TE WHATU ORA, HEALTH NEW ZEALAND, TE TOKA TUMAI v C and S [2022] NZHC 3283

TE WHATU ORA, HEALTH NEW ZEALAND, TE TOKA TUMAI v C and S [2022] NZHC 3283 [7 December2022]NOTE: PURSUANT TO S 139 OF THE CARE OF CHILDREN ACT 2004 ANDSS 11B, 11C AND 11D OF THE FAMILY COURT ACT 1980, ANY REPORT OFTHIS PROCEEDING MUST NOT INCLUDE ANY NAME OR PARTICULARSLIKELY TO LEAD TO THE IDENTIFICATION OF BABY W.FOR FURTHER INFORMATION, PLEASE SEEhttps://www.justice.govt.nz/family/about/restriction-on-publishing-judgments/IN THE HIGH COURT OF NEW ZEALANDAUCKLAND REGISTRYI TE KŌTI MATUA O AOTEAROATĀMAKI MAKAURAU ROHECIV-2022-404-2237[2022] NZHC 3283IN THE MATTER of an application pursuant to s 31 of the Careof Children Act 2004 to place a child underthe guardianship of the CourtBETWEEN TE WHATU ORA, HEALTH NEWZEALAND, TE TOKA TUMAIApplicantAND C and SRespondentsHearing: 6 December 2022Appearances: P White and S Tune for the ApplicantS J Grey, assisted by K Murfitt, for the RespondentsA Ross KC and L C Sizer for New Zealand Blood and OrganService, Intended Third PartyJudgment: 7 December 2022JUDGMENT OF GAULT JThis judgment was delivered by me on 7 December 2022 at 5:00 pmpursuant to r 11.5 of the High Court Rules 2016.Registrar/Deputy Registrar[1] Baby W needs an urgent heart operation. His loving parents want the best forhim. They accept the need for surgery but have not consented to blood transfusionbecause of concerns that the blood will contain COVID-19 mRNA vaccine with spikeproteins that are not safe for Baby W. Instead, they seek the use of blood from directeddonors, that is selected donors who are not vaccinated with the mRNA vaccine.The medical specialists at Starship Children's Hospital and the New Zealand Bloodand Organ Service (NZBS) do not support the use of directed donor blood in this case.[2] Given the urgent need for surgery despite this impasse as to what bloodproducts Baby W should receive, Te Whatu Ora, Health New Zealand, Te Toka Tumai(Te Toka Tumai) applies to the Court for an order that Baby W be placed under theguardianship of the Court.1 It seeks to have the medical specialists appointed as agentsof the Court for the purpose of consenting to surgery and related medical issues, andthe parents otherwise appointed as general agents of the Court.[3] The parents (as respondents) oppose the application. They have also filedinterlocutory applications to join NZBS as a third party and seek an interim orderagainst NZBS that it provide a direct donor service to facilitate the collection of bloodfrom compatible unvaccinated individuals and process it so it may be used inBaby W's treatment. NZBS opposes those applications on procedural and substantivegrounds. Given the urgency, they were heard together with the originating applicationand I address them in this single judgment.Factual background[4] Baby W is a six month old boy. He has been diagnosed with a congenital heartdefect. He has a severe obstruction to the outflow tract of his right ventricle(the pulmonary valve allowing blood to flow from the heart to the lungs). This severeobstruction is causing increased thickening, known as hypertrophy, of his rightventricle. His heart condition has become more severe over his six months of life.He has a gradient in his right ventricular outflow tract that is over three times thenormal pressure.1 Health New Zealand was established under s 11 of the Pae Ora (Healthy Futures) Act 2022.Te Toka Tumai is its Auckland District, responsible for Starship Children's Hospital.[5] In order to survive, Baby W needs surgery to relieve the right ventricularoutflow trapped obstruction and enable free flow of blood. His right ventricle willcontinue to deteriorate without surgery. He has been started on medication to slow hisheart rate and help manage the thickened heart muscle, but the underlying heart defectcan only be managed through surgery. With this treatment, Baby W has a long-termsurvival prognosis in excess of 90 per cent.[6] In late October 2022, clinicians performed a catheter balloon dilation ofBaby W's pulmonary valve in an attempt to open it. After the procedure, Baby W'sparents were distressed to hear that clinicians had needed to give Baby W "a top up"of blood. Although they had consented, Baby W's parents told the team that if anyfurther procedures were to be done going forward, they would have to find analternative as the parents' wish was not to have any blood other than blood that did notcontain the Pfizer vaccine, mRNA, the spike protein or any other associatedcontaminants that may cause myocarditis or clotting. When clinicians reviewedBaby W a fortnight after this procedure, it was clear that the right ventricle was stillpressurised, and that thickening was also developing of the left ventricle.[7] NZBS manages the donation, collection, processing and supply of blood andcontrolled human substances in New Zealand. Baby W's mother communicated withNZBS as she wanted to start the process for directed donor blood. On 9 November2022, NZBS responded saying that directed donation is not supported by NZBS,except in rare circumstances (such as for patients with very rare blood types orantibodies). For this reason, any request for directed donation can be made only bythe specialist doctor or surgeon undertaking the procedure to the local transfusionmedicine specialist.[8] Baby W's parents are concerned that it would not be safe for Baby W to receivea blood transfusion from a COVID-19 mRNA vaccinated blood donor. At a clinic visitat Starship Hospital on 16 November 2022, the parents were warned that surgerywould likely be required. They informed the clinicians that they believed there werespike proteins in the blood of people who have been vaccinated and that these proteinswere causing unexpected deaths relating to transfusions. They emphasised the needto use only blood from unvaccinated donors. Dr Finucane,2 Paediatric CardiacSurgeon in Chief at Starship Hospital, agreed to address the issue again with the NZBSdirector and asked the parents to send through data they had so she could betterunderstand their concerns. Baby W's mother explained that she was a midwife withnursing training.