Mid-Atlantic Health Law TOPICS
New Requirements for Informed Consent
Two recent state court decisions indicate that the burden for patients receiving sufficient information to give informed consent remains squarely with physicians, even as more medical services are being provided by non-physicians, including nurse practitioners and physician assistants.
A. Shinal v. Toms
First, the Pennsylvania Supreme Court held in Shinal v. Toms that physicians in Pennsyl-vania cannot delegate the duty to obtain informed consent to a non-physician provider, and must instead personally engage in a “face-to-face exchange” with the patient. This requirement, a strict interpretation of Pennsylvania’s Medical Care Availability and Reduction of Error Act (“MCARE”), is one of the most stringent informed consent requirements in the country.
In Shinal, a physician’s assistant provided information to a patient prior to the removal a brain tumor, and obtained the patient’s signature on a consent form, which the court concluded was insufficient. After the patient, Shinal, sustained serious injuries during the procedure, Shinal claimed that the doctor had not provided information necessary to allow Shinal to give informed consent. (Injured patients sometimes sue doctors for failing to obtain informed consent, because doing so does not require a showing that the procedure itself was performed negligently.)
Patient advocates celebrated the Shinal decision, arguing that requiring physicians to engage personally in a dialogue with patients would ultimately reduce litigation, and result in increased patient satisfaction, consistent with the purpose of MCARE.
In contrast, physician groups such as the Pennsylvania Medical Society and the American Medical Association have raised concerns that the Shinal decision goes beyond the requirements of MCARE, ignores the realities of an increasingly team based approach to medical care, and could slow patients’ access to procedures.
These groups note that Shinal’s doctor had, in fact, discussed the procedure with her, though the physician assistant had answered follow-up questions and provided the consent form. These groups fear that Shinal makes it unclear if physician assistants can even answer questions about a surgical procedure.
B. Hurley v. Kirk
On the same day as the Shinal decision, the Oklahoma Supreme Court held in Hurley v. Kirk that patients in Oklahoma have a right to know all of the parties substantially assisting with a surgery, as such information may influence a patient’s decision to undergo the procedure.
In Hurley, the doctor required the patient to sign a consent form that stated that the doctor could perform the procedure with whomever the doctor designated as his or her assistant. During the surgery, either the doctor or her assistant accidently perforated the patient’s ureter, causing extensive damage. The patient filed suit on the basis that she would not have consented to the surgery if she had known an assistant would have been performing part of the procedure. As a result of Hurley, Oklahoma physicians must disclose the names of any individuals assisting in the surgery as part of the informed consent process.
Though the requirements of these cases are limited to their respective states, together, they indicate a nationwide judicial scrutiny of the physician’s role in obtaining adequate informed consent from patients, even as non-physician providers play a bigger role in the delivery of medical services. As a result, doctors should carefully review their procedures for obtaining informed consent from patients, particularly if their practice includes other providers.
Alexandria K. Montanio
410-576-4278 • firstname.lastname@example.org
A version of this article was published by The Daily Record on September 11, 2018.