Pennsylvania Upends the Process of Informed Consent – Doctors Cannot Delegate
Learning Objectives and CME/Disclosure Information
This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. Discuss the 2017 ruling by the Supreme Court of Pennsylvania regarding whether a physician can delegate informed consent 2. List which features constitute informed consent
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project
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Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
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In June 2017, the Supreme Court of Pennsylvania determined 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” (emphasis added).
This shocking decision now requires physicians across the Commonwealth of Pennsylvania to change their practice for obtaining informed consent from patients. Physicians now must personally obtain informed consent as well as personally answer their patients’ questions. Physician assistants, nurses, and other medical personnel can no longer obtain informed consent.
As the dissenting opinion stated, “Today’s decision will have a far-reaching, negative impact on the manner in which physicians serve their patients. For fear of legal liability, physicians now must be involved with every aspect of informing their patients’ consent, thus delaying seriously ill patients access to physicians and the critical services that they provide.”
This landmark decision arose from a medical malpractice lawsuit where the patient alleged that the operating neurosurgeon failed to explain the risks of the surgery for a recurrent non-malignant tumor in the pituitary region of her brain or to offer her the lower risk surgical alternative of subtotal resection of the benign tumor, followed by radiation. During the surgery, the patient’s carotid artery was perforated, resulting in hemorrhage, stroke, brain injury, and partial blindness. The patient met once with the neurosurgeon but had her questions about the surgery answered on two separate visits by a physician assistant. In 2002, Pennsylvania enacted the Medical Care Availability and Reduction of Error Fund (“MCARE”) Act. This Act plainly states that that “a physician owes a duty to a patient to obtain informed consent[.]” Therefore, the trial jury could not consider in its deliberations whether the information was given to the patient by the physician assistant. The jury had returned a verdict in favor the neurosurgeon. With this June 2017 ruling, the case must undergo a new trial.
The process of informed consent will depend upon the jurisdiction in which you practice. A review of your informed consent process is warranted even if you do not practice in Pennsylvania.
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