Chantix is a prescription medication used to help people quit smoking. In 2006, the U.S. Food and Drug Administration (FDA) approved this drug. The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine.
Mark Whitely, a 67-year-old man, began using the smoking cessation drug, Chantix in late November 2007 to help end a smoking habit that spanned thirty years. Approximately eight days later, Whitely committed suicide. Whitely is survived by his wife and three adult children.
The victim’s widow, Judy Whitely, on behalf of her husband’s estate, sued Pfizer, Inc., the manufacturer of Chantix, as part of the multidistrict litigation (MDL) in Alabama federal court. All federal lawsuits over Chantix are currently consolidated before Judge Inge Johnson for pretrial proceedings as part of an MDL in the U.S. District Court for the Northern District of Alabama.
Pfizer, Inc., the world’s largest drug company, reached a confidential settlement with the widow of Whitely, who committed suicide after taking its anti-smoking drug, Chantix, averting a trial set to begin shortly. The widow sued Pfizer, Inc., the manufacturer of Chantix, after her husband’s death in November 2007, alleging the company failed to sufficiently warn that Chantix could increase the risk of suicide. The Whitely lawsuit was the first of more than 2,600 Chantix cases pending in federal court in Alabama set for trial, according to court records.
The settlement comes after Pfizer appealed U.S. District Judge Inge Johnson’s order that its Chief Executive Officer, Ian Read and two other executives, testify in person at the Whitely trial. Read and the other executives dropped the appeal recently as moot, or unnecessary, because a settlement had already been reached, according to court records.
All of the complaints involve similar allegations that Pfizer failed to adequately research the side effects of Chantix and study its effects on the brain or warn users about the increased risk of suicidal thoughts or unusual behavior. The MDL plaintiffs assert that Chantix can cause users to suffer behavioral changes, including depression, agitation, hostility, rage and suicidal ideation, and that the drug has led many users to attempt and commit suicide. Pfizer was aware of the drug’s serious neuropsychological effects, the plaintiff’s claim, but recklessly and negligently failed to warn of its risks and intentionally concealed the dangers, misrepresenting that it was safe.
The plaintiffs allege that Pfizer knew of a link between Chantix and suicide and failed to sufficiently warn patients. The plaintiff was prepared to show that as early as 2006 Pfizer was aware of adverse event reports associated with Chantix and that during the fourth quarter of 2007, varenicline, the active ingredient in Chantix, accounted for 988 serious injuries in the U.S., more than any other individual drug during this time period. Other evidence showed that as early as fall of 2007, Pfizer representatives denied that there was a causal relationship between Chantix use and rage or violent behavior.
At a status conference held before Judge Johnson on July 24th the parties informed the court that there are currently 2,627 Chantix cases pending in the MDL. The majority of those cases involve claims where the plaintiffs starting using Chantix prior to the date when Pfizer had placed the black box warning on the medications and plaintiffs allege that Pfizer knew or should have known prior to introducing the drug in 2006 that the warnings were inadequate.
According to a pretrial order issued earlier this year, the first Chantix trial date in federal MDL was expected to begin on October 22, 2012, with a second trial scheduled to begin on January 22, 2013.
This case was being closely watched because it was considered a bellwether, a potential indicator for how the overall litigation may proceed. Set for January, Whitely’s lawsuit was one of four bellwether Chantix cases to proceed to trial in MDL that included over 2,600 lawsuits from around the nation.
Last year, the FDA stated that Chantix benefits outweighed the risks after reviewing the results of two epidemiological studies comparing Chantix smoking cessation pill with NicoDerm patches. The decision came three years after the drug maker added warnings its anti-smoking drug is connected to suicidal thoughts and behavior.
Plaintiffs argue Pfizer erred in not providing Chantix patient’s explicit warnings of possible psychiatric side effects, severe enough to have some patients take their own life. Plaintiffs further allege that Pfizer deliberately withheld the potential dangers of its product. In court papers, plaintiffs routinely reference a May 2011 Institute for Safe Medical Practices (ISMP) analysis that found Pfizer failed to correctly report to the FDA about 150 suicides that were never reported to FDA as such.
The result, according to ISMP: Incidents of suicide associated with Chantix were greatly under-represented to FDA officials.
Pfizer denies wrongdoing and has denied that Chantix was the cause or that the company withheld information about the drug. Pfizer stands by the safety and efficacy of Chantix.
Pfizer has provided warnings on the package insert of reports of suicidal thoughts since 2006, Johnson said in court papers in July.
More than 2,600 patients suffered adverse reactions after taking Chantix. Do you feel that the makers of Chantix were negligent in failing to warn consumers of the risks and dangers of this anti-smoking drug? If Pfizer knew there was a link between their drug and suicidal thoughts, do you think they should be required to print that warning on their packaging?
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