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Signed Consent Form Does NOT Constitute Informed Consent

O. William Brown, M.D
From the Society of Clinical Vascular Surgery

Before any patient is brought into the operating room, the circulating nurse is instructed to make certain that an operative permit or consent form is signed.  In fact in some institutions, a patient may not be brought to the preoperative holding area unless the “consent form” is signed.  However, a signed consent form must never be equated with obtaining informed consent.  In 1914, Justice Cardozo in Schloendorff v. Society of New York Hospital ruled, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.” Though the courts have subsequently argued the boundaries of this theory, the obligation of “full disclosure” by the physician to the patient regarding the patient’s diagnosis and treatment remains uncontested.

While most physicians agree that patients should be “fully informed” they have no idea what legally constitutes informed consent.  At a minimum, informed consent includes discussing with the patient his diagnosis, the physician’s treatment plan, as well as the risks and benefits of the proposed treatment plan.  In addition, the physician must discuss alternative treatment plans as well as the prognosis of the disease with and without the various treatment alternatives.  Whereas this seems self-evident to most physicians, the difficulty arises in determining exactly how detailed the discussion should be in each category.  Specifically, should a patient who is to undergo a saphenous vein stripping be told that he/she could die as a result of the procedure?  Should every patient who is to undergo a carotid endarterectomy be offered carotid angioplasty and stenting as a treatment alternative?  Most courts have suggested that all reasonable risks and alternatives must be discussed.  However this too is subject to significant controversy.

Over the years, the courts have given some guidelines to the medical community as to what needs to be included in a discussion of informed consent.  The courts have suggested that all risks that potentially might affect a patient’s decision to proceed or not proceed with a planned treatment must be discussed.  However, the courts have also emphasized that the physician does not have to read the patients mind as to what is important to the patient.  A patient will not be permitted to claim after undergoing a resection of an abdominal aortic aneurysm that had he known he would have numbness in his incision postoperatively, he would not have undergone the procedure.  It must also be remembered, that the informed consent standard is not predicated on what other physicians in the area consider informed consent but rather what is reasonable under the circumstances.  However the courts have also stressed that the standard should be a national medical standard and not what the lay court or jury felt should be discussed.

Obtaining informed consent is a non-delegable duty. This means that informed consent must be obtained by the attending surgeon. A nurse, physician assistant, or surgical resident cannot obtain informed consent for the operating surgeon.  In truth one partner cannot obtain consent for another partner.

Finally, since we have many young vascular surgeons beginning in practice, let me issue a word of caution regarding quoting "literature results" to your patients.   In Johnson v. Kokemoor, a patient was referred to a neurosurgeon for treatment of an enlarging basilar artery aneurysm.  Following the procedure the patient was rendered an incomplete quadriplegic. The patient was also noted to have visual and speech disturbances. 

At trial, plaintiff introduced evidence that the defendant overstated his experience with this type of aneurysm surgery.  When asked about his experience, the defendant stated he performed the surgery “several” times.  When he was asked what several meant, “the defendant said “dozens” and “lots of times”.

However, the defendant had only performed thirty aneurysm surgeries during his residency and all involved the anterior circulation.  Plaintiff’s expert testified that anterior circulation aneurysm surgery is much less complex than posterior circulation aneurysm surgery.  In addition the defendant had operated on only nine aneurysms following his residency of which only two were in the basilar circulation and neither was a large bifurcation aneurysm like the plaintiffs. The plaintiff further stated that the surgeon underestimated the morbidity of the procedure quoting percentages that if applicable at all would only apply to surgeons with extensive experience.  Finally, the plaintiff introduced evidence that “patients with basilar artery aneurysms should be referred to tertiary care centers-such as the Mayo Clinic, only 90 miles away.”  After an extensive analysis, the court ruled that the defendant’s lack of experience could be admitted into evidence.  The court further concluded “a reasonable person in the plaintiff's position would have considered such information material in making an intelligent and informed decision about the surgery.”