Pang Ah San v Singapore Medical Council

• Jurisdiction: Singapore
• Judgment Date: 29 November 2013
• Date: 29 November 2013
• Docket Number: Originating Summons No 799 of 2012
• Court: High Court (Singapore)

Pang Ah San

Plaintiff

and

Singapore Medical Council

Defendant

[2013] SGHC 266

Sundaresh Menon CJ

,

Chao Hick Tin JA

and

V K Rajah JA

Originating Summons No 799 of 2012

High Court

Professions—Medical profession and practice—Professional conduct—Patient suffered stroke and required permanent tube feeding—Doctor recommended and gave innovative treatment he developed instead of standard treatment—Whether Disciplinary Committee (‘DC’) erred in law in convicting doctor based on surgical ‘treatment’ he provided, when particulars of charge preferred only related to that part of cl 4.1.4 of Singapore Medical Council's Ethical Code and Ethical Guidelines on offering medicinal ‘remedies’—Whether DC erred in law in finding that procedure performed on patient was ‘not generally accepted’ by profession—Whether DC erred in fact in finding that procedure performed on patient was ‘not generally accepted’ by profession—Whether DC erred in law in finding that doctor's breach of cl 4.1.4 amounted to professional misconduct—Section 45 (1) (d) Medical Registration Act (Cap 174, 2004 Rev Ed) (before amendment on 1 December 2010)

The patient (‘the Patient’) suffered a stroke and required permanent tube feeding. The doctor (‘the Doctor’) recommended the use of the loop Percutaneous Endoscopic Gastrostomy (‘loop-PEG’) tube, which he developed, as a preferable alternative to the standard Percutaneous Endoscopic Gastrostomy (‘standard PEG’) in order to feed the patient. The Doctor then performed the loop-PEG procedure on the Patient. Soon after, the Patient's medical condition significantly deteriorated and she passed away 20 days later.

The Doctor was charged for providing treatment to the Patient that was not generally accepted by the profession and outside the context of a formal and approved clinical trial, in breach of cl 4.1.4 of the Singapore Medical Council's (‘SMC’) Ethical Code and Ethical Guidelines (‘the ECEG’) (‘Clause 4.1.4’).

The Disciplinary Committee (‘the DC’) of the SMC found that the Doctor, in using the loop-PEG tube on the Patient, had intentionally and deliberately ignored his ethical obligations enshrined in Clause 4.1.4. The Doctor appealed.

Held, dismissing the appeal:

(1) The offering of a particular remedy that was not generally accepted by the profession was prohibited by Clause 4.1.4, notwithstanding that the particular remedy was not capable of a ‘clinical trial’. The exception of a ‘formal and approved clinical trial’ functioned only as a limited exception, and did not limit the application of the proscription to only remedies that were capable of a ‘clinical trial’: at [27] .

(2) The Doctor could have applied for review and approval from the relevant Institution Review Board (‘IRB’) or ethics committees to conduct clinical trials. The term ‘clinical trial’ in the context of Clause 4.1.4 merely meant any trial which was ‘approved by an ethics committee’, which conformed to the ‘Good Clinical Practice Guidelines’, where applicable, and where ‘informed consent’ had been obtained from the patient. Clinical trials were not limited to drug trials, and could be conducted for new medical devices and new procedures: at [30] to [36] .

(3) Besides containing a scientific aspect, the concept of general acceptance had an empirical aspect. Where the overwhelming majority of the medical profession endorsed a certain treatment, this was prima facie evidence of general acceptance by the profession, particularly if this had been the case over a substantial period of time: at [50] .

(4) The expression ‘not generally accepted by the profession’ meant ‘not generally known or used’. This entailed an ex ante acceptance of the treatment by the profession (ie,positive act of acceptance), rather than a lack of rejection of the treatment by the profession (ie,positive act of rejection) or an ex post acceptance: at [54] .

(5) The underlying basis and guiding principle for labelling a particular treatment as being generally accepted was that the potential benefits and risks of that treatment and the ability to control these were approaching a level of predictability that was acceptable to the medical community in general: at [56] .

(6) A particular treatment would only be caught by the prohibition against offering innovative treatments in Clause 4.1.4 if that particular treatment was significantly different from the standard treatment that was generally accepted by the profession. Important factors in assessing whether a particular treatment was significantly different from the standard treatment were the increase in the amount of risks, the addition of new types of risks, and a significant increase in the degree of ignorance of the risks: at [57] .