[9] A further meeting was held on 21 November 2022. The clinicians conveyedthat their careful review of the data had not convinced them that they should, or could,recommend unvaccinated blood transfusion. By that stage, Dr Finucane had discussedBaby W's need for blood and blood products with the director of NZBS, Dr Cho, whowas also unconvinced.3 Dr Finucane noted that Baby W is almost undoubtedly goingto require albumin and other plasma products during his post-operative course, andthese products are formed from the pooling of various donors. She says it is simplyimpractical to have a directed donor for these products.[10] Dr Finucane had also checked, prior to this meeting, whether there was anypossibility of performing the surgery on Baby W using cardiac bypass without bloodor blood products. Having consulted with cardiac anaesthetists and perfusionists, theyconfirmed Dr Finucane's view that this was not an available option.[11] On 23 November 2022, the medical specialists at Starship Hospital agreed thatthey should press on with a surgical date as soon as possible given Baby W's cardiaccondition. They wanted to meet with the parents as soon as possible. Unfortunately,Dr Finucane's commitments meant she could only give 15 minutes' notice of themeeting, only Baby W's mother was available, and they were unable to connect withhis father by cellphone. The specialists explained to Baby W's mother that they couldnot spend more time considering the parents' request for special donors. Theyinformed her that the parents would need to make a decision soon on whether toconsent to surgery or not. The specialists also explained that, while the parents couldconsent to surgery without signing for blood if they preferred, they would need tounderstand that donation of blood would be inevitable given Baby W's condition.2 Despite being a surgeon, I use Dr in this context.3 Dr Finucane said that Dr Cho was already familiar with the theories being advanced by the parents,which they regard as conspiracy theories, around vaccinated donor blood and Dr Cho wasunconvinced by them.Baby W's mother became extremely upset and criticised the specialists for corneringher without any support present. The specialists apologised for this and explained that,given a legal process was going to commence, that would take some time andBaby W's condition did not allow many days before his risks of surgery wouldincrease.[12] On 25 November 2022, having not heard back from Baby W's parentsformally, another meeting was organised. Dr Finucane said this meeting was hijackedby the parents' support person who proceeded to pressurise the specialists with hertheory about conspiracies in New Zealand and even said that deaths in infants gettingtransfusions were occurring in Starship Hospital. Dr Finucane said that after someminutes, the specialists asked to leave and ended up walking out of the meeting withthe support person continuing to try to talk to them. As a result, they were unable toexplain their position to the parents.Proposed surgery[13] Dr Finucane says the surgery would involve the use of a bypass pump. Bloodand blood products are required to prime that pump as the clinicians start the operationand again as they come off bypass and reverse anticoagulants that have beenadministered while on bypass. The exact quantity needed is impossible to predict, butthe clinicians normally tell the blood bank to provide three units of blood, along withplatelets, fresh frozen plasma and albumin for a case like this. They may order moreblood products if bleeding does not settle in the first hour.[14] Post-operatively, it is expected there would be around five to seven days inintensive care for recovery and a further stay in the ward to recover. During the post-operative stay, there may be a need for further albumin transfusions to minimise therequirement for chest fluid drainage (a common complication following this type ofsurgery). There will also be a need for decisions to be made around different drugsand feeding supplements, especially for the four weeks post-operatively, to promotefaster respiratory weaning, help wound healing and avoid infection. Often thesedecisions will need to be made swiftly and any delays would compromise Baby W'sinterests.[15] Dr Finucane confirms that, as an agent of the Court, she would endeavour toconsult with the parents to the maximum extent before any decisions are made(provided there is sufficient time). The agents would also keep the parents informedof what is happening. Where possible, without compromising Baby W's interests, theagents will take the parents' views into consideration.[16] Dr Finucane says the surgery would take place as soon as possible followingconsent – the necessary steps prior to surgery will likely take about 48 hours tocomplete. She says that Baby W is currently stable, but he remains in urgent need ofan operation, and every day that the operation is delayed his heart is under strain.Delay will cause a deterioration in his right ventricle, and increased risk ofpost-operative complications.Guardianship orders – applicable principles[17] Section 31 of the Care of Children Act 2004 provides as follows:31 Application to Court(1) An eligible person may make an application to a Court withjurisdiction under this section for—(a) an order placing under the guardianship of the Court a childwho is not married, in a civil union, or in a de factorelationship:(b) an order appointing a named person to be the agent of theCourt either generally or for any particular purpose.