Before Pfizer paid at least $299 million to settle claims that its anti-smoking drug Chantix caused harm, the pharmaceutical giant played hardball with Army Pfc. George D.B. MacDonald.
Charged with murdering fellow Fort Benning soldier Rick Bulmer in May 2008, MacDonald claimed his mind snapped after using the medication to stop smoking. Chantix, MacDonald wrote, caused him to "go crazy for a while" before the assault in their barracks.
During his court-martial, Pfizer resisted turning over certain documents to the defense team, including clinical trial studies that were conducted on Chantix.
"I mean, it is the United States and Pfizer versus Pfc. MacDonald here," MacDonald's attorney, Lt. Col. Jan Aldykiewicz, fumed at a pretrial hearing June 1, 2009, a transcript shows.
The trial judge disagreed and refused to compel the company, which wasn't a party to the case, to comply with a subpoena for the material. The military jury subsequently convicted MacDonald of murdering Bulmer, a 23-year-old private from Fresno, Calif., and sentenced him to life without the possibility of parole.
MacDonald has appealed and his case will be heard May 13 by the nation's top military appeals court, which will revisit the trial judge's actions to determine whether they undercut the defense. Three key questions will confront the U.S. Court of Appeals for the Armed Forces when it takes up the case:
Did the original trial judge, Army Col. James Pohl, err in refusing to compel Pfizer to fully comply with the wide-ranging subpoena for Chantix documents?
Did Pohl err in not telling jurors about involuntary intoxication as a defense?
If Pohl made mistakes, is a new trial required?
A lower appeals court concluded last year that the judge had erred in quashing the subpoena but not seriously enough to necessitate a new trial. "There is no reasonable probability that had the evidence been produced, disclosed and used, the outcome of the proceeding would have been different," the U.S. Army Court of Criminal Appeals said in an unpublished opinion. MacDonald, it said, "appreciated the nature, quality and wrongfulness of his acts in stabbing and killing Pvt. Bulmer."
For MacDonald, the upcoming hearing is a chance to regain his freedom. For Bulmer's family, which wants MacDonald to remain incarcerated at the U.S. Disciplinary Barracks at Fort Leavenworth, Kan., the appeal is a bitter pill.
"I think he needs to stay in for as long as possible," Bulmer's widow, Beth Bulmer, said in a telephone interview. "He stood over Rick and thought what he was going to do for 30 seconds. That's premeditated murder."
A MacDonald victory at the hearing could force Pfizer to face subpoenas, this time enforced by a judge's order to comply. Clinical trial documents and more might have to be disclosed, potentially opening new inquiries into a medication that generated $486 million in sales during the first nine months of last year.
"If there's a medical explanation for what occurred in this case, it would be important beyond" MacDonald, said his Augusta, Ga.-based appellate attorney, William E. Cassara, suggesting the possibility that the case could reveal "further examples" of Chantix allegedly causing harm.
Pfizer countered, in a statement to McClatchy, that "there is no reliable scientific evidence that Chantix causes serious neuropsychiatric events including those at issue here."
"Chantix is an important, effective, FDA-approved treatment option for adult smokers who want to quit," Pfizer added in the statement. "Chantix is approved for use in more than 100 countries and has been prescribed to over 20 million patients worldwide, including more than 10 million in the United States."
Questions about the drug's safety have dogged the company. Within weeks of the military trial judge's decision in 2009 to quash the subpoena, Pfizer began getting hit with civil lawsuits claiming Chantix had caused suicides, suicide attempts or other neuropsychiatric problems.
One claim came from Melanie Presley of Tacoma, Wash., who said she used Chantix briefly in 2007. She was also taking medication for other conditions, but all seemed well until one day in early February 2007.
"I woke up in the morning, and I got my daughter off to school," Presley recalled in a telephone interview, "and the next thing I remember, I was standing in the kitchen in a puddle of blood."
Six hours had somehow passed, Presley said, during which time she had used a kitchen knife to cut her left arm. She drove herself to the emergency room, shaken, she said, at the thought that she might have hurt someone else. Presley was one of some 2,700 former Chantix users who ultimately sued Pfizer. On just one day in mid-July 2011, for instance, 92 individuals from cities including Charlotte, N.C.; Olathe, Kan.; Owensboro, Ky.; and Atlantic Beach, Fla., claimed the drug caused suicidal thoughts or other problems.
The swarm of civil lawsuits started piling up after the Food and Drug Administration imposed a "black box" warning on the Chantix label on July 1, 2009. The most serious warning a medication can have and still be sold in the U.S., it appeared about six weeks after Bulmer's killing. The warning cautioned Chantix users to be on the lookout for signs of hostility or agitation, among other potential symptoms. The FDA added that those "who feel like hurting themselves or someone else should stop taking the medicine and call their health care professional right away."
Pfizer began serious settlement discussions in 2012 with the lawyers representing the mass of Chantix civil lawsuits. Most have since been settled at a cost to the company of $299 million through the first quarter of 2013. Pfizer says the settlements will allow the focus to remain on the benefits of the drug.
"The Chantix litigation involves fundamental issues of science and medicine that often are uncertain and continue to evolve," Pfizer told the Securities and Exchange Commission last year.
Since the trial, MacDonald has studied Buddhism, yoga and meditation, according to his half sister, Paige MacDonald. She added in an email that MacDonald "is an optimist in the face of adversity" and is "hopeful his sentence will be reduced to a number, so he can start working off his time with good behavior."
In California, Bulmer's family members struggle on. Some don't want to talk about the case, still an open wound.
Beth Bulmer, for one, has endured occasional health problems and financial challenges. Sometimes, the 25-year-old single mother doesn't feel like leaving home other than for necessities, such as dropping off at school her daughter, Izzabella, the living reminder of her love for Rick.
"It's just too much to bear sometimes," Beth Bulmer said. "It's just too hard."