Health Care Complaints Commission v Le

NCAT Occupational|2025-02-25|Before: Ainslie-Wallace AM

Background

The Respondent was first registered as a medical practitioner in 1992 and was made a fellow of the Royal Australian College of General Practitioners in 1998. At the material times, he owned and consulted from BHC Medical Centre in Lakemba NSW and consulted at Campsie Healthcare Medical Practice.
The complaints arise from the Respondent's use of a treatment for eczema known as "Clark Compound" (CC cream) which was developed by him in about 2000. There was no dispute that CC cream is not approved under the Therapeutic Goods Act 1989 (Cth) (TGA) nor is it regarded as a conventional treatment for skin conditions. It has not been subject to clinical trials.
CC cream contains as active ingredients merbromin, also known as mercurochrome, which is a topical antiseptic, and terbinafine hydrochloride, a topical anti-fungal treatment. The cream also contains a sub-therapeutic amount of a steroid. There are four different formulations of CC cream: "standard" which contains 0.43% of merbromin, "concentrated" which contains 0.86% merbromin, "AV" which contains curcumin instead of merbromin, and "Herbal" which contains St John's Wort instead of merbromin.
The Respondent manufactures CC cream in his rooms and sells tubes containing the cream to his patients for whom he has prescribed it for their skin conditions.
The Complaint related to three patients all of whom the Respondent treated by application of CC cream; Patient A, a 32 year old woman, Patient B who was 12 months old when his parents first brought him to the Respondent and Patient C who was 7 years old.
The Respondent denied the alleged unsatisfactory professional conduct and professional misconduct.

Patient B

Patient B was 12 months old when he first attended the Respondent and had, in the first five months of his life spent about 6 weeks as an inpatient of the Children's Hospital Westmead for treatment of erythroderma. When his parents first brought him to see the Respondent, he was still being managed by the dermatology outpatient clinic of that hospital. The Respondent had 11 consultations with the child between 14 August 2020 and 24 December 2021 while at the same time the child continued to attend appointments at the dermatology clinic. Over the period of his treatment of Patient B, the Respondent prescribed CC cream in various strengths.
On 21 November 2021, a doctor from the dermatology unit of the Children's Hospital Westmead having been shown the CC cream prescribed by the Respondent for Patient B, rang the Respondent to express his concerns about possible mercury toxicity through the use of the CC cream. Blood test results for Patient B showed a high level of mercury in his blood, 343 nmol/l, where the normal range for blood serum mercury is less than 60 nmol/l. The Tribunal noted that after being contacted by the doctor at the Children's Hospital Westmead, the Respondent ordered blood tests for Patient B and did not cease prescribing CC cream for Patient B but continued the use of the cream for another 6 weeks until the blood test results became available.
At no time during his treatment of Patient B did the Respondent speak to or attempt to liaise with the dermatology team at the Children's Hospital Westmead. The Respondent said that he did not because the Hospital had not referred the child to him and did not tell him that he remained under their care. The Respondent added that he did not need to know what treatments the Hospital had tried for Patient B because clearly, they had not worked which was why the child's parents came to him.
We repeat here what was said in the earlier judgment: "[131] Dr Young [The Peer Reviewer] said: … I am highly critical of Dr Le using an unresearched mercury containing compound for over twelve months in an infant leading to raised mercury levels that infant [Patient B], and with a clear demonstrated drop in these levels when the CC was ceased. This evidence supported by toxicologist Associate Professor Naren Gunja in his letter dated 7 August 2023 (Tab 11) who states that the elevated mercury level was due to the application mercury based skin cream to non-intact skin. 132. We cannot help but agree. Here, the Respondent, having been notified of concerns about mercury toxicity in this little boy both by the parents and in a phone call from the treating dermatologist at the Children's Hospital at Westmead, did not immediately stop using the cream, did not apparently tell the parents about the risks of its continued use and prescribed the cream in its concentrated form because 'the parents were happy to continue' using it. 133. When asked why he continued to prescribe the cream for use after being notified of the concern for mercury toxicity, the Respondent said that, in his opinion, the benefits of using CC cream outweighed the risks of mercury toxicity."
In relation to Patient B, the Tribunal found that the Respondent failed to conduct an adequate and appropriate assessment of Patient B at the initial consultation, and inappropriately prescribed CC cream to treat the Patient's severe eczema where there were other, evidence based alternatives available which did not carry the risk of mercury toxicity. The Tribunal also found that the Respondent failed to obtain adequate and appropriate informed consent from Patient B's parents before prescribing CC cream in circumstances where CC cream was not TGA approved nor a conventional treatment for eczema; failed to appropriately liaise with the dermatology team at the Children's Hospital Westmead and prescribed CC cream which contained mercury where there was no evidence that it was safe for use in children and where the risks of mercury toxicity were well known.

