The ethics discussion turned to informed consent at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) annual conference last week. After the Shinal v. Toms case heard in 2017 by the Pennsylvania Supreme Court, what once seemed clear is now in question. The discussion was led by Segun Toyin Dawodu, MD, JD, and focused on the existing requirements for informed consent and how the Pennsylvania case might impact them.

Informed consent is the process needed to ensure the patient understands the purpose, risks, benefits, and alternatives to the proposed test or treatment. Ethically, informed consent is a process of communication that enables the patient to make an informed, voluntary decision regarding specific medical care. It is essential that this communication is part of the permanent medical record.

Doctor directing patient to sign a form

Prior to Shinal v. Toms, informed consent could be obtained by any member of the medical team. This case, which has changed that standard in Pennsylvania and has the potential to affect medical practice nationwide, centers on a patient, Megan Shinal, who had a recurrence of craniopharyngioma after partial resection.

After extensive discussion on her first visit with Dr. Toms, a neurosurgeon, the patient asked him to pursue total removal of the tumor if possible, but to stop if it became too dangerous. Later the patient saw Dr. Toms’s PA who provided specific information and had the patient sign informed consent documentation.

During surgery, Shinal’s carotid artery perforated leading to stroke, brain injury, and blindness.

The patient’s husband then sued Dr. Toms based on lack of proper consent. No negligence was suggested in the suit, and there was no dispute about the accuracy of the information provided by the PA.

Dr. Toms won the case and the subsequent appeal to the PA Superior Court.

However, in June 2017, the Supreme Court of PA, in a 4-3 vote, ruled that the trial court misapplied law by instructing the jury to consider information supplied to Shinal by Dr. Toms’ qualified staff. The case was sent back to lower court for a new trial which remains pending.

This decision suggests that the surgeon performing the procedure or providing supervision must be the person to deliver the informed consent information personally.

The dissenting justices stated that, while the legislature required informed consent in legislation that established The Medical Care Availability and Reduction of Error Fund (MCare Act), it could have, but did not, expressly require that only physicians can provide patients with information regarding informed consent.

Their counterargument stated concerns for delaying treatment of seriously ill patients and overstepping judicial authority.

Why is this important for neurologists?

Clearly, informed consent is a routine aspect of all specialties. Physicians in the state of Pennsylvania should obtain informed consent themselves and not rely on qualified staff based on this ruling. It raises concerns over how many physicians could be at risk for suits, since the Supreme Court of PA is applying this standard to past medical care. In addition, Dr. Dawodu explains that this case can be stated as “persuasive and cited’ in other court systems in the US, raising the possibility of risk for all physicians.

So neurologists, like all physicians, need to consider how informed consent is being obtained, by whom, and how it is documented in their medical practice. Even if it appears they are following the law in their state, as Dr. Toms has discovered, it may not be enough.