(CN) – Parents of a South Dakota teenager who committed suicide while taking the antidepressant Cymbalta can sue the drug’s makers for failure to warn and deceit, the 8th Circuit ruled.
Dr. Richard Briggs, a family physician, allegedly gave samples of Cymbalta to 16-year-old Peter Schilf in 2004, partly because he believed this drug was less linked to suicide than other antidepressants like Prozac.
But the doctor apparently did not know that Eli Lilly & Co. had sponsored five clinical trials of Cymbalta, studying it separately from other antidepressants. There was also a Food and Drug Administration advisory that said drugmakers would have to include “black box” warnings on their antidepressants, informing consumers about the increased risk of suicidality in children and teens with major depressive disorder and other psychiatric disorders.
The Cymbalta samples given to Schilf had been removed from their packaging and contained no warning information.
Schilf’s father, Paul, says he researched Cymbalta with his son, and would not have let the teen take the medication if they saw a warning about suicidality.
Schilf committed suicide one month later in December 2004, and his parents sued Eli Lilly and Quintiles Transnational Corp.
The physician who gave Schilf the Cymbalta samples testified that he did not know five suicides occurred during Cymbalta clinical trials. He also said that Eli Lilly failed to warn about a causal connection between its product and suicidality.
Eli Lilly revised the Cymbalta literature to include the FDA-approved black box warning one month after Schilf’s death.
A federal judge granted summary judgment to the drugmakers after finding that Briggs prescribed Cymbalta with knowledge of its risks.
But the St. Louis-based federal appeals court said that this decision was in error.
“The District Court relied heavily on Dr. Briggs’ statement that he still believed his prescription decision was appropriate, finding that he testified that ‘he would prescribe Cymbalta for Peter Schilf given adequate warnings,'” Judge William Benton wrote for a three-member panel.
“Dr. Briggs’ testimony and behavior indicate that knowledge of the five suicides during the Cymbalta trials or of any causal role for Cymbalta in inducing suicidality may have changed his prescribing behavior,” he added. “There are genuine issues of material fact whether an adequate warning would have changed Dr. Briggs’ decision to prescribe Cymbalta to Peter.”
“There are genuine issues of material fact whether an adequate warning would have changed Dr. Briggs’ decision to prescribe Cymbalta to Peter,” the decision states.
Judge Raymond Gruender partly dissented.
“Dr. Briggs testified that he warned Peter and Cynthia about the risk of pediatric suicide, repeatedly asked Peter whether he was having suicidal thoughts, and asked Cynthia to watch for suicidal tendencies,” Gruender wrote.
“Dr. Briggs’s undisputed testimony establishes that he was familiar with the PHA [public health advisory] warning of an increased risk of suicidality in pediatric users of antidepressants and the need to warn pediatric Cymbalta users and their families to watch for signs of suicidal tendencies.”