The exact words used by the surgeon to express the risks associated with the proposed surgical procedure were “infection, bleeding, nerve damage, dural leak, injury to the nerve, destabilization of the scoliosis requiring fusion, injury to the surrounding structures and anesthesia.” Sounds rather comprehensive to me. How about you? Would you accept those words as being sufficient for informed consent purposes? Well, in Sargent v Shaffer , No. 2013-SC-000111-DG (Ky. Sup. Ct. Aug. 20, 2015), the plaintiff claimed that because she did not understand those words to mean that she might suffer “paralysis, incontinence, loss of bowel and bladder control”—exactly what happened to her—the surgeon did not obtain her informed consent. She was not claiming that the informed consent communication did not happen; she was claiming that she did not understand what the words actually meant. Therefore, the surgeon did not disclose in a medically acceptable way that the patient could wind up totally paralyzed from the waist down.
Before we get to the Supreme Court’s decision, I want to share with you the definition of communication. Merriam-Webster’s Dictionary defines communication as “the act or process of using words, sounds, signs, or behaviors to express or exchange information or to express your ideas, thoughts, feelings, etc., to someone else.” This is in line with the concept supporting the doctrine of informed consent. Essentially, whether you are in a state that uses the professional standard or a state that uses the patient need-to-know standard, the bottom line is that a certain amount of information must be communicated to patients for them to grant their informed consent. Although it is easy to say, “I gave the patient the requisite amount of information,” the bottom line is not whether the patient received it, but whether he or she understood it. With that in mind, we can now turn our attention to the case.
The statute in Kentucky governing informed consent is KRS 304.40-320. It reads as follows:
In any action brought for treating, examining, or operating on a claimant wherein the claimant’s informed consent is an element, the claimant’s informed consent shall be deemed to have been given where:
The action of the health care provider in obtaining the consent of the patient or another person authorized to give consent for the patient was in accordance with the accepted standard of medical or dental practice among members of the profession with similar training and experience; and
A reasonable individual, from the information provided by the health care provider under the circumstances, would have a general understanding of the procedure and medically or dentally acceptable alternative procedures or treatments and substantial risks and hazards inherent in the proposed treatment or procedures which are recognized among other health care providers who perform similar treatments or procedures.
The gravamen of this case turned on the jury instruction issued by the trial court. It read: “With respect to disclosing to Plaintiff, Loretta Sargent, the risks and benefits of the surgical operation he proposed to perform upon her it was the duty of the Defendant, William Shaffer, M.D. to exercise the degree of care and skill expected of a reasonably competent physician specializing in orthopedic spine surgery under similar circumstances.”
The court looked at the issue this way. On 1 hand, the plaintiff was entitled to have the jury made aware that the defendant was negligent if he failed to warn her, who fashioned herself to be a “reasonable individual,” with “a general understanding” of the “substantial risks and hazards inherent in the proposed treatment or procedures as would be divulged by other practitioners under the same or similar circumstances.” On the other hand, the defendant was entitled to have the jury see that regardless of whether the plaintiff personally understood that she faced the risk of paralysis, his warning was sufficient if “a reasonable individual” would come away with “a general understanding” that paralysis was a distinct possibility.
Kentucky, however, uses a “bare-bones” approach to jury instructions. “Bare bones” means that the instructions given to the jury should be just enough “to advise the jury about what it must believe from the evidence in order to return a verdict in favor of the party who bears the burden of proof on that issue.” In other words, in Kentucky, it is left to the attorneys to assert during closing arguments that the jury actually understands what the jury instructions really mean. The court noted that using the “bare-bones” approach requires that “all of the bones” must be presented to the jury. In other words, all essential aspects of the applicable law must be integrated into the jury instructions if the jury is expected to come to a just result. Quoting another case, the court stated: “Instructions must not be so bare bones as to be misleading or misstate the law” (cit. omit.). The court was speaking to the fact that the phrase “general understanding” was omitted from the instructions; thus, the jury was deprived of that qualifying consideration.
Breaking down KRS 304.40-320, the first subsection deals with how the practitioner obtains the patient’s consent. As per the statute, it must be in accordance with how other similar practitioners obtain consent in the professional community in question. Subsection 2, on the other hand, deals with the quality of the information provided to “a reasonable individual.” The bottom line is that this communication must provide this reasonable person with a “general understanding” of the risks that are recognized by similar practitioners providing the same or similar treatment under the same or similar circumstances. In other words, it’s that old saw: “it’s not what you say but how you say it.” The court noted the following.
To the contrary, the “reasonable individual” and “general understanding” standard provided in Subsection (2) of KRS 304.40-320 is perfectly suited for application by jurors of ordinary competence, education, and intellect, save only the need for evidence on whether the “risks and hazards” involved are among those “recognized among other health care providers who perform similar treatments or procedures.”
The court was quick to point out that long, drawn out, and detailed informed consent discussions elaborating and enumerating anything and everything that could go wrong is not what it was advocating. To put it simply, the court stated that:
exhaustive detailed instructions…are not analogous to the simple, singular, and generalized duty established by…KRS 304.40-320(2). The inclusion of this duty does not infuse the instructions with an overabundance of detail, nor does it give undue prominence to certain facts and issues…[and] it would not transform the jury instructions given in this case into a “rigid list” of special duties.
