Janssen Pharmaceuticals to pay record amount, says state Attorney General
State Attorney General Linda Kelly announced a record multi-state settlement with Janssen Pharmaceuticals today.
HARRISBURG – Pennsylvania has joined 36 other attorneys general in the largest multi-state consumer protection settlement to be reached with a pharmaceutical company, Attorney General Linda Kelly announced today.
Kelly said the record $187,047,439.00 settlement was reached with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson, over allegations that Janssen improperly marketed the atypical antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega.
Risperdal is a medication commonly used to treat mental illnesses including schizophrenia, bipolar disorder, and irritability associated with autism. The drug has a number of serious side effects including; hyperglycemia, diabetes, pancreatitis, a heightened risk of neurological problems, cardiovascular complications and weight gain.
According to the states, Janssen promoted Risperdal for off-label uses to both geriatric and pediatric populations and specifically targeted nursing home patients for Alzheimer’s disease, dementia, depression, and anxiety. These uses were not FDA-approved nor shown to be safe and effective. Federal law prohibits pharmaceutical manufacturers from promoting their products for off-label uses.
After an extensive four-year investigation, Janssen agrees to change how it promotes and markets atypical antipsychotics and to stop the false, misleading and deceptive promotion of the drugs.
Additionally, Janssen agreed to a number of condition for five years, including disclosing the risks in the FDA’s black-boxed warnings for atypical antipsychotics in Janssen’s promotional materials and implementing policies to ensure that financial incentives are not given to marketing and sales personnel that encourage or reward off-label marketing.
