The Evolution of the Law of Informed Consent

doctor holding form labelled 'Informed Consent' for patient to sign

The concept of consent in the medical field has evolved considerably. The Britannica Dictionary defines consent as, “to agree to do or allow something: to give permission for something to happen or be done.” In medical and legal contexts, the concept of consent addresses the complexities of the doctor-patient relationship and the responsibility placed on both parties regarding patient care. In this blog, we’ll closely examine the concept of consent, commonly used terminology and how it has evolved over time.

Types of Consent

Consent is an integral part of a physician-patient relationship, and the general concept of consent can be interpreted in a few different ways. There are many different terms in medico-legal vernacular that relate to the idea of consent. Here are a few of those terms:

  • Informed consent is given only when the patient has been provided with adequate information and an explanation of the treatment or procedure recommended by the physician, any material risks associated with it, alternate treatment options, and the anticipated outcome. The information provided must be substantial enough to allow a reasonable person to make an informed decision about their healthcare. It is the responsibility of the treating physician to obtain informed consent, although that responsibility can be delegated in some circumstances.
  • Material risks generally include all frequent risks a procedure or operation poses, any risks that pose a grave outcome, and all other risks a reasonable person in the patient’s position would want to know about. The subjective determination of which risks are material in particular circumstances of the case is made by the physician.
  • Patient comprehension relates to the patient’s capacity to understand the medical information being provided to them by the doctor. Language barriers and complex medical concepts may pose difficulties for the physician in ensuring that the patient or their representative has comprehended the information that was provided to them.
  • Implied consent is given by a patient through their words or behaviour or provided inherently based on the circumstances of the situation in which treatment is provided. Actions like making an appointment, showing up to the appointment, providing a medical history, and submitting to a physical examination are all acts of implied consent.
  • Documentation of consent occurs when a patient signs a consent form that outlines elements like alternative treatment options, material risks, expected duration of the procedure, an overview of the procedure, and the anticipated outcome. The form provides written confirmation that appropriate information was provided to the patient.
  • Express consent can be given by a patient through their words or in written form. Usually, instances where both oral and written consent are given provide the strongest grounds for expressed consent. It is required when a treatment or procedure may be painful, carry with it concerning risks, or may result in a loss of bodily function.

The History of Informed Consent

The classic doctrine of medical ethics in ancient medicine, the Hippocratic Corpus, focused primarily on a physician’s responsibility to provide medical care to patients and to, whenever possible, provide protection from harm and illness. The central concept, as we’ve often heard in the Hippocratic oath, was to “do no harm.” It did not indicate that a physician should provide honesty when speaking to a patient about their health, prognosis, or treatment options. This standard of medical ethics was maintained throughout the duration of ancient and medieval times and even continued into early modern periods. There was little to no consideration given to the patient’s wishes or the idea that requesting and obtaining consent from them should be of vital importance. The primary focus was, in fact, in controlling medical information and the dissemination thereof, often by withholding facts and lying. These actions could be justified by referring back to the “do no harm” concept. Many in the medical field felt that a patient who was told about a bad prognosis or diagnosis would be harmed by that information.

In the eighteenth and nineteenth centuries, rumblings of changes to the concept of consent, disclosure of health information, and a desire to educate the public could be heard. In several seminal texts, American physician Benjamin Rush and Scottish physician John Gregory promoted their views on the changing nature of the medical field and the relationships between patients and their doctors. They advocated for patients to receive sufficient education, to allow them to understand the treatment recommendations made by their doctors in an effort, primarily, to encourage them to comply with said treatment. They did not, notably, promote the idea of informed consent, as we now know it, nor were they of the opinion that patients would have the capacity to fully understand the information their doctors were sharing with them. A notable British case that served to begin developing legal and judicial concepts surrounding consent took place in 1767. The case involved a physician who, without asking for the consent of the patient, used an experimental intervention as a treatment for a patient’s broken leg. The judge ruled in favour of the patient and indicated that the physician should have obtained the patient’s consent before proceeding with treatment.

