CHU KWOK YIU, WILSON v. THE PRELIMINARY INVESTIGATION COMMITTEE OF THE MEDICAL COUNCIL OF HONG KONG

HCAL 714/2022

[2025] HKCFI 3535

IN THE HIGH COURT OF THE

HONG KONG SPECIAL ADMINISTRATIVE REGION

COURT OF FIRST INSTANCE

CONSTITUTIONAL AND ADMINISTRATIVE LAW LIST NO 714 OF 2022

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D E C I S I O N

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A.  Introduction

1.  This judicial review may have been powered by understandable grief. But perhaps the unfortunate result is that a doctor who was a friend of the family of the patient, and who provided long-term care to the patient in circumstances where she outlived the typical prognosis on an incurable disease by many years, has been the subject of multiple attacks on his professional conduct.

2.  The Applicant’s grandmother (“Madam Tung”) died in 2013 after suffering over many years from lung and liver cancer. Since her death, Madam Tung’s family has taken severe issue with the doctor who treated her before she died – the Interested Party (“Dr Teo”). In particular, the Applicant takes issue with Dr Teo’s prescription of a chemotherapy drug called Sunitinib, which was administered on 10 occasions from May 2009 to May 2013.

3.  So the Applicant made a complaint against Dr Teo to the Medical Council of Hong Kong (“Council”). The Council’s Preliminary Investigation Committee (“PIC”) – tasked under statute with screening out complaints that do not demonstrate a prima facie case of professional misconduct – held, after consulting an independent expert, that the Applicant’s complaint did not demonstrate a case for referral to the Council. The Applicant sought a review of the PIC’s decision. But the PIC maintained its view on 17 May 2022, albeit for slightly different reasons (“Decision”).

4.  In these proceedings, the Applicant seeks to challenge the Decision.

5.  At its heart, the Applicant’s complaint is that the prescription of Sunitinib was not necessary or appropriate to treat Madam Tung’s lung or liver cancer. Further, it is said that Dr Teo did not obtain the requisite consent for the use of Sunitinib to “salvage” Madam Tung’s condition.

6.  I granted leave to apply for judicial review. At the substantive judicial review hearing, the Applicant was represented by Mr Wong Chi-kwong and Mr Dexter Leung of Counsel; the PIC was represented by Mr Anthony Chan of Counsel (now Mr Anthony Chan SC); and Dr Teo was represented by Mr Anthony Ismail of Counsel.

7.  At the end of the hearing, I reserved my decision. This is my Judgment.

B.  Factual Narrative

B.1  The parties

8.  As canvassed above, the Applicant is the grandson of Madam Tung, who passed away on 2 October 2013.

9.  The PIC is established by the Council pursuant to section 20BA(2)(d) of the Medical Registration Ordinance (Cap. 161) (“MRO”). Pursuant to section 20S of the MRO, the PIC comprises of 4 registered medical practitioners appointed by the Council, and 3 lay persons appointed by the Council.

10.  It is convenient to outline the PIC’s function at this juncture, as provided for under the MRO and the Medical Practitioners (Registration and Disciplinary Procedure) Regulation Cap 161E (“Regulation”). If the Council receives a complaint that a doctor had committed professional misconduct – and assuming that complaint is neither groundless nor frivolous, when it would be screened out by the Chairman and Deputy Chairman of the PIC under section 6(3) of the Regulation – the complaint is referred to the PIC for its consideration. The PIC will then have to decide whether there is a prima facie case of professional misconduct. If so, it may then refer the complaint to the Council for consideration on the merits, and an inquiry may be held. After the inquiry, and if the doctor is found to be guilty of professional misconduct, the doctor may be sanctioned.

11.  So, in short, the PIC serves as a second-layer filter as to whether an inquiry should be held.

12.  Dr Teo was and is a clinical oncologist, a fellow of the Hong Kong Academy of Medicine and the Hong Kong College of Radiologists and provides specialist and clinical services in clinical oncology at the Central Comprehensive Cancer Centre (“Centre”) at Room 522, Central Building, 1 Redder Street, Central. At the relevant time, the care of Madam Tung was entrusted to him.

B.2  Madam Tung (between 2009 and 2013)

13.  Madam Tung was diagnosed with primary hepatocellular carcinoma (“HCC”) i.e. liver cancer in 2007. She underwent surgery on 17 December 2007 and 17 January 2009. Unfortunately, her HCC relapsed in 2009, and she could no longer undergo any further surgery. This is known as “unresectable” cancer (i.e. a cancer that cannot be surgically removed).

14.  According to Dr William Foo (“Dr Foo”), the expected median overall survival was about 10 months and the median time to radiological progression was about 5 months. This is not disputed by the Applicant. So in other words, it would be expected that the HCC would progress, and that the patient would not live long.

15.  In such circumstances, on 8 May 2009, Dr Teo first prescribed a drug called Sorafenib. In medical terms, it is an inhibitor of several serine / threonine and receptor tyrosine kinases. Dr Teo further prescribed 200mg per day of Sorafenib on 29 May 2009, 26 June 2009, 7 August 2009, 7 September 2009, and 14 September 2009.

16.  In turn, Madam Tung’s alphafetoprotein (“AFP”) levels – which indicate how rapidly a cancer might be progressing, where higher AFP levels indicate a more rapid progression – decreased from 15 May 2009 (124.2 ng/ml) to 12 June 2009 (64.7 ng/ml), and remained relatively steady thereafter (83.4 ng/ml and 74.3 ng/ml respectively on 26 June 2009 and 7 August 2009 respectively) until 7 September 2009, when it rose to 141.6 ng/ml. Madam Tung’s AFP levels also rose to 152.1 ng/ml and 242.3 ng/ml on 5 October 2009 and 2 November 2009 respectively.

17.  Given the signs of cancer progression, Dr Teo prescribed another drug Sunitinib – together with Sorafenib – on three occasions: 14 September 2009, 29 September 2009, and 5 October 2009. On each occasion, 12.5 mg of Sunitinib per day was prescribed to her.

18.  Sunitinib, like Sorafenib, is an inhibitor of multiple receptor tyrosine kinases. But, usually, it is used to treat gastrointestinal stromal tumours, advanced renal cell carcinomas, and neuroendocrine tumours of pancreatic origin. The suitability of Sunitinib as treatment for Madam Tung’s condition is precisely the gist of the present judicial review.

19.  According to Dr Teo, before prescribing Sunitinib on 14 September 2009, he had explained its use to both Madam Tung and Mr Simon Chu (“Simon”), who was Dr Teo’s friend, Madam Tung’s eldest son, and the person who had always accompanied Madam Tung to Dr Teo’s medical appointments. Dr Teo believed he had obtained both Madam Tung’s and her family’s consent. However, there was no written documentation of any consent.

20.  After 5 October 2009, however, this “combination use” of Sorafenib and Sunitinib (as termed by the Applicant) was dropped thereafter as the HCC continued to progress.

21.  In lieu, from November 2009 to January 2010, Sorafenib was combined with a different set of (cytotoxic) drugs, capecitabine and oxaliplatin. This combination was known as “SECOX”. According to Dr Foo – which is not disputed by the Applicant – it was not a “recognised, standard treatment” for HCC. Rather, such treatment was still subject to a multi-centre phase II trial in Hong Kong and Singapore. Again, according to Dr Foo, this unconventional approach seemed to work to an extent. While Madam Tung’s AFP levels decreased, they were still significant.

22.  After January 2010, the cytotoxic drugs were dropped. Dr Teo continued to administer Sorafenib until 16 May 2012 (i.e. for almost 2.5 years), but at half dosage. From January 2010 to October 2010, Madam Tung also underwent radiotherapy to treat various metastatic sites.

23.  In around March 2010, things grew even more complicated. A new lesion (an area of abnormal tissue or damage) appeared in the apical right lower lobe (“RLL”) of the lung, alongside multiple lesions in Madam Tung’s liver, sternum, C7/T1 vertebra, and neck nodes. At the time, Madam Tung was not fit for a biopsy, so the lesion was monitored by several interval scans.

