Suppose you invent or design a gizmo, a widget, a better mousetrap. You use it in your private office, and it works—well, most of the time it works. At any rate, you have an ego, and people with egos need to express them. You talk to one of our many vendors or laboratories, depending on the widget in question, who agrees that, yes, indeed your widget has potential. They decide to “sponsor” you to promote the product or technique at meetings and in writings. Good for you. Suppose now that during one of your ministrations, a patient is injured as a result of this “experimental” whatever. Should the patient have been informed that what you were doing was “untested,” “experimental,” “off-use,” or that an outside party was compensating you to document and develop this widget or gizmo? This is essentially what Shapira v Houghton , No. 392, 2013 (Del. Sup. Ct., Aug. 7, 2014), is all about. The trial court found for the plaintiff, and this appeal ensued.
The facts of the case are straightforward. Houghton fell, broke several ribs, was in a lot of pain, and was attended to by Dr Shapira. Dr Shapira used a non-FDA approved catheter to deliver analgesics in a unique way. He did not tell the patient about other, more traditional, means of pain control. The next day, Houghton removed the catheter, Shapira reinserted it, and injured some internal organs—hence the lawsuit. As an aside, Shapira had entered into a contract with the manufacturer to become a member of the company’s speaker’s bureau. The company paid Shapira to give presentations to other physicians about the device and the procedure, and Shapira created a promotional pamphlet about the procedure. He also created a database at the hospital to collect information about his patients’ responses to the procedure. As the number of patients began to increase, Shapira requested and received approval from the hospital’s institutional review board to study the effectiveness of the procedure using the patient data he was collecting. As a result of what he was doing, not only was Shapira a thoracic surgeon but also he now considered himself an “interventional pain management physician.”
The informed consent claim to the suit had 2 components. The first was that Shapira should have informed Houghton of the experimental off-use of the catheter and the risks and alternatives compared with more conventional methods of pain control. The second, and the driving force behind this article, was the claim that Shapira breached the standard of care by not disclosing his personal conflict of interest regarding the use and promotion of the procedure. Delaware’s informed consent statute expressly requires a physician to disclose “alternatives to treatment which a reasonable patient would consider material to the decision whether or not to undergo the treatment.” Given Shapira’s own testimony that he did not disclose alternative means of pain management other than the one he was promoting, the jury could have easily found for the plaintiff on that issue alone. However, of greater interest was the claim concerning the conflict of interest.
Delaware defines informed consent as the following.
… the consent of a patient to the performance of health care services by a health care provider given after the health care provider has informed the patient, to an extent reasonably comprehensible to general lay understanding, of the nature of the proposed procedure or treatment and of the risks and alternatives to treatment or diagnosis which a reasonable patient would consider material to the decision whether or not to undergo the treatment or diagnosis.
Thus, physicians must give the patient all information necessary to understand “(1) the nature of the proposed procedure, and (2) the material risks and alternatives to the procedure.” In exercising this requisite, the practitioner must do this to the extent that other health care practitioners would; in other words, whatever other doctors would tell the patient, he would be obligated to do. Whether this was done is a question for the jury. The real question is what is considered “material”? The court noted the following factors as examples of atypical factors for disclosure that have been considered to be material in other cases: a doctor’s inexperience with a procedure, and a hospital (or an office) being understaffed on the day of the procedure. The defendant argued that if doctors are required to disclose every potential conflict, no one would know how much personal financial information must be included.
The court said that the defendant’s argument failed because the conflict of interest bears directly on the materiality of risks and alternatives. In upholding the trial court’s verdict in favor of the plaintiff, the court was quite blunt in stating the following.
This is not a case where a doctor fails to disclose that she owns some stock in a publicly-traded medical company. Shapira was making a name for himself, and earning money, by promoting the … procedure. In addition, he was gathering data about the procedure’s efficacy. He had a strong incentive to play down the risks of the procedure and play up the problems with alternative treatments. Under these circumstances, the conflict evidence was relevant to the informed consent claim and admissible.