(7) Flexibility in varying surgical techniques was a necessary part of surgical practice, and such variations should generally not be considered to be significantly different from the standard technique. Patients' access to treatment customised to suit their unique circumstances would not be so restricted, as long as the risks in the customised treatment were not significantly increased, or where there was insufficient evidence to assess the risks, the treatment was given as part of a one-off therapy (or an approved clinical trial): at [57] .

(8) In the present case, although the loop-PEG procedure involved a surgical procedure, what took centre-stage was the employment of the loop-PEG tube, a medical device. What was at the heart of the complaint was the whole concept of how this device was to operate in the Patient's body in place of the standard PEG. Therefore, the Doctor's argument referring to the flexibility inherent in surgical practice did not quite apply: at [58] .

(9) Therapy was defined as an activity that was undertaken with the primary purpose of benefiting the patient. Where the primary purpose of an activity was to generate new information or test a hypothesis, that activity would be considered research: at [62] .

(10) Therapy was excluded from the regulatory regime which provided for prospective review applicable to research. The protection of the interests of the patient undergoing treatment under therapy instead of research was ensured largely by post hoc regulation via the law of medical negligence and disciplinary proceedings: at [64] and [65] .

(11) The objective of distinguishing research from therapy was to identify an activity where there was a deviation between serving the best interests of the patient and the interests in developing generalisable knowledge. Prospective reviews for research were in place so that the researcher was not the sole judge of the ethical acceptability and scientific merit of a proposed programme of research: at [67] .

(12) If the experimental or innovative treatment in question was therapy administered in the best interests of the patient, it was exempted from the general proscription against ‘remedies that are not generally accepted by the profession’ in para 1 of Clause 4.1.4. The burden was on the doctor to prove on a balance of probabilities that the treatment in question was part of therapy administered in the best interests of the patient: at [68] .

(13) Where the standard treatment was likely to be wanting or ineffective, it might well be that the doctor's use of innovative treatments would likely be considered to be therapy, provided that it was shown to be in the best interests of the patient: at [72] .

(14) The DC was entirely correct in arriving at its conclusion that the loop-PEG procedure was ‘not generally accepted by the profession’. The loop-PEG was significantly different from the standard PEG because the loop-PEG had no bumper-bolster mechanism which ensured apposition of the stomach wall to the peritoneal surface of the abdominal wall. The loop-PEG procedure was ‘not generally accepted by the profession’ because there was no other medical literature available on the loop-PEG other than the articles written by the Doctor, the experts had never seen the loop-PEG device prior to their engagement, and the experts did not know of anyone else using the loop-PEG: at [78] and [79] .

(15) The loop-PEG procedure was given as part of research and not therapy. There was no compelling reason to offer the Patient the loop-PEG when the standard PEG would have sufficed. The Doctor seemed to be embarking on a research trial to establish a wider usage of a new procedure and device for general use, rather than customising treatment to suit the unique circumstances of the Patient: at [109] .

(16) The DC did not err in finding that the Doctor's breach of Clause 4.1.4 amounted to professional misconduct because the Doctor had intentionally and deliberately ignored his ethical obligations. In the absence of compelling reasons to administer the loop-PEG procedure on the Patient, the fact that the Doctor honestly believed in the efficacy of his innovative treatment and that the treatment was in the interest of the Patient should not be relevant to the issues of whether the treatment was generally accepted by the profession or whether the breach of the ECEG was intentional or deliberate: at [118] , [124] and [126] .

[Observation: The IRB played an important role in the ethical governance of research. However, IRBs should not be held legally responsible for any unintended consequences arising from the employment of innovative treatment. It was the researcher/doctor who should be wholly responsible: at [37] and [70] .

Where the doctor had doubts as to whether an innovative treatment would constitute research or therapy, and where the standard treatment had not been shown to be ineffective or where urgent treatment was not required, it would be prudent to seek the approval of the IRBs if seeking such approval was not impracticable: at [69] .]

Gobinathan Devathasan v Singapore Medical Council [2010] 2 SLR 926 (folld)

Khoo James v Gunapathy d/o Muniandy [2002] 1 SLR (R)...