Informed-consent ruling may have “far-reaching, negative impact”

Andis Robeznieks , Senior News Writer

A recent ruling by the Commonwealth of Pennsylvania Supreme Court in Shinal v. Toms could “have a far-reaching, negative impact” on physician practices, according to Justice Max Baer.

The Commonwealth of Pennsylvania Supreme Court, in a 4–3 decision, ruled that, not only do surgeons have the duty to provide their patients with information about the alternatives, risks and benefits of a particular procedure in order to obtain informed consent; the surgeon has to be the person who delivers that information personally.

“The law simply does not support such a proposition,” Baer wrote in the dissenting opinion, with two other judges—including Chief Justice Thomas Saylor—joining in.

Four other justices disagreed, however, and the case has been remanded back to a lower court for a new trial.

“In addition to my conclusion that the majority's holding is legally inaccurate, I fear that today's decision will have a far-reaching, negative impact on the manner in which physicians serve their patients,” Baer wrote. “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. Courts should not impose such unnecessary burdens upon an already strained and overwhelmed occupation when the law does not clearly warrant this judicial interference.”

The Litigation Center of the American Medical Association and the Pennsylvania Medical Society (PAMED) had filed an amicus brief in support of Steven A. Toms, MD, that argued he had fulfilled his obligations under Pennsylvania’s Medical Care Availability and Reduction of Error (MCARE) Act as well as common law established in previous Pennsylvania court rulings.

“Neither common law nor statute has prescribed who must provide the information,” the brief states, adding that the language in the MCARE Act “focuses on what a patient has been told or has otherwise been provided, and not on who provided it.”

The MCARE Act, which mandated that a patient’s informed consent be obtained before a medical procedure, was signed into law in March 2001, three years before Megan Shinal underwent surgery for partial removal of a brain tumor. By 2007, the craniopharyngioma tumor had returned along with severe headaches. She was referred to Dr. Toms, a neurosurgeon then with the Geisinger Health System.

The tumor had increased in size to where it was jeopardizing Shinal’s eyesight and carotid artery, threatening the hormone functions of her pituitary gland, and “would eventually become life-threatening” if left untreated, according to the factual summary provided in the court ruling written by Justice David Wecht.

Dr. Toms met with Shinal on Nov. 26, 2007, where he told her that less aggressive surgery could be safer in the short term, but there was a likelihood that the tumor would again grow back. Dr. Toms testified that the decision of how far to proceed was discussed at length with the final determination to be made during surgery and that, if the risk became too great, the attempt at total removal would stop, according to the summary in the amicus brief.

“If you can get it all, I want you to get it all,” Shinal told him, the brief states.

Shinal spoke on the phone with Dr. Toms’ physician assistant on Dec. 19, 2007, and asked about scarring, whether radiation would be necessary and about the date of the surgery. On Jan. 17, the physician assistant took Shinal’s medical history, conducted a physical exam, provided her with additional information about the surgery and gave her an informed-consent form that she signed.

The surgery took place Jan. 31, during which Shinal’s carotid artery was perforated, leading to hemorrhage, stroke, brain injury and partial blindness, Wecht wrote.

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A lawsuit alleging Dr. Toms had not obtained informed consent was initiated by Shinal and her husband on Dec. 17, 2009. The brief notes that Shinal “did not assert that the harm was the result of negligence” and that “there is no contention” that Dr. Toms’ staff provided inaccurate information during the informed consent process.

A jury found for Dr. Toms. Shinal appealed and the Pennsylvania Superior Court affirmed the decision. The case was heard before the Pennsylvania Supreme Court in November 2016. The case was decided June 20.

According to Wecht, a key issue is “whether the trial court misapplied the common law and the MCARE Act when it instructed the jury that it could consider information provided to Mrs. Shinal by Dr. Toms' ‘qualified staff’ in deciding whether Dr. Toms obtained Mrs. Shinal's informed consent to aggressive brain surgery.”

Baer argued that it did not.

“Thus, while the MCARE Act assigns to physicians the duty to obtain informed consent and requires that certain information must be conveyed to patients to inform their consent, the act conspicuously does not mandate that only physicians themselves can provide information to patients to inform their consent,” Baer wrote. “The legislature could have, but did not, expressly require that only physicians can provide patients with information regarding informed consent.”

The majority dismissed arguments that were based on Pennsylvania common law, declaring that they were Superior Court cases that predated a 2002 Pennsylvania Supreme Court case that held that the duty to obtain informed consent rests with the physician performing a procedure and not the hospital where it will be performed.

In a summary of the case posted on the PAMED website, it’s noted that the decision “could have significant ramifications for Pennsylvania physicians” in that they can “seemingly no longer rely on the aid of their qualified staff in the informed consent process.”

PAMED General Counsel Angela Boateng also weighed in.

“It was not uncommon for other qualified staff to assist a physician in providing the requisite information or answering follow-up questions a patient may have had. The Medical Practice Act and other professional regulations permitted this level of assistance,” she commented. “The patient’s ability to follow up with the physician or his qualified staff was usually aimed at promoting a patient’s understanding of the treatment or procedure to be completed. The court’s decision, however, has put an end to this practice.”