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The US Justice Department announced on Monday that Johnson & Johnson has agreed to settle all criminal and civil claims against it for marketing the antipsychotic drug Risperdal for off-label uses and for paying kickbacks. A payment of $2.2 billion would be sufficient to let the company off the hooks.
The agreement, which is supposed to be one of the largest of its kind would also settle charges against Johnson & Johnson over marketing of another antipsychotic drug Invega and heart medicine Natrecor.
The company agreed to pay $1.72 billion for settlement of civil claims while another $485 million would be paid in criminal fines and forfeiture sums. The company has also agreed to change its business practices and focus on ethical business behavior.
Speaking on the agreement, U.S. Attorney General Eric Holder said, “The settlement also addresses allegations of conduct that recklessly put at risk the health of some of the most vulnerable members of our society – including young children, the elderly and the disabled.”
The General Counsel of Johnson & Johnson, Michael Ullmann said the resolution, “allows us to move forward and continue to focus on delivering innovative solutions…”
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Even though Risperdal had received FDA approval only for Schizophrenia, Johnson & Johnson subsidiary, Janssen Pharmaceuticals pushed the drug to physicians for treatment of symptoms like hostility, confusion and agitation in elderly patients affected by dementia.
Court documents show company representatives received high incentives for promoting off-label uses of the drug. Despite repeated warnings from the FDA, the company formed a dedicated “ElderCare Sales Force” to promote off-label use of Risperdal.
Besides targeting elderly patients affected by dementia, the company also instructed its sales force to market the drug to child psychiatrists for treating children in off-label uses like attention deficit disorder and autism. Risperdal increased the risk of children experiencing elevated levels of a hormone that stimulated breast development.