24.  On around 19 July 2012, a biopsy of the lesion in the RLL was conducted. It was confirmed that the lesion was a second cancer: namely, non-small cell lung carcinoma (“NSCLC”) – i.e. lung cancer. It was further confirmed that the lesion was not due to HCC. The relevant portions of Dr Teo’s medical records dated 1 August 2012 indicate:

01 August, 2012

Diagnosis: HCC with intrahepatic metastases and cirrhosis

HCC bone and liver metastases (1/8/12)

NSCLC (lepidic type adenocarcinoma) (1/8/12) – Apex RLL

Complaint: Nil

Findings: LPS = 90

PET-CT (31/7/12) showed new primary tumor (NSCLC) located at apex of RLL and metastases (likely from HCC) to C7, T2, T4 and sternum, and, also 2 new liver tumors (likely recurrent HCC).

25.  So Dr Teo arranged treatment (including curative and palliative radiotherapy) for NSCLC. He also prescribed Sunitinib to “replace” Sorafenib. In his Representations to the PIC, Dr Teo also said that Sunitinib was to “palliate the advanced HCC”.

26.  A consent form was signed by Madam Tung dated 1 August 2012 (“Consent Form”). The Consent Form provides as follows, that:

(1)  Dr Teo diagnosed Madam Tung as having HCC / metastases.

(2)  The “Recommended Treatment” was Sunitinib, and it was to be administered orally.

(3)  The purpose of administering Sunitinib was to “shrink the tumour or control the disease (especially in the presence of symptoms), alleviating the effects of cancer on you as much as possible”.

(4)  Dr Teo had already “explained the nature, risks, and benefits of treatment to the patient using the patient’s mother tongue or through an interpreter, and have answered the patient’s enquiries”, and he had used his best efforts to sufficiently explain to the patient and/or the patient’s family the following: (1) the course of the treatment, (2) the purpose of the treatment, (3) potential risks of treatment, and (4) other treatment alternatives, including no treatment.

(5)  In response, Madam Tung (or her guardian) confirmed – through ticking boxes next to the following declarations – that (inter alia) (1) Dr Teo had already discussed the purpose, possible benefits and potential risks of treatment and other treatment alternatives, (2) the Consent Form does not include all information possibly relevant to the treatment or procedure, and that Madam Tung confirmed she had already “separately obtained written and oral information concerning the treatment or procedure and its risks”, and (3) more importantly, Madam Tung could – “at any time” (“隨時有權”) – change her decision and not receive Sunitinib.

(6)  Madam Tung’s Chinese signature, and a witness’ name and signature was affixed to the Consent Form.

27.  Simon confirms that (1) he had trusted Dr Teo for “his expertise in cancer treatment”, and more importantly, (2) the Patient signed the Consent Form, and “let the medical staff tick the boxes” in the Consent Form for her. But Simon says Madam Tung was not told of how Sunitinib was to be used as a “second line” / off-label treatment.

28.  Sunitinib was prescribed on 7 occasions thereafter: on 1 August 2012, 12 October 2012, 9 November 2012, 7 December 2012, 4 January 2013, 1 March 2013, and 2 May 2013. On each occasion, 25mg of Sunitinib per day was prescribed to her. And after every two weeks of Sunitinib treatment, there would be a 1-week break.

29.  From 1 August 2012 to 27 May 2013, Madam Tung’s AFP levels ranged from 10.8 ng/ml to 20.94 ng/ml.

30.  According to Dr Teo’s medical records, on around 6 to 7 June 2013, a combination of other chemotherapy drugs – Avastin, Alimta, Carboplatin and Afinitor – was prescribed for the first time. This combination was further prescribed on 14 June 2013, and 17 June 2013. Other drugs were prescribed in combination with Alimta in August 2013.

31.  According to Madam Tung’s last AFP test conducted by Chan & Hou Medical Laboratories Ltd, Madam Tung’s AFP levels as at 22 July 2013 stood at 6.16 ng/ml.

32.  But ultimately – and sadly – Madam Tung succumbed to her illness and passed away on 2 October 2013.

B.3  The reaction of Madam Tung’s family members

33.  Madam Tung’s family members were understandably distraught at her passing. As the Applicant’s father and Madam Tung’s son Mr Augustine Chan (“Augustine”) put it, he had held a “high hope” that Dr Teo could keep Madam Tung’s HCC and NSCLC in check.

34.  But given what happened after Madam Tung’s death, “distraught” might be putting it too mildly. In the evidence, there is a barrage of complaints from the Applicant and his family members which, to me, were either (a) not relevant to the grounds of review as contained in the Form 86, (b) were not even pursued with any gusto by the Applicant’s counsel, Mr Wong and Mr Leung, or (c) not borne out by the evidence.

35.  First, there was a complaint that Dr Teo should have taken better care of Madam Tung by conducting a biopsy before 20 July 2012 (and indeed, on 8 March 2010) as to the lesion in the RLL of Madam Tung’s lung – even though the Applicant’s Counsel agrees this was a non-starter, given that “Madam Tung was not fit for a biopsy at the time”.

36.  Second, there was a complaint that Madam Tung’s “condition” – which may refer to either (1) the NSCLC itself, or (2) Madam Tung’s bleeding in her lung that she experienced from 17 June 2013 to 15 July 2013 – may be caused by the “aggressive combination of chemotherapy drugs for treatment of NSCLC and HCC”. As will be seen below, not even Professor Lee – the Applicant’s expert – says this.

37.  Third, there was a complaint that Dr Teo had misdiagnosed the lesion in the RLL of Madam Tung’s lung. The complaint arose in the following manner.

(1)  In around mid-October 2013, Augustine – and I presume, Madam Tung’s family members – received Madam Tung’s death certificate. To their surprise, the causes of death were: (1) metastatic hepatocellular carcinoma (i.e. HCC), (2) haemothorax, and (3) pneumonia. There was no mention of NCLSC.

(2)  This prompted Augustine to ask Simon to approach Dr Teo for an explanation as to Madam Tung’s causes of death in around mid-October 2013. In response, Dr Teo provided a medical report dated 23 December 2013 (“Medical Report”). It consists of 2 pages.

(3)  The relevant portion of the Medical Report is as follows:

Meanwhile, CT-guided RLL lung nodule biopsy was done on 19/7/12 which showed adenocarcinoma without mutations in Exon 18, 19, 20 and 21 of the EGFR gene. The different diagnoses were non-small cell lung carcinoma and metastatic hepatocellular carcinoma. It was not possible to differentiate between these two diagnoses pathologically at that juncture.

Assuming that the diagnosis was metastatic hepatocellular carcinoma (the more likely diagnosis from the statistically point of view) rather than non-small cell lung carcinoma, Sorafenib was stopped in view of disease progression and Sunitinib was started instead on 1/8/12. In addition, after discussion with the family the pros and cons of the treatment strategy, decision was made to irradiate the bone metastases at C7, T2, T4, manubrium and sternum and the right lower lobe tumor while Sunitinib was being continued at reduced dose for the recurrent hepatocellular carcinoma …

(4)  Plainly, the first sentence of the second paragraph as quoted above was wrong. As Dr Teo’s contemporaneous records show, he diagnosed the lesion in the RLL to be NSCLC (and not metastatic HCC) (“Error”). According to Dr Teo, he made the Error because the Medical Report was prepared without reference to a full set of contemporaneous medical records.

38.  Dr Teo also took the chance to clarify the Error in a without prejudice meeting requested and attended by the Applicant’s solicitors on 3 October 2015 (“WP Meeting”). Dr Teo’s solicitors, “Mr Kan” of Howse Williams, and Augustine’s solicitors also attended. According to Mr Kan’s contemporaneous records, he made the following two notes: “We knew lung CA I wrote report Simon w/o looking at records” and “report wrong…Simon asked for simple…but did dx lung CA Bx did”. “Dx” refers to diagnose, and “Bx” refers to biopsy.

