Estate of Ian Clarke v Accident Compensation Corporation and Waitemata District Health Board

IN THE DISTRICT COURT HELD AT AUCKLAND Decision No. |10/2009 UNDER The Injury Prevention, Rehabilitation, and Compensation Act 2001 IN THE MATTER of an appeal pursuant to section 151 of the Act BETWEEN ESTATE OF IAN CLARKE Appellant (Appeal No. AI 160/04) AND ACCIDENT COMPENSATION CORPORATION a body corporate duly constituted under the provisions of the said Act Respondent AND WAITEMATA DISTRICT HEALTH BOARD Third Party HEARING: at AUCKLAND on 9 April 2009 APPEARANCES: Mrs D Clarke for the Estate. Mr D Tui, counsel for respondent. Mr B Turner, counsel for the Waitemata District Health Board RESERVED DECISION OF JUDGE J CADENHEAD ISSUES [1] . The issue is the decision by the Accident Compensation Corporation ("the Corporation") dated 12 September 2003 declining an application for the appellant for cover for medical misadventure: including medical error and medical mishap. [2] The claim for the appellant is in respect of treatment provided to the late Mr Ian Clarke by the North Shore Hospital in 1995 and more particularly, in 2000. I:JUDICIAL\CADENHJ\ACC\ Reserved decision - G Nesbit 241.07 [3] The claim was considered by the Corporation under both medical error and a medical mishap (although the claim was in essence a claim for medical error) BACKGROUND OF FACTS [4] On 13 May 1995, Mr Clarke was admitted to the North Shore Hospital complaining of palpitations and dizzy spells. Mr Clarke had had a 10 year history of episodic palpitations. Following investigations, Mr Clarke was discharged the same day. Following review by Dr Arthur Coombes on 14 June 1995, Mr Clarke was started on Sotalol. [5] On 12 June 2000, Mr Clarke presented to his general practitioner, Dr Cecil Armstrong, with visual disturbance, confusion and speech difficulties. Dr Armstrong immediately referred Mr Clarke to the North Shore Hospital where Mr Clarke was investigated and discharged the next day. Mr Clarke was prescribed Warfarin. (6] Mr Clarke was seen by Dr Armstrong on 20 June and 1 August 2000. Mr Clarke was readmitted to North Shore Hospital on 7 August 2000 and remained an inpatient until his death. Investigations revealed that Mr Clarke had suffered a left- sided stroke. Mr Clarke was seen by Dr Ernest Willoughby, visiting neurologist, on 11 August 2000. Mr Clarke died on 18 August 2000 of an intracerebral haemorrhage. [7] Mrs Daphne Clarke, Mr Clarke's wife, was critical of the treatment provided by the North Shore Hospital and sent a letter to the North Shore Hospital seeking answers to a number of questions regarding the treatment provided to Mr Clarke. Dr Hamish Hart, Clinical Director of Medical Services, wrote to Mrs Clarke on 2 August 2001, responding to her questions. [8] In or about May 2003, Mrs Clarke lodged a claim for cover with the Corporation for medical misadventure arising from the death of Mr Clarke. [9] The Corporation investigated the claim, receiving clinical information from the North Shore Hospital in relation to its treatment of Mr Clarke. The Corporation also received the following letters: [a] Letter from Dr Armstrong dated 10 June 2003. [b] Letter from Dr Hart dated 17 July 2003. 10] The information was then forwarded to Dr Matsis for an independent specialist report. [11] Dr Matsis prepared a report on 1 September 2003 opining that the treatment provided by the North Shore Hospital was reasonable and appropriate and, as such, no medical error had occurred. Further, Dr Matsis opined that there was no medical mishap as Mr Clarke's death, consequent to the treatment provided at the North Shore Hospital, was not 'rare'. [12] The Corporation wrote to Mrs Clarke on 12 September 2003 to advise that the claim for cover was declined. REVIEW HEARING [13] Mrs Clarke completed an application for review form on 1 December 2003. [14] A review hearing was conducted on 24 February 2004 and a decision issued by the reviewer on 1 March 2004, dismissing the review. The reviewer broadly summarised Mrs Clarke's arguments as follows at pages 3 and 4: "... She [Mrs Clarke] believed that from the time her husband was first admitted to North Shore Hospital in 1995 the treatment he received from that hospital, his GPS and the specialist was a continuous medical misadventure. She was in no doubt that North Shore Hospital had misdiagnosed and underestimated the seriousness of her husband's condition ..." [15] The reviewer proceeded to determine at pages 7 and 8: "Mrs Clarke is clearly not satisfied with the outcome of ACC's investigation. She believes that her husband was not well served by a number of health professionals involved. While I acknowledge her concerns and am sympathetic to the loss of her husband, I have no choice but to find that she has not discharged the requisite onus of proof in terms of satisfying the criteria for a medical misadventure claim. No contrary specialist evidence was provided by Mrs Clarke. There is no evidence of medical misadventure caused by the treatment provided. In fact, there is clear independent evidence to the contrary." [16] . A notice of appeal was lodged on or about 26 March 2004. [17] The