Ensuring informed consent | aad.org
Ensuring informed consent

Legally Speaking

Clifford Warren Lober

Dr. Lober is a dermatologist in practice in Florida and a partner in the law firm Lober, Brown, and Lober.

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The telephone rings again in Bryan’s office. Taylor, a dermatologist who has been his client for years, is concerned about Jordan, a young patient who has had a less-than-optimal surgical result.

Taylor: I am really worried, Bryan. Jordan, a 17-year-old patient of mine, is quite upset about the appearance of a scar on his chest. I did surgery on a lesion about five months ago and he has developed a thickened scar at the surgery site.

Bryan: Did you get informed consent before you did the procedure?

Taylor: Yes, my nurse had him sign a written consent form before we did the procedure.

Bryan: Did one of Jordan’s parents sign the consent form? Was anything discussed with Jordan and his parents before he signed the form?

Taylor: No, Jordan’s parents were aware he was going to have surgery but they were not with him the day he had the procedure. Only Jordan signed the form. Since all of the possible risks were mentioned on the form and we were running behind schedule, we just had him sign the paper. [pagebreak]

Bryan: First, in order for a patient to give his or her informed consent, the patient must have the legal capacity to consent. In most states a person must be at least 18 years old to do so unless there are specific legally extenuating circumstances that vary from state to state (e.g., emancipated, married, or pregnant minors). Furthermore, informed consent is not a signed piece of paper. It is the process of explaining to the patient the risks and benefits inherent in the procedure, including the risk of doing nothing. The signed sheet of paper is merely a written acknowledgment that the informed consent process has taken place. You should also be aware that in some states the person performing the procedure must be the one who obtains the informed consent.

Taylor: Does the fact that Jordan’s parents were aware that he was going to have surgery matter?

Bryan: What matters is not that they were simply aware, but that they truly understood the risks and benefits of the procedure. Although they did not have to be physically present the day of surgery, their informed consent should have been obtained before the surgery was performed.

Taylor: Do I have to mention absolutely every possible risk?

Bryan: No. Courts have ruled that mentioning every single possible complication or risk ever reported is counterproductive to the intent of an informed consent. The patient needs to have a reasonable, realistic understanding of the risks the procedure entails, such as scar formation, allergic reactions, etc. Catastrophic complications, such as paralysis or death, and the risk of doing nothing should also be discussed. [pagebreak]

Taylor: Is Jordan’s signature on the form of any significance?

Bryan: In this case, no. Even if Jordan was of age, merely slapping a form down in front of him and hurriedly having him sign it is legally meaningless. The signed form may have the effect of causing Jordan or his parents to hesitate seeking legal counsel if they mistakenly assume it is valid, but any plaintiff lawyer will let them know that the “consent” is not worth the paper it is written on.

Taylor: Does the written consent form have to be witnessed?

Bryan: That is required by the laws of virtually every state. Even if it is not required, I would strongly urge you to do so.

Taylor: Are there instances when I do not need to get informed consent? Perhaps this situation qualifies.

Bryan: Yes, there are exceptions. The emergency exception, for example, allows you to treat a patient who is unconscious or otherwise unable to give consent when a delay in treating the patient would result in a major complication, such as paralysis or death. Even in an emergency situation, however, try to get a close relative to give consent.

Taylor: What if no relatives are nearby?

Bryan: Try to reach them by telephone and, if you are successful in doing so, have your nurse or another adult witness the conversation and then document it in the patient’s medical record.

Taylor: Is this the same as “therapeutic privilege?”

Bryan: No. Therapeutic privilege is when the physician withholds the information from a patient because disclosure to the patient is medically unwise. It is used almost exclusively in psychiatric situations. When it is used to avoid obtaining informed consent, the burden is on the physician to demonstrate that disclosure would have significantly harmed the patient and that this harm would have clearly outweighed the benefit of having obtained informed consent. [pagebreak]

Taylor: That certainly doesn’t help in this case. What if a patient simply says he trusts me and does not want to hear about the risks of a procedure?

Bryan: Waiver is also an exception to the need for informed consent. The patient has the right to waive receiving the information, but in those rare instances you should document his denial in the medical record and have the patient sign that statement. If the patient refuses to sign, have a witness sign.

Taylor: One last question, Bryan. If I am in the middle of a procedure and find that it is medically advisable to go beyond the procedure to which the patient initially consented, can I do so?

Bryan: This situation has been referred to as the “extension doctrine.” This exception to the requirement of obtaining informed consent is most frequently invoked in situation where the patient is under general anesthesia and it is clearly inadvisable to terminate the surgical intervention knowing that further surgery is necessary, such as in the case of a metastatic cancer that has spread beyond the area suspected before surgery was undertaken. Since the vast majority of your procedures are done in the outpatient setting under local anesthesia, the extension doctrine would rarely be appropriate since the patients are capable of giving informed consent.

Taylor: What should I do now with respect to my unhappy patient?

Bryan: Treat his scar and try to minimize it. Not only will this hopefully improve the patient’s appearance, but it also shows your genuine concern. Remember, one of the strongest triggers of a malpractice suit is the patient feeling that the doctor doesn’t care or doesn’t have the time for him or her. Alternatively, even if you have an unsatisfactory result, patients usually hesitate to sue a doctor they feel cares. [pagebreak]

KEY POINTS

  1. Informed consent is explicitly not a signed sheet of paper. It is the process of informing the patient of the risks and benefits of a procedure, including the risk of doing nothing.
  2. Patients must have the legal capacity to give informed consent. Patients who are under age, heavily sedated, intoxicated, etc., cannot give informed consent.
  3. There are exceptions to the need to get informed consent, such as the emergency exception, therapeutic privilege, waiver, and the extension doctrine. These exceptions should rarely be invoked in the outpatient dermatology setting.
  4. If a therapeutic result is less than that desired or expected, treat the patient to obtain the best outcome under the circumstances. Let the patient know you care. Patients hesitate to sue a doctor they feel cares for them.

If you have any suggestions for topics to be discussed in this column, please e-mail them to me at loberc@gmail.com. See the February 2013 issue of Dermatology World for disclaimers.