Global pharmaceutical giant Johnson & Johnson and its subsidiaries have agreed to pay more than $2.2 billion to settle criminal and civil allegations of off-label promotion of drugs and payment of kickbacks, the Department of Justice announced Monday.
The settlement is one of the largest in the history of healthcare fraud in the U.S., the DOJ said in a press release, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and 45 states totaling $1.72 billion.
[See also: Johnson & Johnson subsidiary settles deceptive marketing case for $181M]
In the plea agreement to resolve the criminal charges, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, pled guilty to misbranding the antipsychotic drug Risperdal for non-approved uses, such as treating elderly dementia patients for symptoms such as anxiety, agitation, depression, hostility and confusion.
Janssen will pay a criminal fine of $334 million and forfeiture of $66 million. Janssen’s guilty plea will not be final until accepted by the U.S. District Court, the DOJ said in the press release.
The civil agreement, totaling about $1.6 billion, resolves multiple allegations filed by whistle-blowers under the False Claims Act, including off-label promotion of Risperdal, Invega, a newer antipsychotic drug, and Natrecor, a heart failure drug, and kickbacks to long-term care pharmacy provider, Omnicare. Omnicare paid $98 million in 2009 to settle its side of the allegations.
The civil agreement settles allegations only, noted Johnson & Johnson in a statement released Monday. “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 statement reads.
[See also: Feds said to reject $1B Risperdal settlement offer from Johnson & Johnson]
The company also noted that Risperdal continues to maintain FDA approval for the drug’s intended use.
Because the company had previously accounted for the settlement, no additional charges to the company’s earnings will be recorded, Johnson & Johnson said in the statement.
As part of the civil and criminal agreements, the company is taking part in a five-year corporate integrity agreement with the Department of Health and Human Services’ Office of Inspector General.