(2) In this section, eligible person, in relation to a child, means any of thefollowing persons:(a) a parent or guardian of the child:(b) a grandparent or an aunt or an uncle of the child:(c) a sibling (including a half-sibling) of the child:(d) a spouse or partner of a parent of the child:(e) the child himself or herself (who may apply without anylitigation guardian):(f) the chief executive:(g) any other person granted leave to apply by the Court.[18] The High Court and the Family Court have concurrent jurisdiction under s 31.4[19] Section 33(1) provides:33 Orders of Court(1) A Court to which an application is made under section 31 may—(a) make an order described in section 31(1)(a); or(b) make orders described in section 31(1)(a) and (b); or(c) make—(i) an order described in section 31(1)(a); and(ii) an order appointing any person whom the Courtthinks fit to be the agent of the Court either generallyor for any particular purpose.[20] Section 36(3) relevantly provides:(3) If the consent of any other person to any medical, surgical, or dentaltreatment or procedure (including a blood transfusion) to be carriedout on a child is necessary or sufficient, consent may be given—(a) by a guardian of the child; or[21] Importantly, s 4(1) provides:(1) The welfare and best interests of a child in his or her particularcircumstances must be the first and paramount consideration—(a) in the administration and application of this Act, for example,in proceedings under this Act; and(b) in any other proceedings involving the guardianship of, or therole of providing day-to-day care for, or contact with, a child.Issues[22] The overriding issue is whether the proposed treatment is in Baby W's bestinterests. Despite the procedural complexity, two interrelated factual issues underpinthe dispute:4 Care of Children Act 2004, s 30.(a) whether the clinicians' proposed use of NZBS blood products is safe;and(b) whether the parents' proposed use of directed blood is a safe and viablealternative.[23] It is necessary, however, to address these issues within the constraints of thisurgent proceeding. Te Toka Tumai commenced this proceeding on 28 November2022. At the first call on 30 November 2022, an urgent half day hearing was allocatedfor Te Toka Tumai's application. The parties filed affidavit evidence, includingTe Toka Tumai's rebuttal evidence envisaged in the timetable directions. Therespondents then filed a further affidavit from Dr Bridle, Associate Professor of viralimmunology at the Ontario Veterinary College, University of Guelph in Ontario, towhich I will refer below.Permission to proceed by originating application[24] I first address the procedural order sought by Te Toka Tumai for permission tocommence this proceeding by origination application.5 This is not opposed.By consent, I make an order permitting this proceeding to be commenced byoriginating application. That is in the interests of justice.Guardianship orders soughtLeave to apply[25] Te Toka Tumai seeks leave, pursuant to s 31(2)(g), to apply for an order placingBaby W under the guardianship of the Court. Ms Grey, for the parents, submitted thatcaution is required before granting leave to the clinicians since they have competingduties to others. She submitted that here there are strong reasons against grantingleave since the clinicians have dismissed the parents' concerns.[26] Section 31(2) specifies persons who are eligible to apply for an order placinga child under the guardianship of the Court and requires any other person to seek leave5 High Court Rules 2016, r 19.5(3).to apply. The leave requirement is an additional safeguard. The focus is on thestanding or interest of the person seeking leave rather than the merits of the applicationwhich must be considered if leave is granted. Here, the applicant is Te Toka Tumai(not the clinicians proposed to be appointed as agents of the Court if an order placinga child under the guardianship of the Court is made). Te Toka Tumai is charged withBaby W's medical care and treatment and has a bona fide interest in his welfare. Thisis a sufficient basis to be granted leave to apply for an order placing Baby W under theguardianship of the Court. I grant Te Toka Tumai leave under s 31(2)(g).Substantive orders sought[27] The substantive orders sought are as follows:(a) Placing Baby W under the guardianship of the Court from the date ofthe order until completion of his surgery and post-operative recoveryto address obstruction to the outflow tract of his right ventricle and atlatest until 31 January 2023.(b) Appointing Dr Annabel Kirsten Finucane and Dr Alan Magee as agentsof the Court for the purpose of consenting to surgery to addressobstruction of Baby W's outflow tract of his right ventricle and allmedical issues related to that surgery including the administration ofblood and blood products to Baby W, where the administration of bloodand blood products is in accordance with good clinical practice and inthe best interests of Baby W as assessed by Dr Finucane and/orDr Magee.(c) Other than the matters covered in (b) above, appointing Baby W'sparents as general agents of the Court for all other purposes.(d) Directing Dr Finucane and Dr Magee to keep the respondents informedat all reasonable times of the nature and progress of Baby W's conditionand treatment.