Chantix Injury Lawsuits Moving Forward in Federal MDL

Lawyers will begin taking individual plaintiff depositions next month in some federal lawsuits over Chantix filed by individuals who allege that the smoking cessation drug caused users to commit suicide or suffer serious injury due to psychological side effects.

Hundreds of Chantix injury lawsuits are consolidated as part of an MDL, or multidistrict litigation, in the U.S. District Court for the Northern District of Alabama, where the cases are being coordinated during pretrial proceedings by U.S. District Judge Inge Johnson.

All of the complaints involve similar allegations that side effects of Chantix, a popular prescription medication sold by Pfizer to help people stop smoking, may increase the risk of serious injury or death due to suicidal thoughts and other unusual, aggressive behavior that has been reported to occur in some users after taking the medication.

According to a prior case management order, a small group of cases have been selected for inclusion in an “initial discovery pool”, which will be prepared for early trial dates in the MDL, known as bellwether trials. In complex litigation involving a large number of claims with similar allegations, such trials are often helpful in allowing the parties to gauge how juries are likely to respond to evidence and testimony that will be presented throughout many cases in the litigation.

Although the first Chantix trials are not expected to begin until the second half of 2012 at the earliest, the discovery obtained during such cases and the outcomes of any trials may be useful in leading to an eventual Chantix settlement agreement.

Lawyers involved in the Chantix litigation appeared before Judge Johnson earlier this month for a status conference, where the parties informed the court that depositions of Pfizer employees continue and that depositions of individual plaintiffs selected for inclusion in the initial discovery pool will begin in mid-September 2011.

In an order issued after the conference, Judge Johnson instructed Pfizer to turn over a number of documents to the Court for review in camera, which the drug maker has claimed contain privileged information. The next status conference is scheduled for September 16.

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. Most of the Chantix injury lawsuits currently filed allege that Pfizer failed to adequately research their medication or warn about the risk of these problems earlier.

This year, the FDA also issued a drug safety communication about the potential risk of heart problems from Chantix, warning that the smoking cessation drug might increase the risk of certain cardiovascular events, including the risk of heart attack, among individuals who had cardiovascular disease. In recent months, a number of lawyers have begun reviewing potential Chantix heart attack lawsuits against Pfizer as well.