Asserting a Chicago federal appeals panel wrongly invalidated a jury’s verdict, attorneys for the widow of a Chicago lawyer who committed suicide after taking the generic version of the antidepressant drug Paxil, have asked the U.S. Supreme Court to throw out the appellate ruling and order more proceedings on whether pharmaceutical company GlaxoSmithKline should be made to pay for allegedly not revising their drug’s warning label to reflect an increased risk of suicide.
On Dec. 19, attorneys for Wendy Dolin filed a petition with the U.S. Supreme Court, asking the nation’s high court to take up their appeal of the decision from the U.S. Seventh Circuit Court of Appeals in Chicago, which had found a federal jury was wrong to order drugmaker GSK to pay Dolin $3 million. In that decision, the appellate judges had essentially found GSK could not be held liable for the content of the warning label on its medication, because those labels were controlled by the U.S. Food and Drug Administration.
“The Seventh Circuit’s decision creates a world where a drug manufacturer is permitted under the First Amendment to promote its drug for non-FDA approved indications, … but a drug manufacturer is prohibited from issuing warnings concerning life threatening risks associated with its drug,” Dolin’s attorneys wrote in their petition.
The petition was filed about four months after a panel of three Seventh Circuit judges threw out the verdict in favor of Dolin, widow of lawyer Stewart Dolin, who killed himself in 2010 in a downtown Chicago transit station. Wendy Dolin alleged her husband was taking paroxetine, the generic version of GSK’s Paxil. She alleged the drug’s label, which was written by GSK and is identical for the name brand and generic versions, did not adequately warn the drug could increase the risk of suicide. Dolin alleged GSK knew of the alleged increased risk, yet chose not to revise the warning label.
Bijan Esfandiari Baum Hedlund Aristei & Goldman P.C.
GSK, however, said it tried several times to secure approval from the FDA to revise the label, but the FDA declined.
After years of proceedings in federal district court in Chicago, a jury found in favor of Dolin at trial. GSK appealed, and the Seventh Circuit overturned the verdict.
In the appellate decision, the judges, led by Circuit Judge David Hamilton, found GSK had asked the FDA four times to change the labels, but the FDA had ordered GSK to use standard language the FDA approved for paroxetine and other antidepressants. This showed GSK had no control over the labels, Hamilton said.
In their petition to the Supreme Court, however, Dolin’s lawyers said this finding represented a misreading of the case. They asserted the FDA had not disallowed the revisions, but rather had directed GSK to publish suicide risk warnings as a supplemental warning, known as a Changes Being Effected, or CBE, provision.
Dolin’s attorneys further argued the Seventh Circuit’s decision ignored key legal precedents, including the Supreme Court’s 2009 ruling in Wyeth v Levine, which held drug companies can revise labels to enhance warnings, without FDA approval.
Dolin’s attorneys painted the Seventh Circuit ruling as “unreasonable,” as it came despite contrary findings from “nine jurors and two distinguished district court judges reviewing the same facts” who “found that GSK was not prohibited from issuing stronger warnings.”
“There is no evidence the FDA ever rejected a paroxetine-specific adult suicide warning,” Dolin’s lawyers claimed. “The FDA’s invitation to GSK to use the CBE (which GSK could use unilaterally without the FDA’s invitation) to issue a paroxetine-specific adult suicidality warning in a place within the label that is outside the class labeling section can hardly be considered or interpreted as a rejection of a paroxetine-specific adult suicide warning.
“…It is akin to being invited to dance but construing that invitation as clear evidence of rejection.”
Dolin’s lawyers noted the Supreme Court is scheduled to hear arguments in a similar case, Merck v Albrecht.
In that case, the U.S. Third Circuit Court of Appeals came down on the question opposite the Seventh Circuit. In their decision, Dolin’s lawyers assert, the Third Circuit judges determined such labeling questions were appropriate for a jury, and “a reasonable juror could conclude that ‘the ball was in (drugmaker) Merck’s court’ to submit a revised CBE for the correct enhanced warning.”
Dolin’s lawyers asked the Supreme Court to delay action on their petition until resolving the Albrecht case. But after Albrecht, the lawyers asked the high court to vacate the Seventh Circuit decision and remand the case for new proceedings.
The petition was filed by attorneys Bijan Esfandiari, of the firm of Baum Hedlund Aristei & Goldman P.C., of Los Angeles, and David E. Rapoport and Mathew S. Sims, of the Rapoport Law Offices P.C., of Chicago.
GSK has been represented by attorney Lisa Blatt, of Arnold & Porter Kaye Scholer, of Washington, D.C., and by the firms of Dentons US LLP, of Chicago, and King & Spalding, of Atlanta.