NY Attorney General Eric Schneiderman announced a record $181 million settlement with Janssen Pharmaceuticals and its parent company Johnson & Johnson to resolve charges of improper marketing and advertising of the powerful anti-psychotic drugs Risperdal and Invega.
The settlement, joined by New York and 36 other states and the District of Columbia, represents the largest multi-state consumer protection-based pharmaceutical settlement in history. New York will receive nearly $9 million.
The other states that were part of today’s settlement are Alabama, Arizona, Colorado, Connecticut, Delaware, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin and Wyoming.
In a complaint filed in New York County Supreme Court, Attorney General Schneiderman charged that from 1998 through at least 2004, Janssen engaged in deceptive and misleading practices when it marketed Risperdal, Risperdal Consta, Risperdal M-Tab and Invega for off-label uses.
As a result of the states’ investigation, Johnson & Johnson agreed to change its marketing of Risperdal and Invega, and to cease promoting “off-label” uses of the drugs not approved by the FDA.
“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,” Attorney General Schneiderman said. “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.”
Risperdal is an anti-psychotic medication used to treat mental illnesses including schizophrenia, bi-polar disorder and irritability associated with children and adolescence with Autism.
Invega, which is derived from risperdone, is also marketed for the treatment of schizophrenia and bipolar mania. The complaint charged that Janssen promoted Risperdal for unapproved uses, including dementia in elderly patients, schizophrenia and bi-polar disorder in children and adolescents, and depression, anxiety, obsessive compulsive disorder, conduct disorder, post-traumatic stress disorder, and Alzheimer’s disease. Further, the complaint charged that Janssen concealed and misrepresented information regarding the side effects and efficacy of Risperdal thereby putting patients at risk.
The settlement also requires Janssen to report clinical research results regarding Risperdal or Invega in an accurate, objective and balanced manner; disclose on its website a searchable listing of all HCPs and related entities who or which received any payments directly or indirectly from Janssen; provide clear and conspicuous disclosure of the risks associated with the use of Risperdal or Invega in all of its promotional materials; and provide accurate, objective and scientifically balanced responses to requests for off-label usage information by doctors.