The Eighth Circuit Court of Appeals reinstated a failure to warn lawsuit against Eli Lilly over Cymbalta on Friday.
The appellate court found that there was a genuine issue of material fact regarding whether Lilly’s failure to warn about increased suicide risks among teens would have affected the plaintiff’s doctor’s decision to prescribe Cymbalta.
Cynthia Schilf took her 16-year-old son Peter to discuss his depression with their family practitioner, Dr. Richard G. Briggs, in 2004. Dr. Briggs diagnosed Peter with depression and gave him samples of the antidepressant medication Cymbalta. The samples had been removed from the packaging and thus had no warning information.
Dr. Briggs spoke with Cynthia and Peter about the risks of antidepressant treatment. Dr. Briggs recalls telling them that while there "may be an increased association with antidepressants and suicidal ideations and gestures ... no completed suicides occurred during the clinical trials," and "Cymbalta was not specifically studied."
Dr. Briggs was referencing an FDA study and chose to prescribe Cymbalta in part because he believed it was less linked to suicide than another antidepressant evaluated in that study, Prozac. In fact, there were five completed suicides in Lilly-sponsored clinical trials of Cymbalta, which was studied separately from the drugs Dr. Briggs referenced.
According to court documents, Peter and his father searched the internet for Cymbalta and found Lilly's website. Peter's father testified that if he had noticed a warning about suicidality, he would not have allowed Peter to take the medication. A month after he received the Cymbalta samples, Peter committed suicide.
One month later, Lilly revised the Cymbalta literature to include FDA-approved black box warnings about the link between anti-depressants and increased suicide risk among adolescents.
To survive summary judgment on a failure to warn claim, the Schilfs had to establish that there was a genuine issue of material fact whether an adequate warning would have altered Dr. Briggs' decision to prescribe Cymbalta. The district court granted summary judgment to Lilly, finding that "a warning from [Lilly] would not have informed Dr. Briggs of anything he did not already know" about the risks of Cymbalta.
The Schilfs appealed to the Eighth Circuit Court of Appeals, arguing that the district court erred because the following available warnings would have affected Dr. Briggs decision:
- Five suicides occurred during Cymbalta clinical trials (including one during a trial for a condition other than depression).
- There is a causal role for Cymbalta in suicidality.
- The suicide risk in taking antidepressants is increased in children and adolescents.
The Eighth Circuit agreed, finding genuine issues of material fact as to whether Dr. Briggs knew the suicide-related information that an adequate warning would have contained, and as to whether he would have prescribed Cymbalta if he had the information.
The case has been remanded to the District Court for South Dakota.
- Paul Schilf v. Eli Lilly & Company (Eighth Circuit Court of Appeals)
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- Antidepressants: Are FDA Warnings Keeping People From Getting Help? (FindLaw's Injured)