The Supreme Court sided with the plaintiff and remanded the case for a new trial.
Previously, I gave you a generally accepted definition of communication. Given the court’s decision, we need to go a little deeper and understand the definition of understanding. Again, according to Merriam-Webster’s Dictionary , the basic definition is (a) to have a mental grasp (comprehend) whatever it is under discussion; and (b) to have the capacity to apprehend general relations of particulars and to possess the power to make experience intelligible by applying concepts and categories. What does this mean to us as orthodontists?
When I travel around the country and speak at various orthodontic training programs, I often visit the clinic and see residents interacting with patients. I also get letters and calls from practitioners from across the United States asking me for advice about a situation that occurred in their office. Invariably, when I converse with these residents or practitioners, and they explain the interaction with the patient, I pay particular attention to the language they use. I will often say “tell me the exact words you used with the patient.” I’m rarely surprised.
Whether it is a resident talking to a patient in the clinic or a seasoned practitioner relating an account of an occurrence in the office or reading a communiqué that was sent to a patient, I often hear, to 1 degree or another, dentalese , not English. Yes, it can be Arabic, Spanish, Canto/Mando, or whatever, but you should be catching my drift. Very often, practitioners are speaking in tongues that the rank and file of our basic patient base doesn’t understand. That’s why many of our practice management gurus will tell you to use a treatment coordinator to transmit information during the case presentation. They are closer to the source of an adequate communicative skill set.
I am constantly hearing residents telling patients that they must obtain diagnostic records. The first thing I think of when I hear the word records is vinyl discs that play music. As I watch patients’ faces, I can see that they have no idea what the records are. I will often step in and say to the patients that we need the pictures of their face and teeth, x-rays of their teeth and jaws, and molds of their teeth. You can literally see the light bulb go on over their heads. They get it; they understand.
I hear doctors say to patients that they need orthognathic surgery or that a supernumerary tooth needs to be extracted. Seriously! Do they really expect patients to understand these words. When patients hear that the maxillomandibular relationship requires surgical intervention, do they really get the concept? When they are told that the risks include temporary paresthesia, do they truly comprehend what is being said?
The general admonition by many linguistics is that we should endeavor to communicate at a sixth-grade level. Although that might be fine for the Park Avenue white-collar crowd, my humble opinion is that we need to dumb it down to the fourth-grade level. No, I’m not disparaging or insulting the education of our patient base. I’m trashing our educational system in general: not only the system that educates our patient population, but also the system that educates us.
Every now and then, we must deal with some really serious stuff. Periodontal breakdown that can result in loss of teeth. Poor hygiene that can cause significant enamel destruction. Growth run amuck—either too much or too little. Root resorption resulting in loss of multiple teeth. Undiagnosed pathology. The list goes on. Many of these occurrences are, if not rare, certainly not everyday encounters. However, when they happen, they are all too real to the hapless recipients. Shouldn’t they know the risks that orthodontic treatment entails? Shouldn’t they be told in language that they can understand what their orthodontic problem is, why treatment is recommended, what they can expect or not expect from treatment, what are the risks and consequences of orthodontic therapy, what other alternatives exist and why they may or may not be superior to the conventionally accepted approach, how long treatment will take, how much it will cost, and your guestimate about long-term stability? Oh, I get it: informed consent.
Yep; that’s what the court was talking about. Some of us use videos; maybe patients get the message, maybe they don’t. Other doctors have them sign a form that we gave them XYZ information and that they understood it; but did they? We give them a form to sign to cover our “you know what,” but did they know what was really said between the lines? We have conversations with patients or their parents, but we don’t know whether they understood what the words we used really meant. A major claim that plaintiffs make when informed consent is a claim, beside the fact that the information was not divulged, is that, in response to our assertion that we provided the requisite information, they didn’t understand what we were saying. They didn’t know that whatever admonitions we articulated were things that could actually happen to them. So what do we do about it? As Yul Brenner said to himself in The King and I , “tis a puzzlement.”
There is plenty of literature validating the concept that patients really don’t understand what we are telling them. In addition, our literature, our evidence, shows that even when we disclose the information we think we need them to know, they don’t retain a lot of it afterwards. What this tells me is that we must try harder to do a better job at communicating. This is where the rubber meets the road.
From a risk-management perspective, nothing is more important than developing a strong doctor-patient relationship, and nothing helps to do that more than having an earnest conversation with the patient for everyone to be on the same page regarding the problem, how we are going to try to fix it, what can go wrong, and what are the realistic expectations if we proceed. Conceptually, you and the patient will walk hand in hand down the path that eventually leads to the promised land, wherever that happens to be.
No way do I want to hear Strother Martin echo, “what we have here is a failure to communicate”; no way do I want to expend the effort to communicate if it is not understood. I’ll need those wasted breaths somewhere down the line. Bottom line? We need to ensure that our patients truly understand what we are telling them. How do we do this? Have them repeat back to you the information that you want them to walk away with and have them do it in their own words. When the patients can express the informed consent discussion back to you, you can be satisfied that they will never be able to say that they didn’t understand. By doing this, you can be sure that they got the message. Why? Because they just said it.
Now all you have to do is figure out how to prove it. Think Nixon and Watergate.