Health Care Complaints Commission v Bright

NCAT Occupational|2019-09-30

Introduction

These reasons are in respect of five complaints brought by the Health Care Complaints Commission (HCCC) against Dr Ralph Bright (the practitioner) in an application filed in the Tribunal in January 2019.
Although the practitioner was originally legally represented in the proceedings, and a Reply was filed on his behalf, in August 2019, his solicitors advised that they were instructed to cease acting, that the practitioner would not file any material in the proceedings, nor would he attend the hearing. The matter proceeded by way of tender of documents and submissions made by counsel for the HCCC. None of the HCCC's witnesses, and in particular the four expert witnesses, were required for cross-examination. As foreshadowed by his solicitor, the practitioner did not appear or participate in the hearing. Other than the Reply, no material was filed by or on his behalf.
The complaints agitated by the HCCC fall into two discrete areas. The first area relates to the practitioner's prescribing of compounded peptide preparations, and the second, to his administration of stem cell therapy. An ancillary complaint deals with the inadequacy of the practitioner's record keeping. The stem cell complaints deal with treatment of two patients. One patient was an elderly woman with a diagnosis of dementia. This patient died on the day of her treatment. The second patient received treatment which was experimental and had no known efficacy or benefit for the patient's condition of bilateral vestibular dysfunction (BVD). The practitioner's peptide prescribing was for three patients, and for himself.

Background

The practitioner obtained the degrees of MB.BS from the University of Otago, New Zealand in 1974.
On 14 June 1974, the practitioner was first registered in Australia.
Between 1978 and approximately 2000, the practitioner engaged in general practice.
From 2000, until he surrendered his registration on 31 August 2019, the practitioner engaged in cosmetic practice with the bulk of the work undertaken by him in 2016 being liposuction and fat transfer.
On 9 November 2012, the practitioner performed stem cell therapy on Patient E. Patient E sought treatment to help improve or to treat his BVD.
On 20 December 2013, the practitioner performed stem cell therapy in his surgery on Patient D, a 75 year old woman with a diagnosis of dementia. Later that day, on return to her nursing home, Patient D died.
On 19 October 2016, the Medical Council of NSW (the Council) received a complaint about the practitioner from the Director, Pharmaceutical Regulatory Unit, Legal and Regulatory Services Branch, NSW Ministry of Health about the practitioner's prescribing of peptides for three patients and himself.
Following a hearing under s 150 of the National Law on 30 August 2016, the practitioner's registration was made subject to conditions including a condition limiting his ability to practise stem cell therapy to new patients presenting for treatment of osteoarthritis, or new patients participating in research approved by a Human Ethics Research Committee; and existing patients returning for injection of stored cells for the treatment of osteoarthritis. The practitioner was required to practise under Category C supervision of the Medical Council of NSW (the Council) supervision policy. The practitioner was also required to submit to an audit of his practice.

The issues

In light of the practitioner's non-appearance at the hearing or the lack of filing of any material other than the Reply, our first task was to determine on the material tendered by the HCCC, whether every particular of the complaints was established on the evidence. We were then required to determine whether the conduct established was unsatisfactory professional conduct and/or professional misconduct.
Also requiring determination was whether it was appropriate to provide a period of seven years before the practitioner may again apply for registration.

The relevant provisions of the National Law and legal principles

We commence our recording of the relevant provisions of the National Law by setting out s 3A. Section 3A provides as follows: 3A Objective and guiding principle [NSW] In the exercise of functions under a NSW provision, the protection of the health and safety of the public must be the paramount consideration.
These proceedings are brought under Part 8 of the National Law. Conduct which may constitute unsatisfactory professional conduct includes the conduct set out in s 139B. In this case the HCCC relies on s 139B(1)(a), (b) and s 139B(1)(l) of that section. The relevant provisions are: 139B Meaning of "unsatisfactory professional conduct" of registered health practitioner generally [NSW] (1) Unsatisfactory professional conduct of a registered health practitioner includes each of the following - (a) Conduct significantly below reasonable standard Conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of the practitioner's profession is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. (b) Contravention of this Law or regulations A contravention by the practitioner (whether by act or omission) of a provision of this Law, or the regulations under this Law or under the NSW regulations, whether or not the practitioner has been prosecuted for or convicted of an offence in respect of the contravention. … (l) Other improper or unethical conduct Any other improper or unethical conduct relating to the practice or purported practice of the practitioner's profession.
The HCCC assert that the conduct in which the practitioner engaged is unsatisfactory professional conduct of such a serious nature that it justifies the suspension or cancellation of the practitioner's registration and constitutes professional misconduct. Professional misconduct is defined in the National Law as follows: 139E Meaning of "professional misconduct" [NSW] For the purposes of this Law, professional misconduct of a registered health practitioner means - (a) unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or (b) more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration.
The primary purpose of protective orders made at the conclusion of proceedings is to protect the public, not to punish the practitioner (see Clyne v NSW Bar Association [1960] HCA 40; (1960) 104 CLR 186).
The HCCC bears the onus of proof in these proceedings. The particulars of the complaint must be established to the civil standard (on the balance of probabilities) to the level of satisfaction described in Briginshaw v Briginshaw [1938] HCA 34; (1938) 60 CLR 336.
Consideration of what constitutes unsatisfactory professional conduct and professional misconduct for the purposes of the National Law is explained by Basten JA in Chen v Health Care Complaints Commission [2017] NSWCA 186 at [20]-[21] as follows: There is no category of unsatisfactory professional conduct which is not capable, depending on the circumstances, of giving rise to professional misconduct and hence engaging the power of either suspension or cancellation of registration. The only requirement is that it be "sufficiently serious" to justify such an order, a characterisation which must depend upon an evaluative judgment made by the Tribunal. Some, perhaps all, categories include conduct which may reveal a defect of character as to which the Tribunal may conclude that the person should not be allowed to practise his or her profession unless at some future date the practitioner is able to satisfy the Tribunal that the defect has been overcome. Incompetence or inadequate care may in some circumstances be remediable by specific steps; in other circumstances the Tribunal may be concerned that the carelessness, for example, is such as to cast doubt on the suitability of the person to practise medicine. Each of the criteria for cancellation or suspension may be analysed in this way. Each case will depend upon an evaluative judgment to be made by the Tribunal as to the nature and seriousness of the conduct. It follows that the legislative scheme is inconsistent with the implication of the abstract condition sought to be imposed by the practitioner on the language of s 149C(1). Finally, in determining whether to suspend the practitioner's registration or cancel it, it is entirely appropriate for the Tribunal to take into account the consequences of the order being considered. Unless a period of suspension is made conditional, renewal of the practitioner's registration will occur automatically on completion of the period of suspension. By contrast, an order of cancellation will require the practitioner to justify re-registration. Uncertainty as to the future may lead the Tribunal to cancel a registration rather than suspend it. [footnotes omitted]

