The lawsuit was brought by the widow of Mark Alan Whitely, from Minnesota, who allegedly killed himself in November 2007 as a result of taking the controversial drug. The lawsuit alleged that Pfizer failed to sufficiently warn that Chantix could increase the risk of suicide.
In July 2009, the FDA announced an update to Chantix (known generically as varenicline) warnings, alerting patients to the risk of serious mental health events linked to use of the smoking cessation drug. Pfizer, maker of Chantix, was required to put a Boxed Warning on the Chantix label, highlighting the risk of depressed mood, hostility and suicidal thoughts when using the medication. When the FDA made its announcement in 2009, it had received 98 crude reports of completed suicide associated with Chantix (a crude report means the FDA had not examined each report in depth to ensure there were no duplicates). It had a further 188 crude reports of suicide attempts.
The Whitely lawsuit is reportedly the first of some 2,500 Chantix cases that have been combined in a multidistrict litigation in Alabama for pretrial evidence-gathering and the first trials.
The consolidated cases are In re Chantix (Varenicline) Products Liability Litigation MDL 2092, 09-cv-2039 U.S. District Court, Northern District of Alabama (Florence).