Informed Consent Ruling May Disrupt the Practice of Medicine and Medical Research Nationwide

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In 2008, a surgeon by the name of Steven Toms, MD signed up Megan Shinal for reoperative surgery. She had a recurrent craniopharyngioma that required resection. He discussed the risks of surgery with the patient including the fact that either a subtotal or total resection (with higher risk of complications) may be needed, and the actual procedure (whether subtotal or total resection) was left open. A longer discussion regarding the specific risks of surgery including informed consent was held by his physician assistant, not by the surgeon himself.

Shinal decided to undergo surgery, but the question of whether to proceed with total vs subtotal resection was unresolved at the time of the initial consultation with Toms, the authors note. Shinal subsequently spoke with the physician assistant about scarring, the craniotomy incision, potential radiation, and the date for surgery.

During surgery, the surgeon unfortunately perforated the carotid artery, leading to permanent severe neurologic injury. The patient sued arguing that if she knew that total resection carried such a high risk, she would have opted for the lesser risk procedure.

Holly Fernandez Lynch, JD, MBE, and colleagues from the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine in Philadelphia, examined the potential consequences of a 2017 decision from the Pennsylvania Supreme Court. In a 4-to-3 decision, the court ruled that a physician may not “fulfill through an intermediary the duty to provide sufficient information to obtain a patient’s informed consent.”

Shinal signed a consent form indicating that she had discussed the risks and benefits of alternative treatments. “However, the form did not specifically address the differential risks of the two surgical options,” Lynch and colleagues write.

Dr Toms testified at trial that he discussed with Shinal her goals and the risks and benefits of total vs subtotal resection, including the potential harm that ultimately occurred, Lynch and colleagues explain.

As a result of this supreme court of Pennsylvania decision, excess caution for obtaining informed consent canu nnecessarily burden physicians and sideline other qualified healthcare professionals from the process of helping patients understand risks and benefits of treatments, according to lawyers who’ve studied the caseĀ Shinal v Toms.

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