Johnson & Johnson (J&J) and its subsidiaries have agreed to pay more than $2.2 billion to resolve criminal and civil cases arising from the marketing of the prescription drugs Risperdal, Invega and Natrecor for uses not approved by the Food and Drug Administration, and from payment of kickbacks related to promotion of those drugs. The settlement is one of the largest health care fraud resolutions in the nation’s history. J&J will also be subject to a 5 year Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General (OIG).
A criminal information filed against Janssen Pharmaceuticals, Inc. (Janssen), a J&J subsidiary, alleges that the company promoted Risperdal, a prescription used for the treatment of schizophrenia, for unapproved, off-label use in non-schizophrenic dementia patients. Additionally, a civil complaint has been filed against Janssen, including allegations that Janssen violated the False Claims Act by submitting claims for off-label use of Risperdal that federal health care programs do not cover, making false and misleading statements about the efficacy of Risperdal, and paying kickbacks to physicians for prescribing Risperdal. Further, the complaint alleges that J&J and Janssen were aware that Risperdal posed an increased risk of strokes in the elderly and health risks to children, but continued to promote the drug to both vulnerable populations. J&J and Janssen also allegedly paid kickbacks to Omnicare Inc. (Omnicare), the nation’s largest pharmacy for dispensing drugs to nursing home patients. Omnicare’s consultant pharmacists allegedly provided routine recommendations to nursing home physicians to prescribe Risperdal and other J&J drugs to its elderly patients. The settlement against J&J and Janssen further alleges that the companies promoted Invega, a new antipsychotic drug, for unapproved, off-label use, and that they made false and misleading statements about the drug’s safety and efficacy.
The civil settlement involves another of J&J’s subsidiaries, Scios Inc. (Scios), which allegedly submitted false claims related to the heart failure drug Natrecor. Scios promoted an unapproved, outpatient use of the drug by sponsoring an extensive physician speaker program and urging doctors and hospitals to set up outpatient clinics specifically to administer infusions of the unapproved outpatient drug, sometimes providing funds to defray the costs of setting up the clinics.
The Department of Justice news release is available at:
Department of Justice. “Johnson & Johnson to Pay More than $2.2 Billion to Resolve Criminal and Civil Investigations.” Justice News. 4 Nov. 2013.