You wouldn't expect the Armed Forces Institue of Pathology (AFIP) to be a place for medico-legal resources, but the AFIP's Web site is rich with legal information. Two excellent resources are the annual publications, Legal Medicine and The Journal of Nursing Risk Management. Printed below is a sample article from on Informed Consent from the 1999 publication of The Journal of Nursing Risk Management. By reading an entire journal, nurses can earn up to 6.7 CME hours; physicians can earn up to 5.
Traditionally, health care providers who performed unauthorized
procedures were sued under intentional tort theory. The particular intentional tort
invoked was battery.1,2 Early in this century,
Justice Cardozo underscored the laws interest in protecting patient autonomy when he
declared that "[e]very human being of adult years and sound mind has a right to
determine what shall be done with his own body; and a surgeon who performs an operation
without his patients consent commits an assault for which he is liable in
Major legal decisions in a number of jurisdictions two decades ago
dramatically accelerated the evolution of informed consent cases from lawsuits in battery
to negligence. 4,5,6,7,8,9 In each case, the patient
underwent treatment but a foreseeable complication inherent to the procedure arose. The
risk of that complication was not disclosed when the patients consent was obtained,
and the patient contended that consent would not have been granted if that risk had been
A meaningful discussion with a patient about proposed treatment
presupposes that the patient comprehends his medical condition and its seriousness. Only
then can the necessity for therapy or the prognosis of the illness without treatment be
realistically discussed. The proposed treatment should be explained, focusing upon its
benefits, risks and potential complications. Alternative courses of action, including no
intervention, should similarly be reviewed. For clinicians, a problematic aspect of these
disclosures is their scope. The level of detail concerning the operation, the number of
alternatives, and the type of risks that must be addressed can be difficult to gauge. The
courts have attempted to provide guidance, but not without ambiguity.
The Supreme Court of California noted in Cobbs v. Grant that
"[t]wo qualifications ... need little explication. First, the patients interest
in information does not extend to a lengthy polysyllabic discourse of all possible
complications. A mini-course in medical science is not required; the patient is concerned
with the risks of death and bodily harm, and problems of recuperation. Second, there is no
health care providers duty to discuss the relatively minor risks inherent in common
Canterbury v. Spence suggested a different criterion, that
"the test for determining whether a particular peril must be revealed is its
materiality to the patients decision: all risks potentially affecting the decision
must be revealed." 5 This statement raises a
corollary issue that has been resolved by the courts in two vastly different ways, whether
the standard of disclosure should be viewed legally from the perspective of the provider
or the patient. Currently, a thin majority of jurisdictions, such as North Carolina,
Florida, New York, and Virginia, retain a professional standard of disclosure.3 Courts in those states treat informed consent cases similarly
to other medical malpractice lawsuits. The applicable standard is the reasonable provider
practicing in the same or similar circumstances, and expert medical testimony must be
presented in court on that issue.
Other jurisdictions view consent cases differently than typical medical
malpractice lawsuits. Regarding the risks that should be disclosed prior to initiating
treatment, the majority in Cobbs stated that "the weighing of these risks
against the individual fears and hopes of the patient is not an expert skill. Such
evaluation and decision is a nonmedical judgement reserved to the patient alone."
Expert testimony at trial, therefore, is not required, making it theoretically easier for
a plaintiff to litigate such a claim. Courts in approximately 20 states, including
Maryland, Massachusetts, Ohio and Washington, have joined California in adopting this
reasonable patient standard.
Many states have enacted statutes that address informed consent.
Fifteen legislatures have established a professional disclosure standard, five have
established a reasonable patient standard, and nine states do not clearly specify either
standard. In addition, Hawaii, Louisiana and Texas have created "disclosure
panels," composed of professional peers, to establish the appropriate information to
be disclosed about a given procedure or treatment. 3
Defenses are available in a lawsuit alleging failure to obtain informed
consent. As with all negligence claims, to be compensated, the alleged breach must have caused
the patients injury. With informed consent, this causal link is broken when the
patient would have undergone the treatment had a full disclosure been presented. In all
but a few jurisdictions, the patients retrospective hypothetical decision is
measured at trial by a reasonable patient, or objective standard. A subjective
standard that focuses upon a particular patients informational needs, no matter how
idiosyncratic, has generally been considered by the courts as overly susceptible to
manipulation and hindsight. A corollary defense can be interposed when the undisclosed risks
are generally known to a particular patient (e.g., radiation exposure to a
radiologic technician), too remote, or relatively insignificant. A patient can waive
the right to informed consent. Many states that mandate informed consent by legislation
also address its waiver. For instance, New York provides a defense to informed consent
litigation when the patient assures the provider that he would undergo the treatment
regardless of risk or he indicates that he does not want to be given the information
required by law. 10 Adequate documentation clearly assumes
special importance if a defense of waiver is later challenged.
Emergency medical care is often provided without documenting
consent. Due to circumstances, the patients right to disclosure may be considered
waived, not by articulated choice but by clinical necessity (i.e., time is of the
essence). From another standpoint, consent can be implied by the patients act of
seeking medical attention at a time when obtaining truly informed consent may be
Finally, clinicians may withhold information to protect patients from
suffering severe adverse medical effects from the disclosure alone. Since this defense,
known as therapeutic privilege, runs absolutely counter to the goal of patient
autonomy embodied in the doctrine of informed consent, sufficient documentation of the
medical rationale for its invocation is essential. Obviously, documented concurrence by
professional peers that the information should be withheld for medical reasons strengthens
the basis for invoking this privilege.
