Wednesday, September 01, 2004
by Daniel J. Schulte, J.D.
MDA Legal Counsel
Published in the September 2004 issue of the Journal
Dear Dan Schulte: A few weeks ago, an overweight patient came to my office with a prescription written by her physician for a retainer-like device. She wanted me to fit her for the device.
The device is to be inserted into the patient’s mouth at mealtime. The device supposedly reduces the volume of the mouth requiring the patient to take smaller bites and eat slower. This is advertised to result in weight loss. This was my first encounter with such a device. Now another patient without a prescription has asked me about a similar device and would like my opinion on whether the device is the right weight loss device for him and, if so, to fit him for one. This patient also gave me a copy of an advertisement for this device which states that a company has a patent on the device and offers a $3,000 reward to any patient that turns in a dentist making and selling the same device on their own. Would the fitting of this type of device, the sole purpose of which is to facilitate weight loss, be considered the practice of dentistry? Can I legally advise a patient whether this device will be effective in causing weight loss? Will my malpractice insurance cover a claim by a patient who I have fitted for this device if it causes a problem? What happens if I decide to manufacture this device on my own for a patient?
Answer: The practice of dentistry is defined in Michigan’s Public Health Code as “the diagnosis, treatment, prescription, or operation for a disease, pain, deformity, deficiency, injury, or a physical condition of the human tooth, teeth, alveolar process, gums or jaws, or their dependent tissues, or an offer, undertaking, attempt to do, or holding oneself out as able to do any of these acts.” This is a very broad scope of practice. Even though the device you describe is used in connection with weight loss, its use does impact the physical condition of the teeth, alveolar process, gums, etc. I assume that the proper fitting of this device would involve the taking of impressions, bites, casts and other measurements from the patient similar to what would be done to fit a retainer or denture. Therefore, the fitting of this device should only be performed by a dentist. Prior to doing so, however, the patient should be properly examined by the dentist to determine if the use of such a device will cause the patient harm, adversely affect any ongoing treatment or cause other complications. The dentist should also consult and advise the patient on all of the potential harmful effects, interactions and complications so that the patient can make a fully informed decision as to whether or not to use the device.
The scope of the practice of dentistry obviously does not include weight loss counseling nor does it include the evaluation of the efficacy of this or any other weight loss device. Dentists should not provide such counseling and/or evaluation. Only if the patient has decided to try one of these retainer-like devices after the appropriate examination and consultation with his/her physician should a dentist even consider fitting a patient for the device. Dentists who decide to engage in the practice of fitting these devices should contact their malpractice insurance carrier first. The procedure and the process to be followed in fitting this device for its manufacture should be fully disclosed to the malpractice insurance carrier. The most prudent course of action would be to obtain a written declaration from the malpractice insurance carrier that coverage will be provided for claims arising out of or related in any way to fitting the device.
If this company has a valid patent on this device it would be unlawful for you to duplicate and sell the device for a profit unless you have been granted a license by the company allowing you to do so. You may ask the company for the patent number assigned to the device. You can then look up the patent on the U.S. Patent and Trademark Office Web site and find out the name of the owner of the patent and exactly what has been patented.