Later, in the early 1800s, English physician Thomas Percival in his work Medical Ethics would continue to promote similar benevolent deception-type ideas. The American Medical Association adopted Percival’s work in its “Code of Medical Ethics” published in 1847. This text held as the standard of ethics in both America and England for more than a century. There were a small handful of notable voices, however, that did directly address the idea of consent in medical ethics. One of those voices was Worthington Hooker, an American physician, who published his book Physician and Patient in the late 1840s. In it, he promoted the idea that patients have a right to information and opposed the concept of benevolent deception.

The idea of informed consent, however, didn’t become a part of medical or legal vernacular until the 1950s. It first appeared in a written opinion from an American judge. In that case the court, for the first time, recognized a physician’s failure to obtain informed consent as legitimate grounds for a medical malpractice lawsuit, thus allowing patients to hold physicians liable for withholding information. The judge, in equating the physician’s actions as negligence, set a new precedent for consent. The opinion, however, sparked debate and controversy, and in the early 1970s a new judicial standard known as the reasonable person standard was established as a result of a landmark federal case in the United States. That standard helped physicians determine whether or not to inform a patient of potential risks based on their instinct of whether or not a reasonable person in the same position as the patient would wish to be informed. The reasonable person standard was also adopted by the Supreme Court of Canada and courts in England.

Several years later in 1980, the Supreme Court of Canada handed down their own landmark decisions regarding consent. Those cases, Hopp v. Lepp and Reibl v. Hughes, were critical in continuing to establish the rights of patients and forcing medicine to adopt a patient-centered approach regarding the dissemination of information and informed consent. In Hopp v. Lepp, the patient, who ultimately became the plaintiff in the case, had undergone an operation on a spinal disc. The surgery, though competently performed, resulted in the patient’s permanent disability. The plaintiff’s lawsuit alleged that the physician failed to disclose both that they had never before performed this operation and that there was an alternative option where the patient could have had the surgery performed at a larger medical facility.  In a unanimous decision, Chief Justice Bora Laskin wrote the opinion on behalf of the court. It rejected the idea that physicians get to decide which risks and alternative options should be disclosed to the patient and instead held that a doctor must inform their patient of all the risks that a “reasonable person in the position of the patient” would want to be aware of. It indicated that a doctor must answer all of a patient’s questions about the diagnosis, treatment, and alternative options honestly and without withholding information.

Several months later the second critical case, Reibl v. Hughes, served to truly define the concept not just of consent but of informed consent. In this case, the patient and plaintiff had undergone a competently performed endarterectomy. The result of that surgery, however, was catastrophic. He had a stroke which caused him to become permanently paralyzed on his right side. The patient alleged that the doctor had failed to inform him of the risks of the surgery. The decision was again unanimous, and Chief Justice Laskin wrote the court’s opinion. In this opinion, the court confirmed that a doctor has a duty to disclose risks associated with a procedure or treatment as a critical part of the relationship between a doctor and a patient. This case went further than Hopp v. Lepp in that it didn’t stop the doctor’s responsibility for disclosing information by drawing a line at the questions posed by a patient. They held in this decision that the doctor must disclose any and all material risks regardless of whether or not the patient asks about them. In this case, the defendant was initially found liable by a lower court for battery and negligence for his failure to disclose the material risks of the surgery and potential outcomes. However, in the decision made by the Supreme Court of Canada, the defendant was only found negligent. Chief Justice Laskin made a clear distinction between medical malpractice claims involving battery and those involving negligence. In his opinion he wrote, “where surgery or treatment had been performed or given to which there has been no consent at all or where, emergency situations aside, surgery or treatment had been performed or given beyond that to which there was consent”, he continued, “unless there had been misrepresentation or fraud to secure the consent to the treatment, a failure to disclose the attendant risks, however serious, should go to negligence rather than battery.” These two cases served to alter the standard for disclosure to a more patient-centered test and defined informed consent in modern Canadian medicine. Helping patients receive more pre-treatment information has empowered them significantly to actively participate in decisions about their own bodies and health.

