Janssen Pharmaceuticals, Inc., and its parent company Johnson & Johnson, agreed Thursday to a multi-state settlement to resolve charges of improper marketing and advertising of the anti-psychotic drugs Risperdal and Invega. The company will pay $181 million to 36 states and the District of Columbia.
Prosecutors charged that Janssen Pharmaceuticals has engaged in deceptive and misleading practices for years by marketing Risperdal, Risperdal Consta, Risperdal M-Tab and Invega for off-label uses. As a result of the 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.
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. Additionally, the complaint charged that Janssen concealed and misrepresented information regarding the side effects and efficacy of Risperdal thereby putting patients at risk.
“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,” New York’s attorney general Eric T. Schneiderman said, in a press release. “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.”
Although Janssen agreed to the conditions of the settlement, the company did not admit to any wrongdoing.
A press released issued Thursday by Johnson & Johnson said, “As part of the settlement, Janssen reaffirmed it would not promote any of its atypical antipsychotics for off-label uses or make any false or misleading claims related to those products. The company takes its obligation to ensure the safe and appropriate use of its medications very seriously and has a system in place to ensure that marketing and promotion policies are followed.”
“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,” Michael Yang, Janssen president, said in the release.