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J&J to Pay $2.2 Billion Risperdal Settlement

As reported by Bloomberg News and the U.S. Department of Justice, Johnson & Johnson and its subsidiaries will pay $2 billion to resolve both civil and criminal charges over misbranding of its drugs Risperdal, Invega and Natrecor for uses that were not FDA approved.

The Risperdal settlement is one of the largest health-fraud penalties ever paid in the history of the U.S., and includes criminal fines and civil settlements with state and federal governments of $1.72 billion.

Risperdal settlement one of the biggest U.S. health-fraud penalties

In a press release issued on November 4, Attorney General Eric Holder said, “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud.  And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”

Holder told Bloomberg that Johnson & Johnson “recklessly put at risk the health of some of the most vulnerable members of our society — including young children, the elderly, and the disabled.” Janssen – a unit of Johnson & Johnson – will plead guilty to misdemeanor charges over its off-label promotion of Risperdal to elderly patients suffering from dementia. In its lawsuit, the government argued that despite studies showing adverse Risperdal side effects in elderly patients, including an increased risk for strokes, the company marketed its atypical antipsychotic as completely effective and enjoying “an excellent safety and tolerability profile” in geriatric patients.

The civil settlement also resolves accusations that Johnson & Johnson relied on kickbacks to increase sales of Risperdal to nursing home residents. J&J and Janssen will now pay $149 million over accusations that these payouts caused Omnicare – the country’s largest pharmaceutical distributer to nursing homes – to submit fake claims to federal health care programs.

Antipsychotic marketed for off-label use in children

Allegations made by the government include that Janssen also promoted Risperdal for use in children despite knowledge that the drug could increase levels of prolactin – the hormone that can stimulate gynecomastia, or breast tissue growth in males. Risperdal was originally approved in 1993 for the treatment of certain psychotic disorders, but Janssen quickly began marketing the medication for several unapproved uses, including dementia, bipolar disorder, anxiety disorders and other off-label treatments, according to documents filed by U.S. Attorney Zane Memeger.

According to the Department of Justice press release, one of Janssen’s ‘Key Base Business Goals’ was to corner Risperdal’s market share among adolescent and minor patients. Sales representatives were told to push the drug heavily during their talks with child psychiatrists and mental health centers that treated minors. At the time, unapproved uses the drug was prescribed for included attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism.

The atypical antipsychotic was not cleared for use in children for any reason until 2006, and Janssen was warned several times by the FDA to stop promoting its drug to this market, yet continued to do so.

Accord will not resolve litigation in Louisiana, Arkansas and SC

The settlement, however, will not resolve claims brought by attorneys general in South Carolina, Arkansas and Louisiana, where J&J is facing a hefty fine – $1.8 billion – for alleged Risperdal ad campaigns that misrepresented the side effects and risks of the drug, with the intention of misleading doctors and their patients.

J&J has said the company intends to appeal the Risperdal lawsuit verdicts over drug sales.