[Continuing the "Does generic = brand?" thread]
http://www.law360.com/lifesciences/articles/515187?nl_pk=108c332a-78f2-4138-8e88-7c15072002c6
GSK Can't Escape Suit Over Reed Smith Atty's Suicide
In a groundbreaking ruling Friday, an Illinois federal judge determined that GlaxoSmithKline PLC can be held liable for a Reed Smith LLP corporate and securities partner's suicide even though he took a generic version of the antidepressant Paxil, not the brand-name version made by the company.
The decision contradicts dozens of court rulings nationwide that brand-name drugmakers cannot be held liable for an injury caused by a generic drug. Only a handful of courts, including the Alabama Supreme Court, a California state appeals court and a Vermont federal court, have held otherwise.
The case appears to be the first time a court in the Seventh Circuit has considered the issue, according to the opinion by U.S. District Judge James Zagel.
The suit concerns the 2010 suicide of Stewart Dolin, the onetime chairman of Reed Smith's corporate and securities group. Six days after he began taking paroxetine hydrochloride, a generic version of Paxil, to treat work-related anxiety and depression, he left his Chicago office and killed himself by jumping in front of an “L” train.
Dolin's wife Wendy sued GSK and the manufacturer of the generic drug he took, Mylan Inc., 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 Dolin's suicide, the company can be found negligent, he said.
The judge rejected GSK's contention that the negligence claims were product liability claims in disguise, saying Illinois law did not require him to construe one as the other.
“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,” he said.
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, Judge Zagel said: the reasonable foreseeability of an injury, the injury's likelihood, the burden of guarding against the injury and the consequences of putting that burden on the defendant.
The factors indicate GSK owed a duty to Dolin, according to the judge. GSK should have expected generics manufacturers would make paroxetine once the patent for Paxil expired, and it knew the companies would have to follow GSK's label for the drug, he said. GSK failed to show that the likelihood of an injury was so remote that it eliminated its duty of care, he said.
To guard against the risk of suicide by someone like Dolin, GSK could have simply changed its warning label, Judge Zabel said. 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.
“That GSK did not manufacture the pill Mr. Dolin ingested is largely immaterial on this point,” the judge said. “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.”
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, according to Judge Zabel.
R. Brent Wisner of Baum Hedlund Aristei & Goldman PC, an attorney for Wendy Dolin, 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.
“If you create a drug and know that it poses serious risks, regardless of whether consumers use the brand-name or generic version of that drug, you have a duty to warn,” Wisner said in a statement.
GSK criticized the ruling, saying that nearly 90 other decisions, including all six federal appeals court decisions to date, have rejected brand-name maker liability for generic-drug injuries.
“Holding a branded manufacturer liable for its generic competitor's product forces the branded manufacturer into the role of an insurer for the generic industry … [s]uch a result would chill research and innovation,” the drugmaker said in a statement.
A Reed Smith representative declined comment on the ruling, saying the case was not a firm matter. Reed Smith has represented GSK in other product liability matters.
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.
Wendy Dolin is represented by Bijan Esfandiari, Michael Baum, Frances Phares and R. Brent Wisner of Baum Hedlund Aristei & Goldman PC and Joshua Weisberg and Lindsey Epstein of Rapoport Law Offices PC.
GSK is represented by Alan Gilbert and Melissa Economy of Dentons and Andrew Bayman, Todd Davis and Christopher Benson of King & Spalding LLP.
Mylan is represented by Robert Haley of Swanson Martin & Bell LLP and Clem Trischler and Jason Reefer of Pietragallo Gordon Alfano Bosick & Raspanti LLP.
The case is Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403, in the U.S. District Court of the Northern District of Illinois.
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