Melchior v Sydney Adventist Hospital Ltd
[2008] NSWSC 1282
•9 December 2008
CITATION: Melchior and Ors v Sydney Adventist Hospital Ltd and Anor [2008] NSWSC 1282 HEARING DATE(S): 06/11/2008, 07/11/2008, 10/11/2008, 12/11/2008, 13/11/2008, 17/11/2008
JUDGMENT DATE :
9 December 2008JUDGMENT OF: Hoeben J DECISION: Judgment in favour of the defendants.
The plaintiffs are to pay the defendants’ costs of these proceedings.CATCHWORDS: MEDICAL NEGLIGENCE - failure by surgeon to administer an anticoagulant following Achilles tendon repair operation - content of duty of care owed by surgeon - breach of duty by surgeon and hospital - application of section 5O Civil Liability Act 2002 - causation - whether administration of anticoagulant would have prevented pulmonary embolism - late application to amend Statement of Claim. LEGISLATION CITED: Civil Liability Act 2002
Civil Liability Amendment (Personal Responsibility) Act 2002
Civil Procedure Act 2005
Compensation to Relatives Act 1897CATEGORY: Principal judgment CASES CITED: Bonnington Castings Ltd v Wardlaw [1956] AC 613
Chappel v Hart [1998] HCA 55; (1998) 195 CLR 232
Desmond v Cullen [2001] NSWCA 238; (2001) 34 MVR 186
Dobler v Kenneth Halverson [2007] NSWCA 335
Fairchild v Glenhaven Funeral Services Ltd [2003] 1 AC 32
Halverson v Dobler [2006] NSWSC 1307
Rogers v Whitaker (1992) HCA 58; (1992) 175 CLR 479 at 483
Rosenberg v Percival [2001] HCA 18; (2001) 205 CLR 434
Rufo v Hosking [2004] NSWCA 391; (2005) 61 NSWLR 678
Seltsam Pty Limited v McGuiness and Another [2000] NSWCA 29; (2000) 49 NSWLR 262
Vairy v Wyong Shire Council [2005] HCA 62, (2005) 223 CLR
Ruddock v Taylor [2003] NSWCA 262; (2003) 58 NSWLR 269 at 286
Wyong Shire Council v Shirt (1980) 146 CLR 40PARTIES: Elizabeth Melchior - Plaintiff
Stephanie Melchior by her next friend Elizabeth Melchior - Plaintiff
Gerard Melchior by his next friend Elizabeth Melchior - Plaintiff
Hugh Melchior by his next friend Elizabeth Melchior - Plaintiff
Beverley Melchior - Plaintiff
Sydney Adventist Hospital - First Defendant
Doctor Scott Newman - Second DefendantFILE NUMBER(S): SC 20167/2007; 20168/2007; 20187/2007; 20188/2007; 20189/2007; 20318/2007 COUNSEL: Mr M Cranitch SC/Mr A Campbell - Plaintiffs
Ms J Sandford - 1st and 2nd DefendantsSOLICITORS: Gerard Malouf & Partners - Plaintiffs
Ebsworth & Ebsworth Lawyers - 1st Defendants
Sparke Helmore - 2nd Defendants
IN THE SUPREME COURT
OF NEW SOUTH WALES
COMMON LAW DIVISIONHOEBEN J
Tuesday 9 December 2008
JUDGMENT20167/07 – Elizabeth MELCHIOR v SYDNEY ADVENTIST HOSPITAL LTD & ANOR
20168/07 - Elizabeth MELCHIOR v SYDNEY ADVENTIST HOSPITAL LTD & ANOR
20187/07 - Stephanie MELCHIOR by her next friend Elizabeth MELCHIOR v SYDNEY ADVENTIST HOSPITAL LTD & ANOR
20188/07 - Gerard MELCHIOR by his next friend Elizabeth MELCHIOR v SYDNEY ADVENTIST HOSPITAL LTD & ANOR
20189/07 - Hugh MELCHIOR by his next friend Elizabeth MELCHIOR v SYDNEY ADVENTIST HOSPITAL LTD & ANOR
20318/07 - Beverley MELCHIOR v SYDNEY ADVENTIST HOSPITAL LTD & ANOR
1 HIS HONOUR:
- Nature of Proceedings
These proceedings have been brought by the widow, children and mother of the late Mark Melchior (the deceased) as a result of his death on 10 June 2004. There is a claim under the Compensation to Relatives Act 1897 and claims for nervous shock. It was agreed that liability should be decided as a separate issue.
