27 Jul Avoid Liability by Obtaining Effective Informed Consent
Avoid Liability by Obtaining Effective Informed Consent
By Judy Regan, MD, JD, MBA, and Edward Hadley, JD
For informed consent to be effectively obtained, the law requires that physicians notify patients of the nature, risks, benefits and alternatives of a medical procedure before the procedure is performed. If a physician fails to do so, the physician may be subject to liability for failure to obtain informed consent, even if the physician complies with the recognized standard of acceptable professional practice (“the standard of care”) in the performance of the procedure itself. Errors in obtaining informed consent may subject the physician to liability under one of two legal theories: the tort of failure to obtain informed consent, or medical battery. A failure to obtain informed consent occurs when a patient consents to the treatment but later claims the physician failed to advise the patient of the risks and benefits of the treatment and alternative treatments in accordance with the standard of care. A medical battery occurs when a patient does not consent to the treatment provided, such as operating on a different body part or performing a procedure that was not authorized. This paper reviews the tort of failure to obtain informed consent.
INFORMED CONSENT EXPLAINED
The tort of failure to obtain informed consent is codified at T.C.A. § 29-26-118. It states that in a malpractice action, the plaintiff shall prove by evidence “that the defendant did not supply appropriate information to the patient in obtaining informed consent … in accordance with the recognized standard of acceptable professional practice in the profession and in the specialty, if any, that the defendant practices in the community in which the defendant practices and in similar communities.” A claim of failure to obtain informed consent is a type of medical malpractice claim requiring proof of the applicable recognized standard of acceptable professional practice.
A claim of failure to obtain informed consent is established when a physician fails to disclose a particular risk of a procedure, which the standard of care required her to disclose, the risk occurs, and the physician’s failure to disclose the risk is found to be the cause of the patient’s damages.2 When proving the element of causation, the patient must establish that a reasonable person in the patient’s position would not have consented to the treatment if the physician had explained the risks, benefits, and alternatives in compliance with the standard of care. In Ashe v. Radiation Oncology Associates, the Court established that the causation standard to be applied is an objective standard. In other words, would a reasonable person in the patient’s position have chosen a different course of treatment? Under this standard “patients must prove that the physician’s conduct fell below the applicable standard of care and that a reasonably prudent person in the patient’s position would not have consented to the procedure if they had been suitably informed of the risks, benefits, and alternatives.” The finder of fact presented with a claim of failure to obtain informed consent must inquire whether the patient was provided sufficient information to allow him or her to make an intelligent and informed decision. Expert testimony is required for the patient to prove his or her case.
Generally, a hospital cannot be held liable for a failure to obtain informed consent of the patient for a physician-performed treatment. Frequently, physicians rely on hospital personnel to obtain a patient’s signature on an informed consent form and presume that informed consent has been obtained once the form has been signed. A signature on a form alone will not defeat a claim of failure to obtain informed consent; nor will failure to obtain a signature on a form result in liability. In Bryant v. HCA Health Services of Tennessee, Inc.,4 the Tennessee Supreme Court determined that a hospital, as opposed to a physician, is not required to obtain the informed consent of a patient before the commencement of a medical procedure. The decision was based on T.C.A. § 29-26-118. The statute was found by the Court to refer to the physician performing the procedure and not to the hospital. The Court stated that the large majority of states that have considered this issue have reached the same conclusion. However, the Bryant Court recognized a narrow circumstance in which a hospital may adopt an independent legal duty to obtain a patient’s informed consent. Such a duty may be adopted when a hospital participates in a clinical study monitored by the FDA and is required by FDA regulations to obtain the informed consent of patients for certain experimental treatments under the supervision of an Institutional Review Board. The implication is that summary judgment will be appropriate for the hospital as to the informed consent portion of medical malpractice claims because the responsibility to obtain informed consent falls on the physician. Unless the hospital undertakes some independent duty, such as with FDA-monitored clinical studies, it has no liability exposure for failure to obtain the patient’s informed consent to a physician-performed procedure. Similarly, a signed consent form will not absolve a physician of liability. The physician has a duty to explain the risks, benefits, and alternatives of a treatment to the patient as required by the recognized standard of acceptable professional practice. Boilerplate hospital consent forms alone rarely satisfy this standard even when a short description of the procedure, usually paraphrasing the patient’s description, is written on the form.
