The Chief Executive Officer (CEO) of Pfizer, one of the world’s largest pharmaceutical companies, will be required to appear in person to testify in the first product liability lawsuit over Chantix, which is now expected to go to trial early next year.
Pfizer faces an estimated 2,500 Chantix lawsuits filed on behalf of users who committed suicide or suffered severe injuries that were allegedly caused by the psychological side effects of the stop-smoking drug.
Three top executives at Pfizer, including CEO Ian Read, are being ordered to appear in court for the trial of the first case, despite on-going efforts by the company to avoid requiring live testimony.
Last month, Pfizer reached a confidential settlement agreement in a Chantix case that was originally scheduled for trial to begin on October 22, involving a lawsuit brought by the family of a man who committed suicide while taking the prescription medication to help him quit smoking. Prior to agreeing to resolve the case, Pfizer was unsuccessful in attempts to have the trial postponed or avoid in-person testimony from the executives.
The next case is now scheduled for trial to begin in January 2013, involving a lawsuit brought by Billy Bedsole, who alleges that side effects of Chantix caused him to to suffer suicidal thoughts and other unusual behavior, which ultimately caused him to be institutionalized for psychological treatment.
Lawsuits Allege Pfizer Withheld Information on Chantix Risks
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, but plaintiffs allege the drug maker should have provided this information much earlier.
All Chantix injury lawsuits filed in U.S. District Courts throughout the United States are consolidated for pretrial proceedings before Judge Inge Johnson in the Northern District of Alabama. The Bedsole case is one of a series of lawsuits scheduled for early trial dates, known as “bellwether” trials, because they are designed to allow the parties to gauge how juries are likely to respond to certain evidence and testimony that will be offered throughout the litigation.
According to the complaint (PDF) filed by Bedsole, he began using Chantix in July 2007, and subsequently began experiencing thoughts of suicide, memory loss, depression, erratic behavior, mood swings, anxiety and other psychological problems that caused him to be hospitalized and suffer damages.
Bedsole alleges that Pfizer knew about the potential risk of psychological problems from Chantix, but failed to adequately warn doctors and patients in hopes of building the medication into a blockbuster. According to the complaint filed against the company, Pfizer has exhibited a pattern of delaying the release of unfavorable data since at least 2004, when the first case of Chantix suicide reportedly occurred during a clinical trial.
The lawsuit charges the company with negligence, breach of warranty, fraud, willful, wanton, and malicious conduct and others, seeking both compensatory and punitive damages against the company.
Plaintiffs have maintained that Read and the other employees are crucial witnesses in the “Chantix story” and that any inconvenience caused by requiring in-person testimony is outweighed by the benefits that will be provided for the jury, in properly evaluating the weight of the evidence. Plaintiffs indicate that the executives have been actively involved with the development and marketing of Chantix.