issue for determination in this appeal is whether the appellant is entitled to cover for medical misadventure for the death of Mr Clarke. THE COURSE OF THE PROCEEDINGS [18] I first heard this case on 30 August 2006. Mrs Clarke did not have legal representation, but she had formidable objections as to what had happened. Similarly, she did not have any professional medical evidence to support her case. I heard submissions and adjourned the case part heard and directed as follows: "I part-heard this case, and after considerable submissions I came to the view that I required further information. Accordingly, I have adjourned the appeal part-heard, but I make the following directions: I direct a further report from Dr Hart explaining the change of stance between his letters of 2 August 2001 and 17 January 2003 as to the prescription of the drugs, particularly aspirin. I, also, desire an opinion from Dr Willoughby as to the administration of Warfarin and the issue of aspirin. It is noted that Warfarin was apparently administered, and that he made comments concerning that on 1 1 August 2001. After these materials are obtained I desire those materials put before a cardiologist, who should provide a report detailing the heart condition of the deceased, and also commenting on the effect of these drugs. It is desirable that Mrs Clarke attend the cardiologist before he prepares his report, as she has concerns concerning her late husband's condition. Mrs Clarke should address to the cardiologist her concerns to him, and I direct that he should report in addition to the matters that I have raised on those concerns. After these reports have been obtained, I direct a further independent opinion from a neurologist as to the issues of medical error in respect to Dr Willoughby's treatment of the deceased. In particular, I desire comments as to the administration of the alleged drugs. I direct that the respondent pay the costs of these reports and commission them. However, in respect to Dr Hart, it is understood his report will be organised by the Waitemata District Health Board. When all the information is to hand leave is given to file supplementary submissions by all parties. When all this information and final submissions have been filed, there should be a tele-conference with myself as to the setting aside of time to argue the case." [19] I took this course to meet the observation that the medical evidence presented was not independent and there were aspects of it that needed clarification. I particular, I desired a further neurological report along with a cardiologist report. I desired that the detailed queries that Mr Clarke was putting to me should be answered by an independent cardiologist. [20] These materials took some time, but by 20 November 2008 submissions were in concerning the new reports and a further hearing was held. Mrs Clarke had voluminous notes in her submissions of a medical nature and it was agreed that she would further see Dr Smith and put those queries to him and he would report back to the Court. [21] Dr Smith's report is dated 20 February 2009 and he has provided answers as best he could to the detailed questions and queries of Mr Clarke and I set these answers out later herein. LEGISLATION [22] The treatment provided to Mr Clarke in 2000 and his death on 18 August 2000 occurred during the operation of the Accident Insurance Act 1998 ("the 1998 Act"). The claim for cover, however, was lodged in May 2003, during the operation of the Injury Prevention, Rehabilitation, & Compensation Act 2001 ("the 2001 Act"). [23] Pursuant to section 360 of the 2001 Act, a claim for cover lodged after 1 April 2002 in respect of a personal injury suffered before 1 April 2002 must satisfy the requirements both under the 2001 Act and the Act in force when the personal injury occurred; here being the 1998 Act. [24] For all intents and purposes, the legislation under the two Acts has remained the same. For convenience, the 2001 Act is referred to below. [25] Pursuant to section 20(2)(b) a claimant is entitled to cover for personal injury caused by medical misadventure suffered by the person. [26] Section 32(1) reads: "Personal injury caused by medical misadventure means personal injury that - ( a ) is suffered by the person seeking or receiving treatment given by or at the direction of a registered health professional (except when subsection (6) applies); and (b) is caused by medical error or medical mishap." [27] "Medical error" is defined under section 33(1) of the 2001 Act and means, inter alia: "... The failure of a registered health professional to observe a standard of care and skill reasonably to be expected in the circumstances." [28] "Medical mishap" is defined under section 34 as meaning, inter alia: ".... an adverse consequence of treatment when - (a) the treatment is given to a person, is given properly, and is given by or at the direction of a registered health professional; and (6) the adverse consequence is suffered by the person; and ( c) the adverse consequence is severe (as defined in subsection (2)); and (d) the likelihood that treatment of the kind that was given would have the adverse consequences