- Minimizing Risk: Documenting Informed Consent
- October 3, 2008 | Author: Marshal S. Endick
- Law Firm: Wilson Elser Moskowitz Edelman & Dicker LLP - New York Office
Every person has the fundamental right to limit access to his or her own body. This right is so important that the United States Supreme Court has affirmed the ability of competent adults to refuse lifesaving medical treatment.1 Performing unauthorized dental treatment can expose the practitioner to civil and even criminal liability. Yet it is not enough for the practitioner to simply ask the patient if she will consent to a procedure; the patient's consent must be "informed." In New York, lack of informed consent means the failure of the person providing the professional treatment or diagnosis to disclose to the patient such alternatives thereto and the reasonably foreseeable risks and benefits involved as a reasonable medical, dental or podiatric practitioner under similar circumstances would have disclosed, in a manner permitting the patient to make a knowledgeable evaluation.2 Other jurisdictions have similar statutory or common-law requirements.
While it is essential that a practitioner obtain a patient's informed consent through direct discussion with the patient, from a risk management perspective, it is extremely important that the obtaining of consent be documented.
Perhaps the best defense to a claim of lack of informed consent is a consent form signed by the patient before a procedure begins. Ideally, a patient should sign a consent form well in advance of the treatment to avoid a claim that she felt "pressured" or did not have adequate time to ask questions or consider other options. A good informed consent form should generally include:
- An identification of the practitioner who will be performing the procedure;
- The purpose of the proposed procedure;
- A brief description of the procedure, written so a layperson can understand it;
- The benefits of the proposed procedure;
- The risks and possible complications of the procedure;
- Alternatives to treatment and their risks, including the risks of non-treatment;
- A statement that success cannot be guaranteed;
- A statement that there may be unforeseen events during the procedure which can require treatment outside the scope of the consent; and
- A signed acknowledgment by the patient that he understands all the above, has had any questions answered to his satisfaction and agrees to the procedure.
As tempting as it may be, a consent form need not set forth every conceivable risk no matter how remote. In fact, if a complication occurs which is not covered in an exhaustive list, a jury will more easily conclude that it was not covered by the informed consent discussion. The more prudent course is to disclose the reasonably foreseeable risks, preceded by the "catch all" caveat that the "risks include, but are not restricted to, the following."
The informed consent form may need to be modified, depending on the particular procedure. Many dental societies and organizations have developed standard forms for various procedures which can be used as a model.
A consent form is not necessary for routine care and minor procedures, such as examinations and dental prophylaxis. Any significant incursion into bodily integrity, however, should be preceded by the execution of a consent form. One test is whether a "reasonable" practitioner would have obtained informed consent under the circumstances. When in doubt, however, the patient should sign a consent form.
Although most jurisdictions do not require that a patient's granting of informed consent be documented in writing, the value of obtaining written consent, in addition to verbal consent, cannot be overemphasized. Without a written consent form, claims involving lack of informed consent inevitably devolve into a "he said/she said" contest over a discussion that occurred years earlier. Jurors tend to identify with the patient in such disputes. Practitioners who fare the best against claims of lack of informed consent often have the added protection of a written note in their chart confirming that a discussion was had with the patient about the procedure and the patient's questions were answered. Often, the patient will state that he/she signed the form but was anxious or rushed and did not really read it. The resulting credibility contest between dentist and patient can be greatly swayed in the dentist's favor by the existence of a note in the chart confirming that a discussion took place.
There is no substitute for communicating clearly, openly and honestly with patients concerning all treatment, especially invasive or risky treatment. Documenting that such communication has occurred serves a valuable risk reduction function. Unfortunately, a written consent form is not an iron-clad defense to a claim of lack of informed consent. Conversely, the absence of a signed consent form is not necessarily an insurmountable hurdle in defending against such claims. Nevertheless, the time spent documenting the granting of informed consent is a small price to pay for the protection it affords the practitioner.
1 Cruzan v. Director, Missouri Department of Health, 497 U.S. 261 (1990).
2 New York Public Health Law §2805-d.