Health & Justice: Be Sure to Share
Informed Consent and the Legality of Decision-Making in Healthcare
By Megan L. Adkins, J.D.
By Megan L. Adkins, J.D.
As care systems and biomedical knowledge evolve, relationships among medical providers, patients, and their families continue to change, with a pendulum swing toward more patient autonomy. While medical “paternalism” was once the core method of decision-making, shared decision-making is now most common. In this collaborative approach patients, in partnership with their physician, are encouraged to consider the available care options and the likely benefits and harms of each, to communicate their preferences, and help select the best course of action that fits.[1]
Shared decision-making requires a two-way dialogue between the physician and the patient. The SHARE Approach allows physicians to Seek their patient’s participation, Help their patient explore and compare treatment options, Assess their patient’s value and preferences, Reach a decision with their patient, and Evaluate their patient’s decision.[2]
This interaction builds a bridge of trust between the physician and the patient. Physicians should always try to build a strong bridge of trust with their patients, not only because it improves the quality of care, but also because trust often deteriorates quickly if medical complications arise. This break in trust between the physician and the patient can prompt litigation.
Physicians have a legal and ethical duty to provide adequate information to their patients so that they can process the information and make appropriate decisions. [3] Shared decision-making is a widely promoted ethical approach, while informed consent is the legal process used to promote patient autonomy. Informed consent is a cornerstone of medicine, ensuring ethical treatment decisions and patient-centered care as patients have the right to make informed and voluntary treatment decisions.[4]
Informed consent is more than merely a signature on a document; it is a communication process between the physician and the patient. This process ensures that the patient is fully informed about the nature of the procedure or intervention, the potential risks and benefits, and the alternative treatments available. Informed consent respects patient autonomy, promotes trust in the patient-provider relationship, and safeguards against unethical practices.
No procedure can be performed without the patient’s consent, which must be both voluntary and knowing. For consent to be valid, the patient must be competent. In the setting of informed consent, competence or capacity means the patient has the mental ability to understand problems and decide whether to accept or reject medical treatments that are offered.
Once informed consent is obtained, a patient may withdraw their consent at any time during a procedure or intervention. If this occurs, the physician must stop the treatment and engage in a new informed consent discussion if the patient elects to proceed.
Informed Consent Litigation
It is a well-established principle of law that, as an aspect of proper medical practice, physicians have a general duty to disclose to their patients, in accordance with accepted medical standards, the risks and benefits of the treatment to be performed.[5] To prevail on an informed consent claim, a plaintiff (patient) must establish that:
- the provider had a duty to disclose information that they knew or should have known would be significant to a reasonable person in the patient’s position,
- the provider failed to disclose the information, and
- the failure to disclose caused the patient’s harm.
To prevail on an informed consent claim, a plaintiff’s attorney must retain a medical expert witness to testify regarding the professional standard of care, opine that the defendant physician breached the standard, and that the breach caused injury to the plaintiff. The defendant physician will also retain a medical expert to review the treatment and opine that the physician met the standard of care.
Historically, informed consent medical malpractice cases litigated in the Commonwealth of Kentucky have focused on doctors obtaining consent but failing to disclose the risk of treatment to the patient. For example, in a case from the 1970s where an ophthalmologist was sued for the alleged failure to properly disclose to the patient the risks and hazards involved in a proposed surgical procedure, the Court held “the plaintiff alleged that a physician had failed to disclose a risk which he had known to exist, or had failed to inform [the patient] of the risks of a medical procedure to the same degree as physicians of ordinary prudence and skill would have done.”[6]
In other words, the professional standard of care requires that a physician disclose sufficient facts that a reasonable physician, faced with this particular set of circumstances, would disclose. Thus, the standard is set by the profession, and the individual physician must adhere to accepted medical standards.
Notably, there are circumstances that negate the need for a plaintiff to retain a medical expert to establish the professional standard of care. The Kentucky Supreme Court has held “a failure to adequately inform the patient need not be established by expert testimony where the failure is so apparent that laymen may easily recognize it or infer it from evidence within the realm of common knowledge.”[7] Put simply, if the physician’s failure to inform is so blatant that a person with an average level of medical knowledge does not need a medical expert to explain the nuances of the failure, then a medical expert is not required for a plaintiff to prevail on a lack of informed consent claim.
The Importance of Documentation
Patients and/or their families may not accurately remember all the facts disclosed by a physician in a discussion regarding informed consent for a procedure or intervention. Thus, a physician must document the content of informed consent sessions. The informed consent discussion and its documentation should be completed by the physician who will be performing the procedure. Delegating the responsibility to obtain consent to someone else does not absolve the physician of liability if that consent session is incomplete or ineffective.
If informed consent litigation ensues, defense attorneys can present a more effective defense if the physician has ensured that nothing is lost in translation from the medical field to the legal field. Thorough documentation allows attorneys to convey to the jury more than just what was communicated to the patient during the informed consent discussion, but also why it was communicated and how it was communicated. Giving the jury this greater understanding is key to the jury understanding the physician’s position and avoiding potential mistrust and anger arising from perceived injustice to a patient that may lead to a jury awarding a larger verdict.
The physician should date and time the written summary of what was said and to whom, making note of relatives, friends, or support staff such as nurses or interpreters who are present. All elements of the discussion should be documented in writing: diagnosis, proposed treatment with its risks and benefits, and alternative treatments with their risks and benefits. The physician should document that the patient understood the concepts as discussed and agreed to proceed. In addition, the physician should document that the patient was provided with appropriate literature, that the patient had the opportunity to ask questions, and that those questions were answered. The standard procedure consent document often means little, particularly in its generic form, and does not guarantee protection in court. The real work of obtaining informed consent is documented in office or hospital notes.
In sum, it is vital for physicians to engage in shared decision-making with their patients and often the patient’s immediate family members. Thorough documentation of this discussion is necessary and places the physician in the best position to defend a lack of informed consent allegation if litigation were to arise.
Megan L. Adkins is a medical negligence and insurance defense attorney with Sturgill, Turner, Barker & Moloney, PLLC. She can be reached at madkins@sturgillturner.com or (859) 255-8581. This article is intended as a summary of state and/or federal law and does not constitute legal advice.
[1] Montori VM, Ruissen MM, Hargraves IG, Brito JP, Kunneman M. Shared decision-making as a method of care. BMJ Evid Based Med. 2023 Aug;28(4):213-217. doi: 10.1136/bmjebm-2022-112068. Epub 2022 Dec 2. PMID: 36460328; PMCID: PMC10423463.
[2] AHRQ Pub. No. 25-0005-6-EF. October 2024
[3] Berg JW, Appelbaum PS, Lidz CW, et al. Informed Consent: Legal Theory and Clinical Practice, 2nd edition, Oxford University Press, New York 2001.
[4] Shah P, Thornton I, Kopitnik NL, et al. Informed Consent. [Updated 2024 Nov 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK430827/
[5] Sargent v. Shaffer, 467 S.W.3d 198, 206 (Ky. 2015), overruled on other grounds by Univ. Med. Ctr., Inc. v. Shwab, 628 S.W.3d 112 (Ky. 2021).
[6] Keel v. St. Elizabeth Med. Ctr., 842 S.W.2d 860, 861 (Ky. 1992).
[7] Keel, 842 S.W.2d at 862; see also Cf. Jarboe v. Harting, Ky., 397 S.W.2d 775 (1965); Butts v. Watts, Ky., 290 S.W.2d 777 (1956).
