I got this e-mail the other day, and it prompted this article.

Larry:

Is malpractice dependent upon on a bad outcome, or is it a free-standing bad act? In discussing orthodontic clear aligner therapy with some of my general dentist friends, it appears that at least one of the companies that sells this product requires that the practitioner submit a panorex or full-mouth series of x-rays along with the impressions. When I inquire about this diagnostic process, my general dentist colleagues’ responses usually begin with crooked teeth and end with straight teeth. I have gently suggested that they might be exposing themselves to potential liability by not performing a cephalometric analysis, and I have even offered to assist them with this.

Their response has been that, if it is not required by whoever is constructing the series of aligners, they don’t believe they are responsible for obtaining this information or making a comprehensive diagnosis. When I inform them that any legal claims made by patients will be judged by the standard of care of the orthodontic profession, they appear to be ignorant or unconcerned. To my way of thinking, rendering orthodontic treatment without first performing a comprehensive diagnosis bears a similarity to extracting third molars without getting those pesky x-rays to check for position and root morphology. When I bring this issue up with my general dentist colleagues, the response is inevitably, “Oh, I just pick the ‘easy’ cases.”

I find this somewhat puzzling, since after over 20 years as an orthodontist, I am unable to ascertain which are the “easy” cases until I have obtained comprehensive records to make sure there are no surprises in store; and even then, sometimes surprises happen.

Part of the impetus for my concern occurred at a recent dental meeting when a general dentist colleague showed me the models of a 70-year-old patient she was considering treating with a series of aligners. I found her lack of understanding of the can of worms she was about to open a bit unsettling. Retrospectively, if I think about the 10 years that I was a general dentist before I became an orthodontist, I can understand the flawed perspective of general dentists who perform orthodontics, regardless of the appliance used, although I can’t help but wonder if some of our supply vendors aren’t part of this problem.

I know there is no easy answer to my concerns and questions, but I don’t understand why our profession seems to be ignoring this issue and the potential consequences. What do you think?

Thanks – J. C.

Our reader asks some fundamental questions that deserve straightforward answers. His first question asked whether liability for malpractice is based on a bad outcome or whether one had to engage in a bad act. The answer is neither. For a doctor to be found guilty of professional negligence, he or she must have breached a duty to conform to a certain standard of care, and the breach of the duty owed must be the direct and proximate cause of the patient’s injury. Therefore, a bad result is not evidence of malpractice as long as the standard of care was adhered to, and breaching a standard of care is not negligence unless the deviation from that standard of care directly resulted in an injury to the patient.

The second question asks whether a comprehensive diagnostic workup is required for all orthodontic patients. The answer once again is no. As I understand the standard of care, it first requires a doctor to obtain all necessary diagnostic records to adequately diagnose a patient’s orthodontic condition or chief complaint and, second, to develop an appropriate treatment plan that addresses that condition or concern. I have never read a legal opinion stating that a cephalometric film was required for every patient. For instance, you have a 30-year-old nongrowing adult with a pleasing profile and soft-tissue drape. Everything about her outward appearance is normal; intraorally, her occlusion is Class I with normal overbite and overjet. All hard and soft tissues appear to be within normal limits, and the patient’s chief complaints are a maxillary central diastema and 3 mm of mandibular anterior crowding, or any other “simple” kind of dental malpositional aberration that we can imagine.

The bottom line is that there is nothing really wrong with her function, and it is merely a slight matter of esthetic concern. Do we need a cephalometric x-ray to diagnose and plan this patient’s treatment? Not in a million years. The purists in our midst would say “but how do you know that there is no underlying skeletal component if you don’t look at the skeleton?” Of course, they are right, but the bottom line is so what? How many of you would really treat cephalometric readings that were abnormal if the patient were absolutely normal looking with no objective or subjective disfigurements or complaints? Would you really recommend an orthognathic surgical evaluation or proceed with implants to try to change the vertical dimension in a patient where there was no effect on the hard or soft tissues, merely to obtain cephalometric readings that were closer to the norm? I think we would be hard pressed to find an ethical plaintiff’s expert witness who would testify that not treating numeric cephalometric eccentricities in and of itself is a breach of the standard of care.

