New York State Attorney General Eric Schneiderman on Wednesday 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 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.
In the complaint filed Wednesday in New York County Supreme Court, Attorney General Schneiderman charged that from 1998 through at least 2004, Janssen Pharmaceuticals 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 U.S. Food and Drug Administration (FDA).
Off-label use refers to prescribing a drug for a condition other than what it’s been approved for, or to an age group other than that for which the drug was originally intended.
“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,” Schneiderman said.
Risperdal is an anti-psychotic medication used to treat mental illnesses including schizophrenia, bipolar disorder and irritability associated with children and adolescents 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.
The other states that were part of Wednesday’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.