Shand v Accident Compensation Corporation (Treatment Injury)

IN THE DISTRICT COURT AT WELLINGTON ITE KOTI-A-ROHE KI TE WHANGANUI-A-TARA [2018] NZACC 152 ACR 145/16 UNDER THE ACCIDENT COMPENSATION ACT 2001 IN THE MATTER OF AN APPEAL UNDER SECTION 149 OF THE ACT BETWEEN ISOBEL SHAND Appellant AND ACCIDENT COMPENSATION CORPORATION Respondent Hearing: 27 February 2018 Supplementary submissions completed 18 July 2018 Appearances: Mr J Miller for the appellant Mr S Bisley for the respondent Judgment: 25 September 2018 RESERVED JUDGMENT OF JUDGE DENESE HENARE [Treatment Injury- s 32 and s 33 Accident Compensation Act 2001] Contents Paragraph No. The claim......... The requirements of a treatment injury ....................................*.*. ........ (9] Issue One - Whether Ms Shand provided informed consent to treatment ..... [16] The availability of a donor kidney ...... . [16] The case for the appellant .......... .. .... [31] Discussion ........... ....... [32] Conclusion......... . . . . . . . ...... [108] Issue Two - Whether cortical necrosis was caused by treatment....... [114] The transplant surgery ....... .. ..... [114] Events following the transplant surgery ................ [1 16] The case for the appellant ........ ...... [136] Discussion ...... [141] Conclusion......... . ....... [156] Issue Three: Whether increased antibody levels are an ordinary consequence of treatment..............*... *****.* * *.*... [160] Discussion ..... [168] Conclusion.......... . . ........ [174] Result............. .......... [175] [1] The appellant, Isobel Shand was eleven years old when she received her first kidney transplant. This kidney functioned well for a time but slowly failed, necessitating a return to haemodialysis in 1999. [2] Eight years later, Ms Shand underwent her second kidney transplant. This transplant did not function due to cortical necrosis'. The claim 3] On 1 October 2014 Ms Shand sought cover for a treatment injury. The injury claim form noted: Renal transplant: kidney rejected immediately after surgery, due to inappropriate kidney and damage during surgery. [4] The claim was investigated by the Corporation who obtained reports from Dr Leikis, Renal Physician at Wellington Hospital, Dr Munn, Renal Physician at Auckland City Hospital, Dr Dittmer, Renal Physician at Auckland City Hospital and Dr Voss, Independent Renal Physician about the failure of the kidney transplant. [5] The Corporation also investigated whether informed consent had been obtained and sought opinions from Dr Matheson, Renal Physician Wellington Hospital, Dr Pidgeon, Renal Physician at Wellington Hospital, Dr Panlilio, Renal Physician at Palmerston North Hospital and Dr Voss. Ms Shand and her mother Ms Dorn also provided statements for the purposes of the investigation. 6] On 22 June 2015 after considering the evidence, the Corporation declined cover for a treatment injury. The Corporation concluded in the treatment injury report which formed part of the decision that: 1. No failure to provide treatment was identified. The decision to use this kidney was reasonable and appropriate. Dr Voss states: Cortical necrosis is described as failure of the transplanted kidney. Necrosis is described as the sum of the morphological changes indicative of cell death and caused by the progressive degradative action of enzymes, it may affect cells or part of a structure of an organ. Dorlands Medical Dictionary 32nd edition I strongly believe that having not offered this kidney would have been irresponsible of the practicing clinicians, would have been wasteful of a pooled kidney; and in fact would have been a failure to provide treatment to Ms Shand if the kidney had not been offered or provided to Ms Shand. There is clear documentation in the notes that the kidney was considered marginal. There is significant literature in the international transplant world that marginal kidneys (as this was) whilst do not have an excellent outcome, on balance they are worth transplanting. 2. Treatment provided was of a reasonable and appropriate standard. Dr Voss states: I think a question that follows this is was the medical care substandard at any time at the control of the doctors. I believe not so. There were times when more information could have been gathered and there was discrepancy in tests, and in such situations further tests were arranged. Examples were an ultrasound scan finding was not consistent and so other radiological investigations including CT scan and DTPA nuclear medicine scans were done to get a better idea of assessment of function. Interestingly these showed some blood flow to the kidney and therefore the transplant was pursued. 3. The failure of the transplanted kidney was not caused by treatment factors. The primary kidney failure which occurred in this case was due to cortical necrosis. Dr Stephen Munn states: The initiating injury that caused the cortical necrosis was either: (i) due to events in the deceased's donor and/or during cold storage of the kidney or (ii) Due to poor perfusion of a portion of the kidney because of pre-existing damage to the small arteries of the kidney as evidenced by the biopsy report of the donor kidney before its implantation. Importantly, none of the alleged contributors to the failure of the kidney allograft are likely to be relevant. The cold ischemic time of 18 hours is, in my view, not pertinent. The only alternative treatment pathway that could have avoided the two physical injuries is described in item one (above) would have been to decline to use this particular kidney. There is inadequate support for either of the biopsies being responsible for the non-function of the kidney. 4. No failure to obtain informed consent was identified. Dr Voss provided a report regarding informed consent. Please refer to the full report enclosed. He states, in part: I believe additional points to clarify with Ms Shand with this particular transplant are: ) The kidney was marginal in the form of a small kidney; 2) The NZCKS score of 5 (being therefore still adequate to utilise); (3) Its degree of match to her (4/6 mismatch); (4) The direct cross match result was negative. The detail Dr Matheson states in the hospital record that was given to her and Ms Shand's comments make it clear Ms Shand was given at least this information - in fact she was given more, namely Auckland declining the kidney - and along with other information she presumably had received prior to listing the transplantation I interpret is clearly adequate information. Travelling from Palmerston North and subsequently signing the consent form would support Ms Shand had adequate information to make her comfortable to proceed with signing of the renal transplant consent form at the time. First and foremost ACC must be able to determine that a treatment failure has occurred, in which the treatment provided was not of a reasonable and appropriate standard. Once this has been determined, ACC must identify that a physical injury has occurred as a result of this failure, it would have been avoided if the treatment failure had not occurred. After assessing the information provided, this claim has not met the legal criteria for treatment injury, and is declined [7] On 16 July 2015, the Corporation confirmed the decision would not be revised. The claim was referred to review which upheld the Corporation's decision. Ms Shand and Mr Dixon provided evidence by affidavit. Ms Shand and her mother gave evidence at review. [8] Ms Shand seeks cover for three treatment injuries. First, she seeks cover for the transplant surgery on the basis she did not give informed consent to treatment. Secondly, the treatment caused the cortical necrosis. Thirdly, the treatment caused the increased antibody levels. The requirements of a treatment injury [9] In order to establish cover for a treatment injury, Ms Shand must meet the requirements of s 32(1) of the Accident Compensation Act 2001 (the Act) which relevantly provides: 32 Treatment injury Treatment injury means personal injury that is- (a) suffered by a person- seeking treatment from 1 or more registered health professionals; or receiving treatment from, or at the direction of, 1 or more registered health professionals; of (ifi) referred to in subsection (7); and caused by treatment; and (c) not a necessary part, or ordinary consequence, of the treatment, taking into account all the circumstances of the treatment, including- (i) the person's underlying health condition at the time of the treatment; and (ii) the clinical knowledge at the time of the treatment. [10] Section 32(2) provides that treatment injury does not include personal injury that is wholly or substantially caused by a person's underlying health condition. [11] Section 32(3) provides that the fact the treatment did not achieve a desired result does not, of itself, constitute treatment injury. [12] Treatment for the purposes of determining whether a treatment injury has occurred is defined in s 33 which provides: 33 Treatment (1) For the purposes of determining whether a treatment injury has occurred, or when that injury occurred, treatment includes- (a) the giving of treatment: a diagnosis of a person's medical condition: (c) a decision on the treatment to be provided (including a decision not to provide treatment): ( d ) a failure to provide treatment, or to provide treatment in a timely manner: obtaining, or failing to obtain, a person's consent to undergo treatment, including any information provided to the person (or other person legally entitled to consent on their behalf if the person does not have legal capacity) to enable the person to make an informed decision on whether to accept treatment: [13] In summary, treatment includes: The giving of treatment; A decision on the treatment to be provided; A failure to provide treatment Failing to obtain a person's consent to undergo treatment, including any information provided to the person to enable the person to make an informed decision on whether to accept treatment. [14] In Adlam,' the Court of Appeal held that a treatment injury occurs where there is departure from a standard and that departure has caused a personal injury. The focus of the treatment injury provisions is on the sufficiency of treatment provided. The Court stated: [62] Taken as a whole the provisions indicate a legislative intent to limit cover for persons who suffer injury while undergoing treatment, rather than providing cover for all those who suffer. The injury said to be a treatment injury must be the consequence of a departure from appropriate treatment choices and treatment actions. The drafting could have simply provided for cover for all injury suffered while a person undergoes treatment. But that course was not taken. Rather, boundaries were set out that have the effect of limiting the availability of cover for injury during treatment. A failure in the sense of omitting to take a step required by an objective standard is necessary. Issues [15] The issues to be determined in the appeal are: [a] Whether Ms Shand provided informed consent to treatment; [b] Whether cortical necrosis was caused by treatment. [c] Whether the increased antibody levels are an ordinary consequence of treatment. Adlam v Accident