Compliance

In Utah Consent is a Conversation . . . Then You Write it Down

In Utah, what are the best practices for informed consent with patients in order to protect your practice in case of a medical malpractice lawsuit?


What must a Utah plaintiff prove to prevail in a medical malpractice lawsuit alleging lack of informed consent?

Our firm just won a seven-day jury trial in Provo involving a 70-year-old woman who had a large staghorn kidney stone. The Urologist, concerned for sepsis and the patient’s highly resistant upper UTI, prescribed a 14-day, outpatient course of IV Gentamycin in preparation for the kidney stone removal surgery. The surgery went well, but the patient suffered some permanent vestibular injury from the infusions, and claimed lack of informed consent.

The patient had not signed a classic informed consent document for the drug administration (like she did for the surgery), but she had signed a medication information sheet that discussed the potential for balance and dizziness problems from the Gentamycin. It was enough to satisfy the jury. It was extremely helpful to defend the case to have the patient’s signature.

Utah Code Annotated § 78B-3-406 outlines Utah’s informed consent law, but here are some principles:

    • Consent is presumed and implied, and does not need to be written (but it helps a great deal!)

    • Written informed consent shifts the burden to the patient to show incapacity or fraud.

    • The patient must prove that the clinician failed to advise of the substantial and significant risks of serious harm.1 This goes to the frequency and severity of complications. In other words, health care practitioners do not have to disclose risks that are remote or not severe. Of course, those terms can be hotly contested by competing experts.

    • The patient must meet the additional burden of proving that the unauthorized treatment was the proximate cause of the injury suffered.2
Virtually every state statute governing informed consent in a medical context (including Utah’s) mandates the use of an objective standard. This means that the patient must prove that a reasonable person in the patient’s position wouldn't have consented to the treatment rendered if the collateral risks were adequately disclosed.3

 

How can practitioners optimize their informed consent discussions and forms to strengthen the defense of claims alleging lack of informed consent?

Untitled design (14)Written informed consent documents and notations in the record of consent discussions greatly increase the ability to defend claims. The absence of those writings can have immense legal implications for the defense of a medical malpractice claim.

Having a perfect form in compliance with Utah’s informed consent statute does not provide a bullet-proof defense against a negligence claim (where the claim relates to a breach of the standard of care, unrelated to informed consent), but it always helps.
 
Patients who have signed a document that a risk was disclosed cannot come back (sometimes years) later and say, “I never knew that could happen.”

All written informed consent forms should have the patient affirm that he/she:
    • "Accepts the risk of substantial and serious harm, if any, in hopes of obtaining desired beneficial results of health care.”4

    • Has received and understands the risks of the contemplated treatment.

    • Has had all of his/her questions answered to the patient’s satisfaction.

    • Has had other options (including no treatment) explained to the patient.

    • Has had the opportunity to request a copy of the document.

    • Has the capacity to understand and sign it.

    • No guarantees as to the outcome have been made, or can be made, to the requested treatment.

Since the process of informed consent often demands a discussion between the clinician and the patient, charting the process with reasonable detail provides additional safeguards.

Competent adults are presumed to have the capacity to consent to their own healthcare.5 In cases in which the patient lacks the capacity (due to age, mental disability, or incapacitation), consent may be obtained through proxy. Parents or guardians have the authority to provide informed consent on behalf of their minor children. Likewise, adult children (who have capacity themselves) have the authority to provide informed consent on behalf of their incapacitated family members.6

Relatively few medical malpractice claims are premised exclusively on lack of informed consent, but many allege inadequate disclosure as a boilerplate allegation. Following the principles in this article will help you defeat non-meritorious claims.


1 U.C.A § 78B-3-406(1)(b)(iv).

2 U.C.A § 78B-3-406(1)(b)(vii).

3 U.C.A § 78B-3-406(3)(e).

4 U.C.A § 78B-3-406(1)(b)(vi).

5 U.C.A. §§ 75-2a-104. Under 75-2a-103(13) of the Code, "Health care decision making capacity" means an adult's ability to make an informed decision about receiving or refusing health care, including: (a) the ability to understand the nature, extent, or probable consequences of health status and health care alternatives; (b) the ability to make a rational evaluation of the burdens, risks, benefits, and alternatives of accepting or rejecting health care; and (c) the ability to communicate a decision.

6 U.C.A. § 75-2a-108(2). The following classes of the incapacitated person’s family, in descending order of priority, may provide consent by proxy: the patient’s spouse, unless the patient is divorced or legally separated; a child; a parent; a sibling; a grandchild; or a grandparent.

The content of this publication or presentation is intended for educational purposes only; is not an official position statement of Mutual Insurance Company of Arizona (MICA); and should not be considered or relied upon as professional, medical, or legal advice or as a substitute for your professional judgment. Consult your attorney about your individual situation and the applicable laws. The authors, presenters, and editors made a reasonable effort to ensure the accuracy of the information at the time of publication or presentation but do not warrant or guarantee accuracy, completeness, or currency of such information. As medical and legal information is constantly changing and evolving, check for updated information and consult your attorney before making decisions.

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