(e) Reserving leave to the parties to apply to the Court for a review of theseorders should this be warranted.Joinder of NZBS[28] The respondents apply to join NZBS as a third party. While headed as anapplication, the document is really a third party notice. There is no separate statementof claim or cause of action articulated against the proposed third party.The respondents' memorandum in support relies on r 4.4(1)(c) of the High Court Rules2016, which allows a defendant to issue a third party notice if the defendant claimsthat a question or issue in the proceeding ought to be determined not only between theplaintiff and defendant but also between one or both of them and the third party.However, that rule is inapt in the context of this originating application seeking aguardianship order in respect of Baby W. The guardianship issue is distinct from anissue as to whether NZBS should change its approach in relation to directed blood.This proceeding is not the appropriate vehicle to determine that issue. The powers ofthe Court under s 35 of the Care of Children Act to make orders about the role ofproviding day-to-day care of a child do not assist. As Mr Ross KC for NZBSsubmitted, the need for urgency in a guardianship application such as this is anotherinterests of justice reason why joinder of third parties would not be appropriate.If there is a case against NZBS, it should be heard separately.[29] Further, the purpose of joinder is to enable the respondents to seek an orderagainst NZBS requiring it to (cooperate to) provide a direct donor service to facilitatethe collection of blood from compatible unvaccinated individuals (that is,unvaccinated with mRNA vaccine) and process it so it may be used in Baby W'streatment. This highlights that Te Toka Tumai cannot require NZBS to providedirected blood against NZBS' clinical judgment. NZBS blood is the only bloodavailable to Te Toka Tumai. It is not, as Ms Grey suggested, a matter of balancing therisk of delaying surgery against the risk of using blood with residual mRNA on thebasis that selected donors can provide blood (whether within days or two weeks).Without joinder and an order against NZBS to change its position, there is no viablealternative to Te Toka Tumai's proposed surgery using NZBS blood products.It follows from this, and acceptance that Baby W needs urgent surgery, that an orderenabling the surgery to proceed using NZBS blood products without further delay isin Baby W's best interests.[30] As NZBS also opposes the interim order sought on substantive grounds, I willalso address that application rather than declining joinder on solely proceduralgrounds.Interim order[31] Despite the respondents' procedural difficulty, Mr Ross fairly seeks to addressthe substantive grounds by reference to public law judicial review principles. Whileno such claim has been articulated, if the respondents were applying for judicial reviewagainst NZBS, the Court could make an interim order if it were necessary to preservethe respondents' position pending substantive determination of the judicial review.Here, however, the order sought is not in the nature of an interim order preserving theirposition or the status quo. It is a mandatory order that is effectively final in nature.[32] Further, judicial review is focused on the lawfulness of decisions. The fact thatTe Toka Tumai cannot require NZBS to provide directed blood against NZBS' clinicaljudgment exposes a further difficulty with the order sought against NZBS.In Shortland v Northland Health Ltd,6 the Court of Appeal held that a clinical decisioncould not be unlawful if it was made in good faith and in accordance with goodmedical practice.[33] Despite Ms Grey's characterisation of NZBS' refusal to agree to directed donorblood and criticism of its approach to informed consent, there can be no doubt thatNZBS has exercised its clinical judgment in good faith. Subject to considering theevidence as to whether that clinical decision was in accordance with good medicalpractice, which I will address below, it is not a clinical decision that is amenable toreview by the Court.6 Shortland v Northland Health Ltd [1998] 1 NZLR 433 (CA) at 441-443.Jurisdiction for guardianship order[34] Unlike other cases cited, this case does not concern parental refusal to consentto medical treatment on religious grounds and no such balancing of this right and theright to life is required. The parents' concerns may be as characterised as a belief (andMs Grey submitted it was much more than that) but it is a belief as to the medical riskinvolved in blood products from vaccinated people rather than a belief in terms of s 15of the New Zealand Bill of Rights Act 1990. The parties are all concerned to act inBaby W's best interests to protect his life. The dispute is as to what blood products heshould receive in order to do so.[35] There is no doubt the Court has jurisdiction to place a child under theguardianship of the Court and appoint a doctor as an agent of the Court for the givingof consent to medical treatment involving blood transfusion.7 The Court's jurisdictionis unaffected by the recent restructuring of the hospital system such that the applicantis Te Toka Tumai instead of the District Health Board. The Court's jurisdiction is notousted by s 37 of the Care of Children Act which governs urgent blood transfusions.8Section 37 can assist in establishing what must be shown when seeking interventionby the Court – the reasonable opinion of the medical practitioner that a bloodtransfusion is necessary to save the life of the patient, to prevent injury to physical ormental health or to save the patient from prolonged and avoidable pain and suffering.9Where it is unnecessary for the child to have a blood transfusion at the time of theapplication, but there is a risk this need would arise in the course of treatment, theCourt engages in a two-step analysis:10At the first stage it is necessary to assess the likelihood that the condition ofthe patient will become such that a blood transfusion is to be considered. Thesecond stage is when that condition has developed and the appropriate medicaltreatment is to be determined. on such applications there must be a real or substantial risk that thepatient's condition will in the course of medical care be such as, on acceptedmedical practice, would call for blood transfusion and that in the event thatcondition develops a blood transfusion will be necessary.7 Section 33(1); and Re J (An infant): B and B v Director-General of Social Welfare [1996] 2 NZLR134 (CA) (under s 9 of the Guardianship Act 1968). Fitzgerald v R [2021] NZSC 131, referred toby Ms Grey, does not suggest otherwise.8 At 142 (relating to the predecessor of s 37, s 126B of the Health Act 1956).9 At 142.10 At 143.