Compensation Corporation [2017] NZCA 457 Issue One - Whether Ms Shand provided informed consent to treatment The availability of a donor kidney [16] The kidneys were offered to Auckland, Wellington and Christchurch renal transplant centres in accordance with the New Zealand kidney allocation scheme protocol. [17] In the Treatment Injury advice to the Corporation dated 16 September 2014, Dr Munn commented: The kidney doctors at Wellington Hospital had a difficult choice to make because the kidney that was being offered for her was imperfect in a number of ways. The deceased donor was 55 years old and there had been biopsies taken of each kidney. The left kidney, the one finally accepted for Isobel, was shown, on frozen section (rapid) preparation of the biopsy specimen to have damage to the filtering units (glomeruli) and drainage tubules, scarring, and thickening of the walls of the small arteries inside the kidney. In NZ such pre-existing disease in a potential deceased donor kidney is scored based on a system proposed by Remuzzi (1). The score provided on the basis of the frozen section was 5. The general agreement by the kidney transplant groups in NZ had been that scores of 1-3 meant the kidney was acceptable to use as a single kidney, scores of 4-6 meant that both deceased donor kidneys should be offered to a single recipient and scores of 7 or greater meant that neither kidney should be used. [18] Dr Munn noted the antibody testing of the kidney that had become available and that Ms Shand had antibodies to a number of potential donors. Dr Munn stated: The kidney that had become available was blood group compatible and, importantly, tested negative on the lymphocytetoxic crossmatch (a test used to look for pre-existing antibodies in the donor that could damage the cells in the donor kidney). The latter test was very significant because Isobel had had a previous kidney transplant some years before and, as a result of that, had antibodies to a number of potential donors in the community (based on a test called the panel reactive antibody test). [19] Dr Munn went on to comment that the renal physicians were aware of Ms Shand's existing high levels of antibodies: Because of the high levels of antibodies existing in Isobel's blood, the kidney doctors in Wellington were loath to give up one of the few kidneys that would likely come along from a donor that was crossmatch negative for Isobel. One of these doctors, Dr Phil Matheson, discussed this issue with Isobel herself. The offer of the kidney to Ms Shand [20] Dr Matheson stated in his report of 20 February 2015 that the Wellington renal physicians met as a team and he discussed the situation extensively with them. He said the decision to offer the kidney to Ms Shand was not straightforward. Dr Matheson explained the basis of the team's decision to make the offer to Ms Shand: Comment: The decision was based on the knowledge that the donor organ was not ideal. The kidney was slightly small and had moderate vascular disease on retrieval biopsy. This increased the risk of primary non function: that is to say the kidney would never work. Against this is the fact that the deceased donor had normal renal function at the time of death. Recipient factors were also taken into account. She was a sensitised recipient (my note refers to PRA 54-70%- when preparing this report I have reviewed the New Zealand Blood Service records. The current PRA (panel reactive antibody) titre was 73% for class 1 HLA and 61% for class II HLA. The peak class I HLA was 95% while the peak class II PRA was 61%). This means she had pre-formed antibodies to most common tissue types. Sensitised transplant candidates are less likely than unsensitised candidates to have a suitable cross match and usually have a long wait before a suitable donor becomes available. On 18/4/07 Ms Shand had been on the transplant waiting list for 91 months. The potential donor was of slight build; this may reduce the kidney function achieved after a successful transplant but is less relevant for a small female recipient than a large male recipient. Ms Shand is a slight woman whose dialysis target weight was 58kg. [21] Dr Matheson referred to his handwritten note recorded at 1830 on 18 April 2007. He recorded his discussions both with his colleagues and with Ms Shand earlier that day. Dr Matheson recorded he telephoned Ms Shand in the afternoon and recorded she was keen to accept a transplant even after he discussed concerns regarding the donor. He said: I spoke to Isobel by phone at c 1600 today. She has been well, no recent infections. Had wisdom teeth removed last year (previous dental abscess). She was very keen to accept a transplant, even after I discussed concerns regarding donor (see below). She had ate or drank at c 1 100 and would travel to Wellington with her mother this evening (sic). [22] The donor information was recorded by Dr Matheson as follows: Donor 55 yo 9 slight build 56 kg. No past medical history SAH 3/7 ago. . (cannot read) 68, terminal 58 urea "good" Urine output maintained Hep B s Ab tve CMV +ve x clamp time 0647 Kidneys macroscopically normal but a little small L 10x4cm R 9x4cm No atheroma, single vessels [23] Dr Matheson recorded information about Ms Shand as recipient: Recipient 30 year old woman - kidneys failed in 1988 because of FSGS. . .. Deceased donor renal transplant 1989 C K 1F - still in situ). Transplant failed 1999 - chronic rejection. Haemodialysis dependent since June 1999 (Recently completed home training and dialysed at home today via tunnelled dialysis catheter). Previous parathyroidectomy. ? Macroprolactinoma. [24] Dr Matheson went on to record information under the heading Retrieval biopsy noting glomerulosclerosis and other details in respect to the left and right kidney. Dr Matheson also noted: i.e. the vessel wall thickness equalled the lumen, suggesting previous | BP or renal disease. Ian Dittmer (Auckland) reviewed biopsy and turned down kidneys for Auckland recipients (1 20 ranked). [25] Dr Matheson summarised the concerns he discussed with Ms Shand: ...this is a marginal donor on biopsy features, the transplant may not work but we feel there is a reasonable chance of success and this is a good opportunity for Isobel, who is a sensitised recipient (PRA 54-70%) and may be less likely to get a negative crossmatch in the future. She is slight (TW=58kg). All of these concerns were discussed with the recipient. (emphasis added) (26] In her statement to the Corporation in December 2014, Ms Shand disputed she was phoned by Dr Matheson. She said she received a call from Dr Penguin, and not Dr Matheson 'even though this is recorded in the medical notes'. In her affidavit of 15 January 2016, Ms Shand recalled that her conversation was with Dr Pidgeon. Ms Shand stated: 3. I was informed by Dr Pidgeon that a kidney transplant had been selected for me. Dr Pidgeon told me that the kidney had been rejected by Dr Ian Dittmer at Auckland Hospital. I was told that the Wellington renal team had decided to accept the kidney as because of my size, it was a perfect match as the lady donor weighed 56 kg. At this point, I asked Dr Pidgeon whether there was anything else wrong with the kidney and he said "no". 4. When I received the call from Dr Pidgeon, I told him that I was interested but I wanted to get a second opinion from renal specialist, Dr Norman Panlilio. I was not very keen to accept the transplant without having the benefit of this second opinion. My nurse, Maryanne, rang Dr Panlilio, for me to speak to him. I questioned many times regarding whether the kidney was too small, and he told me that it was a good and healthy kidney otherwise they would not transplant it. 5. When I arrived at Wellington Hospital on 18 April 2007, I met with Dr Philip Matheson and Dr Pidgeon. I again asked Dr Pidgeon in person about the fact that Auckland had rejected the kidney. Dr Pidgeon again advised me that it was a healthy kidney and they would not transplant it if it was not. I was in surgery within 30 minutes of arriving at the hospital. [27] In response to Ms Shand's affidavit, Dr Pidgeon reported on 23 February 2015 that he could not recollect a discussion with Ms Shand before the transplant, and if he had spoken to her it would have been by phone on the evening of surgery. Dr Pidgeon said if he had given information, it would have been the same information given by Dr Matheson. [28] Following his first report on 18 May 2015, and with additional information provided by Ms Shand and Ms Eliasen, Dr Voss commented on the issue of informed consent: I believe that any reasonable dialysis patient or experienced (previous) renal transplant patient would have had more than once information about short term complications and long term complications with any renal transplant. I believe additional points to clarify with Ms Shand with this particular transplant are: 1. The kidney was marginal in the form of a small kidney. 2 . The NZKAS score of 5 (being therefore still adequate to utilise). 3. Its degree of match to her (4/6 mismatch). 4. The direct cross match result was negative. The detail Dr Matheson states in the hospital records that was given to her and Ms Shand's comments make it clear Ms Shand was given at least this information - in fact she was given more, namely Auckland declining the kidney - and along with other information she presumably had received prior to listing for transplantation I interpret is clearly adequate information. Travelling from Palmerston North and subsequently signing the consent form would support Ms Shand had adequate information to make her comfortable to proceed with signing of the renal transplant consent form at the time. I therefore believe Ms Shand received adequate information - maybe not all on her second transplant date. Through the experience of a previous renal transplant, two transplant worker protocols, assessments and pre second transplant information Ms Shand should have received adequate information in some form or another that I believe one can conclude she had been fully informed to her satisfaction. . . . As an additional comment, on the background of a young active and industrious woman who is running her own business and trying to get on in life with kidney failure it is devastating for Ms Shand to have had a failed and never functioned second transplant that has resulted in an even higher PRA in her. This high PRA will reduce her chances of a third successful transplant, however I believe the consent process cannot necessarily predict this outcome, nor can it be expected to predict in more detail immediately prior to surgery. The consent process in Ms Shand's case cannot be blamed for failing to provide this detailed information on or about 18 April 2007 to Ms Shand. This is renal transplant medicine and it is sadly demoralising for Ms Shand to have suffered from this adverse outcome. [emphasis added] [29] On 18 April 2007, a nurse recorded Ms Shand's arrival at 2030hrs at Wellington Hospital. Ms Shand was admitted by Dr Masson, Registrar and she signed two written consent forms. The first form was a request for anaesthesia. The second form was a request for surgery. [30] In her letter of 16 June 2015, Ms Shand confirmed