A Major Court Decision: Only Physicians Can Obtain Consent

Carolyn Buppert, MSN, JD

Disclosures

September 18, 2017

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Who Gets Informed Consent? A Court Decides

When a patient is "signed up" for surgery, a surgeon may be in the habit of enlisting a nurse, nurse practitioner (NP), or physician assistant (PA) to take over some of the informed consent process. When one state's highest court was asked to decide whether that is appropriate, the majority opinion was "no." The Supreme Court of Pennsylvania held that only the physician performing the procedure should be involved in the discussions with patients about whether to have surgery, the risks, and the alternatives.[1]

Response from Carolyn Buppert, MSN, JD
                      Healthcare attorney

The Story Behind the Decision

A young woman with a history of a nonmalignant brain tumor saw a surgeon about removing new tumor growth. Her tumor had been resected previously, through a nasal approach, but the surgeon had not been able to remove all of it. The residual tumor had grown; it was extending into vital structures of her brain and causing headaches. She consulted a neurosurgeon, who advised her of the risks associated with surgery. The surgeon reviewed the alternatives—a less aggressive approach (safer in the short run), and a more aggressive approach, which may be more dangerous in the short run but would offer a better chance of resecting all of the tumor. She left the meeting saying that she would have surgery but had not decided on the approach.

After that, the patient's preoperative interactions were with a PA. In a telephone call, they discussed the incision and scarring, whether radiation therapy would be needed, and the date of the surgery. Later, the PA performed the patient's preop history and physical, provided presurgical information, and obtained the patient's signature on the consent form. The consent form gave permission to resect a recurrent craniopharyngioma. The risks were pain, scarring, bleeding, infection, breathing problems, heart attack, stroke, and death. The form also said that the patient had discussed alternative treatments and their advantages and disadvantages and that the patient agreed that she had sufficient information to make an informed decision. The form did not list the risks associated with total vs subtotal resection.

The surgeon attempted a total resection. He perforated her carotid artery, leading to hemorrhage, stroke, brain injury, and partial blindness. About 2 weeks later, the patient filed a lawsuit, claiming that the surgeon and the hospital had failed to obtain informed consent. The surgeon had failed to offer the lower risk alternative, she said, and if she had known the risks of the total resection, she would have chosen the subtotal approach.

The hospital was released from the case because common law—court cases—hold that the responsibility for informing the patient and getting informed consent is solely the surgeon's. A jury was to decide the issue of whether the surgeon provided enough information to allow the patient to give informed consent.

The surgeon testified that he reviewed with the patient the alternatives, risks, and benefits of total vs subtotal resection. He said that he shared with the patient his opinion that, although a less aggressive approach to removing the tumor was safer in the short term, such an approach would increase the likelihood that the tumor would grow back. He was unable to recall many of the specifics of his conversation with the patient, but he testified that he advised her that total surgical resection offered the highest chance for long-term survival. He said that she had talked about wanting to see her child grow up, and he deduced from that that she wanted what was best for long-term survival.

The surgeon agreed that it was his responsibility to obtain the patient's informed consent but argued that he was not required to supply all of the information personally. It is the information conveyed, rather than the person conveying it, that is important, he argued, and it was appropriate for him to delegate some of the informed consent process.

At trial, the patient said that she could not recall being informed of the relative risks associated with the surgeries other than coma and death. She testified that had she known the alternative approaches to surgery, she would have chosen subtotal resection as the safer, less aggressive alternative.

The judge instructed the jury that in assessing whether the surgeon obtained the patient's informed consent, they could consider relevant information communicated by "any qualified person acting as an assistant" to the surgeon. The jury found in favor of the surgeon.

The patient appealed, arguing that the judge's instruction to the jury was wrong; a Pennsylvania law—MCARE (Medical Care Availability and Reduction of Error) Act—and previous cases require that a surgeon personally deliver the information the patient needs when deciding whether to have surgery and to decide among alternative approaches. MCARE defines informed consent as follows:

(a) Duty of physicians. Except in emergencies, a physician owes a duty to a patient to obtain the informed consent of the patient or the patient's authorized representative prior to conducting the following procedures: (1) Performing surgery, including the related administration of anesthesia. (b) Description of procedure. Consent is informed if the patient has been given a description of a procedure set forth in subsection (a) and the risks and alternatives that a reasonably prudent patient would require to make an informed decision as to that procedure. [2]

An erroneous jury instruction is grounds for a new trial.

An appeals court sided with the judge and jury, who had sided with the surgeon. But then the Pennsylvania Supreme Court reversed, saying, "A physician's duty to provide information to a patient sufficient to obtain her informed consent is non-delegable." The Supreme Court ordered a new trial.

Three of the seven Supreme Court justices—the "minority"—sided with the physician, saying that it didn't matter if the physician or a qualified member of his staff provided the patient with the needed information, as long as the patient was informed. The justice who wrote the dissenting opinion said that he feared "that today's decision will have far-reaching negative impact on the manner in which physicians serve their patients."

The Significance of This Case

Although this case binds only those in Pennsylvania, it alerts surgeons in other states to conduct an assessment of their consent process. Consider:

  • The elements of information that need to be addressed;

  • Whether anyone other than the surgeon provides the information and answers the patient's questions;

  • Accessibility to the surgeon, if the patient has new questions;

  • How the discussion is documented, including patient responses;

  • The adequacy of the consent form in describing risks and alternatives; and

  • When there is a choice of surgical approach, whether the patient agrees in writing to one of the approaches.

