Accusations about the introduction of a misbranded drug have led to a guilty plea by Janssen Pharmaceuticals, a branch of Johnson & Johnson. The company will have to pay a $400 criminal penalty and a $1.25 billion civil settlement in relation to events surrounding a drug called Risperdal. That drug was approved ten years ago for the treatment of acute mania, Bipolar 1 Disorder, and schizophrenia. However, back in March 2002, the company also started to market the medication as a possible treatment of dementia-associated agitation in elderly individuals. Although the Food and Drug Administration allows doctors to use their judgment to prescribe drugs for off-brand purposes, they do not allow drug companies to do the same in marketing. The Department of Justice contended that risks to elderly persons were both known and downplayed by Janssen.
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