Patient C

Patient C was 7 when his parents brought him to see the Respondent on 15 October 2021.
At the first consultation, the Respondent noted that the child had inflamed excoriated patches over his whole body, some weeping. He indicated infected eczema. The Respondent prescribed CC cream to be applied: "generous amount of Clark Compound to the rash, itchy skin, rough skin areas, ie affected areas three times a day". Over the time of his consultation with Patient C, the Respondent prescribed CC cream in various strengths.
At the time of his prescription of CC cream to Patient C, the Respondent had received a report dated December 2021 which contained the following (emphasis added): "Reviews assert that the foetal development in utero and the development of infants early in life are at particular risk of poisoning from methylmercury (Bose-O'Reilly et al., 2010); a concern heuristically generalised to other organic mercuries. … In the interest of caution, it would be advised that infants, and pregnant or breastfeeding women avoid topical merbromin. It is surprising that this restriction is not placed on the existing merbromin product available in Australia, unless some data has been provided to the regulator which could allay our concerns …"
The Respondent was in possession of this report when Patient C was under his care. Days before he first saw Patient C, the Respondent had been informed of the mercury toxicity in Patient B's blood serum. When blood tests were performed on Patient C at the Children's Hospital Westmead, they revealed that as at 15 February 2022, he had serum mercury levels of 79 nmol/L.
The Respondent said in his evidence to the Tribunal that he "thinks" he advised Patient C's parents about the risks of elevated mercury levels through using CC cream. There is nothing in the notes which suggests the parents were advised.
When the concerns about possible mercury toxicity in Patient B were brought to his attention by the dermatologist at the Children's Hospital Westmead, the Respondent said that he would continue to prescribe CC cream but would monitor patients by blood tests. He did not have any blood tests conducted on Patient C.
Neither when he received the results of Patient B's serum mercury levels nor when he received the report from NICM Health Research Institute, did he stop prescribing CC cream for Patient C.
Dr Young, the Peer Reviewer said at [161] of the earlier judgment: "I believe a competent GP would have changed their prescribing to avoid harm on learning that a treatment caused raised mercury levels. In Dr Le's case, being the manufacturer of the cream, ceasing the cream's manufacture would have been appropriate. He did not consider the balance of benefit and harm in a clinical-management decision. Dr Le's continued use of CC Cream after the discovery that his paediatric patient [Patient B] had an elevated serum mercury was medically negligent - he risked harm and injury to future patients."
The Tribunal found the particulars of the Complaint in relation to Patient C made out, namely that the Respondent inappropriately prescribed CC cream where it was not clinically indicated, failed to appropriately manage Patient C's itchiness, a symptom of eczema, inappropriately continued to prescribe CC cream in the knowledge that another of his paediatric patients had an elevated serum mercury level following the use of CC cream and knowing the risks of mercury toxicity, failed to refer Patient C to a dermatologist where the patient's condition had not improved.
In relation to his treatment of the three patients, the Tribunal found the Respondent's conduct amounted to unsatisfactory professional conduct. In relation to his treatment of Patients B and C the Tribunal considered the Respondent's conduct amounted to professional misconduct.
We repeat here the Tribunal's reasons: "[221] In relation to Patient B the Tribunal points to Respondent's conduct in failing to liaise with the dermatologists at the Children's Hospital Westmead to determine what treatments had been tried, in failing to obtain any documentation from that hospital, in particular the biopsy report and in continuing to prescribe CC cream to Patient B where there was no evidence that it was safe to use in children and after being told of concerns about mercury toxicity is, of itself, of such seriousness as to amount to professional misconduct. [222] Equally, in relation to Patient C, to prescribe CC cream for him knowing of the serious concern of mercury toxicity in the Patient B's blood, and in not informing the parents of that risk nor in ordering blood tests, this too amounts to professional misconduct. [223] The Respondent's single minded and unswerving belief that CC cream could succeed where other mainstream treatments had failed is reflected in his treatment of Patient A where there is no evidence that he discussed with her what, if any previous treatments she had used on the lump, that he did not obtain her informed consent to use his cream and when the area around the lump became itchy after using the cream, did not stop and consider whether the continued use of the cream was appropriate. [224] Further it caused him to not offer or recommend those mainstream treatments for these patients but discouraged his patients from using them in preference for using CC cream which had no scientific basis that it was effective amounts to professional misconduct."
