Mitchell v Accident Rehabilitation and Compensation Insurance Corporation

IN THE DISTRICT COURT HELD AT WELLINGTON Decision No. 57 /98 UNDER The Accident Rehabilitation and Compensation Insurance Act 1992 AND IN THE MATTER of an appeal pursuant to section 91 of the Act BETWEEN VIRGINIA ANNE MITCHELL of Kihikihi Appellant (Appeal No. DCA 221/97) AND ACCIDENT REHABILITATION AND COMPENSATION INSURANCE CORPORATION a body corporate duly constituted under the provisions of the said Act Respondent HEARD at WELLINGTON on the 16th day of February 1998 APPEARANCES J Miller for appellant B Corkill for respondent DECISION OF JUDGE A W MIDDLETON The issue in this appeal is whether the appellant is entitled to cover under the Act for medical misadventure because the adverse consequences she suffered were the result of medical error, medical mishap or a negligent failure to obtain informed consent. The appellant who is now aged 43 lodged a claim with the respondent on 12 August 1996 in which she stated that she suffered arachnoiditis as a result of undergoing two myelograms in 1974 and 1977. The appellant said that she suffered pain following the first procedure which had not been preceded by any pre-medication. She said that she felt tremendous pressure and burning in her spine which had spread through her head, body and legs. She stated that no effort seemed to be made to 2 remove the Myodil which was the oil based contrast agent used in the procedure. She said that as a result she remained in hospital for some three days. She said that following the second procedure in 1977 she did not react well and again no pre- medication was given. She said that again she suffered pain in the legs and back and could barely walk after the procedure. A full description of the background history was related in the subsequent discussion paper issued by the respondent's Medical Misadventure Advisory Committee. Following the meeting in October 1996 that statement was: "This claim is for arachnoiditis allegedly due to two Myodil myelograms with the use of the oil based contrast Myodil in both 1974 and 1977. . The Committee has various reports before us in this claim including a report from Dr Gordon Howie a Spinal Surgeon in Auckland. He sets out the history of spinal problems that Mrs Mitchell has suffered from since relatively an early age, apparently at the age of 19. The Committee has noted this would be in 1974. Mrs Mitchell underwent a posterior cervical fusion which was carried out by Orthopaedic Surgeon Mr Taine in Hastings. She subsequently had myelography in Dunedin and she had an occipito cervical decompression at C1, 2 and 3 which was carried out by Professor Robinson in Dunedin. She has had ongoing problems with pain. An MRI scan according to Mr Howie in his letter of 29 May 1995 states that the changes on the MRI scan with contraction of the distal thecal sack was certainly strongly suggested of arachnoiditis and is likely to account for her leg pain. He states as you know arachnoiditis may follow myelography with an oily medium. Mr Howie then states later in the letter that she would appear to have a claim for medical misadventure given the severity of her symptoms but of course as more cases come to light the frequency may rise above the ACC's 1% threshold. The Committee in considering Mrs Mitchell's claim has noted the history of severe back pain. We have also particularly noted Mrs Mitchell had spinal surgery in both 1974 and 1977. While the Committee accepts that there is a causal relationship between the use of oil based contrast such as Myodil and the development of arachnoiditis the Committee also notes that there is a causal relationship between spinal surgery and the development of arachnoiditis. In Mrs Mitchell's case she has had two back operations. A posterior cervical fusion in 1974 and an occipito cervical decompression in 1977. In the literature the association of spinal surgery with arachnoiditis it occurs in up to 20% of cases in combination with oil based contrast media such as Myodil. The percentage of arachnoiditis is greater than 20%. There is nothing before the Committee to establish medical error. Medical mishap rarity - the incidence of arachnoiditis following spinal surgery alone occurs in up to 20% of cases and with Myodil is considerably higher. This claim therefore would not satisfy the rarity criteria laid down in the Act. With respect to severity although Mrs Mitchell is significantly disabled, this is not a rare consequence. Our recommendation is that the claim be declined to become final after 15 working days. PROPOSED ADVICE: The proposed advice of the Committee is that cover be declined, as neither medical error nor medical mishap have occurred. This advice to become final advice following the 15 day consultative period, should no evidence to the contrary come to light. 