Reed Smith Partner's Widow Loses $3 Million Verdict on Appeal
A Chicago jury's $3 million award to the widow of former Reed Smith partner Stewart Dolin has been dismissed after an appeals court held that GlaxoSmithKline was prevented by the FDA from adding a suicide warning to the label for Paxil.
August 23, 2018 at 02:03 PM
4 minute read
A federal appeals court has thrown out a $3 million verdict awarded last year to the widow of a former Reed Smith partner, ruling that federal law prohibited pharmaceutical giant GlaxoSmithKline plc from adding a suicide warning label to an antidepressant that the plaintiff argued caused her husband's death.
Former Reed Smith partner Stewart Dolin committed suicide in downtown Chicago in 2010 while taking a generic version of Paxil, a drug formerly manufactured by GSK. Dolin's widow, Wendy Dolin, sued GSK and alleged that the company covered up results of a clinical study that showed the drug paroxetine had caused suicides in adults. A federal jury in Chicago awarded Stewart Dolin's family $3 million in April 2017.
The U.S. Court of Appeals for the Seventh Circuit ruled Wednesday that the case should have been dismissed before trial because GSK was prevented in 2007 by the U.S. Food and Drug Administration from adding suicide as a warning for adults on the label for Paxil.
Manufacturers of generic drugs are required to use the same warning label from a drug's branded version, which led to the dismissal of generic drug manufacturer Mylan Inc. from Wendy Dolin's suit in 2014.
“GSK asked the FDA for permission to modify the paroxetine label as plaintiff argues was needed,” Seventh Circuit Judge David Hamilton wrote for a three-judge panel. “The FDA said no, repeatedly. Federal law thus pre-empted plaintiff's Illinois law claim that GSK should have warned of a risk of adult suicidality on the paroxetine label in 2010.”
GSK had added a suicide warning for adults to its Paxil label in 2006, following its own study that showed a statistically significant increase in the risk of suicide among clinically depressed adults. But a broader review of trial data regarding antidepressants known as SSRIs by the FDA in 2007 was less conclusive.
The regulator required that all drugs in the SSRI family, including Paxil, use the same warning label that said “studies did not show an increase in the risk of suicidality … in adults beyond age 24,” said the Seventh Circuit in its ruling this week.
Following that 2007 decision by the FDA, GSK asked four times to update its Paxil label to include an adult suicide warning for paroxetine. The FDA refused those requests.
“These requests by GSK and the responses are clearly documented. They are not subject to reasonable dispute. This is clear evidence that, as of 2007, the FDA rejected an adult‐suicidality warning for paroxetine,” the Seventh Circuit said.
The trial last year shed light on the personal stress and anxiety that can be a side effect of Big Law mergers. GSK argued that the 57-year-old Stewart Dolin committed suicide as a result of fears of inadequacy and a potentially diminished role at Reed Smith, which he joined in 2007 when the global legal giant acquired Sachnoff & Weaver, where Dolin served on the midsize Chicago shop's management committee.
GSK turned to King & Spalding and Dentons for trial work and Arnold & Porter Kaye Scholer on appeal. Wendy Dolin was represented by lawyers from Baum, Hedlund, Aristei & Goldman and the Rapoport Law Offices in Chicago.
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