it covers a time period when the risperdol label was linked to schizophrenia. with regard to the criminal >> did the risk ever turn into actual harm? >> with regard to the evidence in this case, we don't have evidence of actual patient harm. what we have are statements and representation that indicate that risk was being minimize with regard to the use of the product in the elderly. especially with regard to the risk of stroke and with regard to diabetes and things of that nature. it is incumbent on the government to take a look at these type of behavior is to make sure we are prosecuting this case appropriately to make sure of efficiency. >> one thing that ties the pieces of this case together is the fact that all of that relates to conduct that undermines the regulatory system that has been set up to protect the safety of the medicines we take. part of it relates to activities of the company in marketing actual harm? efforts but also, the omnicare portion of the case relates to kickbacks. that were pai which have the potential to undermine the medical judgmen

the companies put down the risk of risperdol.ut simply the alleged conduct is shameful and it is unacceptable. it displayed a reckless indifference to the safety of the american people, and it instituted a clear abuse of the public trust. >> joining us in the studio, patrick burns in taxpayers against fraud. this originated with a whistle blower, as it were, who brought it to the government's attention. but didn't quite get the government's attention. why was it a problem, and what does this tell us? >> well, wrestle blowers come to the government for examples of fraud, and the government often doesn't quite understand the fraud. fraud is like a magic act. if it was that obvious everyone would see it, and no one would profit. so the government looks at it. they don't quite understand it. then they start lawyering it. what happened in this particular case was the whistle blower realized essentially what was going on here was p a, yola was being paid, this was poisoning for profit. he was very upset about it. he went ultimately to

in particular, one of the key drugs that that were highlighted, risperdol, had been approved for use of schizophrenia and only that using at the company promoted it and sold it and induced others to buy it through kickback schemes and other inducements to treat the elderly who were suffering from alzheimer's or other forms of dementia, to treat children and to treat the disabled. drugs forromote purposes that they are not intended for and have not been approved by the fda, we don't believe that is a violation of the first amendment. >> isn't this off label marketing? >> what we are prosecuting is promoting drugs for purposes that have not been approved, that have not been shown to be safe or even effective. that's what this case is about. the statute requires that for intended uses, the labeling for the drug provide directions for use. and reflect any restrictions. what we are talking about in this case involves promotion for intended uses without the required instructions for use that the statute mandates. general, therey are lots of questions about the shooting at lax on friday. wh