HKSAR v. MAK WAN LING

HCCC 437/2015

[2020] HKCFI 2424

IN THE HIGH COURT OF THE

HONG KONG SPECIAL ADMINISTRATIVE REGION

COURT OF FIRST INSTANCE

CRIMINAL CASE NO 437 OF 2015

________________________

________________________

_______________

D E C I S I O N

_______________

The application

1.  The defendant faces one count of Manslaughter, contrary to Common Law and punishable under Section 7 of the Offences against the Person Ordinance, Cap 212. She was originally charged and tried together with two other defendants: Chow Heung-wing, Stephen (D1) and Chan Kwun-chung (D2). The defendant was D3 at the time. The jury was unable to reach a verdict in her case and she has to face a re-trial on her own.

2.  The prosecution applied to amend the indictment.

1^st proposed amendments

3.  I will set out the indictment with the 1^st proposed amendments:

“PARTICULARS OF OFFENCE

MAK Wan-ling, on the 10th day of October, 2012, in Hong Kong, together with Chow Heung-wing, Stephen and CHAN Kwun Chung, unlawfully killed CHAN Yuen-lam also knowns as CHAN Oi-lin, (‘the said CHAN Yuen-lam lam’) by gross negligence in that-

(i (1) Being a properly registered Doctor responsible for administering to the said CHAN Yuen-lam a product known as CIK/AI therapy on behalf of the DR Esthetic Centre (Causeway Bay) Limited and / or Hong Kong Mesotherapy Centre Limited, both companies being part of the ‘DR Group’, owed a duty of care to the said CHAN Yuen-lam;

(ii (2) In Breach of that duty of care, in the knowledge that the said CIK/AI therapy was based on experimental process for the treatment of cancer and which involved the extraction, manipulation in a laboratory and reintroduction of blood taken from the said CHAN Yuen-lam (“(‘the said blood product”), product’), failed to take reasonable care for the safety of the said CHAN Yuen-lam by –

(a) Failing to ensure that a properly qualified person or a properly accredited laboratory was responsible for preparing and producing the said blood product.

(b) Failing to ensure that all necessary viral and bacteria tests had been carried out on the said blood product and that such had been documented prior to administering it to the said CHAN Yuen-lam so as to ensure the said blood product was free of contamination.

(c) Failing to ensure that the said CHAN Yuen-lam was fully informed of the risks involved in the administration of the said CIK/AI therapy;

(d) Administering the CIK/AI therapy to the said CHAN Yuen-lam without first having obtained a proper consent from the said CHAN Yuen-lam by reason of her failure to properly inform, and advise the latter that;

(i) CIK/AI therapy was still undergoing clinical trial as a modality of treatment for cancer;

(ii) even as a modality for treatment of cancer, the efficacy of CIK/AI treatment was unproven and uncertain;

(iii) the proposed use of CIK/AI therapy for the purpose of improving or enhancing immunity (or as a wellness remedy for health promotion) had not been scientifically proven;

(iv) there was no scientifically proven benefit to be derived from the use of CIK/AI therapy on healthy persons or non-cancer patients such as the said CHAN Yuen-lam;

(v) the preparation of CIK/AI therapy involved culturing of blood cells in a medium exposed to open air over a duration of time thus carrying with it a risk of infection or contamination by bacteria;

(vi) CIK/AI therapy was attendant upon by risks of adverse effects or reactions such as systemic bacterial infection, wound infection, hypotension and hypersensitivity, which could be life-threatening in which case emergency admission to hospital would be necessary;

(vii)there was no medical indication for CIK/AI therapy in healthy persons or non-cancer patients such as the said CHAN Yuen-lam;

(viii) there were various safe and non-invasive alternative means for enhancing or improving immunity in human bodies and the use of CIK/AI therapy for such purpose was not necessary or medically justified;

(e) Being a registered medical practitioner, failed to give any or any sufficient regard for the fact the intended use of CIK/AI therapy on the said CHAN Yuen-lam:

(i) constituted a clinical trial in respect of which no application had been made to (and no approval had been obtained from) the relevant ethics committee of the Medical Council of Hong Kong and the Department of Health as stipulated in s.22 under Part F of the Code of Professional Conduct published by the Medical Council of Hong Kong (in January 1999); or

(ii) constituted an alternative treatment modality within the meaning of s.24 under Part F of the said Code of Professional Conduct;

which ought not have been carried out in the circumstances.