Look, many us have an entrepreneurial spirit. Everyone with an ego and a soapbox can come up with his or her own cephalometric analysis, maxillary molar distalization gizmo, technique or approach to treatment, practice management philosophy, and so on. Our profession is not only ripe for this type of thing but is rife with it as well. Don’t get me wrong; it’s not necessarily a bad thing. Gordon Gekko taught us that greed is good. Well, at least it can be—sometimes.
Coming up with new ideas about how to look at something, how to treat it, how to retain it or make it better in any one of a number of ways is something that many of us have done. There is nothing inherently wrong in doing this. The problem that it poses, the point of this article, is that there are times when we are faced with a jurisprudential consideration and an ethical one as well. Do we need to tell a patient not only what we are doing, but also why we are doing it, and that there may be other ways of addressing whatever it is when these other ways may be against our interests?
In the greater scheme of the world, what we do is small potatoes. Whether we are considered 3-mm carpenters, tooth jockeys, or, more grandly, smile architects and designers of dentofacial esthetics, the bottom line is that we don’t do heart or brain surgery. We don’t do organ transplants. We don’t help to prevent or treat contagious pandemics. We are who we are, we do what we do; it is meaningful, but it is arguably meaningless when placed on the triple-beam balance scale of life. Orthodontics, arguably, is overwhelmingly elective. It is, for the rank-and-file end user of our services, a big-ticket item. It is expensive and a luxury for which common folk scrimp and save to be able to give their kids a little leg up, a rite of passage, better self-esteem—we could all go on and on. Yes, it also lets that kid with the open bite finally bite a piece of pizza like everyone else.
Because almost nobody needs to undergo orthodontics, once they decide to do so, they must give us their informed consent. We tell them what precisely their problem is, why it “needs” to be addressed, how we plan to address it, what they will have to go through during treatment, what the alternatives are, the risks and benefits of each, what their responsibilities are, how we will attempt to maximize the retention of our efforts, how long the process will take, and how much it will cost. These are the things we must tell our patients. It’s that tiny one in the middle that this article is about—the one about how we plan to address it.
There are often many ways that a given malocclusion can be treated. In my humble opinion, that’s one of the things that makes orthodontics so great. At our daily diagnostic seminars, our residents and faculty may often suggest approaches ranging from nonextraction to 4 first premolar extraction to an atypical extraction pattern to reproximation for treating the same borderline case. Fascinating, to be sure. Even more incredible is that once a treatment plan has been established, the mechanotherapeutic approach to effectuate the goals of treatment often makes one feel as if he or she is at an open-air bazaar. Everybody wants to use different biomechanics, wire sequencing, force applications, retention modalities, and so on. I really love orthodontics.
But here’s the kicker. Let’s say the patient has a Class II molar relationship. Headgear might be the classic approach used to address this condition. You have developed a type of jig that relies on intermaxillary force activation to accomplish the distalization. You want to further develop and refine this jig. You want to write about it, lecture on it, get paid for it, and have a vendor or laboratory promote and distribute it. This is the approach you present to the patient. What’s wrong with that? Well nothing, as long as the patient is told about your financial interest in using this type of jig and its potential clinical consequences as opposed to headgear. What am I talking about? I’m talking about the possibility of excess proclination of the mandibular anterior teeth, possible greater mandibular anterior instability, possible periodontal compromise of the mandibular anterior gingival segment, possible taxing of the temporomandibular apparatus, and so on. That’s what this case was all about. Not that you can’t use your widget. Not that you shouldn’t use it. The requirement is that you merely inform the patient of this little conflict of interest; as long as you do, no problem. Since not all Class II patients are the same, and if intermaxillary mechanics was the preferred way of addressing the anteroposterior discrepancy, no problem.
Informed consent is just that: informing the patient so he or she can make a decision. Is this conflict the type of thing that someone would consider material? Are you kidding me? Of course, some people will find it material. You or I might not, but we are not the patients. We are invading the patients’ bodily integrity, and only they have the right to allow us to do that, and they can only grant that right when fully informed. Remember what discount clothing giant Sy Syms used to advertise: “An educated consumer is our best customer.” The same sentiment applies to us and our patients.