File photo of hydrocodone bitartrate and acetaminophen pills, also known as Vicodin
Washington:
Johnson & Johnson will pay $2.2 billion to the US government to end civil and criminal investigations into kickbacks to pharmacists and the marketing of pharmaceuticals for off-label uses, a person familiar with the settlement said on Monday.
The settlement with the company and its subsidiaries covers the marketing of schizophrenia treatment Risperdal and of heart drug Natrecor, said the source, who spoke on condition of anonymity.
Risperdal is sold by J&J unit Janssen Pharmaceuticals Inc, which is expected to plead guilty to misdemeanor allegations of misbranding, the source said.
J&J disclosed in a securities filing in 2011 it had reached an agreement to resolve criminal penalties related to the promotion of Risperdal, a one-time big-selling product for the company, but that certain issues remained open.
Attorney General Eric Holder was scheduled to speak about the settlement at a news conference at the US Justice Department at 11:15 a.m. EST (1615 GMT).
As part of the settlement, Justice Department lawyers filed a civil complaint against J&J in US District Court for the Eastern District of Pennsylvania on Monday. A settlement agreement was expected to be filed as well.
From at least 1999 through 2005, J&J and Janssen promoted Risperdal for such unapproved uses as controlling aggression in elderly dementia patients and treating behavioral disturbances in children, according to the complaint.
The off-label marketing caused US government insurance programs to pay hundreds of millions of dollars for uncovered claims, the complaint said.
The settlement with the company and its subsidiaries covers the marketing of schizophrenia treatment Risperdal and of heart drug Natrecor, said the source, who spoke on condition of anonymity.
Risperdal is sold by J&J unit Janssen Pharmaceuticals Inc, which is expected to plead guilty to misdemeanor allegations of misbranding, the source said.
J&J disclosed in a securities filing in 2011 it had reached an agreement to resolve criminal penalties related to the promotion of Risperdal, a one-time big-selling product for the company, but that certain issues remained open.
Attorney General Eric Holder was scheduled to speak about the settlement at a news conference at the US Justice Department at 11:15 a.m. EST (1615 GMT).
As part of the settlement, Justice Department lawyers filed a civil complaint against J&J in US District Court for the Eastern District of Pennsylvania on Monday. A settlement agreement was expected to be filed as well.
From at least 1999 through 2005, J&J and Janssen promoted Risperdal for such unapproved uses as controlling aggression in elderly dementia patients and treating behavioral disturbances in children, according to the complaint.
The off-label marketing caused US government insurance programs to pay hundreds of millions of dollars for uncovered claims, the complaint said.
© Thomson Reuters 2013
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