Pharmaceutical giant Pfizer has petitioned a federal judge to throw out all Chantix lawsuits filed after the company added a ‘black box’ warning to labels of the controversial smoking cessation drug in July 2009. The drugmaker is also seeking summary judgement in a number of cases that were filed after the statute of limitations based on the black box warning. To date, hundreds of lawsuits have been filed against Pfizer in courthouses around the country on behalf of individuals who allegedly committed or attempted suicide, engaged in radically aggressive behavior, or were otherwise seriously injured by the drug’s side effects.
What’s the problem?
May 23, 2012 – Last week, Pfizer filed a Motion for Summary Judgement to dismiss all cases in which plaintiffs were prescribed Chantix after July 1, 2009, when the U.S. Food & Drug Administration (FDA) required the company to affix a prominent warning to the drug’s label describing its profound psychological side effects. The motion was filed in the U.S. District Court for the Northern District of Alabama, where all federal Chantix lawsuits have been consolidated into a multidistrict litigation (MDL) before Judge Inge Johnson.
Additionally, Pfizer is arguing that July 1, 2009 should be used as the date to measure the statute of limitations on Chantix lawsuits, resulting in the dismissal of all cases from states:
- with one year statutes that were not filed before July 1, 2012;
- with two year limits that were filed after July 1, 2011;
- with three year limits that were not filed before July 1, 2012.
First approved by the FDA in 2006, Chantix (generic: varenicline) is a widely-prescribed prescription medication designed to help people quit smoking. The drug works by blocking receptors in the brain that are stimulated by nicotine, thereby reducing the positive feelings that come from cigarettes. Unfortunately, this same mechanism has resulted in a large number of reports of unanticipated, highly aggressive behavior, suicidal thoughts and ideation.
In 2009, the FDA required Pfizer to add a so-called ‘black box’ warning to the labels of Chantix describing the potential risk for changes in behavior, depression and suicidal thoughts. The black box warning is the strictest such warning allowed by law.
The vast majority of the complaints allege that Pfizer was negligent in failing to adequately research Chantix before releasing it, and for failing to warn the public about the serious side effects associated with the drug.
For its part, Pfizer argues that the black box warning added in July 2009 is sufficient under the law, and that no one who was prescribed the drug after that point should have legal grounds to claim there was a failure to warn of potential psychological complications.
Judge Johnson has yet to rule on the Motion for Summary Judgement, and Pfizer has not indicated how many cases may be subject to dismissal. If Johnson grants the request, Pfizer has stated that it will seek an entry into each individual case at a later date. The first Chantix trial date in the federal MDL is scheduled to begin on October 22, 2012.