she spoke to Dr Masson. The case for the appellant [31] Mr Miller submitted: [i] Ms Shand did not receive adequate information about the particular characteristics and risks of the transplant kidney specifically, that it was a marginal kidney and might not work, and therefore she did not give informed consent to the treatment. [ii] Both Ms Shand and the renal physicians involved in her care were faced with a difficult decision regarding whether to accept a kidney which was acknowledged as being suboptimal, or wait for a further donor. It was not easy to predict when such a kidney may have become available to her. It was a difficult decision to make with life-changing consequences either way. Mr Miller submitted in these circumstances, Ms Shand should have received the maximum amount of information available to enable her to make a fully informed decision regarding whether to accept the kidney transplant. [iii] Ms Shand's evidence is she was informed the kidney was small, but it was a perfect match for her because of her size. Ms Shand obtained a second opinion. In Mr Miller's submission, these are not the actions of someone who was "very keen" to accept the kidney as noted in the medical records. Equally, the letter from Dr Panlilio dated 23 February 2015, records Ms Shand queried whether she "has to accept the kidney". In Mr Miller's submission, this is evidence that Ms Shand had reservations about undergoing the transplant. [iv] The issue of informed consent is a question for the courts and not one for medical opinion alone. Mr Miller submitted Dr Voss's opinion is phrased in speculative terms: . I believe she had the opportunity to have clarified on what grounds and then made a decision as to whether she was to proceed. . I assume they did so no grounds that they did not have a suitably small sized patient ... I believe that this would all be discussed with Ms Shand in her initial transplant listing ... a and subsequent relisting for transplantation. . ... information she presumably had received ... Ms Shand should have received adequate information in some form or another. [emphasis added] [v] Mr Miller submitted Dr Voss's opinion on informed consent seems to be underpinned by a consideration that if Ms Shand was informed generally around the risks of rejection and non-function then this was sufficient. Mr Miller submitted this does not answer the question of whether Ms Shand was informed about the specific features of the transplant kidney, which meant that she was at a higher risk of complications as a result of the transplant. Discussion [32] At the outset, having read Ms Shand's evidence in the appeal, I acknowledge the very real consequences of the failed kidney transplant that she has endured and continues to do so, both physically and emotionally. [33] Ms Shand feels she was not 'properly informed of the issues that the kidney had' and does not consider she 'was in a position to give informed consent to the kidney transplant.' Ms Shand stated in retrospect she would never have accepted the kidney. [34] Ms Shand's case is her renal physicians failed to have regard to all the warning signs which were present before the transplant so she could not, and did not give informed consent. Legal principles [35] Mr Miller and Mr Bisley referred to principles relating to informed consent established by the New Zealand Medical Councils and in case law. [36] In Rogers v Whitaker the High Court of Australia discussed whether the appellant failed to advise and warn the respondent of the risks inherent in the operation and in consequence, whether there was a breach of this duty. The Court held that medical practitioners are not required to inform the patient of every conceivable risk. However, there is a duty to warn a patient of material risks. The Court stated:$ The New Zealand Medical Council Statement for the Medical Profession on Information and Consent, June 1990. Rogers v Whitaker [1992] 175 CLR 479. Ibid p. 490 The law should recognise that a doctor has a duty to warn a patient of a material risk inherent in the proposed treatment; a risk is material if, in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. [37] The Court noted patient and community expectations are important in the provision of advice and information, and recognised that: . .. while evidence of acceptable medical practice is a useful guide for the courts, it is for the courts to adjudicate on what is appropriate standard of care after giving weight to "the paramount consideration that a person is entitled to make his own decisions about his life". [38] This statement of opinion in Rogers v Whitaker was adopted by the Court in New Zealand in B v Medical Council of New Zealand'. Elias J opined the reasonableness of the standard takes into account all the circumstances, not only usual medical practice, but also consideration of the interests of the patient. However, the approach is not one of making the practitioner a guarantor of result. A standard inevitably affected by hindsight is unfair. [39] In Ambros," informed consent was considered by the Court of Appeal: [47] The next area where the traditional causation test has been challenged is where informed consent to treatment has not been obtained. In such cases, the causation question must depend on what the particular claimant would have done had the risks of the medical procedure been properly explained. Clearly, if the claimant would have continued with the procedure even if the risks had been explained, then there is no causation. If the claimant would have refused medical treatment then the non-disclosure has caused the claimant's damage. [40] Mr Miller cited a case in the United Kingdom, where the Supreme Court' discussed the duty to take care in obtaining informed consent, and the test of materiality. The Court stated: 87. ... An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient Ibid at p487 B v Medical Council of New Zealand HC Auckland 11/96, 8 July 1996. Accident Compensation Corporation v Ambros [2007] NZCA 304 Montgomery v Lanarkshire Health Board [2005] UKSC 11 is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it. . . . 89. ... The significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have upon the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available, and the risks involved in those alternatives. The assessment is therefore fact- sensitive, and sensitive also to the characteristics of the patient. 90. Secondly, the doctor's advisory role involves dialogue, the aim of which is to ensure that the patient understands the seriousness of her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so that she is then in a position to make an informed decision. This role will only be performed effectively if the information provided is comprehensible. The doctor's duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp, let alone by routinely demanding her signature on a consent form. 109. An important consequence of this is that it is not possible to consider a particular medical procedure in isolation from its alternatives. Most decisions about medical care are not simple yes/no answers. There are choices to be made, arguments for and against each of the options to be considered, and sufficient information must be given so that this can be done ... [emphasis added] [41] The Supreme Court is clear that a patient must be given sufficient information of the anticipated benefits and risks of the proposed treatment so that the patient can consider options and make an informed decision. The information communicated must be comprehensible. [42] The authorities indicate that a medical practitioner does not have the obligation to inform every conceivable risk or every technical detail which a patient cannot be expected to understand. However, failure to obtain informed consent requires a departure from a proper standard of care, namely the provision of sufficient information about the benefits and risks of treatment. [43] I accept Mr Miller's submission there is difference between information provided pursuant to a patient's general right to know, in contrast with information to inform the patient's conduct in matters such as consent to a medical procedure. An individual may have special needs and circumstances, which if known to the doctor, will indicate that additional information is required. [44] A preliminary issue arises regarding a conflict of evidence as to which clinician was responsible for offering the kidney to Ms Shand and obtaining her informed consent. I turn to consider this issue. The clinician responsible for offering the kidney [45] Ms Shand's first note of her recollection of events was provided to the Corporation in December 2014. Ms Shand stated she received a call from Dr Penguin, not Dr Matheson. Ms Dorn's evidence corroborates Ms Shand's evidence. I observe that Ms Dorn's evidence at review is of a telephone discussion "discussing all the draws and pros and all this sort of thing". Ms Dorn said there were a number of phone calls on the afternoon of 18 April 2007. It is apparent from her evidence, that events were somewhat frenetic. Ms Eliasen, the dialysis nurse says she does not know who called, suggesting it might have been Dr Panlilio. Ms Shand said she asked Dr Penguin whether there was anything wrong with it and he stated 'no' [46] Ms Shand said at review: I spoke to Dr Grant Pidgeon, because he rings you, he is transplant coordinator. We're advised of that. That's-when we go in for our reviews and everything, we're given a pager, we're told "Dr Grant Pidgeon will ring you". You know the minute, if you get a call from Dr Grant Pidgeon that's your transplant. If he calls, you know what it's for. So, you know that you need to answer that phone call. That's what he does, so I knew that. He rung when I was ten. I knew who he was, I knew that that's the phone call I wait for. [47] The evidence of Dr Pidgeon (not Dr Penguin) is that he may have phoned Ms Shand but he cannot recall speaking to her and there is no contemporaneous note of him doing so. [48] If Dr Pidgeon did phone Ms Shand, he says he would have addressed the concerns identified by Dr Matheson, that is: The characteristics of the kidney, Ms Shand's history and circumstances, and the risks and benefits of transplanting the kidney were as Dr Matheson described in his evidence and notes. Dr Pidgeon said he would have given the same information to Ms Shand if he had spoken to her on the telephone on the afternoon of 18 April 2017. Dr Pidgeon said he would have recommended implantation on the basis that it was a reasonable kidney giving Ms Shand a good chance of renal function and dialysis independence, albeit with a risk of primary non- function. Dr Pidgeon stated he did not have a recollection of the discussion he had with Ms Shand at the relevant time. He confirmed that standard practice is to inform a transplant recipient of the risks and likely outcomes of transplantation, including concerns regarding the calibre of the kidney and the risk of primary non-function. [49] In my opinion, seven factors cast doubt that Dr Pidgeon was the clinician responsible for offering the kidney. [50] First, Ms Shand and Dr Matheson agree the phone call was made in