39.  Augustine maintains in his affirmation that the Error was never admitted to Madam Tung’s family members. In support, he also draws upon various letters sent by Howse Williams – Dr Teo’s solicitors – dated 18 April 2017, 12 May 2017, and 23 June 2017 which do not mention the Error. On a related but separate note, he also alleges that it is “totally inconceivable” how the Error could have arisen, as Dr Teo had supposedly prepared the Medical Report for 2 months and is a reputable specialist in clinical oncology.

40.  I share – to a degree – Augustine’s bewilderment that the Medical Report was not prepared according to the contemporaneous documents. I think this was avoidable. But the fact is that the contemporaneous records suggest Dr Teo correctly diagnosed the RLL of Madam Tung’s lung as NSCLC. So I would think that any suggestion that Dr Teo seemed to have “misdiagnosed” Madam Tung’s condition is incorrect.

41.  Indeed, on 7 September 2016, Augustine commenced a claim in his capacity as a co-executor of Madam Tung’s estate against Dr Teo in HCPI 996/2016. This was settled by a Tomlin order made on 26 September 2017.

B.4  The Complaint to the PIC

42.  Thereafter, the Applicant became “curious about the treatment received” by Madam Tung because “she had a lot of pain and suffering during the treatment process”.

43.  After reviewing the list of prescriptions of Sorafenib and Sunitinib from May 2009 to 2 May 2013, Augustine also grew curious as to whether Sunitinib had a “higher efficacy or a lower toxicity” than Sorafenib, or why there had been a change from Sorafenib to Sunitinib.

44.  In these circumstances, the Applicant instructed his solicitors – Paul CK Tang & Chiu – to seek an Expert Opinion from Professor Vivian WY Lee (“Professor Lee”), an Associate Professor in the School of Pharmacy at CUHK, and a specialist in cardiology pharmacotherapy, on a host of issues. The Applicant’s solicitors did so on 7 September 2018 and 10 September 2018.

45.  Professor Lee was asked to deal with the following issues: (1) whether Sorafenib and Sunitinib drugs were approved by the Food and Drug Administration of the USA (“FDA”) during 8 May 2009 to 2 May 2013, and whether they were approved in Hong Kong, (2) whether the dosage of the two drugs prescribed to Madam Tung was effective at the time, (3) whether Madam Tung suffered from toxicity of the 2 drugs, and (4) whether there was “reasonable therapeutic management” on Dr Teo’s part for prescribing Sorafenib and Sunitinib to Madam Tung.

46.  This Expert Opinion was provided on 10 April 2019 (“Lee Expert Opinion”). Professor Lee relevantly concluded as follows:

(1)  While Sorafenib was approved by the FDA for the management of unresectable HCC, Sunitinib was not.

(2)  Sunitinib is considered to be an “investigational approach”, meaning it is not approved by the FDA or supported by the evidence from clinical trials.

(3)  Sunitinib is not considered as an appropriate alternative “as the initial treatment based on both phase II and III trials”. Further, Sunitinib is considerably “inferior” to Sorafenib. According to the various studies published in (inter alia) the Journal of Clinical Oncology, Sunitinib was “associated with more frequent and severe toxicities than sorafenib”. Certain studies also show that the overall survival (“OS”) for patients prescribed with Sunitinib was “neither superior nor equivalent but significantly inferior to that with sorafenib”.

(4)  There was evidence that Madam Tung suffered toxicity of the 2 drugs including hypertension (high blood pressure), hand-foot syndrome (skin reaction which could cause pain, redness and swelling of Madam Tung’s foot and hand), diarrhea, thrombocytopenia (decreased platelet count), anaemia (decreased red blood cell), and nausea.

(5)  Given all of the above, the “addition of sunitinib to sorafenib is not considered a reasonable therapeutic management” (§15). It is also said that the “combination therapy” of Sorafenib and Sunitinib “increased” (definitively) the “treatment-related toxicity” to Madam Tung.

47.  On the other hand, she also fairly concluded that:

(1)  In Hong Kong (and not in the USA), both drugs are “registered in Hong Kong”, according to the Drug Office of the Department of Health in Hong Kong (§8).

(2)  The research studies that she cited (which contended that Sunitinib involved inter alia greater toxicity) involved sunitinib delivered in dosages ranging from 37.5 mg per day to 50 mg per day, and the dosage of both Sorafenib and Sunitinib prescribed to Madam Tung was “at the lower range” (§§11, 13).

(3)  Indeed, according to the research studies cited by Professor Lee (such as Faivre et al. 2009), it is unclear whether the adverse events associated with toxicity – such as haemorrhage, hepatic encephalopathy, and asthenia – was “treatment-related” (i.e. strictly related to the prescription of Sunitinib. Further, according to one study (Koeberle et al. 2010), it was even suggested that “continuous SU (sunitinib) treatment with 37.5 mg daily is feasible and has moderate activity in patients with advanced HCC and mild to moderately impaired liver dysfunction” and considered “promising”.

48.  On the strength of the Lee Expert Opinion, the Applicant made the following complaints to the Council on 6 August 2019 (“Complaint”). Per his Statutory Declaration, he inter alia complained that:

(1)  Dr Teo’s prescription of Sunitinib breached paragraph 9.1 of the Code of Professional Conduct of the Council of Hong Kong as of 2016 (“2016 Code”), which provided that “A Doctor may prescribe medicine to a patient only after proper consultation and only if drug treatment is appropriate”. This was primarily because Professor Lee opined that the addition of Sunitinib to Sorafenib was not a “reasonable therapeutic management”, and because there was “no evidence from clinical trial to support that Sunitinib was a drug appropriate for HCC”.

(2)  Dr Teo also breached paragraph 22.3 and Section 2 of the 2016 Code, as he did not explain to her or her family members that the use of Sunitinib was an investigational approach. Nor did Madam Tung sign any written consent for participating in such an investigational approach.

(3)  Dr Teo also breached paragraph 12.3(a) of the 2016 Code for charging excessive fees for the prescriptions of Sunitinib and made an “unreasonable profit” in this regard.

49.  Enclosed with the Complaint was inter alia the Death Certificate of Madam Tung, the Medical Report, the medical records relating to Madam Tung’s treatment by Dr Teo, a table which lists when Sorafenib and Sunitinib was prescribed by Dr Teo from May 2009 to May 2013, and the Lee Expert Opinion (and the materials it was based on).

50.  On 12 August 2019, the Council indicated that the Complaint would be attended to, and that a copy of the Complaint would be sent to Dr Teo.

51.  On 3 January 2020 and 4 March 2020, the Council requested the Applicant to collect Madam Tung’s medical records from HKSH and St Paul’s for its perusal.

52.  On 20 April 2020, the Council wrote a letter to Dr Teo, indicating that a complaint had been made against him. Dr Teo was invited to submit a written explanation if he wished to before 20 May 2020. Dr Teo says that he did not receive this letter, but nothing turns on this.

53.  On 17 August 2020, the Council wrote to Dr Foo, a specialist in Clinical Oncology, a Consultant in Clinical Oncology at the Queen Elizabeth Hospital, and Director of Radiotherapy & Oncology of the Hong Kong Baptist Hospital, for his expert advice.

The Medical Council of Hong Kong (“the Council”) has received a complaint against a registered medical practitioner from a member of the public and would like to invite you to provide expert opinion on the matter.

The complaint was about a doctor prescribing “Sunitinib” to a Patient [i.e. Madam Tung] through an investigational approach without prior consent from the Patient and/or her family members. Having considered the complaint, the Preliminary Investigation Committee (“PIC”) of the Council opines that it is necessary to seek expert opinion from a specialist in Clinical Oncology to comment on the case and the overall management of the doctor(s) on the Patient. If you could offer expert opinion on this case, we will forward all the relevant documents in connection with the case to you for your perusal.