Complaint 2 contended that the Respondent's prescribing and compounding conduct amounted to unsatisfactory professional conduct. In short, it alleged that the Respondent: 1. Continued to prescribe CC cream after receiving the blood test results showing high levels of mercury in Patient B's blood (Particular 1); 2. Failed to disclose his financial interest in the sale of CC Cream (Particular 2); 3. Breached the Medical Council of NSW's Complementary Health Care policy by failing to ensure that his prescription of CC cream did not discourage the use of evidence based treatment and in failing to provide patients with an objective account of the risks, benefits, efficacy and cost of CC cream (Particular 3); 4. Failed to comply with the Pharmacy Board of Australia and Medical Board of Australia's joint statement on compounded medicines because there were other appropriate products available and there was insufficient evidence to support the cream's intended use (Particular 4); and 5. Breached the Therapeutic Goods Regulations 1900 (Cth) by manufacturing the cream in bulk (Particular 5).
The Respondent admitted this particular. In April 2017, the Respondent had been advised that he could not manufacture cream in bulk and that a therapeutic substance could only be manufactured for a patient extemporaneously and that the substance had to be labelled in a particular way. Notwithstanding this advice, the Respondent continued to manufacture the CC cream in bulk amounts.
This Complaint was established.
It is against this background that we turn to consider what protective orders should flow from our findings.
Disciplinary proceedings are subject to well established objects and principles. First, s 3 of the National Law says that the scheme of national registration and accreditation of medical practitioners is to provide for the protection of the public by ensuring that only health practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered. Section 3A provides that the protection of the health and safety of the public must be the paramount consideration in exercising the functions under a NSW provision.
It is well established that the protection to which the sections speak is not limited to past or potential patients but includes protecting the public from similar misconduct or incompetence as well as upholding public confidence in the high standards of the medical profession.
Meagher JA described the exercise of disciplinary powers in Health Care Complaints Commission v Do [2014] NSWCA 307 at [35] "The objective of protecting the health and safety of the public is not confined to protecting the patients or potential patients of a particular practitioner from the continuing risk of his or her malpractice or incompetence. It includes protecting the public from the similar misconduct or incompetence of other practitioners and upholding public confidence in the standards of the profession. That objective is achieved by setting and maintaining those standards and, where appropriate, by cancelling the registration of practitioners who are not competent or otherwise not fit to practise, including those who have been guilty of serious misconduct. Denouncing such misconduct operates both as a deterrent to the individual concerned, as well as to the general body of practitioners. It also maintains public confidence by signalling that those whose conduct does not meet the required standards will not be permitted to practise."
In Prakash v Health Care Complaints Commission [2006] NSWCA 153 at [91] Santow JA said that the orders not only protect and maintain high standards but: "…There is also an element of deterrence or, to put it more positively, encouragement to other practitioners to recognise the importance of complying with professional standards and the risks of failing to do so."
In Director-General, Department of Ageing, Disability and Home Care v Lambert [2009] NSWCA 102 at [83] Basten JA said: "As is well-established in the disciplinary jurisdiction generally, including with respect to legal and medical practitioners, the specific purpose for which orders are made is protective in the public interest and is not punitive with respect to the individual: That is not to deny that such orders may be punitive in effect, a matter which may have particular significance in respect of the privilege against self-incrimination: Nor does it necessarily follow that punitive effects may not be relevant in formulating a protective order. For example, the fact that there are such punitive effects may remind the Court that a protective order should be limited to that which is reasonably necessary to provide the required level of public protection (reference to weighing the punitive effects in the balance should be understood in context as limited to the purpose identified here). Further, the punitive effects may be directly relevant to the need for protection. Thus, in a particular case, there may be a factual finding that the harrowing experience of disciplinary proceedings, together with the real threat of loss of a livelihood may have opened the eyes of the individual concerned to the seriousness of his or her conduct, so as to diminish significantly the likelihood of its repetition. Often such a finding will be accompanied by a finding that the person concerned has achieved a level of insight into his or her own character or misconduct, which did not previously exist." (citations omitted)

