By: Staff Writers | Published: March 9th, 2010
U.S. District Judge Inge Prytz Johnson, who is presiding over the consolidated federal Chantix lawsuits, has established a discovery plan for the exchange of information during pretrial litigation, which seems to indicate the the first Chantix trial is unlikely to reach a jury until at least 2012.
All lawsuits filed in federal court against Pfizer over alleged side effects of Chantix, their popular smoking cessation treatment, have been centralized for pretrial litigation before Judge Johnson in the U.S. District Court for the Northern District of Alabama as part of a multidistrict litigation (MDL). The cases involve similar allegations that Pfizer failed to adequately research their medication or warn about the risk of suicide from Chantix or other psychological side effects.
When the Chantix litigation was consolidated in October 2009, there were 34 lawsuits pending in different federal district courts throughout the United States. Since then, several dozen more cases have been transferred into the MDL. In addition, Chantix lawyers are continuing to investigate hundreds of other potential cases that are expected to be filed in the coming months.
According to a Pretrial Order issued February 24, Plaintiffs and Defendants with Chantix cases in the MDL will produce documents, exchange information about their cases and conduct depositions between now and the end of 2011.
“This Joint Coordinated Plan of Discovery is intended to conserve judicial resources, eliminate duplicative services by all counsel and co-counsel, eliminate duplicative discovery, serve the convenience of the parties and the witnesses, and promote the judge and efficient conduct of this litigation,” wrote Judge Johnson in the Order.
The discovery plan calls for plaintiffs to provide Fact Sheets about their case within 60 days of the order, and individuals who file a lawsuit over Chantix in the future must complete the Plaintiffs’ Fact Sheet within 60 days of their case being docketed in the MDL. Defendants will produce documents relevant to the cases between now and August 2010, with the first depositions of Pfizer employees allowed to begin in September 2010. Depositions of individual plaintiffs, family members, physicians, sales representatives and other third party witnesses will begin in December 2010.
Expert witnesses must be designated by April 2011 and May 2011, for the Plaintiffs and Defendants respectively, with expert depositions set to begin in July 2011 and conclude by October 3, 2011. Motions practice on general causation and liability will then occur through the end of 2011, with case specific expert discovery not permitted to begin until after the Court decides the issues that are generally applicable to cases in the litigation.
“The Parties shall meet and confer at a later date, once discovery that is the subject of this Plan is substantially complete, to discuss a schedule for further case specific discovery,” ordered Judge Johnson. “Until that time, absent court order, no discovery other than that permitted by this Plan may be conducted.”
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.