Pang Ah San v Singapore Medical Council

• Jurisdiction: Singapore
• Judge: Sundaresh Menon CJ
• Judgment Date: 29 November 2013
• Neutral Citation: [2013] SGHC 266
• Court: High Court (Singapore)
• Docket Number: Originating Summons No 799 of 2012
• Year: 2013
• Published date: 02 January 2014
• Hearing Date: 03 May 2013
• Plaintiff Counsel: Gregory Vijayendran, Lester Chua, and Jason Gabriel Chiang (Rajah & Tann LLP)
• Defendant Counsel: Melanie Ho, Chang Man Phing, Sim Mei Ling, and Chang Qi-Yang (WongPartnership LLP)
• Subject Matter: PROFESSIONS,Medical profession and practice,professional conduct
• Citation: [2013] SGHC 266

V K Rajah JA (delivering the grounds of decision of the court): Introduction

These grounds relate to an appeal against the decision (“the DC Decision”) of the Disciplinary Committee (“the DC”) of the Singapore Medical Council (“the Respondent”), which found Dr Pang Ah San (“the Appellant”) guilty of professional misconduct for performing a loop Percutaneous Endoscopic Gastrostomy (“loop-PEG”) procedure on one Mdm Goh Lee Kheng (“the Patient”). The DC held that the treatment was not generally accepted by the profession outside the context of a formal and approved clinical trial, and that the Appellant had breached Clause 4.1.4 of the Singapore Medical Council’s Ethical Code and Ethical Guidelines (“the ECEG”) (“Clause 4.1.4”). We affirmed this decision.

This appeal raises some important issues relating to the use of innovative medical treatment in Singapore. When will offering innovative treatment without prior regulatory approval under the current regulatory regime be permissible? How does the current regulatory regime balance the need to ensure the safety of patients without stifling innovation which might benefit patients? What are the steps doctors should take to comply with the existing regulatory framework?

A critical challenge faced by the medical community today is the insidious trespassing of commercial priorities into the healthcare delivery system. This may sometimes give rise to an evaluative bias in favour of treatment or remedies that elevate the interests of the medical practitioner over those of the patient. Left unchecked, this may over time erode patient trust and confidence in medical practitioners. However, medical practitioners also have a legitimate right to give appropriate levels of consideration to proper business considerations. Plainly, the right balance has to be struck between professional virtues and business considerations. On the one hand, the right incentives can spur medical innovation for the common good. Yet on the other hand, processes must be in place to guard against the siren call of financial incentives which may potentially cloud the doctor-innovator’s evaluation of the risks and benefits of administering an innovative treatment. Situations may arise where the interests of the doctor-innovator may even conflict with the patient’s best interests. This potential pitfall is exacerbated by medical uncertainty, information asymmetry, and patient vulnerability. Clearly, technical competency alone is merely a pre-condition to maintaining the trust of patients and society. Ethical codes and guidelines marking out the boundaries of professional practice must also be adhered to. Medical ethics benchmark professional values and standards, and thereby distinguish practices which are acceptable from those which are not. To uphold high standards of practice within the medical profession and maintain public confidence in the medical profession, the Respondent has the vital role of formulating and enforcing ethical standards on professional medical practice and standards of behaviour for the common good. In these grounds, we are concerned specifically with Clause 4.1.4 and the issue of permissible innovative treatment. We will be using the terms “doctor” and “medical practitioner” interchangeably. We use the term “treatment” in general to mean treatments which are administered solely for the benefit of the patient, administered solely for a research objective, and administered for a mixture of both purposes.

The facts

The Appellant is a general surgeon of 26 years’ standing, and has run a surgical practice at Mount Alvernia Medical Centre for the last 18 years. He specialises in general surgery, in particular, surgery of the gastrointestinal tract, and has performed numerous gastrostomy and laparotomy procedures, including 50 standard Percutaneous Endoscopic Gastrostomy (“PEG”) procedures.

The Respondent is constituted under the Medical Registration Act (Cap 174, 2004 Rev Ed) (“the MRA”) and regulates the conduct of medical practitioners in Singapore.

The Patient was 84 years of age in 2008. She suffered a stroke and required permanent tube feeding. Ms Liew Swee Fong (“Ms Liew”), the Patient’s daughter-in-law, sought advice from the Appellant, who recommended the use of the loop-PEG tube as a preferable alternative to the standard PEG in order to feed the Patient. After receiving the consent of the Patient’s family, the Appellant then carried out the loop-PEG procedure on the Patient on 7 July 2008. The Patient was discharged two days later. Soon after, the Patient’s medical condition significantly deteriorated and she passed away 20 days later.