the afternoon. Dr Pidgeon says his phone call, if he made one to Ms Shand, would have been from his home at night. According to the hospital records, Ms Shand arrived at the hospital at 2030. A phone call could not have been made by Dr Pidgeon during the evening having regard to the time for travel from Ms Shand's home to the hospital when Ms Shand had already presented at the hospital. [51] Secondly, there is no contemporaneous record to support a phone call from Dr Pidgeon. Dr Pidgeon's evidence is he cannot recall a specific involvement at that time and cannot recall the discussion with Ms Shand. If Dr Pidgeon was the clinician responsible for offering the kidney to Ms Shand and obtaining her consent, then it is expected he would recall his specific involvement by reference to contemporaneous records. He would be under a duty to do so. [52] Thirdly, in an undated letter from Ms Shand's dialysis nurse, Ms Eliassen says she does not know who called, suggesting it might have been Dr Panlilio. [53] Fourthly, Dr Matheson records on 18 April 2007 that he spoke to Dr Dittmer and he obtained information about the rejection of the kidneys by Auckland. There is no evidence from Dr Dittmer that he spoke to Dr Pidgeon at the relevant time. [54] Fifthly, Dr Panlilio's evidence is that kidney transplant communications are handled directly by the transplant centre, in this case, Wellington hospital. He said the MidCentral Physicians are called by the transplant centre to inform them that one of their patients is being transplanted and to enquire about events in the recipient's recent history that may preclude transplantation. I observe that Dr Matheson's notes refer to up to date information about Ms Shand, that she was on home dialysis and he records the times when she ate and drank on that day. [55] Sixthly, the Reviewer received oral evidence from Ms Shand and Ms Dorn at review. I observe the Reviewer commented in his decision of 25 April 2016 that there were inconsistencies in Ms Shand's evidence and he considered "that time is now a factor affecting the accurate recollection of events". The Reviewer also sent a written question to Dr Matheson who affirmed his note on 18 April 2007 as true and correct. [56] Seventhly, Dr Matheson admits he called Ms Shand and he was the clinician responsible for offering the kidney and obtaining her consent. Dr Matheson's involvement is supported by his contemporary records, and confirmed in his evidence upon investigation of the claim. [57] Whilst it cannot be conclusively denied that Ms Shand spoke to Dr Pidgeon, I conclude Dr Pidgeon was not the clinician responsible for offering the kidney to Ms Shand at the relevant time. [58] I conclude the clinician responsible on behalf of the Wellington renal physicians for offering the kidney to Ms Shand and responsible for providing information at the relevant time, was Dr Matheson. [59] I turn to consider the information provided to Ms Shand in determining whether the information was adequate or sufficient to enable Ms Shand to give informed consent. The information provided 60] Ms Shand disputes she received information that the kidney was marginal and may not work. She stated: 8. At no time was I ever told of anything other than the kidney was small, and was suitable for me because of my weight. I do not believe that a person who had been dialysing for 3 hours was in a position to make a life changing decision such as this. When I read in my medical notes that the kidney was a marginal kidney that may never work I was very upset as I would never have wanted a bad kidney like that. If I'd known this, I would have waited another 10 years to get a really perfect kidney. [emphasis added] [61] In his report of 20 February 2015, Dr Matheson confirmed he discussed the information recorded in his notes of 18 April 2007 with Ms Shand. He said his practice is to discuss the possibility that a transplant would not work. He commented: In addition to those specific notes that were written at the time of offering the kidney I offered the general comment that I cannot recall ever having spoken to a potential recipient of a kidney without discussing the possibility that the transplant would not work. My discussion was along the lines of "this transplant may never work and there is a 5-10% chance the transplant will not be working one year after transplantation". The ANZDATA registry report in 2006 reports that 10% of second and subsequent kidney transplants from deceased donors had failed within the first year after transplantation. [62] Dr Matheson confirmed that: In my opinion the hospital notes written by me on 18/04/07 clearly demonstrate that Ms Shand was adequately informed of this particular kidney transplant based on what was known at the time of treatment. [emphasis added] [63] Likewise, Dr Panlilio confirmed his discussion with Ms Shand. He stated: Ms Shand called me that day to enquire whether she has to accept the kidney. Knowing Ms Shand's history in dealing with medical practitioners, I hesitated to give any advice. She pressed on wanting me to decide whether she should accept the kidney or not. When I told her that I cannot give advice she was already given the information from Wellington directly, she told me that it was my personal opinion that she is after. I then said that because of her high level of antibodies, she might not have many opportunities to be offered a kidney. [emphasis added] (64] Mr Miller submitted the following information concerning the kidney transplant should have been communicated at the relevant time: The kidney was from a deceased donor who had died of a terminal illness. [65] Dr Matheson's note of 18 April 2007 refers to deceased donor renal transplant. Ms Shand was on the deceased donor waiting list. It is understood that the main source of kidney transplant in New Zealand is from a deceased donor unless a living donor is prepared to donate a kidney. In his evidence, Dr Pidgeon noted Ms Shand's kidney transplant in 1989 was from a deceased donor. [66] There is no evidence of the relevance of a kidney from a deceased donor who died of a terminal illness. The relevant consideration noted by Dr Matheson and confirmed by other specialists is that the donor had maintained normal renal function and urine output throughout the terminal illness. The deceased donor biopsy suggested hypertension and renal disease as well as vascular disease. [67] Ms Shand's evidence is if she had known the kidney had disease, she would have rejected it because she is a "germaphobe". There is no suggestion whether this phobia expressed in 2016 by Ms Shand was known to physicians in 2007. [68] Ms Shand stated the kidney had the CMV virus. Dr Munn noted in the treatment injury advice the donor had previously been exposed to the CMV virus whereas the recipient had not. Dr Matheson's notes refer to "Donor CMV +ve and Recipient previously CMV - ve." [69] Dr Leikis stated CMV is noted for post- operative management and is not part of the allocation protocol. . He stated Ms Shand was treated appropriately post operatively for the CMV positive donor, negative recipient status. [70] Dr Matheson recorded his knowledge of the retrieval biopsy at the relevant time: Retrieval biopsy of the donated organs showed that on the left kidney there was mild glomerulosclerosis with 18/147 glomeruli sclerosed. There was very mild focal interstitial fibrosis and tubular atrophy measured at>5%. The kidney was slightly small and had moderate vascular disease on a retrieval biopsy. This increased the risk of primary non-function.... [71] In respect to the conditions of hypertension and renal disease, Dr Matheson's note of 18 April 2007 recorded: . the vessel wall thickness equalled the lumen, suggesting previous BP or renal disease. [72] I observe there is no suggestion of raised blood pressure and renal disease. Neither is there suggestion of existing raised blood pressure or renal disease at the relevant time. The suggestion is of previous raised blood pressure or previous renal disease. Dr Matheson noted as a relevant consideration that at the time of death, the donor had normal renal function. [73] However, Dr Matheson recorded the kidney had moderate vascular disease on the retrieval biopsy which increased the risk of non-function. His notes record: The decision was based on the knowledge that the donor organ was not ideal. The kidney was slightly small and had moderate vascular disease on the retrieval biopsy. This increased the risk of primary non function; that is to say that the kidney would never work. Against this is the fact that the deceased donor had normal renal function at the time of death. [emphasis added] [74] In his 2015 evidence, Dr Matheson confirmed his written notes outlined the basis of the risks he communicated to Ms Shand which included the degree of vascular disease. All of which was relevant to the issue of a marginal kidney that may not work, and which Dr Matheson says formed part of his discussion with Ms Shand. The kidney was considered suboptimal and had been rejected by not one but two other major transplant centres. [75] Various descriptions have been used by specialists to characterise the kidney or donor, including suboptimal by Dr Munn. Exactly what was conveyed by Dr Matheson is relevant to the issue whether Ms Shand was able to make an informed decision. [76] In her evidence at review, Ms Shand states if she had been told the kidney may not work "I would never have gone for it". More broadly, Ms Shand says she has subsequently discovered a great deal of detail in her medical notes, and she would not have consented if she thought the kidney would not work. The Court must be cautious about hindsight information. What is relevant is information known at the particular time, appreciating that bombarding a lot of technical details is unhelpful, as the authorities indicate. [77] Dr Matheson described the donor as 'marginal' due to biopsy features. This factor together with Ms Shand's position as a sensitised recipient meant the transplant may not work, but there was a reasonable chance of success. Dr Matheson said: My written note from 18/04/07 summarised the team's reasoning as follows: "In summary this is a marginal donor on biopsy features, the transplant may not work but we feel there is a reasonable chance of success and this is a good opportunity for Isobel who is a sensitised recipient (PRA 54-70%) and may be less likely to get a negative crossmatch in the future. She is slight (TW [target weight] =58kg. All of these concerns were discussed with the patient". (emphasis added) [78] In his evidence, Dr Matheson said in addition to the specific features which supported his view the transplant may not work, he discussed the issue also having regard information data on risk. He said: My discussion is along the lines of "this transplant may never work and there is a 5-10% chance the transplant will not be working one year after transplantation". The ANZDATA registry report in 2006 reports that 10% of second and subsequent kidney transplants form deceased donors had failed within the first year after transplantation. The risk of a deceased kidney donor transplant failing within one year of transplantation