INSIGHTS: When has an obligation to obtain informed consent been discharged?

Medical practitioners have a duty to ensure that their patients understand the general nature and material risks of the treatment they will undergo. The recent NSW Court of Appeal decision in Biggs v George[1] considered the duty of medical practitioners to warn patients of material risks and what is required to discharge that duty.

The key points to come out of this judgment are that:

• medical practitioners must take reasonable care to ensure that a patient understands the material risks of having surgery and are satisfied that the information has been understood. This is particularly so where language barriers exist; and
• even if a misunderstanding exists with respect to what the patient believes to be the case and what the medical practitioner has said, this does not automatically equate to a breach of duty of care.

Background

Ms Sandra George (the plaintiff) was a Macedonian speaker with a poor understanding of English. She underwent an operation at St Vincent’s Hospital to remove a tumour which was located on her acoustic nerve.[2] The operation was performed following consultations involving interpreters. The first two consultations occurred at a clinic held in Moree ran by St Vincent’s Hospital. On these two occasions, a friend translated for the plaintiff. The latter two consultations were held at St Vincent’s Hospital in Sydney and an accredited interpreter assisted. The specific involvement of the appellant in these consultations will be discussed further below.

During the surgery, an adjoining facial nerve was severed resulting in the plaintiff suffering from facial palsy.[3] In 2012, the plaintiff commenced proceedings in the District Court of NSW claiming damages for negligence against the surgeon, Dr Neil Biggs and St Vincent’s Hospital, on the basis that the hospital was vicariously liable for the actions of its employees. The allegations were: [4]

• that there was a failure to warn of the risk of damage to the facial nerve when operating to remove the tumour, being the risk which eventuated in this instance; and
• that the operation was carried out negligently.

At trial, Levy DCJ found that there was a failure to warn of the risk and awarded Ms George $331,000 in damages.[5] The decision was appealed to the Court of Appeal.  The issues for determination on appeal were:

• the content of the duty of care owed by a medical practitioner in warning a patient of the risks associated with a surgical procedure and whether this duty was correctly articulated at trial;
• whether adequate warnings had in fact been given; and
• whether there was a failure in communication and whether that materially affected the plaintiff’s decision to have the operation.

Scope of duty of care

When discussing the duty of care owed by the medical practitioners involved in the care of the plaintiff, the trial judge relied on the established principles as set out in the High Court decision of Rogers v Whitaker [6] where it was held that “except in cases of emergency or necessity, all medical treatment is preceded by the patient’s choice to undergo it” a choice which is “in reality, meaningless unless it is made on the basis of relevant information and advice”. [7]

In this case, the issue was whether the specific risk of facial nerve palsy was communicated to the plaintiff “in terms which are reasonably adequate” [8] for the purpose of informing the choice to be made by the patient, “having regard to the patient’s apprehended capacity to understand that information”. [9]

The trial judge established that there were two issues for determination in relation to duty of care:

• Did the plaintiff establish that, during the consultations prior to the operation, a medical practitioner had not communicated the nature and extent of the risk of injury to her facial nerve, and if injured, the potential consequences? [10]
• If she did not establish that fact, did she establish that, in attempting to communicate, the medical practitioner had failed to take reasonable steps to ensure that she understood the information being portrayed given the language barrier? [11]

The trial judge set out a 16-step consent process to be followed in order for medical practitioners to comply with the duty to convey relevant information. The appellants submitted that the 16-step process “constituted an ideal, rather than a practical statement of the content of the duty”. [12] They also argued that the 16 steps imposed an “onerous obligation on a medical practitioner to be affirmatively satisfied as to the patient’s comprehension of the information being conveyed”. [13]

Basten JA of the Court of Appeal held that these complaints were justified and confirmed that: [14]

A correct statement of the content of the duty would have involved no more than that the medical practitioners were to take reasonable care to ensure that the material risks attending the surgical procedure were conveyed to the claimant.

