Laurie Stupak [B.J.'s mother] claimed that Roche was liable under negligence and strict liability for failing to warn that its prescription acne medication Accutane could cause suicide without premonitory [warning] symptoms.The package of Accutane that B.J. Stupak was taking warned only of "changes in mood," although the Physician's Desk Reference said:
... may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide.The court ruled that because Roche did not know at the time that patients on Accutane could experience a desire to kill themselves without any warning signs, that the Stupaks could not sue the company:
Because Stupak has failed to identify any evidence in the record that Roche knew or should have known that Accutane could cause suicide without premonitory symptoms, we affirm the district court's grant of summary judgment.Stupak, D-Mich., has been a critic of Accutane for years -- both his sons took it. He told his story to a Congressional hearing in 2002.
The Drug and Device Law blog notes that the ruling, from the 11th Circuit Court of Appeals is unpublished but may nonetheless influence the trial judge to turn down other cases.