This a specific category of malpractice that arises when a healthcare provider fails to properly inform a patient about the risks, benefits, and alternatives of a medical treatment or procedure, and this failure leads to harm or injury to the patient. Informed consent is a fundamental legal requirement in medical practice, the Constitution of South Africa ensures the right to bodily integrity, which is closely linked to the right to be fully informed before undergoing any medical treatment or procedure.

If a patient was not adequately informed about the risks and benefits of a procedure, and they suffer harm as a result, it may lead to a claim for informed consent negligence.

Thus, informed consent is critical in both preventing medical malpractice claims and protecting patients’ rights. Medical practitioners must adhere to strict standards of disclosure and patient communication to avoid legal repercussions. The failure to inform or to obtain proper consent can expose healthcare providers to legal liability for negligence and malpractice, particularly when harm to the patient occurs.

The National Health Act 2003 (NHA) lays forth the legal requirements for informed consent in South Africa.

The user (or patient) must provide informed consent prior to a medical professional performing a health service. This implies that after being properly informed about the surgery, the patient must provide their consent.

A health service cannot be rendered without informed permission, as stated in section 7 of the NHA. However, in other situations, this isn’t the case.

Circumstances when this doesn’t apply:

1. When the patient is unable to provide informed consent; instead, consent is provided by someone who has been either authorised to do so by law or court order; or required in writing by the user to provide consent on the patient’s behalf.
2. If the patient is incapable of providing informed consent and no one is required or allowed to do so, a family member may provide consent in the following order:

• spouse or partner
• parent
• grandparent
• adult child
• brother or sister

3. If there is a significant risk to the public’s health from not treating the patient or a group of individuals who include the patient, then providing a health service without informed permission is permitted.

4. The patient has not explicitly, implicitly, or via their actions declined the health service, and any delay in its delivery could cause the patient to die or suffer severe health damage.

The NHA mandates that a healthcare provider notifies a patient of his or her health status, unless there is compelling evidence that doing so would not be in the patient’s best interests, the patient’s options for therapy and diagnostic procedures, the advantages, dangers, and outcomes connected to each choice, the freedom to decline medical care, as well as the consequences, dangers, and duties associated with doing so.

In order to accommodate the user’s literacy level, the healthcare provider must, where possible communicate with them in a language they can understand. The user’s informed consent must be obtained by the healthcare professional using all reasonable means.

A significant case Castell v De Greef 1994 (4) SA 408 (C) A, in 2004 brought the courts’ perspective on risk and informed consent into compliance with the dominant human rights culture.

A patient who suffered from infection and necrosis following a double mastectomy and reconstruction filed a lawsuit against her plastic surgeon. The probability of complications from the procedure was 50%.

In an appeal, the Cape Town-based South African Supreme Court ruled that the plastic surgeon had failed to disclose the dangers.

The patient would not have had the surgery if she had been aware of the hazards, it was decided. The judge said, ” …I am of the view that there is not only a justification, but indeed a necessity, for introducing a patient-oriented approach in this connection.”

With this decision, the Supreme Court of Appeal established the “reasonable patient” standard for disclosure in providing informed consent.

The court defined a risk as being material if:

• A reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it;
• the medical practitioner is or should reasonably be aware that the patient, if warned of the risk, would be likely to attach significance to it.

In line with the fundamental right to self-determination and individual autonomy, this ruling changed the criterion for disclosure from a “reasonable doctor” to a “reasonable patient.”

Other Medical Malpractice include:

1. Negligence: If a medical professional’s actions fall below the accepted standard of care, causing harm to the patient, they may be found negligent. In NM v MEC for Health, Gauteng (2020) a state hospital was successfully sued by a mother whose child had cerebral palsy as a result of the carelessness of the medical staff. The court acknowledged the long-term effects of medical malpractice on the child’s quality of life and granted substantial compensation. This case made clear how crucial it is to hold public healthcare facilities responsible for the quality of service they provide.

2. Breach of Duty: If the practitioner fails to inform the patient properly or fails to obtain informed consent, it can constitute a breach of their duty to the patient.

It is critical to get legal counsel if you or a close family member has been the victim of medical negligence. It’s also possible to file a complaint with the Health Professions Council of South Africa (HPCSA).

By Kgomotso Sebothoma (Candidate Legal Practitioner) | Litigation Department