Janssen Pharmaceuticals and parent company Johnson & Johnson, after marketing anti-psychotic drug Risperdal off-label, will now pay $2.2 billion to settle criminal and civil lawsuits. The settlement will be one of the largest penalties of healthcare fraud ever levied in the United States.
Janssen will plead guilty to a criminal misdemeanor charge of misbranding Risperdal after branding the drug for uses not approved by the Food and Drug Administration (FDA). Janssen settled civil claims for unapproved marketing of Risperdal towards children, the elderly, and the mentally disabled, paying kickbacks to doctors and pharmacies. Other drugs, including the anti-psychotic drug Invega and heart drug Natrecor, were included in the civil settlement. The civil settlement also resolves three whistle-blower lawsuits filed under the False Claims Act.
Risperdal was approved by the FDA in 1993 for managing manifestations of psychotic disorders. Janssen would eventually sell or attempt to sell Risperdal for diseases such as dementia, bipolar disorder, and other mood disorders.
Lawsuits are still pending in Arkansas, Louisiana, and South Carolina. Judges and juries in those states have awarded about $1.8 billion in damages, fines, and attorneys fees.
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Risperdal® and Invega® are registered trademarks of Johnson & Johnson. Natrecor® is a registered trademark of Scios Inc.