I know I’m gonna start some fights here, so let’s get to it. When you obtain a patient’s informed consent, does it have to be in writing? Apparently not in Nebraska. Now those of you who know me can attest to the fact that I’m way too lazy to look up what the law is in each state, so before going any further, here’s what you need to do. Call your malpractice carrier (sorry, American Association of Orthodontists Insurance Company, but you’re going to get a lot of phone calls) or speak to a local health care attorney in your state and find out if you do or if you don’t. We’re talking about needing to get it in writing. Bank v Mickels, 302 Neb 1009 (Neb Sup Ct, April 25, 2019) gives us some insight into this question.
The plaintiff had a rotator cuff tear, underwent surgery, and was healing uneventfully until he was involved in a motor vehicle accident as a passenger; yes, he was wearing a seatbelt. During follow-up visits to check on his rehabilitation and before the accident, the defendant gave the plaintiff a local anesthetic injection to allow him to test the range of motion in the affected shoulder. The patient subsequently developed a serious infection in the surgical site; this resulted in the need for revision surgery after the infection was brought under control; and, ultimately, the need for shoulder replacement surgery. The ensuing malpractice suit claimed that the surgeon was (1) negligent in that the injection and excessive range of motion manipulation caused the infection, (2) that both procedures resulted in the need for joint replacement surgery, and (3) that the doctor did not obtain his informed consent to the injection and manipulation procedure.
The expert witnesses for each side proffered their respective arguments concerning whether or not the standard of care was met. As to the claim for lack of informed consent, the plaintiff claimed that it had to be in writing; the defense argued that it did not. The jury found for the defendant. The plaintiff then brought this appeal to the State Supreme Court. The Supreme Court upheld the trial court’s findings pertaining to the negligence claim and then went on to address the claim for lack of written informed consent.
Nebraska, like many states, has a statute that specifically deals with informed consent; it is Section 44-2816 of the Nebraska Hospital-Medical Liability Act. The pertinent paragraph reads:
Informed consent shall mean consent to a procedure based on information which would ordinarily be provided to the patient under like circumstances by health care providers engaged in a similar practice in the locality or in similar localities. Failure to obtain informed consent shall include failure to obtain any express or implied consent for any operation, treatment, or procedure in a case in which a reasonably prudent health care provider in the community or similar communities would have obtained an express or implied consent for such operation, treatment, or procedure under similar circumstances.
In restating what this means, the court stated that the purpose of the statute was to ensure that doctors
…provide their patients with sufficient information to permit the patient himself to make an informed and intelligent decision on whether to submit to a proposed course of treatment or surgical procedure. Such a disclosure should include the nature of the pertinent ailment or condition, the risks of the proposed treatment or procedure, and the risks of any alternative methods of treatment, including the risks of failing to undergo any treatment at all….
Quoting a Kentucky case that influenced its decision, the court noted:
Consent is a process, not a document. Authorization for treatment is the culmination of a discussion.…the documentation, the so-called consent form, is not the consent, for that lies instead in the conclusion of the discussion between the patient and the physician…. (Cit. Omit.)
The court went on to state that as a general rule, the statutory language is to be given its plain meaning, and it is not the function of the courts to interpret language that is plain, direct, and unambiguous. The court stated that the statute describes the type of information that needs to be given; it does not note any particular form that such a transmission of information must take, and it goes so far as to state that informed consent may be express or implied. The court was firm in its position that if the legislature wanted informed consent in Nebraska to be written, they could have mandated that by inserting it into the statutory language as other state legislatures have done; however, it was not the function of the court to do so. This part of the trial court’s verdict was also upheld in favor of the defendant.
