Risperdal Settlement Over Illegal Marketing Reached for $1 Billion

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Johnson & Johnson will pay the U.S. government more than $1 billion to settle claims that it illegally marketed the antipsychotic drug Risperdal, urging doctors to use it in ways never approved by the FDA. 

The settlement would see payments go to a number of states that have sued Johnson & Johnson for Medicare fraud and accused the company of downplaying the side effects of Risperdal while illegally marketing the drug.

Whether the company will agree to plead guilty to criminal charges, in addition to the monetary settlement, has not yet been determined.

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The U.S. Department of Justice (DOJ) has been investigating Johnson & Johnson’s marketing of Risperdal since 2004, when it began looking into an alleged kickback scheme between the drug maker and Omnicare, the nation’s largest provider of drugs to nursing homes.

Risperdal is frequently used as a “chemical restraint” in nursing homes, used to subdue unruly residents. However, studies have shown that the drug increases the risk of death in patients with dementia, and there have been nationwide efforts to curb its use for such off-label purposes.

Off-label marketing occurs when a drug company promotes the use of its drug for purposes other than those approved by the FDA, and is illegal. Doctors can prescribe a drug for any purpose they see fit, but companies cannot promote them for unapproved uses.

In 2009, Omnicare reached a settlement with DOJ over kickback charges. The DOJ investigators indicated that Johnson & Johnson paid Omnicare millions to push off-label use of Risperdal to nursing home doctors and hid the kickbacks as data fees, education fees and payments to attend Omnicare meetings. In January 2010, the DOJ filed a civil False Claims Act complaint against J&J.

A number of states are likely to split some of the settlement payments, but some states will opt out, having pursued their own claims against Johnson & Johnson. A Texas Risperdal lawsuit trial begins next week, and South Carolina is pursuing $327 million in damages against the company on its own. A Louisiana jury has already turned in a $257.7 million verdict against Johnson & Johnson in that state.

Tags: Antipsychotics, Dementia, Johnson & Johnson, Louisiana, Risperdal, South Carolina, Texas
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5 Comments

Colleen
My son was giving Risperdal along with his ADHD med’s at night. During that time had severe nightmares every night, neither of us got any sleep because of it, headaches. Finally took him off of it and all med’s.
Annette
My son was giving Rispedome for a behavior problem and send to a behavior hospital where they give evey kid there this drug so that there not out of control. with in 3 months in gain 35 pounds was dizziness.had alot of headach has the same nightmars every night . pains in this legs can;t sleep unless I give him Melatonin and he never had a problem before and to top it all off he started to have breast never took off his shirt he new something was not right 6 weeks went back untill I could go back to the doctor I told her I want him off of this He lose the weight and the breast but still has headach and still has a problem sleeping still on melatonin
Janice
My son takes risperidone, the off brand of risperdal. What should I be concerned about, if anything. I have to admit I am a little freaked out over this as my son has been taking this medication for quite some time. Any feedback would be greately appreciated.
PJ
Risperdal is also the drug of choice for chemical lobotomies, when given w/ a certain brand name anticoagulant. First comes the delirium, then the mechanical ventilation, then a shortened life-span, with shortened quality of life. Off-labeling marketing is a nice was of saying iatrogenic event. Need medical expert witness, for death by delirium, and Risperdal, in AZ. Serious need only apply
Daniel
Risperdal is a cousin of Zyprexa and Seroquel. PTSD treatment for Veterans found ineffective. Risperdal and Eli Lilly Zyprexa can cause diabetes. This is a powerful drug that can damage a young person physiologically for life. Please take with caution and learn as much as you can about side effects. *FIVE at FIVE* The Zyprexa antipsychotic drug,whose side effects can include weight gain and diabetes, was sold for “children in foster care, people who have trouble sleeping, elderly in nursing homes. *Five at Five* was the Zyprexa sales rep slogan, meaning *5mg dispensed at 5pm would keep patients quiet*. WARNING- If a drug Risperdal (Zyprexa) lists anything about the pancreas among the side effects, it probably means it can cause diabetes. Risperdal,Zyprexa is glorified Thorazine at ten times the price. — Daniel

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