is rare (as defined in subsections (3) and (4)). " [29] Subsection (3) defines "rare" in the following terms: The likelihood that treatment of the kind that was given would have the adverse consequence is rare only if the probability is that the adverse consequence would not occur in more than 1% of cases in which the treatment is given." [30]. In relation to decisions by the Corporation on claims for personal injury caused by medical misadventure, section 62 further provides: "When actioning a claim for cover for personal injury caused by medical misadventure, the Corporation must either: a) in the case of medical error, obtain and have regard to independent advice from a suitably qualified person or body; or (6) in the case of medical mishap, have regard to: (i) independent advice from a suitably qualified person or body; or (ii) information obtained in a similar case or class of case." [31] The onus is on the appellant to establish that Mr Clarke had a valid claim for cover for medical misadventure. [32] The relevant principles in relation to medical error were considered in Glasson (170/05). I held at pages 6 and 7: "[27] What has to be proved is the failure of a doctor to observe a standard of care and skill reasonably expected in the circumstances. A doctor is not an insurer concerned with desired results: what must not be taken into account is hindsight reasoning that might have produced a different decision or better result. (28] It is necessary that the respondent must obtain, and have regard to independent advice from a suitably qualified person when actioning a claim. The insurer has a statutory injunct to have regard to that independent advice. Clearly, while not conclusive, the opinions of the independent doctors commissioned must be given considerable weight. [29] The statutory regime mirrors to a large extent the situation at common aw. It is relevant to consider some of the principles relative to medical negligence enunciated by Courts of high authority. (30] I have had regard to the following cases: Maynard v West Midlands Regional Health Authority [1985] All ER 635; Sidaway v Bethlem Royal Hospital Governors [1985] ] All ER 643; B v Medical Council (High Court, Auckland, 1 1/96, Elias J, 8 July 1996); and Bolitho v City and Hackney Health Authority [1998] AC 232 and from them, the following principles may be stated: (1) Where you get a situation which involves the use of some special medical skill or competence, the test as to whether there has been negligence or not is the standard of the ordinary skilled person exercising and professing to have that special skill. A person need not possess the highest expert skill; it is well- established law that it is sufficient if that person exercises the ordinary skill of any ordinary competent person exercising that particular profession (2) In respect to the standard of care of an inexperienced doctor in Wilsher v Essex AHA [1986] 3 All ER 801, the majority of the Court of Appeal stated, in respect of a junior doctor working in a specialist unit, that the relevant standards had to be those of a "reasonably competent doctor in that position". The proposition espoused by Mustell LJ was not challenged on appeal: [1998] AC 1074 HL). In Djemal v Bexley HA (1995) 6 Med LR 269 it was held that the standard of care of a reasonably competent senior houseman acting as a casualty officer should be judged without any reference to the length of experience. The test to be applied was not to the individual but to the post that he occupied. (3) A person is not guilty of negligence if he/she has acted in accordance with a practice accepted as proper by a responsible body of medical people skilled in that particular art. Putting it another way around, a person is not negligent if he is acting in accordance with such a practice merely because there is a body of opinion who would take a contrary view. (4) It is ultimately for the court, not for medical opinion, to decide what was the standard of care required of a doctor in the circumstances of each particular case. The Court is not bound to hold that a doctor escapes liability for negligent treatment or diagnosis just because he/she leads evidence from a number of medical experts who are genuinely of the opinion that the defendant's treatment or diagnosis accorded with sound medical practice. However, such medical evidence is treated with great respect and the circumstances in which the court would disregard this type of the evidence would be rare. However, the evidence tendered should always be subject to critical and logical analysis. [31] The onus is on the appellant to establish that she suffered a personal injury caused by either medical mishap to a balance of probability." MEDICAL REPORTS [33] It appears to be accepted that the provision of the treatment at the North Shore Hospital, in particular the provision of Warfarin to Mr Clarke, contributed to the third stroke and his death on 18 August 2000. The issues in this appeal is whether the provision of this treatment constituted medical error or, alternatively, was an adverse consequence of treatment properly given that was both rare and severe. [34] Originally