Sept. 10, 2018 – CHICAGO, IL – – The Seventh Circuit Court of Appeals panel that overturned a $3 million verdict against GlaxoSmithKline (GSK) for failing to include a suicide warning on the company’s antidepressant, Paxil, committed a “grave error,” said plaintiff Wendy Dolin in a petition for rehearing.
Wendy Dolin: Court Panel’s Ruling to Overturn $3M Paxil Suicide Verdict ‘Sets Dangerous Precedent’
Wendy Dolin’s husband, Stewart, was a prominent Chicago attorney who took his own life in 2010 a few days after he started taking paroxetine, a generic version of Paxil. Mrs. Dolin filed a wrongful death lawsuit against GSK in 2012, alleging GSK had known for decades that Paxil could increase the risk of suicidal behavior, but never changed its label to reflect the suicide risk.
Following a five-week trial and three days of deliberations, a jury concluded in April of 2017 that GSK failed to adequately warn of the adult suicide risks associated with Paxil and that GSK’s negligence caused the July 2010 suicide death of Stewart Dolin.
On appeal, the Seventh Circuit Court panel acknowledged that, in 2006, “GSK re-analyzed the placebo-controlled data on paroxetine and found a link between paroxetine and suicide in adults.”
Nevertheless, the panel concluded federal law under the Food Drug and Cosmetic Act (FDCA) prohibited GSK from issuing warnings concerning the life-threatening suicide risks because the U.S. Food and Drug Administration (FDA) had rejected GSK’s attempts to change Paxil’s suicide risk warning language.
According to Dolin, GSK’s proposed adult suicide warning was never rejected by the FDA, rather the FDA specifically invited GSK to formally submit a Changes Being Effected (CBE) supplement to strengthen the Paxil suicide warning.
In 2007, the FDA and GSK were discussing changes to the warning label for all selective serotonin reuptake inhibitors (SSRIs), the class of drugs of which Paxil is a part. The FDA told GSK in a 2007 email that changes to the Paxil label should be submitted separate from SSRI class labeling revisions, as GSK had proposed to include its Paxil-specific warning in the middle of the SSRI class warning:
“[T]he Agency has reviewed your proposed changes, and we do not believe that your product specific analysis should be included in the class labeling revisions since the labeling is targeted at the class of drugs. If you would like to discuss this matter further, please submit a formal meeting request.”
Dolin said this exchange between FDA and GSK does not meet the relevant standard set forth by the Supreme Court’s decision in Wyeth v. Levine, which found that state law failure-to-warn claims against drug manufacturers are only preempted by federal law if there is “clear evidence” that FDA would have rejected the warning in question.
In broadly rejecting preemption, Levine recognized that “[f]ailure-to-warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times.”
According to Dolin, the FDA invited GSK to submit a separate supplement to issue a Paxil-specific suicide warning for the drug’s label, even though GSK did not require the FDA’s “special permission” to do so (it could have unilaterally submitted the CBE supplement).
“It is surprising that the panel construed the FDA’s invitation to GSK to submit a separate CBE supplement as clear evidence of a rejection of the suicide warning,” said Dolin’s attorney, Bijan Esfandiari. “It is like being invited to dance but construing that invitation as clear evidence of rejection.”
“With its ruling, the panel tossed out the jury’s verdict, disregarded the findings of two district court judges below (who found no preemption) and vitiated the conclusions of other district courts (and indeed another panel within this circuit) who, until now, have unanimously found no preemption in such cases,” the petition says.
Dolin added that the Seventh Circuit Court panel’s decision could have a lasting impact, and as such, must be corrected to protect the public:
“The FDCA regulations which were designed to be a weapon of the public against drug manufacturers to ensure they deliver unadulterated drugs and appropriate warnings concerning the risks and benefits of their drugs, have now been turned into a weapon against the public,” says Dolin’s Paxil suicide rehearing petition. “The panel’s ruling sets a dangerous precedent that should be corrected either by the panel itself or the Court en banc.”