Health Care Complaints Commission v Hart - [2021] NSWCATOD 36 - NSWCATOD 2021 case summary — Zoe

NSWNSWCATOD

Health Care Complaints Commission v Hart

[2021] NSWCATOD 36

NCAT Occupational|2021-02-04|Before: Dr J

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At a glance

Source facts

Court

NCAT Occupational

Decision date

2021-02-04

Before

Dr J

Source

Original judgment source is linked above.

Judgment (46 paragraphs)

[1]

Background

These complaints mainly concern treatment of 29 patients and some self-prescribing between early 2014 and 2019. For Complaints 1-29, it is alleged that Dr Hart failed to provide appropriate care and treatment for the patients in that he prescribed certain peptides to them: without conducting an appropriate assessment; without obtaining an adequate history; without obtaining adequate and informed consent; without adequately monitoring the patient; without adequately communicating with the patient's regular GP; and without having an appropriate therapeutic purpose or adequate level of training. For some patients it was also alleged that Dr Hart prescribed multiple peptides which were marketed as performing the same function.
The 29 complaints fall into four categories. The first category comprises 15 male patients in their 20s and 30s. The second category comprises 6 male patients aged from their mid-40s to mid-70s. These patients were also prescribed peptides but should have been screened for other medical conditions. The third category comprises seven patients who were existing patients of Dr Hart in the Sydney CBD or at the Hart Clinic in Mosman. Dr Hart conducted face-to-face consultations with these patients and his record keeping for those patients was adequate. The fourth category is a younger woman to whom Dr Hart prescribed Melanotan II, an injectable tanning product. We have not addressed the complaints by reference to these categories. Instead we have focused on the various categories of particulars in the complaints.

[2]

[8]

Monitoring

When prescribing the same or similar peptides for a second or subsequent time, Dr Hart did not ask the patient whether the peptides were achieving the desired results or whether they were producing any untoward symptoms or side effects. He admitted that he assumed that because the patient was re-ordering, there was no need to ask these questions. He did not monitor any patient for side effects.
Dr Hart prescribed CJC-1295/Ipamorelin combo 160mg to Patient D in June 2015. On 22 November 2015, Patient D emailed Peptide Clinics saying "after injecting in the abdomen my skin has become irritated very quickly." The support team referred the email to Dr Hart. Dr Hart responded to Patient D saying that he "might have developed an allergy to the peptide". He recommended stopping for three months and then starting again with two days off per week. When Patient D ordered more of the same peptide less than three months later, Dr Hart wrote the prescription for a quantity of four because that is the quantity Patient D had requested. The support team sent out the same standard instructions that had been provided to Patient D previously. Dr Hart admitted that the recommendations in his email were inconsistent with those instructions and that this was very poor medical care.
Dr Hart wrote three scripts for multiple peptides in a single month for Patient A. On 12 May 2015, Dr Hart prescribed Thymosin Beta 4 - 30mg (10 weeks). Further scripts for bremelanotide 20mg (up to 66 doses) and CJC-1295/Ipamorelin combo 80mg (up to 26 weeks) were prescribed 8 days later on 20 May 2015. On 31 May 2015, Dr Hart prescribed Thymosin Beta 4 45mg (18 weeks) and IGF-1LR3 5mg (up to 10 weeks). Throughout the rest of 2015, Dr Hart continued to prescribe the peptides that Patient A requested and that were consistent with his stated "goals". Because Patient A had not reported any "untoward effects from his initial use of peptides", Dr Hart said he "appeared to be deriving benefit from the treatments".
In the summary to the HCCC about Patient A, Dr Hart wrote that Patient A's "administration of peptides was substantial, however his treatment regime remained appropriate and was closely monitored by me". Dr Hart now concedes that he did not monitor Patient A. He wrote the scripts without reviewing previous scripts, several scripts were for quantities in excess of what Patient A could safely use in the time frame and he did not know what effects, if any, Patient A was deriving from the peptides.
In February 2016, Dr Hart prescribed various peptides to Patient G including four quantities of SARMs s22 Forte 15mg (3000 mcg/ml). If Patient G had injected this peptide in accordance with the instructions emailed to him, it would have lasted one year. Three months later, in May 2016, Dr Hart wrote another script for SARMs s22 Forte in a quantity that should have lasted another year.
For Patient I, Dr Hart wrote scripts for 8 quantities of SARMs s22 Forte 15mg on 5 February 2016. That amount should have lasted 20 weeks. A week later, on 12 February 2016, Dr Hart wrote another script for 8 quantities of the same peptide. He admits that he did not check the frequency or quantity of previous orders and assumed that Patient I was not experiencing any untoward effects. Dr Hart wrote the second script because Patient I ordered it, it was consistent with his stated goals and no contra-indications were recorded on the questionnaire. He did not monitor Patient I.
Dr Hart prescribed Patient V with various peptides over a 2-month period in 2015. Fourteen months later, in May 2016, Patient V ordered SARMs s22 Forte, a peptide he had not previously ordered. Dr Hart said that he would have reviewed Patient V's new questionnaire before writing that script. When he was told that the only questionnaire on the record was the 2015 questionnaire, Dr Hart said he assumed that if the questionnaire had not been updated, nothing had changed. It is apparent from this answer that Dr Hart did not require each patient to complete a new questionnaire even after 14 months had elapsed. That fact reinforces our finding that he was not assessing or monitoring this patient adequately.
Dr Hart maintained at the hearing that he saw Patient W regularly and monitored his progress although he conceded that his notes were too brief. He saw this patient at his Sydney CBD practice following a shoulder injury. Prof Carter expressed the opinion that Dr Hart did appropriately monitor this patient and Patient E.
Dr Hart did not adequately monitor or follow up with any of the 29 patients apart from Patients E and W, after first prescribing.

