Lawsuit blames violence on stop-smoking medicine
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Sean M. Wain reportedly had a respectful relationship with his wife, Natalie, although a newspaper account noted "hints of unrest" in the marriage.
It also claimed the 34-year-old construction contractor had cancer.
Still, those factors don't explain the unexpected murder-suicide on May 17, 2009 in the front lawn of their Economy home in Beaver County.
At 5:30 a.m. that Sunday, Mr. Wain ambushed and killed his wife, 33, with two 20-gauge shotgun blasts, one to the hip then a fatal one to her head, before putting the shotgun barrel into his mouth and pulling the trigger.
For three hours, three of their four frightened children, aged 10 to 14, could only look out the window at their parents' lifeless bodies before a newspaper delivery woman discovered the bodies about 8:30 a.m. and summoned police.
Now a federal lawsuit filed by the deceased couple's estate say Mr. Wain's uncharacteristic violence wasn't precipitated by cancer nor marital problems. The lawsuit blames Pfizer Inc.'s stop-smoking drug Chantix.
It's one of nearly 1,500 suits nationwide filed against Pfizer on claims Chantix produces side effects that caused "serious injury and death" without warning.
The local suit, filed earlier this month in U.S. District Court of Western Pennsylvania, claims that Mr. Wain, a smoker, received a doctor's prescription in October 2007 for Chantix (generic name varenicline), along with a trial pack he first tried Nov. 20, 2007.
His attorney, Victor Pribanic, said weird dreams prompted Mr. Wain to discontinue using the drug the first time.
But in May 2009, he resumed taking the prescription. The lawsuit says a heated argument the evening before the shooting took place, ended when Mrs. Wain left their home. Mr. Wain, who spent that evening playing cards, lay in ambush the next morning when she returned home, according to the Ellwood City Ledger. Police would find Mr. Wain lying dead atop the shotgun.
The lawsuit says Chantix causes neuropsychiatric injuries that can lead to "behavioral changes, depression, aggression, agitation, hostility, rage, suicidal ideation, suicide attempts and, in many instances, successful suicide."
The plaintiffs' injuries, including those experienced by the children, and damages directly resulted from Chantix use, the suit says.
In 2009, the federal courts consolidated many of the lawsuits filed against Chantix into "multi-district litigation" in Birmingham, Ala., to streamline pretrial procedures. The number of suits, however, is expected to grow to about 2,000 before the two-year statute of limitations deadline expires July 1 -- the date in 2009 when the U.S. Food and Drug Administration required Pfizer and GlaxoSmithKline, the maker of the stop-smoking drug Zyban, to include black-box warnings on the drugs concerning risks of "serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts."
Pfizer studies have shown Chantix to be safe and effective. But the FDA analyses "revealed that some who have taken Chantix and Zyban (wellbutrin) have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying," the FDA said. "In many cases, the problems began shortly after starting the medication and ended when the medication was stopped."
Black-box warnings are the most severe required by the FDA, short of restricting the drug's use or removing it from the market, said Jeffrey Ventura, FDA spokesman.
In requiring the warning, the FDA also ordered both companies to conduct clinical trials to determine how often serious neuropsychiatric symptoms occur in patients who use various smoking cessation therapies, including nicotine patches. This time testing must include patients who currently have psychiatric disorders.
Despite the FDA action, Pfizer said Chantix is "an effective treatment option for smokers who want to quit" and has been approved for use in 100 countries. Worldwide it has been prescribed to 13 million people with more than 7 million in the United States.
Ernest Cory, an attorney in Birmingham, Ala., and lead counsel in the multi-district litigation, said roughly 90 percent of pending Chantix cases involve neuropsychiatric injuries in which a large component involve "overt acts of suicide, attempted suicide or overt acts of violence to a third party." Some cases involve neuropsychiatric injuries that suits claim to be permanent even after the patients quit using the drug.
"This is a very specific injury that clearly Pfizer never tested for nor did clinical trials for, nor warned for, until it was put on the market and people started killing themselves for no apparent reason, with no other stressors in their lives," Mr. Cory said. "It is inconceivable how people who wanted to improve their health and quit smoking suddenly wanted to kill themselves."
Circumstances that led to lawsuits include an Ohio woman who shot and killed herself in her living room in front of her children, aged 14 and 17, following an argument over a peanut-butter-and-jelly sandwich.
In another, a California man stormed the cockpit of a commercial airliner on a flight from New York to California. The crew managed to restrain him until the plane landed.
According to another suit, a young Minnesota woman who had been on Chantix for five or six days, attacked and beat her boyfriend and tried to throw him through a plate glass window before police were summoned.
A study by Thomas J. Moore, senior scientist for the Institute for Safe Medication Practices, and colleagues published in September in the Annals of Pharmacotherapy found common characteristics of thoughts, acts of aggression and violence in 26 cases involving Chantix users.
According to the study, those cases included a woman who struck her 17-year-old daughter in the mouth while the daughter was driving a car, with a granddaughter also present; a 42-year-old man who punched a complete stranger at a bowling alley; and a 24-year-old woman who started beating her boyfriend in bed because he "looked so peaceful." She later attempted suicide.
The study said "the actual or intended victims" of the aggression or violence were anyone who happened to be nearby -- boyfriend, husband, fiancee, daughter, wife, co-workers, strangers."
The most frequent common characteristics, the report said, were "inexplicable unprovoked" events with the victim being a person nearby. There was no indication of prior history of similar behavior in the patient.
Mr. Moore of the safe medication practices group said his study found Chantix to have the most disproportionate association with violence of the 1,700 drugs his group studies.
There are numerous clinical Pfizer studies stating Chantix is safe and effective that the FDA reviewed before approving its use in 2006. But those early trials didn't include real-life conditions of smokers, which can include mental conditions and chronic illnesses.
But since the drug went on the market, the FDA has received reports of 279 suicides, 9,600 serious adverse events and 30,000 adverse events. None has been confirmed to be linked directly to Chantix, but the FDA uses such events to spot potential drug effects and help determine whether health-risk labeling is required.
Although Chantix now carries a black-box warning, the lawsuit filed by the Wain couple's estate says no such warning was on the product when Mr. Wain received his prescription in 2007.
Despite repeated denials that Chantix use can cause behavioral changes, Pfizer told Congress in August 2008 that prior to Nov. 20, 2007, it had received 322 reports of suicidal thoughts, 37 reports of suicide attempts or suicidal behavior and 16 reports of completed suicides.
Pfizer, however, said it has acted responsibly at all times in regard to Chantix.
"To date, Chantix has been studied in more than 30 clinical trials involving more than 80,000 smokers who took the medicine, and none of them found any reliable scientific evidence that Chantix causes the neuropsychiatric events alleged in many of the lawsuits," it said. "The company is continuing to study the medicine in certain populations and will vigorously defend it in the litigation."
But the Wain estate lawsuit claims available data "is inconclusive, but suggests the efficacy of Chantix appears to be no better than placebo or the nicotine patch."
The lawsuit also says the Wain children "have suffered mental anguish, pain and distress, torment, suffering, and emotional distress by unexpectedly and shockingly finding their parents had been killed."
First Published May 31, 2011 12:00 am