Informed Consent: Not a Mere Formality

Most healthcare malpractice claims allege a failure to properly diagnose or treat a medical condition, which is what most providers think of when attempting to reduce their litigation exposure. However, another important aspect of patient care—informed consent—can be an independent basis for a medical malpractice lawsuit. It is important for providers to recognize that informed consent is an important component of care, not a mere formality.

Basis for Informed Consent

Kentucky’s Informed Consent Statute, KRS 304.40-320, was enacted in 1976. Pursuant to Kentucky law, healthcare providers have a duty to disclose certain information to patients when recommending a procedure or treatment. The provider must disclose the expected benefits and “substantial” risks of the treatment as well as “acceptable” alternatives. This information must be imparted in such a way that a non-medical person would understand it.

Informed consent claims typically arise when a patient suffers a rare and/or significant complication of a procedure or treatment without being told of the possibility of that outcome. Patients typically allege that had that risk been divulged, they would not have agreed to the procedure. While the pertinent information varies by procedure, there are some general guidelines a provider can follow to protect themselves from informed consent claims.

Provider Guidelines

First, providers should make sure the informed consent discussion is conducted with the appropriate person. In most instances, it is the patient. However, if the patient is mentally incompetent, under the influence, or under duress such that the patient’s ability to understand might be impaired, consent may be properly obtained from a patient representative. Examples include a patient who is under anesthesia or other mind-altering medications. It could also include a patient who suffers from dementia or another condition impacting cognition or memory. It could include patients who are not proficient in reading or speaking English.

If a provider doubts the patient’s ability to understand the information, she should consider suggesting that the patient return with a trusted representative (e.g., a spouse, adult child, sibling, or parent) for a follow-up discussion. If the patient has a designated Healthcare Power of Attorney, that individual should be included in the conversation. Providers should document who was present when the informed consent discussion(s) took place and that the patient (or, if applicable, the patient’s representative or POA) appeared competent to understand the information provided.

Valid informed consent requires the information to be conveyed in such a manner that it would provide a “reasonable individual” with an understanding of the “substantial risks and hazards inherent” as recognized by the medical community. Providers are not required to disclose every risk possible. Indeed, a provider must balance the duty to inform with the responsibility not to unreasonably dissuade patients from receiving necessary medical care.

Ensuring Informed Consent

To avoid a claim for lack of informed consent, providers should advise patients of two categories of risk: (1) the most common or likely risks of the procedure, and (2) the most severe complications that could occur, no matter how rare. Providers should also discuss the treatment’s success rate and describe what a realistic outcome might be given the patient factors at play.

This information should be communicated in terms patients can understand. The average American reads and comprehends at the 7th-to 8th-grade level, and this is likely true of Kentucky’s patient population. This means providers must avoiding using complex medical terminology. For example, if a procedure carries the risk of nerve damage, use that phrase instead of “neuropathy.” Instead of “dysphagia,” explain that the procedure could result in some temporary difficulty swallowing.

Once the proposed treatment is described, providers must disclose what reasonable alternatives are available and the general risks and benefits of each.

Finally, the conversation must include an opportunity for the patient to ask questions.

Discussions between providers and patients constitute the informed consent process, and this exchange of information is the basis of an informed consent claim. The formal “Informed Consent” document patients typically sign upon the conclusion of that conversation does not constitute informed consent; such documentation is merely evidence that informed consent took place.

What Should Be Documented?

Providers should author a visit or progress note memorializing the discussion. This should include the names of all persons present. It should also include a recitation of the specific risks disclosed. Providers should avoid generic statements such as “The risks and benefits of the procedure were discussed.” Instead, consider the following: “The benefits and expected outcome of the procedure were discussed as well as the most common and severe risks, which include but are not limited to _______.”

The note should also reflect that reasonable alternatives were discussed and that the patient was given an opportunity to ask questions.

If possible, this documentation should be done contemporaneous with the discussion. And, if practicable, a copy of the note should be printed, signed by the patient, and copied or scanned into the record. A copy should be given to the patient. Providers should ensure the informed consent note is entered into the record prior to the procedure.

An “Informed Consent” form, such as those utilized by ambulatory surgery centers and hospitals, can certainly be used to help memorialize the consent process. However, these forms should not be the only documentation. These forms are infrequently tailored to the specific procedure, provider, or patient. Therefore, where possible, information regarding the specific risks, benefits, and alternatives should be added to these forms, and reference should be made to the complete note (discussed above).

There is one caveat to the above suggestions. This article assumes a non-emergency situation with a patient who has the capability of receiving, comprehending, and considering the risks and benefits of treatment. In an emergency, where informed consent cannot be reasonably obtained before providing care, it is not required.

Lack of informed consent claims can be brought regardless of whether the procedure itself is ultimately found to have complied with the standard of care. For this reason, engaging in and documenting thorough informed consent discussions is vitally important to a provider’s practice.

Stephanie M. Wurdock is a healthcare attorney who works closely with providers, insurers, and risk managers to defend claims of medical malpractice. She is a member at Sturgill, Turner, Barker & Moloney, PLLC in Lexington. She can be reached at swurdock@sturgillturner.com or 859.255.8581. The suggestions