Informed Consent in Pennsylvania – The Supreme Court of Pennsylvania Issues a Wake-Up Call
October 17, 2017
It has been nearly four months since the Supreme Court of Pennsylvania issued its opinion in the case of Shinal v. Toms. In its opinion, the Court considered the issue of informed consent under Pennsylvania law and issued a clear directive – the duty to obtain informed consent from a patient is a physician’s duty alone and the duty cannot be delegated to others. This proposition is not new. However, never before has a Pennsylvania court put such a fine point on the concept. In doing so, the decision has caused physicians and health care facilities to reevaluate policies and procedures related to how informed consent is obtained from patients. This isn’t necessarily a bad thing. However, following the literal interpretation of the Court’s ruling is not as easy it sounds in the world of modern medicine.
Informed consent involves giving a patient meaningful information about a procedure, its risks, alternatives, and any other information that a patient would find material in deciding whether or not to consent to having the procedure. The information should be given in plain and understandable terms. If an informed patient consents to have a procedure, the permission given removes any concern that the touching of the patient is illegal battery.
Existing Pennsylvania law concerning informed consent clearly contemplates physicians playing a primary role in the process. Pennsylvania’s Medical Care Availability and Reduction of Error (MCARE) Act states that, except in emergent situations, it is the duty of a physician to obtain informed consent from a patient before certain procedures. Covered procedures include surgery (including related administration of anesthesia), radiation or chemotherapy, administering a blood transfusion, inserting a surgical device or appliance, and administering experimental drugs or treatment. Title 28 (Health and Safety) of the Pennsylvania Code of Regulations also contains references to informed consent in various contexts.
Given the time constraints of a busy physician, nurses and physician assistants often have the most direct interaction with a patient and commonly assist to answer questions of the patient before a procedure. In Shinal, the Court was presented with the question of whether and to what extent a physician can utilize non-physician assistants to obtain informed consent from a patient.
The Shinal decision is a clear statement that a physician cannot delegate the duty to obtain informed consent to others. Interestingly, in its opinion the Court discusses informed consent as a “meeting of the minds” between patient and physician. In order to satisfy this duty, the decision contemplates meaningful personal interaction and discussion. Information provided to a patient by non-physician assistants, while potentially helpful to a patient, will not be considered in determining whether a physician fulfilled his or her legal duty to obtain informed consent. This will require a physician to ensure they are actively involved in the entire informed consent process.
From a patient’s perspective, it’s hard to argue against the holding of the Shinal decision. For Physicians and health care facilities it has created some difficult questions. Here are some to consider:
- Does the decision take into consideration the impact this will have in terms of time and cost? The dissenting opinion discusses these types of concerns, but the majority opinion is the law. The duty to obtain informed consent is non-delegable by a physician.
- How do we define what procedures require a physician to obtain informed consent? If a procedure falls within those identified under MCARE, a physician must obtain informed consent from the patient. Outside of specific procedures listed, such as surgery, it can be a challenge to define whether a procedure is covered. For example, is a Peripherally Inserted Central Catheter (PICC) Line covered? Because physicians are ultimately responsible for obtaining informed consent, members of the Medical Staff must be directly involved in making these decisions. The informed consent process for anesthesia should also be looked at carefully.
- Do consent forms mean anything anymore? Yes, informed consent forms can be helpful documentation of the informed consent process. The Shinal case doesn’t touch on what the ideal consent form should look like. In the wake of the decision one can imagine the emergence of consent forms dozens of pages long that attempt to describe every possible nuance involved with a procedure. At some point this would seem to run counter to information being exchanged in a plain and understandable way. No matter what your form looks like, the key is that there is meaningful interaction between the physician and patient. Ideally, a consent form should be signed and dated by the patient and physician at the same time.
- How long is a consent form valid? A related issue is how to handle consent for identical repeat treatments. While the Shinal decision did not directly address these issues, the consent process should be an ongoing exchange of information and its documentation should be executed at the end of that process. In any event, a fresh consent should be obtained and documented if there are any changes to material facts that would impact the patient or change a course of treatment.
It is recommended that physicians and health care facilities take this opportunity (or mandate, depending on how you look at it) to review policies and procedures related to how informed consent is obtained from patients. As part of that process, it is advisable to review your informed consent form and train physicians on proper documentation.
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