[9]

The standard

The Code of Conduct sets out the expectations of medical practitioners. At 3.2.7 the Code states that good medical practice involves: Only recommending treatments when there is an identified therapeutic need and/or a clinically recognised treatment, and a reasonable expectation of clinical efficacy and benefit for the patient.
A central issue in the proceedings was whether Dr Hart accepted that he had prescribed the peptides "without an appropriate therapeutic purpose". Dr Hart's solicitors wrote to the HCCC on 1 July 2016 attaching a list of the peptides he had been prescribing, the effect of the treatment and the dosage instructions. Based on that summary and his oral evidence, Dr Hart admitted that, other than in relation to the peptide AOD-9604, he failed to provide appropriate care to each patient to whom he prescribed the peptides. However, he believed, both at the time and now, that: 1. the prescribed peptides were largely able to achieve the desired effect or goal (such as fat breakdown, fat burning, muscle tissue growth, enhanced libido and enhanced tanning) however, he knew at the time that there was no high quality data supporting that view; 2. exceptions to that general claim are Follistatin 314R and mechano growth factor (MGF) which were not particularly effective; and 3. the recommended dosages were appropriate.
"Therapeutic use" is defined in s 4 of the Poisons and Therapeutic Goods Act 1966 (NSW) as having the same meaning as in the Therapeutic Goods Act 1989 (Cth). Section 3 of that Act relevantly defines "therapeutic use" to mean "use in or in connection with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons". Dr Hart says he now understands and accepts that there was no therapeutic purpose for prescribing peptides to any of the 29 patients.
Below we summarise the evidence about the efficacy of peptides given by Professor Carter, a clinical endocrinologist. We agree with that evidence. We have also included a summary of Dr Hart's former and current understandings.

[22]

