Public Health Law Map - Beta 5 - Medical and Public Health Law Site

not to inform patients about the risks of the treatment.
The community standard has the most extreme results in very limited subspecialty
areas of practice. In these areas, the number of practitioners is small, and there are
only a few training centers. This results in an intellectually homogeneous group of
physicians who tend to approach patient care in a similar manner. It is common for
subspecialty practitioners to become true believers in the efficacy of a given
treatment and to promote that treatment to patients. In this situation, the community
standard will be to offer the patient only enough information to convince him or
her to have the treatment. Risks will be ignored because the physicians have
convinced themselves that it would be unreasonable to refuse the treatment.
Another area in which the community standard becomes a problem occurs when a
small group of a larger specialty adopts a therapy that is rejected by the majority of
the specialty. Since informing their patients of the majority view would make it
impossible to perform the procedure, the minority-view physicians must ignore the
controversy. For example, there has been a great controversy in ophthalmology
over performing radial keratotomies. A small group of ophthalmologists began
performing this procedure on large numbers of patients without traditional
controlled studies on the benefits and long-term risks of the procedure. [Freifeld K.
Myopic haste? (100,000 plus have had new eye surgery). Forbes. May 6,
1985;95:135.] A disclosure based on the views of the majority of the profession
would have required that the patient be told that this was an unproved,
experimental treatment that carried potentially severe long- term risks. Fewer
patients would consent to an essentially cosmetic procedure if given this
information. As a result, the majority view was discounted, and patients were told
little about the uncertainty concerning the existing and future risks of the treatment.
When a national study panel disputed this practice and called for proper studies of
the procedure, the advocates of radial keratotomies sued the members of the study
panel for antitrust violations. [Norman C. Clinical trial stirs legal battles: legal
disputes in Atlanta and Chicago over surgery for myopia raise issue of how
controversial surgical techniques should be assessed. Science. 1985;1316:227.] The
court found these allegations groundless and ruled for the study panel members.
[Schachar v. American Academy of Ophthalmology, Inc., 870 F.2d 397 (7th Cir.
1989).]
c) Fraud in Consent
Both the community standard and the reasonable-person standard are used for
judging the information to be given to passive patients, who do not ask questions. If
the patient does ask questions, the physician must answer these questions
truthfully. More important, the answers must be sufficiently complete to convey the
requested information accurately. The physician cannot hide behind the patient’s
inability to phrase a technical question properly. Under either standard, a patient
who asks to be told all the risks of a procedure is entitled to more information than a
patient who sits mute. Failure to disclose a risk in reply to a direct question may
constitute fraud, even if the appropriate standard for judging informed consent
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