Volume 56, Number 3 - Summer 2010

 

By Doug Free, Esq.

Nearly 40 years ago, the California Supreme Court ruled that physicians have a duty to obtain their patients’ informed consent prior to performing certain procedures.[1] Since then, other judicial decisions have made it clear that physicians who do not obtain informed consent from their patients can in some cases be held liable under theories of battery, fraud, intentional infliction of emotional distress, and other legal causes of action. Given that many of these theories are premised upon alleged intentional acts, it is quite possible that physicians who are sued under these legal theories may find themselves without insurance coverage in the event of a judgment. Physicians can also be held liable, under theories of negligence, in instances where the information provided was insufficient to allow the patient to make a meaningful decision about the risks and benefits of a given procedure.

The law does not require that physicians obtain informed consent in all instances. Rather, the law holds that in cases involving “simple and common” procedures only the patient’s “consent” must be obtained as opposed to informed consent. Conversely, in cases that are not “simple and common,” the patient must give informed consent as evidence that they have been advised of the risks of the relevant procedure and have chosen to undergo the procedure despite those risks.

The law is not entirely clear as to exactly which procedures do or do not require informed consent. This issue has been addressed in several court decisions, and the question of whether consent is or is not required becomes very fact-specific. At a bare minimum, any known risks of death or injury must be disclosed, as well as any other information as a “skilled practitioner of good standing would provide under similar circumstances.”[2]

In short, there is no bright-line test for determining when consent is and is not required. Nonetheless, obtaining informed consent is generally recommended if there is any question that the procedure is sufficiently complex to warrant obtaining informed consent, or if there is any possibility of adverse consequences as a result of the procedure.

Not all procedures require written materials and/or a signature by the patient. While some procedures do require the patient to consent in writing, the law is less specific about many other procedures. Many physicians use a standardized form to get written consent. While such forms can be helpful, they are no substitute for the physician and patient sufficiently discussing the relevant factors at issue—and for documenting this discussion in the patient’s chart.

Many studies conducted over the last decade have revealed widespread problems arising from patients who do not understand the informed consent materials provided by their physicians. At least two primary causes of this lack of understanding have been discovered: language barriers and varying degrees of illiteracy.

As shown above, informed consent can become quite complex even for patients who possess a reasonable ability to read and comprehend the information their physician is attempting to convey. Imagine then the difficulties that arise with patients who either do not understand the language that is being used and/or are unable to read with sufficient ability and comprehension.

As with many problems, the first step toward a solution often begins with awareness. By understanding that not all patients have the same level of comprehension, it may be possible to use protocols that will increase the odds that patients leave your office sufficiently informed of the risks and benefits of a given procedure. Properly implemented, such protocols could prove to be helpful to your defense in the event of a claim or lawsuit alleging lack of informed consent.

The law in California is still evolving with respect to the fact that the state’s physicians are increasingly serving a population of patients whose primary language is something other than English. At present, hospitals have an absolute duty to accommodate such patients, and recent regulatory guidelines suggest that a similar standard may apply to physicians providing treatment to Medi-Cal and other federally funded patients.

As to physicians generally, it is not presently clear to what extent they are required to accommodate the needs of non-English-speaking patients. Nonetheless, it is in everyone’s best interest to implement reasonable steps designed to ensure that these patients understand information conveyed by the physician and are informed in their health care decisions.

One possible solution is to employ bi- or multi-lingual staff. In addition, if patients who speak a given language are expected to present for treatment, it would be advisable to have consent forms printed both in English and the other language. As noted above, however, keep in mind that a simple and standardized consent form is not a valid substitute for a complete and meaningful discussion between physician and patient. 

Depending on the risks of the procedure, as well as the language barrier, physicians would be well advised to hire a certified interpreter to assist with the informed consent process. In such cases, the patient’s chart should reflect that a certified interpreter was present during discussions, and that the patient was sufficiently apprised of any known risks for the procedure. The expense of using an interpreter would be money well spent in the event of a lawsuit by a patient who alleges failure to adequately describe the risks of a given procedure.

Studies have shown that a large percentage of patients lack sufficient literacy to comprehend information conveyed as part of the informed consent process. As in the case of patients with language barriers, the law is unclear at present as to the physician’s duty to ensure that patients have comprehended written materials presented by the physician. Illiteracy may be very hard for physicians to detect, as many patients may appear to read relevant materials when in fact they are unable to read or comprehend.

While there are no hard and fast solutions to this problem, of key importance, once again, is the need for the physician to take the time to adequately discuss a given procedure and its known possible complications with each patient. Equally important, as noted above, is the need to document this discussion in the patient’s chart.

Apart from the absolute need for a sufficient discussion, there are tools and techniques available to assist with the informed consent process for patients with reading limitations. One such tool is the use of picture books wherein the pictures are as important as the text for informing the patient about the risks of the procedure at issue.

In addition, many physicians are beginning to use multimedia tools for informed consent. Such tools are often created with one specific procedure in mind. They sometimes come in the form of a DVD that the patient watches in a designated section of the office. There are also computer-based programs that require some degree of patient interaction and in effect “test” the patient’s comprehension of the risks involved.

Multimedia tools will likely become more important as laws relating to the informed consent process continue to evolve. By providing such tools to the patient prior to any discussion of the procedure, the physician may find it easier to make a meaningful assessment of the degree to which the patient is informed of the risks of the impending procedure. Assuming that the multimedia tools are current and accurate, the fact that such tools were used could be helpful in the event of a lawsuit alleging failure to obtain informed consent.

The informed consent process entails a definite degree of complexity even in cases where complicating factors such as language barriers or literacy problems are not present. Factor one or both of these into the mix, and the potential for a meaningful informed consent dialog will likely diminish significantly.

As stated above, the law is still evolving with respect to the impact of language barriers and literacy on the informed consent process. Being aware that these issues most likely exist in your practice is step one toward reducing the consent impediments that these issues can create. 

There are tools designed to help facilitate the informed consent process for patients with language barriers and for patients whose reading skills may be limited or nonexistent. While these tools can be of great benefit to both the patient and the physician, there is no substitute for a meaningful discussion with the patient, documented in the patient’s chart.

1. Cobbs v. Grant, 8 Cal.3d 229 (1972). 
2. Arato v. Avedon, 5 Cal.4th 1172 (1993).

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