NC Court Rules Informed Consent is Binding Unless There is Fraud

When patients sign a valid consent form for surgery or another procedure, they will have a difficult time proving they did not give informed consent. This was demonstrated in Hauser v. Brookview Women’s Center, in which the court sided with a doctor after a woman sued him for performing a more extensive operation than planned, from which she suffered serious complications. The doctor had documented several discussions with the patient about the procedure, its risks and alternatives, and she had signed a valid consent form, which included permission for the doctor to perform a different procedure if events arose during surgery that necessitated it.

Informed consent and the law

Before undergoing any treatment, a doctor has a duty to explain the anticipated benefits, associated risks, and alternatives to the proposed procedure. The information must be presented in plain language and doctors must assess the patient’s understanding of what they are agreeing to. This essential communication allows patients to have enough information to make informed decisions about their health care such that they can give, or withhold, their consent. The Joint Commission also requires documentation of all elements of informed consent.

States use different standards for determining if there is informed consent and there are three acceptable legal approaches, according to the National Center for Biotechnology Information (NCBI). Many states use the reasonable patient standard, which looks at what the average patient would need to know to make an informed decision. Alternatively, there is the subjective standard, which refers to what the patient in question would need to know and understand to make an informed decision. The third option is the reasonable physician standard, which refers to what a typical physician would say about this procedure.

Exceptions to informed consent are made in cases of life-threatening emergencies when there is not adequate time to secure consent, or if the patient is incapacitated or voluntarily waives consent.

Informed consent lawsuits arise when a patient suffers harm from a medical intervention to which they did not consent, or to which they would not have consented had they been reasonably informed of the associated risks, benefits, and/or alternatives. A viable claim of informed consent requires three elements: the healthcare provider did not compliantly present the risks, benefits, and alternatives of the proposed treatment; but for receiving compliant consent, the patient would not have consented to the treatment; the treatment was a substantial factor in causing the patient harm.

Hauser v. Brookview Women’s Clinic

In Hauser v. Brookview Women’s Clinic, plaintiff Winifred Hauser sued both the practice and Dr. Donald Pittaway, who performed her 2009 hysterectomy. The doctor had first recommended a total vaginal hysterectomy (TVH) due to a bulge in the patient’s vaginal wall in 2006. The plaintiff did not schedule the procedure, and by 2008, significant changes in her uterus led the doctor to recommend a laparoscopic-assisted vaginal hysterectomy (LAVH) instead. The records from several visits showed lengthy discussions between the doctor and patient regarding her condition and symptoms and the recommended treatment. The plaintiff finally decided to proceed with LAVH in 2009. Records from a pre-surgical appointment reflect that the doctor again spoke to the patient at length about the procedure, and he gave her a pamphlet to read. The patient signed a consent form acknowledging, among other things, that they had discussed the procedure, alternatives to the procedure, and the risks associated with each, and that all questions had been answered. The consent, which the woman signed, also acknowledged that unexpected events during surgery may necessitate a different procedure.

Two days later, the doctor performed the procedure and discovered that Hauser’s uterus was much larger than the physical exam had indicated and that a minimally invasive LAVH was no longer possible. In his notes, he reported, “There was essentially no access to the lateral aspects of the uterus to be able to perform the surgery laparoscopically.” As a result, the surgeon opted to perform a much more extensive total abdominal hysterectomy (TAH).

Following surgery, the patient suffered severe complications prior to her release from the hospital 10 days later.

At trial, the plaintiff claimed that she had not consented to the TAH and that the alternatives had not been explained to her.

What the court said

In December 2020, the North Carolina Court of Appeals sided with the defendants, finding that the plaintiff had given informed consent. The court cited the North Carolina General Statutes, noting that “a written consent that meets certain standards and is signed by the patient is presumed to be a valid consent. This presumption may be subject to rebuttal only upon proof that such consent was obtained by fraud, deception or misrepresentation of a material fact.”

The court also found that the actions of the defendants in obtaining the patient’s consent was in accordance with standards of practice and that a reasonable person, from the information provided, would have a general understanding of the procedures and of the usual and most frequent risks and, given the information, would have undergone such a procedure.

While the consent form signed by Hauser identified the LAVH as the procedure, it also contained this verbiage: “Unexpected events may happen during the operation…. They may require a different procedure from that listed above. If this happens, I give permission for such surgical procedures determined to be necessary.”

“Based on the plain language of the consent form, Ms. Hauser’s signature evidenced her authorization for defendant doctor to perform the LAVH and ‘such surgical procedures determined to be necessary,’” the court held.

The plaintiff, however, compared her consent to a patient agreeing to minor left hand surgery but receiving major surgery on her right foot. But as the defendant’s medical expert witness, Dr. Andre Hall, pointed out, the “actual consent” given by the plaintiff was to “remove the uterus.” Dr. Hall explained that it “would have been a completely different issue if…Ms. Hauser, say, woke up and her gall bladder was removed.”

The takeaway

The Hauser decision demonstrates that once a compliant consent form is signed, it is binding and cannot be overcome except in cases of fraud, deception or misrepresentation. The decision also serves as a reminder for healthcare providers to discuss both the planned procedure and any other procedures that may become necessary during surgery.

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