Following their 16-year-old’s suicide, a Pennsylvania couple brought a federal lawsuit against the manufacturer of the antidepressant drug Paxil. The parents claimed that the drug manufacturer knew of the specific risks of teen suicides from their drug, but neglected to warn doctors, parents, and teens about the risks.
The Pennsylvania doctor had initially treated the teenager for acne, prescribing a strong prescription drug, Accutane, that has been linked to mood changes and suicides in teenagers. The teenager returned to the negligent doctor, complaining of nausea and redness of his skin. The doctor misdiagnosed dysmorphic disorder, a psychological condition where a “normal- appearing” person is preoccupied with some imagined defect in appearance.
Wrong Medication Prescribed
Concerned that the boy’s body dysmorphic disorder could worsen into depression and lead to suicidalor hostile behavior, the negligent doctor prescribed the antidepressant Paxil, despite the fact that it is not approved for use by teenagers. The teenager took Paxil for several months, stopped for several months, and then resumed taking Paxil without ever telling the family doctor of his having stopped. Three days after resuming the Paxil, the boy committed suicide. The physician was not liable because, at the time the doctor prescribed Paxil, the package insert did not include any warnings of increased risk of suicide and did not include any pediatric dosage recommendations.
The drug company denied any liability and claimed that since the Food and Drug Administration (FDA) did not require suicide warnings on the drug packaging, no warnings were necessary.
Adult Use Only
In refusing to dismiss the lawsuit, the federal judge noted that, while the FDA firmly dismissed any links between Paxil and adult suicides, the FDA had not addressed warnings for children and teenagers because Paxil simply is not FDA approved except for adult use. The judge decided that if the drug manufacturer “indeed possessed information, not available to the FDA, upon which it could have unilaterally added a warning to its labeling,” a jury could find the manufacturer liable for the teenager’s death.