In a groundbreaking ruling, an Illinois federal judge determined that GlaxoSmithKline PLC (GSK) can be held liable for a corporate and securities lawyer’s suicide. The lawyer had taken a generic version of the antidepressant Paxil, not the brand-name version made by the company. The decision is in conflict with some other court rulings around the country holding that brand-name drugmakers cannot be held liable for an injury caused by a generic drug. The Illinois court follows rulings by the Alabama Supreme Court, a California state appeals court and a Vermont federal court. The ruling by U.S. District Judge James Zagel, the Illinois judge, in my opinion is legally sound.
The case appears to be the first time a court in the Seventh Circuit has considered this issue. The suit involves the 2010 suicide of a lawyer, who was the onetime chairman of a large law firm’s corporate and securities group. Six days after the lawyer began taking paroxetine hydrochloride, a generic version of Paxil, to treat work-related anxiety and depression, he left his office and killed himself by jumping in front of a train.
The decedent’s wife sued GSK and Mylan, Inc., the manufacturer of the generic drug her husband took, claiming they failed to warn patients that adult users of paroxetine were at greater risk of suicidal behavior. Judge Zagel dismissed Mylan from the suit, but granted only part of GSK’s motion for summary judgment. While GSK cannot be held strictly liable for the suicide, Judge Zagel ruled that the company can be found to have been negligent. The judge rejected GSK’s contention that the negligence claims were actually product liability claims “in disguise,” saying Illinois law did not require him to construe one as the other. Judge Zagel wrote in his order:
The injury here did indeed occur in connection with a product. And GSK manufactures products. Yet plaintiff has not brought suit against GSK for tortious conduct committed strictly as a manufacturer of products. And, though GSK implicitly urges to the contrary, I see no reason why all suits brought against GSK must be brought against GSK qua manufacturer.
Judge Zagel said that in order to determine whether a Defendant owes a duty to a Plaintiff, even if they are not directly connected, Illinois courts are supposed to consider four factors, which are:
These factors indicate GSK owed a duty to Dolin, according to Judge Zabel. He said that GSK should have expected generics manufacturers would make paroxetine once the patent for Paxil expired, adding that GSK brand manufacturer knew the companies would have to follow its label for the drug. Judge Zabel said GSK failed to show that the likelihood of an injury was so remote that it eliminated its duty of care.
Judge Zabel said to guard against the risk of suicide by someone like this lawyer, GSK could have simply changed its warning label. There is a danger of overwarning about a risk, but GSK did not argue that the danger outweighed the duty it owed to Dolin, he said. Judge Zabel added:
That GSK did not manufacture the pill (the lawyer) ingested is largely immaterial on this point. GSK will not be tasked with the burden of crafting one new warning label for Paxil, and then other discrete warnings for various generic iterations of the drug — that all of the iterations of paroxetine are bioequivalent and require the same warning is precisely the point.
Judge Zabel pointed out that GSK “has been compensated for taking responsibility for paroxetine’s design and warning label” through the Hatch-Waxman Act, which extended brand-name makers’ exclusivity over sales of their drugs. Judge Zagel dismissed Mylan from the suit based on the U.S. Supreme Court’s landmark Bartlett ruling last year, in which it held that federal law preempts design defect claims against generic-drug makers.
The Plaintiff is represented by Bijan Esfandiari, Michael Baum, Frances Phares and R. Brent Wisner of Baum Hedlund Aristei & Goldman, a firm with offices in Los Angeles, Philadelphia, and Washington D.C., and Joshua L. Weisberg and Lindsey A. Epstein of the Chicago-based Rapoport Law Offices. Wisner praised Judge Zagel for eliminating the “doughnut hole of liability” faced by Illinois generic-drug users seeking to hold a manufacturer accountable for their injury.
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