Informed Consent and Standard of Care

Recently we reviewed the legal concept of informed consent and its causation requirement. This week we will review what information the patient needs to be given to meet the standard of care when dealing with informed consent. Informed consent is, in other words, the duty to disclose the risks attendant with any recommended care or treatment. Only then can the patient's agreement and their consent, be considered informed. It is a discussion focused on what the patient is entitled to know about the risks of undergoing, or in the alternative, foregoing the recommended treatment or care.

Legal Duty and Standard Established

The extent or scope of the standard by which to properly inform a patient (informed consent) was first articulated by the Supreme Court of Canada (SCC) in Hopp v. Lepp as follows:

In summary, the decided cases appear to indicate that, in obtaining the consent of a patient for the performance upon him of a surgical operation, a surgeon, generally, should answer any specific questions posed by the patient as to the risks involved and should, without being questioned, disclose to him the nature of the proposed opera­tion, its gravity, any material risks and any special or unusual risks attendant upon the performance of the operation. However, having said that, it should be added that the scope of the duty of disclosure and whether or not it has been breached are matters which must be decided in relation to the circumstances of each particular case.

In that case, the patient was unsuccessful in his claim in negligence for the surgical technique. He also asserted a claim for the failure of the surgeon to provide an informed consent. The concept of such a duty was affirmed by the SCC, but the patient was unsuccessful in establishing a breach of the duty. The duty was further clarified by the SCC in Reibl v Hughes. In that case, the patient suffered a stroke following the operation which was a known possible risk. He became partially paralyzed and could not return to his work. As a result, he could not qualify for an employee pension benefit which would not have vested for another 18 months. Here the patient was not informed of the risk of stroke despite asking about its possibility but rather was told that without the surgery he would more likely suffer a stroke. The SCC found this to be a breach of the duty holding that:

...even if a certain risk is a mere possibility which ordinarily need not be disclosed, yet where its occurrence carries serious consequences, as for example paralysis or even death, it should be regarded as a material risk requiring disclosure.

Objective Determination of the Scope of The Duty

Reibl v Hughes also marked a change in the scope of the duty to disclose. Up to this point, the question of what should or had to be disclosed was a matter that the courts looked to the medical profession, through expert evidence, to help them decide. The SCC rejected that approach and adopted a more objective standard which allowed for considerations of what the reasonable patient would want to know before consenting to the proposed procedure. Expert medical evidence is still necessary to allow the court to understand the risks and their materiality, but that cannot be the sole consideration. This is no longer a question about whether the physician carried out their professional activities by applicable standards but rather the focus is the patients right to know the risks in undergoing, or foregoing, the recommended procedure.

Right To Withdraw One's Consent

This right was recognized and affirmed by the SCC in Ciarlariello v. Schacter. The patient has a right to bodily integrity and may withdraw their consent at any time after which the physician must not take any further steps towards completing the procedure.

What are Material Risks

A physician does not have to advise the patient of every possible risk, only those that are material. A material risk has been defined as being one that a patient would likely consider significant in deciding on whether to undergo, or forego, a medical procedure. Maybe the best articulation of a material risk is found in the Brito v. Wooley decision of the British Columbia Supreme Court as follows:

What constitutes a special, material or unusual risk will depend on the particular facts of the case. A mere possibility will be included as a material risk if the occurrence of that mere possibility is serious, for example, if it can result in paralysis or death; and, Material risks include those risks which the doctor knows, or ought to know, that a reasonable person in the patient's position would consider in deciding whether to undergo a procedure or treatment.

Takeaways

1. It is now well established that a health care worker has a duty to fully inform a patient of the risks of undergoing, or foregoing, the recommended procedure;
2. What needs to be disclosed to receive an informed consent is all of the material risks being those most likely to occur and those, although remote, which would have serious consequences for the patients future;
3. Further, any and all patients questions about the procedure and its risks must be answered;
4. A patient may withdraw their consent at any time.

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