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Back To Vidyya Medico-Legal Resource Watch


The Armed Forces Institute of Pathology


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.

INFORMED CONSENT

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 law’s 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 patient’s consent commits an assault for which he is liable in damages." 3

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 patient’s consent was obtained, and the patient contended that consent would not have been granted if that risk had been disclosed.

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 patient’s 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 provider’s duty to discuss the relatively minor risks inherent in common procedures...." 6

Canterbury v. Spence suggested a different criterion, that "the test for determining whether a particular peril must be revealed is its materiality to the patient’s 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

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 patient’s 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 patient’s retrospective hypothetical decision is measured at trial by a reasonable patient, or objective standard. A subjective standard that focuses upon a particular patient’s 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 patient’s 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 patient’s act of seeking medical attention at a time when obtaining truly informed consent may be impossible.

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.

Documentation

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 those disclosures.

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 patient’s 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."

Case Study

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 patient’s 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."

Comments

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 one’s 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.

REFERENCES

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. 1064 (1972).

6. Cobbs v. Grant, 8 Cal.3d 229, 502 P.2d 1, 104 Cal. Rptr. 505 (1972).

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. Super. 1978).

15.  Harrison v. Brodmerkel, 127 Pbgh Leg. J. 151 (Comm. Pleas, Alleg. County, 1979).


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