It is also a violation of the federal law for anyone to advertise a product in a manner that falsely represents or implies that the product has FDA approval for a particular use that the FDA has not actually approved.

California law also requires that advertisements not be “false, fraudulent, misleading or deceptive.”  Violation of California’s prohibition against false advertising can result in civil monetary liability and both criminal and licensing board sanctions.  Thus, it is very important when a medication or device is recommended for a use other than one approved by the FDA, that the consumer be clearly advised that the suggested use is “off-label” and not approved by the FDA.

It is also important to note that the use of products or devices for off-label purposes carries a heightened risk of civil liability if the modality is not effective or causes a complication.  Thus, it is very important that the informed consent process include clearly advising the patient of the basis for the doctor’s belief that the product or medication will benefit the patient, (e.g., medical literature, personal anecdotal/clinical experience, etc.).  If a written consent is warranted, such as with any type of surgical procedure, I strongly recommend that all of the matters discussed with the patient, including the fact that the proposed usage is “off-label,” be included in the written consent form.