The information that must be disclosed to obtain a patient’s informed consent is governed by the recognized standard of acceptable professional practice in the applicable specialty in the community in which the physician practices, which includes available treatment modalities and facilities, and by the circumstances of the patient’s condition, which include the patient’s capacity to understand details of the risks, benefits and alternatives. While a physician is not required to disclose every aspect of the proposed procedure or every inherent risk, “a physician should disclose the nature of the patient’s ailment; the nature of and the reasons for the treatment or procedure; the risks involved with such treatment or procedure; whether such procedure is experimental; alternative methods of treatment along with the risks and benefits associated with it; and the patient’s prospects for success.” Further, performing the procedure itself in accordance with the standard of care will not absolve a physician of liability for a claim of failure to obtain informed consent. Tennessee cases addressing the tort of failure to obtain informed consent have established that the skill with which the procedure at issue is performed is not relevant. The tort focuses only on how the physician obtained the patient’s consent to perform the procedure.6 Thus, a procedure could be performed perfectly, a patient experience a complication, and the physician still be liable for failure to obtain informed consent. ?When a physician makes a thorough disclosure of benefits, risks and alternatives but misrepresents information in the disclosure, medical battery rather than failure to obtain consent occurs, because there is no effective consent and, thus, no authorization for the procedure. In Holt v. Alexander, the patient relied on her surgeon, who represented that her urologist approved the surgical procedure. However, the urologist was not even aware the procedure was going to be performed. Thus, the Court of Appeals found a claim for medical battery.
INFORMED CONSENT GUIDELINES
The following guidelines should be considered by physicians when obtaining a patient’s informed consent: ?
- Obtain a signed informed consent form from the patient before each invasive procedure. Document any disagreement with a patient over the treatment protocol recommended. ?Keep the informed consent form with the patient’s medical record.? Disclose what a reasonable person would want to know about the procedure proposed. ?Be aware of the consent laws for minors. ?Do not pressure, manipulate or coerce the patient toward a particular decision.?Review the record carefully to make sure competency is not an issue. ?Make sure the patient understands the explanation of his or her options.?For an informed consent form, contact your liability carrier.
- Document the actual risks and benefits of the procedure that were stated to the patient.
- Document the actual alternative treatments that were explained to the patient and the risks and benefits of those alternatives.
- Document the patient’s propensity to receive the information.
- Make documentation unique to the patient.
- Document questions by the patient.
1. Tennessee Medical Association: TMA Law Guide, Informed Consent. Available at http://www.tnmed.org.
2. Ashe v. Radiation Oncology Associates, 9 S.W.3d 119, 121 (Tenn. 1999).
3. Shadrick v. Coker, 963 S.W.2d 726, 732 (Tenn. 1998).
4. Bryant v. HCA Health Services of Tennessee, Inc., 1999 WL 10085 (Tenn. Ct. App. Jan. 12, 1999).
5. Porch SD, IV: The Tennessee Supreme Court Fills in the Blanks. TN Bar J 36(8), Aug 2000.
6. German v. Nichopoulos, 577 S.W. 2d 197 (Tenn. Ct App. 1978).
7. Holt v. Alexander, WL 94370 (Tenn. Ct. App. 2005).
Dr. Judy Regan is an associate clinical professor of psychiatry at Vanderbilt University School of Medicine and an associate with North, Pursell & Ramos, PLC, in Nashville; Mr. Hadley is a partner with NPR, with a practice that includes defending physicians in malpractice and licensure actions.