The Dangers of Delegation
Can you delegate informed consent to another professional? Pennsylvania court says no.
Patients rely on their physicians, including ACR members, to share clinically relevant information. You apply your medical judgment when you decide what to tell a patient about a particular study or procedure she or he may undergo.
The patient may then evaluate its benefits, risks, and alternative clinical options more clearly and thoroughly. This communication helps you uphold the Hippocratic Oath to “do no harm.” Proper informed consent represents a fundamental, if underappreciated, legal obligation that you must fulfill. Do it correctly and you exercise reasonable care and may avoid potential claims of negligence. Do it poorly, or not at all, and you risk losing a patient’s trust and possibly being sued for malpractice. In this column, we will discuss a notable case that imposes a challenging duty on all physicians to personally obtain informed consent.
In the case of Shinal versus Toms,1 the Pennsylvania Supreme Court held that, at least for certain procedures, both case law and the Pennsylvania Medical Care Availability and Reduction of Error (MCARE) Act of 2002 mandate that the physician performing the procedure must personally obtain the patient’s informed consent and cannot delegate that task to any other staff member.
The patient met with a neurosurgeon at the Geisinger Medical Center for an initial consultation to discuss removing a recurrent, non-malignant tumor from her brain’s pituitary region. The neurosurgeon testified later at trial that he and the patient discussed her goals, life plans, and the risk of various surgical approaches, including potential damage to her nearby carotid artery and optic nerve. The neurosurgeon believed that the patient wanted him to “push forward” during the surgery if he thought he could remove the tumor with a “reasonable risk.” He testified that he reviewed with the patient the benefits, risks, and alternatives of total versus subtotal resection. The patient decided to undergo surgery but had not yet determined a surgical plan.
She then had a telephone conversation with the neurosurgeon’s physician assistant. They discussed scarring that would likely occur from surgery, whether radiation was needed, and the date for surgery. The patient ultimately met with the physician assistant, who obtained her medical history, conducted a physical, and provided her with surgery-related information. She signed an informed consent form. The form noted that the patient gave the neurosurgeon permission to resect a recurrent craniopharyngioma and identified surgical risks, including “pain, scarring, heart attack, stroke, injury and death.”
The patient underwent a total resection of her brain tumor. During the operation, the neurosurgeon apparently perforated her carotid artery. She suffered hemorrhage, stroke, brain injury, and partial blindness. The patient and her husband eventually filed a medical liability lawsuit in Pennsylvania trial court. They alleged that the neurosurgeon failed to obtain her informed consent for the surgery. The trial court ruled that a qualified professional acting under an attending physician’s supervision may convey information to a patient in the consent process.
The patient and her husband appealed. They contended that the trial court erroneously instructed the jury that it could consider relevant information that any qualified person working with the physician had provided. Additionally, they alleged that the court’s instructions to the jury conflicted with Pennsylvania’s MCARE law because that statute required a physician to obtain informed consent directly from a patient. The neurosurgeon maintained that, although a physician had the duty to obtain such consent, he did not have to supply all of the requisite information himself. He essentially focused on the end result — the consent — rather than the means of who communicated with the patient.
Notably, the Pennsylvania Supreme Court agreed with the patient, ruling that a physician who performs surgery or other treatment cannot delegate the legal duty to a subordinate. The court held that only “a direct dialogue and two-way exchange” with the patient will make the physician confident that the patient fully understands the benefits, risks, likelihood of success, and alternatives. If the law allowed physicians to delegate vital information to their staff, “it would undermine patient autonomy and bodily integrity by depriving the patient of the opportunity to engage in a direct dialogue with his or her chosen health care provider.” One justice dissented, emphasizing that the majority’s holding would “delay seriously ill patients access to physicians and the critical services that they provide.”
Although this case involved a surgical procedure, the Pennsylvania statute also applies the requirement to administering radiation or chemotherapy. It is not clear whether a court might regard this to include any use of ionizing radiation. More troubling is the court’s statement that Pennsylvania common law also imposes a non-delegable duty on physicians to personally obtain informed consent. This approach might easily be used to extend the requirement well beyond the specific procedures listed in the statute.
We wish to remind members that the specific requirements for obtaining informed consent are largely a matter of state law. Therefore, the College recommends that members and their practices consult with qualified health care attorneys to clarify the requirements for obtaining informed consent in their states and designing appropriate protocols to meet those requirements.
1. Shinal v Toms, 122 A3d (Pa 2017).
By Bill Shields, JD, LLM, CAE, and Tom Hoffman, JD, CAE