$2.2 Billion Risperdal Anti-Psychotic Drug Settlement
Written by James P. Nevin
Janssen, part of the well-known Johnson & Johnson company, pled guilty to misbranding its anti-psychotic medication Risperdal in a $2.2 billion dollar settlement. The company entered a guilty plea to one misdemeanor ending a complex legal case spanning almost a decade.
The settlement is the largest in U.S. history involving a single drug. It's the result of four lawsuits filed in federal court in Philadelphia by whistle-blowers under the False Claims Act, which allows private citizens to sue on behalf of the government and share in the recoveries.
Janssen pled guilty to marketing the drug for uses not approved by the U.S. Food and Drug Administration. The company settled civil claims that it marketed Risperdal without approval for the elderly, children and the mentally disabled. Janssen allegedly sought to sell Risperdal to elderly patients for a wide range of off-label treatments including bipolar, dementia, and mood and anxiety disorders, the drug was only approved for the management of psychotic disorders. Through the company's ElderCare sales force the drug was promoted to nursing homes even though it had never been tested on the elderly in clinical trials. The company has denied civil claims that it paid kickbacks to physicians and Omnicare Inc., the largest pharmacy for nursing homes.
As part of the settlement Johnson & Johnson signed a five-year corporate integrity agreement with the inspector general of the Department of Health and Human Services. Part of that agreement includes accountability, according to U.S. District Judge Timothy Savage, "this company is going to be under a magnifying glass for a period of time."