My interpretation of the facts of this case, which come from the Supreme Court opinion, is that the patient didn't have the full picture, even with the PA's counseling. She didn't understand the important choice she was facing or, at least, was never required to clearly state her choice of approach. [3] The surgeon made assumptions based on her comments at the consultation about wishing to live into the future. The PA's notes did not include reference to discussion about choice of approach. So, although the controversy about whether a surgeon can patch together what the surgeon told the patient with what an assistant/delegatee told the patient to make a sufficiently whole informed consent discussion is not really applicable to this case, in my view, the end result is appropriate for this set of facts.

The Court's Majority Opinion

The majority opinion may indicate how those who are not clinicians view how healthcare should work. It may be instructive to clinicians, who become accustomed to their own habits and culture, to see how the four state Supreme Court justices described their views of this case.

The justice writing the majority opinion said that the legislature, in enacting the MCARE statute, meant exactly what the language says:

Under the plain language of this section, the duty to obtain a patient's informed consent for the several enumerated procedures, including surgery, belongs to the physician.... Nothing in the plain language of the Act suggests that conversations between the patient and others can control the informed consent analysis or can satisfy the physician's legal burden.... Under the rules of statutory construction, we cannot ignore the plain meaning of a statute when the words of that statute are unambiguous....

Although it is undisputed that the duty to obtain informed consent is imposed solely upon [the surgeon], we must resolve whether [the surgeon] can satisfy this duty wholly or in part through his staff's communications with [the patient].

...[W]e hold that a physician cannot rely upon a subordinate to disclose the information required to obtain informed consent. Without direct dialogue and a two-way exchange between the physician and patient, the physician cannot be confident that the patient comprehends the risks, benefits, likelihood of success, and alternatives.

It is incumbent upon the physician to cultivate a relationship with the patient and to familiarize himself or herself with the patient's understanding and expectations. Were the law to permit physicians to delegate the provision of critical information to staff, it would undermine patient autonomy and bodily integrity by depriving the patient of the opportunity to engage in a dialogue with his or her chosen health care provider. Only by personally satisfying the duty of disclosure may the physician ensure that consent truly is informed.

Thus, we hold that a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patient's informed consent. Informed consent requires direct communication between physician and patient, and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patient's informed consent belongs solely to the physician.

Assess Your Informed Consent Processes

Here are suggestions for surgeons who want to assess their own process of obtaining informed consent:

  1. Expand consent forms to include more detail than is common. Instead of documenting "Discussed alternatives," list the alternatives discussed and identify the patient's choice among the alternatives; that is, include a statement on the form, "The patient has directed me to attempt a total resection of the tumor."

  2. Don't make assumptions about the patient's choice based on the patient's expression of general goals. Require that the patient choose among the alternatives.

  3. If nicking of the carotid artery, or other arteries, is a risk, state that clearly, along with the sequelae of nicking the artery.

  4. The counseling provided patients by registered nurses, advanced practice nurses, or PAs should be reinforcing and repetitive, not the nuts and bolts of the discussion needed to enable the patient to give an informed consent.

  5. Strive to be present when the patient signs the consent, so as to provide the opportunity for additional questions and answers, in addition to what was discussed during the surgical consultation visit.

  6. If you are in Pennsylvania, personally conduct all of the informed consent process.

Role of Other Healthcare Professionals

Here are suggestions for nurses, NPs, and PAs who may be asked to participate in the informed consent process:

  1. When a surgeon requests assistance with counseling and teaching patients about their surgery, know that you aren't liable, legally, for obtaining informed consent. You'll want to do your best, of course. You still have a duty to advocate for the patient.

  2. If you are a nurse, a patient has questions about the surgery, and those questions are not within the realm of nursing care, contact the surgeon and state that the patient has questions. Do not be persuaded to be a conduit of information between surgeon and patient. The patient should have telephone or face-to-face contact with the surgeon for the purpose of receiving answers to the questions.

  3. If you are an NP or PA who is employed by the surgeon for the purpose of assisting with pre- and postop care, and you are very familiar with the surgery, including risks and possible alternatives, you may agree with your employer—the surgeon—to be a conduit of information. The surgeon still carries the legal responsibility. Work it out with the surgeon as to how your discussion with the patient and your instruction will fit with his or her discussion and instruction. It will be helpful to your employer if you are comprehensive in your explanation of risks and alternatives and defer any detailed discussion of surgical approach to a one-on-one discussion between patient and surgeon.

  4. If you are an NP or PA not employed by the surgeon but employed by a hospital, it is not wise to be involved in a self-employed surgeon's informed consent process. Although neither you nor your employer—the hospital—is likely to be held liable in court if some elements of informed consent aren't covered, the patient still may sue, and you and the hospital will need to argue for dismissal from the case. And, when a hospital supplies advanced practice providers to take over responsibilities of physicians who are self-employed, there can be Stark law compliance problems for both the hospital and the physician practice.

Web Resources

Can Nurses Be Required to Obtain Informed Consent?

6 Ways Docs Go Wrong with Informed Consent

Informed Consent: The Time to Improve Was Yesterday

How Much Detail is Required on a Surgical Consent?

Malpractice: Your Informed Consent May Not Be Good Enough

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