While in the operating room, it may be difficult for the representative to know if the surgeon has made a medical decision to use the device in an off-label manner or if the surgeon is not aware of the device's indications for use. To clarify any ambiguity regarding the doctor's use of the device, the best practice should be for the representative to verify with the doctor that he or she is aware of the device's indications for use. As long as the doctor has used his or her own medical judgment to use the device off-label, and the off-label use was not promoted by the manufacturer or the representative, the representative should not take any further action in the operating room.
After the procedure is over, the representative should report the off-label use to the device manufacturer, even if an adverse event did not occur. The reason for this reporting is two-fold. First, reporting off-label use will alert the manufacturer to innovations in the medical field. The manufacturer may be able to use that information to have the device cleared for additional indications of use with the FDA, increasing the device's profitability. Second, the manufacturer needs to be aware of off-label uses of the device, because the manufacturer may be held liable for failure to warn about risks of off-label uses of which the manufacturer knew of or should have known.
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Eric Zalud is chair of the Litigation Practice Group at Benesch, Friedlander, Coplan & Aronoff LLP. He focuses his practice on products liability matters including medical device defense.
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