Lock v Accident Rehabilitation and Compensation Insurance Corporation

IN THE DISTRICT COURT HELD AT WELLINGTON Decision No. 23/92 UNDER The Accident Rehabilitation and Compensation Insurance Act 1992 AND IN THE MATTER of an appeal pursuant to section 91 of the Act BETWEEN DOMINIC KENT LOCK of Wanganui Appellant (Appeal No. DCA 36/95) AND ACCIDENT REHABILITATION AND COMPENSATION INSURANCE CORPORATION a body corporate duly constituted under the provisions of the said Act Respondent DECISION OF JUDGE A W MIDDLETON ON THE PAPERS The issue in this appeal is whether the appellant suffered a medical misadventure following post operative tissuing of intravenous peripheral parenteral nutrition. The appellant who is now aged 5 years underwent surgery at the Starship Children's Hospital in Auckland when he was then two days old. A claim was lodged with the respondent in January 1993 accompanied by a first medical certificate signed by Dr Nelson of the Auckland Children's Hospital whose diagnosis was that on 26 December 1992 "drip tissued. Total parenteral nutrition entered skin tissues causing adverse swelling and erythema" When the claim was received the respondent requested a report from the hospital and in a report dated 24 March 1993 signed by Dr Hamill it was noted that the doctor treating the appellant was Dr Nelson and the report stated: "1. IV line is left foot tissued on 26.12.92, discovered at 0850 that morning. IVN was being infused through the drip; therefore this fluid entered the tissue. 2 2. This was discovered within 1/2 hour of it happening (area checked at 0820). 3. Skin necrosis occurred at the site of the tissued drip (? ?? ? ? ? of left foot). 4. This has now healed with scarring (as assessed by Mr Smith and myself on 5/2/93 at outpatients clinic, Children's Hospital). 5. Due to be seen by Mr Smith in about 3 months from 5/2/93." As a result of that report the respondent referred the claim to its Medical Misadventure Advisory Unit as the legislation requires it to do. Before the Committee met it requested information from the hospital and from the appellant's general practitioner Dr Loos to enable the Committee to have sufficient information on which to advise the respondent. The hospital made available the nursing notes and Dr Loos provided a report dated 17 March 1994 in which he stated: "re: Master D. Lock. DoB 20.12.92 Date of injury 26.12.92 Thank you for your letter of 11th March 1994. I delivered Dominic Lock on 20th December 1992 and shortly thereafter he was transferred to the care of the neonatal paediatricians at National women's Hospital and then to paediatricians at Starship. The IV drip which tissued was inserted by one of the paediatricians and I am unable to make any comments as to the circumstances surrounding the injury. I have seen Dominic's foot recently and the scarring to the top of the foot is quite substantial. I am unsure how much of a disability this will pose for him but I feel it is appropriate that Mrs Lock has made a claim and that perhaps a plastic surgeon is invited to examine the foot and determine whether something remedial can be done or whether in fact, he will suffer a permanent disability. I hope these comments are of some use to you." The Medical Misadventure Advisory Committee concluded that the claim for cover should be declined. The report from the Committee noted: "DISCUSSION In relation to rarity, the occurrence of extravasateon from an IV site into surrounding tissue is more than 1%. On consideration of severity, there was no evidence which would establish that Dominic has suffered significant disability in terms of the Act. The Committee noted from the medical reports that IV sites must be checked hourly. It appears in Dominic's case however the IV site was checked half hourly as it was checked at 8.20 am and then found to be tissued at 8.50 am. In the Committee's view extra care was given above and beyond normal protocol. The Committee felt the hospital observed a reasonable standard of care. 3 ACTION REQUIRED: The Committee's proposed advice is there was no evidence of medical error. In regard to mishap the injury was not found to be rare or severe. The recommendation therefore is decline claim for cover and this should go on to become final advice after a fifteen day consultative period should no evidence to the contrary come to light. INTERCOMMITTEE ACTION: Mrs Lock (Dominic's Mother) wrote in a letter. She commented on the Committee's assumption that Dominic's drip was being checked every half hour. She spoke to the Charge nurse and was told that the nurse checked the drip at 8.20 am which was Dominic's hourly check and the drip was found to be tissued at 8.50 am because Dominic was crying and distressed. She questioned whether the nurse should have picked up signs prior to the drip tissuing. Mrs Lock states her GP Dr Loos and Charge Nurse Twomey both told her it was a rare occurrence. Chairperson Ms Sandra Moran considered the report, and commented the claim does not fall within our perimeters of responsibility on the evidence before the Committee. She states that there was no evidence of error or mishap, as tissuing is not rare and there was no evidence of severity because Dominic was a baby. ACTION REQUIRED: Finalise the Committee's proposed advice for decline claim for cover." As the appellant's parents were concerned that the matter had not been adequately considered a further meeting was arranged at the Starship Hospital on 2 June 1994 at which the appellant's parents were present. Also