Protective Orders

The Commission seeks orders that the Respondent be suspended for six months and that a reprimand be recorded on his registration. The Commission further sought that when the Respondent returns to practice after the period of suspension, his registration be subject to the following conditions: "1. To obtain Medical Council of NSW approval prior to changing the nature or place of practice; 2. Not to manufacture, compound or prescribe compounded substances; 3. Not to possess, supply (including manufacture or compound) administer, prescribe any substance containing merbromin or mercurochrome including derivatives; 4. The Practitioner is not to treat or manage any dermatological condition for any patient. (a) In the event that a patient presents with a dermatological condition, the practitioner must refer the patient for management to another medical practitioner for treatment and management. (b) Within 7 days of the end of each calendar month, the practitioner is to provide the Council wit a record of all patients presenting with a dermatological condition. The record must include: i The date and time of the consultation ii The first name and surname of the patient iii The date of birth of the patient iv The nature of the consultation v The details of the presenting dermatological condition vi The full name and registration number of the medical practitioner to whom the patient was referred to (sic)".
Condition 5 requires the Respondent to submit to an audit of his medical records within 6 months or his return to practice and thereafter as required by the Medical Council. The purpose of the audit is to assess the Respondent's compliance with good medical record keeping standards, legislative requirements and compliance with conditions.
Conditions 6, 7 and 8 relate to the provision of information to the Medical Council, the Council being the appropriate review body in relation to the imposed conditions and the application of the imposed conditions.
The Respondent consented to the order for suspension of his registration and the recording of a reprimand on his registration. He did not object to the imposition of the conditions proposed by the Commission save for Conditions 2 and 4.