Particulars alleged

This prescribing complaint is in respect of three patients of the practitioner who are identified as Patient A, B, and C, and in respect of the practitioner's self-prescribing.
The particulars in relation to Patient A, a 42 year old male who suffered from pudendal neuralgia, are that he was prescribed compounded peptide preparations, and other substances in circumstances which: 1. were not in accordance with recognised therapeutic standards, contrary to cl 34 of the Poisons and Therapeutic Goods Regulation 2008 (the PTG regulation); 2. due to a lack of clinical trials, contra-indications were unknown; 3. the recommended dose and quantity were unknown.
It is also alleged that the practitioner failed to conduct an appropriate assessment of Patient A prior to prescribing the peptides, and that he failed to obtain an informed consent before prescribing.
In a Reply, dated 20 March 2019, signed by his then solicitor, the practitioner does not admit the facts and allegations in respect of Patient A and "further says there were no recognised therapeutic standards as alleged in para 1(a)".
Patient B, is described as a 50 year old female who, in about September 2013, was diagnosed as suffering motor neurone disease. She consulted the practitioner between December 2013 and January 2015.
The particulars in respect of Patient B, in broad terms, are similar to those alleged in respect of Patient A, but also include a particular of a failure to properly monitor the effects of prescribing the peptides.
The practitioner's Reply in respect of this patient is identical to his response in respect of Patient A. He specifically asserts there were no "recognised therapeutic standards".
Patient C was a 50 year old female with advanced osteoarthritis in both knees.
The particulars alleged in respect of Patient C are identical to those in respect of Patient B.
The practitioner's Reply in respect of Patient C is identical to his response to Patients A and B.
The particulars alleged in respect of the practitioner's self-prescribing of peptides are, in broad terms, identical to those of the other patients. However, there is also a particular that the practitioner inappropriately self-prescribed various Schedule 4, Schedule 4D and Schedule 8 drugs contrary to the Medical Board of Australia's Good Medical Practice: A Code of Conduct for Doctors in Australia 2014 and the Guideline for self-treatment and treating family members, Medical Council of NSW, published 2 December 2014.
In his Reply, the practitioner admits the facts in paras 12 and 14 of the complaint. However, he does not admit his self-prescribing was inappropriate. He further states "the Code of Conduct and Medical Council's guidelines are not mandatory and do not have force of law".

Further matters in the Practitioner's Reply

The practitioner denies that he is guilty of unsatisfactory professional conduct in respect of the matters set out in Complaint One. While the practitioner does not admit his conduct in respect of Complaint Two constitutes unsatisfactory professional conduct, he admits the background facts pleaded in respect of this complaint but not the facts and allegations in paras 1, 2, 3 and 4 relating to Patient D. Patient D is the aged patient who suffered dementia and who died after stem cell therapy administered by the practitioner.
The practitioner admits Complaint Three (the record keeping complaint). As we later briefly explain, we are satisfied this admission is properly made.
The practitioner does not admit he is guilty of unsatisfactory professional conduct in respect of Complaint Four. This complaint deals with Patient E, who the practitioner purported to treat with stem cell therapy for BVD and/or osteoarthritis. He asserts the primary purpose of the treatment was for osteoarthritis, not BVD and he denies there is no clinical evidence demonstrating the safety and effectiveness of stem cell therapy for the treatment of osteoarthritis.
The practitioner does not admit he is guilty of professional misconduct.