54.  On 17 August 2020, Dr Foo agreed to give his expert opinion. On 23 October 2020, Dr Foo rendered his Expert Opinion (“Foo 1^st Expert Opinion”). Dr Foo found that as part of his factual summary:

(1)  After Dr Teo treated Madam Tung with Sorafenib in May 2009, her AFP fell to 64 ng/ml from 124 ng/ml.

(2)  In September 2009, given the signs of profession (with rising serum AFP and new lesions appearing after a CT scan of the liver), Sunitinib was added. And in November 2009, Sorafenib was combined with the cytotoxic drugs as part of SECOX. In July 2012, the AFP levels fell to 10.6.

(3)  In August 2012, a new lesion was found in Madam Tung’s right lung. It was then biopsied. At that point, “It remained unclear whether it was a metastatic lesion from the liver cancer or a new primary lung cancer. Dr Teo treated the lesion as for metastatic liver cancer. The specific treatment was switched from sorafenib to sunitinib. It was used from August 2012 to May 2013”.

55.  On this basis, Dr Foo then went on to give the following comments:

(1)  When Madam Tung’s cancer relapsed in 2009, available options were scarce, and she could not have more surgery. The “only standard treatment” was Sorafenib, and that was the “best available, evidence-based treatment”. As mentioned above, Madam Tung was expected to live about another 10 months.

(2)  In September 2009 (as Madam Tung’s cancer progressed), there “was not any evidence-based treatment options”. Sunitinib was thus added. At the time, Sunitinib was reported in phase II clinical trials and was not a standard treatment.

(3)  Dr Foo further opined that “It was added, I presume, when there was no better option. Otherwise it would have been supportive care only. I cannot say I agree with this addition of sunitinib to sorafenib as there was absolutely no evidence. Yet I cannot say Dr Teo was wrong either because I cannot put up any evidence against this”.

(4)  Dr Foo also opined on the administration of SECOX. Dr Foo said that he was aware of the treatment, and further opined that if there was “no other evidence-based alternative, this was the closest one could get to treat hepatocellular carcinoma”. Like Sunitinib, there was “no evidence in medical literature for or against using SECOX at that time”.

(5)  As to the lesion in the RLL of Madam Tung’s lung, Dr Foo opined that it “was not possible to determine its nature” – namely, whether it was a new primary cancer in the lung or metastatic HCC. In these circumstances, Dr Foo thought that Dr Teo did nothing wrong if he administered Sunitinib, on the basis that it was to treat the HCC. There was “little choice at the time other than Sunitinib”.

(6)  Dr Foo also opined that Sunitinib was not used as an “investigational approach”, as it was “not used as in a clinical research”. Indeed, if Sunitinib was used in an investigational manner, there would have been “strict protocols”.

(7)  Dr Foo opined that – ultimately – the use of Sunitinib was used with a “salvage intent” and not in an experimental setting, irrespective of whether it was used in combination with Sorafenib in 2009, or alone in 2012.

(8)  Even after consulting the Lee Expert Opinion, Dr Foo opined that Sunitinib could not be said to be inferior – as the studies cited by Professor Lee involved clinical trials that were in the “first line setting”. However, Sunitinib was not used in a “first line setting” for Madam Tung. Rather, it was used after Sorafenib (i.e. a second line setting). And one could not extrapolate those results to “second line settings”.

(9)  Dr Foo also stated that the use of Sunitinib ‘off-label’ was “a completely legitimate way of using medications in unusual situations e.g. when there are no other viable option”.

56.  In his conclusion, Dr Foo also said this, which is worth quoting in full:

Relapsed liver cancer is not curable. The outlook is grave. The expected life span is about a year. The purpose of treatment is to extend survival. Dr Teo started with the standard treatment of sorafenib. The expected median survival was around 10 months according to medical literature. As expected the effect was short-lived. On progression of the cancer, he used drugs that were much less evidence-based (sunitinib, capecitabine, oxaliplatin), interspersed with radiation therapy (both external and internal) to extend her survival. Apart from sorafenib, all the other medication used was based on some evidence (phase I/II trials or ongoing local clinical trials) but not solid evidence like phase III clinical trials. At the end, under the aggressive treatment from Dr Peter Teo, she survived for over four years.

…

I do not see the point of accusing Dr Teo for medical negligence. He treated Mdm Tung aggressively within the limit of medical knowledge at that era. He extended her survival way beyond expectation.

57.  The PIC met on 8 January 2021 to deliberate on the Complaint. It decided that there was insufficient evidence to show a reasonable prospect of Dr Teo being found guilty of misconduct in a professional respect, and the Complaint was dismissed. No inquiry was to be held. This was because:

After deliberation and consideration of all information presented, the Committee confirmed that the studies quoted by Dr Vivian WY LEE were published after 2009 (when the incident happened). The Committee accepted the expert opinion of Dr FOO. The Committee noted that there had been proper consents before treatment and sunitinib was used after first line and standard treatment failed. The Committee also noted that the patient had actually benefited from the treatment by surviving beyond the mean survival years for similar conditions.

58.  On 10 February 2021, Dr Teo was told by the Council that in light of all the information provided, the PIC had concluded the case should not proceed any further and that no inquiry would be held.

59.  On the same day, the Applicant’s solicitors were informed by the Council that no inquiry would be held. In that letter, the PIC was said to have “considered” large portions of Foo 1^st Expert Opinion in reaching its conclusion. It was also said that the PIC thought that:

…there had been proper consents before treatment and Sunitinib was used after first line and standard treatment failed. The PIC also noted that the Patient [i.e. Madam Tung] had actually benefited from the treatment by surviving beyond the mean survival years for similar conditions. All in all, the PIC considered that there was insufficient evidence to show a reasonable prospect of Dr TEO being found guilty of misconduct in a professional respect.

B.5  The Review

60.  In a letter dated 14 April 2020, the Applicant took issue with the PIC’s decision. Amongst other things, the Applicant took issue with:

(1)  Various factual inaccuracies, including how it was wrong for the PIC – which substantially relied on Foo 1^st Expert Opinion – to say that it was not possible to determine whether the lesion in the RLL of Madam Tung’s lung was NSCLC or metastatic HCC, when Dr Teo himself in August 2012 had diagnosed the lesion to be NSCLC (paras 9 to 12).

(2)  Dr Teo’s (mistaken) characterization of the lesion in the RLL of Madam Tung’s lung as metastatic HCC was a cover-up: “the logical inference is that in December 2012 Dr. Peter Teo was fully aware of his wrongdoing in the prescription of Sunitinib to Madam Alice Tung and wanted to retrospectively justify his wrongful prescription of Sunitinib by inventing the aforesaid ‘statistically point of view’”.

(3)  That it was quite impossible for the PIC to have come to the conclusion that there had been “proper consents” in light of the Applicant’s contention that there was nothing in Dr Teo’s medical records which showed that he had discussed or explained the use of Sunitinib as part of an “investigational approach”. In particular, it was necessary to examine (1) when, where and from whom the alleged consent was obtained by Dr Teo, (2) how the consent was obtained, and (3) what was actually said by Dr Teo.

61.  To further support the Review, the Applicant furnished a second Expert Opinion from Professor Lee (“Lee 2^nd Expert Opinion”) to the PIC. Professor Lee opined as follows:

(1)  The concurrent use of Sorafenib and Sunitinib in the management of HCC was inappropriate.

(2)  The opinion that Dr Teo added Sunitinib when “there was no better option” was not supported by any clinical evidence. In particular, given both Sorafenib and Sunitinib had similar pharmacological actions, they would also share “similar adverse drug reaction profile”. Thus, one would expect “additional side effects” as well.

(3)  In fact, Professor Lee placed greater emphasis on the Cheng A et al, 2010 study (“Cheng Study”) which was commenced in July 2018 and terminated on 22 April 2010 due to a “higher incidence of serious adverse effects in the Sunitinib group”. According to Professor Lee, this demonstrated that the “side effect profile of Sunitinib was worse than Sorafenib already”. Thus, it was not ‘surprising’ that Madam Tung had shown symptoms of toxicity.