2 The plaintiffs allege that the deceased died as a result of an operation which took place on 1 May 2004. The operation, which was Achilles tendon repair surgery, was carried out by Dr Newman, the second defendant, at the Sydney Adventist Hospital, which is the first defendant.
3 As against the first defendant, the plaintiffs relied upon the following particulars of negligence:
(a) Failing to administer Clexane.
(b) Failing to clarify the post-operative order and instructions for Clexane.
(d) Failing to provide a system whereby it was mandatory that all post-operative drug orders were written on the medication chart and that a patient could not be moved from one area to another before this was done.(c) Failing to ensure the prescription of Clexane was adequate to avoid the post-operative complication of DVT and fatal pulmonary embolus.
4 As against the second defendant, the plaintiffs relied upon the following particulars of negligence:
(a) Failing to prescribe Clexane on the medication chart when an order was written on the operation chart.
(b) Failing to ensure that the nursing staff administered Clexane post-operatively.
(d) Failing to provide proper and professional medical care to the deceased.(c) Failing to ensure that the prescription of Clexane was adequate to avoid the post-operative complication of DVT and fatal pulmonary embolus.
5 Clexane is an anti-coagulant or blood-thinning agent. It is one of a group of drugs described in the evidence as “low molecular weight Heparin” (LMWH).
6 In summary, the plaintiffs’ case against the defendants is that not only should they have prescribed Clexane post-operatively for the deceased but that they should have ensured that the dosage of Clexane was sufficient to have prevented or substantially reduced the chance of him developing a fatal pulmonary embolus. These are the allegations in the Amended Statement of Claim filed 28 October 2008.
Factual Background
7 Unless otherwise indicated, I find the facts to be as follows.
8 The deceased was born in August 1962 and was 41 at the time of his death. He married in December 1987 and had three children. He had a varied employment history, including a period of time in the Navy. At the time of his death he was running his own IT consulting company and was performing work for the New South Wales Department of Commerce at Parramatta.
9 His wife is a registered nurse and throughout the marriage worked either full time or part time in that occupation depending upon the demands of looking after the children. She described the deceased as an active person, but one who did not engage in any regular sporting activity. In 2004 he resumed playing soccer, but did not attend midweek training sessions. Apart from that activity, he did not engage in any active exercise and used to drive to work.
10 The plaintiff was six feet in height and his weight was estimated by the anaesthetist at 98 kgs. His wife described him as “a large man”. Exhibit A is a photograph of the plaintiff sitting down taken after the operation. Doctor Newman retained a recollection of the deceased and described him as follows:
- “He appeared to me to be a man of solid build. I didn’t get the impression he was obese but he looked otherwise healthy.” (T35.37)
- “My impression of Mr Melchior was that he was not obese. He was of a solid build, but assessing this gentleman lying in the bed and moving in the bed I did not get the impression of him being obese. To qualify as a medical risk factor, he would really need to be obese. That was not my impression.” (T.79.13)
The deceased answered “No” to the question whether he was overweight in the Patient History form which he completed at the hospital.
11 There was a suggestion in submissions that the deceased was obese or significantly overweight. I accept that the plaintiff may have been overweight and may have been somewhat unfit, but I reject the proposition that he was obese. That does not accord with Exhibit A and does not accord with the assessment by his wife, Dr Newman and by himself. I am not satisfied that the deceased’s size and weight amounted to an additional risk factor for the operation which he underwent.
12 The plaintiff suffered his injury on the afternoon of 1 May. His wife was present at the time. He was playing soccer when he collapsed. He was helped from the playing field and his wife drove him to the Adventist Hospital. His wife stayed with him in the emergency department for about 15 minutes and then left to look after the children.
13 Later that afternoon the deceased telephoned his wife and advised her that he had ruptured his right Achilles tendon and would be undergoing an operation. His wife returned to the hospital at approximately 7.30pm and stayed with him until about 10pm when she again had to leave in order to look after the children.