the respondent relied on the specialist medical advice from Dr Matsis dated 1 September 2003, wherein Dr Matsis considered both the issues of medical error and medical mishap. In terms of medical error, Dr Matsis stated, inter ilia: "The subsequent presentation on 7/8/2000 was due to a further embolic stroke as evident by CT scan findings. Quite appropriately, the patient was established onto low molecular Heparin to allow a bridge until the increased Warfarin dose could become therapeutic. Subsequently, the patient's deterioration was due to haematitic transformation of the previous infarct areas. This phenomenon is well described in the medical literature and is the major risk of anti-coagulating patients with cerebrovascular ischaemic disease. The major bleeding risk of Warfarin therapy has been quantified: one additional bleed will occur after the treatment of 77 patients; treating 18 patients will prevent one additional stroke ... [35] In respect to medical mishap, Dr Matsis stated, inter alia: "... The injury resulted from treatment properly given by or at the direction of a registered health professional and the probability of the treatment causing the injury is not rare (greater than 1%) though the injury was severe with death. In the meta-analysis described earlier, the published event rate of major bleeding occurred in 1 of 77 patients treated with Warfarin (1.3%)." [36] Dr Matsis' opinion on medical error is consistent with a report provided by Dr Hart dated 17 July 2003 wherein Dr Hart stated, inter alia, at the last page of his report: "...I believe that his [Mr Clarke's] treatment was evidence-based and appropriate. The outcome was obviously unfortunate, but always a possibility." [37] In relation to Dr Hart's alleged admission in his letter of 2 August 2001, it appears that the argument for the appellant is that Dr Hart acknowledged in the said letter that both warfarin and aspirin were provided to Mr Clarke by the North Shore Hospital staff prior to his death and had contributed to the third stroke and death. Dr Hart's statements in his letter of 2 August 2001 on these matters are set out below: "... On 11 August, your husband was reviewed by the visiting neurologist, Dr Ernest Willoughby. He agreed that there was a left-sided stroke. His advice was to continue Warfarin and to add low dose Aspirin. Later the same day, your husband deteriorated and a CT was repeated. This revealed a haemorrhagic stroke in the right choroid plexus. Warfarin and Aspirin were discontinued .. . . . Turning to your specific questions: (4) Poor treatment and advice On arrival, your husband was on Warfarin which is appropriate for a patient who has atrial fibrillation. The dilemma was whether to stop the Warfarin in order to reduce the risk of haemorrhage. In order to help with this decision, your husband was reviewed by a neurologist who advised us to continue Warfarin and Aspirin as the risk of further embolic stroke was high. Unfortunately, both Warfarin and aspirin contributed to the third stroke." [38] Dr Hart states that both Warfarin and aspirin were provided and that both drugs had contributed to the third stroke. 39] Notwithstanding Dr Hart's above statements, it appears that such statements in relation to the provision of aspirin are not accurate. In a subsequent letter to the Corporation dated 17 July 2003, Dr Hart stated: "The drug chart in Mr Clarke's notes documents that at no time during his second admission [ ie in August 2000] was he given aspirin. His medication included Sotalol, Warfarin, Cefuroxine, Metronidazole, Paracetamol, Maxillon, Cyclizine, Vitamin K and Prothrombinux." [40] Dr Hart's letter of 17 July 2003 is consistent with Dr Matsis' review of the file. He stated at page 2 of his report: "A neurological opinion was sought and the advice was to continue the Warfarin and then add low-dose Aspirin after a two week interval. On the afternoon after the neurological review, Mr Taylor deteriorated and subsequent repeat CT scans showed haemorrhagic extension of the previous infarct with midline shift. There were also other areas of new infarction. A haematology opinion was sought and the advice was to reverse the warfarin. I can see no evidence of the patient receiving aspirin in the medical notes. Subsequently, Mr Taylor deteriorated over the next 7 days, dying on the 18 August 2000." [41] It appears then that Dr Hart's reference in his letter of 2 August 2001 to both Warfarin and aspirin being administered to Mr Clarke was incorrect. I sought further medical assistance on this point and other matters raised by Mrs Clarke. THE SECOND HEARING [42] At the hearing of this appeal on 30 August 2006 the appeal was adjourned part heard and directions made in respect of obtaining further specialist medical evidence. [a] Since that hearing the following medical evidence has been filed: [b] Statement of Dr Hamish Hart, cardiologist, dated 28 September 2006; [c] Statement by Dr Ernest Willoughby, neurologist, signed in August 2007; [d] Report from Dr William Wallis, neurologist, dated 14 December 2007; [e] Report from Dr Warren Smith, cardiologist, dated 8 January 2008. [43] Mrs Clarke