Expert evidence

The HCCC relied on a report of Professor John Carter, a highly credentialed endocrinologist in respect of Complaint One.
In his written submissions, Mr C Mitchell, counsel for the HCCC, very helpfully set out the relevant opinions expressed by Professor Carter in respect of each of the peptides prescribed by the practitioner for the patients and himself. At para 48 he notes "Professor Carter provides an overview of IGF-1-LR3, CJC- 1295 and SARM LGD-4033 in his report."
We note that Professor Carter opines that the only clinical indication for IGF-1-LR3 is its use as a replacement therapy for patients with IGF-I deficiency. He also opines that there are no accepted standards in terms of dose or duration for prescribing for muscle growth. Professor Carter states there is no stated rationale by the practitioner for his prescribing and this pharmaceutical is not appropriate because of the lack of supportive clinical data. There are contra-indications to the prescribing of IGF-1-LR3, namely glucose intolerance, including diabetes.
Professor Carter also explains that the safety, quality and efficacy of the peptide, CJC-1295 has not been established, and because of the lack of clinical data, there are no therapeutic standards for its prescription. Professor Carter opines that the prescribing of the peptide is contra-indicated in persons with diabetes or glucose intolerance, carpal tunnel syndrome and oedema. He further opines there are no clinical trials which support the use of CJC-1295 for improving pudendal nerve function.
Similar opinions are expressed by Professor Carter about the safety, quality and efficiency of SARM LGD-4033 in clinical situations in normal adults. He also explains that, by reason of the lack of clinical data, it is not possible to identify definite contra-indications to the peptide. He opines the reasons for prescribing identified in the practitioner's notes (tender hamstrings and muscle weakness) are unacceptable.
Professor Carter explains that the drugs prescribed were expensive, with raw materials sourced from China (with an inability to verify the quality of ingredients) and the products were compounded in pharmacies where the standards of compounding are not regulated by the Therapeutic Goods Administration (TGA). It is Professor Carter's view that peptides should only be prescribed by a practitioner having the level of training and expertise of an experienced clinical endocrinologist.
Professor Carter opines that the practitioner did not prescribe for Patient A for an appropriate therapeutic purpose and that his conduct in so doing fell significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience (the standard).
It is also Professor Carter's opinion that, in the absence of clinical trials, there were definite contra-indications to prescribing IGF-1-LR3, CJC-1295 and SARM LGD-4033 for Patient A, and that the practitioner did not record potential contra-indications. He also found the practitioner's conduct was significantly below the expected standard because he prescribed peptides for the patient where the appropriate dose was unknown.
Professor Carter is critical of the practitioner's failure to conduct a full examination and to take a comprehensive history before prescribing. He further finds that the practitioner failed to obtain a proper written consent from the patient, including an acknowledgment of the lack of the proven efficacy of the peptides, as well as potential side effects. Professor Carter explains the need for written consent in respect of CJC-1295 by reason of the lack of proven efficacy of this peptide and its potential for side effects.
We note the first particular relied on by the HCCC is where the practitioner's prescribing of the peptides was in circumstances where: a. the purpose for prescribing was not in accordance with recognised therapeutic standards, contrary to clause 34 of the Poisons and Therapeutic Goods Regulation 2008 ("the PTG regulation).
No copy of the relevant regulation was included in the evidence relied on by the HCCC. We observe that clause 34 is in the following terms: 34 Quantity and purpose of prescriptions to be appropriate An authorised practitioner must not issue a prescription for a restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances. Maximum penalty - 20 penalty units or imprisonment for 6 months, or both.
We note that the expression "restricted substance" is not defined in s 3 of the Regulation. However, cl 32 enables a medical practitioner to prescribe a "restricted substance". A list of prescribed restricted substances is found in Appendix D to the Regulation. Professor Carter's report does not address which, if any, of the peptides prescribed fell within the class defined in the Regulation. We note that the Therapeutic Goods Administration (TGA) has not approved CJC, GHRP6, SARM, IGF1LR3 and melanotan II for any clinical indication, but they are available as S4 prescription only medications listed in Appendix D of the TGA's Poisons Standard. The prescribed restricted substances in the NSW Regulation include some, but not all, the substances prescribed by the practitioner. Further, we note in respect of each peptide, Professor Carter says that due to lack of clinical trials, there are no therapeutic guidelines. We note this is a similar position to that taken by the practitioner in his Reply.
On a plain reading of particular 1(a), the expert evidence does not support a finding that it is established. It appears what is meant to be asserted is that the practitioner prescribed the peptides in circumstances where there were no therapeutic standards and therefore his prescribing was below the standard reasonably to be expected. We are not satisfied that the particular is established in respect of this patient, or in respect of any other patients and the practitioner.
However, we agree with and adopt Professor Carter's opinion that the contra-indications to the peptides prescribed is generally unknown due to lack of clinical trials. We also accept his opinion about the lack of evidence to support a recommended dose.
The absence of detailed notes infers that the practitioner did not conduct a proper assessment of Patient A before prescribing peptides. We rely on Professor Carter's view in finding this particular established. We also take into account the practitioner's admission that his medical records did not comply with the Regulation in force from time to time Our examination of the medical records discloses that there is no written consent form, nor do the notes document a discussion about the peptides or their efficacy for Patient A's condition.
We also accept Professor Carter's opinion that the practitioner failed to take adequate steps to obtain informed consent in writing from Patient A prior to prescribing the peptides, including that the patient acknowledged he knew of the lack of proven efficacy of the peptides, and had received advice about and understood the potential side effects.
We note that Patient B, a particularly vulnerable patient with a terminal diagnosis of Amyotrophic Lateral Sclerosis (also referred to as Motor Neurone Disease), provided a signed generic consent form for stem cell therapy. However, the records contain no discussion about risks and benefits, if any, of the peptides prescribed for her or any informed consent to the prescribing of GHRP-6. Accordingly, we adopt Professor Carter's opinion that no proper informed consent was obtained from this patient.
Our examination of the medical records of Patient C leads to identical findings to those in respect of Patient B.
We turn then to our examination of the evidence relevant to the practitioner's self-prescribing. We commence by noting that particular 12(b) is not established for the same reasons as discussed in relation to Patients A, B and C.
In his Reply the practitioner refers to the Good Medical Practice: A Code of Conduct for Doctors in Australia 2014 and the Medical Council of NSW's Guideline for self-treatment and treating family members but says the codes do not have the force of law.
The HCCC rely on Schedule A to the complaint to set out the details of the practitioner's prescribing for himself, and Patients A, B and C. The schedule discloses, in 2013, the practitioner prescribed Melanotan for himself on two occasions. In 2015, and again in 2016, the practitioner is shown to prescribe SARM-S22 for himself on two occasions in each year. The schedule does not include Schedule 8 or Schedule 4D drugs prescribed by the practitioner for himself. However, the relevant prescriptions are found in the practitioner's own clinical notes. The records disclose the practitioner wrote many prescriptions for himself between 2013 and 2016. These include prescriptions in 2016 for Keflex, Codeine Linctus, Temazepam and Mogadon.
Professor Carter opines that the safety of Melanotan II, which the practitioner asserted he prescribed for sun protection, has not been proven in large clinical studies.
While we note that the practitioner asserts the Code of Conduct does not have the force of law, it is a policy issued under s 39 of the National Law. Its purpose is to provide practical guidance to medical practitioners in Australia. The Code stresses that practitioners should seek independent objective advice for their own medical care and highlights the need for practitioners to be aware of the risks of self-diagnosis. Section 3.14 of the Code explains the rationale behind the recommendation that, except in an emergency or very limited circumstances, a practitioner should not treat close friends or family. That rationale is self-evident. A practitioner is unlikely to be able to exercise the necessary objectivity and such prescribing may result in the possible discontinuation of care for the close friend or family member.
Professor Carter was, unsurprisingly, strongly critical of the practitioner's extensive self-prescribing. He found the practitioner's conduct to be significantly below the expected standard. We agree with and adopt Professor Carter's opinion on this topic. We also accept, for similar reasons to those in respect of Patients A, B and C, that the practitioner's self-prescribing of peptides occurred in circumstances where there was a lack of clinical trials to support the prescribing as safe and efficacious and where contra-indications were unknown.
Mr Mitchell submits that we should also find that the practitioner's self-prescribing was improper and unethical.
The words "improper" and "unethical" appear in s 139B(1)(l). The Tribunal in Health Care Complaints Commission v Reid [2018] NSWCATOD 162 at [523]-[525] discussed the meaning to be attributed to the words as follows: The words "improper" and "unethical" are not defined in the National Law. The words have been considered in a number of cases in the Tribunal (see HCCC v Little [2016] NSWCATOD 146; HCCC v Liu [2016] NSWCATOD 133; HCCC v Perera [2018] NSWCATOD 112.) Reliance has been placed on the dictionary definition of "improper". That is, not in accordance with propriety of behaviour, manners etc or abnormal or irregular behaviour." Unethical is discussed in Perera by reference to the dictionary definition as follows: " Unethical " is defined in the Macquarie Dictionary as follows: contrary to moral precept; immoral. in contravention of some code of professional conduct.
We are satisfied that the practitioner's extensive self-prescribing of peptides was improper because of the lack of supporting clinical data. We are further satisfied his self-prescribing of Schedule 8 and Schedule 4 drugs was unethical. It was clearly in breach of the Code of Conduct which, although not having the force of law, provides clear and cogent guidance to medical practitioners. The practitioner's extensive self-prescribing was flagrantly in breach of the Code.
For the reasons enunciated above, notwithstanding our finding that particulars 1(a), 4(b), 8(c) and 12(b) are not established, having regard to the overall conduct, we are satisfied that the practitioner's prescribing demonstrated a lack of judgment or care exercised by him in the practise of medicine which was significantly below the standard reasonably expected of a practitioner of this practitioner's level of training and experience. We are satisfied Complaint One is proved.