3 FINAL ADVICE: No new relevant information has been received that challenges the Committee's finding, therefore proposed advice is confirmed, and final advice is that cover be declined as neither medical error or medical mishap has occurred." The evidence disclosed that unfortunately all the hospital records prior to 1978 had been destroyed and the only record available is that the appellant had been admitted to the Napier Hospital under the care of Mr G Taine, an orthopaedic surgeon, between 29 September 1974 and 1 October 1974 and again on 3 May 1977 to 14 May 1977. As a result of the findings of the respondent's Medical Misadventure Advisory Committee, the respondent notified the appellant on 18 December 1996 that her claim for cover was declined. The appellant applied for a review of that decision. The appellant was represented by her advocate at the review hearing and she gave evidence herself. In addition, she had provided a substantial quantity of reports and articles from medical journals in support of her claim for cover. In a careful decision the review officer considered the claim under the various headings pertaining to s.5 of the Act. She accepted that the appellant does suffer arachnoiditis which is the cause of the problems in her lumbar spine. She accepted also that the x-ray reports indicate the presence of Myodil in her spine. The review officer concluded that there was insufficient evidence to support the claim that the appellant had suffered a medical error in failing to remove all the Myodil from the spine as recommended by the insert pack provided with the Myodil. She concluded further that on the basis of the evidence, while the use of Myodil in myelograms had been dispensed with by 1982, there was insufficient evidence to establish that when used on this appellant it was not then a proper procedure. The review officer concluded that while Mr Taine had a duty of care to advise the appellant of the known risks associated with Myodil, there was no evidence that he was aware of the information contained in the Myodil insert and thereby failed to inform the appellant of those risks. She found that had Mr Taine administered the Myodil he might well have had access to the information in the pack but the procedure was carried out in the Radiology Department and not by Mr Taine. She concluded that there was therefore insufficient evidence on which to establish that there had been a failure to obtain informed consent. The review officer concluded that on the basis of the medical evidence it was not established that the appellant had suffered a medical mishap. It is against that decision which the appellant now appeals. Since the appeal has been lodged additional evidence has been provided in the form of a report from Mr Taine to the respondent's counsel dated 10 February 1998 in which he states: 4 "The events which you have now brought up occurred 24 years ago, and in the absence of any records, hospital or my own, one is relying entirely on recollection. I have nevertheless discussed the situation with one of the Radiologists who was active at the time, and this has helped to clear some of the dates and attitudes concerning the use of Myodil. From what you say one would have full sympathy for Mrs Mitchell [nee White] in the predicament in which she has since found herself. One thing that puzzles me is that Mrs Mitchell had a second Myelogram in 1977: if the first one in 1974 had caused so much reaction, one wonders why the one wonders why the (sic) second one was done and did this one aggravate her problems. It would be undisputed that some degree of Arachnoiditis resulted from these investigations; and because of this known fact attempts were always made to remove as much as the ' dye' as possible at the end of the viewing procedure. But it was usually impossible to remove all of the material owing to the nature of the anatomy of the Subarachnoid space where it had been placed. In the 1970's and until about 1985, when CT Scans and MRI investigations came on the scene, Myelograms were done routinely, average of about one a week, as it was an extremely useful procedure. Short term side effects were known about, but these were not considered to be an inhibiting factor and severe or long term reactions were rare. The volume of material produced by Mrs Mitchell in support of her claim is understandable, but if problems such as hers were at all frequent we would have been more prudent in our decisions as to whether a Myelogram was necessary or not. In hindsight the subsequent severity of her Arachnoiditis would have been totally unexpected. 