This article is the final one of 4 derived from a symposium on malpractice risk management at the 91st Clinical Congress of the American College of Surgeons, San Francisco, Calif., in October 2005. Mr. Nelson updated his comments in February 2007.
Part 1 March 2007 Informed refusal
James M. Goodman, JD
Part 2 April 2007 Common errors in self-defense
Claudia Dobbs, MA
Part 3 May 2007 Patient safety as risk management tool
Thomas J. Donnelly, JD
Part 4 THIS ISSUE
Responsibilities in obtaining informed consent
James M. Nelson, JD
You the physician—not a medical assistant, not a clerk, not a nurse—must initiate and complete the process of informed consent. You must personally obtain the patient’s consent before performing any operation, minor or major, in the office, surgical center, or operating room.
The setting should be an examining room or hospital room, not a waiting room, nursing station counter, or gurney in the operating room holding area. Exceptions occur, but considering how litigious society is today, these criteria represent the ideal.
Does the patient understand?
You must feel assured that the patient is capable of participating in the discussion, both receptively and expressively, and that she can make a sound and reasoned decision. Exceptions can apply in emergencies and for minors or adults who are otherwise not competent to grant informed consent.
If the patient wants to have a loved one or close friend join the discussion, invite that person into the room. However, he or she should play a peripheral role only.
You initiate the informed consent process, but the patient must conclude it by granting or refusing consent.
Focus the discussion
The preeminent case law on informed consent is Cobbs v. Grant, which the California Supreme Court handed down in 1972. Even today, many states follow this law. The California justices held that a patient’s “right of self-decision” was a measure of the doctor’s “duty to reveal.”
In other words, presenting information to the patient and receiving her consent requires both the physician and patient to participate. The process may require a few office contacts and perhaps 1 or 2 office visits or hospital calls. The seminal event is a focused discussion between you and the patient.
The physician describes the proposed treatment or procedure in language the patient can understand. That is, the information must be conveyed in a way that a reasonable person in the patient’s position would expect to hear it.
A situation that I recently confronted was a lapse of 8 months between the time the patient gave informed consent and the actual surgery. Here’s how that case unfolded:
- A couple of months after the surgeon obtained informed consent from the patient, and just before the day of the scheduled surgery, the patient called the surgeon and said: “I feel better. I don’t want to have the surgery.”
- A couple of months after that, the patient again called: “I’ve changed my mind,” she said. “I don’t feel well. I want the surgery.” So the surgeon performed the operation that the patient had consented to more than 8 months earlier.
Was the surgeon obligated to conduct another history, physical examination, and informed-consent discussion with the patient—long before the patient is on the gurney under preanesthesia and ready to go into the operating room? In this case, the surgeon should have—and did—talk briefly with the patient, reminding her of their earlier discussion. The patient confirmed her intent to have the surgery.
But the patient later alleged: “I lost the documents I was given and I wasn’t really prepared for the surgery.” She sued for negligence, claiming the surgery resulted in continuing severe pain. Informed consent was an issue at trial because:
- the surgeon did not document the final informed-consent discussion
- the patient denied that the discussion took place.
This situation doesn’t happen often, but it had significant consequences for my client.
Explain the likely outcome
Express the likelihood of success in general terms, not as a percentage. Courts have frowned on such statements as, “The failure rate for this procedure is 1% to 2%.” They’ve preferred that the physician simply state that a successful outcome is likely.
Another mandatory point of communication is the expected benefit and outcome. This includes a discussion of potential risks or complications that a reasonable person would consider important: any risk of death, serious injury, or significant complication—but not necessarily minor or trivial side effects.
You must tell the patient about any reasonable alternatives to the planned treatment or procedure, along with their potential risks, complications, and outcomes. We’ve found that physicians who satisfied their responsibility to discuss alternative treatments or operations sometimes failed to explain the risks, benefits, and complications.