has filed further submissions dated 13 June 2008. NEW MEDICAL EVIDENCE [44] The purpose of obtaining further comment from Dr Hart was to seek clarification from him regarding a reference, in his report dated 2 August 2001, to Mr Clarke having received both Warfarin and aspirin prior to his death. Dr Hart's subsequent report of 17 July 2003 made no reference to the aspirin. [45] In his statement of 28 September 2006, Dr Hart confirmed that the reference to both Warfarin and aspirin on 2 August 2001 was incorrect - refer to paragraph 3 of the statement. Dr Hart stated at paragraph 7: "Although it was intended to give Mr Clarke aspirin, his deterioration meant that he was not given it and Mr Clarke's drug charts confirm this. As a result aspirin cannot have contributed to Mr Clarke's third stroke." [46] : Dr Hart proceeded to state at paragraph 8: "Anticoagulants such as warfarin are standard treatment for patients like Mr Clarke who have atrial fibrillation and have also had a stroke. Anticoagulants are prescribed to prevent the clotting which can cause stroke, however they increase the risk should the patient haemorrhage." [47] 'Dr Willoughby saw Mr Clarke on 11 August 2000 and prescribed, inter alia, Warfarin. Dr Willoughby was asked to provide comment in respect of his treatment of Mr Clarke. [48] In a statement signed in August 2007, Dr Willoughby set out the relevant history of the drugs administered to Mr Clarke in August 2000. Dr Willoughby noted that on 'admission to North Shore Hospital on 7/8/2000, he [Mr Clarke] was taking warfarin regularly'. Warfarin was withheld after admission and clexane instead administered until 11 August. Warfarin was restarted on the evening of 10 August and whilst Dr Willoughby prescribed the continuation of Warfarin on 11 August the same had not yet been administered when Mr Clarke 'deteriorated suddenly that afternoon with a further stroke.' The stroke caused severe neurological impairment' and Mr Clarke died on 18 August. 10 [49] Dr Willoughby said at paragraph 1 1: "A further CT brain scan on the evening of his acute deterioration on 11/8/2000 was reported to show several new infarcts, the largest being in the right occipital lobe and in the left parietal lobe. There wee also new infarcts in the left temporal lobe, the left thalamus and basal ganglia and right cerebellum. The right occipital and left parietal infarcts contained some haemorrhage within them but the appearances were not those of primary cerebral haemorrhages. There was, however, haemorrhage in the right choroids plexus with blood present in the fourth ventricle. In the original left occipital infarct there was only mild evidence of haemorrhage. The radiology report concludes 'multiple bilateral haemorrhagic and non-haemorrhagic infarcts with intraventricular extension and diffuse swelling of the right hemisphere." [50] Dr Willoughby considered the radiological findings and stated: "[ 12] My interpretation of the new changes in the CT brain scan is that Mr Clarke had further multiple cerebral emboli, some of which were haemorrhagic, i.e. the primary cause of his sudden deterioration was the appearance of new multiple embolic infarcts and not simply haemorrhage into the original infarct. Large infarcts of that sort may have an associated haemorrhage, especially if the patient 's on anticoagulant treatment. The presumed source of the emboli was his heart and thrombus was noted in both atria at post-mortem, although that was one week after his acute deterioration at which time the effects of the anticoagulants had been reversed. (13] I have read Dr Matsis' report. Page 2 of that report says 'Subsequently the patient's deterioration was due to haemorrhagic transformation of the previous infarct areas'. Based on the medical records, I believe that statement would be more correct if it stated: 'Subsequently the patient's deterioration was due to multiple new cerebral infarcts, (two of which were haemorrhagic) associated with haemorrhage into the previous infarct.' [14] Mr Clarke presented a complex and difficult management problem with a sad outcome but, under the circumstances, I don't believe there is anything inappropriate about his medical management at North Shore Hospital." TWO FURTHER INDEPENDENT SPECIALIST MEDICAL OPINIONS [51] The background is set out at pages 1 to 3 of Dr Wallis' report. His medical findings are set out from page 3. Dr Wallis concluded that there had been neither medical error nor medical mishap in respect to Dr Willoughby's treatment of Mr Clarke. He was also of the opinion that the treatment at North Shore Hospital was not responsible for Mr Clarke's death. [52] Finally, Dr Smith, in his report dated 8 January 2008, considered the treatment provided by Dr Hart and his team. As per the Court's directions, Mrs Clarke had an opportunity to meet with Dr Smith prior to the preparation of the report and outline her concerns to the specialist. These concerns are summarised at 11 pages 1 and at page 2 of Dr Smith's report along with Dr Smith's advice, in response, to Mrs Clarke. [53] Dr Smith was of the view that there had been neither medical error nor mishap in relation to the treatment provided to Mr Clarke. CAUSATION [54] Dr Wallis has indicated that he is of the opinion that the treatment provided to Mr Clarke did not cause his death and that an underlying disease was in fact responsible. [55] Dr Wallis' said: "I. The pre-existing atrial fibrillation was treated with warfarin appropriately, as shown by satisfactory INR recordings, performed by the general practitioner. Warfarin treatment for atrial fibrillation does not always stop cerebral emboli. All it does is reduce the risk, and the reduction of the risk of stroke is considered a worthwhile exchange for the increase in risk of complication from warfarin treatment. ..... 