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Medtronic plc Message Board

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  • ma45342312 ma45342312 Jul 4, 2011 11:32 AM Flag

    Ty Webb/Mitch Cumstien


    I truly agree with both previous posters.

    It is becoming apparent that not all adverse events in the clinical trial that gained product approval for infuse were properly reported.

    What has changed from 2008 till now? Now we have a physician that works in the field or orthopedic surgeon who is now pointing out the issue. A colleague has turned on his own field. Basicly a whistleblower.

    So the next question is ......Is it criminal? A physician signs what is called an investigator's agreement with the sponsor prior to starting a given clinical trial. This is mandated by the FDA. This is normally an 8 or so page long document writing by a lawyer employed by the sponsor. It is designed to make sure everyone knows their legal responsibilities in the clinical trial. In that document it states "I the physician will report any and all adverse events in a timely manner"

    Once a physician signs this document prior to the clinical trial this is the point that the physician becomes an investigator.

    I have not seen the actual investigators agreement for this particular trial. But that language is in all investigators agreements. Either written like I wrote it or something like that. It is FDA mandated that it has to be in there. The sponsor has by law a given number of days to report serious adverse events to the FDA. This is designed to protect the public from investigational products that are not functioning as they should.

    So the legal framework for a lawyer to go after the sponsor or the investigator is there. Legal documents were signed prior to the clinical trial that gained product approval.

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