prescribed Chantix after July 1, 2009, when the FDA added a prominent warning to the drug’s label about the psychological side effects of Chantix.

The motion also argues that July 1, 2009 should be used as the date to measure the Chantix statute of limitations, resulting in the dismissal of all cases from states with one year statutes that were not filed before July 1, 2010; from states with two year limits that were filed after July 1, 2011; and for cases from states with three year limits that are not filed before July 1, 2012.

Chantix (varenicline) was approved in the United States by the FDA 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. However, the impact of the drug on the brain has resulted in a number of reports from users who experienced sudden, unusually aggressive behavior, thoughts of self-harm and suicide.

In June 2009, the FDA added a “black box” warning to the medication about the potential risk of changes in behavior, depression and suicidal thoughts, which is the strongest warning that can be placed on a prescription medication in the United States.

All of the injury lawsuits filed against Pfizer allege that drug maker failed to adequately research their medication before introducing it, or adequately warn consumers or the medical community about the risk of Chantix side effects.

Pfizer argues that the Chantix label warning added by July 1, 2009 is adequate as a matter of law, and argues that no one who was prescribed Chantix after that date should be allowed to claim that there was a failure to warn of the potential psychiatric side effects.

Plaintiffs have not yet responded to the Motion for Summary Judgment, and Pfizer has not identified how many cases may be subject to dismissal. If the Court grants the motion, the drug maker has indicated that it will seek an entry in each individual case at an appropriate later time.

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.