A recent court decision in Pennsylvania may have far-reaching implications for surgeons and other physicians who regularly obtain informed consent. Although the decision is binding only in Pennsylvania, it should serve as a warning for providers all across the United States.
The case involved a woman with a nonmalignant brain tumor that had been partially resected in a previous procedure but had begun to grow back. The woman was experiencing headaches and had consulted a neurosurgeon about surgery to resect the residual tumor. The surgeon discussed two different surgical approaches with her: a conservative approach, which was safer in the short term but offered a limited chance of long-term success, and a more aggressive approach. The surgeon explained that the latter surgery would be riskier up front but could result in a much better outcome over the long term.
The woman left the physician’s office having agreed to the surgery. But she had not made up her mind about which approach to choose.
All subsequent interactions at the provider’s officer occurred between the woman and the surgeon’s PA. The PA documented pre-op discussions around the risks and benefits of the surgery and the availability of treatment alternatives. But neither the documentation nor the consent form addressed the risks and benefits of the conservative versus the aggressive approach. Nevertheless, the patient signed the consent.
On the day of the surgery, the neurosurgeon decided on the more aggressive approach, later stating that he deduced from his discussion with the patient that she wanted the surgery that had the best chance of long-term success. During the procedure, he perforated her carotid artery, causing hemorrhage, stroke, partial blindness and brain injury. Soon after, the woman sued, claiming that the physician had failed to obtain informed consent for the more aggressive procedure. If she had known the risks, she claimed, she would never have agreed.
In the subsequent jury trial, the jury sided with the physician. Their decision, however, was based on what was later determined to be questionable instructions from the presiding judge, which stated that “any qualified person acting as an assistant” to the surgeon could convey the information necessary to obtain consent. The plaintiff appealed, citing Pennsylvania’s Medical Care Availability and Error Reduction (MCARE) Act, which requires that, except in an emergency, a surgeon deliver the information a patient needs to give informed consent personally. This erroneous jury instruction was grounds for a new trial.
The appeals court sided with the judge and jury and again decided in favor of the surgeon. However, the Pennsylvania Supreme Court, in a 3 to 4 decision, disagreed.
What the Court Said
The justice who wrote the majority opinion relied mainly on the plain language of the MCARE Act, stating:
…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….
…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.
“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.”
Some Important Take-Homes
While the above case binds only in Pennsylvania, it underlines some important risk management procedures that physicians should consider when obtaining informed consent. For example, consent forms should always detail the exact procedure to which the patient is giving consent. If there are a number of possible approaches, the form should clearly state which approach the patient is consenting to.
Additionally, physicians should make certain that they discuss all risks and alternatives with the patient and clearly document what the patient understood. They should also limit discussions with other professionals to teaching or reinforcing the information they have conveyed. A nurse can provide a patient with pre-op instructions and post-op instructions for wound care. And a PA or NP can reiterate what the surgeon said in terms of possible complications and risks. But the surgeon should make every effort to be present when the consent is signed, either to allow time for further questions or to document that the patient had no further issues they wished to discuss.
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