Without stating it, our reader next asked, when a laboratory does not require certain records to fabricate the appliance, does that mean that those records were not necessary? Also, if something goes wrong with the treatment, isn’t it because the doctor breached the standard of care by not having those records? The answer is of course not. The laboratory needs what it needs to do what it does. You are the doctor. It is your responsibility to properly diagnose a patient to determine what the particular problem is, and what the possible treatment methodologies are that will adequately address the problem. If you determine that the patient’s problem requires only minor orthodontic tooth movement, then any of several appliances would be appropriate options to present to the patient. It is not the laboratory’s business to diagnose and plan the treatment for orthodontic patients—it’s your job. You must determine what diagnostic records are necessary. You must obtain them and ensure that they are of diagnostic quality. You must make the diagnosis. You must determine what needs to be done to achieve certain treatment goals. In conjunction with the patient, you must determine what appliances will allow you to effectuate the chosen treatment plan. You are the one who must ensure that the appliance chosen is doing what it was supposed to do. You are the one who shoulders the responsibility for the finished result. Also, let’s not forget that you are the one who gets paid by the patient to do all of this, not the laboratory. It is not a laboratory-patient relationship; it is a doctor-patient relationship.

Our reader was concerned about the potential liability exposure his colleagues might have as well as which standard of care they would be held to. Let’s look at these separately. Obviously, just electing to treat a patient exposes a doctor to potential liability for malpractice, and the requirements for a plaintiff to be successful in a malpractice case have already been elaborated. I see just as much potential liability exposure for our reader and anyone else who wants to help a general dentist colleague by taking a specific x-ray, analyzing it, and making diagnostic and treatment recommendations for this GP who will then do or refrain from doing x, y, or z, knowing that your superior knowledge on the subject might well be followed to the letter.

If the circumstances are just right, it could be construed that you have created a doctor-patient relationship with the generalist’s patient, and, possibly, you might be held liable for the generalist’s negligent diagnosis or treatment along with the resulting bad outcome because of your participation or control regarding the treatment. Countless lawsuits on this subject have been played out in courts across the country, and various jurisdictions have come up with different results. It is important to see this activity for what it is: another potential pool of liability into which one might slip and fall.

What standard of care will a generalist performing orthodontics be held to? Usually, it is determined by a simple test. The expert witnesses will testify as to whether this was the type of orthodontic problem that a general dentist, in the locale in question, would treat. Or is it the type of orthodontic problem that would normally be referred to a specialist? If it falls into the first class, the doctor could be expected to be held to the standard of care of a generalist rendering specialty treatment. If it is in the other category, then a general practitioner would probably be held to the standard of care of a specialist performing orthodontic treatment. Again, different jurisdictions have made different rulings on this issue. The bottom line here is that any doctor, performing any procedure, must have the requisite skill, knowledge, experience, expertise, and so on, that would enable him or her to perform the procedure safely and render a prognosis of a reasonable outcome in the particular circumstance.

The next question is whether any vendor who touts a product through its stable of educators should bear some responsibility for the problem perceived by our reader. Let’s be honest here. First, what is the problem? The problem, as I see it and as I hear about it from colleagues all over the country, is that some of these products have mechanical limitations for rendering certain types of tooth movement. So what? Many appliances over the years have had the same problem. The real underlying problem is that the level of differential diagnostic and mechanotherapeutic sophistication of a general practitioner performing orthodontics might not be sufficient to determine all nuances of a patient’s problem or which appliances might have a mechanotherapeutic advantage in a certain situation. If this is true, then it stands to reason that the results of some general dentists using the widget or gizmo of the day are less than desirable. Quite honestly, so are some results produced by conventional straight-wire appliances, whether performed by orthodontists or general dentists, but that is a different story. The bottom line is that the onus for the result rests with the treating doctor, not on the appliance used and certainly not on a company or its agents who are trying to provide the profession and the public a new and useful product through continuing education. Sure, they make a profit, but this is a capitalistic society, and, short of fraudulently presenting or withholding material information, I can’t see how liability would attach for doing what they are doing when we, the doctors, are the ones rendering the treatment. Remember, it’s not guns that kill people; it’s the person pointing the gun and pulling the trigger who bears the responsibility.

Finally, our reader asks, why isn’t our profession doing something about this problem? The only thing our specialty should do, and it is doing it at the local, regional, and national levels, is to provide a forum for educators and practitioners to get up in front of our rank-and-file practitioners and give them the good, the bad, and the ugly regarding the many orthodontic diagnostic approaches and the various therapeutic modalities that are available on the market today. I don’t want to believe that these educators would withhold negative information, if it exists, about any product merely because they might be on a company’s payroll. I would like to think that, as doctors, we are only interested in what works best in a given situation. I’m not naïve. If you have a choice between 2 products that yield similar results and 1 has a higher profit margin, as long as the patient has been fully informed regarding all aspects of the proposed treatment, go for it. Just remember, the patient must always come first.

Our reader should be congratulated for asking out loud the same questions that many of us have silently harbored.