Wyman v Accident Compensation Corporation

IN THE DISTRICT COURT AT WELLINGTON DECISION No. 272/2006 UNDER The Injury Prevention, Rehabilitation and Compensation Act 2001 IN THE MATTER OF an appeal pursuant to section 149 of the Act (Appeal No. AI 257/04) BETWEEN NGAIRE CLAUDIA WYMAN Appellant AND ACCIDENT COMPENSATION CORPORATION Respondent Hearing: 19 July 2006 Appearances: Piers Hunt advocate for appellant Ms Berry with Mr Sumner for respondent Judgment: 6 November 2006 RESERVED JUDGMENT OF JUDGE D A ONGLEY [1] The question in this appeal concerns the test of rarity for an adverse outcome of medical treatment for the purpose of cover for personal injury caused by medical mishap under s32 of the Injury Prevention, Rehabilitation, and Compensation Act 2001 before amendment on 1 July 2005. Although pain was a common consequence of the treatment in question and was not rare, the appellant claimed that severe pain was rare and that the adverse outcome of treatment was both rare and severe. Background [2] Between 1997 and May 1999 the appellant sought medical assistance for neurological symptoms which included headaches, weakness in her legs and pain in 1 her feet and legs. Despite seeing three doctors she obtained no definitive diagnosis of her condition. Dr Abernethy, neurologist, initially suspected Chronic Demyelinating Peripheral Neuropathy (CIDP), but with the later development of further symptoms, favoured systematic lupus erythematosis (SLE) as a possibility. After normal results from nerve conduction studies, Dr Abernethy wrote to the appellant's general practitioner giving his opinion that there was a low likelihood of a nerve biopsy being abnormal, but stating his intention to proceed with a fasicicular sural nerve biopsy because the patient was desperate for a solution. The biopsy was a diagnostic process to eliminate the possibility of vasculitic involvement even though the possibility was fairly remote. [3] On 6 May 1999, Dr Abernethy undertook a sural nerve biopsy of the left vastus lateralis muscle. He later stated in a report to Capital Coast Health that the possible adverse outcomes of the procedure were discussed with the appellant at length before the procedure, and that no difficulties were encountered in the operation. In the operation he removed a section of nerve tissue from the appellant's left leg. He also removed some muscle tissue from her thigh. [4] The sural nerve biopsy immediately left the appellant with extensive and intensive pain in her left leg and as time progressed the pain continued and became worse and the leg became hypersensitive. It is reported that the appellant found herself unable to work full-time and had difficulty sleeping as the slightest touch caused an agonising reaction. The symptoms did not resolve and no remedial treatment is available [5] The appellant lodged a claim for medical misadventure on 9 July 2003. It was originally lodged as a medical error claim but there is no evidence to support medical error and the claim was considered as a medical mishap claim. [6] In a report of 16 September 2003 Dr Abernathy referred to the report of world recognised authority Peter James Dyck in a comprehensive monograph Peripheral Neuropathy concluding that 10% of persons with neuropathy undergoing sural nerve biopsy had greater degrees of pain or paraesthesia after a year. Dr Abernathy concluded that a larger percentage of people may have similar symptoms 2 to the appellant. Form that information, the respondent considered that the adverse consequence of increased pain was not rare in terms of s34 of the Act. [7] The Respondent received an independent report of 31 October 2003 from Dr Wallis, neurologist. Dr Wallis believed the appellant had received a physical injury as a result of medical treatment. He said: "Pain is common consequence of sural nerve biopsy. In a recent prospective study of several nerve biopsy, reviewing a consecutive series of 50 cases, 33% of patients had persistent and increased pain at the site of the biopsy. In this series the sural nerve biopsy only altered the diagnosis in 14% of patients but it did affect the management in 60% of the patients." [8] In answer to the question "If there is no evidence of medical error, does the claim meet the criteria for medical mishap" Dr Wallis wrote:. "Although it would meet the ACC misadventure criterion of severity, it does not meet the criterion of rarity. The Corporation requires probability of the treatment causing injury as 1% or less before this criterion is met. As around 30% of patients will have pain at the site of a sural nerve biopsy, this complication is not rare." Decision [9] The Respondent issued a decision on 7 November 2003 declining the medical misadventure claim. The medical error claim was declined because there was no evidence pointing to a failure by Dr Abernethy to observe skill and reasonable care in the circumstances. The medical mishap claim was declined because the criteria under s34 of the Act were not met. ACC accepted that the severity requirement was satisfied, but did not believe the Appellant met the rarity requirement because pain following sural nerve biopsies is common in around 30% of patients. Review [10] Prior to a review of the Corporation's decision, the appellant was examined by Dr R D Wigley on 13 March 2004. Dr Wigley considered the appellant's physical injury resulted from medical treatment. He noted that she had pain before the biopsy but the pain since the biopsy was of a completely different character, affecting only the left side, whereas the burning pain before the biopsy was bilateral and she still 3 had that symptom at tolerable level on the right sole. In his discussion on diagnosis, Dr Wigley said: "She shows excessive sensitivity to stimuli characteristic of reflex sympathetic dystrophy and this can also be called complex regional pain syndrome. This can be a rare but very distressing complication of any nerve