7. ... just after he saw Dr Willoughby, Mr Clarke had a rapid deterioration and CT imaging disclosed multiple cerebral infarctions, showing haemorrhagic transformation. The appearance on the scan and at post-mortem examination, however, did not indicate that these were primary parenchymal haemorrhages caused by warfarin treatment. Patients with embolic infarction show a tendency to transform bland infarctions to haemorrhagic infarctions (haemorrhagic transformation). These transformations occur frequently and sometimes may become confluent and appear as parenchymal haemorrhages (reference 3). In such a situation it is unclear whether patients should remain on anticoagulants to reduce the risk of further emboli from atrial fibrillation, or stop the anticoagulants to reduce further bleeding (reference 3). There is no consensus in the medical literature about the best course of action in this dilemma, and clinical judgement is usually applied by the patient's doctor. In this case, in view of the very widespread damage to the brain, containing a substantial amount of haemorrhagic .. transformation, the decision was made to withdraw anticoagulant treatment. 8. The post-mortem examination showed not only haemorrhagic transformation of multiple embolic' cerebral infarctions but evidence of a widespread problem with venous and arterial thrombotic reactions. These included pulmonary embolismusing a large infarction of the right side of the lung, a venous clot within the right atrium, arterial clot in the left atrium, and an infarction of the spleen. Although it is difficult to be sure about this, it is likely that this patient also had an underlying coagulapathy. The information in the notes, however, does not allow one to establish the mechanism of this coagulapathy. The evidence is that, at least terminally, something went wrong with this man's coagulation system producing the widespread blood clots, not only with the arterial system, but the venous system. Of note, patients with atrial fibrillation do have a higher risk of pulmonary embolismch venous emboli also occur in a reasonably high proportion of patients who are acutely ill from stroke and relatively immobilised (reference 4). 12 10. In this particular case, I believe that death and cerebral events resulted from complications of his underlying disease, namely atrial fibrillation caused coronary heart disease. Despite adequate treatment with warfarin, he did not have a drop in the INR that probably resulted in a chain of events as described above. In my view, the process as described here are a part of the natural history of the type of underlying disease affecting Mr Clarke. I cannot see any evidence that the patient's treatment in North Shore Hospital was inappropriate or caused him any harm. In my opinion, there was no evidence of medical misadventure as defined by the old ACC Act, either mishap or error."... [56] At page 5, in respect to the question 'Has a physical injury occurred as a result of medical treatment?' Dr Wallis replied ' No'. [57] Dr Wallis further stated at page 6: 'In my opinion, the clinical picture and post-mortem examination are compatible with the natural history of a patient's underlying disease, which could not be brought under control despite quite satisfactory and adequate treatment. " [58] With respect to medical error, Dr Wallis stated at page 5: "... Dr Willoughby's opinion was correct and his suggestions were also correct. There is no evidence that anything suggested by Dr Willoughby caused this patient harm. There is no question of medical error on the part of Dr Willoughby." [59] In relation to the treatment from Dr Hart and his team at North Shore Hospital, Dr Smith was of the view that the treatment was not negligent. Dr Smith stated, inter alia, at pages 4 and 5 of his report: 'I agree with Dr Willoughby that Mr Clarke had suffered further multiple cerebral emboli, some (but not all) of which were haemorrhagic. In light of these findings it was now unlikely Mr Clarke would survive regardless of what further treatment he received The management of a presumed embolic stroke is complex because of the need to balance the need for anticoagulation to prevent further brain injury against the danger of bleeding into the damaged tissue affected by the infarct. In this case, the greater risk was deemed to be further emboli, which events unfortunately proved correct as despite clexane and warfarin, multiple further infarcts developed. Equally unfortunately, bleeding occurred, mainly into some of these new infarcts and to a lesser extent into the old infarct. The issue of aspirin is irrelevant as its use was not advised for another two weeks and regardless, the combination of clexane and warfarin would be considerably more powerful to prevent further clots forming than warfarin and aspirin. The presence of hypertension, a common complication of brain swelling, was an additional risk factor for haemorrhage. .. . On the balance of probabilities, can the injury be attributed to the treatment the claimant received? Response: Partly. 