Pfizer, Inc.'s Chantix is a smoking cessation drug that has been linked to depression, changes in behavior, hostility and suicidal thoughts. Here's an update on the status of the ongoing litigation, the FDA's recent black box warning and requirement that the pharmaceutical giant conduct further clinical trials and plaintiffs' requests to consolidate cases into a MDL (Multidistrict Litigation).

What is Chantix?

Chantix is a prescription drug that is supposed to help people stop smoking by blocking brain receptors which are commonly simulated by nicotine. In other words, it acts to reduce the “positive” feelings that people get when smoking. Approved by the U.S. Food & Drug Administration (FDA) in 2006, its use, along with Pfizer's marketing practices, has been controversial. Chantix has been linked to depression, changes in behavior, hostility and suicidal thoughts. The company now faces numerous lawsuits and FDA restrictions.

Product liability / wrongful death litigation

Numerous product liability lawsuits have been filed across the country alleging that Pfizer failed to adequately research Chantix before releasing it and failed to warn consumers about Chantix's side effects. The company recently lost a bid to dismiss a wrongful death lawsuit filed by the family of a consumer who committed suicide after taking the drug – which will likely clear the way for others to file such lawsuits. The FDA has stated that:

Some people who have taken Chantix … have reported experiencing unusual changes in behavior, become depressed or had their depression worsen, and had thoughts of suicide or dying. In many cases, the problems began shortly after starting the medication and ended when the medication was stopped.

FDA's black box warning

On July 1, 2009, the FDA announced that it is requiring Pfizer to include a black box warning on Chantix. It is the strictest warning the FDA can issue. The FDA is also requiring Pfizer to conduct additional clinical trials in order to provide more information about the occurrence of neuropsychiatric symptems after taking the drug. To read the FDA's announcement, click here.

Multidistrict litigation (MDL)

On July 2, 2009, a group of 20 different plaintiffs who have already filed Chantix lawsuits in at least 10 jurisdictions requested that their cases be consolidated into a Multidistrict Litigation (MDL) in order to avoid repetition in the pretrial litigation process and inconsistent rulings.