The United States Department of Justice announced that Johnson & Johnson will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations that the company encouraged doctors to prescribe Risperdal for uses that were not approved as safe and effective by the Food and Drug Administration (FDA).
“Unfortunately, drug companies like Johnson & Johnson continue to put profits over the safety of patients. Criminal and civil fines are only the first step in holding Johnson & Johnson accountable for its improper marketing of Risperdal,” stated Laura Yaeger, an attorney in Morgan & Morgan’s mass tort and class action practice group.
Risperdal is an antipsychotic drug approved to treat schizophrenia, bipolar disorder, and irritability in people with autism.
As alleged in lawsuits filed by several whistleblowers, Johnson & Johnson knew that Risperdal increased the risk of male patients experiencing elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Despite having knowledge of these potential risks, Johnson & Johnson marketed Risperdal as safe and effective for symptoms of childhood disorders, such as attention deficit hyperactivity disorder, obsessive-compulsive disorder, and autism. As a result, boys and young men developed gynecomastia, the formation of male breasts, which can cause nipple pain, nipple discharge, and psychological issues.
“Boys and young men are the victims here. Gynecomastia, development of male breast, is an irreversible disease often requiring surgery and leading to psychological trauma. Johnson & Johnson should be held accountable to these boys and young men,” noted Ms. Yaeger, who represents patients in Risperdal lawsuits.
Until late 2006, Risperdal was not approved for use in children for any purpose. The FDA had repeatedly warned Johnson & Johnson against promoting Risperdal for pediatric use.
Furthermore, the whistleblower lawsuits alleged that Johnson & Johnson’s sales representatives “promoted Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion."
In connection with the settlement, Johnson & Johnson subsidiary Janssen Pharmaceuticals plead guilty to a criminal charge that the company misbranded the antipsychotic drug. Janssen admitted in its plea agreement that the company promoted Risperdal as a safe treatment for elderly, non-schizophrenic dementia patients, a use that had not been approved by the FDA.
The whistleblower lawsuits alleged that Johnson & Johnson caused false claims to be submitted to Medicare and Medicaid by promoting Risperdal for off-label uses that the federal healthcare programs did not cover. In addition, the company was accused of making false and misleading statements regarding the safety and efficacy of Risperdal, and paying kickbacks to physicians to prescribe the drug.