14 In the Patient History form the deceased answered “No” to the question whether he had experienced blood clots in the past. He indicated on that form that he lived with his wife and children. On the Patient Assessment form a nurse recorded that his wife would be his carer on discharge. From the forms completed by the deceased and by the nursing staff, there was nothing unusual in the deceased’s pre-operation medical history.
15 In 2004 Dr Newman was practising as an orthopaedic surgeon with a sub-speciality in foot and ankle surgery. He commenced this sub-specialist training (a four year course) in 1996. He commenced private practice in that speciality in October 2000. He had appointments as a VMO at a number of hospitals, including the Sydney Adventist Hospital. As of May 2004, there were three or four orthopaedic surgeons with that sub-speciality practising in Sydney.
16 Doctor Newman remembered seeing the deceased in the ward before the operation. On that occasion he examined the deceased and asked him whether he had any significant health problems or health issues. He also made inquiries as to whether or not he was a cigarette smoker, a diabetic and whether he had any problems with his kidneys or liver. In relation to the treatment of the deceased’s injury, the evidence of Dr Newman was:
- “I, well, I discussed with Mr Melchior the fact that these injuries can be treated non-surgically or surgically and we needed to decide whether we were going to take a non-surgical approach or a surgical approach. I described to him that patients in his, in a younger age group who are more likely to be active, tended to do better if they are treated surgically and I explained that surgically the tendon, the two tendon ends, can be brought together. And I indicated to him how this works by showing the two tendon ends by my fingers.
- Q. You are holding up your hands with the two index fingers apart?
A. To demonstrate when an Achilles tendon tears it separates and there is a gap. I explained if I were to treat him non-surgically we would not be closing that gap. However, by treating him non-surgically we would position his ankle in a cast that would partially close the gap. Some scar tissue would form between the two ends and the tendon would eventually become joined.
- Patients in an older age group manage quite well that way but patients in a younger age group have a risk of re-tearing the tendon because the tendon is just joined by scar tissue.
- Q. Can I just confirm with you is this information that you imparted to him in the conversation by the bedside?
A. That’s correct, and I do it for all the patients I see with this injury.
- Q. In terms of the options for management, did you discuss with him any particular issues associated with either option?
A. I did say to him that when you embark on surgical treatment for this injury like any operation, there are risks and there are risks associated with the anaesthetic, I didn’t go into that. I said that is something you could talk to the anaesthetist about, but also risks associated with the operation itself, and I listed those. And, as I always do, and it is my routine, I list the fact that he could get an infection, you could have wound healing problems, he could get a relatively unusual condition called reflex sympathetic dystrophy, I didn’t explain that in any great detail, and I did say to him also that he could develop a clot in the calf, but also that the risk of that wasn’t affected by operating or not operating, that is a risk.
- Q. When you say the risk in that respect is not affected by operating or not operating, what are you able to say you gave to him by way of information in that regard?
A. It is a risk of the injury, you sustain an Achilles tendon tear and there is a risk of developing a deep venous thrombosis afterward.
- Q. And that risk obtains irrespective of the form of management?
A. It’s not influenced by operating or not operating, it is influenced to a degree by splinting. If the patient was managed without any form of splintage one could assume the risk of deep venous thrombosis may be lessened, possibly lessened.
- Q. Did you proffer to him any recommendations in terms of the type of management that might be suitable for his particular circumstance?
A. I suggested to him that at the age of 42, and being somebody in good health, he is better managed surgically, operatively. I suggested that to him. He was certainly presented with the advantages and disadvantages of both options and he was quite clear that he wanted to pursue the surgical option.
- Q. In terms of ongoing management did you discuss what that would entail, or likely entail with him?
A. I did. I went through with him in some detail the period, the things that he would expect after the operation. I explained to him that he would be splinted for a period of six weeks initially with a temporary plaster and that’s one that is applied in the operation theatre and goes across the front of the leg, below the knee as far as the toes and it holds the ankle in a toe-down position to protect the tendon repair.
- …
- Q. I think you mentioned that the risks associated with surgery, being infection and wound healing, were matters you discussed with him. Did you raise any measures with him that might be taken in connection with those matters?