On 8 August 2008, two of the Patient’s children, Mr Tan Kwang Chuan and Mdm Tan Sok Hia, made a complaint to the Respondent via a joint statutory declaration. After several exchanges of letters between the Appellant and the Complaints Committee (“CC”), the CC determined that a formal inquiry should be held by a DC.

A Notice of Inquiry was issued against the Appellant. The Appellant 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 Clause 4.1.4. The Notice of Inquiry served on the Appellant stated as follows:

That you, Dr Pang Ah San, a registered medical practitioner, did between 7 July 2008 and 9 July 2008 at Mount Alvernia Hospital provide treatment to Mdm Goh Lee Kheng (the “Patient”) that was not generally accepted by the profession outside the context of a formal and approved clinical trial, in breach of Clause 4.1.4 of the Singapore Medical Council’s Ethical Code and Ethical Guidelines (the “ECEG”).

Particulars (i) Clause 4.1.4 of the ECEG provides, amongst other things, that a doctor shall not offer to a patient remedies that are not generally accepted by the profession except in the context of a formal and approved clinical trial; (ii) On or about 30 June 2008, you recommended the insertion of a “loop” percutaneous endoscopic [gastrostomy] tube (a “Loop PEG Tube”) for the Patient; (iii) The Loop PEG Tube was a novel device in that it differed from the normal percutaneous endoscopic [gastrostomy] tube both in terms of design as well as in terms of the method of insertion, and was therefore not a device that was generally accepted by the profession; (iv) Accordingly, the pre-operative procedures and protocols, the insertion of the Loop PEG Tube as well as the post-procedure treatment and protocols all ought to have been carried out only in the context of a formal and approved clinical trial; (v) You failed to inform the Patient of the novel nature of the Loop PEG Tube prior to obtaining her consent for the surgery. In particular, you failed to inform the Patient that she would be one of the first few patients in the world to have a Loop PEG Tube inserted; (vi) On 7 July 2008, you, together with Dr Chia Siew Cheng, performed surgery on the Patient to insert a Loop PEG Tube, and you did so outside the context of a formal and approved clinical trial; (vii) Following the insertion of the Loop PEG Tube, you, together with Dr Chia Siew Cheng, provided post-operative care and monitoring of the Patient outside the context of a formal and approved clinical trial,

and that in relation to the facts alleged, you have been guilty of professional misconduct within the meaning of Section 45(1)(d) of the Medical Registration Act (2004 Rev Ed.) (Cap. 174, the “Act”).

[emphasis in original in bold]

Dr Chia Siew Cheng (“Dr Chia”), the Appellant’s wife, who assisted in the procedure on the Patient, was also similarly charged, but was acquitted by the DC.

The DC inquiry was held over eight days. The witnesses that were called to give evidence at the inquiry were as follows: For the Respondent: Mr Tan Kwang Chuan, the Patient’s son; Mdm Tan Sok Hia, the Patient’s daughter; Ms Liew, the Patient’s daughter-in-law; and Professor Ti Thiow Kong (“Prof Ti”), the Respondent’s expert witness. For the Appellant: The Appellant (“Dr Pang”); and Professor Teo Eng Kiong, an editor of the Singapore Medical Journal (in respect of whom Dr Pang issued a subpoena). For Dr Chia: Dr Chia; and Dr Francis Seow-Choen (“Dr Seow-Choen”), Dr Chia’s expert witness.

At this point, we think it is appropriate to elaborate on the procedures concerned. For a helpful description of the standard PEG procedure, we refer to the Appellant’s article, published in Pang A S, “A new feeding tube which is secure and easy to change” Singapore Medical Journal 2009; 50(7): 740–742, at 740:

Loss of a normal swallowing reflex as in dysphagic stroke is the commonest indication for long-term tube feeding. For this, either the nasogastric tube or the percutaneous endoscopic gastrostomy tube is used, with the former being uncomfortable. …

...

Most medical and nursing societies recommend the gastrostomy (G) tube for long-term tube feeding. The G tube passes directly to the stomach through the anterior abdominal wall. ... The G tube has been in existence for more than a century. There are many insertion methods, broadly classified as surgical, laparoscopic, radiological and endoscopic. The endoscopic method is the most popular today because it is simple, safe and requires only local anaesthesia. A G tube inserted by the endoscopic method is commonly called a percutaneous endoscopic gastrostomy (PEG).

The PEG has been in routine use, worldwide, for about 30 years . Clinical experience has found the pull-method of PEG to be safe, producing a stoma that fits the tube snugly, with a low risk of leakage. ...

[emphasis added in italics and bold italics]

We refer to the same article for a general description of the loop-PEG procedure at p 741:

A third-generation (3G) tube manufactured by SGN Pte Ltd, Singapore, and marketed under the brand LOOPPEG™...