'Informed Consent' would not have been an issue at that time. One would nevertheless feel that although some degree of reaction would not be rare [even 20% ], the degree and persistence in this case could well be considered rare [1% or less]. To answer your questions specifically:- a] I would not have seen the particular insert but were fully aware of the questions it raised; the radiologist almost certainly would have seen it. WE did not undertake Myelograms lightly but it was such a valuable method of investigation at this time, as it could confirm or eliminate the need for surgery. As we were aware of the possible discomforts it could cause, it was still not done without good reason. The reaction in this case; the severity and long duration would have been quite rare. bl We were fully aware of problemis that could arise, but I cannot recall having seen the particular article of 1954. c] The general view of Myodil in 1974, and up to 1981, was that it was a very valuable agent albeit with some side effects, but these were not severe enough to prohibit 5 its use; nevertheless when a new material came along in 1981 [an aquase based material] it was welcomed. Even this has since been superseded by the use of CT Scans and now MRI. d] In 1974 we probably would have mentioned the possible side effects but these would not have been stressed as they were not severe, although it was customary to give the patient 1-2 litres of water to drink before the examination. Informed Consent was not an issue in the 1970's." In addition, there is a report from Mr Howie whose previous report was before the Medical Misadventure Advisory Committee and is referred to by it. In a report dated 23 July 1997 Mr Howie, a spinal surgeon states in a letter to the appellant: " Further to your urgent request for further information I have discussed the incidence of post-Myodil myelography complications with Dr John Wilson. Neuroradiologist, who confirms that the incidence of definite arachnoiditis as being less than one per cent. I am unable to give you details of other cases." The appellant also provided a report dated 31 October 1997 from Dr C Burton, Senior Medical Director of the Institute for Low Back and Neck Care, Minneapolis, USA. In that report Dr Burton states: "Thank you for forwarding your records and imaging studies regarding your intractable pain syndrome. Your MRI scan from Manukau Radiology, dated 4/23/96, is an excellent, high-quality study which shows classic, diffuse, severe lumbosacral adhesive arachnoiditis. The pattern is that which is typically seen following the introduction of a long-acting toxic agent into the subarachnoid space. Your case is most unusual in that your Myodil myelogram was performed to evaluate cervical disease, and you have never had a lumbar operation. Actually, your situation is quite rare because the very great majority of all lophendylate myelograms (Pantopaque, Myodil, etc.) were used to evaluate patients with lumbar problems who were considered to be surgical candidates. For this reason, essentially everybody who underwent lumbar myelography with lophendylate was a candidate for subsequent surgery. From a clinical observation, it is also sadly evident that, as the adhesions of the scar tissue being created progressed, subsequent myelograms would often present a pattern which suggested to the clinicians and radiologists that there was recurrent pathology (such as a recurrent disc herniation) when, in fact, there was none. This unfortunate circumstance, which occurred over many years, was the cause of many unnecessary surgical procedures but also made it extremely difficult to decipher the actual role of lophendylate in producing scar tissue, the influence of surgical procedures, and the reintroduction of blood elements in the spinal fluid. 6 Your case is unusual in that you never had lumbar spine surgery. It is clear that the adhesive arachnoiditis in your case reflects the presence of toxic material placed to evaluate cervical pathology. The anatomic correlation of the nerve roots of the cauda equina, enmeshed in scar tissue, for the type of MRI pathology shown in your case, has been well established, and I am enclosing a photograph for your review and information. As you know from our conversation, a number of advanced techniques are now being utilised to treat patients with problems such as yours because the worldwide use of Depo Medrol or Depo Medrone has continued to produce cases of severe lumbosacral adhesive arachnoiditis when this material has been placed into the subarachnoid, rather than the epidural, areas of the spine." Mr Miller submitted: 1. That the issues raised in the appeal in relation to medical error came under three headings, being: (a) Was there failure to remove the dye? (b) Did the continued use of Myodil between 1974 and 1977 constitute a medical error when it should have been known at that time that it should not be used? (c) Was there a lack of informed consent? 2. That in relation to the Myodil insert pack leaflet referred to by the review officer it stated under the heading of "Administration and Dosage": "The material should be removed by aspiration after the examination unless it is required for further study". He noted further that the leaflet stated "Post-myelography arachnoiditis which may be severe, occurs in some patients". That subsequent radiological examination confirms the presence of Myodil in the appellant's spine which indicates that it had not been properly removed. 