Examples of peptides prescribed with no therapeutic purpose

In August 2016, Dr Hart wrote a summary of his treatment for the purpose of responding to the peptide complaint. He wrote that he considered Patient A to be a suitable patient for peptide treatment to assist him in pursuing his health and lifestyle interests. On 8 April 2016, Dr Hart had prescribed Patient A with 3 quantities of oxytocin (each expected to last 30 days) for the first time. He does not know why he wrote that script and agreed that there was no stated goal, much less a therapeutic purpose, for doing so.
As with Patient A, Dr Hart agreed that there was no therapeutic purpose for prescribing oxytocin to Patient G on 29 December 2015 or for prescribing Melanotan II to Patient K.
Patient T indicated that his interests were "anti-aging, muscle building, fat loss/weight loss, safe enhanced tanning, injury repair and increased libido." Because these interests effectively covered the field, Dr Hart prescribed everything he asked for.
Patient F presented complaining of poor energy levels and gastrointestinal pain and discomfort. After a series of tests, Dr Hart suggested various vitamins (D3 and K2) and supplements as well as Melanotan II.
Patient W was 49 years old and had difficulty recovering full use of his shoulder. On 14 April 2014, Dr Hart diagnosed Patient W with adult growth hormone deficiency and issued a prescription for NutropinAq (somatropin). Dr Hart acknowledged that none of the tests he ordered suggested that Patient W was deficient in adult growth hormone. While he did not have a "laboratory deficiency", Dr Hart said he had symptoms that were consistent with a deficiency. He acknowledged that there was no quality evidence that a rotator cuff tear would benefit from peptides.
Dr Hart treated Patient Z, who was 53 at the time. He reported taking numerous medications including DHEA (dehydroepiandrosterone), metformin, oxytocin, testosterone cream and clomiphene 50mg. Dr Hart tested Patient Z's DHEA levels, which are known to decline with age. He accepted that there is no high quality evidence supporting prescribing DHEA in healthy adults.
In September 2015, Dr Hart prescribed clomiphene 50mg for Patient Z. That medication is used to increase testosterone production in men. Dr Hart agreed that there was no clinical indication to prescribe this peptide. He says it was prescribed on a trial basis, as a substitute for testosterone cream, to see if it would help Patient Z's low energy, mood and low libido. He admitted that he did not record that reason in his notes. On 28 January 2016, Dr Hart prescribed testosterone cream again without ordering a blood test to ascertain his testosterone levels. When Dr Hart did request a blood test a month later, Patient Z's testosterone was above the normal range. Dr Hart said that he wrongly thought that the optimal range was higher than the normal range.
Patient E completed the online questionnaire on 7 April 2015 when he was 39 years old. He indicated that he had suffered from a shoulder injury and had undergone surgery in 2014 and 2015. He consulted Dr Hart in his surgery on 9 April 2015 reporting neck tension and pain. He had had a plate removed seven weeks earlier and his shoulder had not fully recovered. Patient E was looking for alternatives to surgery.
Dr Hart tested Patient E's testosterone level thinking that low testosterone may be preventing his shoulder from healing properly. The results of the testosterone test were 28 nmol/l. That reading is considered to be at the upper end of the normal range for a person of his age, but Dr Hart said he mistakenly compared the level against what he expected for a healthy 20 year-old. He prescribed testosterone even though Patient E was not androgen deficient. In his statement of 10 March 2020, Dr Hart suggested that there was a clinical basis for prescribing testosterone to Patient E. He now accepts that there was no clinical basis for doing so.
Dr Hart also prescribed metformin for Patient E. He had read that it reduced the conversion of testosterone to estrogen so he thought it would help a patient to recover from an injury. He now accepts that it has no clinical basis for the treatment of muscle injuries.
We find Complaint 5, particulars 6 and 7 to have been proved, that is, there was no clinical basis for Dr Hart to prescribe testosterone propionate or metformin to Patient E.
In accordance with the evidence, particularly Prof Carter's opinion, Dr Hart prescribed each of the substances listed in the 29 complaints without an appropriate therapeutic purpose.

[23]

