New York state will receive nearly $9 million as part of a $181 million settlement between 37 states and the District of Columbia and Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc. over allegedly deceptive marketing practices.
The plaintiffs charged that Janssen Pharmaceuticals, from 1998 through 2004, engaged in deceptive and misleading practices in marketing Risperdal, Risperdal Consta, Risperdal M-Tab and Invega for off-label uses.
Johnson & Johnson maintained the settlement is not an admission of wrongdoing or a violation of any law or regulation.
New York Attorney General Eric Schneiderman said 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.
“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,” Schneiderman said in a statement. “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 approved 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 disorder.
The complaint charged that Janssen promoted Risperdal for unapproved uses, including 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.
The complaint also charged that Janssen concealed and misrepresented information regarding the side effects and efficacy of Risperdal.
The settlement in part requires Janssen to report clinical research results regarding Risperdal or Invega in an accurate, objective and balanced manner; disclose on its website a searchable list of all health care providers and related entities that received any payments directly or indirectly from Janssen; and provide accurate, objective and scientifically balanced responses to requests for off-label usage information by doctors