attending were Grace Koroheke - Manager Quality and Human Resources, Bernadette Twomey - Charge Nurse from Ward 24B, and Monique Davies - the Hospital Complaints Co-ordinator. In the course of that meeting the appellant's parents had the opportunity to question the hospital staff about their concerns as to the adequacy and extent of the treatment given to the appellant and, in particular, the timing of the checks. After the Medical Misadventure Advisory Committee had advised the respondent that it considered the claim should be declined the appellant's mother notified the respondent that she considered that the details of the nursing notes had not been adequately considered. However, the Committee had available to it all the medical records and reports, the nursing notes and the minutes of the 2 June 1994 meeting and concluded that the claim should be declined. When the appellant was notified of the decision to decline the claim and application for review was lodged. The review officer heard evidence from the appellant's mother and also inspected the appellant's foot. The review officer concluded that if the appellant was to succeed in his claim it could only be if the evidence established a medical misadventure within the terms of s.5 of the Act. She concluded that the evidence did not satisfy the requirements of s.5 and the application was declined. It is against that decision which the appellant now appeals. In the notice of appeal the appellant has stated that he did not receive adequate nursing care and that he was entitled to cover because of the rarity and severity of his injury. The appellant submitted that the principal ground for the appeal was that there had been insufficient investigation of the appellant's case by the respondent. In her initial submissions the appellant's mother raised the issue that there was no written evidence of a check by Nurse Burrow of the appellant's IV line at 8.20 am when Nurse Burrow claimed to have made such a check. She submitted that Nurse Forgesson had discovered the tissue drip at 8.50 am when she heard the appellant cry. In her submission the appellant's mother notes that it must be concluded that it took half an hour for 10 mis to leak into the appellant's tissue so that the extravasateon occurred immediately following Nurse Burrow's check and consequently raised a doubt as to how thorough that check was. She submitted that this was reinforced by a comment from the surgeon Mr Smith. His comment appears in a report supplied to the appellant's mother on 15 November 1993 which was also available to the respondent and the review officer. In that statement Mr Smith said: "I have been asked to reply to your letter of 21 October relating to the tissue injury Dominic sustained whilst a patient in the Intensive Care area of Ward 24B. The nursing and medical staff regret that Dominic has an area of 'scaring' left on his foot but are reassured of the fact that the scar will greatly improve as he grows and that it causes no functional disability. Although not wanting to reduce the significance of the injury, it must also be pointed out that Dominic would have died had no surgery been performed. Prior to 1950 when surgery for this condition was first developed in New Zealand, all patients suffering Dominic's condition did die. There are a hundred or so complications Dominic could have suffered in relation tot he operation, many of them more serious than the tissue injury. I have talked with the sister-in-charge of the ward and it appears that the normal checks carried out by the nurses directly looking after Dominic, have been observed. Please accept our regret that the tissue injury occurred. I will personally be pleased to discuss this matter further with you at our next clinic appointment." The appellant also takes issue with the review officer's finding that the damage to the appellant was not of sufficient severity to bring it within the requirements of s.5. The Court received submissions from Mr TP Cleary on behalf of the respondent. Mr Cleary submitted that the respondent was entitled to be guided by the findings of the Medical Misadventure Advisory Committee which concluded that in terms of s.5(1) a medical error had not occurred because "the scarring to the left foot after post operative tissuing of intravenous peripheral parenteral nutrition is not considered to have been deemed to a failure by the registered health professional to observe a standard of care and skill that was reasonable in the circumstances". He submitted further that the adverse consequence was not rare within the meaning of s.5(2) nor was it of the severity required to bring it within the specific definition in s.5(4). 5 When the file was referred to me I was concerned that there had been no . independent specialist assessment in relation to the appellant's nursing care. For that reason I directed that all the relevant information be referred to a paediatric specialist for consideration and a report. As a result the relevant material was submitted to Mr K C Pringle, the Associate Professor of Paediatric Surgery at Wellington School of Medicine. His report of 19 September 1997 states: "Re: Dominic Kent LOCK File Number: K4103623/001 Review Decision Number: 19/94/036 I reviewed all of the information supplied to me by the ACC including the Counsel's file. This included a paper entitled 'Paediatric Intravenous Catheter Complications in Critically Ill Children: A Prospective Study' Paediatrics 89 1145-1150 1992. The information supplied was that