PHILADELPHIA--(EON: Enhanced Online News)--Global healthcare giant Johnson & Johnson has agreed for its subsidiary Janssen Pharmaceuticals to plead guilty to criminal charges and Johnson & Johnson will pay $2.2 billion to resolve criminal and civil liability arising from their unlawful promotion of certain prescription drugs, the Justice Department announced today. The global resolution is one of the largest healthcare fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.
Johnson & Johnson subsidiary Janssen Pharmaceuticals, Inc. has agreed to plead guilty to two counts of introducing a misbranded drug, Risperdal, into interstate commerce in violation of the Food, Drug, and Cosmetic Act. The criminal plea agreement also includes certain non-monetary compliance commitments that the federal government will enforce through a Corporate Integrity Agreement entered into between it and Johnson & Johnson.
Johnson & Johnson and Janssen will also pay $1.273 billion to resolve its civil liabilities with the federal government under the False Claims Act, as well as the states. The civil settlement resolves claims relating to the Johnson & Johnson/Janssen drugs Risperdal, Invega, and Natrecor.
The government's case against Johnson & Johnson and Janssen was based partly on a qui tam lawsuit filed by attorney Thomas W. Sheridan of the law firm of Sheridan and Murray, LLC 1600 Market St., Suite 2500 Philadelphia PA 19103 (215-977-9500) on behalf of a former marketing manager at Janssen. The federal whistle-blower law, entitled the False Claims Act, was enacted in 1863 and was originally designed to restrict war profiteering following the American Civil War. The False Claims Act prohibits people or businesses from defrauding the government and provides incentives for individuals who suspect wrongdoing to come forward. The qui tam lawsuit filed by Sheridan provided the government with information relating to a range of improper marketing practices on the part of Johnson & Johnson/Janssen relating to the drug Risperdal from 1999 through 2005 and the drug Invega from 2007 through 2009.
Johnson & Johnson/Janssen promoted the sale and use of its drug Risperdal for individuals and specific conditions for which it was not approved as safe and effective by the FDA. Johnson & Johnson/Janssen improperly promoted the sale and use of Risperdal for behavioral disturbances in elderly dementia patients. Johnson & Johnson/Janssen improperly promoted the sale and use of Risperdal for treatment of children and adolescents under the age of 18 suffering from conduct disorders and attention deficit hyperactivity disorders. Johnson & Johnson/Janssen improperly promoted the sale and use of Risperdal to treat conduct disorders in individuals with mental retardation and developmental disabilities.
The lawsuit filed by Sheridan provided information that Johnson & Johnson/Janssen were improperly marketing and promoting the sale and use of Risperdal to highly vulnerable patients including elderly dementia patients, children and adolescents and a significant number of Americans suffering from developmental disabilities and mental retardation. The lawsuit filed by Mr. Sheridan also provided information regarding Johnson & Johnson/Janssen's illegal payments to health care professionals and long-term pharmacy care providers to improperly promote and prescribe Risperdal in violation of the Federal Anti-Kickback Statute.
DOJ documents can be located at the below links