Experts Permitted to Testify About Chantix Suicide Side Effects: MDL Judge

A federal judge has rejected an attempt by Pfizer to bar the testimony of several plaintiffs’ expert witnesses, who are expected to offer opinions in the Chantix litigation about the risk of depression and suicidal thoughts that may occur while taking the controversial stop-smoking drug.

Pfizer currently faces more than 2,600 Chantix lawsuits filed on behalf of individuals who have committed suicide or experienced severe injuries from psychological problems that were allegedly caused side effects of Chantix.

As the parties prepare for the first Chantix trials in the federal MDL later this year and early next year, Pfizer asked U.S. District Judge Inge Johnson to exclude certain general causation and liability opinions that are expected to be offered by six plaintiff experts, including Dr. Richard E. Olmstead, Dr. Curt Furberg, Dr. Shira Kramer, Dr. Antoine Bechara, Dr. Josephe Glenmullen and Dr. Jon Wesley Boyd.

These experts had been identified by the plaintiffs to provide an opinion about either the reasons Chantix side effects cause suicidal symptoms or depression, the methods by which these psychological problems could occur or that Pfizer knew or should have recognized that the drug had the potential to cause these adverse effects.

In an order (PDF) issued August 21, Judge Johnson denied the drug maker’s motion to exclude the expert testimony, allowing the experts to offer testimony. However, Judge Johnson did indicate that they will not be permitted to testify about what the defendants knew or that they intentionally misled the FDA about the suicide risks of Chantix.

CHANTIX SUICIDE LAWSUITS SET FOR TRIAL IN MDL

Judge Johnson is presiding over pretrial proceedings in all federal lawsuits over Chantix, which have been consolidated as part of an MDL, or multidistrict litigation, in the U.S. District Court for the Northern District of Alabama.

Chantix (varenicline) was approved in the United States 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.

Within months after the medication was introduced, reports began to surface about individuals committing suicide or engaging in other unusual behavior on Chantix, which was allegedly caused by the neuropsychological effects of the medication on the brain.

In July 2009, the FDA added a “black box” label warning to the smoking cessation drug about the risks of psychological side effects, which Judge Johnson already determined last month was adequate as a matter of law to alert people about the potential psychological side effects of Chantix.

The complaints all involve similar allegations that Pfizer failed to adequately research the Chantix suicide side effects or warn users about the increased risk of suicidal thoughts or unusual behavior.

According to a pretrial order issued earlier this year, the first Chantix trial date in the federal MDL is expected to begin on October 22, 2012, with a second trial scheduled to begin on January 22, 2013.

These cases, known as bellwether trials, are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that is likely to offered throughout many cases in the Chantix litigation. The outcomes of the cases may also help facilitate or promote a Chantix settlement agreement or other resolution for the cases.