(4)  Professor Lee also contended that – with reference to one particular study in 2010 (Wörns MA et al 2010) (“Wörns Study”) – Sunitinib had a “modest” clinical efficacy when used as a “second line treatment”. Further, the study showed that its use would pose a higher risk of “haematological complications” which were observed in Madam Tung.

(5)  Professor Lee also says that Dr Teo should have been aware of the unfavourable studies (including the Cheng Study) by the time Sunitinib was prescribed for 7 more times from August 2012 onwards. At the very least, the “continuation treatment of using Sunitinib as the salvage / second line treatment on Madam Tung after 2010 is not justified”.

(6)  Finally, Professor Lee contended that there was simply “no record documented that Dr Teo had ever discussed with Madam Tung on the risks and benefits as well as side effects of using Sunitinib” together with Sorafenib. Indeed, if Sunitinib was used as a salvage intent, such intent should have been made known to and consented by Madam Tung and her family.

62.  At this juncture, it is helpful to look at the Wörns Study. I would note that the authors also made the following observations that are pertinent to the present case:

(1)  Apart from the growing body of evidence that sunitinib is active in advanced HCC, some retrospective studies supported the hypothesis that sunitinib may be active in patients with metastatic renal cell carcinoma after progression under prior sorafenib treatment. No cross-resistance could be observed in these studies, although both agents encounter very similar targets and pathways. Some authors suggested that due to a lower 50% inhibitory concentration … for the receptor tyrosine kinases targeted by sunitinib, the drug resistance that emerged after the initial use of sorafenib would be overcome by sunitinib, whereas the development of resistance to initial sunitinib would not be salvaged by sorafenib” (citing Dudek AZ et al, 2009).

(2)  “All patients” who were administered Sunitinib experienced adverse events, which were “predominantly grade 1/2 in severity and included fatigue (n = 8; 73%), nausea (n = 7; 64%), diarrhea (n = 6; 55%), pain (n = 5; 45%), dry skin (n = 4; 36%), thrombocytopenia (36), and taste alteration (n = 4; 36%). Some experienced grade 3 to 4 adverse events (such as ascites, pleural effusion, haemorrhage, leukopenia) but were relatively rare. No grade 5 drug-related events (i.e. death) occurred.

(3)  In its discussion of the clinical trial results, the authors of the Wörns Study concluded that “sunitinib provided modest antitumor activity in our cohort”. That said, the authors also emphasised that there were various limitations to their study, and that the reason behind the “promising survival data” may be “additionally explained by the fact that the majority of” patients were presented with very well-preserved liver function.

63.  In these circumstances, on 9 August 2021, the PIC informed Dr Teo that it had received “new information” for the Complaint. Again, the PIC invited Dr Teo to submit written explanation if necessary.

64.  On 4 October 2021, Howse Williams – Dr Teo’s solicitors – submitted his written representations (“Dr Teo’s Representations”). They contained (1) a chronology of the material events, including a clarification that the Sunitinib prescribed from 1 August 2012 was to “palliate the advanced HCC” instead of NSCLC, and (2) the following pertinent observations:

(1)  Professor Lee’s Expert Opinions were of little or no probative value, as she is a pharmacist specialising in cardiology pharmacotherapy, and not the clinical management of cancer.

(2)  Dr Foo had already opined that the prescription of Sunitinib as a “salvage treatment” was appropriate in the circumstances.

(3)  Although the phase III trial concerning Sunitinib as described in the Cheng Study was discontinued, not all clinical trials relating to Sunitinib were discontinued.

(4)  Dr Foo was right to point out that the Cheng Study related to the prescription of Sunitinib as a “first line treatment”, which was inapplicable in the present case as Sunitinib was used as a “second line treatment”.

(5)  The Wörns Study actually supported rather than undermined Dr Teo’s management decision altogether.

(6)  There was no evidence that Madam Tung had suffered from any significant side effects from the use of Sunitinib. Nor is there any evidence that there was any evidence that there was any relationship between the eventual death and the use of Sunitinib, which happened more than 4 years after its first prescription. That was why Dr Foo was right to conclude “That Sunitinib was inappropriately used for lack of medical evidence could not be established”.

(7)  Prior to prescribing Sunitinib in September 2009 and August 2012, Dr Teo did “properly explain the treatment” to both Madam Tung and her family, including Simon. His explanation included the “condition, potential risks and benefits of treatment, and alternative(s)”.

(8)  To substantiate the above contention, Dr Teo attached the Consent Form (as dated 1 August 2012). Dr Teo also represented that the same consent had been obtained in September 2009. In these circumstances, the PIC’s conclusion that there had been “proper consents before treatment” was unimpeachable.

(9)  Dr Teo also clarified that he had made the Error in the Medical Report and had admitted the Error to Madam Tung’s family. He also said that he had correctly diagnosed the lesion in the RLL of Madam Tung’s lung – that was supported by the contemporaneous medical records.

65.  In these circumstances, on 12 November 2021, the PIC invited Dr Foo to produce a supplemental expert report based on inter alia the Applicant’s letter dated 10 February 2021 and the letter from Dr Teo dated 4 October 2021.

66.  Dr Foo rendered his supplemental Expert Opinion on 7 February 2022, which amended his 1^st Expert Opinion (“Foo 2^nd Expert Opinion”) in the following material ways:

(1)  In his factual summary, Dr Foo deleted the reference to how Dr Teo had treated the lesion in the RLL of Madam Tung’s lung as metastatic liver cancer. He also added references as to the size of the lesion in the RLL of Madam Tung’s lung from 8 March 2010 to 19 July 2012.

(2)  He also added this important comment:

Options for effective and safe systemic treatment for the lung cancer for Mdm Tung was scarce, given the pathological diagnosis of EGFR-wild type adenocarcinoma of lung. Chemotherapy was an option on paper but not pragmatically. At the same time the hepatocellular carcinoma was also progressing. At the end all lesions, lung cancer and liver cancers, were treated with radiotherapy.

In retrospect one might conclude that the biopsy from the lung, even though it confirmed the diagnosis of primary lung cancer, did NOT change anything in management.

(3)  In other words, Dr Foo commented that the lesion in the RLL of Madam Tung’s lung could only be treated with radiotherapy (and not pragmatically by any other chemotherapy drug). The HCC – which had been treated with Sorafenib – would continue.

(4)  He further commented that the use of Sunitinib “in such circumstances” (I presume this refers to its use from May 2009 to May 2013 and not a specific period) is known as an “off-label use”. This is a “completely legitimate way of using medications in unusual situations e.g. when there are no other viable option”.

(5)  Dr Foo also added the following comment:

Having gone through Dr Teo’s medical record, I found it very comprehensive, with history, physical and investigation findings listed in detail. Every move and the planning were recorded. It was not at all evasive. One can follow the medical reasoning easily.

On the matter of documented consent, there was none. It does not imply there was no consent. I would view this as implied consent, as the patient came for treatment for almost four years. I would leave Dr Teo to explain this.

(6)  In his conclusion, Dr Foo also added this.

I must point out again that no matter how much sunitinib is inferior to sorafenib, all the comparisons were in the first line setting. The paper by Worns [6] concluded ‘…sunitinib provide modest antitumour activity in patients with advanced HCC after progression under sorafenib….’ It was a small retrospective study involving only eleven patients. It showed 40% of patients with stable disease on first radiological follow up. This study did NOT negate using sunitinib after sorafenib. Dr Teo was in fact using sunitinib in an off-label application. I must emphasise that off-label use is completely acceptable. With sunitinib 25 mg daily (half the standard dose), 2 weeks on and 1 week off, Dr Teo was able to hold the liver cancer in check for another year (together with radiotherapy), as shown by the lowish AFP levels.