Commentary
This issue is really about risk tolerance. Let’s forget for a moment that certain states require that a patient’s informed consent be in writing. Instead, let’s focus on what is really going on. We must obtain our patient’s informed consent. Legalities aside, obtaining informed consent is the most ethical thing that we do. Now, depending on which state you practice in, you are either using the professional standard or the patient need-to-know standard. The minority of jurisdictions, Nebraska being an example, employ the professional standard. As noted by the court, a practitioner is required to impart to a patient “…information which would ordinarily be provided to the patient under like circumstances by health care providers engaged in a similar practice in the locality or in similar localities.” In other words, the caliber of the information provided is that which other practitioners would impart; some would posit that this is akin to the fox guarding the henhouse. Over the last 50 years, the majority of jurisdictions have come to adopt the patient need-to-know standard, the premise being that a doctor is obligated to provide the patient with whatever information a reasonable patient would deem material to accept or reject a contemplated course of therapy. Obviously, the latter is somewhat more onerous for the doctor but far more enlightening and respectful of a patient’s autonomy.
Regardless of the degree of information divulged, we are still faced with the issue of not how to divulge it, but how to document that this exchange of information occurred and that it was understood by the patient to the extent they could then grant their informed consent to the proposed therapy. Note the language: we don’t give informed consent, we get informed consent. What we give is information, and in return, we receive the patient’s knowledgeable acquiescence to our ministrations. It is their bodily integrity we are about to invade; they have to knowledgeably allow us to do it.
This is when risk tolerance comes into play. And that is what this case was all about—documentation to ameliorate risk. The doctor said he discussed the procedure and the risks; the patient says he did not. Where is the proof? If we harbor a low-risk tolerance threshold, we need to rely on definitive means of proving that the required exchange took place, such as a consent form signed by the patient. Those of us with a higher risk tolerance might use a less formal means of sustaining our burden of proof, such as writing what we told the patient in their chart. Even with a signed form, a patient could still argue adequacy of the information; but there would be no question as to whether an exchange of information, of some yet-to-be-determined substance, occurred. Again, legal requisites aside, how strongly do you believe the need to prove that you obtained your patient’s informed consent? What are the means you will use to memorialize in some fashion that this informed consent process occurred? What is your risk tolerance relative to this issue?
Think of it as a risk management ladder. The higher the rung you stand on, the stronger the argument that informed consent was obtained. The highest rung on the ladder might be to videotape your consultation. It is an excellent way to prove exactly what was discussed. It is also an excellent way to prove what information was not divulged. In addition, one could easily argue that the patient did or did not understand the information divulged on the basis of their captured response. The next rung down might arguably be audiotaping the consultation. My favorite method, albeit more involved, uses a form that the patient has to complete in their own hand. It would go something along the lines of “My doctor has told me that my orthodontic problem is _______________.” They would then have to fill in the missing verbiage. It might continue with “My doctor has explained to me that the risks, compromises, or limitations associated with my treatment are ________________.” Once again, they would have to fill-in-the-blank. You can have as many fill-in-the-blank sentences as you need to meet your risk tolerance. I’m sure you get the point I’m trying to make. By doing it this way, a patient could never argue that they didn’t understand it because, after all, they wrote it in their own hand. It is quite proper to feed them the answers if needed, as this, in and of itself, is part of and enhances the informed consent process.
As we move further down the rungs of the ladder, we might use any one of a number of proprietary forms, the American Association of Orthodontists one being a good example. Stepping down a rung, one might see practitioners writing down what they told the patient in the chart and having them sign or initial the entry, with the lower rung now supporting doctors who write the same thing sans a patient’s signature. Further down on the ladder, one might see an entry that says informed consent discussed with the patient, whereas one of the bottom rungs might reveal the lack of any documentation as to whether or not informed consent had been obtained, your word against the patient’s word.
The real risk here is falling into the trap of relying on form over substance. The form I’m referring to is not the informed consent form per se; it is the adopted practice of using a form as a substitute for the discussion. It is a fallacy of believing that a signed form connotes that a verbal discourse took place. It is accepting the delusion that the patient fully comprehends the information they need to grant informed consent. It is the fiction of the process. Should proof of informed consent be in writing? Sure. Does it mean adequate informed consent was obtained? No way.
Let’s retitle this article; how about “Is there a right way?”
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