this child was born on 20 December 1992 at a birth weight of 3185 gms. After consideration of all of the information supplied, I feel that there are two basic issues which I should address. The first is the question as to whether there was any negligence. This issue, as I understand it, revolves around the fact that there was no more than half an hour between the time that the IV site was last checked and the time that the extravasateon was discovered and there is a valid question as to whether that is sufficient time to provide enough of an extravasation to result in skin loss. The second question is, perhaps, more difficult to answer. That is the question of as to what exactly is the incidence of skin sloughing in children receiving total parenteral nutrition supplied through peripheral intravenous cannuli. I have chosen to deal with these two issues as separate entities. Was the fact that the IV tissued and caused skin necrosis associated with any negligence? The nursing report clearly states that on the day of question the site had been checked at 0820 by a staff nurse and found to be satisfactory. At 0850 the site was checked again and it was found that the IV had tissued and the foot was blistered in two places. The IV was removed at that point. The entry immediately before that for the night shift records the IV as running at 20 mis/hour. This is entirely appropriate for a child with a birth weight of 3185 gms. If the IV tissued immediately after the site had been checked, then a maximum of 10 mis of TPN solution could have been injected into the subcutaneous tissues. To put things into perspective, the average 3 kilogram baby's foot is a little bit larger than the average adult thumb. In fact, I measured the volume of the foot of a baby that weighed 2.9 kgs, and a second baby of 3.6 kgs by dipping the baby's food in to a mug of water up to the medial and lateral malleoli (ankle) and measuring the displaced volume of water. The result I obtained was 20-30 mls. It can be seen from this that 10 mls of TPN solution injected into the subcutaneous tissues of the foot results in a considerable expansion of the volume of the foot, and in so doing would stretch the skin, and badly compromise the blood supply to that portion of the skin. Even if the IV had extravasated 15 minutes before the problem was discovered, that would have still left a volume of 5 mis of TPN solution injected into the subcutaneous 6 tissue, and even that much fluid, if the strapping for the IV had been placed immediately above the site of the tip of the cannula, could have resulted in sloughing of the skin. Total parenteral nutrition solution, in its own right, tends to be quite irritant and even relatively small volumes injected into a closed space either side of the strapping of an IV could result in skin sloughing. I should point out that all children's IV's are strapped to splints, in an effort to decrease the amount of movement and increase the length of time the IV lasts. There is always a compromise between tying the IV down tightly enough to prevent dislodgement and displacement and loss of the IV and the consequent need to place another IV cannula, and tying the IV down tightly enough to actually cause problems from the strapping As I read through the nursing notes, I note that the IV in question was actually placed the previous evening at 2045 hrs. This is almost exactly 12 hours prior to the extravasateon. This is certainly within the normal life expectancy of an IV with peripheral infusion of TPN, especially without Heparin. One study that I was able to access was 'The Efficacy of Heparin in Maintaining Peripheral Infusions in Neonates' A. Moclair & I Bates. Eur J Paediatra (154 56:567-570, 1995) suggested that the mean survival' of peripheral IV cannuli was approximately 25 hours in children in whom no Heparin was included in the IV solution, and this extended out to 69 or 72 hours if 0.5 or 1 unit of Heparin/ml was added to the IV infusion. However, this paper points out that failure of the peripheral infusion is almost inevitable, with 69/72 episodes of cannula placement failing (that is becoming extravasated) and needing to be replaced. The point that I think deserves to be emphasised is the fact that with a total foot volume between approximately 20 and 30 mis, an infusion of even 5 or up to 10 mis into the subcutaneous tissues of the foot is highly likely to result in sloughing of the tissues. The foot is perhaps more susceptible to this problem than the hand, especially in the situation where the foot is taped into an equinous position, to try and prolong the life of the IV infusion. 2. What is the incidence of skin sloughing in babies receiving TPN? The paper quoted in the documents I received gives a risk of extravasateon as 179 in 654 catheters sited. That is a much lower incidence than the incidence quoted by Moclair and Bates (QV) of almost 100% of cannuli ultimately extravasateng. Unfortunately, Moclair and Bates do not give any figures as to the number of the extravasated IV's that cause skin sloughing. In fact, after repeated Medline searches, I have been unable to come up with a solid estimate. In contrast, the paper by Garland et al states that extravasateon occurred in only the 179 of 654 catheters, with a range for the 'survival' of the infusion of 13-202 hours. The lower limit is certainly compatible with the situation in this case. They point out that only two extravasateons resulted in skin sloughing. Those two episodes of skin sloughing are either