The Duty of Informed Consent

Surgeons have a duty to obtain a patient's informed consent before proceeding with treatment. Consent means they cannot operate if you object to it, even if they believe you are going to die. Informed means they must provide accurate information about all your options, in particular the main surgical options, the main radiosurgical options, and the possibility of watch and wait, so you are not consenting out of ignorance. The duty to obtain informed consent constitutes a part of the standard of care that all surgeons must adhere to, legally.

However, many AN patients feel in retrospect that they were misinformed by their doctors.  Either they were not told that they could wait-and-watch for a while, or that they have non-invasive options for treating their ANs.  More often, alternative options were mentioned, but greatly misrepresented, so the patient rejected them for reasons that prove to be wrong (the so-called "AN Myths").  Given the risks inherent in AN treatments, wrong treatment decisions can have a permanent and devastating impact on the patient's quality of life.

As in the case of one patient, who was upset enough to create a booklet for his ENT, this is usually done out of failure to keep up-to-date, rather than out of malice.  In fact, being out-of-date is much more common for doctors than we think, especially in such a rapidly changing field as ANs.  However, the difficulty of keeping up-to-date does not constitute a reasonable excuse for the specialists to whom we are referred upon diagnosis.  A dictionary defines a medical specialist as one who devotes his attention to a particular class of  diseases. If a doctor allows himself to be put in a position of an AN “specialist”, then certainly he has the responsibility to be knowledgeable on all current procedures in his field.

So is the standard of informed consent being breached, in the case of ANs? Most patients, after learning more, tend to agree.  Unfortunately, this will continue until the doctors have a reason to act differently, and no reason is more effective in medicine than fear of a lawsuit.  When breach of duty to provide informed consent is viewed as a legal theory, it would have to be decided individually for each legal case, until enough cases are done to form a strong precedent.  At that point, the answer becomes an unequivocal yes, and the medical establishment has no choice but to change.

For the first few individual cases, the question is: will a jury agree that the patient was not properly informed when agreeing to surgery?  The answer is: they will buy it if they are instructed to buy it. So jury instructions are important. In order to get the judge to accept jury instructions, they have to contain statements of "black letter" law.  This law comes either from statutes or from case holdings, this varies from state to state. It may not be covered by state statutes at all but may be the province of the incumbent medical regulatory body in each state.

So the first thing is to examine the statutes of the statewide medical regulatory body.   They are usually broad, and allow a lot of latitude, but it will probably come down to this: the duty to inform a patient regarding alternatives to surgery will be restricted to those treatments accepted in the medical community as "standard." In other words, it would be below the standard of care for the surgeon to recommend shamanism, witchcraft or voodoo.

So is radiosurgery different from voodoo? Normally, this is decided by the standards-making body for the jurisdiction, probably the National Institutes of Health in the case of ANs. Once such a body accepts various forms of radiosurgery as viable, endorsed alternatives, we're home free on the standard of care issue. Unfortunately, at the moment, they have nothing to say on this issue, since the last NIH consensus statement on ANs has been declared outdated, and a new one does not exist yet.

So what do we do?  Well, we can look at what AN treatments are accepted by Medicare and offered by leading nationally recognized hospitals.  This is all true for both Gamma Knife and FSR (as well as microsurgery), which means that they are certainly not on par with shamanism. 

One can also consider a case of Joanne Motichka (a.k.a. Matuschka), a painter who was diagnosed with breast cancer in 1991 and had complete breast removal (radical mastectomy) two weeks later.  Five years later, in 1996, cases like hers stopped being recommended for radical mastectomy -- partial removal followed by radiation proved just as effective.  However, in 1991, what happened to Matuschka was standard procedure...   But after doing some more research, and showing her medical records to other specialists, she decided that there was enough information around, even in 1991, that her doctor should have known that her surgery was not necessary...  In March 1999, a New York court agreed, and awarded her $2.2 million in damages. [See TIME, April 12, 1999, p. 70]

Acoustic Neuromas are much less of a cause celebre than breast cancer, and our struggle for informed consent is still ahead of us. Two events would give a large impetus to this struggle:  recognition by a conservative (and probably heavily lobbied) national standards organization such as the NIH, or a ruling by a brave judge. Both of these are uphill pushes. There are two weapons to use in pushing both of these along. The first is gathering of evidence as to the efficacy of alternatives to surgery. The second is a lobbying effort at the right level, to the right standards organization.

There is actually very little controversy as to what the AN patients want to see happen; we are not aware of anyone in disagreement with a document drawn up by the patients on ANA's e-mail forum, outlining the standards of care that we want the medical establishment to provide to newly diagnosed AN patients.  But so far, there is a large gap between our vision and the reality facing most newly diagnosed patients; as one patient commented:

Perhaps a warning label should attached to the “Informed Consent” that is presented to a patient. It could read something like this, “the Informed part of this statement is the patient's responsibility.”

original version by Keenan Davis

Last Edited: Wednesday, October 30, 2002