Liability suit seeks change to informed consent

By American Medical Association National, News, Pennsylvania Source

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  • September 19, 2016

A case before the Supreme Court of Pennsylvania could have major implications on how physicians obtain informed consent prior to a surgery.

At stake in Shinal v. Toms, is whether a patient’s informed consent to surgery can be predicated on information provided in part by a physician’s assistant, as opposed to just the physician. Both the Medical Care Availability and Reduction of Error Act (MCARE) and common law have made it the physician’s duty to see that the proper information is conveyed, but the question is whether delegating tasks to qualified professionals is also within the bounds of the law and common medical practice.

How the case unfolded

In 2004, Megan Shinal underwent surgery to remove a tumor, but it regrew and by 2008 she was experiencing severe headaches and was referred to Steven A. Toms, MD, for a second surgery.

This type of surgery—the removal of a craniopharyngioma, a very serious and recurrent rumor located deep in the base of the brain—is one of the most complex surgeries in all of neurosurgery. For this reason, there were numerous important surgical decisions to be made, some by the surgeon and some collaboratively with the patient.

The major decisions were which of two surgical approaches to take—through the nose and the sphenoid bone, or through the skull—and whether to remove the entire tumor or leave a portion of the tumor in place. Removing the entire tumor usually produces a better long-term outcome, but involves more surgical risk. One of those risks is a potential rupture of the carotid artery, which can cause serious injuries. Yet, the alternative to surgery would be to accept disability and then death as near inevitable outcomes.

Dr. Toms testified that he and Ms. Shinal discussed this issue at length and that she had agreed that he would determine during the surgery whether he should remove the entire tumor.

The complaint filed by Ms. Shinal and her husband at first included a detailed negligence claim, but this theory was abandoned before trial. Instead, the plaintiffs asserted that Dr. Toms had not advised of the risk of damage nor adequately explained the risks and complications associated with the surgical approach, particularly the risks and benefits of a total vs. partial tumor removal.

They asserted that, because Dr. Toms’ physician assistant had provided the information to inform the consent, and not Dr. Toms himself, Mrs. Shinal had not been adequately informed and did not provide consent.

What has been provided, not who provided it

Informed consent doctrine has focused on providing the patient with appropriate information to make a knowledgeable decision to proceed or to forgo surgery. Neither common law nor statute has prescribed who must provide the information.

The record reflected that Dr. Toms’ staff had provided certain information to Ms. Shinal and the trial court properly instructed the jury to consider the testimony.

“Imposition of a duty is quite different from mandating that the physician provide all of the information,” the Litigation Center of the AMA and State Medical Societies said in an amicus brief. “Physicians’ delegation of some of their duties to other health care professionals while maintaining liability if those delegated services are not properly performed is commonplace.”

“Surgeons may be the ‘captain of the ship,’ and liable for a crew member’s errors, but they do not work alone and need not personally perform every task,” the brief said. “The trend of delegating will only be more common in the future as medical care seeks greater efficiencies.”

The brief asked the Court to affirm the decision that information relative to obtaining a patient’s informed consent could be provided by qualified staff on behalf of the surgeon.