[36] On one view, the two step analysis is not required in this case as at the time ofthe application it is necessary for Baby W to have heart surgery and it is necessary forhim to have a blood transfusion in the course of that surgery. In any event, there is atleast a real or substantial risk that in the course of that surgery, on accepted medicalpractice, Baby W will need a blood transfusion. As indicated, the issue is as to theblood products used in such a transfusion.The parents' concerns and proposed alternative[37] Ms Grey characterises the applicant as having refused an important additionalblood screening protection that the parents have requested to avoid an identified riskfor Baby W. She submits the applicant has refused to consider directed donor bloodnot because it is impossible or impracticable but apparently based on their ownideological reasons and because they claim the blood in the blood bank should beassumed to be safe until proven otherwise. She submits the law requires NZBS tobase its decisions on the best evidence. She also characterises this as the first casewhere an applicant for guardianship for medical reasons is asking for a guardian to beappointed so it can offer a lower level of medical care than is sought by the parents.[38] Ms Grey submits that the best way to protect against the spread of diseasethrough transfused blood is to carefully screen blood to avoid the contaminant in thefirst place (citing the approach to Mad Cow disease).[39] I turn to the two factual issues underpinning the dispute.Whether the proposed use of NZBS blood products is safe[40] Baby W's parents are concerned not to use blood that may be contaminatedwith residual artificial mRNA spike protein that is not safe because it can causemyocarditis and death. Baby W's mother says that spike protein will be present in theblood of those who receive the vaccine – the only question is how much will be presentand for how long. She says their concerns have been dismissed by Dr Finucane bylabelling the parents as conspiracy theorists without addressing their concerns.She says that Dr Finucane claims no expertise about the Pfizer vaccine or residues inthat vaccine and provides no evidence to justify her opinion. Baby W's motherdescribes her understanding about "emerging" concerns, and Ms Grey sought to drawan analogy with the delayed acceptance of risk relating to blood unscreened forHepatitis C in the early 1990s.11 Baby W's mother is also concerned that another babywho received blood from NZBS for a heart operation has been coughing up bloodclots. She is concerned this may be associated with spike protein or othercontamination in the blood.[41] I note that Baby W previously received blood in October, but I place no realweight on this. It was not relied on as proof of safety. Nor do I consider that previousconsent undermines the genuineness of the parents' current concerns.[42] The parents' concern about using blood is based on the concern that mRNAvaccine is not safe. A good deal of the evidence filed on the parents' behalf related toconcerns about the safety of Pfizer (Comirnaty) vaccine generally rather than thesafety of blood transfusions. This included Ms Murfitt's affidavits and Dr Bridle'sfirst affidavit. Ms Murfitt is a solicitor and is not qualified to give expert medicalevidence.12 Dr Bridle's affidavit attached his evidence filed in a different proceeding.In that proceeding, Cooke J preferred other evidence that the Pfizer vaccine is safe.13[43] At the hearing, Ms Grey pointed to the provisional consent to the distributionof the Pfizer (Comirnaty) vaccine, legislative changes to facilitate its distribution, thewarnings in its New Zealand data sheet, its updated summary of risk managementplan, the adverse events safety report as at 31 August 2022,14 the statement in thatreport that the protective benefits of vaccination against COVID-19 far outweigh thepotential risks of vaccination, and the Coroner's finding dated 15 September 2022 thatRory Nairn's cause of death was myocarditis due to vaccination.[44] The affidavits of Ms Hertzler and Dr Catherwood, and Dr Bridle's furtheraffidavit, addressed blood transfusions. Ms Hertzler's evidence provided her account11 Department of Health Report of Inquiry into Matters Relating to the Safety of Blood Products inNew Zealand (December 1992).12 Ms Murfitt says she is vaccinated but not with the mRNA vaccine, and is willing to donate bloodfor Baby W. She attaches lengthy open letters she has sent to the Government in relation toconcerns with the Pfizer vaccine.13 NZDSOS Inc v Minister for COVID-19 Response [2022] NZHC 716 at [115]-[119].14 Ms Grey submitted that adverse events are underreported.of her child's tragic death in the USA but provides no evidence as to what hasobjectively been determined as the cause of death. Dr Catherwood did not confirmthat her evidence is within the scope of her expertise or experience. She cited a studywhich found that vaccine-associated synthetic mRNA persists in systemic circulationfor at least two weeks. As Mr White for Te Toka Tumai pointed out, however, thatstudy stated that vaccines using mRNA technology "to date remain safe".