Condition 4

In support of Condition 4, the Commission submitted that the evidence in the Stage 1 hearing demonstrated that the Respondent's future practise should be subject to conditions and in particular that he should not be permitted to treat patients with dermatological conditions.
The Commission referred to the Respondent's use of CC cream in preference to orthodox and TGA approved treatments, including his use of CC cream containing merbromin. The Commission submitted that the evidence before the Tribunal at the Stage 1 proceedings supports a finding that the Respondent was unswervingly of the opinion that CC Cream was appropriate to prescribe, even in young children, in the face of information that it was not safe and that belief in the efficacy of his product clouded his professional judgment.
While the Respondent maintained CC Cream had been subject to and verified by scientific research, the report from the NICM Health Research Institute made it clear that it tested the cream only for skin sensitivity rather than potential toxicity. In fact, it was in this report, of which the Respondent had a copy, that warned against use of the cream on children and other vulnerable people because of the risk of mercury toxicity, a risk which it is acknowledged, eventuated.
Further it was argued that the Respondent persisted in prescribing CC cream for Patient A in the face of her deteriorating condition while explaining her failure to improve based on the Patient's conduct rather than acknowledging that the CC cream was not effective and in failing to try other treatments.
The Respondent did not try and demonstrated a lack of confidence in conventional treatments for the patients referred to in the complaint, preferring to use his CC cream. His lack of apparent confidence in conventional treatment such as steroid cream, was demonstrated in his patient consent form and its clear preference for CC cream over steroid treatment.
The Respondent did not refer the three patients to whom the complaint refers to specialists when the application of CC cream had not improved their conditions.
The Commission further argued that the Respondent, having been cautioned against bulk production of the cream and advised that the cream should be compounded at the time of its provision to the particular patient, continued to produce the cream in bulk to provide to his patients.
Finally, it was submitted that the Respondent preferred to prescribe his own cream to his patients which provided a financial gain to him and which he did not disclose.
In short, the Commission submitted that the Respondent's conduct leads to serious concerns about his management of patients with dermatological conditions and that his belief in the efficacy of his own devised cream clouded his judgment and management of the patients to which the complaint refers. It was also argued that the Respondent demonstrated no insight into the effects of his conduct on the welfare of the patients and, it was suggested, he persisted in asserting CC cream's efficacy to treat skin conditions.
The Respondent argued that the imposition of Condition 4 would render a crushing blow to his practice given that a number of his patients came to him for the specific purpose of his treating their skin conditions. Of the Respondent's current patients, 25 to 30% of those attending seek treatment for skin conditions and of those some 40 to 50% are children. It is the Respondent's position that if he was prevented from treating a dermatological complaint it might lead to him being unable to treat skin conditions which are incidental to a serious illness which might need immediate treatment.
In the alternative to the proposed Condition 4, the Respondent proposed that to have his practice audited and that the auditor: "… pay particular attention to: Management of skin conditions and consent for skin treatments Benefits, side effects, risks and other mainstream treatment options available being discussed with patients. …"
It was argued that this condition would have the effect of providing for the health and safety of the public without preventing the Respondent from offering treatment for skin conditions.

Condition 2

The Respondent opposed the making of Condition 2, namely that he not manufacture, compound or prescribe compounded substances, arguing that it was a necessary part of general practice to be able to do so.
While it might be a part of general practice, it is a condition which, in the Tribunal's view, is necessary to be imposed on the Respondent.
Following the s 150 Panel hearing, a condition was imposed on the Respondent's registration that he not possess, supply (including manufacture or compound) administer, prescribe any substance containing merbromin or mercurochrome including derivatives. It is not suggested that the Respondent failed to comply with the condition, however the Respondent compounded several formulations of CC cream which did not contain merbromin, which he continued to prescribe and sold to his patients who, he said, preferred it to orthodox skin treatments. While not attended by the spectre of mercury toxicity, the CC cream was, according to the Peer Reviewer's report, more expensive than an equivalent cream readily available from pharmacies. Those creams had not been subject to testing and were not TGA approved.
The Respondent's compounding of CC cream was also in breach of the Pharmacy Board of Australia and Medical Board of Australia's Joint statement on compounded medicines, that is that there was an appropriate commercial alternative product available and where there is insufficient evidence to support the cream's intended use based on recognised therapeutic standards. Further, the Respondent created the creams in bulk contrary to clear indication from a representative of the Pharmaceutical Unit of NSW Health in which he was counselled that he was not to manufacture cream in bulk.
Counsel for the Commission argued that if Condition 2 was not imposed, it is likely that the Respondent would compound another product of his own creation for the treatment of skin conditions for his patients in preference to conventional treatments.
There is considerable force in this submission. We will impose Condition 2 on the Respondent's registration.

