The resolution exceeded $2.2 billion, comprising $485 million in criminal fines and forfeiture and $1.72 billion in civil settlements. Pediatric Risperdal marketing was a civil allegation; Janssen’s criminal plea concerned promotion to elderly non-schizophrenic dementia patients.
In addition to promoting Risperdal for elderly dementia patients, from 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities.
The resolution exceeded $2.2 billion, comprising $485 million in criminal fines and forfeiture and $1.72 billion in civil settlements. Pediatric Risperdal marketing was a civil allegation; Janssen’s criminal plea concerned promotion to elderly non-schizophrenic dementia patients. The complaint alleged FDA had not approved Risperdal for any pediatric use until late 2006. Except for criminal pleas, settled claims were allegations only with no determination of liability.