67.  The PIC met on 23 April 2022. In the Minutes of the meeting, the PIC referred to the above additions / amendments in the Foo 2^nd Expert Opinion and maintained its view that no inquiry should be held as there was insufficient evidence to show a reasonable prospect of Dr Teo being found guilty of misconduct in a professional respect.

After deliberation and consideration of all information presented, the Committee accepted the expert opinion of Dr FOO, and was satisfied that proper consent had been given.

68.  The PIC’s decision was relayed to the Applicant’s solicitors on 17 May 2022. After reciting the pertinent parts of Foo 2^nd Expert Opinion, the PIC stated that it “concurred with the opinion of the independent expert”, and that the PIC noted Madam Tung had been treated by Dr Teo for “almost four years and was satisfied that implied consent had been given”. This is the “Decision”.

69.  In these circumstances, the Applicant launched his application for judicial review against the Decision.

C.  Grounds of Review

70.  By the Form 86, the Applicant advances 3 grounds of review against the Decision. In gist, he contends that the Decision was Wednesbury unreasonable in 3 main respects.

(1)  First, the Decision was Wednesbury unreasonable because the PIC refused to refer the issue as to whether the prescription of Sunitinib by Dr Teo was “necessary and appropriate in view of the diagnosis of NSCLC” to the Council.

(2)  Second, the Decision was Wednesbury unreasonable because the PIC refused to refer the issue of the appropriateness of the off-label use of Sunitinib for the treatment of HCC to the Council, given – in particular – Professor Lee’s opinion that Sunitinib was of “low efficacy” and severely toxic.

(3)  Third, the Decision was Wednesbury unreasonable because the PIC refused to refer the issue of whether Madam Tung had given proper informed consent for the off-label use of Sunitinib for the treatment of HCC to the Council.

71.  The PIC and Dr Teo, of course, contend that the Decision was not unreasonable. They characterise the challenge as, in effect, seeking a review on the merits, where the PIC made a professional and independent assessment based on the available evidence that there was no real prospect of a finding of misconduct against Dr Teo. They further contend that the Applicant failed to exhaust available remedies, though I do not need to deal with the latter point given my conclusion on the merits.

D.  Law

72.  As alluded to above, there is a three-stage process for handling complaints against registered medical practitioners: see Chairman, Preliminary Investigation Committee, Medical Council of Hong Kong v Hospital Authority [2022] 1 HKLRD 330 at §5. The present case concerns the second stage.

73.  At the second stage:

(1)  Under section 9(2) of the Regulation, the Secretary of the Medical Council (“Secretary”) is obliged inter alia (1) to notify the defendant of the receipt of the complaint, information or referral, and indicate any matters or allegations which may appear to raise a question whether the defendant has been guilty of misconduct in a professional respect, and (2) to invite him to submit to the PIC in writing any explanation of his conduct or of any matter alleged in the complaint, information or referral which he may have to offer.

(2)  Further, under section 11(2) of the Regulation, the Secretary shall put before the PIC the complaint or information received (if any), any statutory declaration received with it, any written explanation submitted by the defendant, any documents, medical or other reports produced by the defendant, and any other document or matter in the nature of evidence relevant to or in support of the complaint, information or matter and which is available.

(3)  Section 11(7) further empowers the PIC to make further investigations, obtain further clarifications from the defendant with regard to the case being considered by the Committee and with regard to his explanation, and may obtain such additional advice or assistance as it considers necessary.

(4)  Under section 11(8) of the Regulation, the Committee “shall”, having regard (“在顧及”) to any written explanation submitted by the defendant and all the materials put before it by the Secretary under section 11(2) of the same, consider (“考慮”) the case, and decide whether to refer the matter for inquiry.

74.  The test for whether the defendant has been guilty of misconduct in a professional respect is not in dispute. The question is whether the “doctor’s conduct has fallen short of the standard expected among doctors”: see Dr Chan Po Sum v Medical Council of Hong Kong [2015] 1 HKLRD 330 at §50.

75.  The role of the PIC is to screen out some complaints, where disturbance to medical practitioners is not justified. Again as alluded to above, the PIC must find that there is a prima facie case of professional misconduct by a doctor before it refers the complaint for an inquiry. There is some dispute as to what this precisely means.

76.  It is not disputed that the PIC should examine whether the complaint has any “real prospect of being established”, and may conduct preliminary investigation into its prospects, and may refuse to refer the complaint to the Council if that real prospect is not present: see Law Yiu Wai Ray v the Medical Council of Hong Kong [2016] 4 HKC 1 at §135(4).

77.  But Mr Wong, for the Applicant, stresses that in deciding whether a complaint has a “real prospect of being established”, the PIC should not “resolve any conflicts of evidence”. This is particularly when the nature of the procedure itself means the complainant does not have the right of access to the doctor’s response, and the full state of materials at the second stage: see Law Yiu Wai Ray at §135(5). In this regard, the PIC must approach its task with the “utmost caution”. Mr Wong also refers to Mr K v Preliminary Investigation Committee of the Medical Council of Hong Kong [2020] HKCFI 321 at §35, which repeated the principles. But it is also important to note that the context of that case was where the PIC had considered that there was “no evidence” to substantiate the complaint of professional misconduct (which is not what the PIC did or said in the present case).

78.  On the other hand, both Mr Chan and Mr Ismail submit – to the extent that Law Yiu Wai Ray might seem to lay down a rule whereby the PIC is not to resolve any conflict of evidence whatsoever – that should not be followed. This is because of various reasons:

(1)  First, at the very least, there is clear Court of Appeal authority to the effect that the PIC is entitled to use its professional knowledge to assess the expert evidence and where appropriate prefer the evidence of one expert of another: see Lau Wah v Medical Council of Hong Kong [2021] HKCA 1136 at §§12(2) and 27-31. Indeed, this must be one of the reasons why the PIC is comprised (in part) of 4 medical professionals. If the matter turns on conflicting expert opinions on a matter of medical judgment, there will be circumstances where the PIC can confidently and safely prefer one expert over the other. Thus, insofar as it is alleged that the PIC was wrong to have resolved any conflict of evidence by preferring Foo 2^nd Expert Opinion over the Lee Expert Opinions, that must be wrong.

(2)  Second, to require the PIC to refer a case to an inquiry whenever there is a conflict of evidence would render the PIC’s evaluative, screening and preparatory functions, as envisaged under section 11 of the Regulation, nugatory. It would lead to the rather absurd result that whenever (1) the complainant has some inkling or evidence of misconduct (i.e. the complaint is not frivolous / groundless), and (2) the doctor chooses to defend himself, the PIC is obliged to refer the complaint for an inquiry. It would also run contrary to the language of the Regulation, namely that the PIC shall have regard and “consider” the doctor’s written explanation, documents, medical or other reports. That means, as an active intellectual process, engaging with and deliberating upon the materials, representations and submissions.

(3)  Third, if the PIC must send the complaint the way of the Council (1) if there is no evidence contrary to the complaint, and (2) if there is evidence contrary to the complaint, then the PIC may have a perverse incentive to just send the complaint to the Council. But, in doing so, the PIC would fail to perform its other public law / statutory duties, including properly to grasp the issues and deal with them in a proper manner: see Mr K at §§38-39.

79.  The result of this judicial review does not turn on this fine point of law, as I will explain below. But in any event, I accept Mr Chan’s and Mr Ismail’s submissions that the PIC is not automatically required to send a complaint for an inquiry once there is a “conflict” of evidence. I think this is supported by a fuller reading of Law Yiu Wai Ray, and as a matter of principle:

(1)  At §111, Zervos J referred to both Dr Li Wang Pong Franklin v Medical Council of Hong Kong & anor [2009] 1 HKC 352 – which referred to the case of R v GMC, ex parte Toth [2000] 1 WLR 2209. In Toth, Lightman J laid down the proposition that it is not for the PIC to “arrogate” to itself the role of weighing up conflicting evidence or judging the prospects of success, which was adopted by A Cheung J (as the CJ then was) in Franklin Li.