A. I did. I explained to him we would splint, intravenous antibiotics during the operation and then post-operatively during his time in hospital, which in his case would have represented one further dose of antibiotics and I did explain that we would be administering, I didn’t explain – no that’s all. It would have been the antibiotics only at that stage, yeah.
- Q. You also mentioned that you raised with him the possibility of a blood clot?
A. Uh-huh.
- Q. Did you discuss with him any matters or measures that might be taken in that respect?
A. I don’t recall in his particular instance, I don’t honestly recall.
- Q. Did you have a standard practice at that time in relation to measures in that regard for this type of surgery in this type of patient?
A. Yes. My standard practice was to ensure that all patients received a dose of Clexane. In other words thrombo-embolic phrophylaxis either intra-operatively or pre-operatively depending on the circumstances.” (T.36-40).
17 It was submitted that I should not accept Dr Newman as a witness of truth and that his evidence should be discounted. The only basis put forward for that submission was the alleged contradiction between Dr Newman’s stated belief that the medical literature did not recommend the administration of LMWH post-operatively for operations of this sort, and the fact that he had prescribed Clexane post-operatively for six weeks for a patient in 2007 who had undergone Achilles tendon repair surgery. I found Dr Newman’s explanation to be reasonable and understandable (T.97-98). I accept Dr Newman as a witness of truth and I believe he was doing his best to assist the Court.
18 The deceased signed the Consent to Medical or Surgical Treatment form in the presence of Dr Newman and the deceased’s signature was witnessed by him. That document set out in summary form some of the risks associated with any operation.
19 It was necessary for Dr Newman to perform other more urgent operations before he was able to operate on the deceased. The deceased’s operation took place at 11.38pm and concluded not long after midnight. The conduct of the operation was routine and no complications arose during it.
20 Following the operation, Dr Newman completed the operation record. On the Operation Chart under the heading “Post-operative Instructions”, Dr Newman wrote the following in an abbreviated form:
- “To elevate the foot, administer intravenous antibiotics overnight, the staff to perform distal observations on the record and Clexane.”
All that was written by way of specific medication instruction was the word “Clexane”. He did not make any entry in relation to Clexane on the Medication Chart.
21 Doctor Newman explained what he meant to achieve by writing “Clexane” as part of the post-operative instructions as follows:
- “A. In the case of a patient with a ruptured Achilles tendon, if I’m notified by a CMO in the emergency department about that type of patient, my routine instructions would be for that patient to be fasted in view of the fact that they will be going to the operating theatre for an operation most likely. I request that the limb be kept elevated. I usually don’t request any splintage for a case such as that. And, if there was going to be a significant delay in that patient getting to the operating theatre for whatever reason that night I would ask that the patient be administered a single dose of Clexane, 40 milligrams. (T.33.15)
- “A. For this particular patient I can’t recall but given that I was working on the assumption that he had already had a dose of Clexane in the emergency department a few hours before, I would not have been thinking that he needed to have Clexane within the next few hours and any documentation of Clexane that I would have been making on the operation record or in the medication chart, would have been applying to a dose to be given 24 hours after the first dose.
- Q. Can you explain what informed that rationale for treatment?
A. It’s a routine that Clexane be given once a day, usually at the same time. Its half life is 24 hours.
- Q. In this type of presentation and in Mr Melchior’s case what is the duration for which the treatment is ordered by yourself?
A. A single dose, a single dose.
- Q. How frequently?
A. Given once a day. So the single dose that I anticipated that he would have received in the emergency department would have been adequate. However, in writing, in writing Clexane on the operation record, and I don’t recall this, but the only interpretation I can give of having written it there was to cover the base of if maybe, if he stayed for longer than 24 hours, so if he was still in the hospital in 24 hours after he received the first dose, then that dose of Clexane would have been relevant for him.
- Q. So it is for the duration of the stay in hospital?
A. It is the duration of the stay in hospital.
- Q. And post-operatively, as in post discharge I should say?