(iii (3) Her aforesaid breach of duty amounted to gross negligence on her part; and

(iv (4) Her aforesaid negligence was a substantial cause of the death of the said CHAN Yuen lam.”

Hearing on 1 September 2020

4.  At the hearing on 1 September 2020, after considering written submissions and hearing oral submissions from both parties, I referred to the transcript of the Closing Speech of the prosecution (which will be set out later here) during the first hearing and made some observations, principally to the prosecution.

5.  I referred to the preamble of section (ii) in the original indictment, which read: “In breach of that duty of care, in the knowledge that the said CIK/AI therapy was based on experimental process for the treatment of cancer…”, I was of the view that the wording “experimental process for the treatment of cancer” already encompassed the proposed 2(d)(i)(ii), with those particulars being further explanation or elaboration of the experimental nature of the treatment. Adding those two particulars might unnecessarily burden the jury and overload the indictment.

6.  I also pointed out that, in my view, particulars 2(d) (iii), (iv), (vii) and (viii) covered the same issue: that there was no proof that CIK/AI therapy would improve one’s immunity. I indicated just having particular (iv) was sufficient to make this point, without overloading the indictment.

7.  I made the point that particulars (v) and (vi) had always been the main thrust of the prosecution case. Having said that, there was indeed an overlap of (c) and (d). I suggested the prosecution to consider deleting (c) altogether, as (d) already covered (c).

8.  As for 2(e) in the 1^st proposed amendments, I indicated, with reference to the transcript, that the prosecution case had always been that the CIK/AI treatment should not have been given to any person, including the deceased.

9.  Bearing in mind how the issue of the alleged breach of the Code of Professional Conduct came to be introduced and canvassed by the prosecution rather late in the first trial, and that it was not the main thrust of the prosecution case, I was of the view that adding those particulars would unnecessarily complicate the issues for the jury.

10.  As a result of my indication, the prosecution submitted a 2^nd proposed amendments for my consideration.

2^nd proposed amendments

“PARTICULARS OF OFFENCE

Mak Wan-ling, on the 10th day of October, 2012, in Hong Kong, together with CHOW Heung-wing, Stephen and CHAN Kwun-chung, unlawfully killed CHAN Yuen-lam also known as CHAN Oi-lin, (‘the said CHAN Yuen-lam’) by gross negligence in that –

(1) Being a properly registered Doctor responsible for administering to the said CHAN Yuen-lam a product known as CIK/AI therapy on behalf of the DR Esthetic Centre (Causeway Bay) Limited and / or Hong Kong Mesotherapy Centre Limited, both companies being part of the ‘DR Group’, owed a duty of care to the said CHAN Yuen-lam;

(2) In breach of that duty of care, in the knowledge that the said CIK/AI therapy was based on experimental process for the treatment of cancer and which involved the extraction, manipulation in a laboratory and reintroduction of blood taken from the said CHAN Yuen-lam (“the said blood product”), failed to take reasonable care for the safety of the said CHAN Yuen-lam by-

(a) Failing to ensure that a properly qualified person or a properly accredited laboratory was responsible for preparing and producing the said blood product.

(b) Failing to ensure that all necessary viral and bacteria tests had been carried out on the said blood product and that such had been documented prior to administering it to the said CHAN Yuen-lam so as to ensure the said blood product was free of contamination.

(c) Failing to ensure that the said CHAN Yuen-lam was fully informed of the risks involved in the administration of the said CIK/AI therapy.

(c) Administering the CIK/AI therapy to the said CHAN Yuen-lam without first having obtained a proper consent from the said CHAN Yuen-lam by reason of her failure to properly inform and advise the latter that:

(i) CIK/AI therapy was still undergoing clinical trial as a means of treatment for cancer and, in that regard the efficacy of CIK/AI treatment was unproven and uncertain;

(ii) there was no scientifically proven benefit to be derived from the use of CIK/AI therapy on healthy persons or non-cancer patients such as the said Chan Yuen-lam;

(iii) the preparation of CIK/AI therapy involved culturing of blood cells in a medium exposed to open air over a duration of time thus it carried a risk of infection or contamination of the patient on whom it was administered;

(iv) the administration of CIK/AI therapy had risks of adverse effects or reactions such as systemic bacterial infection, wound infection, hypotension and hypersensitivity, which could be life-threatening in which case emergency admission to hospital would be necessary;

(v) there were various safe and non-invasive alternative means for enhancing or improving immunity in human bodies and the use of CIK/AI therapy for such purpose was not necessary or medically indicated;

(d) Failing to give any or any sufficient regard for the fact the intended use of CIK/AI therapy on the said Chan Yuen-lam ought not have been carried out in the circumstances.