Particulars alleged

Four particulars are relied on in respect of the practitioner's treatment of Patient D with stem cell therapy. We accept that the reference in particular 1 referring to Patient A is a typographical error.
It will be remembered that Patient D was a 75 year old woman who suffered from frontal lobe dementia, hypertension and atrial fibrillation. She resided permanently in a nursing home. Patient D's close relation, Person F, had undergone stem cell therapy in 2013 and contacted the practitioner seeking stem cell therapy for Patient D. Person F was Patient D's attorney under an Enduring Power of Attorney.
Patient D underwent stem cell therapy at the practitioner's practice (Macquarie Stem Cells) on 20 December 2013, and was discharged that evening to her nursing home. She died at about 7.45pm the same evening. An inquest was conducted before Deputy State Coroner Dillon. The Deputy State Coroner found Patient D died due to hypovolaemic shock following uncontrolled blood loss caused by mini liposuction stem cell procedure performed on her at the practitioner's practice.
It is not in dispute that Dr Norrie, Patient D's general practitioner, completed a patient medical history form on 21 November 2013 which disclosed that Patient D was taking aspirin as a blood thinner. Further, on 16 December 2013, a copy of Patient D's medication chart was faxed to the practitioner from her nursing home. The medication chart disclosed Patient D's medications included aspirin and krill oil daily.
The practitioner reported that he had a conversation with Patient D's relative, Person F, telling him that Patient D should cease the use of aspirin four days prior to the planned surgery. Person F had no recollection of this instruction. Patient D's nursing home records disclose that she took all of her medications on the morning of the surgery. No enquiries were made by the practitioner prior to commencing the stem cell procedure about whether Patient D had ceased taking her medication.
Patient D's records after the stem cell procedure disclosed her fluctuating blood pressure and heart rate. However, she was discharged between 5pm and 5.30pm. Person F expressed concern about Patient D and asked the registered nurse at the nursing home if Patient D should be taken to hospital. The nurse checked with the practitioner who, at about 6.45pm, said he did not think hospitalisation was necessary. The nurse again contacted the practitioner at 7.15pm. At that time, Patient D's blood pressure was 106/60 and her heart rate was 90 beats per minute. The practitioner indicated that Patient D's observations were satisfactory and she did not need to be taken to hospital. At 7.50pm the nurse was unable to rouse Patient D, who was observed to be cold with no pulse.

Expert evidence

The HCCC rely on expert evidence from Dr John Flynn (Dr Flynn). Dr Flynn holds the degrees of MB.BS and in 1986 became a member of the Royal Australian College of General Practitioners. In 1999 he became a Fellow of the Australasian College of Cosmetic Surgery. In 2004 he gained a Diploma of Lipoplasty, ACCS. Dr Flynn is currently engaged in full time cosmetic surgery practice.
The HCCC also rely on an expert report by Dr Christopher Juttner (Dr Juttner), a fellow of the Royal Australasian College of Physicians. Dr Juttner has extensive experience in stem cells, and between 2011 and 2014, was a Board Member of the National Stem Cell Foundation of Australia. Dr Juttner's report distinguishes between proven stem cell therapies and unproven ones. He provides extensive evidence about stem cell therapy. In relation to the use of stem cell therapy for osteoarthritis at page 18 of his report he notes: In my opinion it is difficult to be authoritative and certain whether stem cell therapy has been proven to be effective in osteoarthritis, but my view is that it has not been proven to be effective….
The HCCC further rely on a report of Professor Colin Masters, Laureate Professor of Dementia Research, Florey Institute and the University of Melbourne.
Laureate Professor Masters is highly critical of the practitioner's treatment of Patient D with stem cell therapy. He finds at para 3(b) of his report that "there is no evidence that parenteral (intravenous) stem cell therapy for Alzheimer's disease and dementia is safe", and goes on to note there is emerging evidence that the tissue derived stem cell therapy for degenerative conditions may be unsafe.
At para 5 of his report Laureate Professor Masters states: In my opinion, it was completely inappropriate and unethical to administer autologous adipose tissue-derived stem cells to [Patient D]. She was in an advanced stage of dementia, frail, and in poor general health (atrial fibrillation and urinary tract infections). As such she was at risk of an adverse outcome following such a procedure.
At para 6 of his report Laureate Professor Masters opines: …it was inappropriate for Dr Bright to perform this type of liposuction and infusion of autologous material in general, and specifically in this case of advanced dementia in a frail individual of poor general health, both because of the lack of scientific evidence of likely benefit, and also because of the high risk of an adverse outcome in this individual patient based on her poor general health. Dr Bright's conduct falls well below any standard of care expected of a practitioner of an equivalent level of training or experience.