13. The haemorrhagic transformation of the large right occipital and parietal infarcts in particular, is likely attributable to the combined effects of warfarin and clexane treatment. However, even had such bleeding not occurred, Mr Clarke would have been severely impaired by multiple areas of brain injury from stroke . .. Did the registered health professional otherwise giving or directing treatment for that patient fail to provide treatment? Response: No. The team were placed in an invidious position between preventing additional embolic stroke and minimising the risk of intra cerebral haemorrhage for Mr Clarke. In these circumstances I consider that the patient was treated to the best of their ability and that treatment was acceptable and proper." [60] The specialist evidence is that the treatment did not fall below the requisite standard. [61] The issue on medical mishap is whether the personal injury suffered by Mr Clarke as a result of the Warfarin treatment was 'rare'. [62] In respect of this issue, Dr Wallis stated at pages 5 and 6 of his report: Although warfarin treatment in patients with atrial fibrillation is associated with a risk of haemorrhage, the risk of brain haemorrhage is in fact relatively low and well below 1% per year (reference I). In this regard, it is important to point out that the figures quoted for complications from warfarin reatment generally apply to all forms of haemorrhage. Most studies define such haemorrhages as serious if there is bleeding within the brain or if there is loss of more than a few pints of blood. A loss of blood can be within the gastrointestinal system or in fact any organ. It is true that the risk of warfarin treatment, when one takes all the bleeding complications into account, is greater than 1% per year. The point, however, is that the risk of bleeding from the brain is less than 1% (references ] and 3). (e) If there is no evidence of medical error, does the claim meet the criteria for medical mishap?: No. Specifically to meet the rarity criterion of medical mishap, the probability of treatment causing an injury (let us say a brain haemorrhage from warfarin treatment), should occur in 1% or less of patients. Although cerebral haemorrhage from warfarin treatment is rare, as defined by this criterion, this patient did not have a haemorrhage caused by warfarin treatment. What he had was multiple brain emboli, originating because of atrial fibrillation, causing cerebral infarctions, which subsequently underwent haemorrhagic transformation. These changes are not caused by warfarin treatment but rather by a haemorrhagic transformation one encounters in a good proportion of patients having embolic infarctions, whether on or off anticoagulants. His warfarin treatment was stopped to prevent worsening of the blood from the haemorrhagic transformation. " [63] Similarly, Dr Smith stated at page 5 of his report: 14 "4. If there is no evidence of medical error, does the claim meet the criteria for medical mishap? Response: No. The probability of the treatment causing the injury is > 1%. In the study of > 10,000 patients receiving oral anticoagulants in Canada already referred to in (2), the haemorrhagic risk was 4% per year, and when confined to periods while the INR was actively monitored, 6%. These figures of course include bleeding from any location, not just cerebral haemorrhage. On the other hand, patients like Mr Clarke would be at considerably higher risk of intracerebral bleeding than the average patients in this and similar studies because of the presence of a recent stroke with a moderately large infarct documented on CT scan." RESPONSE BY THE APPELLANT [64] Mrs Clarke responded by what she considers to be deficiencies with the treatment provided historically to Mr Clarke, including the treatment provided in August 2000. Mrs Clarke also suggests that events as long ago as July 1982 were in some way responsible for later health problems suffered by Mr Clarke. Further, Mrs Clarke referred to alleged inconsistencies in the clinical documents. Mrs Clarke does not accept that the specialist medical opinions of Drs Wallis or Smith were either independent or correct. Mrs Clarke was critical of the information sent to the specialists (believing the same 'could only have been to influence the outcome of' the specialists' opinions) and suggests that Dr Smith 'personally knows Dr Hart'. [65] I took the view that the considerable points made by Mrs Clarke should be considered by Dr Smith and that she should see him and he should report back to the Court with his views. THE RESPONSE OF DR SMITH [66] I set out hereunder the final comments of Dr Smith in his letter dated 20 February 2009: "In respect of Mrs Clarke's 14 points in support of her claim that Mr Clarke was "injured because he did not receive treatment of a reasonable standard", I can summarise my conclusions reached, previously set out in detail (1). No one could agree on what type of arrhythmia Mr Clarke suffered from. I do not see evidence of disagreement. A diagnosis of PAT was made which was not unreasonable on the available evidence. 