3. That while some practitioners continued to sue Myodil during the 1970s they should have been aware that its use was being reduced in other countries and that by the time this appellant required treatment it should not have been used. 4. That despite the fact that it was still used the treatment provided this appellant fell below a standard of reasonable care in that the Myodil was not immediately withdrawn from her system after the procedure and she was subjected to a second similar procedure in 1977 despite her severe reaction in 1974. 5. That on the issue of informed consent, if there was a risk of arachnoiditis the appellant should have been warned of this before the procedure was undertaken. 6. That in his text "medical negligence" Professor Michael Jones in 1996 said at page 101 in relation to informed consent: " In other words the court may condemn even a universally followed practice as to risk disclosure as negligent on the basis that the hypothetical reasonable doctor would not have adopted it." Mr Miller submitted that the suggestion by Mr Taine that the severity of the appellant's arachnoiditis was totally unexpected was by itself an acknowledgement of medical mishap. This is supported by the statements of Or Burton that the appellant's case was most unusual. He submitted further that in his decision in Craddock v ACC (129/97) Mr P J Cartwright as the Appeal Authority had accepted that arachnoiditis constituted personal injury by accident. He submitted that in that case the specialist Dr Sew Hoy considered that Myodil on its own was an uncommon or rare cause of arachnoiditis and that an estimate of 3% may be an over-estimate. He submitted that in respect of this appellant's adverse consequence from the Myodil procedure predated any surgery as it had in Craddock, but the subsequent surgery this appellant had was for cervical and not lumbar problems which makes the adverse reaction rare. That in making this submission he considered that the Medical Misadventure Advisory Committee which took the statistic of 20% failed to take into account all the issues which had occurred in relation to this appellant, particularly in the failure to inform the appellant of the enormous risks. Mr Corkill submitted in relation to medical error: 1. That the only accurate evidence available in relation to the use of Myodil in the 1970s is that of Mr Taine who confirmed that it was used routinely until 1985 and that the known side effects were not severe enough to prohibit its use. That there is no other evidence which establishes that health professionals in New Zealand had been alerted to the dangers and after effects which warranted withdrawal of Myodil from general use. That the pamphlet insert with the Myodil is dated 1973 which establishes that it was still being produced at that date and that unless the patient fell within the contra indications described in the insert there was no reason to think it was negligent per se to use Myodil. That Mr Miller's quote from the insert did not include the full statement in relation to the possibility of adverse reactions. He submitted that the statement should have been read in the context of the whole paragraph which states: " Post myleographic arachnoiditis, which may be severe, occurs in some patients. This has not been associated with a specific disease or technique of investigation. The literature contains reference to adhesions and fibrous exudate being found an operation in patients who had at some time undergone myleography with lophendylate. The sporadic nature of these reports, and some times the sparseness of information about the patients condition prior to myleography make it difficult to evaluate the role of 8 Iphendylate. However the reports emphasise the importance of removing as much Myodil as possible at the time of investigation." That that information had to be considered alongside the opinion of reasonable practitioners at that time. That while the appellant had previously indicated that there was a 1954 article which may have been available at the Hastings Medical Library which cast doubt on the use of Myodil its mere existence could not be said to be a matter within the knowledge and responsibility of practitioners at that time. That a report from Mr C Wrightson in July 1997 notes that it is difficult to now remember dates as to when he became aware of the serious problems with Myodil and he only had a "strong feeling" that in the late 1960s practitioners became wary of Myodil. In relation to medical mishap, Mr Corkill submitted: 2. That the appellant must show that the adverse consequence she suffered as a result of the Myodil injections were both severe and rare and in this case the adverse consequence is the development of arachnoiditis. While the respondent has accepted that the consequence suffered by the appellant was severe it does not accept that it is rare. That the only evidence of a rarity less than 1% is the hearsay evidence contained in Mr Howie's letter of 23 July 1997. That even Dr Burton allows for 1% to 5% range. That while Mr Taine had said that the severity of the reaction might be thought to be rare, on the totality of the evidence the adverse outcome