The company for the Chantix lawsuit was set to go to trial; but just one week before the landmark case, Pfizer made a deal with the plaintiff, and the family of a suicide victim is awarded an undisclosed amount of money.
The widow of Mark Alan Whitely sued Pfizer after his death in November 2007, alleging the company failed to sufficiently warn that Chantix, a smoking cessation drug, could increase the risk of suicide. The Whitely lawsuit was the first of more than 2,500 Chantix cases pending in federal court in Alabama set for trial, according to court records.
“We can confirm that we have settled this case,” Chris Loder, a Pfizer spokesman, said in an e-mailed statement. “Terms are confidential.”
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 yesterday because a settlement had been reached, according to court records.
“Mr. Whitely’s family is happy with the settlement,” Ernest Cory, a Birmingham, Alabama-based lawyer representing the plaintiffs, said in a telephone interview.
The Whitely case and other lawsuits have been combined in a multidistrict litigation before Johnson in Alabama for pretrial evidence-gathering and the first trials.
Safety concerns have plagued Chantix almost since the pill was approved in 2006 and, consequently, have frustrated Pfizer, which had high hopes the drug would generate impressive – and much-needed – sales.
The lawsuits claim that Chantix causes depression and other psychiatric disorders, some so severe that patients attempt or commit suicide. The plaintiffs allege that Pfizer knew of a link between Chantix and suicide and failed to sufficiently warn patients.
Pfizer has denied that Chantix was the cause of Whitely’s suicide or that the company withheld information about the drug.
Pfizer has provided warnings on the package insert of reports of suicidal thoughts since 2006, Johnson said in court papers in July. The notice was updated in 2007 and 2008, culminating in a ‘black box warning’ being placed on the package insert in July 2009.
The plaintiffs’ lawyers contend that Pfizer should have provided such warnings earlier.
Cory said he didn’t believe the Whitely settlement was a signal that Pfizer was pushing to settle the cases that have been consolidated before Johnson in federal court in Florence, Alabama.
The next trial is not scheduled until January 22 and involves a man who claims Chantix caused him to have suicidal thoughts. Whether CEO Read will be asked again to testify remains to be seen, but it is likely the same arguments over an appearance will occur, even though his deposition was videotaped.
Last year, the FDA declared that Chantix benefits outweigh their risks after reviewing the results of two epidemiological studies that compared the controversial Chantix smoking-cessation pill with NicoDerm patches. The decision came three years after the drugmaker added warnings its anti-smoking drug is connected to suicidal thoughts and behavior.