Allegation of unsatisfactory professional conduct

This complaint is agitated under both s 139B(1)(a) and s 139B(1)(l) of the National Law.

Consideration

Particular 1 of this complaint asserts a lack of appropriate judgment by the practitioner where first, the procedure was experimental, and not conducted as part of a clinical trial, secondly, in circumstances where there was no reasonable chance of a successful outcome, and thirdly because Patient D was not a suitable candidate for the procedure, given her overall health and co-morbidities.
We commence by noting the findings of the Deputy State Coroner as the result of his inquiry into Patient D's death. In his reasons the Deputy State Coroner posed the question "Was it reasonable or appropriate to conduct that procedure?" (the stem cell procedure). Deputy State Coroner Dillon found: The reasonableness or appropriateness of applying this experimental procedural to [Patient D] is highly questionable. On the evidence available to me, it seems highly unlikely to have been significantly beneficial to [Patient D] even if she had lived. The operation is unproven scientifically. It has not been the subject of rigorous clinical trials in humans. It was described even by Macquarie Stem Cell's own literature as 'experimental' but the procedure was not conducted in accordance with protocols for the conduct of clinical trials or scientific experiments. No explanation is given in the materials supplied to the patient or to this court as to how the stem-cell therapy may work to improve serious brain lesions such as the Frontal Lobe Dementia from which [Patient D] suffered. As far as is possible to tell, Dr Bright appears to have no idea whether the procedure had any genuine therapeutic value for the treatment of brain lesions…. While all medical and surgical procedures necessarily start off experimentally, there is a world of difference between rigorously and ethically conducted clinical trials that are reviewed at every stage by qualified peers and this procedure, which, in relation to the treatment of dementia at least, has some of the troubling hallmarks of 'quack' medicine; desperate patients, pseudo-science and large amount of money being charged for unproven therapies.
In fairness to the practitioner, the Deputy State Coroner Dillon noted that the practitioner had not charged for this procedure, but had been prepared to accept a transfer of shares with an uncertain, if any, value.
We agree with and accept the Deputy State Coroner's conclusions as soundly based on the evidence before us. We are strongly in agreement with the opinion of Laureate Professor Masters. We are satisfied particular 1 is established.
Particular 2 relates to a lack of informed consent prior to the performance of stem cell therapy on Patient D.
In his submissions, Mr Mitchell notes first, that Patient D lacked capacity to provide consent. We accept that submission. It is confirmed by Person F's emails to the practitioner. Secondly, he refers to the consent form signed by Person F as not adequately describing the risks of the procedure including haemorrhage, death and depression of brain function.
The consent form signed by Person F was a generic consent form. It does not disclose the risks referred to by Mr Mitchell being the matters that Patient D suffered (haemorrhage and death). Further, we note that the background to the complaint refers to Person F having enduring guardianship. That asserted fact is contrary to the evidence before the Deputy State Coroner, and the consent form itself. The consent form refers to Person F's appointment under an Enduring Power of Attorney, not a Deed of Enduring Guardianship appointing Person F as guardian with the power to consent to medical decisions on behalf of Patient D. We note Person F's evidence before the Deputy State Coroner was that he did not have an appointment made by the Guardianship Division of this Tribunal. Further, it appears Person F was in fact an attorney under an Enduring Power of Attorney. Such a document is to deal with financial matters, not what are colloquially described as "lifestyle" decisions, and may include authority to give medical consents, as may be authorised under a Deed of Enduring Guardianship. It is clear from the evidence before the Deputy State Coroner the practitioner did not check Person F's authority to give the relevant consent.
The requirement that a patient be aware of a material risk and give an "informed consent" to a medical procedure is a fundamental well-known requirement (see Rogers v Whitaker [1992] HCA 58; (1992) 175 CLR 479) before such procedure.
We agree with and accept Dr Flynn's opinion that while the practitioner may have disclosed there was unlikely to be any benefit to Patient D, he did not advise Person F of the material risks associated with the procedure, given the patient's condition. We find that the "informed consent" process fell significantly below the expected standard.
It is convenient that we deal with particulars 3(a), (b), (c) and (d) of this complaint as well as particulars 4(a)-(d), as there is considerable overlap in the sub-particulars, and the expert evidence in respect of them.
In general terms, particular 3 asserts the practitioner failed to provide adequate pre-operative care and assessment to Patient D, in that he failed to examine Patient D on the day of surgery, relied on third party information about her health, did not undertake a proper pre-operative assessment including consideration of among other matters, her medications, and failed to inform himself on the day of the procedure whether she had ceased taking her regular medications. Particular 4 asserts the practitioner failed to provide adequate post-operative care and assessment of Patient D.
The HCCC rely on the expert report of Dr Flynn to establish particulars 3 and 4.
In his report, the Deputy State Coroner refers to a "cluster of errors" which led to the death of Patient D. Amongst the matters he identifies are: Third, the preparation for the procedure failed in fundamental respects. Fourth, there was no consultation between Dr Norrie, [Patient D's treating GP practitioner and Dr Bright about the patient or the procedure. Fifth, a basic error was made by Macquarie Stem Cells in failing to check [Patient D's] medication chart. Sixth, [Patient D's slow recovery and low blood pressure were not recognised by Dr Bright as signs of significant blood loss and risk of hypovolaemic shock. Seventh, she was prematurely discharged to the nursing home, rather than being taken to hospital for emergency treatment. Eighth, Dr Bright failed to give sufficient and proper weight to the concerns and personal knowledge of [Person F].
Dr Flynn, at para 6 of his report, opines that if the practitioner's intention was that aspirin should have been ceased before surgery, there should have been more effort to convey this to the GP, the nursing home staff and to Person F. He notes that aspirin should have "ceased 5-7 days before surgery".
Dr Flynn also opines that Patient D was a "poor selection for a risky procedure with no reasonable chance of success". He concludes that the failure to engage with Patient D's general practitioner was significantly below the standard expected.
At para 11 of his report, Dr Flynn reports on the post-operative care provided to Patient D. He concludes All things considered, it appears that observation on [Patient D] in recovery was sub-optimal and records are inadequate. Opportunities for referral to a hospital facility went unrealised. In my view this does not meet the expected standard and falls significantly below and invites strong criticism.
Dr Flynn also expresses the opinion that in "the physical circumstances" of Patient D, a transfer to hospital, rather than discharge to her nursing home, was warranted. He also opines there was sufficient information once Patient D had returned to the nursing home to recommend transfer to a hospital.
On all of the evidence before us, we find the particulars of Complaint Two are established. In reaching this conclusion, we find that the conclusions reached by the Deputy State Coroner on the evidence before him accurately summarise the failures of the practitioner's pre- and post-operative care of Patient D. We are fortified in our findings by the detailed report of Dr Flynn. We accept Dr Flynn's opinions in their entirety.
Dr Flynn's report is only addressed to issues arising under s 139B(1)(a) of the National Law. However, we are independently satisfied that the practitioner's administration of stem cell therapy on this frail, elderly patient, with no therapeutic basis, was improper and constitutes unsatisfactory conduct under both s 139B(1)(a) and s 139B(1)(l).

