February 2002 Bulletin

Informed consent

More than a signed consent form is needed

By Phyllis J. Garrison

A patient appears in the ED complaining of classic symptoms of appendicitis. The diagnosis is confirmed, an on call surgeon appears, talks with the family about the patient’s condition, risks of surgery, need for the surgery, alternatives and recovery. The operation takes place. Wife leaves the hospital several hours later. A hospital nurse calls the wife, explaining that the informed consent document was never signed.

A patient is taken into surgery. After being given the initial medication to prepare for anesthesia, the anesthesiologist appears bedside and asks the patient questions and talks about the risks, effects and recovery from the proposed anesthesia. The patient had signed a consent to surgery, including anesthesia, one hour prior to this conversation.

Which of these situations presents the greatest risk of liability for the physicians if the patient has a poor outcome?

In the first instance, all that is missing is a form. The essential elements of the information was transmitted to the patient, who saw the physician before any judgement altering medication was administered and had an opportunity to ask questions and receive answers about the risks, benefits, alternatives and recovery expectations of his surgery. The second situation appears to be less problematic at first glance. The informed consent was signed by the patient. Discovery during litigation would reveal, however, that the patient was not sufficiently "informed."

The consent form is nothing but a piece of paper. It is certainly evidence that a session where information was exchanged between physician and patient took place. In most states its existence creates a "presumption" that the patient received all legally required information about the upcoming procedure. In court, however, that presumption can be overcome by testimony or other evidence to the contrary.

The form cannot replace the actual interaction of the physician and patient. The physician can delegate the act of obtaining the signature on the form. But the law is clear and consistent: only a physician has the requisite education, training and skill to determine risks and benefits and alternatives of a procedure that physician will perform, be it surgery, endoscopy or anesthesia or intervention radiology. There must be an opportunity in advance of the procedure, when the patient is not under the influence of judgment altering medication, for the patient to ask the physician questions and have the physician answer those questions unless the questions are about non-medical portions of the procedure. An nurse or technician can address questions such as, "how long do these procedures generally take?" but not questions such as, "What will happen if a tumor is discovered?"

Must the physician always be physically available to the patient prior to the procedure? Not necessarily. Many physicians record video tapes explaining the risks, benefits, alternatives. Modern technology allows these to be interactive. Brochures or pamphlets written or approved by the physician can be provided to the patient in advance. Most often, if well designed, these methods will answer all patient questions or concerns. Note that, if the patient has further questions about the medical portion of the procedure, the patient must be offered an opportunity to address these with the physician.

How much should the patient be told about risks? The patient must have information that a reasonable layperson would need to determine whether he/she would proceed with the proposed treatment. This is a judgment call. One does not want to unnecessarily alarm the patient. Most physicians turn to the literature and disclose all but the most remote or rare possibilities. In almost every procedure there is a "worst scenario." This can be death or loss of limb, sight, hearing etc. If the worst that can happen is disclosed to the patient, the patient cannot successfully later complain that he/she would not have proceeded had the patient known lessor or minor problems would and did occur.

Following this advice can protect the physician from accusations that the patient was not sufficiently informed prior to submitting to treatment. The situations described at the onset are not fictitious. Your writer, a health care attorney, was the wife and the patient respectively.

Phyllis J. Garrison Esq., is an attorney with Bose, McKinney and Evans, Indianapolis, Ind.

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