(2)  However, the proposition in Toth was later qualified by Sullivan J in R v GMC, ex parte Richards [2001] 1 Lloyd’s Rep Med 47 – which was referred to by the Judge at §112. There, Sullivan J said that Lightman J’s comments should not be read as suggesting that the screener – the PIC in this case – can never “under any circumstances resolve any conflict of evidence”. Rather, it should not normally seek to resolve “substantial conflicts of evidence”.

(3)  The Judge then went on in §113 to say this:

It should be noted that Sullivan J in Richards, whilst giving a general endorsement of Lightman J’s analysis in Toth, went on to qualify Lightman J’s statement that it is not the role of the PPC to resolve conflicts of evidence by saying that the PPC ‘should not normally seek to resolve substantial conflicts of evidence’… The qualification by Sullivan J should be treated with caution and does not, in my view, permit the PIC to have a general role in resolving disputed evidence for that is not the function of a screening body.

(4)  But rather conspicuously, Zervos J did not doubt Sullivan J’s comment that it could never be the PIC’s role to resolve conflicts of evidence altogether.

(5)  I think my conclusion is also consistent with the Judge’s comments that (1) the second stage involves a more “rigorous check” and a “more detailed consideration of the complaint” – which must be with reference to contrary evidence (see §44), and that (2) the MRO and the Regulation – even at the second stage – set out to provide a “just balance between the legitimate expectation of the complainant that a complaint of professional misconduct will be fully investigated and the need for legitimate safeguards for the medical practitioner, ‘who as a professional person may be considered particularly vulnerable to and damaged by unwarranted charges against him’” (§115). Plainly, the longer the spectre of disciplinary sanctions hang over the doctor, the more likely and irretrievable the reputational damage to the doctor.

(6)  Zervos J also recognized that the PIC’s consideration and, if necessary, further investigation, is to identify whether the materials placed before it would justify referral of the case to the Council for inquiry: see §135(3).

(7)  Referral is justified when (and only when) the PIC reaches the view that the complaint has a real prospect of being established. Considering whether there is a real prospect does not depend on the mere presence or absence of any conflict of evidence, but on an assessment of the materials overall (including where they might be thought to conflict). This seems to me to balance appropriately the interests of the complainant, the interests of the doctor the subject of the complaint, and the public interest in the maintenance of appropriate standards for the medical profession.

80.  It is not easy to conclude that the PIC had acted contrary to public law principles. Indeed, it is only in a highly exceptional case that the Court would interfere with the PIC’s decision whether to hold an inquiry, particularly if that decision turns on the assessment of the evidence concerning the medical profession. The Court respects the role of the PIC and that the PIC may use its professional knowledge to assess the evidence. The Court should not and would not likely lightly impose its views on the appropriate weight to be attributed to the evidence on the views of the PIC. The function of the Court does not involve re-examining whether the decision of the PIC was correct or not. The Court can only consider whether the decision of the PIC was without legal basis, Wednesbury unreasonable, or procedurally unfair: see Lau Wah at §12(2) and (3).

81.  That is consistent with the high threshold generally for finding irrationality or Wednesbury unreasonableness in a public law challenge, but is especially so where the decision concerns an assessment of the professional conduct of a professional by the professional body. Hence, where the PIC concludes, on the basis of the materials and information before it, that there is insufficient evidence to show a reasonable prospect of the doctor being found guilty of misconduct in a professional respect, that is a valid and sufficient reason for the PIC’s decision: see Leung Wai Kuen v Preliminary Investigation Committee of the Medical Council of Hong Kong [2021] HKCFI 132 at §§20 and 22.

82.  It is also trite that the reasonableness of the decision falls to be determined at the date and evidence known to the decision-maker at the time: see, for example, Secretary of State for Education and Science v Tameside Metropolitan Borough Council [1977] AC 1014, 1052C-E; R v Ministry of Defence, ex parte Smith [1996] QB 517, 554C-D.

83.  Bearing these principles in mind, I now turn to the respective grounds of review.

E.  Ground 1

84.  For Ground 1, the Applicant complains that the Decision was unreasonable because it did not refer the issue of whether the prescription of Sunitinib in view of the NSCLC was necessary and appropriate to the Council. I do not think this Ground has any merit.

(1)  It was not Professor Lee’s opinion that Dr Teo used Sunitinib to treat Madam Tung’s NSCLC. Rather, she has only said that Sunitinib was not necessary or appropriate to treat “unresectable HCC”.

(2)  Further, the contemporaneous medical records of Dr Teo – as well as the Consent Form – show that Sunitinib was used to treat Madam Tung’s HCC. As alluded to above, Sunitinib “replaced” Sorafenib as treatment. If Sorafenib was used to treat HCC (and there is no dispute that is the case), and Sorafenib “replaced” it, then logically Sunitinib was used by Dr Teo to treat HCC.

(3)  So I do not actually think there was evidence before the PIC to support the Applicant’s view that Sunitinib was prescribed “in view of” Madam Tung’s NSCLC, or that NSCLC would have made Sunitinib inappropriate or unnecessary in itself or to a greater extent.

(4)  It seems to me that it was eminently reasonable for the PIC to have been – as put by Mr Wong – “silent” as to this issue, precisely because this was not actually an issue that the PIC thought it had to ponder.

(5)  Equally, it was also reasonable for the PIC to have put weight on Dr Foo’s opinion that Madam Tung’s NSCLC “did not change anything in the management concerning Madam Tung” for the reasons he gave. NSCLC was treated by radiotherapy (out of the scarce options that existed), and HCC was treated by the substitute drug of Sunitinib.

85.  In these circumstances, I do not need to deal with whether Sunitinib was contraindicated for the treatment of NSCLC or not.

86.  Nor do I have to consider in any depth whether Dr Teo misdiagnosed the lesion in the RLL of Madam Tung’s lung as metastatic HCC, in light of (1) how it is clear that Dr Teo did not, from the contemporaneous records, (2) Sunitinib was used to treat the diagnosis of HCC, and (3) Dr Foo’s comments that the diagnosis of NSCLC would not have made a difference as to whether the prescription of Sunitinib was appropriate or necessary.

87.  In gist, the issue of whether the prescription of Sunitinib was inappropriate or unnecessary in light of Madam Tung’s NSCLC was not actually or properly put before the PIC. The PIC certainly cannot be blamed for not “dealing” with it.

88.  Ground 1 thus fails as being not reasonably arguable with any realistic prospect of success.

F.  Ground 2

89.  Under Ground 2, the Applicant contends that the Decision was unreasonable as the PIC failed to refer the issue of whether the ‘off-label’ use of Sunitinib was necessary and appropriate to the Council in light of Madam Tung’s HCC. In gist, Mr Wong’s argument is that Sunitinib is of “low efficacy” and “severe toxicity”.

90.  Again, I fail to see how Ground 2 could arguably be made out.

91.  First, even in Lee 2^nd Expert Opinion, Professor Lee admitted that the Wörns Study – which is the only study cited in the context of Sunitinib being prescribed as a “second line”, instead of a “first-line treatment”, for HCC – showed that Sunitinib had a “modest” clinical efficacy. This was also noted in Dr Teo’s Representations and Foo’s 2^nd Expert Opinion. The Wörns Study, Dr Teo’s Representations, and Foo’s 2^nd Expert Opinion were all before the PIC.

92.  In such circumstances, Mr Wong is wrong to say that there were “conflicting expert opinions” between Professor Lee and Dr Foo as to the efficacy of Sunitinib in a second line treatment – which, of course, is the relevant context. Thus, I do not think Mr Wong is right that given this “conflict”, the PIC acted unreasonably in not referring this issue to the Council for an inquiry.

93.  Further, I would think that for this reason alone the PIC had ample basis to conclude that Dr Teo’s “second line treatment” involving – and thus ‘off-label’ use of – Sunitinib was not inappropriate or unnecessary, particularly when it is indisputable that Madam Tung’s HCC was progressing as the expected life span of someone with relapsed liver cancer was about 10 months.