Particulars alleged

This complaint relates to a failure by the practitioner to comply with the Health Practitioner Regulation (New South Wales) Regulation 2016. During the hearing, we permitted the HCCC to amend the complaint where necessary to rely on the Health Practitioner Regulation (New South Wales) Regulation 2010 (the 2010 regulation). Each regulation is in substantially similar terms.
The practitioner in his Reply, admits Complaint 3.

The regulations

As noted in the HCCC's submissions, based on the 2016 regulation, cl 6(1) of the regulation provides that a medical practitioner must, in accordance with Parts 3 and 4 of the regulation, maintain a medical record in accordance with Schedule 4.
Schedule 2 of the 2010 regulation provides as follows: 1 Information to be included in record (1) A record must contain sufficient information to identify the patient to whom it relates. (2) A record must include the following: (a) any information known to the medical practitioner who provides the medical treatment or other medical services to the patient that is relevant to the patient's diagnosis or treatment (for example, information concerning the patient's medical history, the results of any physical examination of the patient, information obtained concerning the patient's mental state, the results of any tests performed on the patient and information concerning allergies or other factors that may require special consideration when treating the patient), (b) particulars of any clinical opinion reached by the medical practitioner, (c) any plan of treatment for the patient, (d) particulars of any medication prescribed for the patient. (3) The record must include notes as to information or advice given to the patient in relation to any medical treatment proposed by the medical practitioner who is treating the patient. (4) A record must include the following particulars of any medical treatment (including any medical or surgical procedure) that is given to or performed on the patient by the medical practitioner who is treating the patient: (a) the date of the treatment, (b) the nature of the treatment, (c) the name of any person who gave or performed the treatment, (d) the type of anaesthetic, if any, given to the patient, (e) the tissues, if any, sent to pathology, (f) the results or findings made in relation to the treatment. (5) Any written consent given by a patient to medical treatment (including any medical or surgical procedure) proposed by the medical practitioner who treats the patient must be kept as part of the record relating to that patient.
The record keeping complaint relates to the practitioner's asserted failure to keep adequate records for Patients A, B, C, D and the practitioner's own self-prescribing.
The HCCC rely on the opinions expressed by Professor Carter in support of this claim.

Consideration

In the table to his report, Professor Carter sets out his response to the question "Were Dr Bright's records for this patient adequate for the prescribing and treatment provided?" The same question is posed for each patient the subject of the complaint.
Professor Carter's response in respect of each patient is substantially identical. He notes there is poor documentation in respect of Patient A, apart from mentioning aspects such as pudendal neuralgia. He expresses similar comments about Patient B's records noting "very poor documentation relating to a full medical history and examination". He goes on to set out the type of information which should have been documented about this patient and concludes the departure was significantly below the standard and invited his strong criticism.
Similar comments are made by Professor Carter about Patient C's records.
In respect of the practitioner's self-prescribing, Professor Carter notes there are no hand-written records post 2012 and "there is no record indicating the reason for prescribing peptides and no record of his medical examination or history".
The medical records for Patient D are subject of criticism by Dr Flynn.
Notwithstanding the practitioner's admission of this complaint, we are independently satisfied from our examination of the records that they do not comply with Schedule 2 of the 2010 regulation, or Schedule 4 of the 2016 regulation. We also adopt as relevant to this complaint, the opinions expressed by Professor Carter and Dr Flynn.

Complaint Four

This complaint is in respect of Patient E. The complaint is agitated under both s 139B(1)(a) and s 139B(1)(l) of the National Law. The background to the complaint discloses that Patient E has suffered from BVD since approximately 2000. He located the practitioner after an internet search about BVD. He had unsuccessfully sought medical advice and treatment for BVD from about 2006.

