Accountability for Informed Consent in Healthcare: Considering Shinal v. Toms

Laura M. Cascella, MA, CPHRM

Issues related to informed consent are a persistent area of concern in healthcare and a source of liability exposure. MedPro Group malpractice claims data show that more than one-fourth (27 percent) of all communication-related malpractice claims involve allegations associated with informed consent.¹ Of these allegations, the majority are related to inadequate consent processes and failure to manage patient expectations.

Because of these risks and the important role that informed consent plays in patient-centered care and shared decision-making, healthcare providers and organizations should assess their consent policies and protocols to identify improvement opportunities and monitor for adherence. An initial task during the assessment should focus on reviewing policies related to accountability for the consent process, including responsibility for having the consent discussion with the patient, responding to follow-up questions, and completing appropriate documentation.

A recent court decision in Pennsylvania has renewed discussions about accountability for informed consent. The case, Shinal v. Toms,² involved a patient who was undergoing surgery to remove a brain tumor. The patient was referred to a neurosurgeon who met with her to discuss surgery options (partial versus total removal of the tumor) and risks. The patient elected to have total removal if the neurosurgeon determined that approach was feasible during the surgery.

A few days after the consultation, the patient called the medical center with several follow-up questions related to scarring, the need for radiation therapy, and timing of the procedure. The neurosurgeon’s physician assistant (PA) answered the patient’s questions, and later the PA provided the patient with additional information about the surgery and obtained her signature on the informed consent form.

After suffering severe injuries during the procedure, including brain injury and partial blindness, the patient filed a lawsuit alleging inadequate informed consent.³ In a 4-3 ruling in favor of the plaintiff, the Pennsylvania Supreme Court held that:

Informed consent requires direct communication between physician and patient, and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patient's informed consent belongs solely to the physician.⁴

Although this ruling was controversial, and the long-term legal implications are still unfolding, Shinal v. Toms does give healthcare providers and organizations reason to carefully consider their current consent policies.

Over the years, MedPro has consistently advised policyholders that the informed consent process is a nondelegable duty that the healthcare provider who is performing the surgery, procedure, or treatment must perform through discussions with the patient — or in certain cases, the patient’s guardian or authorized representative.

Qualified staff members may also participate in the informed consent process by providing general educational information and reinforcing specific information that the treating healthcare provider has communicated to the patient. However, if a patient has questions or is wavering about a decision, staff should refer the patient back to the treating practitioner. Staff members also may help facilitate the completion of forms after the treating practitioner has disclosed all relevant information to the patient.

Although the examples of staff involvement above are generally accepted practices in many healthcare settings, providers should stay alert to state laws and evolving professional guidance in light of the Shinal v. Toms case and other potential cases that might establish case law related to informed consent.

Further, healthcare providers should avoid the common misperception that a signed consent form, by itself, demonstrates consent. The form merely documents one phase of the informed consent process. For the patient to be truly “informed,” he/she must understand the information that the healthcare provider has disclosed. Thus, as part of the consent process, the provider should consider:

• The patient’s current understanding of his/her condition and the proposed treatment plan
• The patient’s overall capacity to understand
• Cultural considerations and personal values that might affect the patient’s decision-making
• Any language barriers that could impede the consent process

Additionally, patients should have ample time during appointments to ask questions, voice concerns, and clarify information with the treating provider.

For more information about the framework for informed consent and legal/professional considerations, see MedPro’s guideline titled Risk Management Strategies for Informed Consent. For curated resources on this topic, see MedPro’s Risk Resources: Informed Consent.

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¹ MedPro Group. (2019). Verbal and written: Claims involving informed consent issues. Retrieved from www.medpro.com/documents/10502/5086245/Verbal+and+Written_Claims+Involving+Informed+Consent+Issues.pdf

² Shinal v. Toms, 162 A. 3d 429 (Pa: Supreme Court 2017); Justia, Shinal v. Toms M.D. (majority). Retrieved from https://law.justia.com/cases/pennsylvania/supreme-court/2017/31-map-2016.html

³ Crane, M. (2017, November 30). Legal risks of delegating informed consent to an NP or PA. Medscape. Retrieved from www.medscape.com/viewarticle/887074

⁴ Shinal v. Toms, 162 A. 3d 429 (Pa: Supreme Court 2017)

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