Legal Risks of Delegating Informed Consent to an NP or PA

Mark Crane


November 30, 2017

In This Article

Problem With an Informed Consent Prior to Surgery

Megan L. Shinal had undergone surgery for partial removal of a brain tumor. Several years later, by 2007, the craniopharyngioma tumor had returned along with severe headaches. She was referred to Steven A. Toms, MD, chief of neurosurgery at Geisinger Medical Center in Danville, Pennsylvania.

The tumor had grown in size to where it was jeopardizing the patient's eyesight and carotid artery and "would eventually become life-threatening" if left untreated, according to the court decision.

Dr Toms met with the patient and discussed surgery options—total versus partial removal of the tumor. The surgeon testified that he told her that less aggressive surgery could be safer, but there was a likelihood that the tumor would grow back again. The decision of how far to proceed was discussed at length, and the final determination would be made during surgery. "If you can get it all, I want you to get it all," he testified that the patient told him.

A few days later, the patient telephoned Dr Toms' physician assistant and asked questions about scarring, whether radiation would be necessary, and about the date of the procedure. The PA took her medical history, conducted a physical exam, and provided her with more information about the surgery. He gave her an informed consent form that she signed.

During the operation, the neurosurgeon perforated Shinal's carotid artery, resulting in hemorrhage, stroke, brain injury, and partial blindness. At the trial 2 years later, the patient testified that had she known more about the alternative approach, she would have chosen partial removal of the tumor as the safer, less aggressive option.

She filed a lawsuit alleging that Dr Toms had not obtained her informed consent. Shinal didn't assert that the harm she suffered was the result of negligence, and there was no contention that Dr Toms' staff provided inaccurate information. Over objections of Shinal's attorney, the trial judge instructed the jury that they could take into account any information provided by Dr Toms' PA.

A jury found for Dr Toms. The patient appealed and challenged the trial court's informed consent jury instructions. Her attorney argued that whatever the PA told the patient during the informed consent process shouldn't be admitted into evidence because the surgeon is required to personally provide all of the information. An appeals court denied her claim, and she filed an appeal with the state Supreme Court, which reversed that decision last June. The court ordered a new trial.

What Impact Will the Court's Ruling Have?

Several attorneys and physicians disagree on the court's ruling and what effect it will have. Some argued that it has long been common practice for physicians to allow allied health professionals to participate in the informed consent process.

"Medicine is now a team-based profession where many professionals participate in the patient's care," said Charles Cutler, MD, an internist and immediate past president of the Pennsylvania Medical Society. "Requiring the surgeon to give all of the informed consent all the time breaks down the team approach."

"Up until now, especially with uncomplicated straight-forward procedures, it was common that some responsibility for informed consent could be delegated," he said. "Procedures such as colonoscopies, blood transfusions, and many biopsies are low risk and shouldn't require the surgeon to do it all."

"I don't know if courts are the best venue to deal with this. We're hoping for some legislative or regulatory action to clarify everyone's roles," he said.


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