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.