A fundamental premise of medicine is that a competent patient has the right to decide what medical care, if any, he or she is to receive. The physician provides information to the patient that allows the patient to choose to undergo or to refrain from undergoing a proposed surgical or other procedure. “A physician’s duty to disclose to a patient information material to the decision whether to undergo treatment is the central constituent of the legal doctrine known as ‘informed consent’...”¹

In the realm of surgery, “the informed consent doctrine… grants the competent patient the right to medical self-determination regarding an operative or surgical procedure… The goal of the informed consent doctrine is to provide the patient with material information necessary to determine whether to proceed with the surgical or operative procedure or to remain in the present condition.”²

To succeed on a claim based upon lack of informed consent, the plaintiff (the patient who is suing for injuries) must prove that the defendant (the physician being sued) failed to disclose a material risk or alternative to the medical procedure, that the plaintiff would not have consented had he or she been fully informed of the risk and alternative, and that the lack of informed consent proximately caused the injury that the plaintiff attributes to the medical procedure.

Scope of Disclosure by a Physician

A physician is obliged to disclose the risks, benefits and alternatives of a proposed procedure. When an implant or medical device is part of the procedure, then the risks and alternatives of the implant or device should be discussed with the patient.

The physician is not burdened with an obligation to disclose every conceivable risk of a procedure. Instead, the physician must disclose “only those which are material to the intelligent decision of a reasonably prudent patient.”³ “A physician is not required to enumerate in detail every aspect of surgery or every possible thing that might go wrong.”⁴

A physician is not obliged to disclose rare and remote risks: “... health care providers are generally not required to disclose risks that are not material, such as those that are extremely unlikely to occur...”⁵

In a surgical malpractice case, a patient suffered permanent leg paralysis following chest surgery. In affirming a verdict for the surgeon, the appellate court found that the evidence supported the jury’s finding that the surgeon was not negligent for failing to advise the patient of the risk of paraplegia. Evidence showed that paraplegia “would be extremely uncommon and an unexpected complication of any chest surgery. Furthermore, [the defendant’s] expert testified that given the unexpected nature of this type of complication, failure of [the defendant] to specifically advise her of this remote possibility did not constitute a departure from the required standard of care,” observed the court.⁶

A surgeon does not have a duty to disclose alternatives that the surgical community does not consider to be feasible. Only reasonable therapeutic alternatives to surgery are encompassed by the duty to disclose alternatives. Caution: The alternative of “doing nothing” should be disclosed and documented where appropriate.

Exceptions to the Duty to Procure a Patient’s Informed Consent

Situations may arise in which the consent of a patient is not practical. Those situations can serve as defenses to claims by the patient of a breach of the duty to obtain an informed consent.

States have recognized, either by statute or by case law, several such situations that can serve as defenses. The risk may have been too commonly known to necessitate disclosure. The patient may have assured the physician that he or she did not want to be advised of the risks of the procedure. Consent may not have been reasonably available, such as where emergency care is being provided or the patient is unconscious.

The “therapeutic privilege” may also be a defense. The physician may have reasonably believed that disclosure of risks and alternatives could have adversely and substantially affected the patient’s physical or emotional condition. However, this defense can be easily challenged. If utilized, there should be extraordinary documentation and a second opinion–also documented.

Detailing the Disclosure and Consent

Recording in the hospital chart and the written informed consent form the material details of a surgeon’s disclosure and the patient’s informed consent can be of significant assistance in the defense of a lawsuit claiming lack of informed consent. A contemporaneous writing can avoid the natural waning of memory occurring between the date of surgery and the date of a trial of a lawsuit.

The fact that a patient signed a written consent form does not by itself allow a surgeon being sued for lack of informed consent to have the claim dismissed. This is purely a jury question.

Despite a signed consent form, a surgeon is still obliged to explain risks and alternatives. As one court explained: A consent form is inadequate if it is “generic” in that it does “not contain any details about the operation… [and does] not disclose the risks specific to the… [controverted] operation, or alternatives to that operation…”⁷

The importance of documenting the disclosed risks and alternatives of a proposed surgical procedure was revealed in a recent case in which a patient underwent surgery at a Veterans Affairs (VA) facility to implant a penile prosthesis. The implant later became infected. The patient had to undergo explant surgery. The patient alleged that the surgeries resulted in pain and scrotal swelling as a result of the surgeries. The patient argued in court that the VA did not obtain his informed consent prior to the implant surgery. The Board of Veterans’ Appeals affirmed a decision that denied compensation under the applicable federal statute. The patient had argued that “a progress note indicating that informed consent was obtained… does not contain any reference to the possibility of infection or any other specific risk of the surgery.” However, the Secretary cogently explained that “the progress note only references the informed consent document, which clearly lists ‘infection or erosion of prosthesis requiring total removal’ as a known risk.”⁸