Healthcare giant Johnson & Johnson and its subsidiaries will pay more than $2.2 billion in criminal and civil fines to resolve allegations that it improperly promoted three drugs, including the antipsychotic drug Risperdal. The agreement represents the third-largest pharmaceutical settlement in United States history. Risperdal no longer has patent protection but it was once a best seller for Johnson & Johnson, accounting for $3.1 billion in sales in 2004 alone.
As part of the settlement, Johnson & Johnson has agreed to plead guilty to a misdemeanor offense after the company acknowledged it marketed Risperdal to older adults for unapproved uses. The guilty plea includes a fine and forfeiture of $485 million. The civil portion of the suit alleges that Johnson & Johnson wrongfully promoted Risperdal for use in children and the developmentally disabled, in addition to paying kickbacks to doctors and pharmacists in exchange for writing more prescriptions. Although the company has agreed to settle the civil portion of the suit for $1.72 million, it did not admit any wrongdoing.
In a news conference announcing the settlement, Eric Holder Jr., the United States attorney general, said the company’s practices “recklessly put at risk the health of some of the most vulnerable members of our society – including young children, the elderly and the disabled.”
According to the Department of Justice, Johnson & Johnson officials tried to expand the use of Risperdal to older dementia patients soon after the drug was approved in 1993 to treat symptoms of psychiatric disorders like schizophrenia. But the FDA consistently rejected efforts by the company to expand the drug’s use to older dementia patients. The company claimed that Risperdal could address symptoms that made treating elderly patients a challenge, especially in a nursing home setting, including agitation, confusion, hostility and impulsiveness. The company’s sales brochures highlighted these symptoms and minimized the fact that the drug was approved to treat schizophrenia.
The Department of Justice also alleges that the company knew that Risperdal posed a serious health risk for older adults, including an increased risk for stroke, but played them down. Ironically, the drug’s label was eventually updated to warn against the use in older patients with dementia.
The civil suit against Johnson & Johnson also claims that the company has long promoted the use of Risperdal in people with disabilities and children, despite not receiving FDA approval to market to children until 2006. Furthermore, it is alleged that J&J subsidiary Janssen told its sales representatives to visit child psychologists and mental health facilities that mainly focused on children, promoting the drug as a safe treatment for disorders like ADHD and obsessive-compulsive disorder.
The use of Risperdal, especially for an unapproved use, can lead to a number of serious and potentially life threatening side effects. If you believe that you may have been injured as a result of prescription Risperdal you may be entitled to compensation. For more information or a free consultation and case evaluation, contact the experienced personal injury attorneys at Sibley Dolman Gipe Accident Injury Lawyers, PA. (833) 606-DRUG .