[45] I only received Dr Bridle's further affidavit on the morning of the hearing.Te Toka Tumai and NZBS had no opportunity to reply to it. Dr Bridle was critical ofthe affidavits of Dr Morley (Chief Medical Officer of NZBS) and Dr Finucane for notincluding citations to support their opinions. Dr Bridle referred to the risk ofmyocarditis. He included evidence that one study demonstrated mRNA vaccine-derived spikes could be detected in blood up until at least two weeks post-inoculationand another study demonstrating a vaccine-induced spike in plasma 10 dayspost-inoculation at a concentration that Dr Bridle said was "disconcertingly high".He said that spike proteins from mRNA vaccines can circulate in the blood for at leastfour months post-inoculation. He recommends the precautionary principle, that anaction should not be taken if there are legitimate scientific questions about the impactof the action. In this regard, Ms Grey submitted that Baby W's clinicians and NZBSshould be looking for proof of safety, not proof of harm.[46] Dr Morley's evidence (including her reply affidavit) is that there is no scientificevidence there is any COVID-19 vaccine related risk from blood donated by donorspreviously vaccinated with any New Zealand approved COVID-19 vaccine, and thereare no known or suspected harmful vaccine related effects of blood from a vaccinatedindividual to a recipient of any age, after millions of transfusions around the world.There is no evidence that trace amounts of vaccine in blood or blood products couldcause myocarditis. If there is any spike protein at all in blood, it will be in the picogramrange (one trillionth of a gram).[47] Professor Turner, Medical Director of the Immunisation Advisory Centre at theUniversity of Auckland, also filed an affidavit in reply. She says that there is noevidence of harm from antibodies being present in blood, which are produced inresponse to both natural infection and vaccination. She says that, although unlikely tobe present in blood products, any components or products of the vaccine(nanoparticles, mRNA or the spike protein) would not be harmful if they weretransferred through blood transfusion.[48] No cross-examination was sought in this urgent proceeding and so the evidenceof these deponents was not tested. It would not be appropriate to make conclusivefindings on contested matters of expert opinion evidence based on affidavits.However, it appears to be common ground and I do accept that mRNA vaccine-derivedspikes could be detected in blood up until at least two weeks post-inoculation. It isalso common ground that NZBS only asks blood donors to wait until the day afterCOVID-19 vaccination. I accept too that Baby W is vulnerable given his age andcondition. Even so, I accept Dr Morley's evidence that after millions of transfusionsaround the world since mRNA vaccines have been administered, there are no knownharmful vaccine related effects of blood from a vaccinated individual to a recipient ofany age. This is consistent with Professor Turner's affidavit that there is no evidenceof harm from antibodies being present in blood. I also accept the evidence that usingNZBS blood is consistent with established medical practice.[49] Even if I could conclude that there is a real risk to safety with bloodtransfusions using blood from mRNA vaccinated donors, that risk would need to bebalanced against the risks of the alternative (if available), namely using blood fromdirected donors not vaccinated with mRNA vaccine.Whether the proposed use of directed blood is a safe and viable alternative[50] The respondents propose an alternative treatment strategy involving the use ofdirected blood. Their submissions are based on their belief that requiring the use ofblood from donors not vaccinated with mRNA vaccine is a safe and viable alternative.Baby W's mother says that ample donors are on stand-by waiting to give their pre-screened blood.[51] Even assuming that the respondents have 20 to 30 supporters who have beenpre-screened in accordance with the NZBS handbook and who are not vaccinated withmRNA vaccine,15 the respondent's expert evidence supporting directed blood islimited to the evidence of Dr Bridle. His opinion is that it would be in the best interestsof Baby W to have his surgery conducted with blood products used for transfusion thathave been derived exclusively from donors who did not receive a COVID-19 vaccine.Indeed, he says:Having learned how much misinformation is being presented to the public bythe NZBS also compels me to recommend that a moratorium be placed on theuse of their blood products from people who have received a COVID-19'vaccine'. This should occur until such time as they can prove, with robustscientific evidence, that these blood products do not represent any risk ofcontaminating anyone with bioactive and potentially toxic LNPs, mRNAsand/or spike proteins that have been associated with known cardiovascularside-effects such as myocarditis, pericarditis, and blood clots.[52] But Dr Bridle does not claim expertise in blood transfusion services and doesnot address the necessary balancing of risks.[53] Dr Bridle's opinion does not overcome the clear evidence of Dr Morley.As Mr Ross submitted, Dr Morley's evidence is not properly characterised as basedon administrative convenience. Mr Ross described it as a more fundamental concernthat the use of directed donation blood would damage an excellent blood service forall New Zealanders.