(3) Her aforesaid breach of duty amounted to gross negligence on her part; and

(4) Her aforesaid negligence was a substantial cause of the death of the said CHAN Yuen-lam.”

11.  One can immediately see that the 2^nd proposed amendments did away with the original particular 2(c) and combined the allegation under the original 2(c) with the new 2(c). Further, the proposed particulars under the 1^st proposed 2(d) have been pared down to give a more succinct allegation under the new 2(c).

12.  In the new 2(d), the prosecution did away with the reference to “clinical trial” and “alternative medical modality” originally in the 1^st proposed amendments and now only alleged a failure on the part of the defendant to give regard for the fact that the CIK/AI treatment should not have been carried out on the deceased in the circumstances.

Section 23 of the Criminal Procedure Ordinance Cap 221

13.  The application was based on Section 23(1) of the Criminal Procedure Ordinance (CPO) Cap 221 which reads:

“(1) Where, before trial or at any stage of a trial, it appears to the court that the indictment is defective, the court shall make such order for the amendment of the indictment as the court thinks necessary to meet the circumstances of the case unless, having regard to the merits of the case, the required amendments cannot be made without injustice.”

Prosecution submission

14.  The prosecution submitted that the purpose of the application to amend the indictment was to provide better particulars regarding the alleged breach by the defendant to the deceased in relation to her failure to inform the deceased of factual information regarding CIK/AI therapy.

15.  The prosecution pointed to evidence already adduced in the first trial and submitted that the amendments would allow parties to focus clearly on their respective cases.

16.  It was submitted that there was no risk of prejudice to the defendant as these were the same issues canvassed during the first trial and the evidence would be adduced by the same prosecution witnesses as in the first trial.

17.  Whilst this case is not a “re-trial” in the sense of one being ordered under section 83E of the Criminal Procedure Ordinance, Cap 221, the prosecution relied on the case of R v Booker[1]in support of their application.

18.  The prosecution also relied on the fact that amendment to the indictment had been granted in Hong Kong, as shown in the case of the retrial of Tsang Yam-kuen Donald[2].

19.  The prosecution submitted that the amendment did not change the prosecution’s underlying case against the defendant.The proposed amendments did not require the prosecution to adduce any additional evidence beyond those adduced during the first trial. The proposed amendments did not impose any additional burden on the defendant but would bring more focus and clarity to the trial.

20.  After paring down the scope of the amendments, the prosecution explained the 2^nd proposed amendments were the result of taking on board what the Court had said during the last hearing. The prosecution also referred to the word “necessary” in section 23 of CPO, and to authorities in England and Hong Kong, and submitted that the section was to be approached in a broad manner: R v Smith & Ors[3] and AG v Chan Hung-hoi[4].

Defence stance

21.  The defendant did not oppose to amendment 2(a) in relation to the addition of the words “or a properly accredited laboratory”.

22.  The defence relied on the Australian authority of Mejid Hamzy v R[5] and the cases cited in the judgment: R v Anderson[6] and Gilham v R[7] and submitted that whilst the prosecution might “remould” its case on a retrial, it had to retain the basic factual premises that underline the prosecution’s case. A retrial should not be used by the prosecution to reconstruct, supplement or “patch up” its case.

23.  The defence submitted that proposed amendments not only caused unnecessary complexity to the indictment, they would also result in an unnecessary overloading of the indictment – something which the Courts in Hong Kong had traditionally frowned upon. A number of cases were cited in support: R v Ma Lap Sun[8] citing R v Au Yeung Siu Wai & Another[9] and AG v Wong Sek Shing[10].

24.  The defence also relied on the case of R v Novac[11]on this point.

25.  The defence maintained that adding the additional particulars to the original 2(c), as now shown in the new 2(c) was unnecessarily making the indictment more complex and amounted to an overloading of the indictment.

