Johnson & Johnson (J&J) and its subsidiary Janssen Pharmaceuticals have agreed to pay more than $2.2 billion to resolve criminal and civil allegations that the company marketed two powerful antipsychotic drugs, Risperdal and Invega, and one drug used to treat heart failure, Natrecor, for unapproved "off-label" uses. All three of the drugs were aggressively marketed by the company to control erratic behavior in vulnerable patients including children, seniors, and the mentally disabled. The settlement is the third largest settlement with a drug maker in U.S. history.
In 1993, Risperdal was approved for treatment of schizoprenia, but J&J soon began promoting the drug for "off-label" uses that helped the drug become its #1 selling product by 2005 with sales over $3.5 billion. In the plea agreement, Janssen admitted to promoting Risperdal as way to control behavior in seniors with dementia -- a use which is now explicitly prohibited on the drug's warning label because it can increase the risk of stroke and death in elderly patients.
In 1999 FDA had warned Janssen that marketing to Risperdal as a safe and effective for the elderly would be "misleading," but over the years the company persisted in targeting nursing homes, nursing home pharmacists, and doctors who treated the elderly. All the while, the company downplayed the drug's risks, including diabetes, weight gain, and risk of stroke. Meanwhile the company also increased marketing of Risperdal to child psychiatrists as a treatment for common childhood disorders, such as attention deficit disorder and autism.
The off-label uses of Risperdal, Invega, and Natrecor caused wasteful spending by federal and state health programs like the Department of Veterans' Affairs, Medicare, and Medicaid. As part of the settlement, the company agreed to pay $1.72 billion in civil payments to federal and state governments as well as $485 million in criminal fines and forfeited profits.
[1] Perrone, M. et al. "Johnson & Johnson To Pay $2.4 Billion To Resolve Drug Marketing Allegations," Huff Post (11/04/2013; 01/23/2014).
In 1993, Risperdal was approved for treatment of schizoprenia, but J&J soon began promoting the drug for "off-label" uses that helped the drug become its #1 selling product by 2005 with sales over $3.5 billion. In the plea agreement, Janssen admitted to promoting Risperdal as way to control behavior in seniors with dementia -- a use which is now explicitly prohibited on the drug's warning label because it can increase the risk of stroke and death in elderly patients.
In 1999 FDA had warned Janssen that marketing to Risperdal as a safe and effective for the elderly would be "misleading," but over the years the company persisted in targeting nursing homes, nursing home pharmacists, and doctors who treated the elderly. All the while, the company downplayed the drug's risks, including diabetes, weight gain, and risk of stroke. Meanwhile the company also increased marketing of Risperdal to child psychiatrists as a treatment for common childhood disorders, such as attention deficit disorder and autism.
The off-label uses of Risperdal, Invega, and Natrecor caused wasteful spending by federal and state health programs like the Department of Veterans' Affairs, Medicare, and Medicaid. As part of the settlement, the company agreed to pay $1.72 billion in civil payments to federal and state governments as well as $485 million in criminal fines and forfeited profits.
[1] Perrone, M. et al. "Johnson & Johnson To Pay $2.4 Billion To Resolve Drug Marketing Allegations," Huff Post (11/04/2013; 01/23/2014).
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