A. No.” (T.41-42)
22 Doctor Newman made no inquiries, either before or after the operation as to whether the deceased had in fact been given Clexane before the operation. He made no inquiries after the operation as to whether Clexane had been administered after the operation. He made no inquiries as to what steps, if any, had been taken by the Hospital staff in relation to his writing of the word “Clexane” under the heading “Post-operative Instructions” on the operation chart. There is nothing in the hospital notes which would indicate that the deceased was administered a dose of Clexane, either before or after the operation. I am satisfied that the deceased was not administered a dose of Clexane either before or after the operation nor at any time while he was at the hospital.
23 In relation to the medication chart, Dr Newman’s evidence was:
- “Q. In relation to the order for Clexane that you had entered up on the operation chart, did you enter that up on the medication chart?
A. I didn’t.
- Q. Is there some reason for that?
A. It was an oversight on my part.” (T.45)
It was common ground that directions for the administration of medication by an operating surgeon should be placed on the Medication Chart.
24 Doctor Newman saw the deceased on the morning following the operation and observed no abnormality at the operation site. That morning the deceased’s wife visited him at 10.30am. The deceased was in bed with his right leg elevated. Affixed to the right foot and calf were a back slab and a bandage. The deceased was discharged at 2pm on crutches. He was directed not to place any weight on his right leg. The back slab held the foot in a fixed position with the toes pointing downwards.
25 The deceased remained at home for a couple of days and then resumed work. The sleeping arrangements had been changed so that it was not necessary for the deceased to use the stairs. The deceased was not able to drive to work. His wife used to drive him to a friend’s place at Cherrybrook and that friend would then drive him to work at Parramatta. The same procedure in reverse order was followed when he returned home at the end of the day. He was able to perform his work because it was a sedentary job.
26 Matters continued in that way until 18 May 2004 when the deceased and his wife attended Dr Newman in his rooms at the hospital. Doctor Newman inspected the operation site and removed the stitches. The back slab was removed and a fibreglass cast was attached to the deceased’s right foot and calf. Thereafter the deceased achieved mobility by using Canadian crutches. At the time the deceased rarely went shopping or engaged in activities of that kind. He did attend a soccer game where his son was playing but most of the time when he was not at work, he remained at home with his leg elevated.
27 On 27 May the deceased’s wife awoke to cries for help from him. When she went downstairs to his bedroom, she found him collapsed on the floor complaining of a bad pain in his stomach. He was semi-conscious at the time and shortly afterwards lost consciousness. He was taken by ambulance to the Sydney Adventist Hospital and placed on life support. He died on 10 June 2004 without regaining consciousness.
28 Doctor Newman was asked why he had only contemplated administering one dose of Clexane post-operatively while the deceased was in hospital. He responded:
- “A. I had no standard recommendations for that because I believe there is no evidence that that makes a difference to a patient’s risk of developing thrombo-embolic disease and to do so was also working outside of the guidelines and representations for thrombo-embolic phrophylaxis as available at the time.
- Q. Which particular guidelines do you say informed your approach to practice in May 2004?
A. I’m exposed to a number of guidelines and every year I received guidelines from the hospitals I work at, in particular Westmead Hospital, also as well the Sydney Adventist Hospital. There are guidelines published in the journals which I routinely receive and there is a guideline that is a document put together by the Australian and New Zealand working group on thrombo-embolic phrophylaxis in surgery which is mailed to all MDA national members on an annual basis. It is a little, small document, but it has all the recommended guidelines as far as thrombo-embolic phrophylaxis is concerned. So I put all those together when I make a decision about the administration of that medication.” (T.42.21)
29 On the same topic he said:
- “Q. You have also mentioned some other guidelines and what were they specifically?
A. These are guidelines that are produced by Westmead Hospital, the Sydney Adventist Hospital’s Orthopaedic Surgical Department. I am also exposed to discussions of this topic at scientific conferences, in particular the Australian Orthopaedic Foot and Ankle Society conference which I attend every year and it is almost every year there is some discussion on this topic and it is a hot topic for discussion in orthopaedic surgery circles in general. So this is, you know, the commonly discussed issue, hence there are a number of guidelines available.
- Q. Did you see any necessity to prescribe Clexane post-operatively after discharge?
A. No.
- Q. Why not?
