Averting trial of a closely watched bellwether products-liability case, Pfizer Inc. (NYSE: PFE) settled claims the pharmaceutical maker failed to state adequately the psychiatric risks–including suicide–associated with use of the company’s smoking-cessation drug Chantix.
Pfizer, the world’s largest drug company, entered into a confidential settlement with Judy Ann Whitely, the widow of Mark Alan Whitely, who killed himself in 2007, after taking Chantix to help end a smoking habit that spanned three decades.
Set for trial in January, Whitely’s lawsuit was one of four bellwether Chantix cases to proceed to trial in multidistrict litigation that includes over 2,600 lawsuits from around the nation.
The Whitely settlement came on the heels of a recent pre-trial ruling that Pfizer’s chief executive officer, Ian Read, and two other company executives could be called to testify at trial.
The company asked the U.S. Court of Appeals for the Eleventh Circuit to reverse the pretrial ruling by U.S. District Court Judge Inge Pritz Johnson, in Florence, Ala. Given the settlement, attorneys for the drugmaker withdrew the appeal.
With the national deluge of similar lawsuits against the maker of Chantix, and an expectation of additional filings to come, the United States Judicial Panel on Multidistrict Litigation (USMDL) in 2009 consolidated the Chantix cases and transferred them to the U.S. District Court for the Northern District of Alabama.
Plaintiffs argue Pfizer erred in not providing Chantix patients explicit warnings of possible psychiatric side effects so severe that some patients will try to take their own life.
Plaintiffs allege further that Pfizer deliberately withheld the potential dangers of its product. In court papers, plaintiffs routinely reference a May 2011 Institute for Safe Medicine Practices (ISMP) analysis that found Pfizer failed to correctly report to the Food and Drug Administration 150 suicides that were not reported to the FDA as such.
The result, according to ISMP: Incidents of suicide associated with Chantix were vastly underrepresented to FDA officials.
For its part, Pfizer denies any wrongdoing and stands by the safety and efficacy of Chantix, which gained regulatory approval in May 2006.
Chantix came to market with a warning on its product insert that use of the medication poses severe risks.
Following a spate of suicides and attempts by Chantix patients, the U.S. Food and Drug Administration amended packaging requirements on the product.
Since July 2009, the FDA has required a so-called black-box warning for Chantix, to alert physicians and patients of possible side effects, including severe depression, thoughts of suicide and suicide.
Pharmaceutical industry analysts say Pfizer’s Chantix revenues have slid amid news reports of patient suicides. In the first half of 2012, generated revenues of $350 million, or 10 percent less than the product brought Pfizer in the year-ago period, Pharmalot reported.
The consolidated cases are In re Chantix (Varenicline) Products Liability Litigation MDL 2092, No. 09-cv-2039, N.D. Ala. (Florence).
Information on the Chantix Suicide MDL is available on the court’s website, at.
Orders in the MDL are viewable online, at http://www.alnd.uscourts.gov/mdl-2092/MDL_2092_Orders.cfm.
The Institute for Safe Medicine Practices (ISMP) analysis, published in May 2011, is available at the organization’s website, at http://www.ismp.org/quarterwatch/2010Q3.pdf.