Johnson & Johnson and its subsidiaries, Janssen Pharmaceuticals and Scios have finalized previously disclosed settlement agreements with the U.S. Department of Justice (DOJ) and 45 states resolving federal investigations and state Medicaid claims related to past promotional practices of Risperdal (risperidone) from 1999 through 2005, and other matters. The resolution includes total settlement amounts of approximately $2 billion to the federal government and state Medicaid programs, an amount previously accrued, and no additional charge to the company’s earnings will be recorded in connection with this settlement.

Janssen will plead guilty to a single misdemeanor violation of the Food, Drug and Cosmetic Act for past promotional practices of Risperdal, subject to approval by the U.S. District Court. The agreement also resolves allegations related to the sales and marketing of Invega, Natrecor by Scios, and allegations related to Janssen’s interactions with Omnicare. The company has cooperated with the government since the separate investigations began nearly a decade ago, and the agreements resolve all related federal criminal and federal civil liabilities on these matters. Janssen accepts accountability for the actions described in the misdemeanor plea. The settlement of the civil allegations is not an admission of any liability or wrongdoing, and the company expressly denies the government’s civil allegations.   

The civil matters concerning Risperdal involved numerous discussions with the FDA, dating back to 1994. This resolution does not change the FDA’s approval of Risperdal as safe and effective for its approved indications. Risperdal is supported by more than 20 years of extensive research and clinical studies and remains an important treatment option for people with serious mental illness. Risperdal continues to be appropriately reimbursed by Medicare and Medicaid. 

“Today we reached closure on complex legal matters spanning almost a decade. This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients around the world,” said Michael Ullmann, vice president and general counsel, Johnson & Johnson. “We remain committed to working with the FDA and others to ensure greater clarity around the guidance for pharmaceutical industry practices and standards.”

The resolution also includes a five-year corporate integrity agreement (CIA) between the Office of Inspector General of the U.S. Department of Health and Human Services and Johnson & Johnson.  Johnson & Johnson and its subsidiaries have compliance programs that have been continually strengthened and that will continue as part of this agreement. The CIA is largely consistent with existing compliance programs, and reflects the companies’ commitment to ensuring integrity in the delivery of essential medicines to patients.

Janssen will pay $400 million and plead guilty to a one-count misdemeanor misbranding charge. Janssen and Scios will pay approximately $1.6 billion to settle three pending civil False Claims Act cases in federal district courts related to Risperdal and Invega, Natrecor and Omnicare.