In legal disputes involving informed consent, similar to all claims of
professional negligence, the focus inevitably seems to fall upon documentation. Memoranda
of discussions between a health care provider and a patient concerning proposed therapy
are evidence of the discussions existence and their content. Therefore, the quality
of any recorded memorandum translates directly into the quality of trial evidence, which,
in turn, often determines a trial's outcome.
Standard Form 522 (SF 522), entitled "Request for Administration
of Anesthesia and for Performance of Operations and Other Procedures," is signed by
the counseling health care provider, the patient and a witness before procedures in
federal health care facilities. Although SF 522 addresses, in general terms, major topics,
(e.g., treatment, alternatives, risks, etc.), a progress note detailing the discussion of
the proposed treatment is required by military services and the VA. 11,12,13
Since the mass-produced form is "standard," i.e., routine, its evidentiary value
as a memorandum documenting health care provider-patient communications about subtle
details of treatment is arguably not as great as a specially drafted progress note about
By statute, certain jurisdictions, including Florida, Georgia and
Texas, have concluded that any signed consent form is presumptively valid. Other
jurisdictions, however, have impugned signed consent forms when there is evidence that the
patient was not aware of a specific material risk. 14 A
Pennsylvania court set aside a directed verdict against a patient who had signed a consent
form before undergoing endoscopy. 15 The court asserted
that since "the issue is whether the patients consent is given with a true
understanding of the nature of the operation to be performed, the seriousness of it, ...
and possible results, ... the courts will look beyond forms signed by patients to
determine if the duty to inform has been discharged."
A recently resolved malpractice claim brought against the United States
under the Federal Tort Claims Act illustrates some points. A woman diagnosed with
rheumatoid arthritis had been treated for several years by a rheumatologist at a military
medical facility with anti-inflammatory medications and gold. After she developed a
reaction to gold, she was prescribed azathioprine (Imuran), an immunosuppressive
antimetabolite, and instructed to return in three weeks. At the return visit, the patient
reported symptomatic improvement, and a complete blood count was normal. No specific
follow-up recommendations were documented. Three weeks later, the patient presented to the
emergency department of the same facility with headache, earache, sore throat, and bloody
nose. She was prescribed an antibiotic with an antihistamine for "acute
sinusitis/possible pharyngitis" and discharged. Over the next week, she developed a
perineal hematoma, a blood-tinged vaginal discharge and petechiae of the lower
extremities. A repeat complete blood count was notable for pancytopenia, including 400
white blood cells and 4,000 platelets. The patient was admitted to the Intensive Care
Unit, and Imuran was discontinued. Gynecologic consultation was obtained for a presumed
necrotizing vulvar fasciitis. When the infected wound was surgically debrided, a cervical
biopsy was performed. This led to a second biopsy that revealed invasive squamous cell
carcinoma. Less than eight months later, the patient died.
A claim was subsequently filed by the patients estate alleging
that the health care provider negligently treated the patient, failed to inform her of the
risks of taking azathioprine, and did not monitor her properly. Peer reviewers criticized
the failure of the practitioner to adequately disclose the risks and alternatives of
taking an immunosuppressive medication or, at least, the failure to document those
disclosures. The prescribing health care provider affirmed the former criticism by
replying that "[w]hen she asked me about the side effects of Imuran, I said that it
affected the blood system. I did not go into great details of the possibilities of
leukopenia, thrombocytopenia, etc., more than I would with any other patient."
Some health care providers may view "getting consent" as an
obstacle, the clerical formality of securing a signature on a document so that treatment
can begin. Their focus is erroneously placed on the document, not the disclosure process.
In an environment obsessed with limiting risk through "routine" documentation,
the process of discussing proposed treatment with a patient becomes an onerous task,
instead of an opportunity to build rapport. The day of "not going into great
details" with ones patients regarding the risks of proposed treatments has
passed. Furthermore, in this era of powerful medications, such as immunosuppressants,
glucocorticoids, anticoagulants, broad-spectrum antibiotics, and gene therapy, the duty to
obtain informed consent is no longer restricted to physicians.
1. Second Restatement of Torts, Section 13.
2. Mohr v. Williams, 95 Minn. 261, 104 N.W. 12 (1905).
3. Schloendorf v. Society of New York Hospitals, 211 N.Y. 125,
105 N.E. 92 (1914).
4. Hunter v. Brown, 4 Wash. App. 899, 484 P.2d 1162 (1971).
5. Canterbury v. Spence, 464 F.2d 772, cert. denied, 409 U.S.
6. Cobbs v. Grant, 8 Cal.3d 229, 502 P.2d 1, 104 Cal. Rptr. 505
7. Wilkinson v. Vesey, 110 R.I. 606, 295 A.2d 676 (1972).
8. Bly v. Rhodes, 216 Va. 645, 222 S.E.2d 783 (1976).
9. Sard v. Hardy, 281 Md. 432, 379 A.2d 1014 (1977).
10. New York Public Health Law § 2805-d.3,4.(b).
11. AFR 160-12.
12. NAVMEDCOMINST. 6320.16.
13. Department of Veterans Affairs. Manual M-2, Part I, Chapter
23. Washington, DC: Department of Veterans Affairs; Feb 1990.
14. Sauro v. Shea, 390 A.2d 259 (Pa.
15. Harrison v. Brodmerkel, 127 Pbgh
Leg. J. 151 (Comm. Pleas, Alleg. County, 1979).