was 7.7% in 2005-2009 in Australia and New Zealand (ANZDATA registry report 2012). The position of Auckland and Christchurch [79] Mr Miller submitted that in addition to the rejection by Auckland, knowledge that another transplant centre had rejected the kidney would more likely have provided further corroboration to Ms Shand that another independent body had found it too risky for implantation. [80] I observe the exchange of correspondence between Dr Dittmer and Ms Shand in 2015 in which she is concerned to ascertain reasons for rejection of the kidney by Auckland and Christchurch. Ms Shand stated: Ms Shand: I have just read a letter from Dr Voss written to ACC and it states that it is quite possible the Auckland potential recipients have too large a body mass to tolerate a marginal kidney. Would this be a true comment as I thought you declined it due to the NZCKS score? Also I would like to find out why Christchurch considered using en bloc kidney, both kidneys for a potential recipient. It is not known what processes were considered in Christchurch for their final decision however the eventual outcome was not to use the kidney I assume. [81] Dr Dittmer replied to Ms Shand in an email on 25 May 2015 that: The Auckland group declined the kidney on the score as you note, I do not know re Christchurch, you would need to contact them. (emphasis added) [82] Mr Miller submitted this email explains that Auckland Hospital declined the kidney on the basis of the NZKAS score. In the absence of a more complete explanation from Dr Dittmer, it is unsafe to draw an inference that the score alone was the sole basis for the rejection by Auckland. I observe Dr Matheson's comment in his note of 18 April 2007, he was informed by Dr Dittmer at the time that the Auckland recipients were ranked: Ian Dittmer (Auckland) received biopsy and turned down kidneys for Auckland recipients (1st 20 ranked). [83] This note appears to suggest that Auckland did not reject the kidney outright but considered it a possibility for 20 recipients, before doing so. [84] There is no dispute Ms Shand was informed there had been a rejection by the Auckland transplant centre. This warning alerted her particularly to the significance of risk and she was astute to investigate that fact with Dr Panlilio. [85] The evidence of Ms Shand and her mother is they were not aware at the time, that Christchurch had rejected the kidney. Dr Matheson's note of 18 April 2007 does not mention Christchurch and there is no evidence to suggest that he knew of the Christchurch position at the relevant time. I observe that Dr Dittmer's note of 28 April 2015 recorded the Christchurch Team considered whether a dual transplant might be feasible for one patient but this did not proceed. [86] Mr Miller submitted if Dr Matheson did not know, he should have known about Christchurch. There is no evidence that Dr Matheson knew of a rejection by Christchurch. There is no evidence before me that he should have known or evidence of a standard that required him to make an enquiry of another transplant centre. Neither is there any evidence before me about the reasons for rejection of the kidney by Christchurch. In the absence of such evidence, the Court cannot make a finding that Dr Matheson should have made enquiry of Christchurch at the relevant time. The kidney had been given an NZKAS score of 5 which meant according to the national standard procedure that it should not be implanted alone but only as dual implant. [87] Following the hearing, the Court enquired as to the date of the histopathology report. Mr Miller and Mr Bisley agree the histology report was not officially reported on 18 April 2007. [88] Mr Miller submitted the official histology report recorded the revised scores. However, at the time of operating there was a NZKAS score of 5. Dr Munn noted this was a calculated risk which was justified when the score was downgraded following surgery, to 3. Dr Munn explained the position: It had a Remuzzi score of 5 which made it a kidney that others had declined. After discussing this with the patient (there is no record about how long this discussion was, only that it took place) a decision was made to proceed. With the benefit of subsequent review of the donor kidney histology after paraffin (slow) processing of the biopsy, it would seem that this risk might have been justified because the Remuzzi score was downgraded to 3, a score that most would accept as being reasonable for use of that single kidney in a recipient. It is important to note that the doctors making the decision to use this kidney were not in possession of this more favourable histological data at the time the decision was made to proceed. [89] Mr Miller submitted there was a departure from a standard and if it is not a departure from a standard, it is a departure from the standard New Zealand medical response. There is no evidence before me of a standard and departure from it. [90] Dr Munn's evidence refers to a general agreement by the kidney transplant groups. Dr Voss stated under the NZ kidney donor scheme criteria, the kidney was suitable to be used: The better of the 2 kidneys on the frozen section was utilised and transplanted into Ms Shand.... It was known that the kidney was considered adequate to be used based on the New Zealand transplant criteria. However it was rejected by Auckland and Christchurch renal transplant units. Apparently, Christchurch considered using en bloc (both kidneys) for a potential recipient. It is not known what processes were considered in Christchurch for their final decision. Their criteria are not clear and in my opinion irrelevant to the decision that Ms Shand received the solitary donor left kidney in Wellington. Under the NZ kidney donor scheme criteria the kidney was certainly suitable to be used, however one could have considered using the kidneys en bloc (both kidneys) [91] No specialist has argued a breach of a standard or breach of a standard medical practice or of a breach of the general agreement. [92] In terms of what was communicated to Ms Shand, Dr Matheson's evidence is that he discussed the 'biopsy features' of the kidney, which is directed at the issue of material risk. The significance of this risk goes also to information that the kidney was marginal and it might not work. These concerns were sufficiently understood by Ms Shand and caused her to ring her renal physician, Dr Panlilio. If the kidney implant failed, then the inevitable increase in antibody levels meant that another (better) kidney implant would be virtually impossible, resulting in a slow death on dialysis. [93] Dr Voss, Dr Munn and Dr Pidgeon reviewed Dr Matheson's notes of his discussion with Ms Shand and considered the information was sufficient to identify and alert Ms Shand to the anticipated benefits and risks. Information that the transplant may not work arising from the key features of the kidney being marginal, rejection by Auckland, and size of the kidney as against risks presented by Ms Shand's own characteristics as a sensitised recipient. [94] The overall context was of a reasonable chance of success and good opportunity for Ms Shand. This advice was given following Dr Matheson's discussions with his colleagues in the Wellington renal team of physicians, Dr Dittmer and enquiry of Ms Shand's up to date position with her MidCentral physicians, as confirmed by Dr Panlilio. [95] I now turn to discuss other factors that Ms Shand contends impacted on her capacity to give informed consent. Other factors [96] Ms Shand stated she had been receiving dialysis on the afternoon of 18 April 2007 and she was unable to make an informed choice about her treatment. I observe Dr Matheson was aware Ms Shand was 'dialysed at home today' because he recorded that fact in his note of 18 April 2007. There is no evidence before me that receiving dialysis at the time meant Ms Shand was unable to assess her options. [97] Ms Shand says she was not aware of the cold ischaemic time of the kidney of 18 hours and the HLA mismatch. [98] Dr Leikis opined the cold ischaemia time is multifactorial, dependent on location of donor and recipient hospitals, and transport logistics. It is also dependent on a recipient getting to the transplanting hospital and being prepared for surgery. Whilst the ischaemia time should be kept as short as possible, Dr Leikis thought 18 hours in this case was acceptable. [99] Dr Munn did not think the cold ischaemic time was pertinent. Dr Munn said that in 2007 the cold ischaemic time for all deceased donor kidneys in the USA was 18 hours. Dr Voss opined the cold ischaemia time had no effect on transplant survival. [100] Based on the evidence of logistics and multifactorial matters, it is apparent information about cold ischaemia time was not known and could not have been known at the time the kidney was offered to Ms Shand. Upon review, the specialists considered the cold ischaemia time here was acceptable. [101] Dr Munn confirmed the available kidney was blood group compatible and tested negative on the lymphocytetoxic crossmatch which he explained is a test used to look for pre-existing antibodies in the donor that could damage the cells in the donor kidney. There was also regard to Ms Shand as a sensitised recipient and awareness of her antibodies based on a reactive antibody test as noted by Dr Munn. [102] Dr Munn went on to say the degree of HLA mismatch is not associated definitively with primary non-function, although it may be relevant to long term attrition rates. Dr Leikis noted the degree of mismatch is an integral part of the standard national allocation scheme and the kidney was allocated in accordance with the standard. [103] In his February 2015 report, Dr Matheson said he reviewed the New Zealand Blood Service records. He noted that Ms Shand had pre-formed antibodies to most common tissue types, and sensitised transplant candidates are less likely than unsensitised candidates to have a suitable cross match, and usually have a long wait before a suitable donor becomes available. [104] Whilst Dr Matheson may not have used the technical language which Ms Shand has seen in medical reports, the features of HLA mismatch are part of the factual matrix of a marginal kidney and Ms Shand as a sensitised recipient, which Dr Matheson says he discussed with Ms Shand. [105] Dr Voss referred to Ms Shand having received information and education as a longstanding recipient on the waiting list. There is no evidence before me of the general information or education given to Ms Shand as recipient on the waiting list. Whilst such information might prepare an individual on the waiting list in general terms, in my opinion that does not obviate and is not in substitution for the requirement to provide information on material risks and benefits of the kidney offered to Ms Shand in order to obtain informed consent. [106] The hospital notes indicate Dr Masson, Registrar met Ms Shand on arrival at the hospital and he admitted her and conducted the necessary pre-operation tests. Ms Shand signed a consent form for 'cadaveric renal transplant and blood transfusion'. Dr Masson signed this form. I observe Dr Voss' comments regarding the shortcomings of the form presented. I