26.  The defence strongly opposed to the addition of 2(d) in the 2^nd proposed amendments, which read: Failing to give any or any sufficient regard for the fact the intended use of CIK/AI therapy on the said Chan Yuen-lam ought not have been carried out in the circumstances.  

27.  The defence submitted that such an amendment would result in the defendant facing a significantly different case from that previously advanced against her. The original indictment did not allege that the therapy should never have been carried out, rather the thrust was that there was failure in various respects in carrying out the therapy.

28.  With reference to the closing speech of the prosecution, while the prosecution had addressed to the jury that the CIK/AI therapy was “an unproven and wholly unnecessary medical procedure…”, the defence submitted that there was a clear difference between therapy that was “unproven and wholly unnecessary” and therapy which “ought not to have been carried out.”

29.  The defence referred to its closing speech to the jury, pointing out that while there was much evidence led by the prosecution as to whether the CIK therapy should have been carried out, it was not an allegation in the indictment that the defendant “breached her duty simply by carrying out the therapy”. The breach of duty alleged was that in carrying out the therapy she failed with respect of the three matters which were clearly set out in the indictment. I was informed that the defence chose not to address this issue as it was a “jury point”.

30.  Further, the defence submitted that only one of the professional experts, i.e. Professor Yuen, who had expressly said that the CIK was a wrong treatment which should not have been done. There was no direct evidence from any other experts that the CIK therapy was “wholly unnecessary” or “ought not have been carried out at all”.

31.  The defence submitted that it was particularly objectionable in the context of a retrial in this case following the inability of the jury to reach a verdict. The prosecution was clearly endeavouring to “patch up” its case by way of reconstruction and/or supplementation, which was not permissible.

32.  Additionally, the defence submitted that the amendments would result in injustice to the defendant in her having to undertake further substantial preparation for her retrial. The defendant had already been through the ordeal of a lengthy trial and had already undertaken significant preparation for the trial. If amendments were allowed, the defendant would need to undertake enquiries with potential medical experts as to whether there was any justification for the proposition that the therapy ought not to have been administered, as opposed to whether it was proven or necessary. The defence submitted that it was an unjustified burden that should not be permitted.

33.  I should point out that the defence also opposed to 1^st proposed amendments in relation to the alleged breach of the Code of Professional Conduct. Since the prosecution is no longer applying to add those particulars regarding “clinical trials” or “alternative medical treatments”, there is no need for me to set out the grounds of opposition raised by the defence.

Consideration of the submissions

34.  Since the prosecution replaced the 1^st proposed amendments with the 2^nd one, I only need to consider the 2^nd proposed amendments.

35.  None of the cases cited by both parties are on all fours with the present case. A particular feature of this application is that the evidence already adduced during the first trial covered the particulars proposed. I don’t think any purpose would be served by referring to the facts of the cases cited, save to say that I am in agreement with the principles enunciated.

36.  The trial judge retains a discretion in deciding whether to permit the amendment of the indictment but fairness to the defendant must be central to the decision: Booker. Whilst the prosecution may “remould” its case on a retrial, it must retain the basic factual premises that underline the prosecution’s case. A retrial should not be used by the prosecution to reconstruct, supplement or “patch up” its case: Hazmy and the cases cited therein. In considering the application, the judge is obliged to make such amendment as necessary to meet the circumstances of the case, unless the required amendments cannot be made without injustice: Chan Hung-hoi.

37.  The issue I have to decide is whether the proposed amendments ie. 2(c) and 2 (d) provide better particulars in accordance with evidence already adduced during the 1^st trial (which will be adduced again during the re-trial) concerning the case the defendant has to face, or they amount to a “reconstruction” or “patching up” of the prosecution case. More importantly, I have to decide whether to allow the proposed amendments would be unfair to the defendant.

38.  Before considering the proposed amendments, I think it might be useful to see how the prosecution framed its case against the defendants in general in its closing speech (as recorded in the live notes).