then approximately 1.1% of catheters that extravasate result in skin slough, or alternatively only 0.3% of all catheters inserted in this study resulted in skin sloughing. However, these results bypass the real question which is 'what is the risk of a skin slough occurring in a newborn baby undergoing a course of peripheral TPN over several days'. Unfortunately, I have been unable to find any hard data on this question, but my clinical experience from my time at the Royal Children's Hospital in Melbourne and at the University of Iowa, is that the risk of skin slough in such circumstances is well over 1%. In fact, it is my impression that the risk of skin sloughing in a course of peripheral TPN that extends over a period of time longer than one week would probably be in excess of 5%, and probably closer to 10%. I did give some consideration to actually examining the scar, and if I had been attending a clinic in Wanganui in the last few months I would have taken the opportunity to have done so. However, it seems to me that the severity of the scar per se is not an issue, and it is probable that the actual disability in the future is going to be minimal. I have therefore decided not to add the cost and the inconvenience to the family of five hours of travel by car in order to actually view the scar. In summary, it is my view that there is no evidence for negligence. With a total foot volume of somewhere between 20 and 30 mls in a child of this age, even as little as 5 cc's of fluid would be an increase in volume of the order of 17-20%, and 10 cc's, which could have been delivered over half an hour would be somewhere between 30% and 50% of the volume of the foot. The skin loss suffered by this child is entirely compatible with the times given. The second issue is the question of the incidence of skin sloughing in a situation where there is a course of total parenteral nutrition being administered over several days. Although I have no hard data on which to base the opinion, it is likely that at least 1% of IV infusions that extravasate cause skin sloughing and over a course of peripheral TPN administration over several days, then the incidence of skin sloughing would be of the order of 5-10%." After Mr Pringle's report was made available to both parties I invited further submissions which I have now received. The appellant's mother has submitted that Mr Pringle has provided no new data on the question of incidence of skin necrosis caused by IV lines. She has submitted further that he had seen the appellant with his original deformity, tracheo- oesophageal fistula, in September 1995 and as a result of a diagnosis he then made he had concluded that the appellant's problems had been overcome. However, in January 1996 the appellant had to undergo emergency treatment to remove a plum pip which had become stuck in his oesophagus. Then in the winter of 1996 he was hospitalised for pneumonia. The appellant's mother has indicated that she has referred these matters to me in order to demonstrate that Mr Pringle's prognosis at that time was wrong and that his present opinion may also be wrong. She submitted further that on the appellant's first appointment with Mr Pringle his mother had shown him the appellant's scar, a matter which he now says he does not recall. I have received further submissions from Ms P J Zumbach on behalf of the respondent. She submits that while the appellant's mother has queried Mr Pringle's findings the Court should not look beyond his qualifications and experience. In order to qualify for cover under the Act it is necessary for the appellant to bring the claim within the definition of medical misadventure provided in s.5 of the Accident Rehabilitation and Compensation Insurance Act 1992. That section states: 8 "5. Definition of 'medical misadventure'- - (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 show 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 (6 ) 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. (3) Where the likelihood that an injury would occur is in the ordinary course rare, but is not rare having regard to the circumstances of the particular person, it shall not be medical mishap if the greater risk to the particular person injured - - Was known to that person; or (6 ) In the case of a person who does not have legal capacity, was known to that person's parent, legal guardian, or welfare guardian, as the case may be, - prior to the treatment. (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. (5) Medical misadventure does not include personal injury arising from abnormal reaction of a patient or later complication arising from treatment procedures unless medical error or medical mishap occurred at the time of the procedure. (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. (7) Medical misadventure does not include a failure to diagnose correctly the medical condition of any person or a failure to provide treatment unless that failure is negligent. (8) Where personal injury to a person results from medical error or medical mishap that occurs in a clinical trial, that personal injury shall constitute medical misadventure only where - (a) The trial - 9 (i) Has been approved by an ethics committee approved by the Health Research Council or the Director-General of Health; and (ii) The ethics committee has certified that it is satisfied that the trial is not conducted principally for the benefit of the manufacturer or distributor of the medicine or item in respect of which the trial is carried out; or () The