Prescribing multiple peptides which performed the same function

In relation to Patient A, it is alleged that Dr Hart failed to provide appropriate care and treatment in that he prescribed multiple peptides which performed the same function, namely: CJC-1295, hexarelin, IGF-1 LR3, ipamorelin, MGF and SARMs.
Dr Hart agreed that both SARMs and CJC-1295 were prescribed for muscle building but said that they each used a different mechanism to achieve that goal. Dr Hart regarded these treatments as appropriate, but took no steps to determine whether the creams were actually achieving Patient A's goals. Dr Hart also conceded that while he regarded each peptide as safe individually, he was not aware of whether the four peptides would react together. He maintained that different mechanisms of action give additional effects although he conceded that there was no quality data to support that opinion.
The first time Dr Hart wrote a script for Patient B was on 25 September 2014. He prescribed CJC-1295/Ipamorelin combo 20mg, SARMs s22 20mg and AOD-9604 24mg. Dr Hart acknowledged that by writing scripts for multiple peptides he did not know which one, if any, was responsible for any change. He repeated that the "mechanisms of action" were different for each one. Three weeks later, Patient B asked for the same three peptides and Dr Hart wrote a prescription for them. He did not know whether Patient A was abusing these peptides and did not turn his mind to the wisdom of prescribing them. Six months later Dr Hart prescribed GHRP-2 in combination with two other peptides. He admitted that he did not know what effect these combinations were having on Patient B.
Dr Hart also prescribed multiple peptides to Patient G. While he said he thought about the dangers of prescribing so many peptides in high doses, he did not act on that thought. He said he was aware that it was a prolonged course but he assumed that Patient G, and other patients, would not take more than the recommended dose.
Patient L expressed interest in muscle building. On 19 October 2015, Dr Hart prescribed CJC-1295/Ipamorelin 20mg cream, MGF 10mg cream and SARMs s22 Forte 50mg cream. Dr Hart knew that there is no evidence that these peptides have a cumulative effect. He did not mention that to Patient L.
Patient AA first consulted Dr Hart on 17 June 2014 and informed him that he had previously used steroids. Patient AA returned for a second consultation a month later. During a third visit on 7 August 2014, Dr Hart said he planned to test Patient AA's testosterone levels because steroid abuse can suppress testosterone production. The patient's goal was to increase fertility. Dr Hart admitted that he did not check for testicular atrophy or sterility. Patient AA's testosterone level was 22.6 nmol/l on 19 August 2014. Dr Hart prescribed anastrozole, an aromatase inhibitor which inhibits the production of estrogen from androgens. Anastrozole is normally used to treat breast cancer in post-menopausal women. Dr Hart agreed that there was no clinical purpose for prescribing that drug. He said he thought it was based on something he had read from overseas.
At a consultation on 22 October 2014, Dr Hart wrote a plan to consider SARMs. On 16 December 2014, he prescribed clomiphene with no therapeutic purpose for doing so. Dr Hart also accepted that there was no therapeutic purpose for treating Patient AA with metformin in 2015.
On 8 August 2016, Dr Hart prescribed a form of testosterone, Reandron 1000 by injection 0.3ml twice a week. He denied that this was an excessive dose, saying that he gave smaller doses rather than one big dose. We agree with Prof Carter's evidence that this dose was clearly excessive. The normal dosage is 4ml corresponding to 1000mg Reandron (testosterone undecanoate) every 10-14 weeks. Dr Hart's dose is 1.5 times the 10-weekly dose and double the 12-weekly dose.
Patient AB reported fertility issues and sleep apnoea. Dr Hart prescribed vitamins D3 and K2. He agreed that there was no therapeutic purpose for doing so. He also prescribed clomiphene, a substance used to make testosterone, and planned to order a clomiphene stimulation test (CST) to see whether clomiphene was effective. On 21 October 2015, Dr Hart wrote that there were no symptomatic changes on CST. Prof Carter's evidence was that there was nothing to indicate that Patient AB was deficient in testosterone. Dr Hart accepted that there is some controversy about how to calculate testosterone deficiency but that, in any case, it was not appropriate for him to trial Patient AB with testosterone.

[27]

Inadequate medical records

The HCCC alleges that Dr Hart is guilty of unsatisfactory professional conduct under section 139B(1)(b) of the National Law. Section 139B(1)(b) provides that: (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.
Under cl 7(1) of the Health Practitioner Regulation (New South Wales) Regulation 2010 (NSW) (repealed): 7 Records relating to patients (1) A medical practitioner or medical corporation must, in accordance with this Part and Schedule 2, make and keep a record, or ensure that a record is made and kept, for each patient of the medical practitioner or medical corporation.
Schedule 2, clause 1 provides that: 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.
Dr Nespolon, the general practitioner who gave expert evidence, expressed the view that there were no clinical records provided that would comply with the requirements of these regulations. We find these particulars to have been proved.

