Discovery Schedule in Chantix Litigation Delayed

The first Chantix lawsuit is unlikely to be ready to go to trial before the second half of 2012, following a revised pretrial scheduling order issued in the federal MDL. The discovery process has been pushed back for all federal lawsuits that allege the stop-smoking drug increases the risk of suicide and other psychological side-effects. 

According to an order issued last week by U.S. District Judge Inge P. Johnson, who is presiding over the consolidated Chantix litigation in federal court, various discovery deadlines were delayed about four months.

While the selection of the first Chantix trials has not yet occurred, the commencement of depositions of common fact witnesses employed by the drug maker was pushed back from September 1, 2010 to January 3, 2011 and the depositions of plaintiffs and other relevant third party witnesses was pushed back from December 1, 2010 to April 1, 2011.

The latest deadline in the pretrial order, involving the date by which any reply briefs must be filed for any motions practice involving expert witnesses, was set for May 11, 2012.

Pfizer faces a growing number of lawsuits over Chantix that have been consolidated before Judge Johnson for pretrial litigation. All of the claims involve similar allegations that Pfizer failed to adequately research the side effects of Chantix or warn about the increased risk of unusual and aggressive behavior, including suicide and unexpected acts of violence.

The federal Chantix litigation was centralized before Judge Johnson in the U.S. District Court for the Northern District of Alabama in October 2009. At that time, 34 Chantix cases were pending in different federal district courts throughout the United States. Since then, at least 60 additional lawsuits have been transferred to Judge Johnson. In addition, as Chantix lawyers continue to review and file new lawsuits throughout the country, they will be transferred to the MDL for coordinated pretrial management.

Judge Johnson has directed the parties to submit a joint proposal by February 1, 2011 regarding the process for selecting a pool of initial cases that will be eligible for case-specific discovery and trial, if necessary. These early cases, which are known as Chantix bellwether lawsuits, are used to help the parties gauge strengths and weaknesses of their cases, and may lead to an eventual Chantix settlement or other resolution for the litigation.

Chantix (varenicline) was approved 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 drug has been linked to increased risks of suicide and suicide attempts, aggressive behavioral changes and other psychiatric side effects, which have resulted in fatal or catastrophic injuries for many users.

The FDA has received hundreds of adverse event reports involving Chantix problems, leading to a “black box” warning being added to the medication in June 2009 about the potential psychological side effects. Pfizer has also been required to conduct clinical trials providing more data on how often neuropsychiatric symptoms with Chantix occur and what conditions cause them.