take into account the consent form is not relied on by the Corporation as evidence to support informed consent. I accept Mr Miller's submission that what is important is the substance of what was conveyed to Ms Shand, not the form. [107] Mr Miller submitted Dr Voss' opinion on informed consent should not carry weight. I accept Dr Voss' conclusions are not determinative on informed consent but they do assist as an independent renal physician reviewing the documentation in the case. Conclusion [108] Dr Matheson, Dr Voss, Dr Munn and Dr Pidgeon agree that the options available to Ms Shand were to accept or decline the proposed treatment. Acceptance of the kidney which had a good chance of functioning. If it failed, there would be increased sensitisation with the consequence of reduced chance for another suitable kidney. Declining the kidney meant losing the chance to find out if it would function. On the other hand, Ms Shand would be left with increased sensitisation and a better chance of receiving another kidney. This carried risk as the pre-existing sensitisation meant there were no guarantees when another kidney might be offered, and a suitable donor might not be available. [109] Dr Matheson did not have a duty to bombard Ms Shand with technical information. The duty was to ensure the information was comprehensible, and in a context where time was an important consideration if Ms Shand was to accept the kidney offered. There was a duty to engage in dialogue of anticipated risks and benefits, the significance of which needed to be understood. [110] I am unable to conclude there was any failure to convey sufficient information of the material benefits and risks of the proposed treatment to Ms Shand. I am satisfied there was no departure from a proper standard of care. [1 11] On the evidence, Ms Shand was provided with information at the relevant time by Dr Matheson that the kidney was marginal (due to size, NZKAS results and the degree of negative cross-match) and may not work. Added to the issue is the understanding Ms Shand's body might reject the kidney and she would be further sensitised, though there was a reasonable chance of success. This was a good opportunity for Ms Shand who was a sensitised recipient, but it was not without risk. The information was based on the features of the kidney biopsy, donor factors and Ms Shand's own characteristics, together with general information based on ANZDATA in 2006. Additionally, Dr Matheson communicated the rejection by Auckland. This information was sufficient to alert Ms Shand to the significance of the anticipated risks and benefits. The evidence of Ms Shand and Ms Dorn is the information received caused Ms Shand to discuss matters with her renal physicians in her home area, particularly with Dr Panlilio. [112] On the basis of the information received, and understanding the options available to her, Ms Shand made an informed decision to accept the kidney. There were other opportunities to seek more information, including from Dr Masson. The Corporation does not rely on the form that Ms Shand signed but the substance of what was communicated. The process provided an opportunity to ask questions, which Ms Shand says she did, in her evidence at review. [113] On balance, I conclude the weight of the evidence shows that at the relevant time sufficient information was provided to Ms Shand in making the offer of the kidney, there was no departure from standards and she gave her informed consent to the treatment. Issue Two - Whether cortical necrosis was caused by treatment The transplant surgery [114] There are patient notes for Ms Shand in evidence dated 18 April 2007 recorded and signed by Philip Masson, Registrar, on the Examination and Progress Form, including his notes of interview with Ms Shand following her admission to hospital. There are notes recorded by and other clinical staff with times recorded by each note. [115] The operation record notes surgery commenced at 11:20pm on 18 April 2007 and was completed at 2:06am on 19 April 2007. The operation notes provided by Mr Evans, transplant surgeon on 19 April 2007 record: Findings: The donor kidney was a reasonable organ with a single upper pole accessory artery arising from the main trunk of the left renal artery. There was a 4 cm subscapular haematoma on the posterior aspect. A wedge biopsy had been taken from the superior lateral edge. Procedure: Left cadaveric organ. Previous failed transplant on right side. ... the patient was of small stature and it seemed more appropriate to place the transplant on the common iliac artery and vein. ... upon release of clamps, the kidney became pink and well perfused. The wedge biopsy site was over sewn with 5/0 proline owing to profuse bleeding Post operative instructions: As per transplant protocol. Events following the transplant surgery [116] Ms Shand had various ultrasounds, renal scans and other imaging following surgery. In his report of 16 December 2014 Dr Munn noted the ultrasound results showed poor blood flow to the lateral portion of the kidney. [1 17] A note signed by Dr Matheson, also on 20 April 2007 records that: Repeat renogram today. Report discussed with Dr Russell Taylor (nuclear medicine). There is slightly more delay in tracer uptake compared to yesterday but the kidney appearance has not changed and he believes that it is adequately perfused. I have discussed this with Richard Evans. We both find these appearances hard to explain but perhaps the easiest explanation is that there is subcapsular haematoma (there was quite a lot of bleeding from the retrieval biopsy site) and that the "un-perfused kidney" is in fact haematoma. [118] At 1636 on 20 April 2007, a renal ultrasound was performed which recorded in part : Tracer uptake is not quite as prompt as it was in the previous renogram. Findings however are still compatible with an adequate blood supply... [119] Renal ultrasound imaging was taken on 21 April and 23 April 2007. The ultrasound of 21 April queried: ? subscapular haematoma on ultrasound 20/04/07, but renogram ok. [120] On 24 April 2007 the renal ultrasound recorded: Findings: Comparison has been made with the scan from yesterday. Surprisingly there is now evidence of blood flow in the renal vein whereas before this was not demonstrable. The kidney still shows echogenicity within the whole of the lateral aspect of the kidney extending from the capsule into the renal sinus fat suggestive of parenchymal abnormality. Impression: Improvement in the venous flow of the kidney ... [121] A handwritten note headed "Retrieval Biopsy on Isobel Shand's kidney" is from LabPlus Auckland City Hospital and is the Histopathology Report: The Report notes: Collected: 18/04/2007 Received: 18/04/2007 Reported 27/04/20007 [122] The report recorded clinical details for the left kidney with a score of "NZKAS = 5", under "Frozen Section", and upgraded to NZCKS score of 3. [123] Ms Shand was discharged from Wellington Hospital on 27 April 2007. [124] On 1 May 2007, an Anatomical Pathology note reported in part: Comment: All of the cortical tissue in this specimen is necrotic, suggesting that diffuse cortical necrosis is present. However, the sample size is small, and inadequate by the Banff criteria. The cortical necrosis may be related to the vascular rejection seen, though this finding is more usual in antibody - mediated (hyperacute) rejection ... [125] On 4 May 2007, a renogram was performed which showed no visible perfusion to the transplanted kidney. [126] By 10 May 2007 when Dr Leikis reviewed the renal ultrascans and evidence from the biopsy, he noted conflicting evidence yet "Isobel remains very well and clinically it appears that she continues to have a viable kidney supported by the ultrasound". [127] On 26 July 2007 Dr Leikis opined Ms Shand's kidney had unfortunately not functioned and the impression of his colleagues at the Renal Department was the kidney had suffered from cortical necrosis. [128] On 5 November 2007 Dr Leikis noted the transplant would be classified as a technical failure. [129] On 25 June 2009 Dr Evans reported to Mr Leikis that Ms Shand had presented for left transplant nephrectomy but he was unable to palpate the kidney. However, he opined there was adequate room within the pelvis for further transplant and that transplant nephrectomy was not necessary. He noted Ms Shand was "now keen to go back onto the transplant list". [130] On 16 September 2009 Dr Leikis wrote to Dr Dittmer at Auckland City Hospital, requesting Ms Shand maintain her waiting time points due to the technical failure of the last transplant. He commented: It is thus felt that Isobel's transplant failed due to technical reasons with no evidence of rejection. We have had correspondence with Palmerston North Hospital suggesting she is fit to go back on the transplant waiting list. I am writing to ask that she maintain her waiting time points that she had at the time of that transplant due to the technical failure aspect of the last transplant. [emphasis added] [131] On 12 December 2013 Ms Burton, Kidney Exchange Coordinator recorded in a note that she and Dr Dittmer met with Ms Shand and others, via video conference, and Ms Shand raised a number of questions relating to decline of a living kidney donor, issues around the waiting list, issues around the failed kidney transplant 151/2 years ago in Wellington, and what she could do to improve her chances of receiving a kidney transplant. [132] Following lodgement of the treatment injury claim in September 2014, the Corporation wrote to Dr Leikis asking him to discuss whether there was a failure to provide appropriate treatment and whether Ms Shand's case should have been managed differently. Dr Leikis responded: Please discuss if there was a failure to provide appropriate treatment in this case considering the long cold ischaemic time, the HLA mismatch and the CMV positive donor kidney to a negative recipient? Ms Shand received a deceased donor kidney transplant on 19/04/2007. The kidney was allocated to Ms Shand in accordance with the standard national allocation scheme. The donor was matched at the HLA-A locus, with 2 mismatches at both the HLA-B and HLA-DR loci. The degree of mismatch is an integral part of the allocation scheme. CMV status is noted for post- operative management but is not part of the allocation protocol. Ms Shand was treated appropriately with Valgancyclovir post operatively for the CMV positive donor, negative recipient status. The cold ischaemia time is multifactorial. It is dependent on the location of the donor and recipient hospitals and the transport logistics required getting the kidney to the recipient. It is also dependent on local surgeon and theatre availability and prioritisation with other acute surgeries. It is also dependent on the recipient getting to the transplanting hospital being admitted and prepared for surgery. The cold ischaemic time should be kept as short as practical although 18 hours remains acceptable. 