[32]

Functional medicine

Patient AE, an 82-year-old woman with dementia, presented with her son on 17 October 2018. Dr Hart recorded that she was complaining of worsening tiredness and shortness of breath on exertion. She weighed 39kg and was depressed.
Dr Hart provided a number of articles by Dr Breseden (and others) which he considered at the time provided a "compelling case" for applying the theories of functional medicine to patients with cognitive decline. In accordance with those theories, Dr Hart suggested that the main cause of dementia was low-grade neurological inflammation. He was looking for the triggers of the inflammation such as environmental and nutritional factors. He ordered a pelvic and breast ultrasound, bone density study, coronary artery calcium CT scan, cone beam dental CT scan and various pathology tests. He recommended that Patient AE undergo a colonoscopy, take various drugs and vitamins and have her home tested for the presence of electro-magnetic fields. While he acknowledged that dementia cannot be reversed, he thought these interventions could potentially change the rate of progression of dementia.
Dr Hart said he thought it was his role to assess the various guidelines both in Australia and overseas before deciding what was best for his patients. He said it takes 13 years from when scientists first discover something for it to be accepted by the medical community. He thought that he should be up to date with the latest findings and apply them in his practice. Dr Hart said he now understands that he needs to practise medicine in accordance with the guidelines and standards referred to throughout this decision and the collective opinion of relevant experts. He referred to those guidelines generically as "the standard of care".
When asked when he became aware that he was not following the relevant standard, he said it was a "process over time". When the Medical Council suspended his registration in 2019, he said he realised that he was at risk of complaints if he did not follow the guidelines even though they are decades behind the times. In our view, Dr Hart has always known that he was not following the so called "standard of care". He knew he was practising outside the standards expected of medical practitioners but he did not stop doing so until his registration was under threat.

Parties

Applicant/Plaintiff:

Health Care Complaints Commission

Respondent/Defendant:

Hart

Legislation Cited (6)

Health Practitioner Regulation (New South Wales) Regulation 2010(NSW)

Health Practitioner Regulation (New South Wales) Regulation 2016(NSW)

Poisons and Therapeutic Goods Act 1966(NSW)

Civil and Administrative Tribunal Act 2013(NSW)

Therapeutic Goods Act 1989(Cth)

Poisons and Therapeutic Goods Regulation 2008(NSW)

Cases Cited (2)

Unsatisfactory professional conduct - knowledge, skill, judgment and care

For Complaints 1 to 29 (Patients A-AC) and Complaint 30 (self-prescribing), the HCCC alleges that Dr Hart is guilty of unsatisfactory professional conduct under section 139B(1)(a) of the National Law. That provision defines unsatisfactory professional conduct to include: 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.
As well, or alternatively, the HCCC alleges that Dr Hart is guilty of unsatisfactory professional conduct under section 139B(1)(l) in that he has engaged in "improper or unethical conduct". We note that the wording of s 139B(1)(l) is "Any other improper or unethical conduct relating to the practice or purported practice" of medicine (emphasis added). Improper or unethical conduct is not a stand-alone example of unsatisfactory professional conduct. The word "other" in s 139B(1)(l) limits the operation of that provision to conduct not falling within the definitions of unsatisfactory professional conduct in s 139B(1)(a)-(k): Attia v Health Care Complaints Commission [2017] NSWSC 1066 at [159]-[160]; Health Care Complaints Commission v Achurch [2019] NSWCATOD 20 at [31].
We have found that the conduct that is alleged to come within the definition of unsatisfactory professional conduct in s 139B(1)(a) does come within that definition. It relates to the knowledge, skill or judgment possessed, or care exercised, by Dr Hart and the conduct took place in the practice of medicine. For that reason the question of whether the same conduct amounts to "other improper or unethical conduct" as described in s 139B(1)(l), does not arise.
The HCCC submitted that certain conduct which was not particularised in the complaints, comes within the definition of "other improper or unethical conduct" in s 139B(1)(l). Examples include allegations that Dr Hart had a financial conflict of interest or received financial gain in relation to the peptide complaint and allegations that he misled the HCCC or the Medical Council in his responses to their communications. As these allegations are not the subject of any particulars in either of the complaints, we have not addressed them. However, as discussed above, the responses Dr Hart gave to the HCCC and the Medical Council affect his credibility both in relation to his understanding of good medical practice at the time of the complaints and the likelihood that he will adhere to those standards in the future.

[2019] NSWCATOD 20

Cited By (6)

Hart v Medical Council of New South Wales

Health Care Complaints Commission v Abrams

Health Care Complaints Commission v Gaberman

Health Care Complaints Commission v Hart

Health Care Complaints Commission v Javaheri

Health Care Complaints Commission v Yildirim