person has not agreed in writing to participate in the trial. (8A) For the purpose of subsection (8) of this section, the term 'treatment' includes anything done or omitted as part of a clinical trial. (9) The Corporation, - - (a) In making any decision under this section in relation to any claim for cover under this Act that is claimed to be based on personal injury resulting from medical error, shall obtain and have regard to independent advice in accordance with procedures prescribed by regulations made under this Act; and (6 ) In making any decision under this section in relation to any claim for cover under this Act that is claimed to be based on personal injury resulting from medical mishap, may be obtained and have regard to independent advice in accordance with procedures prescribed by regulations made under this Act. (10) Where the Corporation considers that medical misadventure may be attributable to negligence or an inappropriate action on the part of a registered health professional it shall - - (a) Give the registered health professional a reasonable opportunity to comment on the matter; and (6 ) If satisfied that there may have been negligence or inappropriate action - - report the circumstances to the appropriate body with a view to the institution of disciplinary proceedings, and to any other body that may be appropriate. (11) For the purposes of section 9(2) of this Act, the term 'registered health professional', in this section, includes a person who has qualifications equivalent to those of a registered health professional in New Zealand." It has to be remembered that under the 1992 Act a specific definition of "medical misadventure" has been provided in contrast to the 1982 Act under which a broad definition was established through case law. The Court has to rely on the information provided by the specialists concerned. The Medical Misadventure Advisory Unit has accepted the evidence that the appellant was checked at 8.20 am on a morning concerned and was then found to be tissued at 8.50 am. That evidence appears to have been accepted in all the reports available to the respondent and the Court except that the appellant's mother has raised doubts as to the validity of the 8.20 am check because of no written evidence of it. However, the Court cannot go beyond the findings of the medical staff involved that such a check was carried out. This was acknowledged by Mr Hamill in his report in March 1993 and has been the evidence of the nurses involved in the appellant's care. The appellant's mother on numerous occasions raised the issue that there was some doubt as to whether that check was made but the various parties involved with the care of the appellant have not accepted his mother's assertions. The Medical Misadventure Advisory Committee found that the treatment provided to the appellant was appropriate and 10 that there was no failure to provide a proper standard of care. This finding is reinforced by Mr Pringle. Further, while Dr Loos raises some doubts about the scarring, these are not endorsed by the other specialists and are considered minimal. There is no evidence of any permanent disability. The evidence of Mr Pringle is that the nursing notes do not indicate that what occurred was outside the normal range of expectancy of such a procedure. In addition, based on his experience and on his research there is a recognised consequence of skin sloughing as a result of this procedure which he estimates at somewhere between 5 and 10 percent of similar procedures. While I can appreciate the appellant's mother's concern for her son and the very strenuous efforts she has made on his behalf, the Court must be guided by the medical evidence. It was for that reason that I sought some assistance by having the file referred to a paediatric specialist who could advise the Court and the appellant on the outcome of this question. The appellant's mother has her personal doubts regarding Mr Pringle's expertise but he is a specialist in the field and without evidence to the contrary the Court must be guided by his opinion. While the review officer did not have the benefit of Mr Pringle's report, I confirm her finding that there is nothing in the evidence which suggests a failure of a registered health professional to observe the standard of care that was reasonable in the circumstances and accordingly there is no evidence of medical error. The issue of whether a medical mishap has occurred must be decided under the headings of "rarity" and "severity". Mr Pringle has stated as his opinion based on his own experience and research that the probability of an occurrence of this nature is between 5 and 10 percent of the number of occasions on which the treatment is given. Consequently the question of rarity takes the claim outside the scope of a medical mishap. Insofar as severity is concerned, the Act provides that the consequence of the treatment is not "severe" if the appellant was an inpatient for less than 14 days and that he suffered no significant disability lasting more than 28 days in total and that he would not qualify for an independence allowance under s.54 of the Act. The medical evidence is that the appellant does not suffer a significant disability and he was certainly not hospitalised for 14 days, nor is there any suggestion that he would qualify for an independence allowance. 11 In the circumstances therefore the appeal must be dismissed. DATED at WELLINGTON this 1 1 day of February, 1998 A W Middleton District Court Judge DC36-95.doc(rd)