Particulars alleged

Three particulars are relied on in respect of this complaint. The first relates to the inappropriate carrying out of the procedure when the primary purpose was to alleviate or cure Patient E's BVD, that there was no reasonable chance of a successful outcome, there is no clinical evidence demonstrating the safety and effectiveness of stem cell therapy and the procedure was experimental and not part of a clinical trial. The second particular asserts a failure to obtain informed consent in writing before the procedure and a failure to document discussion of the informed consent process in the patient's medical records.

The practitioner's Reply

The practitioner disputes the primary purpose of the stem cell therapy administered to Patient E was for BVD not osteoarthritis. He disputes there is no clinical evidence to support the use of stem cell therapy for the treatment of osteoarthritis or that the treatment was experimental.

Patient E's complaint and statement

Patient E made a written complaint to the HCCC on 20 January 2016. He provided a statement dated 8 July 2019. Patient E attended the hearing, but in the absence of the practitioner or his legal representatives, he was not required for cross-examination. We asked Patient E if he would like to speak to us about his complaint. Patient E's views were expressed to us by counsel for the HCCC. We find he was a very vulnerable patient at the time of his consultation with the practitioner, and that he relied on the practitioner's advice. We accept he has been adversely impacted by his stem cell treatment, and that he asked us to rely on his statement.
Although we are conscious that these reasons for decision will be published on NSW Caselaw, we take this opportunity to recommend to the Director of Proceedings that she provide Patient E with a copy of our reasons. We make this recommendation so that Patient E is aware of our findings in respect of his complaint.
In his statement, Patient E records that he attended a consultation with the practitioner on 5 September 2012 with his now wife.
At paras 8 and 9 of his statement Patient E explains: Dr Bright told me that SCT can repair damage in the body. He also said that SCT has a high success rate and that there was a good chance it would work for me. Dr Bright told me that SCT is 100% safe. He did not tell me that SCT is experimental or explain the risks, other than to say there might be some weeping after the procedure.
Patient E also explains that he was not given any handouts or information sheets. He also says the practitioner told him the procedure cost $11,000 to $12,000 but offered a discount price of $3,000.
Patient E did not initially agree to the treatment proposed, but later had a second consultation with the practitioner. During this latter consultation, he explains he was again told that the stem cell therapy was 100 per cent safe. Patient E has no recollection of signing consent forms at either consultation or on the day of the procedure.
Patient E states that since he had stem cell therapy, he has been diagnosed with Lymphoma and that he is currently in partial remission. We note the HCCC submission to the effect that any matter related to Patient E's current diagnosis does not form part of the complaint.
In his complaint form, but not in his Statement, Patient E says: The purpose of the stem cell treatment was purely and solely for the purpose to help improve and/or cure my bilateral vestibular dysfunction (balance disorder due to inner ear hair cells being damaged in both ears as explained to Dr Bright). At the time of the consultation he had asked if I had pain in my wrists, knees or elbows as he had seen success with treating patients with arthritis and osteoarthritis. I explained that I did have some pain in my knees however my knees were not a concern.

The practitioner's statement to the HCCC

In two letters forwarded to the HCCC from his then lawyers dated respectively 12 April 2016 and 5 August 2016, the practitioner responded to Patient E's complaint. In the first letter, his solicitors said that the practitioner had advised Patient E "that he did not know if it would make a difference to [Patient E's] vestibular problems but that Dr Bright had had consistently good improvements with patients with osteoarthritis… Dr Bright provided [Patient E] with no guarantee as to an improvement in his particular circumstances". It was further explained that in accordance with his usual practice, the practitioner had provided Patient E with a copy of his Stem Cell Information Sheet.
In the second letter, the practitioner's solicitors repeated the information that the practitioner had not made "any guarantees that stem cell therapy would be of benefit to [Patient E] noting his particular circumstances".

Expert evidence

The HCCC also rely on Dr Flynn's expert evidence in support of this complaint. Dr Flynn's evidence is explicit. He says that he is not aware of any evidence indicating that stem cell therapy would be of benefit in the treatment of BVD.
It is also submitted by the HCCC that given the absence of a signed consent form in the records, or the lack of any comprehensive recording in the medical notes for this patient, we could not be satisfied a proper informed consent was given by Patient E. Further it is submitted that the medical records maintained by the practitioner did not comply with the 2010 regulation. These submissions are based on opinions expressed by Dr Flynn.

Consideration

We accept the submission made by the HCCC that we should accept and prefer Patient E's unchallenged statement to that provided by the practitioner through his lawyers. First, we accept Patient E's statement is unchallenged. Secondly, the medical records such as they are, support Patient E's evidence. Thirdly, Patient E's completed information form states in answer to the question "What is your diagnosis/disease?", "Bilateral Vestibular Dysfunction".
Any reference in the notes to cartilage damage in the knee only appears after a reference to BVD.
We also accept and adopt as supported by the evidence, Dr Flynn's opinion that there was no reasonable prospect that stem cell therapy would successfully treat BVD and that the procedure was experimental.
We also accept the submission of the HCCC that Patient E did not give a fully informed consent to the procedure, nor was a discussion of consent contained in the medical records. In this respect we accept and prefer the evidence of Patient E to that reported by the practitioner's solicitors. We note the solicitor's letter only refers to "usual practice" and does not refer to any precise recollection of the practitioner.
In summary, we find each of the particulars of Complaint Four is established. As with Patient D, we find not only was the practitioner's administration of stem cell therapy for BVD experimental and demonstrated a lack of appropriate care under s 139B(1)(a), it was also improper under s 139B(1)(l). This is because the practitioner was charging a vulnerable patient a large sum ($3,000) for a treatment which had no proper therapeutic basis, was experimental and unproven. We agree with the comments of the Deputy State Coroner in his discussion of Patient D's treatment being analogous to "quack" medicine. Those comments are equally apposite to Patient E's treatment by the practitioner.

