An appellate court has reinstated a failure-to-warn suit against Eli Lilly & Co. brought by the parents and estate of a 16-year-old South Dakota boy who committed suicide after taking the antidepressant drug Cymbalta.
On Aug. 3, a divided panel of the U.S. Court of Appeals for the Eighth Circuit reversed a decision by a district court in South Dakota granting summary judgment to the pharmaceutical giant. Shook, Hardy & Bacon represented Eli Lilly, while Perdue Kidd & Vickery and Jim Leach represented Paul and Cynthia Schilf, whose son, Peter, killed himself on Christmas Eve of 2004, and Peter Schilf’s estate.
The Schilfs had sued Eli Lilly in 2007, alleging that the company had failed to adequately warn doctors of the dangers of prescribing Cymbalta to children and adolescents, which included an increase in suicidal thoughts. Citing the “learned intermediary” doctrine, the district court found that the company’s warnings were adequate and that Peter Schilf’s physician prescribed Cymbalta in spite of those risks. In its appellate brief, Eli Lilly also claimed that the Food and Drug Administration directed it not to change its labeling until the agency formally approved the addition of the suicide warnings, which did not happen until January 2005 — one month after Peter Schilf’s death. Citing the Supreme Court’s pre-emption ruling last year in Pliva v. Mensing , Eli Lilly argued that it could not have acted without FDA approval, and that Mensing insulates it from having to spread warnings through other means, such as “dear doctor” letters.
In a nine-page opinion, the majority found that there were genuine issues of fact as to whether Peter Schilf’s doctor had enough information about Cymbalta and whether he would have prescribed the drug had he known about its side effects. Judge William Benton cited testimony that Peter Schilf’s doctor was not aware of a clinical study of Cymbalta sponsored by Eli Lilly in which five suicides took place, and that the doctor had chosen Cymbalta because of an FDA study finding that the drug was linked to suicide less than other antidepressants, such as Prozac. Additionally, the majority turned aside Eli Lilly’s pre-emption argument, finding simply that the company’s argument “would not resolve this case” and that Eli Lilly could have passed along the information through its salespeople.
In a dissent, Judge Raymond Gruender argued that the doctor was aware of an FDA press release that addressed links between antidepressants and suicide, and Eli Lilly should have prevailed on summary judgment.
The Schilfs’ lawyers told Legal affiliate The American Lawyer that they were extremely pleased with the decision. “The evidence showed that [Eli Lilly] was more concerned with marketing their drug and gaining market share rather than issuing full warnings,” said James Perdue Jr. of Perdue Kidd & Vickery, who represented the Schilfs alongside his partner, lead trial counsel Andy Vickery. Lead appellate lawyer Leach added that Eli Lilly’s reliance on Mensing was misguided, because that case dealt with generic drugs, not branded drugs like Cymbalta. “They could have changed the label, they could have written a dear-doctor letter, they could have given out information with their salespeople, or they could have put it on their website,” Leach said. “Doctors can’t do research on every single drug out there. They need drug manufacturers to keep them informed.”
Eli Lilly’s attorney, Andrew See of Shook Hardy, referred comment to his client. “We are disappointed in the Eighth Circuit court’s ruling and continue to believe this lawsuit is unjustified,” a spokesperson for Eli Lilly said in an email. “Suicide is always difficult to understand, especially when a young person is involved, and all of us can sympathize with a family living with such a terrible loss. However, based on the relevant facts of this case, we strongly believe that Cymbalta did not play a role in this young man’s death.”
Victor Li is a reporter for The American Lawyer, a Legal affiliate based in New York. This article first appeared on The Am Law Litigation Daily at www.americanlawyer.com. •