15 (it) Premature discharge before observing the full effects of verapamil. I agree a longer period of supervision would have been helpful. (ifi) No information supplied about verapamil and possible side-effects. I am unable to assess the accuracy or otherwise of this assertion - such information should reasonably be expected. (iv) Failure to refer back to Green Lane Hospital. There was no reason to link this episode with prior aortic surgery and therefore no need that I can see to make such a referral. V I presume this should read did not provide a discharge letter on Mr Clarke. This was an oversight and acknowledged by the Clinical Director Dr Borgoyne. (vi) Placing Mr Clarke back on Sotalol. Mr Clarke's stroke was almost certainly due to a blood clot from the heart and was not caused by Sotalol. There was no contraindication on this ground for restarting it again. (vii) Abrupt discontinuation of sotalol. While a graduated withdrawal is recommended sotalol can be safety stopped abruptly when there is concern at its ongoing use and the patient is being monitored. (vini) Administration of clexane despite Mr Clarke's allergy to "sulpha drugs". I do not know of evidence that such an allergy contraindicates the use of Clexane or poses an undue risk of allergic response. Clexane was an appropriate treatment in this context (ix) Maintaining Mr Clarke on his left hand side. I do not believe the staff deliberately sought to inflict pain on Mr Clarke by maintaining this posture, but as elsewhere there seems to be imperfect communication between staff and Mrs Clarke. (x) Continued administration of Clexane. As for (viii). (xi) Placing Mr Clarke in a bed which was too small. This is unsatisfactory but unlikely to have harmed his chance of recovery (xii) Introducing too many drugs and food via naso-gastric tube too quickly. The staff were administering drugs to combat a serious medical condition and such a scenario would not be unusual. As elsewhere, however, there is evidence of an unsatisfactory rapport and level of communication between staff and Mrs Clarke, which might have allayed some of her concerns. (xiui) Similar situation and same comment. (xiv) Concern at adverse reaction to clexane, sotalol and possibly warfarin. Again I think a communication issue - there was no obvious medical contra-indication to their use ( xV ) Lack of compassion. Clearly Mrs Clarke was distressed at the manner in which she considered Mr Clarke was being treated at times and again might have been alleviated with better rapport. (xvi) As above. That completes my further assessment of this complex medical case history. It is clear that cumulative events in Mr Clarke's management have left Mrs Clarke and her family feeling very dissatisfied, and more effective communication during his treatment might have addressed some of her concerns. I have done my best to discuss these concerns with Mrs Clarke but we remain with different viewpoints on a number of issues." 16 [67] Dr Smith in no way resiled from his earlier opinions and it is apparent from the other contents of his letter that he had listened with care and dealt with the various points raised by Mrs Clarke. In some ways Dr Smith acted like a quasi medical referee to me. He was, in my view, independent and was able to deal with the intricate medical issues that were being put forward by Mrs Clarke. DECISION [68] The main difficulty, the appellant faces in this appeal is the weight of the specialist medical evidence that supports the Corporation's decision. Mrs Clarke had provided no specialist opinion to the contrary. [69] Whilst the Court is entitled to take its own interpretation of the clinical/radiological evidence it is respectfully submitted that much weight and guidance ought to be placed on the specialist medical evidence available. It was for that reason that I have adjourned the hearing of this appeal on two occasions and appointed a specialist neurologist, Dr Mccormack, and a cardiologist, Dr Smith, to consider the case in detail. [70] I have great sympathy for Mrs Clarke in the loss of her husband, however, it seems to me that the medical evidence establishes that his death was not caused by medical error or medical mishap. I have only set out some of the medical quotations, but a full reading of them amplifies this decision. [71] I have considered the brief submissions of the third party, which predominately was that the appeal should be dismissed, because of the lack of medical evidence called by the appellant. My decision reflects that situation. [72] For the reasons I have given the appeal fails. There is no order as to costs. DATED 17 June 2009 J Cadenhead District Court Judge 17