The Eight Circuit Court of Appeals reinstated a case against drug maker Eli Lilly over a dangerous side effect of their anti-depressant medication Cymbalta. The court found that the company's practice of removing safety warnings from their sample packages contributed to a 16 year old boy's death from suicide.
The case in question involved the parents of a 16 year old boy who saw his family physician to discuss his problems with depression. The doctor gave the boy samples of Eli Lilly's Cymbalta; since they were not in the drug's complete packaging, they no longer contained the warning that the risk of suicide may increase when taking antidepressants. The family's doctor recalls warning the family that there may be an increased risk of suicide when taking an antidepressant, but he remembers noting that "no completed suicides (were observed) during clinical trials." He also told them that Cymbalta was never specifically studied.
In fact, there had been five completed suicides noted during Cymbalta trials funded by Eli Lilly. Yet when the family searched the drug maker's website, they found no mention of this fact. One month after beginning Cymbalta, the 16 year old boy committed suicide. One month after that, Eli Lilly updated Cymbalta warning labels to include the Food and Drug Administration (FDA) approved black box warning explaining the link between antidepressant use and increased suicide risk in young adults.
In order to sue the drug maker for failure to warn, the family and their attorneys had to prove that an appropriate warning label on the drug's prescribing information would have altered the warning their doctor shared with them. The court of appeals ruled in favor of the family, and the case will now be heard in the District Court for South Dakota.