could even be as high as 20%. In relation to failure to obtain informed consent Mr Corkill submitted: 3. That a failure to obtain informed consent will be medical misadventure only if the registered health professional acted negligently in failing to obtain such consent. That it will only be negligent if it was negligent according to the standards of reasonable practice at the time. In support of this submission he referred me to the decision in Rogers v Whittaker (1992) 109 ALR 625. That it should be noted that the question has to be answered in light of contemporary view as to the nature of informed consent in 1974 and not in 1998 as there has been a considerable development in this field particularly following the Cartwright Report which was published in 1988. That the only evidence as to what occurred prior to the procedure being undertaken is the appellant's own evidence in which she considers that the nature of the procedure was not discussed with her. That Mr Taine considers that in 1974 it is probable that possible side effects would have been mentioned. However, in order to fulfil the requirements of s.5(6) it must also be established that the failure to obtain informed consent was negligent. That in relation to the particular procedure possible side effects were not at that time considered to be severe and there is no evidence that it would not have been carried out had the appellant been advised of possible consequences. 9 There is a considerable volume of material now on the file which I have considered and which I have detailed as far as I consider it necessary for the purpose of completing this decision. As counsel have already indicated the issue falls to be determined under s.5 of the Accident Rehabilitation and Compensation Insurance Act 1992. That section defines medical misadventure and so far as it relates to this appeal states: "(1) for the purposes of this Act, - Medical error' means the failure of a registered health professional to observe a standard of care and skill reasonably to be expected in the circumstances. It is not medical error solely because desired results are not achieved or because subsequent events showed that different decisions might have produced better results: Medical misadventure' means personal injury resulting from medical error or medical mishap: 'Medical mishap' means an adverse consequence of treatment by, or at the direction of, a registered health professional, properly given, if - (a) The likelihood of the adverse consequence of the treatment occurring is rare; and (b) The adverse consequence of the treatment is severe. (2) For the purposes of the definition of the term 'medical mishap', the likelihood that treatment of the kind that occurred would have the adverse consequence shall be rare only if the probability is that the adverse consequence would not occur in more than 1 percent of cases where that treatment is given. . ... (4) For the purposes of the definition of the term 'medical mishap', the adverse consequences of treatment are severe only if they result in death or - (a) Hospitalisation as an inpatient for more than 14 days; or (b) Significant disability lasting for more than 28 days in total; or (c) The person qualifying for an independence allowance under section 54 of this Act. . . .. (6) A failure to obtain informed consent to treatment from the person on whom the treatment is performed or that person's parent, legal guardian, or welfare guardian, as the case may be, is medical misadventure only if the registered health professional acted negligently in failing to obtain informed consent." 10 The evidence clearly establishes that the appellant suffers arachnoiditis which is the cause of her lumbar spinal problems. There is also evidence from the x-ray reports that Myodil still exists in the appellant's spine. In order to establish that she has suffered medical error the evidence must show that the registered health professionals in charge of the appellant in 1974 and 1977 failed to exercise a standard of skill and care which could reasonably be expected in the circumstances. While there is some doubt as to when it became evident that the use of Myodil should cease I am not satisfied that its use in 1974 and 1977 was in any way inappropriate. Mr Taine who regularly prescribed such examinations stated that he continued its use until about 1985. Clearly, the leaflet insert included with the material was printed in 1973 so that by that time it could not be said that it was not an appropriate method of diagnosis. While the insert suggests that there could be side effects and Mr Taine was aware of possible side effects they were not considered to be of sufficient severity to prohibit its use. Moreover, the contra indications referred to in the insert pamphlet noted the possibility of arachnoiditis and that the information in that leaflet taken with the general knowledge of practitioners at that time would clearly indicate that it was a useful tool and did not carry sufficient severe side effects as to prohibit