The issue of informed consent is one of the theories that Plaintiff’s attorneys often use in pursuing a medical malpractice action. The legal dimensions of this theory find their origins in the Law of Battery whereby any unpermitted contact or offensive touching is considered to be a personal indignity. This personal indignity is not allowed. It relates back to a right of privacy that, although not explicitly stated in the Constitution, the Justices believe to be in there somewhere.
Under its police power, a State is allowed to make laws meant to ensure the general welfare. Laws relating to “informed consent” come from this power; the doctrine has evolved over time relating to previous court decisions and legislative enactments.
In 1992, the American Medical Association recognized the physician’s duty to provide sufficient information to the patient so that the patient could make an informed decision as to the treatment plan. They wrote this into their Code of Ethics. The Code specifies that the physician must disclose what a reasonable patient would need to know in order to give an informed consent. This requirement is now referred to as the “patient-centered” standard and is the law in Tennessee. However, most states do not use this patient-centered standard and have instead opted for what is called the “professional disclosure” standard.
Using the “professional disclosure” standare, the physician must disclose what a reasonable physician would disclose under the same or similar circumstances. Note that this standard may not provide the patient with the information he might need to make an intelligent decision. Also, this standard would require a medical expert witness to educate the jury as to what information the reasonable practitioner would need to provide under the circumstances of the case. In the “patient-centered” standard, the jury could decide what is reasonable on their own.
So what constitutes “informed consent”? In Tennessee, informed consent depends on what a reasonable patient would need to know to come to a reasonable decision as to what may be done to his body. The appropriate information that would be needed is a question for the jury and does not require expert testimony. The jury should be able to decide on their own if the patient was given the appropriate information to make a reasonable decision.
The question of what should be discussed with the patient may require expert testimony on the subject. The expert will need to opine on what a reasonable practitioner would need to discuss with the patient so that the patient would have the appropriate information to make an informed decision. Case law has clarified this issue. The practitioner must discuss the diagnosis and the nature of the condition; the reasons for the proposed treatment or procedure; risks involved and prospects for success; alternative methods of treatment along with the risks and benefits of such treatment. The practitioner must also tell the patient if the treatment or procedure is experimental. Whether the information given is sufficient will depend on the risks involved, the nature of the treatment, and the standard of care applicable to the person obtaining the consent. During the process, the patient must be allowed to ask questions and have these questions answered by the provider.
Does the hospital have an independent duty to obtain informed consent? It does not. What does the hospital know anyway? The courts recognize that only the practitioner is competent to explain the procedure or the planned course of therapy to the patient.
However, the hospital may be liable for a physician’s breach of the duty to obtain informed consent. This would occur in the situation where the provider is an employee of the hospital or the hospital controls the provider’s practice is some way. If the hospital knows that the physician is not fulfilling his duty to obtain the consent, it could have some liability. The hospital can protect itself by having a policy which would have some sort of mechanism such as disciplinary action or sanctions, to ensure that the physicians have an incentive to go through the consent process in a reasonable way.
What about the consent form itself? Most hospitals require the patient to sign a document affirming that consent has been given for the planned procedure. Is this document consent in and of itself? Obviously not. By law, consent still lies in the conclusion of the discussion between the patient (or his legal representative if the patient is unable to give consent himself) and the health care provider. However, the document is evidence that the consent process did occur.
In many hospitals, the nurses are assigned the responsibility of having the patient sign the consent form. It seems that this assignment by the hospital may be construed as the hospital assuming the duty of obtaining the consent; but this is not the case. The court cases that have addressed this issue have decided that the consent forms were not designed to replace the informed consent process required of the practitioner who will be performing the procedure. In other words, the hospital cannot gratuitously assume the provider’s duty to obtain consent.
The hospital may perform the ministerial act of documenting such consent, but the practitioner must still be the one to go through the process of obtaining the consent himself. Absent the assumption, the hospital will not be liable for lack of informed consent because the hospital cannot assume this “non-delegable” duty. In general, the courts do not want the hospitals to get involved in issues that lie at the heart of the doctor-patient relationship. This serves as a warning to the practitioner that having someone other than himself go to the patient to get the consent forms signed may come back to haunt him if he does not in some way document that he, himself, went through the process with the patient.
What if there is no consent form in the chart signed by the patient? Most plaintiffs’ attorneys will say, “If there is no consent form, then there was no informed consent.” The form will be evidence that the consent process did occur. Without the form, the practitioner may have to prove that the process did occur in another way. He can do this by writing an appropriate note in the chart. Obviously, this note should be dated prior to the time of the surgery or treatment. He can also do this with oral testimony of witnesses or his own oral testimony under oath at a deposition or in trial. He can also provide evidence with a written statement in an affidavit.
In summary, getting an informed consent in the medical setting is a process whereby the health care practitioner discusses the procedure or treatment plan with the patient. The discussion should provide the patient what he needs to know to make a reasonable decision as to what he will allow to be done to his body. Going through the process is not as easy as you may think.
Professor, Cardiothoracic Surgery, University of Tennessee Health Science Center and Chief of Surgery, VAMC Memphis, TN