Global health care giant Johnson & Johnson (J&J) and its subsidiaries have agreed to pay more than 2.2 billion U.S. dollars to resolve criminal and civil investigations for misbranding antipsychotic drugs and paying kickbacks to pharmacists, the U.S. Department of Justice (DOJ) said Monday.
The resolution, one of the largest health care fraud settlements in U.S. history, included criminal fines and forfeiture totaling 485 million dollars and civil settlements with U.S. federal and state authorities totaling 1.72 billion dollars, U.S. Attorney General Eric Holder said in a statement.
The settlement demonstrated the DOJ's firm commitment to preventing and combating all forms of health care fraud, Holder added.
The department charged that Janssen Pharmaceuticals, a subsidiary of J&J, promoted antipsychotic drug Risperdal for uses not approved by the U.S. Food and Drug Administration (FDA), including controlling anxiety and agitation for elderly dementia patients, from 1999 through 2005.
The company also provided incentives for off-label promotion and based sales representatives' bonuses on total sales of Risperdal in their sales areas, not just sales for FDA-approved uses, the DOJ said.
"J&J's promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society -- children, the elderly and those with developmental disabilities," said Zane Memeger, U.S. attorney for the Eastern District of Pennsylvania .
The FDA said in a statement that it had delivered repeated warnings to Janssen Pharmaceuticals about its "misleading marketing messages" targeted to physicians and later initiated a criminal investigation.
"We stand ready to take similar action in the future, if warranted, to protect public health," said John Roth, director of the FDA Office of Criminal Investigations.
The Justice Department also alleged that J&J paid millions of dollars in kickbacks to Omnicare, the nation's largest pharmacy specializing in dispensing drugs to nursing home patients, under various guises including "grants" and "educational funding."
These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to promote the use of Risperdal and other J&J drugs in nursing homes, the department said.
"Today we reached closure on complex legal matters spanning almost a decade," J&J vice president and general counsel Michael Ullmann said in a statement. "We remain committed to working with the U.S. Food and Drug Administration and others to ensure greater clarity around the guidance for pharmaceutical industry practices and standards."
As part of the deal, the global health care giant, based in New Jersey, has signed a five-year corporate integrity agreement with the U.S. Department of Health and Human Services to scrutinise future practices.