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Johnson & Johnson to pay $181M to settle charges of off-label drug marketing

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Janssen Pharmaceuticals Inc. and its parent company, Johnson & Johnson, will pay a record multistate $181 million settlement to resolve charges it improperly marketed and advertised the anti-psychotic drugs Risperdal and Invega, New York Attorney General Eric T. Schneiderman said Thursday.

Mr. Schneiderman said in a statement that in a complaint filed Thursday in New York County Supreme Court, he charged that from 1998 through at least 2004, Titusville, N.J.-based Janssen engaged in deceptive and misleading practices when it marketed Risperdal, Risperdal Consta, Risperdal M-Tab and Invega for off-label, unapproved uses.

Those off-label uses included dementia in elderly patients, schizophrenia and bipolar disorder in children and adolescents, and depression, anxiety, obsessive compulsive disorder, conduct disorder, post-traumatic stress disorder and Alzheimer's disease, according to the statement.

Risperdal is approved to treat mental illnesses including schizophrenia, bipolar disorder and irritability associated with children and adolescents with autism, according to the attorney general's statement, while Invega is approved for schizophrenia and bipolar mania.

Among other provisions, the settlement prohibits Janssen from making false, misleading or deceptive claims regarding Risperdal or Invega, and requires it to report clinical research results regarding the drugs in an “accurate, objective and balanced manner,” according to the statement.

Thirty-six other states and the District of Columbia are joining in the settlement, which represents the largest multistate consumer protection-based pharmaceutical settlement in history, according to the statement.

Commenting on the settlement, Mr. Schneiderman said in the statement, “Pharmaceutical corporations' illegal promotion of drugs for off-label uses must stop. Consumers, including parents of children with serious mental disorders and vulnerable patients, should be able to trust their doctor's advice without fear that drug companies are manipulating their physician's independent judgment.

“This landmark settlement holds the companies accountable for practices that put patients in danger, and serves as a warning to other pharmaceutical giants that they must play by one set of rules. It goes further by ensuring that the corporations stop rewarding doctors for prescribing certain drugs or presenting scientifically suspect studies as sound.”

Janssen responded in a statement that the settlement is not an admission of wrongdoing and that it has agreed to it in order to “resolve the concerns of the attorneys general under state consumer protection laws and to avoid unnecessary expense and a prolonged legal process. All parties have acknowledged that payment is not a fine or penalty.”

Janssen President Michael Yang said in the statement, “We have chosen this path to achieve a prompt and full resolution of these state claims and to ensure we continue to focus on our mission of providing medicines to meet the significant unmet needs of many people who suffer from mental illness.”