J&J to Pay $2.2 Billion in Criminal/Civil Fines over Antipsychotic Drug Risperdal & 2 other drugs


The New York Times –
November 4, 2013
By Katie Thomas

Johnson & Johnson has agreed to pay $2.2 billion in criminal and civil fines to settle allegations that it improperly marketed the antipyschotic drug Risperdal and two other drugs, including promoting them for uses they weren’t approved for and paying kickbacks to physicians and a large long-term care pharmacy provider, the Department of Justice announced Monday.

In criminal documents filed Monday, federal officials said that Johnson & Johnson’s pharmaceutical unit, Janssen, promoted Risperdal to doctors with elderly dementia patients as a way to treat a host of ailments, like anxiety, agitation and depression, even though it was only approved for schizophrenia. During the period in question, from March 2002 to December 2003, federal officials said the company created written sales brochures for the company’s ElderCare sales force that minimized any mention that it was only approved for use in patients with schizophrenia.

Janssen pleaded guilty to a misdemeanor charge and acknowledged that it had promoted Risperdal to dementia patients who did not have schizophrenia. It will criminal fines totaling $485 million.

The company also agreed to pay $1.72 billion to settle civil cases with the federal government and 45 states. The fine also settles allegations that Johnson & Johnson improperly marketed a newer antipsychotic drug, Invega, as well as the heart failure drug Natrecor.

The settlement over the allegations involving Risperdal has long been anticipated, and the company said it had already accrued the amount needed to pay the fine.

The settlement has not yet been approved by a judge — a hearing is set for Thursday in federal court in Philadelphia.