The Patient’s Right to Refuse Treatment

A patient, in most circumstances, has the right to refuse medical treatment for whatever reason, even when the treatment is critical to preserving their life. This concept was articulated by Justice Sydney Robins of the Ontario Court of Appeal:

“The right to determine what shall, or shall not, be done with one’s own body, and to be free from non-consensual medical treatment, is a right deeply rooted in our common law. This right underlines the doctrine of informed consent. With very limited exceptions, every person’s body is considered inviolate, and, accordingly, every competent adult has the right to be free from unwanted medical treatment. The fact that serious risks or consequences may result from a refusal of medical treatment does not vitiate the right of medical self-determination. The doctrine of informed consent ensures the freedom of individuals to make choices about their medical care. It is the patient, not the physician, who ultimately must decide if treatment — any treatment — is to be administered.”

Patients who make it clear that they wish to refuse treatment after being provided with the information that would have been required for them to provide informed consent are providing informed refusal. After they provide informed refusal, the physician should provide additional information relating to the consequences of refusing treatment and thoroughly explain all other treatment options available.

Similarly, a patient has the right to be discharged from medical care. This concept, known as informed discharge, also requires a doctor to provide additional information to a patient who chooses to be discharged against medical advice. That information should include potential postoperative complications, signs and symptoms to be aware of, and when they would encourage the patient to return for treatment.

Exceptions for Providing Informed Consent

There are only a couple of exceptions wherein informed consent is not required to be obtained before providing medical treatment. The most common example of this is in emergency rooms when immediate medical intervention must be taken and the patient or their representative is unable to provide consent for treatment. These situations typically only involve instances where the patient is suffering greatly or is facing an imminent threat to their life or health. In these situations, however, the medical treatment provided should be limited in scope to only the treatment(s) that are required to mitigate the patient’s suffering or to prevent loss of life or health.

The exception to these instances includes if the patient has made it clear that they do not wish for medical intervention to save their lives or preserve their health. This often occurs when a patient has an advanced directive in place. Advanced directives allow patients to ensure their wishes are respected regarding health care decisions during a time when they are unable to make medically necessary decisions for themselves. There are two types of advanced directives available. The first allows a patient to designate a decision-maker who can provide informed consent on their behalf. The other allows a patient to provide instructions regarding what they want to happen in medical situations. That may include a description of their values or beliefs that would serve to guide the physician’s or representative’s decision.

Informed Consent in Modern Canadian Medicine

The concept of informed consent has developed and evolved for as long as medicine has been practiced. Today in Canada, informed consent is considered obtained only when the patient or their appropriate representative has been provided with complete information about the procedure or treatment the physician is suggesting, including crucial details such as why the treatment is required, the details of the procedure, the anticipated recovery time, the benefits the procedure or treatment will provide, any reasonable alternative treatment options, all material risks of the treatment or procedure, any potential complications that could occur, any side effects the patient may experience during or as a result of the treatment, and any medical and health implications the patient may face if they choose not to receive any treatment.

If You’ve Been Injured by a Physician’s Negligence, We Can Help

If you suspect that you or a family member suffered harm as a result of medical malpractice, including a physician’s failure to obtain informed consent, we can help. For more than 20 years, our team has been advocating on behalf of clients in a wide range of complex legal matters. Our law firm has extensive experience handling complex litigation, and we will draw upon our knowledge, resources, access to experts, and determination to build a claim for damages on your behalf. Our aim is for you to be able to focus on your life, while we focus on your case.

Contact Klein Lawyers at (604) 874-7171 today for a free consultation with a Vancouver medical malpractice lawyer. We serve clients throughout British Columbia including Abbotsford, Burnaby, Coquitlam, Langley, Surrey, and other areas. There’s no obligation, and it’s completely confidential. We’re here to help victims of medical malpractice receive the justice they deserve.