A divided Pennsylvania Supreme Court ruled recently that physicians must communicate directly with patients and not rely on information conveyed by their qualified staff—in this case a physician assistant (PA)—to satisfy the duty to obtain informed consent. The decision makes clear that in Pennsylvania, it’s not just the information that matters, but the person delivering it.

“Informed consent requires direct communication between physician and patient, and contemplates a back-and-forth, face-to-face exchange,” the majority opinion said.

Megan L. Shinal brought a medical malpractice action against Steven A. Toms, MD, the director of the neurosurgery department at Geisinger Medical Center after she suffered permanent injuries following surgery to remove a recurrent non-malignant brain tumor. The action alleged Toms failed to obtain Shinal’s informed consent for surgery to remove the tumor.

As recounted in the opinion, Toms testified at trial that he initially met with Shinal and discussed surgery options—total versus partial removal of the tumor—including the benefits and risks of each approach. Following that visit, Shinal opted to undergo the surgery, but didn’t reach a decision about which surgical approach to pursue.

Shinal later had a telephone conversation with Toms’ PA, who answered her questions about scarring, whether radiation would be necessary, and about the craniotomy incision. Two weeks before the surgery, Shinal met with the PA at Geisinger. The PA took her medical history, conducted a physical, and provided Shinal with information related to the surgery. Shinal at that time signed an informed consent form for the surgery.

While performing a total resection of the brain tumor, Toms perforated Shinal’s carotid artery, resulting in hemorrhage, stroke, brain injury, and partial blindness. Shinal testified at trial that had she known of the alternative approach to surgery, she would have chosen partial removal of the tumor as the safer, less aggressive option.

The trial court granted a motion for summary judgment in Gesinger’s favor, agreeing that Toms, as the treating physician, not the hospital was responsible for obtaining informed consent. See Valles v. Albert Einstein Med. Ctr., 805 A.3d 1232 (Pa. 2002). The trial court also instructed the jury that in determining whether Toms obtained informed consent, they could take into account any information provided by his qualified staff, including the PA.

The jury returned a verdict in Toms’ favor. Shinal appealed, challenging among other things the trial court’s informed consent jury instructions. The appeals court affirmed.

The high court majority reversed, holding the trial court misapplied the common law and the Medical Care Availability and Reduction of Error (MCARE) Act by instructing the jury that it could consider information provided to Shinal by Toms’ qualified staff in determining whether he obtained her informed consent for the brain surgery.

Toms acknowledged that the duty to obtain informed consent resides with the physician, but argued the common law and MCARE Act don’t require a physician to supply all information personally. The high court majority, however, disagreed.

“This Court has held that the duty to obtain informed consent belongs solely to the physician and that it is non-delegable,” the opinion said. The high court noted its previous holding that a hospital has no duty to obtain informed consent, because that obligation resides solely with the physician. “For the same reasons, we hold that a physician cannot rely upon a subordinate to disclose the information required to obtain informed consent.” In the high court’s view, a “direct dialogue” and a “two-way exchange between physician and patient” is key to ensuring informed consent.

The high court also found its interpretation of the common law was consistent with the MCARE Act’s codification of informed consent. According to the high court, the plain language of the statute imposes a specific duty on physicians to provide the patient with the information needed for informed consent.

A dissenting opinion rejected the majority’s “holding that a physician’s qualified staff cannot aid the physician in fulfilling his duty to obtain a patient’s informed consent.” While agreeing that a physician has a non-delegable duty to obtain informed consent, the dissent argued that the MCARE Act does not mandate that only physicians can provide the relevant information.

“[T]here is nothing in the law of this Commonwealth precluding a physician from utilizing his qualified staff to aid in his duty to obtain a patient’s informed consent. If qualified staff is somehow negligent in aiding a physician in informing a patient’s consent, then the physician remains liable if that negligence results in the failure to obtain the patient’s informed consent,” the dissent wrote.

The dissent also was worried that the majority’s approach could inject the courts into the “day-to-day tasks of physicians” and “fails to acknowledge the reality of the practice of medicine.”

The case is Shinal v. Toms, No. 31 MAP 2061 (Pa. June 20, 2017).