“Now, you will recall that at my opening speech, I encapsulated the whole case in one paragraph, and it reads, it is an unproven and wholly unnecessary medical procedure, ie CIK treatment, procured, arranged and administered by one or more of the defendants, who are monitored by – who are motivated by monetary or personal gain involving the infusion of blood product which was improperly prepared, produced and checked prior to infusion, thereby causing the death of the deceased by blood poisoning due to contamination of the blood product by bacteria.” (Day 85, Page 4, line 5 – 15). (Emphasis applied)

39.  I placed emphasis on the words “an unproven and wholly unnecessary medical procedure”. In the original indictment, it was alleged that the defendant, knowing that “CIK/AI therapy was based on experimental process for the treatment of cancer…” did certain acts which the prosecution alleged to be in breach of her duty of care to the deceased. There was of course no mention that the CIK/AI therapy should not have been carried out. It was clearly the prosecution case that the said therapy was “unproven and wholly unnecessary”. The question I have to decide is whether something that is “unproven and wholly unnecessary” is different from something “which ought not have been carried out”, as submitted by the defence.

40.  Now, in relation to the issue of informed consent, the prosecution said this in its closing speech:

“Assuming you were told, ‘In fact CIK treatment is unproven, it is just a theory that it may or may not work, and there are other side effects apart from fever, such as hypotension that could be fatal, and such as anaphylactic reactions, hypersensitivity to the content included in the infusate, and there is also a risk of bacteria contamination. In theory, CIK cells would boost your immunity, but in fact you don’t need it, you can maintain a healthy lifestyle, maintaining a healthy mental balance, that would be the best medicine, or the best method to cope with a balance of your immunity system’, would you still have accepted the treatment and say, ‘I’m willing to try?’” (Day 85 page 78 line 22 to page 79 line 9).

41.  As against D3, the prosecution had this to say, again in its closing speech:

“… it just highlight the fact that within the DR Group the 3^rd defendant is almost a front man, because she is a doctor she lends credibility to the sales effort…And that would give an air of professionalism and independence in the eyes of the customers of the DR group. … It was suggested that the doctors are independent, and that’s why the DR group can have no control over the doctors. So that is the scheme of things devised by the 1^st defendant in the DR group, and the 3^rd defendant is part of the machinery to create this impression of independence or professionalism. And an ordinary person would not know that in fact the advice he or she was receiving from the 3^rd defendant is not truly independent.” (Day 88 page 93 line 8 to page 94 line 4)

…

“But coming back to the 3^rd defendant, she knew about the Declaration of Helsinki. She knows about the duty of a doctor to act in the best interests of the patient, not to give treatment which is unnecessary. Inform the patients of all the information necessary so that an informed decision can be made, balancing the risk and benefit. Did she discharge her duty?” (Day 88, page 109 line 22 to page 110 line 3). (Emphasis applied)

42.  The prosecution spelt out the breach on the part of D3 as a doctor with reference to her duty as required under the Declaration of Helsinki, and again the emphasis on the unnecessary nature of the CIK/AI treatment, thus alleging that the defendant should not have given the treatment to the deceased.

43.  As acknowledged by the defence, leading counsel in his closing speech to the jury commented that “much evidence was brought by the prosecution to the issue whether the CIK therapy should have been carried out at all”:

“Firstly, much of the prosecution’s focus has been on the question as to whether the CIK therapy should have been carried out at all. Much evidence was brought to your attention by the prosecution in this respect. And my learned friend for the prosecution referred to it time and again during his closing remarks. But, you may well feel that that issue is not critical to the case against Dr Mak. And you may feel that because, as you will have already noticed and as we will see again in a few moments when we go to the indictment, it is not the allegation that Dr Mak breached her duty simply by carrying out the therapy. The breached of duty alleged is that in carrying out the therapy, she failed with respect to the three matters which are so clearly set out in the indictment. That is a very important distinction” (Day 94 page 8 line 7-23) (Emphasis applied)

44.  Indeed, as pointed out by the prosecution, in my summing up to the jury, I said:

“It is the prosecution’s case that the CIK treatment was an experimental treatment for cancer patients at the time, in 2012. No matter what the DR Group called the treatment, it was essentially a medical treatment and a medical procedure; there is no evidence of any health benefit of such a treatment which should never have been administered to a healthy person. And, it is the prosecution’s case that each of the defendants owed a duty of care to the deceased, Chan Yuen Lam, in their own capacity.” (Day 95, page 10, line 7-16) (Emphasis applied)

