Trial Underway on Parkinson's Drug Gambling Effect

A bellwether trial is underway before a Minneapolis federal judge in one of 307 consolidated lawsuits claiming the sellers of the Parkinson's disease drug Mirapex failed to alert consumers that it may prompt compulsive gambling and aggressive behavior.

Gary Charbonneau's case is the first to go before U.S. District Judge James M. Rosenbaum. Charbonneau, a retired Milwaukee police officer, says his use of Mirapex from 1997 to 2005 made him addicted to gambling.

His trial is part of the Mirapex products liability multidistrict litigation in the U.S. District Court for the District of Minnesota.

The proceedings commenced July 14 with jury selection and opening statements, according to court records.

Charbonneau says he rarely gambled before being prescribed Mirapex, but once he started taking the drug, he became a casino regular and lost more than $260,000 between March 2002 and February 2006.

The abnormal behavior ceased when he stopped taking the drug, he says.

Charbonneau seeks punitive damages and alleges strict product liability, negligence, negligent misrepresentation and breach of warranty.

He says Mirapex marketers Boehringer Ingelheim Pharmaceuticals, Pfizer Inc. and Pharmacia Corp. knew of a link between the drug and "pathological gambling" as early as September 2004.

However, he says, they failed to properly file adverse-reaction reports with the Food and Drug Administration and instead launched an aggressive marketing campaign touting the drug's purported safety and effectiveness.

The companies say they are not responsible for Charbonneau's gambling losses because they played no part in his gaining access to the casinos.

"Common sense dictates that the event that most proximately caused Mr. Charbonneau to lose money gambling was the gambling itself," they said in a pretrial brief.

The defendants say Charbonneau gambled hundreds of times for more than three years yet blames them for failing to adequately warn of the alleged risk even though the Mirapex label contained such a warning more than a year before he stopped gambling.

The "learned intermediary" doctrine bars his failure-to-warn claims because all required warnings about Mirapex were given to Charbonneau's prescribing doctor, the companies say.

They add that Charbonneau lacks proof that either he or his doctor saw or relied upon disputed media statements or promotional materials on the safety of Mirapex in 2004 and 2005 that would have encouraged use of the drug.

Charbonneau's warranty allegations are groundless, the companies say, because there was no contractual relationship upon which to base a warranty.

Further, the lawsuit conflicts with the FDA's regulatory power over prescription drugs, according to the defendants.

They say that while the FDA knows about "impulse-control issues" in some Mirapex users and received data from the companies about the issue, the drug's approval remains intact without a mandated label change.

Defense attorneys have asked that the trial be divided into liability and punitive damages phases.

Bifurcation is warranted, they say, because information about the drug companies' finances is irrelevant to their liability and that introduction of such data during the liability phase would be unduly prejudicial.

Charbonneau opposes the idea, saying the liability and damages issues are "intertwined" and that the defendants will not be harmed by presentation of their financial data during a single trial on all issues.

More than 300 federal suits over the companies' alleged concealment of Mirapex's link to compulsive behavior were consolidated in the District Court in June 2007.

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Charbonneau is represented by Vincent Moccio, Michael V. Ciresi, Tara Sutton and Gary L. Wilson of Robins, Kaplan, Miller & Ciresi in Minneapolis.Pfizer and Pharmacia are represented by Joseph Price of Faegre & Benson in Minneapolis and Michael K. Brown, Barry J. Thompson, Steven J. Boranian and Mildred Segura of Reed Smith in Los Angeles.Boehringer Ingelheim is represented by Scott Smith of Halleland Lewis Nilan & Johnson in Minneapolis and James E. Gray and Bruce R. Parker of Venable LLP in Baltimore.