By Tom Zanki | Email | Twitter
Johnson & Johnson and its subsidiaries have agreed to pay more than $2.2 billion to settle criminal and civil allegations the company promoted prescription drugs for uses not approved by the U.S. Food and Drug Administration, and paid kickbacks to physicians to pharmacists, the Department of Justice announced today.
The Justice Department said the settlement is one of the largest health care fraud settlements in U.S. history. Johnson & Johnson denies the government charges and said settlement of civil allegations does not amount to an admission of liability or wrongdoing.
The settlement involves the company's promotion of schizophrenia drug Risperdal from 1999 to 2005. The agreement also resolves allegations related to sales and marketing of Invega, also a schizophrenia drug, and Natrecor by Scios Inc., which treats heart failure, and allegations related to Janssen's interactions with pharmacy provider Omnicare Inc.
Under the criminal resolution, Janssen will pay $400 million and plead guilty to a one-count misdemeanor misbranding charge regarding Risperdal. Under the civil settlement, Janssen and Scios will pay about $1.6 billion to settle three pending civil False Claims Act cases in federal district courts related to Risperdal, Invega, Natrecor, and Omnicare.
Johnson & Johnson said has been setting aside funds for settlement and said no additional charge to the company's earnings will be accrued in connection with this settlement.