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Johnson & Johnson to Pay $2.2 to Settle Risperdal Claims

Johnson & Johnson will pay more than $2.2 billion to resolve criminal and civil charges that it improperly marketed the antipsychotic drug Risperdal. The pharmaceutical company is accused of targeting vulnerable patients for off-label uses not approved as safe and effective by the Food and Drug Administration (FDA).

“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder. “[I]t proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people,” he added.

The settlement specifically resolves allegations that Janssen Pharmaceuticals Inc., a J&J subsidiary, promoted Risperdal to doctors who cared for elderly dementia patients as a treatment for anxiety, agitation, depression, hostility and confusion, even though the FDA approved the drug only to treat schizophrenia. The company also allegedly paid kickbacks to those who agreed to prescribe the medication.

As detailed by the Department of Justice, Janssen continued the illegal marketing even after receiving warnings from the FDA. “The FDA cautioned Janssen that behavioral disturbances in elderly dementia patients were not necessarily manifestations of psychotic disorders and might even be ‘appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of an antipsychotic medication for inappropriate behavioral control,’” the complaint against the drug maker stated.

Johnson & Johnson and its subsidiary also aggressively marketed Risperdal to treat children and individuals with mental disabilities for conditions such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism. Moreover, they continued to push the off-label uses despite evidence that the drug posed significant health risks, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production in children.