2 Should Ms Shand's case been managed differently and the cold ischaemic time was lessened, there was an HLA match and the donor kidney was negative, would this have avoided the rejection of the donor kidney? Please explain your answer Not necessarily. Should the above factors have been different, the outcome may not have changed. Ms Shand had primary non-function of her transplant and did not have strong evidence of rejection. The transplant failure was most likely a 'technical failure' with cortical ischaemia seen on a biopsy taken on day 12 post transplantation. This is a non-recoverable finding. Whilst there were some suggestions of an element of vascular rejection this was not confirmed on special stains reported later. The kidney had some degree of vascular disease at the retrieval biopsy although was considered acceptable by organ donation New Zealand for transplantation. There was also a subcapsular haematoma from a retrieval wedge biopsy noted during surgery which was over sewn at the time of surgery due to ongoing bleeding following unclamping of the renal vessels. This was then noted on subsequent ultrasounds with consideration given to surgical drainage of this. It was not felt at the time that this would enhance the transplant function but may have contributed to the primary non-function. The ANZDATA registry 2012 and 2013 reports notes that up to 40-50% of transplants that fail within the first year are due to vascular or technical issues (www.ANZDATA.org.au). Rejection is a biological process that is substantially reduced with a negative crossmatch at the time of transplantation but can occur with any transplant regardless of HLA matching. Ms Shand had a significant level of pre-formed antibodies prior to this transplant due to previous sensitization hence the long wait from 1999 until the offer in 2007. In 2005 her PRA (panel reactive antibodies) were 70% indicating HLA antibodies to 70% of the general population. This makes it very difficult to find a suitable crossmatch. When a suitable donor was found, she may have had pre-formed antibodies against that donor which were below the detectable level at the time of transplantation but could have caused clinical problems post-transplant. With this in mind, she was high risk for rejection and had optimal medical treatment at the time of the transplant for this. The ANZDATA registry report in 2007 showed New Zealand had a rejection rate of 32.8% for second and subsequent transplants within the first 6 months of transplantation. Cold ischaemia time has an influence on delayed graft function and possibly rejection although data is conflicting on this. I have attached a report from the NHS UK transplanting centres showing their cold ischaemic times with Ms Shand's being within the interquartile ranges of most centres. I cannot determine that the outcome would have been different if the cold ischaemic time was less in this case. [emphasis added] [133] There followed further investigation including reports from Mr Munn and Mr Voss. In his report of 16 December 2014, Mr Munn stated that: In my view there have been two physical injuries sustained as a result of the transplant on 19/04/2007. Firstly, there was poor flow to a significant portion of the transplanted kidney and this resulted in that portion undergoing necrosis (identified as cortical necrosis on the biopsy). The area that underwent necrosis was of such a size and distribution that the kidney never functioned sufficiently well to render Isobel free from dialysis. This falls into the category known as "primary non-function." The initiating injury that caused the cortical necrosis was either (i) due to events in the deceased donor and/or during the cold storage of the kidney or (ii) due to poor perfusion of a portion of the kidney because of pre-existing damage to the small arteries of the kidney as evidenced by the biopsy report of the donor kidney before its implantation. Secondly, the transplant procedure has resulted in an increased level of sensitization in Isobel such that almost all potential donors are now unsuitable for her because of antibodies that exist in her blood stream that would result in the early destruction of any tissue, including kidney tissue from such donors. This sensitization, is in effect, the greater threat to Isobel's quality of life and longevity because it may well preclude a future successful transplant. The key treatment-related decision in this case was the one to use this kidney in this patient. This was a calculated risk based on two conflicting considerations. The patient already had a degree of sensitisation and the doctors in Wellington were concerned that Isobel would be unlikely to be offered another deceased donor kidney, at least in the medium term. ........ The injuries that occurred subsequent to the patient and her transplanted kidney were the result of this initial decision. All subsequent actions by the Wellington transplanting team were well within normal parameters and did not contribute to the failed kidney transplant or the increased sensitization of the patient. A haematoma related to the biopsy taken at the time of organ acquisition was noted, but, in my view, is very unlikely to have contributed in any significant way to the extensive cortical necrosis that occurred in this kidney. . . . Isobel was at risk of developing primary non-function of the kidney transplant no matter what kidney was selected for her. Indeed patients who have had a previous transplant and levels of antibodies similar to those that Isobel had are at increased risk of early kidney allograft loss. So there were risks that Isobel would have to take no matter how good the quality of the donor kidney. However, the decision to accept a kidney with the level of pre-existing damage that this particular one had, in my view, added to that baseline level of risk. It made the subsequent injuries endured by Isobel more likely to occur than would have otherwise been expected. [emphasis added] [134] In his report of 18 May 2015, Mr Voss stated: The transplanted kidney did have bleeding from what appears to be to the wedge resection and whether this compressed the kidney and led to ischaemia and subsequent poor blood flow and cortical necrosis or whether the cause of the cortical necrosis was more central such as low blood pressure resulting in low renal artery flow in the days to weeks of post- operative period is not able to be clarified from the information I have read. There are several factors that may have led to the final diagnosed insult of cortical necrosis. Bleeding within the transplanted kidney capsule (from the pre-transplant NZCKS protocol diagnostic biopsy) relative hypotension post-transplant ... Poor renal blood flow from any other cause (unidentified). The transplanted kidney biopsy (1 May 2007, showed some inflammatory changes - - however it is important to note that confirmatory stains excluded rejection). Cold ischaemia time is definitely associated with delayed function and reduced long-term survival of kidney transplants. Ms Shand's kidney never functioned, and had such a short "survival" time that the cold ischaemia time in my opinion did not affect the transplant's survival. . .. It is important to understand that the most likely cause for Miss Shand's transplant function was primary non-function related to cortical necrosis. . . . I strongly believe that having not offered this kidney would have been irresponsible of the practicing clinicians, would have been wasteful of a pooled kidney, and in fact would have been a failure to provide treatment to Ms Shand if the kidney had not been offered or provided to Ms Shand. . . . I think the only thing that could have been done differently was an en bloc transplantation (both kidneys from the donor) and as mentioned above I think it would have probably resulted in a similar outcome - primary non-function and cortical necrosis [emphasis added] [135] In a further report dated 30 June 2017, Dr Voss explained that "technical failure" means the transplant failed from the outset due to mechanical or similar reasons that may be related to the surgical technique or initial processes, for example, poor perfusion of a portion of kidney because of pre-existing damage to the arteries or events in the deceased donor or during cold storage. The case for the appellant [136] Mr Miller submitted that as Ms Shand's injuries were caused by the decision to transplant the kidney which was acknowledged as being "suboptimal" and "not ideal", they should be covered as treatment injuries. [137] Mr Miller referred to the evidence of Dr Voss that the physical injuries suffered by Ms Shand would further affect her immune system, indicated by her increase PRA from approximately 54%-70% range to 99%, in addition to the cortical necrosis. Mr Miller submitted it is incontrovertible these injuries were sustained as a result of the decision to use the transplant kidney. [138] Mr Miller submitted that other treatment factors, such as biopsy and high blood pressure, are causative of Ms Shand's injury. [139] Mr Miller's submission, reproduced as follows is that: [i] The entire kidney treatment process included the hospital responsibility for sourcing a suitable (i.e. without cortical necrosis) kidney for Ms Shand extended through preparation (e.g. cortical necrosis through physical damage caused by biopsy), during operation and aftermath (e.g. overseeing and blood pressure monitoring) is part of the treatment process and therefore it does not matter exactly when the cortical necrosis occurred as long as it was part of that treatment process. [ii] The treatment caused the cortical necrosis injury which satisfies both s 32(1)(a) and (b), referring to the Court of Appeal's decision in Adlam. " Mr Miller submitted this is a separate basis for treatment injury cover to s 33(1)(a), where treatment can still be properly given (including the correct decision as to treatment) and yet gain cover because of an unanticipated consequence. A finding that the correct treatment decision was undertaken under s 33(1)(c) does not exclude cover for treatment injury under s 33(1)(a). [ifi] The appellant also has an arguable s 33(1)(c) claim because there was an incorrect decision regarding the treatment to be provided, namely the decision to transplant a suboptimal single kidney with a New Zealand kidney allocation scheme NZKAS score of 5. 10 Adlam, ibid at para [14] paragraphs [48] and [49]. [iv] The departure from a general standard to the clinical signs would be an incorrect decision under s 33(1)(c), although s 32(1) qualification would still be required. However, assuming the injury caused the treatment under s 32(1)(b), an incorrect decision would logically mean that any such injury could not be a necessary or ordinary consequence of treatment normally given. Applying Adlam, Ms Shand separately qualifies under s 33(1)(c) as the incorrect treatment decision also under s 32 caused her injuries of cortical necrosis and increased antibodies, and it could not be a necessary part or ordinary consequence of correct treatment, nor part of her underlying condition. [140] In essence, Mr Miller submitted the cortical necrosis is an injury caused by the decision to offer the kidney to Ms Shand, as well as potentially factors which include the pre-transplant biopsy. Further, cortical necrosis was not a necessary part, or ordinary consequence of the treatment. Discussion [141] The issue is what is the causative treatment. [142] Mr Miller submitted the entire kidney treatment process covers all stages of sourcing, preparation, operation and follow-up care and it does not matter exactly when cortical necrosis occurred as long as it was part of that treatment process. [143] In accordance with the decisions in Crampton," RW" and Adlam, " causative treatment must be clearly identified. Each case requires determination in light of the specific facts, whether the treatment was causative, or merely incidental to the personal injury. [144] The Court of Appeal's decisions in Ambros" and Adlam's outline the principles applying to causation. Whilst the Court is able to draw "robust" inferences in individual cases, there must be sufficient material pointing to proof of causation, on a 11 Crampton v Accident Compensation Corporation [2013] NZACC 182 at [16] 12 RW, ibid at para [ 133]. Adlam ibid at para [14]. 