Abbott, and likely the IT folks added in here, said it would be very cumbersome to go back and get 53 back up tapes to find all of the messages, but the judge doesn’t care and feels it is important enough to the case. It is a job though and will take a little time, but it can be done, all those perhaps very “fat” tapes of “Exchange” data files or the equivalent. In IT, nobody really wants to the guardian of email exchange, it’s a pain and they are big fat files as they include every embedded document and item sent along with the email. No wonder “secured drop boxes for attachments” are the rage today (grin). If you don’t use one, think about if you have privacy concerns.
It is not the off label use, but rather the off label marketing that is at hand here and there’ a few of these cases in court today with several drug companies. It takes a long time usually to settle. Here’s a couple other fairly recent court cases.
Johnson and Johnson Hit with Off Label Allegations
Lilly Admits $1.4 Billion Zyprexa Mistake – Off Label Use
It sounds like the big question here is “did the orders come down from the CEO to say it was ok or did he give the orders to do so”. With transparency today we sure are digging up a lot from the past that was not available to view, see or hear before. bD
A U.S. judge has ordered Abbott Laboratories to hand over to federal prosecutors some of its chief executive's email messages, as part of a federal probe into whether Abbott improperly marketed the antiseizure drug Depakote for unauthorized uses.
The U.S. Attorney's Office for the Western District of Virginia is investigating Abbott for "potential federal violations arising out of Abbott's impermissible off-label marketing of Depakote as a treatment for agitation and aggression in the elderly, and health-care fraud arising out of that allegedly improper use," U.S. District Judge Samuel Wilson wrote in an opinion dated March 10.
"The government has indicated that it has evidence that the off-label marketing of other FDA-approved drugs may have followed a similar pattern to the off-label marketing of Depakote," Judge Wilson wrote. "If this is so, the off-label marketing of these other drugs may raise the same related health-care fraud issues that the marketing of Depakote raises."
Depakote is approved by the U.S. Food and Drug Administration to treat seizure disorders and acute manic episodes associated with bipolar disorder, and to prevent migraine headaches, but not for treatment of agitation and aggression in the elderly.
Judge Orders Abbott To Turn Over Emails - WSJ.com
0 comments :
Post a Comment