Regulatory

Obtaining Patient Consent in Pennsylvania

The decision in Shinal v. Toms could have significant ramifications for Pennsylvania physicians. With this decision, the Pennsylvania Supreme Court holds that physicians alone have the duty to provide patients with the sufficient information required to obtain informed consent. Thus, Pennsylvania physicians can seemingly no longer rely upon the aid of their qualified staff in the informed consent process.
 
In a decision regarding the Medical Care Availability and Reduction of Error (MCARE) Act's informed consent requirement, the Pennsylvania Supreme Court has ruled that a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain informed consent—the duty to obtain a patient’s informed consent is a non-delegable duty owed by the physician conducting the surgery or treatment.
 
In Shinal v. Toms, a patient alleged that her surgeon failed to provide information required to obtain informed consent prior to the removal of a non-malignant brain tumor. The trial court provided instructions to the jury, permitting them to consider information provided by the surgeon's physical assistant as part of the informed consent process. The trial court subsequently found in favor of the surgeon.
 
The patient later appealed to the Superior Court, challenging the trial court's instruction. The Superior Court agreed with the trial court's instruction and held that information provided by a surgeon's qualified staff could be considered part of the informed consent process.
 
The Pennsylvania Medical Society (PAMED) – with support from the American Medical Association (AMA) – filed an amicus brief of the Superior Court's holding that information provided by a physician assistant or other qualified assistant can be used to obtain a patient's informed consent for surgery.
 
Following arguments before the Pennsylvania Supreme Court in November 2016, the Court issued its decision in the matter on June 20, 2017. The Pennsylvania Supreme Court reversed the Superior Court's order affirming the trial court's jury instruction.
 
The duty to obtain a patient's informed consent is a non-delegable duty, the Pennsylvania Supreme Court ruled, belonging solely to the physician conducting the surgery or treatment. The Court found no provisions in the Mcare Act allowing for information given by a physician's subordinates to satisfy the physician's burden to obtain informed consent.
 
Furthermore, the Court held that a physician cannot be confident that a patient comprehends the risks of and alternatives to treatment without direct dialogue. The physician personally satisfying the duty of disclosure ensures that the patient's consent is truly informed.
 
Reversing the trial court and Superior Court's judgment in favor of the defendant surgeon, the Supreme Court has remanded the case for a new trial.