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Off-Label Use of Drugs and Devices: Defending the Physician
Physicians who wish to minimize their potential liability for off-label prescriptions of drugs and devices have several tools they may use to position themselves favorably in the event of future litigation. Using these “best practices” will go a long way in helping their defense.
Insulating the Physician from Liability
First, physicians should recognize that they have a general obligation to stay abreast of the latest developments in their field through regular review of relevant medical literature and continuing medical education. In addition, “physicians prescribing a drug or device off-label have a responsibility to be well-informed about the [particular] drug or device.” Richardson, 44 S.W. 3d at 15. To the extent the physician learns of potential off-label uses through his or her review of literature or attendance at seminars and conferences, retaining the specific materials about that off-label use will be helpful to show that the decision to use the drug or device in an off-label manner was supported by authoritative studies and the experience of other practitioners. See Bax Global Inc. v. Brenneman, 2007 Ohio 695 (Ohio Ct. App. 2007) (finding that use of a spinal implant at a location for which it was not specifically approved in the United States was not experimental, because there was literature related to use in Europe to support the safety and effectiveness of the off-label use.)
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