[54] Dr Morley says that NZBS has had several cases where it has received advicefrom Starship clinicians that parents of children are requesting directed donation bloodto avoid receiving blood products from donors that have been vaccinated againstCOVID-19. Dr Morley explained NZBS's position to Baby W's parents by letter dated25 November 2022. Her affidavit confirms her view, consistent with the NZBSposition, on why directed donation blood products are not a safe nor viable option forBaby W. She explains that NZBS does not separate blood according to donor COVID-19 vaccination status because (as indicated above) there is no scientific evidence thatthere is any COVID-19 vaccine related risk from blood donated by donors previouslyvaccinated with any New Zealand approved COVID-19 vaccine. She is not aware ofany blood provider that separates blood based on vaccination status.15 Dr Morley states that at a meeting on 30 November 2022 the parents were unable to provideinformation as to the screening processes undertaken in connection with their volunteers.[55] Dr Morley says that directed donation offers no advantage to the recipient andhas been shown, in some studies, to increase transfusion risk. It also introducesunnecessary complexity into well-established blood collection and processing systemsthat increase the risk of errors and inadequate supply for the patient.[56] Dr Morley says that Baby W has the potential need for rapid access to the fullrange of blood and plasma products to support his complex cardiac surgery, whichNZBS may not be able to supply through directed donation. Some NZBS products(including albumin that Baby W is expected to require) are collected using specialisedcollection techniques, from carefully qualified donors and then manufactured usingregulated procedures. Some products are manufactured in bulk in Australia. The onlyway to ensure Baby W has access to the right transfused therapies at the times he needsthem is through the safe and comprehensive portfolio of blood and blood productsdonated by, and manufactured from blood collected from, NZBS' voluntary donors.Ms Grey indicated the parents understand that directed blood products would belimited to red blood cells and platelets, accepting the use of other NZBS bloodproducts and the possible need in an emergency to source further NZBS bloodproducts (that could not be obtained from donors unvaccinated with mRNA vaccine).[57] Dr Morley states that directed donation is not recommended in internationalexpert consensus guidelines and that most national blood providers, including the UK,Australia and Canada, do not support them. NZBS has not recently changed its policy.NZBS has detailed procedures which govern how it collects, tests, processes, stores,releases and delivers blood and blood products. These are carefully designed tocomply with good clinical practice and evidence-based guidelines, including theguidance documents issued by the European Directorate for the Quality of Medicineand Healthcare (EDQM). This is accepted as being international best practice.The EDQM guide addresses both "designated donations" and "directed donations".Designated donations should only occur where there is a clear medical indication (forexample, a patient with a rare blood type where no compatible anonymous donationsare available). Dr Morley says this does not apply to Baby W's case. In relation todirected donations, the EDQM states:Directed donations are those intended for named patients, where the requestfor the donation has been made by patients, relatives or friends. The publicoften believes that directed donations are safer than anonymous, voluntary,non-remunerated donations. However, this is not the case, even if directeddonations are screened and tested in the same manner as voluntary non-remunerated donations.Directed donations are not considered good practice and should bediscouraged.[58] Dr Morley says that in the last six to nine months NZBS has noted a significantincrease in potential blood recipients asking for blood from unvaccinated donors orasking about directed donation. Similar trends have been noted in other countries, asrecorded in a recent article in the British Journal of Haematology, "Refusing bloodtransfusions from COVID-19-vaccinated donors: are we repeating history?".16Mr White indicated a concern that enabling recipients to select blood from differentdonors is inconsistent with best practice guidelines. Dr Morley says that the currentsituation (of increased requests for blood from unvaccinated donors) is a cause ofconcern because it is placing a significant burden on hospital teams caring for bothadults and children, as well as NZBS. NZBS is also concerned about the potentialrisks to the national blood supply that may result from negative impacts on its staffand donors.[59] The respondents' evidence does not support their belief that requiring use ofblood from donors not vaccinated with mRNA vaccine is a safe and viable alternative.Their alternative is not supported by a clinician's opinion nor peer reviewed articlespertaining to Baby W's condition. Dr Bridle is not a clinician. In this sense, the caseis similar to Canterbury District Health Board v L.17 In that case, Fogarty J said thatthe parents had not established an alternative supported by a clinician's opinion or peerreviewed articles pertaining to the young boy's condition. The Judge also did notaccept that the state agency had to eliminate the availability of alternative strategies.But he noted that clinical judgment is fact intensive and not assisted by trying to definea legal test.16 Jeremy W Jacobs and others "Refusing blood transfusions from COVID-19-vaccinated donors:are we repeating history?" (2022) 196 BJHaem 585. This refers to the controversial history ofblood transfusion in the USA, beginning with the barring of African-Americans from donatingblood, followed by segregating and labelling such blood, before official de-segregation of thenation's blood supply occurred.17 Canterbury District Health Board v L HC Christchurch CIV-2005-409-001832, 15 August 2005at [15]-[20].