Consideration

There is no doubt that the Respondent's treatment of the three patients to which the Complaint refers fell significantly below the accepted standard, and, as we have found, in relation to Patients B and C, that conduct was of such a serious nature as to amount to professional misconduct.
However, we do not agree that Condition 4 is necessary for the protection of the health and safety of the public. We reach that conclusion because the Respondent has agreed to Condition 3 being imposed on his registration, that is, that he not possess, supply (including manufacture or compound) or administer any substance containing mercurochrome or merbromin which, in conjunction with Condition 2, will prevent the Respondent from compounding and using any other substance for the treatment and management of skin conditions. We are thus satisfied that the health and safety of the public will be protected from further conduct such as that to which the Complaints relate without the need to impose Condition 4.
It is necessary to impose Condition 5, consented to by the Respondent, to enable Medical Council oversight of the conduct of the Respondent's practice. However, in all of the circumstances the Tribunal considered that it is appropriate that in addition to the matters to be covered by the audit for which the Commission contends, that the auditor also considers the Respondent's management of skin conditions, consent for skin treatments and his advice to patients as to the benefits, side effects and risks of proposed treatment and mainstream treatment options available.

Orders

The Tribunal will thus make the following orders: 1. Pursuant to s 149C(1)(b) of the Health Practitioner Regulation National Law (NSW) (National Law) the Respondent's registration as a medical practitioner be suspended for a period of six months from the date of publication of these orders. 2. Pursuant to s 149A(1)(a) of the National Law, the Respondent is reprimanded. 3. On return to practice following the period of suspension, the following conditions are imposed on the Respondent's registration: 1. To obtain Medical Council of NSW approval prior to changing the nature or place of practice; 2. Not to manufacture, compound or prescribe compounded substances; 3. Not to possess, supply (including manufacture or compound) administer, prescribe any substance containing merbromin or mercurochrome including derivatives; 4. To submit to an audit of his medical practice, by a random selection of his medical records by a person or persons nominated by the Medical Council of NSW and: 1. The audit is to be held within 6 months of the recommencement of practice and subsequently as required by the Council; 2. The auditor is to assess the Respondent's: 1. compliance with good medical record keeping standards, 2. legislative requirements 3. compliance with conditions 4. management of skin conditions and consent for skin treatments 5. discussion with patients of the benefits, side effects, risks of proposed treatment and the availability mainstream treatment options. 1. To authorise and consent to any exchange of information between the Medical Council of NSW and Medicare Australia and Pharmaceutical Services Unit for the purposes of monitoring compliance with these conditions. 2. The Medical Council is the appropriate review body for the purposes of Part B Division 8 of the National Law. 3. Sections 125 to 127 of the National Law are to apply whilst the Respondent's principal place of practice is anywhere in Australia other than in New South Wales, so that a review of these conditions can be conducted by the Medical Board of Australia. 1. The Respondent pay the Commission's costs as agreed or assessed under clause 13 of Schedule 5D of the National Law.

I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales. Registrar DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 04 March 2025

Breached the Therapeutic Goods Regulations 1900(Cth)

REASONS FOR DECISION

On 29 October 2024, Dr Tuan-Anh Le (the Respondent) was found guilty of unsatisfactory professional conduct pursuant to s 139B of the Health Practitioner Regulation National Law (the National Law) and guilty of professional misconduct pursuant to s 139E of the National Law: Health Care Complaints Commission v Le [2024] NSWCATOD 171.
The Respondent elected to have the Complaint brought by the Health Care Complaints Commission (the Commission) heard in two stages, namely whether the Complaints were established and, if so, in a second stage, what protective orders should flow from the Tribunal's findings.
These reasons assume knowledge of the Tribunal's decision cited above however some brief background assists as context for the Tribunal's consideration and the orders made.

At a glance

Court

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Judgment (10 paragraphs)

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Legislation Cited (3)

Cases Cited (4)