Informed consent is defined as: a patient’s knowing choice about treatment or a procedure, made after a physician or other healthcare provider discloses whatever information a reasonably prudent provider in the medical community would provide to a patient regarding the risks involved in the proposed treatment. Black’s Law Dictionary (7th edition, 1999).
The doctrine of informed consent arose in recognition of the value society places on a person’s autonomy and as the primary vehicle by which a person can protect the integrity of his/her body. Missouri common law recognizes the right of individual autonomy over decisions relating to one’s health and welfare. This doctrine is based on the patient’s right to exercise control over his or her body while undergoing treatment, or a procedure, by making an informed choice whether to submit to such treatment or procedure.
Under Missouri law, negligence relating to the failure to provide informed consent is a separate and distinct cause of action from a claim of medical negligence in treatment, or the performance of a procedure. Pursuant to Missouri Statutes and cases, medical negligence is an act or omission of a defendant healthcare provider, failure of the healthcare provider to use that degree of skill and learning ordinarily used under the same or similar circumstances by members of the defendant’s profession, and causation of plaintiff’s injury or death by the failure to use the requisite care.
The elements of an informed consent action are the nondisclosure of the procedure, its risks, or benefits, prior to performing the procedure, and causation between the nondisclosure and the injury. In essence, the issue is whether a reasonable person in plaintiff’s position would have consented to the procedure had a proper disclosure been made.
In 2017, the Missouri Supreme Court held that evidence of informed consent in a case based strictly on medical negligence was irrelevant, and the jury should not consider this evidence in deciding the case. The case was Wilson v. Patel, and the Supreme Court stated that evidence of alleged informed consent could mislead the jury in a medical malpractice case based on negligent performance of care and treatment.
The Supreme Court’s holding that the informed consent documents were irrelevant, essentially prevented the doctor from presenting evidence of his/her disclosure of known risks and complications in the case, and the fact that other medical procedures may be performed if the doctor in his opinion deemed them necessary.
The best practice to minimize the impact of this holding is to always document in the medical records all discussions with the patient and their representatives regarding the procedure, risks, alternatives, benefits, and the necessity of additional procedures. The medical record should contain adequate detail of the discussion and be more than a statement that the procedure, risks, benefits and potential complications were discussed with the patient and the patient has consented to the same.
The medical records should specifically contain a summary of the discussion with the patient, how the patient responded, and any questions that were answered. In so doing, the issue of the discussion of the procedure, risks and benefits is integrated into the medical records in a fashion that is difficult to exclude. It allows the physician to reference his medical records in his defense, if for instance a known complication occurs.
Documentation of these discussions is not so easy to exclude from a lawsuit as a stand-alone Informed Consent document that the patient claims they did not read or review and is therefore irrelevant to the case.
Informed Consent is an essential part of any practice and is critical to preventing a claim of malpractice based on the failure to obtain informed consent. However, informed consent is more than just having a patient sign a document. The medical record itself needs to demonstrate and document the discussions of the procedure, potential outcomes and complications, alternatives, risks, and benefits.