[60] Further, the requirement in the Convention on the Rights of Persons withDisabilities for state parties to prohibit discrimination on the basis of disability has norelevance here. The obligation to ensure that "reasonable accommodation" is provideddoes not require approval of directed donor blood to overcome an identified risk to adisabled baby. It is also misconceived to suggest there is discrimination on the groundsof the parents' opinion about vaccinated blood. In addition, I do not accept thecharacterisation of the use of blood products from vaccinated donors asexperimentation.Conclusion[61] I accept that Baby W's parents have genuine concerns about the risk of usingblood from vaccinated donors that are very different from the views of Baby W'sclinicians and NZBS. As Mr Ross acknowledged, adult patients (with capacity) areentitled to decline to consent to medical treatment. However, the issue here is what isin Baby W's best interests. NZBS practice in relation to directed donors is inaccordance with standard medical practice in the UK, Australia and Canada, and theEDQM guidance. The parents' alternative proposal is not an available alternativeoffered by NZBS. It is not supported by a clinician's opinion knowing Baby W's state,nor by peer reviewed articles. I cannot conclude it is a safe alternative that is inBaby W's best interests.[62] For these reasons, and given that Baby W needs urgent surgery, an orderenabling the surgery to proceed using NZBS blood products without further delay isin Baby W's best interests.Scope of orders[63] The orders sought by Te Toka Tumai are wider than simply enabling consentto Baby W receiving blood products. Te Toka Tumai seeks to extend the clinicians'agency to all medical issues related to the surgery, but acknowledges that it isappropriate that Baby W's parents be appointed as general agents of the Court for allother purposes.18 Te Toka Tumai seeks to extend the clinicians' agency to medical18 See for example Auckland District Health Board v Z (2007) 26 FRNZ 596 (HC); and AucklandDistrict Health Board v W [2012] NZHC 1563.issues related to the surgery given the difficulty medical staff has faced in relation tonutritional supplements, the removal of Baby W from the hospital ward (to attendCourt) against medical advice in Baby W's best interests and the fractured treatmentrelationship between clinicians and Baby W's parents. At the hearing, Mr White alsosought ancillary orders to ensure that Baby W stays in the hospital in accordance withmedical advice and that there is no obstruction of the clinicians. Dr Finucane says itis not safe for Baby W to be taken off the ward. Ms Grey submitted the parents havethe right to balance this risk against the benefit of Baby W being with his mother whois breastfeeding in his best interests.[64] In the circumstances, I consider the scope of the orders sought should extendthe clinicians' agency to medical issues related to the surgery. That includes enablingthe clinicians to make a medical assessment as to whether it is safe for Baby W toleave the ward before and after surgery. It should not be necessary to make moreexplicit ancillary orders to ensure compliance with the Court's primary order.[65] I accept the relationship between the parents and the clinicians has suffered.Both parties will be incentivised to improve the relationship before and after thesurgery and be respectful of one another. As to the identity of the clinicians appointedas agents of the Court, Dr Magee is Baby W's consultant cardiologist. WhetherDr Finucane carries out the surgery depends on timing. Even if she does not, her roleas Paediatric Cardiac Surgeon in Chief at Starship Hospital makes her an appropriateagent. However, I reserve leave to appoint an alternative agent if more appropriategiven availability and relationship issues.Result[66] I make an order permitting this proceeding to be commenced by originatingapplication.[67] The respondents' applications for joinder of NZBS and an interim order aredeclined.[68] I grant Te Toka Tumai leave to apply for an order placing a child under theguardianship of the Court under s 31(2)(g).[69] I make the following substantive order:(a) Placing Baby W under the guardianship of the Court from the date ofthe order until completion of his surgery and post-operative recovery toaddress obstruction to the outflow tract of his right ventricle and atlatest until 31 January 2023.(b) Appointing Dr Annabel Kirsten Finucane and Dr Alan Magee as agentsof the Court for the purpose of consenting to surgery to addressobstruction of Baby W's outflow tract of his right ventricle and allmedical issues related to that surgery including the administration ofblood and blood products to Baby W, where the administration of bloodand blood products is in accordance with good clinical practice and inthe best interests of Baby W as assessed by Dr Finucane and/orDr Magee.(c) Other than the matters covered in (b) above, appointing Baby W'sparents as general agents of the Court for all other purposes.(d) Directing Dr Finucane and Dr Magee to keep the respondents informedat all reasonable times of the nature and progress of Baby W's conditionand treatment.(e) Reserving leave to the parties to apply to the Court for a review of theseorders should this be warranted.[70] Costs are reserved.________________________________Gault JSolicitors / Counsel:Mr P White, Barrister, AucklandMs S Tune, Legal Services, Te Toka Tumai, AucklandMs S J Grey, Solicitor, NelsonCopy to:Mr A Ross KC, Barrister, AucklandMr D T Broadmore and Mr L C Sizer, Buddle Findlay, Auckland