Health Law Gurus

The Doctor Is In – or Better Be, to Satisfy PA’s New Informed Consent Requirements

With the increased presence of qualified staff members in a physician’s office and the constant time-pressure on physicians, many patients rely heavily on individuals other than the physician to answer questions about medications, procedures, and treatment plans. Physicians, in turn, lean heavily on qualified staff members to ensure patients have access to adequate information and to foster the provision of high quality and cost-effective care. However, a ruling by the Supreme Court of Pennsylvania last week has greatly altered the practice of obtaining informed consent in Pennsylvania. As of June 20, 2017, physicians are now required to personally obtain informed consent from patients and to answer patients’ questions themselves.

In 2008, Megan Shinal underwent brain surgery to remove a tumor. During her first and only pre-surgical appointment, her physician, Dr. Steven A. Toms, informed her of the risks, benefits, and alternatives associated with surgical intervention. Ms. Shinal followed up the pre-surgical appointment with a telephone conversation with Dr. Toms’ physician assistant, who answered questions relating to the procedure and its potential side effects. Ms. Shinal also met with Dr. Toms’ physician assistant a few weeks before the surgery. The physician’s assistant obtained Ms. Shinal’s medical history, conducted a physical, provided more information related to the surgery, and had her sign an informed consent form. During the surgery, Dr. Toms perforated Ms. Shinal’s carotid artery, causing hemorrhage, stroke, brain injury, and partial blindness. Ms. Shinal filed suit for medical malpractice and claimed a lack of informed consent.

At trial, the jury was allowed to consider the information provided by Dr. Toms and his physician assistant in assessing whether informed consent was adequate. The jury returned a verdict in favor of Dr. Toms. On appeal, the Supreme Court of Pennsylvania held that a physician owes his or her patients a non-delegable duty to “provide sufficient information in order to obtain a patient’s informed consent.” The Court went on to state that informed consent necessitates direct communication through a face-to-face exchange and the patient must be able to ask sufficient questions to allow for fully informed consent.

This ruling has significant implications for the standard of care required by Pennsylvania physicians, and greatly expands a physician’s responsibility to provide patients with information and receive and respond to patient questions. It also leaves unanswered the threshold of information necessary to allow for informed consent and whether qualified staff members are able to answer questions or provide information beyond that threshold. Further, it fails to acknowledge the modern “team medicine” approach that relies on a variety of highly qualified and regulated practitioners working together to provide high-quality, efficient, and cost-effective care.

The Health Law Gurus™ will continue to monitor the impact of these new requirements for informed consent. Please check back with us for updates.