Originally published August 24 2012
Parents of Cymbalta suicide victim can sue drug maker for deceit and failure to warn, court rules
by J. D. Heyes
(NaturalNews) The parents of a South Dakota teen who committed suicide while taking the drug Cymbalta, an antidepressant, can sue the pharmaceutical manufacturer for failing to warn about the risks, the U.S. 8th Circuit Court of Appeals ruled.
According to reports, 16-year-old Peter Schilf died of a self-inflicted gunshot wound in 2004 after being given samples of the drug by Dr. Richard Briggs, the family physician, in part because he thought Cymbalta was less of a suicide risk than other antidepressants such as Prozac.
However, reports said, Briggs apparently was unaware that the drug maker, Eli Lilly & Co., had sponsored five clinical trials of the drug that separated it from other antidepressants, and that the Food and Drug Administration had issued an advisory saying pharmaceutical manufacturers would be required to carry "black box" labels on their antidepressants, warning healthcare providers and consumers of an increased risk of suicide among younger patients with major depression and other psychological disorders.
The samples that Briggs provided to Schilf had been taken out of their original packaging and did not contain the FDA-mandated warnings, Courthouse News Service reported. The youth's father, Paul Schilf, told the court he researched the medicine with his son and that had he known of the increased suicide risk, he would not have let his son take it.
The youth committed suicide one month after beginning his Cymbalta treatments.
The right decision in a divided court?
In court in St. Louis, home of the 8th Circuit, Briggs testified that he was unaware there were five suicides during the Eli Lilly's Cymbalta clinical trials. He also said the pharmaceutical company failed to warn about the causal connection between the drug and an elevated risk of suicide.
Eli Lilly revised its packaging and Cymbalta literature to include the FDA-directed warning one month after Schilf's death.
The divided appeals court ruling reverses a lower federal court ruling which initially granted summary judgment to Eli Lilly.
In writing for the majority, Judge William Benton said the 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."
"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," Benton continued. "There are genuine issues of material fact whether an adequate warning would have changed Dr. Briggs' decision to prescribe Cymbalta to Peter."
What he knew, and when he knew it
"Dr. Briggs recalls telling them that while there 'may be an increased association with antidepressants and suicidal ideations and gestures,' '[n]o completed suicides occurred
during the clinical trials,' and 'Cymbalta was not specifically studied,'" court documents said.
"In fact, there were five completed suicides in Lilly-sponsored clinical trials of Cymbalta, which was studied separately from the drugs Dr. Briggs referenced," the documents said. "Just over a month before Peter's appointment, the FDA issued a Public Health Advisory telling the public that it directed manufacturers of antidepressants to include in their packaging a 'black box' warning: 'Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders.'"
Judge Raymond Gruender partly dissented, writing that 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."
"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," Gruender wrote.
Sources:
http://www.marketwatch.com
http://www.courthousenews.com/2012/08/13/49204.htm
http://www.courthousenews.com/2012/08/13/Schilf.pdf
All content posted on this site is commentary or opinion and is protected under Free Speech. Truth Publishing LLC takes sole responsibility for all content. Truth Publishing sells no hard products and earns no money from the recommendation of products. NaturalNews.com is presented for educational and commentary purposes only and should not be construed as professional advice from any licensed practitioner. Truth Publishing assumes no responsibility for the use or misuse of this material. For the full terms of usage of this material, visit www.NaturalNews.com/terms.shtml