Pfizer has once-again settled a Chantix lawsuit days before trial was scheduled to begin, resolving a claim that alleged the global pharmaceutical company failed to adequately warn about the risk of psychological side effects associated with their smoking cessation drug.
Chantix (varenicline) is a prescription medication that was approved in 2006 to help people stop smoking. However, after it was introduced, a number of reports surfaced involving individuals who suffered sudden behavior changes, depression, suicidal thoughts and other problems.
Pfizer faces an estimated 2,500 Chantix lawsuits filed on behalf of individuals who committed suicide or suffered severe injuries.
The Chantix settlement was reached in a lawsuit brought by Billy G. Bedsole, Jr., which was scheduled for trial to begin on January 22, in the U.S. District Court for the Northern District of Alabama.
Bedsole claimed that he suffered suicidal thoughts and behaviors from Chantix side effects, causing him to be institutionalized for psychological problems, according to the complaint (PDF).
In a court Order (PDF) issued Tuesday, it was reported that the parties have amicably resolved the case. However, the terms of the agreement were not disclosed.
Bedsole’s case was scheduled to be the first to reach a jury, after Pfizer reached a similar confidential Chantix settlement agreement in another case that was set for trial to begin in October 2012. That lawsuit was brought by the family of Mark Whitely, who killed himself in 2007 while taking the prescription medication.
Both settlements allowed Pfizer’s CEO, Ian Read, to avoid taking the witness stand to testify about whether the drug maker knew about the potential risk of Chantix problems when he was on its development team.
Pfizer has unsuccessfully attempted to fight subpoenas requiring three top executives to testify live at trial. The Whitely case settled after the judge presiding over the case refused to allow the executives to avoid testifying in-person, and an order was issued in November 2012 requiring the executives to appear in court for trial of the Bedsole case.
Bellwether Trials Designed to Promote Agreement to Settle Chantix Litigation
The Whitely and Bedsole cases were selected for early trial dates in the federal Chantix litigation, known as “bellwether” lawsuits, because the outcomes are often useful in helping the parties gauge how juries are likely to respond to certain evidence and testimony that will be offered in a number of cases.
Chantix works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine. However, all of the lawsuits involve similar allegations that Pfizer failed to adequately research the medication or warn about the risk of suicide, suicidal thoughts or unusual agressive behavior that has been found to surface after use of the medication.
In July 2009, the FDA added a “black box” label warning to the smoking cessation drug about the risks of psychological side effects, but plaintiffs allege the drug maker should have provided this information much earlier.
In the federal court system, all lawsuits over Chantix have been centralized before U.S. District Judge Inge Johnson in the Northern District of Alabama for consolidated pretrial proceedings as part of an MDL, or multidistrict litigation.
At a status conference held on January 15, where the Court was informed of the Bedsole settlement, the parties requested additional time to meet regarding the preparation of additional Bellwether cases for inclusion in the trial pool. The parties have been ordered to report on the status of discovery in cases slated for inclusion in the trial pool within the next 30 days, at which time the Judge Johnson indicates the next status conference will be scheduled.
Following the Bellwether trials in the federal MDL, if a Chantix settlement agreement is not reached to resolve a large portion of the cases, Judge Johnson may begin remanding individuals lawsuits back to the U.S. District Courts where they were originally filed for jury trials to be held throughout the country.