injury." [11] He said that there was no medical error, but that there was medical mishap, stating: "In my opinion, there is (evidence of medical mishap), as the complication of reflex sympathetic dystrophy following nerve injury is rare, occurring in much less than 1% of cases, so that the rarity criterion for the Act for medical mishap is reached. It certainly is severe enough to meet the severity criterion." [12] On the question of frequency of increased pain caused by sural nerve biopsy, both Dr Wigley and Dr Wallis referred to Gabriel, C.M., et al. Prospective Study of the usefulness of sural nerve biopsy, JNNP 69:442-446, 431, 2000. In Dr Wigley's discussion of that study, he said: " ... None of these patients had pain as severe as Mrs Wyman has five years after the biopsy so that this must be a rare event occurring in much less than 1% of cases. Further if such severe pain and resulting disability did occur more often than 1% of cases, there could be no ethical justification for continuing to use this procedure, especially as the information gained is of diagnostic value and only sometimes of therapeutic value." [13] Dr Wallis submitted a further opinion on 27 March 2004 in which he said that the terms "reflex sympathetic dystrophy" or "complex regional pain syndrome" should not be applied in this case. Dr Wallis expressed his view that painful conditions of the type suffered by the appellant occurred in more than 1% of cases following a nerve biopsy, so that the appellant did not satisfy the rarity criteria of the Act. He said that severe pain, with all of the features described in this patient's case, is the common and long-recognised complication of all nerve injuries, whether the injury is severe or not severe. He noted that Dr Wigley had been unable to find a description of reflex sympathetic dystrophy following sural nerve biopsy because and said that the reasons were: "(a) reflex sympathetic dystrophy is not a term appropriately applied to a known specific (sural) nerve injury, and therefore to this patient's condition. 4 (b) neither reflex sympathetic dystrophy nor Type 1 and 2 complex regional pain syndromes, are diagnostic terms currently utilized in the neurological literature relevant to sural nerve biopsy." He said: "Dr Wigley provides a useful clinical assessment of this patient, but I do not believe that he is justified in either using the term reflex sympathetic dystrophy in this case or in concluding that the painful condition he describes is rare after a sural nerve biopsy. To the contrary, the phenomena of persistent pain, allodynia, hyperalgesia, and proximal extension of the pain are well known to occur commonly in all forms of nerve injury and also in other peripheral nerve disorders not related to injury. They are not specific phenomena and do not allow one to conclude that this patient has a unique or rare type of painful condition. Although this patient has suffered a great deal from the effects of the nerve biopsy, I do not believe that any of the evidence presented by Dr Wigley indicates that her condition would occur in less than 1% of people undergoing nerve biopsy. This type of painful condition can occur with a variety of nerve injuries, whether major or minor, and it is neither rare nor unique. Although it may be advantageous for a neurologist to examine this patient clinically, I do not see how this would help in settling the disagreement about how to interpret the patient's symptoms and findings. I find no reason to change my opinion that her painful condition is a fairly common complication of the type of nerve injury she suffered from a sural nerve biopsy. I believe that under the current 1% criterion used by the ACC to define the rarity of medical mishap, the claim should be declined despite the report from Dr Wigley. ... " [14] Dr Wigley replied to Dr Wallis' comments on 15 April 2004, acknowledging the differences in opinion as to whether the term reflex sympathetic dystrophy should be used but suggested such arguments be put aside in favour of focus being on the rarity criterion. [15] The review was heard on 21 April 2004. In the decision dated 28 April 2004, the Reviewer identified section 34 of the 2001 Act as the relevant provision. The Reviewer said: "To have a claim for medical mishap two factors must be present. They are a severe consequence and a rare consequence. The two factors must be considered in isolation. They cannot be interlinked. That is, the severity cannot be used to prove rarity, or vice-versa." 5 Argument [16] Under s32 of the Injury Prevention, Rehabilitation, and Compensation Act 2001 as it stood at the time of the claim, personal injury caused by medical misadventure fell into separate categories of medical error (negligence) and medical mishap (rare adverse outcome). There was no medical error in this case and the claim was based on medical mishap. 34 Medical mishap (1) Medical mishap means 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 (b) the adverse consequence is suffered by the person; and (c) the adverse consequence is severe (as defined in subsection (2) (i.e. resulting in death, hospitalisation for 14 days or lasts more than 28 days in total); and (d) the likelihood that treatment of the kind that was given would have the adverse consequence is rare (as defined in subsections (3) and (4)) (2) .... (3) 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 I% of cases in which that treatment is given. …. [17] The respondent submits that the case does not meet the criteria for medical mishap because the consequence of treatment was not rare. The respondent accepts that the consequence of treatment was severe. I find that there is insufficient evidence that reflex sympathetic dystrophy was a separate identifiable adverse consequence of the biopsy. The adverse consequence was nerve damage resulting in increased pain, in this case persistent severe pain. [18] Ms Berry put two alternative propositions for the respondent, first a submission of fact that the appellant's pain was not shown to fall within only 1% of cases, and secondly a submission of law that severity of pain is not the adverse consequence to be measured under s34. 