Basten JA therefore overturned the onerous consent process placed on medical practitioners by the trial judge. However, he did comment that it may also be necessary for practitioners to satisfy themselves that the substance of the information conveyed to the patient had been understood. [15]

Breach of duty of care

The plaintiff had four consultations concerning her condition over a 7-month period. The first consultation occurred with Professor Fagan on 6 March 2009 at a clinic in Moree. The plaintiff gave evidence that she attended this consultation with Mr Madjistorov who spoke English a little better than her. She said that she understood from Professor Fagan that she had a brain tumour, that it was “very bad”, and could be removed by an operation. [16]

The second consultation occurred with Dr Biggs on 3 April 2009. Mr Madjistorov also attended this appointment with the plaintiff. The trial judge accepted that when the plaintiff left this consultation, she was still under the misunderstanding that she had a tumour in her brain that required removal. [17]

The third consultation occurred with Dr Biggs on 14 October 2009. On this occasion, the plaintiff attended St Vincent’s Hospital. She signed a consent form which included the statement that Dr Biggs had explained to her the nature, likely results and material risks of the surgery. Dr Biggs also signed the form. [18] An interpreter was present for this consultation. It was held that: [19]

Where a medical practitioner conducts a consultation with a patient using an interpreter accredited in her language, it will only be in unusual circumstances that any “interpreting issues”, forming the basis for a breach of duty on the part of the practitioner, will arise.

Basten JA went on to say that there would be difficulties with the admissibility of evidence from the interpreter confirming whether the plaintiff had in fact understood what had been explained to her.

The fourth consultation occurred on 30 October 2009 with Dr Mukherjee at a pre-operative clinic. During cross-examination, Dr Mukherjee confirmed that she understood that Dr Biggs had already explored “the various treatment options and their respective advantages and disadvantages”. [20]

The evidence given by the plaintiff may have allowed for a conclusion that there was a misunderstanding on the part of the plaintiff, “but the evidence failed to demonstrate affirmatively that there had been a breach of the duty of care, properly articulated”. [21]

Therefore, the appellants were able to establish that they had warned the plaintiff of the material risks of the surgery despite the language barrier that existed. The fact that a misunderstanding occurred did not amount to a breach of duty.

Causation

Under s 5D(1) of the Civil Liability Act 2002 (NSW), for causation to be established, it is necessary for the court to find “that the negligence was a necessary condition of the occurrence of the harm”. In this case, that required a finding as to what the plaintiff would have done if the practitioners and the hospital had not in fact been negligent. [22]

The question posed by s 5D required consideration as to whether the plaintiff would have had the operation but for the breach of duty. Basten JA stated that to “exclude other powerful operative causes which were not the result of a breach of duty by the hospital, was wrong as a matter of law”. [23]

There were several factors accepted by the plaintiff as being instrumental in her decision to proceed with the surgery. These included the belief that she had a brain tumour, that although the tumour was benign it may turn malignant, and her family history of cancer. [24]

These beliefs held by the plaintiff were due to miscommunication, and therefore, it was held that any failure to warn was not causative of her loss. Consequently, causation was not established.

Conclusion

On appeal, the judgment of the District Court was set aside and the plaintiff was ordered to pay the appellants’ costs of both the trial and the appeal. [25]

Payne J added that the duty upon the appellants required that reasonable care be taken to impart information in “terms which are reasonably adequate for that purpose having regard to the patient’s apprehended capacity to understand that information”. [26] The approach of the trial judge in identifying 16 steps said to be relevant in the duty of care in this case “impermissibly extended the scope of the relevant duty”. [27]

This case acts as a reminder that medical practitioners have a duty to take reasonable steps to convey the material risks of any surgery to their patients. However, the case confirms that if there has been a misunderstanding, it will not necessarily constitute a breach of duty on behalf of the medical practitioner.

Written by: Robert Crittenden, Principal. First published in Lexis Nexis Australian Civil Liability journal, August 2016.