There is, and has been, a lot of confusion regarding the degree to which doctors can enjoy ‘free will’. By that I mean the degree to which doctors can make choices. It could be argued from a very simplistic perspective that medicine, as a science, should be focused on limiting choice and aiming for a more clearly defined and directed response when presented with a health challenge. We realise, however, that in medicine it is dangerous to overly simplify and, considering the art of medicine, we tend to try and create a holistic, therapeutic, environment for as many patients as possible.
What has emerged over the last thirty years is a field called Evidence Based Medicine (EBM) where attempts are made to collect and collate multiple sources of data to determine and predict intervention and response in clinically related conditions. Inevitably the law has become involved, and one of the most important questions concerns the legal standing of guidelines derived from EBM.
Because of liability issues there is a reluctance to make clinical practice guidelines (CPG) statutory requirements; that is to say, guidelines are ‘suggestions’, not ‘instructions’. And why is this important to this case? Let me jump to the processes of the law for a moment. One of the key steps to be taken before a criminal trial is to formally notify the defendant of the nature of the crime(s) they are supposed to have committed: this is the indictment. This is the formal written statement of what crimes have been committed. In the case of Dr Vanessa Kwan, the initial indictment was an extraordinary document. One of the reasons for this is the completely flawed assumption that it appears there is a misunderstanding in legal circles that following guidelines is a ‘duty of care’ and not following them, particularly when associated with a poor outcome, is evidence of a failure of duty of care.
This was one of the most egregious examples of Dr Phoebe Mainland abusing the trust and responsibility placed on her by the High Court in Hong Kong. Dr Mainland, falsely, stated that the Hong Kong Academy of Medicine Guidelines in Procedural Sedation (2009) were mandatory guidelines for all registered medical practitioners in Hong Kong. They are not, and whilst the intention of developing these guidelines was noble enough, the manner of forming them further supports the conclusion that they have no value in law. These were not consensus guidelines, formulated on the basis of the best objective evidence, by the stakeholders. No, these were a set of guidelines developed by a specialty to promote patient safety but also to try and limit control and use of a very important drug, propofol.
Let me remind you of the initial indictment against Dr Kwan:
- It is alleged the Dr Kwan “unlawfully killed” Lee Kar-yin, Josephine, by gross negligence in that:-
- As the registered doctor in charge of the procedure of liposuction performed on Madam Lee, she owed her a duty of care.
- In breach of that duty of care, Dr Kwan failed to take reasonable care for the safety of Madam Lee, by:
- failing to ensure the presence of a properly qualified person to administer and monitor sedation when the said liposuction procedure was performed,
- failing to ensure sufficient oxygen supply during the sedation,
- failing to follow the “Guidelines on Procedural Sedation” on the Hong Kong Academy of Medicine.
- failing to provide proper and sufficient monitoring after the procedure
- failing to provide adequate timely resuscitation to Madam Lee
- Her “aforesaid breach of duty amounted to gross negligence on her part and
- Her aforesaid negligence was a substantial cause of the death of...” Madam Lee.
When it was pointed out that there was no legal basis for a) and c) above, the legal games began, and rather than accepting the fallacy of the charges, the prosecution doubled down and expanded the indictment by extracting specific parts of the guidelines as evidence of failure of duty of care.
“The defendant’s breach of duty of care as framed in the indictment.
There were five main particulars of breach as pleaded in the indictment.
They were as follows:
(ii) In breach of that duty of care, (the defendant) failed to take reasonable care for the safety of the said LEE Kar-ying, Josephine, by:-
(a) Failing to ensure the presence of a properly qualified person to administer and monitor sedation when the said
liposuction procedure was performed to the said LEE Kar-ying, Josephine;
(b) Failing to ensure sufficient oxygen supply to the said LEE Kar-ying, Josephine, during sedation;
(c) Failing to follow the paragraphs 3.3.1 to 3.3.3, 3.3.7, 3.4, 4, 5.1 to 5.3, 220.127.116.11 to 18.104.22.168, 7.3, 7.5, 10 and 11.2
of the “Guidelines on Procedural Sedation” of the Hong Kong Academy of Medicine endorsed by the Hong
Kong Academy of Medicine Council on 22 December 2009 when she was responsible for conducting the
liposuction procedure for the said LEE Kar-ying, Josephine;
(d) Failing to provide the said LEE Kar-ying, Josephine, with proper and sufficient monitoring after the liposuction procedure; and
(e) Failing to provide adequate timely resuscitation to the said LEE Kar-ying, Josephine;
What I found particularly disturbing is that the Court was informed, without any equivocation, that the guidelines had no statutory significance. This was not a case of factual evidence leading to a conviction of guilt: it was the case of a highly unethical “expert”, making false claims, on the basis of guidelines that were created by an understandably biased group for political purposes. That is not how the Law should function.
Clinical Practice Guidelines must be informed by Evidence Based Medicine. That is their strength but also a limitation. What can be said is that in Hong Kong, in 2014, there were no enforceable guidelines related to procedural sedation. Hong Kong needs such guidelines, but they need to be properly formulated; consensus, guidelines followed by all stakeholders.
- Campbell, A and Glass, K.C. The legal status of clinical and ethics policies, codes, and guidelines in medical practice and research. McGill Law J 2000;46:473-89.
- Rosoff, A.J. Evidence-based medicine and the law: the courts confront clinical practice guidelines. J of Health Polit Policy and Law 2001;26(2);327-368.
- Ash Samanta, Jo Samanta, Joanne Beswick. Responsible practice or restricted practice? An empirical study of the Use of Clinical Guidelines in Medical Negligence Litigation, Med Law Rev Volume 2021;292(2):205–32.
- Sykes L.M, Evans W.G, Dullabh H.D. Negligence versus malpractice: the “reasonable man rule" South African Dental J 2017;72(9):430-2.