6 [19] Ms Berry submitted that it is not clear whether the appellant's pain is in fact more severe than the patients in the study five years after biopsy. Further, as the study results have only been independently audited six months after biopsy it is submitted that Dr Wigley's interpretation of the report must be treated with caution; pain suffered for an extended amount of time does not make it rare occurring in less than 1% of all cases. [20] I accept the opinion of Dr Wallis that increased pain is an adverse consequence of sural nerve biopsy occurring in between 10% and 30% of cases in which such treatment is given. Dr Wigley's estimate that the degree and persistence of pain present in the appellant's case represents less than 1% of cases is an extrapolation that may not meet close scrutiny, but it may be accepted for the purpose of this judgment. [21] On the question of interpretation of s34, Ms Berry submitted that the Act requires that the severity of the adverse consequence and the rarity of the adverse consequence following the procedure are to be read separately for the purpose of satisfying the medical mishap criteria. Therefore it is submitted that the approach suggested by the appellant is incorrect in that the appellant's pain lasting five years is proof of severity, not rarity. Reasons for decision [22] In argument the problem has been approached as one of classification of the adverse consequence, that is whether all pain outcomes should be classified together, or whether extreme cases may be taken as a group to meet the rarity test. The appellant argues that the degree and persistence of pain is an adverse consequence that can be measured for the purpose of the tests of rarity and severity under s34. The respondent argues that the adverse consequence is a recognised pain condition which is not rare following sural nerve biopsy. The respondent says that the severity of pain does not make the condition different and therefore rare. The essence of the Reviewer's decision, and of the respondent's argument in this appeal, is that the severity of the injury cannot be used to meet the rarity test. This stems from the way the condition is classified. The respondent says that the type of consequence 7 cannot be broken down into a further subdivision of more or less severe cases that are known to occur as a result of the kind of medical treatment in question. [23] The appellant argues that a severe pain condition caused by a sural nerve biopsy is rare and there is no justification to put it into a general category of all painful outcomes of sural nerve biopsy. I accept that there is a tenable argument that it could be unfair, and possibly illogical, to exclude classifications other than known or accepted diagnostic categories. It may be fairly argued that a particularly painful condition is a rare adverse consequence. [24] But the appellant's argument has to be put in the context of the relevant statutory provisions. It will then be found that the argument overlooks an important aspect of the structure of sections 32 and 34 of the Act. Section 32 provided: 32 Personal injury caused by medical misadventure (1) 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. …. [25] It follows that cover is not given for the adverse consequence, but for the resulting personal injury. Under s34, medical mishap means an adverse consequence of treatment. Cover is given for personal injury caused by medical mishap. Therefore the covered personal injury has to be caused by the adverse consequence of treatment. The adverse consequence is not the end result. [26] In some cases the adverse consequence and the personal injury are the same thing, and the concept of one causing the other may be blurred. Reference is frequently made to the adverse consequence as itself being the injury, and usually whether an adverse consequence is severe is decided by the severity of the personal injury. The circularity of sections 32 and 34 leads to difficulty, in most cases, of separately defining the adverse consequence and the personal injury. But it would 8 be contrary to the spirit and purpose of the Act to require proof of two distinct and causatively linked conditions so the conceptual difficulty is usually ignored. [27] It is important however in the context of the present argument. This appeal must be resolved by seeking to define the adverse consequence of treatment as a treatment outcome that caused personal injury. Viewed in that way, there is no room for the interpretation urged by the appellant. The severe pain which could be shown to be a rare consequence cannot be regarded as a cause of personal injury. Nor can the severe pain itself be regarded as a personal injury because the injury is not the pain itself but the underlying physiological condition. [28] Appying the statutory language to the evidence in this case, the treatment caused an adverse consequence by way of nerve tissue damage from taking the biopsy sample. The adverse consequence was itself an injury, but may be regarded in terms of s32(1)(b) as the cause of the personal injury suffered by the appellant. The severe pain was a consequence of the personal injury but could not be the cause of the personal injury. Even if it regarded as a rare adverse consequence, there is no personal injury resulting from it. [29] For those reasons, I decide that the adverse consequence cannot be classified rare by virtue of the degree of accompanying pain. The adverse consequence fails to meet the test of rarity required for cover for personal injury caused by medical mishap. The appeal is therefore dismissed. Signed at Wellington on 6 November 2006 at 3.40 pm Judge D A Ongley District Court Judge 9