94.  In contrast, I do not think that the Lee 2^nd Expert Opinion really gave much reason as to why the use of Sunitinib in the ‘off-label’ or “second line” context was inappropriate or unnecessary. The high point of Lee 2^nd Expert Opinion was that given that Sorafenib and Sunitinib had similar pharmacological actions, their adverse effects would be similar – so that, if used together, “additional side effects” would be “expected”. But there does not seem to be evidence to support this “expectation”.

95.  Indeed, while Madam Tung did suffer from toxicity-related adverse effects, it is difficult actually to pinpoint whether Madam Tung’s ailments were caused by Sunitinib or Sorafenib, or whether she would have suffered these ailments irrespective of whether Sunitinib was prescribed – such that the PIC could conclude there was a “real prospect” that Sunitinib was not necessary or appropriate, and Dr Teo had committed professional misconduct.

(1)  For example, even according to the American Hospital Formulary Service website accessed on 24 January 2019 by Professor Lee, hypertension occurred in approximately 9.4% of patients with unresectable HCC. Sorafenib may equally cause haemorrhage, Palmar-plantar erythrodysesthesia – also known as hand-foot syndrome – and they are also “common adverse effects of sorafenib”.

(2)  While that is not to say that Sunitinib could not have been the cause of such adverse effects – indeed, the Wörns Study shows that patients do predominantly suffer from Grade 1 or 2 adverse effects after the prescription of Sunitinib – it is difficult to pin Sunitinib to being the root cause of such toxicities, such that they were unnecessary or inappropriate.

96.  The above further suggests that the PIC had ample reason to “concur” with Dr Foo, instead of Professor Lee. This is particularly when Dr Foo is a clinical oncologist with over 35 years of experience, and that Professor Lee is a clinical pharmacist specialising in cardiovascular medicine and not oncology. This Court – unless there are highly exceptional reasons – should not interfere with the PIC’s conclusion, and its choice to prefer one expert over another in matters of professional and medical judgment.

97.  I do not think there is any merit in Mr Wong’s contention that the PIC had “fettered the exercise of its investigatory power and duty by effectively disregarding Professor Lee’s expert opinion and deferring to and endorsing Dr Foo’s expert opinion merely because Dr Foo is a specialist in clinical oncology”. Rather, in both the Minutes and the Decision, the PIC specifically “noted / considered” the Wörns Study as one of the bases for accepting Dr Foo’s expert opinion. That paper concluded Sunitinib provided modest anti-tumour activity in patients with advanced HCC after progression under Sorafenib. As I expressed above, this was a cogent and rational reason for accepting that the second line and ‘off-label’ use of Sunitinib was appropriate, and that there was no real prospect of establishing professional misconduct by Dr Teo.

98.  Ground 2 thus fails as being not reasonably arguable with any realistic prospect of success.

G.  Ground 3

99.  Under Ground 3, the Applicant contends that the Decision was unreasonable because the PIC failed to refer the issue as to whether Dr Teo had obtained proper consent from Madam Tung as to the ‘off-label’ use of Sunitinib.

100.  I will address this issue in two stages. First, whether there was consent as when Sunitinib was prescribed: (a) the 3 occasions from September 2009 to October 2009, and (b) the 7 occasions from August 2012 to May 2013. Second, whether there was consent specifically to the ‘off-label’ use of Sunitinib – and indeed, whether this was a requirement.

101.  It is incontrovertible that August 2012 consent was given by virtue of the Consent Form, which was shown to the PIC. There is no suggestion that Madam Tung was incapacitated. Furthermore, the Consent Form demonstrated that the consent so obtained was fairly comprehensive. According to the Consent Form, not only did Dr Teo explain the purpose, possible benefits and potential risks of treatment and other treatment alternatives, but he had also told Madam Tung that she could stop receiving Sunitinib “at any time”.

102.  I also think it was reasonable for the PIC to have concluded that there had been “implied consent” to the administration of Sunitinib in September 2009 to October 2009 on the evidence that was before it:

(1)  Sunitinib was prescribed on three occasions on 14 September 2009, 29 September 2009, and 5 October 2009.

(2)  The Applicant himself did not complain that Dr Teo failed to obtain consent for Sunitinib per se – rather, the complaint was that Dr Teo did not obtain consent for the use of Sunitinib for an “investigational approach” (but, as is crystal clear, Sunitinib was not prescribed by Dr Teo in a clinical trial setting).

(3)  Dr Teo’s Representations state that he did properly explain the treatment to Madam Tung and his family, including the condition, potential risks and benefits of treatment, and alternatives. The PIC was entitled and obliged to have regard to Dr Teo’s Representations, under sections 9 and 11 of the Regulation. In light of the Consent Form, that was believable.

(4)  The lack of a consent form in 2009 did not mean that no consent had been obtained. This is because the Code that was in force in 2009 did not make written consent mandatory.

103.  As to the second stage, the question arises as to whether there was a requirement at all – under the Codes prevailing in September 2009 or August 2012 – that Madam Tung’s consent as to the ‘off-label’ use of Sunitinib must be obtained. I do not think so. I accept Mr Chan’s straightforward submission that there was no requirement at the time that a doctor must expressly explain to a patient that a particular medication was being used in an ‘off-label’ manner, or as a “second line” treatment. If no particular requirement can be identified – and certainly none has been identified by Mr Wong – it is difficult to see how there is a real prospect that Dr Teo could be said to have committed professional misconduct in this respect.

104.  In any event, I would have thought that the “second line” or ‘off-label’ nature of the prescription of Sunitinib would have been quite clear. Sunitinib was not the “first choice” drug. Madam Tung must have known that she was in a precarious position after 2009 when her liver cancer relapsed. But she signed a Consent Form in 2012 and was administered Sunitinib thrice in 2009. Indeed, it seems to be quite clear that there was implied consent even as to the ‘off-label’ use of Sunitinib. At least, the PIC plainly took that into account in its Decision by saying that Madam Tung had returned to Dr Teo for treatment for 4 years.

105.  Mr Wong contended in his submissions that the PIC failed to exercise its powers under sections 11(2) and (7) of the Regulation to request a complete set of Madam Tung’s medical records – and thus consent forms – from the Centre. However, this was not part of the argument in the Form 86. For this reason, I will not entertain this. Indeed, it is one thing to allege that the PIC reached a Wednesbury unreasonable decision on the materials that it had before it. It is another to allege that the PIC did not carry out its statutory functions properly.

106.  In his 2^nd affirmation, the Applicant also adduced various consent forms to cast doubt as to whether Dr Teo had actually obtained consent from Madam Tung in respect of the prescription of other drugs, such as Sorafenib; and whether Dr Teo had meticulously – or substantively – advised Madam Tung as to all aspects of the prescription of other drugs, such as Alimta and Avastin. In gist, the Applicant tries to portray Dr Teo as taking a cavalier approach towards consent in general, and that he would never “fully” advise Madam Tung or her family members on the prescription of various drugs.

107.  I do not need to concern myself with that, as (1) the present judicial review is strictly related to the prescription of Sunitinib, and (2) the consent forms exhibited in the Applicant’s 2^nd affirmation (as alluded to above) were not even brought to the PIC’s attention when it made its Decision. Whether the Decision was Wednesbury unreasonable must be assessed according to the evidence known to the PIC at the time it made its Decision.

108.  Further, if the Applicant wished to make a complaint against Dr Teo based on these newly produced consent forms and the prescription of other drugs, then he ought to have first exhausted the alternative remedy of the complaint mechanism to the Council and PIC under the MRO and Regulation.

109.  Ground 3 thus fails as being not reasonably arguable with any realistic prospect of success.

H.  Result

110.  I dismiss the Applicant’s application for judicial review.

111.  I do not see why costs should not follow the event, so that the Applicant pays the PIC’s and Dr Teo’s costs. However, I will make this order first on a nisi basis, which will become absolute after 14 days unless before that a variation application is made. Any variation application will be made on paper.