14 Accident Compensation Corporation v Ambros [2008] 1 NZLR 340 (CA) balance of probabilities, for the Court to draw a robust inference. Risk of causation does not suffice. 16 [145] In Adlam, the Court made plain a treatment injury will only occur where there has been some departure from a standard and that departure has caused a personal injury." A personal injury suffered while receiving treatment or incidental to treatment is not enough. The Court stated it must be shown the personal injury has been caused by the treatment. [146] Dr Voss, Dr Leikis and Dr Munn referred to a plethora of explanations for the failure. Dr Munn opined the factors that caused the cortical necrosis are uncertain: ... either due to events in the deceased donor, or during cold storage of the kidney or due to poor perfusion of a portion of the kidney because of pre- existing damage to the small arteries of the kidney as evidenced by the biopsy report of the donor kidney before its implantation. [147] Dr Matheson and Dr Evans were concerned by "unexpected" appearances on the imaging whether there was perfusion or not, and whether there was "?subscapular haematoma". The anatomical pathology report noted cortical necrosis but was uncertain of cause: The cortical necrosis may be related to the vascular rejection seen, though this finding is more usual in antibody-mediated (hyperacute) rejection ... [148] Dr Voss noted "inadequate support" for the biopsy being causative. Dr Munn thought the haematoma very unlikely to have contributed in any significant way to the cortical necrosis. Dr Voss went on to consider whether Ms Shand's blood pressure led to hypo-perfusion of the transplant and cortical necrosis. He said the medical evidence was inconclusive as to whether that caused the failure. [149] The evidence is clear the exact cause of the cortical necrosis is unknown. 15 Adlam ibid at para [14]. 16 Ambros at para [65] - [70]. 17 Adlam at para [45] [150] There are a number of risk factors, but they are not the same thing as causation as the Court of Appeal noted in Atkinson. 18. [151] Mr Miller submitted the causative treatment was the decision taken to offer the kidney to Ms Shand. Mr Miller stated the specialists chose to take on a level of risk in the face of clinical indicators identifying an alternative course normally followed, then if injury resulted that would be classed as an incorrect decision under s 33 (1) (c). [152] In Adlam, the Court of Appeal discussed s 33(1)(c) and noted a treatment injury will only be caused by a decision on the treatment to be given if there is an incorrect decision. Any injury that results from a correct decision will notionally be a necessary part or ordinary consequence of treatment. If the right decision on the treatment to be provided is made, that decision will not be the cause of any personal injury that results. [153] Dr Munn is certain there is no suggestion of any other course of treatment medically available here, beyond the decision to accept this particular kidney. He noted "none of the alleged contributions to the failure of the kidney altogether are relevant". Dr Voss noted not offering the kidney would have been a failure to treat. [154] In my opinion, Mr Miller's submission does not take into account intervening events, and Ms Shand's informed decision to accept the kidney. All treatment given after Ms Shand's decision was caused by that decision. The decision which I have found was properly informed, was not treatment given by a medical professional. [155] Having regard to Ms Shand's evidence, there is no doubt that she hoped she would achieve dialysis independence for a number of years but there was also a chance that it might not work. Cover is not available for the fact that the transplant did not achieve the desired results. Causation cannot be inferred from an unsuccessful outcome. 18 Atkinson v Accident Rehabilitation and Compensation Insurance Corporation [2002] 1 NZLR 374 Conclusion [156] Whilst the medical evidence points to likely causative factors of cortical necrosis, the exact cause is unknown. [157] In an environment when there were a number of factors increasing the likelihood of kidney failure, and in the absence of clear evidence as to what actually caused the cortical necrosis, I have no basis to conclude that any particular factor was the cause. Furthermore, the anticipated risks in light of the features of the kidney and Ms Shand's own characteristics were identified and Ms Shand elected to proceed. I accept Mr Bisley's submission that decision respects "the paramount consideration that a person is entitled to make his own decisions about his life" as the court identified in Rodgers v Whittaker. [158] Since s 32(1)(b) requires me to be satisfied that the cortical necrosis was caused by treatment, and I am not satisfied on the evidence before me, this means the appeal cannot succeed. [159] As a result of my conclusion, it is not necessary for me to consider whether or not the cortical necrosis suffered by Ms Shand was an ordinary consequence of the treatment she received. Issue Three: Whether increased antibody levels are an ordinary consequence of treatment [160] In his report of 16 December 2014, Mr Munn commented the transplant procedure resulted in an increased level of sensitisation. 161] On appeal, Mr Miller submitted that increased antibody levels are a treatment injury. Mr Miller contended that s 22(d) is engaged which provides that a personal injury will have cover if it is a personal injury caused by treatment for another personal injury. [162] Mr Bisley submitted the Corporation accepts that increased antibody levels are a physical injury that was caused by treatment, being the transplant surgery. However, Mr Bisley submitted the increased antibody levels are an ordinary consequence of the treatment. [163] Mr Miller countered that the increase in antibody levels does not survive exclusion as a necessary part or ordinary consequence of the treatment being a well- known side effect of kidney transplant failure. Legal principles [164] In McEnteer", the Court held that whether a consequence is ordinary is a matter of expert opinion, but not expert opinion in the abstract, it must be expert opinion reflecting what actually occurred. [165] In Muirhead?, Judge Powell explained that the words 'ordinary consequence' in s 32(1)(c) are not interchangeable with "regular or usual consequence", "reasonably foreseeable" or "not strange or peculiar". Concentration on the words alone without reference to the rest of the subsection, deflects from the need to link the interpretation of the words and the requirement that all of the circumstances of the treatment must be taken into account, with specific emphasis on the patient's underlying health condition and the state of clinical knowledge at the time of treatment. [166] In Adlam" the Court of Appeal noted any injury caused by a correct decision will notionally be a necessary part or ordinary consequence of proper treatment. [167] In summary, the question is not whether a particular outcome is ordinary for patients generally, but whether it is ordinary for that particular patient, in that particular set of circumstances and in the light of proper standards of treatment. 19 McEnteer v ACC [2010] NZCA 126. 20 Muirhead v ACC [2016] NZACC 272 at [18]. 21 Adlam at [48]. Discussion [168] In the claim filed, increased sensitisation was identified as a consequence of the injury. Accordingly, the Corporation did not make a decision on cover. For this reason, Mr Bisley submitted the District Court has no jurisdiction to consider the issue. [169] Mr Bisley did not press the jurisdictional point at hearing. However, it is the case, there is no decision by the Corporation on the issue because it was raised only at appeal. [170] The Corporation sought further evidence from Dr Voss who responded to specific questions for the purposes of the appeal on 30 June 2017. Dr Voss commented that the development of antibodies in kidney transplant recipients is from the recipient's immune system reacting to the foreign donor tissue surface antigens. It occurs in all cases except identical twin donors and stem cell organs. [171] Dr Voss explained that pre-sensitisation from a previous reaction to foreign tissue increases the risk that a transplant patient will reject the foreign donor. However, it does not increase the risk that antibodies will develop. That risk is 100% for all recipients of a foreign donor. [172] In response to the question whether the development of antibodies could have been avoided in this case, Dr Voss commented they cannot be avoided, only controlled. He said Ms Shand received post-transplant immunosuppressive therapy, which was standard treatment at the time and appropriate in the absence of pre- formed antibodies on the cross-match. In other words, there was no failure to treat following the surgery. [173] Mr Miller submitted the personal injury is the sensitisation caused by treatment, namely the transplant surgery. Mr Miller also submitted an injury results if the kidney fails. In my opinion, this contention does not work logically. I accept Mr Bisley's submission that if increased antibody levels were a treatment injury, every transplant involving a foreign donor would give rise to a covered personal injury. Dr Voss explained sensitisation is present throughout, and it is an inevitable consequence of a transplanted kidney. Conclusion [174] I conclude on the evidence before me the increased antibody levels are an ordinary consequence of the treatment. It follows that s 20(2)(d) is not engaged, and does not affect this conclusion. Result [175] In summary, I conclude: i. On the first issue, Ms Shand gave her informed consent to the treatment on 18 April 2007; ii. On the second issue, the cortical necrosis was not caused by treatment; iii. On the third issue, the increased antibody levels are an ordinary consequence of treatment. [176] I conclude that cover has not been established for the transplant surgery, the cortical necrosis or the increased antibody levels. [177] Accordingly, the appeal is dismissed. There is no issue as to costs. Judge Denese Henare District Court Judge Solicitors: John Miller Law, Wellington for the appellant Buddle Findlay, Wellington for the respondent ACR 145-16-Shand