its use. In the circumstances therefore I do not consider that at the time he prescribed the Myodil myelogram in either 1974 or 1977 Mr Taine acted other than as a prudent and responsible practitioner having regard to the knowledge of that procedure at that time. In relation to whether the appellant suffered a medical mishap, while the respondent has accepted that the consequences suffered by this appellant were severe it is also necessary in order to establish a medical mishap that such consequences would not occur in more than 1% of cases where the treatment is given. The Medical Misadventure Advisory Committee considered that the rate of arachnoiditis following spinal surgery could be as high as 20% of cases in which contrast media such as Myodil is used and Dr Burton gives a range of between up 1 to 5%. The only contrary opinion is the hearsay statement in Mr Howie's report that in a discussion with Dr John Wilson, Dr Wilson considered the rarity would be less than 1%. On that basis I therefore have to agree with the review officer that the appellant has not satisfied the requirements to establish that she has suffered a medical mishap. In relation to the failure to obtain informed consent Mr Taine indicated that that was not an issue in the "1970s". He thinks he would have told the appellant about the nature of the procedure and its possible effects but she states that her recollection was that no such discussion took place. The review officer had obtained support for her finding that the appellant had not established a lack of informed consent by reference to the decision of the Accident Compensation Appeal Authority in Sutherland v ACC (34/97) where the Authority stated: "An informed consent is that consent which is obtained after the patient has been adequately instructed about the ratio of risk and benefit involved in the procedure as compared to alternative procedures or no treatment at all." 11 While Mr Corkill referred me to the decision in Rogers and Whittaker, a recent decision of Mr P J Cartwright as Accident Compensation Appeal Authority in EH v ACC (191/95) reviewed in full the nature and history of the question of informed consent. In particular he referred to the statement of Turner J in the decision of the Court of Appeal in Smith v Auckland Hospital Board [1965] NZLR 191 when he said: "The particular relationship of doctors and patients is sufficient to impose upon the doctor a duty to use due care in answering a question put to him by the patient where the patient, to the knowledge of the doctor intends to place reliance on that answer in making a decision as to a treatment or procedure to which he is asked to consent." The basis of the decision was that at that time the duty of the medical practitioner was to truthfully answer any question posed by the patient. The Appeal Authority then went on to state in the decision in EH, after a further quote in the Court of Appeal decision in Smith that: " From the above extract it seems implicit that in 1966 there were no legal requirements in New Zealand about whether any explanations should be given to a patient in the absence of an express inquiry." In EH the Appeal Authority went on to consider the advancement of the law in the intervening period and particularly that following the issue of the Cartwright Report in July 1988. It seems that following that report the Medical Council in June 1990 issued a significant report to its members on the question of informed consent and has subsequently laid down rules for its members. However, as I read the decision in EH the position which obtained following the decision in Smith was, and would have been, the position which pertained when Mr Taine was advising this appellant. On the basis of the decision in Smith had the appellant posed the question of what possible side effects or adverse consequences might arise from the proposed myelogram, Mr Taine would have been under a duty to give a truthful answer to that question. I do not consider that at that time there was any stronger legal obligation on him than to provide truthful answers even though he considers he may well have explained to her the possible outcomes of the procedure. While Mr Miller referred me to Professor Michael Jones' 1996 statement on medical negligence I do not consider that that is relevant to the situation as it applied in 1974 and 1977. I consider that until the medical profession came to grips with this issue following the issue of the Cartwright Report the position as it pertained following the decision for Smith was the appropriate standard by which the profession should be judged. Accordingly on the evidence before me I do not consider that there was a lack of informed consent so far as this appellant was concerned. 12 It follows therefore that the appellant did not suffer a medical misadventure as a result of undergoing the myelogram examinations in 1974 and 1977. The appeal is dismissed. DATED at WELLINGTON this 30th day of March 1998 A W Middleton District Court Judge dc22191.doc(rd)