A Matter of Informed Consent

Other issues included the value placed on evidence of usual practice where there was inadequate support for it, and the benefit of good clinical record keeping.

Case history

Mrs George, a 63-year-old Macedonian lady living in Moree was diagnosed in late 2008 with a right-sided acoustic neuroma. After a series of consults with medical practitioners and hospital staff, she underwent surgery to remove the tumour in November 2009. During the procedure, she suffered an injury to her seventh cranial nerve resulting in permanent facial paralysis.

An ENT team from St Vincent’s Hospital conducted clinics in Moree. Mrs George had been referred to the clinic by her General Practitioner after experiencing hearing loss and problems with balance. She attended two consultations at this clinic – one in March 2009 with Professor Fagan and a second with Dr Biggs in April 2009. Mrs George asked to have a Macedonian translator present as her understanding of English was limited, but this did not occur. Mrs George was accompanied to the consultations by a friend. Unfortunately for Mrs George, her friend’s understanding of English was not much better than her own. Further appointments (pre-admission and pre-anaesthetic clinics) were conducted at St Vincent’s Hospital with the assistance of trained interpreters, in person and by telephone.

Medico-legal issues

It was alleged that both Dr Biggs and St Vincent’s Hospital were negligent in that they had failed in their duty to properly inform her of the risks of the procedure; and further, had she been properly informed of the nature of her condition, options and risks, specifically facial paralysis, she may not have undergone the procedure. Dr Biggs and St Vincent’s Hospital (as employer of other staff involved in Mrs George’s care) held that facial nerve damage was an inherent risk of the procedure that she had been warned of and therefore she would have, in any event, proceeded with surgery.

When does the consent process start?

At the clinic visit in March 2009, Mrs George acknowledged she was told she had a tumour. However, her evidence was that it was a “very bad” tumour located in her brain and that she required surgery. The records of Professor Fagan indicated the information meant to be conveyed to Mrs George about the tumour was very different.

The Court held that this appointment, while not part of the actual consent process, formed the basis upon which Mrs George was to make decisions about her care and treatment. The medical records and letter back to her GP contained evidence of the discussion, but did not include evidence of Dr Fagan assessing Mrs George’s understanding of her situation. He stated that his usual practice was to be guided by the reactions of the patient and this acted like a filter and allowed him to amend how and what information he provided to the patient.

The Court held that relying on usual practice in this instance was not ideal as the situation was not routine. There were clearly language issues and additional care should have been taken in communicating with the patient, especially because of an untrained interpreter. Importantly, it was stressed that using an untrained interpreter provided no opportunity for the medical practitioner to assess what the patient understood.

The Court outlined the recognised risks of using an untrained interpreter as follows:¹

• there were likely to be significant misunderstandings with regard to history, symptoms, diagnosis and treatment, especially risks
• the more complex the situation, the greater the scope for misunderstandings
• filtering, playing down what is said, altering and censoring of content was likely to occur
• cultural factors would invariably impact on communication.

The Court confirmed that obtaining consent is a fluid process which consists of a sequence of discussions.² Therefore the second consultation in April 2009 was considered to have commenced a more formal consent process.

Mrs George, again accompanied by her friend as interpreter, advised Dr Biggs that she wanted to undergo surgery. Dr Biggs recalled his usual practice was to inform the patient of the risks of surgery, including injury to the facial nerve. Mrs George alleged that Dr Biggs did not inform her of options for conservative treatment or the risks associated with surgery. Significantly, there were no written records of Dr Biggs’ consultation with Mrs George or a letter back to her GP. Dr Biggs stated that from his reading of Professor Fagan’s medical records, the risks had been discussed with Mrs George.

The Court held that in the absence of any records of the consultation, Mrs George’s recollection of events was to be believed over the recall and reliance of Dr Biggs on usual practice, including taking any steps to confirm the patient’s understanding of her condition and treatment.

Attendance at St Vincent’s Hospital

Mrs George attended St Vincent’s Hospital in October 2009 for her pre-admission clinic. A trained interpreter was arranged. Evidence about the discussion or the notes provided by the interpreter did not provide any clarity about the nature of the discussions with Mrs George. The notes of that appointment were made by a resident medical officer. They indicated some discussions, but included errors. Dr Biggs stated he had made a hurried visit to the clinic to obtain consent from Mrs George; however, Mrs George alleged she had not seen Dr Biggs that day. Again, there were no notes of any interaction between her and Dr Biggs or of any discussion.

The Court held that this appointment, especially as a trained interpreter had been arranged, was the ideal opportunity for Dr Biggs and the hospital staff to take the time to thoroughly discuss with Mrs George her illness, treatment options and risks. The Court also held that a brief visit to the clinic to obtain consent was not ideal, as obtaining consent was more than just signing a form.

Mrs George’s procedure was postponed due to the unavailability of ICU beds. She subsequently attended in late November 2009 for the surgery. Dr Mukherjee conducted a consultation with Mrs George via a telephone interpreter. The notes from that consultation indicated there was mention of risks, but this was not a detailed discussion. The Court held that it was definitely not too late at this point to take steps to clarify Mrs George’s understanding of her condition and treatment, including other options.

Conclusion

From the evidence presented on the issue of consent, the Court found that Dr Biggs and St Vincent’s Hospital had breached their duty to properly inform Mrs George because:

• language issues were obvious from the outset
• the medical practitioners should have recognised the risks of using an untrained interpreter
• these risks were a major factor which would, and did, impair consent discussions
• reliance on “usual practice” in the circumstances was far from adequate.

For a medical practitioner to discharge their duty to obtain valid informed consent, it is vital that:

• where language issues are evident or arise, steps are taken to facilitate discussion with the assistance of a trained interpreter
• discussions must include explanations of the illness/condition, treatment options, and the risks associated with those options and of not having treatment
• discussions must include an opportunity for the patient to ask questions and discuss any material risks.

Engaging a trained interpreter early in the process ensures that a thorough history can be obtained, appropriate information can be imparted, and the patient’s understanding can be assessed and confirmed prior to instigating any treatment. In doing so, the practitioner enhances the therapeutic relationship, provides good clinical care and reduces the likelihood of complaints, disciplinary proceedings and negligence claims.

Allyson Alker
Senior Risk Adviser
MDA National

1. George v Biggs & St Vincent’s Hospital [2015] NSWDC 11 at [532].
2. George v Biggs & St Vincent’s Hospital [2015] NSWDC 11 at [474].