A. Because Mr Melchior didn’t demonstrate any significant risk factors that weren’t, would cause me to feel that it was necessary to have him administered any more than just a single dose of Clexane. He was having minor surgery and it was a relatively minor injury and under the circumstances of his presentation there were no factors specifically about Mr Melchior which made me concerned that he was anything more than a low risk patient for a thrombosis, for a DVT.” (T.44.20)
30 Doctor Newman was cross-examined on this topic.
- “Q. There was literature around you say that suggests that one dose either pre or intraoperatively would reduce the incident of DVT, is that correct?
A. The literature was extremely vague on this. One distinguishing - the literature did not distinguish between one or ten or 20 doses. It was very vague on whether it made a difference.
- Q. What literature are we referring to, Doctor, you must surely know? What was the research study that you relied upon at that time?
A. There is an article which appears in 2001 in the Journal Chest, which is a publication of the - an American publication of chest physicians, which is probably the best of all the bodies that look at this particular issue. It is a medical analysis of research available at the time, 2001.” (T.48.24)
31 In response to Dr Newman’s evidence that the medical literature that he was aware of made no recommendation as to the length of time that Clexane should be administered, it was suggested to him that he should have consulted the Monthly Index of Medical Specialities (MIMS). Doctor Newman said that he never consulted MIMS:
- “I didn’t wish to consult the MIMS because I didn’t believe that the MIMS was the most appropriate scientific document. When I’m looking for the best evidence, I look to the best published available literature. That’s why I would go to an article such as the one we have just recently discussed by Geerts, the 2001 issue was the one available in 2004. I would go to other scientific literature, or I would go to the Australian New Zealand Working Group Guidelines, because they are the most eminent and almost certainly the most independent available recommendations on the subject. I wouldn’t regard MIMS as being an independent scientific document, it is put together by drug companies.” (T.77.42)
32 Inquiries were made by both sides as to the availability of hospital guidelines which were in use in May 2004. The second edition of the “Australian and New Zealand Working Party Guidelines for the Prevention of Venous Thromboembolism” was produced, as was the Chest journal article of 2001 referred to in the evidence. The guidelines produced by Westmead Hospital and the Sydney Adventist Hospital in 2004 could not be located and were not available. One document which was produced was the 2004 guidelines of the Sydney West Area Health Service. Doctor Newman was cross-examined as to the content of part of that document. Regrettably, the document was not tendered so that it has not been possible for me to form any opinion as to the recommendations contained therein and their relevance to this kind of operation.
Expert Evidence
33 Five medical experts gave evidence. Their evidence was given in reports, a document entitled “Joint Conference of Expert Witnesses – Memorandum” which recorded comments made by the experts on 27 October 2008 and orally by way of concurrent evidence on 12 November 2008, the fourth day of the hearing.
34 The plaintiffs called Drs Benson and Conrad. Doctor Benson is a physician and a specialist in cardiac and intensive care medicine. At the present time he is a clinical medical perfusionist in the Cardiac Unit at St Vincents Hospital. He is a senior lecturer in these specialities at the University of NSW.
35 Doctor Conrad is a general surgeon, who practises in Macquarie Street and at Penrith. He has a particular interest in phlebology. Until 2004 he was providing surgical services at the Nepean Hospital. He is now a consultant surgeon at that hospital.
36 The defendants called Dr Martin Sullivan, Dr Michael McGrath and Professor John Fletcher. Doctor Sullivan is an orthopaedic surgeon whose speciality is foot and ankle surgery. He has practised in that speciality since 1994 when he was made a clinical fellow. He is a consultant foot and ankle surgeon in the Department of Orthopaedic Surgery at St Vincents Private Hospital and the director of the Foot and Ankle Clinic at the Royal North Shore Private Hospital. He is on the Editorial Board of the international journal, New Techniques in Foot and Ankle Surgery.
37 Doctor McGrath is a consultant physician in vascular medicine. He presently holds that position at St Vincents Hospital, the Mater Miseracordiae Hospital, the New Children’s Hospital Westmead and the War Memorial Hospital at Waverley. He is a senior lecturer in that speciality at the University of NSW.
