Informed consent for off-label use

Does a standard LASIK informed consent cover off-label use? Can a surgical coordinator answer the patient’s questions?

Issue: February 1, 2005

ByAlan E. Reider, JD, MPH

Facts

An ophthalmologist recommends LASIK surgery for a patient whose vision in both eyes is –18 D. The surgeon will use a laser that was approved by the Food and Drug Administration for up to –14 D of correction. The patient is provided with a written informed consent form and shown an informed consent video, consistent with that provided to all LASIK patients. The patient is then advised to ask the surgical coordinator any questions about the surgery.

The physician thinks the patient has been fully informed of the procedure.

Does the informed consent cover the procedure at hand?

The ability of a physician to use a device for an off-label use within his or her practice is a recognized and accepted practice. The FDA limitations do not reach the decisions of physicians within the confines of their medical practice. The use of the laser in this case, therefore, presents no legal problems.

As with any procedure, the use of the laser requires that the patient grant informed consent. In this case, the physician has provided the same informed consent form and video that is used for all patients receiving the same treatment. Neither the form nor the video, however, advises the patient of the proposed off-label use for the laser. Despite the fact that the likelihood of any additional risk is minimal, if there were a bad result from the procedure, a plaintiff’s malpractice lawyer would have a field day in demonstrating that the patient was not fully informed about the risks inherent in the procedure. Therefore, if a physician plans to use a device for an off-label use, the patient should be advised of such use as part of the informed consent process.

Finally, in busy practices it is common for surgical coordinators to take the lead role in connection with the informed consent process. In my view, however, it is a mistake for the physician to be entirely absent from the process. I recommend strongly that surgeons participate, if only to confirm that the patient understands the nature of the procedure and to ask the patient whether he has any questions prior to surgery. Once again, one must think about the potential jury appeal if the patient alleges that he or she was not adequately informed and the physician did not participate in any way in the process. Obviously, the plaintiff’s attorney will focus on the fact that a non-physician is not in a position to be able to respond to any of the questions and concerns of a patient prior to surgery. And if placed on the stand, the surgeon will be hard- pressed to explain why he or she did not take the time to meet with the patient before surgery to be certain that the patient’s questions were answered.

For Your Information:
Alan E. Reider, JD, can be reached at Arent Fox PLLC, 1050 Connecticut Ave. NW, Washington, DC 20036; 202-857-6462; fax: 202-857-6395; e-mail: ReiderA@ArentFox.com.