Professional misconduct

Complaint Five asserts the practitioner is guilty of professional misconduct under s 139E of the National Law. We have earlier in these reasons set out the definition of professional misconduct. The practitioner does not admit that he is guilty of professional misconduct.

Relevant law

We have also earlier set out the discussion by Basten JA in Chen about professional misconduct.

Particulars

The particulars of Complaint One save and except particular 11 are relied on individually as are the particulars 1, 2, 3 and 4 of Complaint Two. The particulars 1, 2 and 3 of Complaint Four are relied on individually. Further the particulars of Complaints One to Four and the particulars thereof are relied on both individually and cumulatively to establish this complaint.

Consideration

The complaints against the practitioner, particularly in the case of Patient D, disclose a reckless disregard for patient safety. We find that the conduct established in respect of Patient D in and of itself is of a sufficiently serious nature to justify the cancellation of the practitioner's registration. In reaching that finding we have given particular weight to the very damming evidence of Laureate Professor Masters, which we accept in its entirety.
That conduct, when considered with the practitioner's conduct in administering stem cell therapy to Patient E for the treatment of BVD in circumstances where the treatment was experimental, and with no clinical support, inevitably leads to a finding of professional misconduct. We also take into account both in the case of Patient D and Patient E the lack of a proper informed consent to the treatment administered.
We also find the stem cell therapy complaints, when considered with the peptide prescribing, cumulatively must lead to a finding of professional misconduct, being matters of such serious departure from accepted standards to justify the cancellation of the practitioner's registration.

Appropriate protective orders

It follows from our findings about professional misconduct that, had the practitioner been registered at the date of the hearing, we would have cancelled his registration.
We turn then to consider what period, if any, should be provided before the practitioner may again seek to be re-registered. Noting the practitioner's age, and his voluntary surrender of his registration, we conclude it is unlikely that he will again apply for registration.
The discussion of Payne JA on this topic in Chen is important. At [88] his Honour explains: The Tribunal was permitted by s 149C(7) to identify a period of a time during which a re-registration application could not be made. Doing so indicated the seriousness, from the Tribunal's perspective, of the conduct. A practitioner wishing to challenge that period may do so by way of appeal. Contrary to the appellant's submission, a time fixed under s 149C(7) does not necessarily mean that the Tribunal has formed a view that things will have changed by the end of the period which has been fixed. The Tribunal is permitted by s 149C(7) to make clear in its orders the seriousness with which it views the conduct of the practitioner reflected in the complaints which have been proven. Such an order plays a part in the general deterrence reflected by the order.
We are conscious that the period before which the practitioner may apply for a re-instatement order by this Tribunal is at the upper end of the period generally sought in matters. In Health Care Complaints Commission v Reid [2018] NSWCATOD 162, the Tribunal, after making a finding of professional misconduct based on a significant number of serious clinical failings and improper and unethical conduct, concluded that a period of five years under s 149C(4)(b) should be imposed. However, as the authorities suggest, while in similar factual circumstances, like conclusions may be reached, each case must be evaluated on its own particular facts and circumstances.
As in Reid we have also found the conduct engaged in by the practitioner in this matter to be serious and a very significant departure from accepted standards. Like the facts in Reid the practitioner engaged in experimental treatment. The practitioner had also surrendered his registration and was of a similar age to the practitioner in this matter.
At the time we commenced this hearing it was not apparent that the practitioner knew of the disqualification period sought by the HCCC. Accordingly, we directed that the HCCC use its best endeavours to serve on the practitioner a copy of the orders now sought. We provided an opportunity for the practitioner to respond to the order to be made under s 149C(4)(b). No response has been received.
In Reid the practitioner appeared and was subject to vigorous and extensive cross-examination. Here the practitioner did not afford himself of the opportunity to give evidence to explain his position, nor did he make himself available for cross-examination. He did not respond to the orders made at the end of the hearing of the evidence. In these circumstances we have no way of knowing about any insight he has gained, or any remorse he may have for the death of Patient D, or the distress caused to Patient E. Further, he has not availed himself of the opportunity to put submissions to us about a period before he may apply for re-instatement. In these circumstances and having regard to the deterrent aspect of s 149C(7) as explained by Payne JA, we find it is appropriate to impose a period of 7 years before any application for re-instatement may be made.
Although the HCCC submit we could make a prohibition order we decline to do so. There is no current relevant evidence to support the making of such an order. Further, the order sought was not specific as to the provision of which health services should be restricted.

Costs

The HCCC seek costs of and incidental to the proceedings. The HCCC has been entirely successful in establishing the complaints in this matter, notwithstanding our findings in respect of the drafting of one sub-particular.
The power to award costs in disciplinary proceedings under the National Law is found in cl 13 of Schedule 5D. The authorities on costs in proceedings under the National Law are well known (see Health Care Complaints Commission v Philipiah [2013] NSWCA 342). We also note the re-affirmation of general principles relating to costs set out in the decision of the plurality in the High Court in Bell Lawyers Pty Ltd v Pentelow [2019] HCA 29.
We are satisfied it is appropriate to make an order that the practitioner pay the HCCC's costs of and incidental to these proceedings as agreed, and failing agreement, as assessed under the Legal Profession Uniform Law Application Act 2014 (NSW). 1. Pursuant to s 149C(4) of the Health Practitioner Regulation National Law it is declared that if Dr Ralph Bright (the practitioner) had been registered at the date of the hearing, the Tribunal would have cancelled his registration. 2. Pursuant to s 149C(4)(b) the practitioner may not seek a review of order 1 of these orders for a period of seven years from the date of these orders. 3. The practitioner shall pay the costs of the Health Care Complaints Commission of and incidental to these proceedings as agreed, and failing agreement, as assessed under the Legal Profession Uniform Law Application Act 2014 (NSW).

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

Amendments 19 November 2019 - Added par 146 21 November 2019 - Paragraph inserted at [143] 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: 21 November 2019

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