More than half of the $2.3 billion in fines the U.S. Attorney’s Office for the Eastern District of Pennsylvania received during the 2014 fiscal year came from consumer health care giant Johnson & Johnson over off-label marketing of drugs.
“Recouping federal funds that were misspent due to fraud, including substantial health care and mortgage insurance funds, is a critical part of our mission,” U.S. Attorney David Memeger said in a statement. “Our nation’s taxpayers deserve our most aggressive efforts to recover their hard-earned tax dollars that have been misappropriated. During fiscal year 2014, we continued to honor this mission with these tremendous resolutions and collections.”
The office received more than $1.6 billion from Johnson & Johnson in civil and criminal penalties from a November 2013 settlement regarding misbranding and off-label use claims involving the company’s antipsychotic drug Risperdal as well as other drugs. Johnson & Johnson paid $1.273 billion to resolve False Claims Act allegations involving Risperdal and the schizophrenia drug Invega, and claims of kickback payments to physicians over off-label prescriptions for Risperdal.
Johnson & Johnson subsidiary Janssen Pharmaceuticals also shelled out $400 million in criminal fines and forfeiture for promoting Risperdal to health care providers for off-label uses.
Risperdal, known generically as risperidone, is approved to treat adults with schizophrenia, bipolar disorder, and irritability with autism. It was later approved for children with the same conditions.
However, even before the Food and Drug Administration (FDA) allowed the drug to be marketed for children, Johnson & Johnson and Janssen urged doctors to use the medication to treat pediatric patients. The drug is also used off-label to treat attention deficit hyperactivity disorder and other behavior problems in children and adults.
Doctors have the authority to prescribe drugs for conditions for which they are not approved. However, drug companies are forbidden to market the drugs for unapproved uses. One issue with off-label prescribing is that the safety and efficacy has not been proven for conditions outside those for which the drug is approved. Patients are also susceptible to side effects.
Children can be especially sensitive to Risperdal side effects, which include gynecomastia, a condition in which boys grow breasts. Gynecomastia can be embarrassing for boys and young men, but it can also be painful. Treatment usually involves surgery such as liposuction or mastectomy.
Johnson & Johnson and Janssen currently face hundreds of lawsuits from people who say they were never warned of the gynecomastia risks associated with Risperdal.
Source: Law 360