45.  It can also be seen, from my summing up to the jury, that I have made fairly detailed reference to the evidence of the various medical experts in relation to the issue that the CIK therapy should not be given to a healthy person:

“You of course heard the many experts saying that CIK therapy at the time was for cancer patient, still experimental, and it is not even proven, and shouldn’t be given to a healthy person. You have heard quite a number of experts saying that. I will just remind you who said what… [reference to the evidence given by various prosecution experts]” (Day 95 page 116 line 9 to page 124 line 14) (Emphasis applied)

46.  With these in mind, I will turn to the 2^nd proposed amendments.

47.  There is no objection to the amendment to 2(a).

48.  In relation to the deletion of the original 2(c) and the addition of the new 2(c) (which is more succinct as compared to the 1^st proposed amendments), I find that the amendments properly reflect, and accord with, the evidence already adduced in the first trial (which will be called again in the re-trial.) Such particulars will assist the jury to address their minds as to the “particulars” of the various alleged breaches on the part of the defendant. I do not find the amendments unnecessarily complicated the issues or overload the indictment.

49.  The main contention is in relation to the new particulars 2(d) in the 2^nd proposed amendments: “Failing to give any or any sufficient regard for the fact the intended use of CIK/AI therapy on the said Chan Yuen-lam ought not have been carried out in the circumstances.”

50.  Whilst it may be arguable that something that is “unproven and wholly unnecessary” may not be exactly the same as something which “ought not have been carried out”, that there is a subtle difference, one must look at what actually took place during the first trial. It is correct that only one of the experts (ie. Professor Yuen) expressly said that the CIK therapy should not be done, the stance of the prosecution, as supported by all the medical experts, was that the CIK/AI therapy should not be given to healthy people.

51.  When a therapy is “unproven”, “wholly unnecessary” and “should not have been administered or given to a healthy person”, it could only mean that the said therapy should not have been carried out. As demonstrated by the final speech of the defence and my summing up on this issue, it is clear that both the defence and I understood the medical evidence from the prosecution was to the effect that CIK/AI therapy should not have been given to/carried out on a healthy person, including the deceased.

52.  While that was not specifically pleaded in the indictment, the defence was left in no doubt what the prosecution was alleging. No opposition was raised at the time when the evidence was adduced, during the prosecution closing speech or during my summing up to the jury. I would add that if there had been an application to amend the indictment during the first trial to include this allegation so as to accord with the evidence already adduced, I would have allowed the application.

53.  I have already referred to the closing speech of the defence acknowledging that “much of the prosecution’s focus has been on the question as to whether the CIK therapy should have been carried out at all”. The defence has chosen not to address such evidence but simply said to the jury, by reference to the indictment, that it was not the allegation against the defendant that she breached her duty by simply carrying out the therapy.

54.  Whilst it was for the defence to decide how they want to run their defence, the stance taken by the defence is not something that I should or would take into account in my consideration of the application. By allowing the amendment to the new 2(d), it will just have the effect of making sure that the indictment accords with the evidence already adduced and to be adduced, or to put it in another way, this amendment is necessary to meet the circumstances of the case. I do not accept that the amendment amounts to a “patching-up” of the prosecution case by way of “reconstruction or supplementation”, as submitted by the defence. The defendant would not be asked to meet a significantly different case during the re-trial.

55.  Further, while I appreciate the defendant has already been through a lengthy trial and has to wait for a long time for the retrial, I do not accept that the addition of the new 2(d) will be unfair or will cause injustice to the defendant. The prosecution has not changed its case against the defendant at all. The case against the defendant is exactly the same. The only difference now is that the particulars will accord with the evidence to be adduced during the retrial. The defence chose not to make enquiries during the first trial when this issue was raised or inferred by the evidence of many prosecution experts (as acknowledged by the defence during its closing speech). There is no question of the defence being required to undertake the work of making enquiries at the eleventh hour. In any event, the trial is scheduled to take at least two months to run, starting in October, so there is still time for the defence to make enquires, should the defence wish to do so. 

56.  For these reasons, I allowed the prosecution’s application to amend the indictment as per the 2^nd proposed amendments.

57.  Having regard to the need to avoid a substantial risk of prejudice to the administration of justice in the present on-going trial, it is ordered that the publication (in any form) of any report of the proceeding concerning the amendments of indictment be prohibited until the conclusion of this trial or until further order.