38 Professor Fletcher is a professor of surgery at the University of Sydney and is the Director of Vascular Surgery at Westmead Hospital and for the Sydney Area West Health Service.
39 The plaintiffs submitted that I should discount the evidence of Dr Sullivan on the basis that he was an advocate for the defendants and that he was not attempting to assist the Court as an expert should. I reject that submission. I found that all the medical experts attempted to genuinely explore the issues and to provide the Court with assistance to the best of their ability. I found that the way in which the issues were dealt with by them demonstrated a high level of objectivity on their part. The fact that the medical experts disagreed on critical issues was not due to anything other than a genuine difference of opinion about the appropriate conclusions to be drawn from either their own experience or the medical literature.
40 In order to better understand the opinions of the medical experts, it is necessary to appreciate the mechanism whereby a Deep Venous Thrombosis (DVT) or a Venous Thromboembolism (VTE) develops. This was usefully explained by Dr McGrath as follows:
- “What - what the expected or the understood process is that a clot would have formed within the veins of the lower extremity and the - the particular limb that was traumatised underwent surgery, that the clot propagated into a more proximal larger vein and that clot passed into the circulation, to the lung circulation and caused the patient's - caused the complication. Clot - we don't attribute a lot of value, if you like, to the - to the - to clots adding to the clot that is within the type of disorder. “ (T.153.15)
41 One matter which did emerge early in the giving of the concurrent evidence was that the medical experts called by the defendants were more experienced and knowledgeable in the areas under discussion than those called on behalf of the plaintiffs. Doctor Benson, although an experienced physician in intensive care and cardiac matters, did not have direct experience in the matters directly under discussion. He could assist on general surgical issues and in relation to his reading of the literature, but he lacked hands-on experience with the particular issues raised by this case.
42 Similarly, Dr Conrad had the wide knowledge which one would expect from a general surgeon with such extensive experience, but he had not carried out an Achilles tendon repair for over 30 years and then only a small number of cases in an emergency situation. It was apparent that his contribution to the discussion between the medical experts came from his recent reading of the medical literature on Pulmonary Emboli (PE), Venous Thromboembolism ((VTE) and Deep Venous Thrombosis (DVT)).
43 By contrast, Dr Sullivan because of his speciality was dealing with these problems on an almost daily basis. He was the only expert who regularly performed this kind of operation. The position was similar with Professor Fletcher and Dr McGrath in that although they were not foot and ankle surgeons, they were confronting vascular problems and dealing with them on a daily basis, as well as contributing to medical knowledge on these subjects by their articles and by their participation in conferences specifically directed to this subject.
44 The contrast between the levels of knowledge of the experts was starkly demonstrated on the issue of whether it was correct to draw a distinction between lower limb injuries generally such as injuries to the knee and hip, and isolated below knee injuries such as to the foot and ankle. Doctor Conrad did not recognise such a distinction. He justified his approach by reference to the studies which related to hip and knee injuries and which recognised that such injuries gave rise to a high risk of VTE and DVT. Because patients with foot and ankle injuries were unable to move the ankle and consequently activate the “calf muscle pump” he considered that such patients were just as much at risk of developing VTE and DVT as those with knee and hip injuries. He could see no reason why the findings in relation to hip and knee injuries could not be extrapolated to injuries involving the ankle and foot (T.105). In that regard there were many studies relating to hip and knee surgery but comparatively few relating to foot and ankle surgery.
45 The fallacy in that approach was demonstrated by Dr Sullivan’s response:
So the true incidence of a clot forming after this type of surgery is much less, it is of the order of half to 1 per cent. Whereas if you are a hip or knee surgeon it is almost a given that if you have a knee replacement and you have no prophylaxis that you will develop a blood clot, a significant blood clot.” (T.106.43)“The literature would suggest that the incidence of forming a clot after this type of surgery is nothing like the incidence of clot formation after a hip or knee replacement and there are anatomical reasons for that. As you go from the heart and travel distally towards the limbs, the vessels, both arterial and venous, get smaller. So when you get to the extremity the veins in the arteries are much smaller. So if the clot forms in the vein in the foot or the ankle it is going to be much smaller than a clot that forms in the knee or the hip, because the veins are a lot bigger and those larger clots, if they dislodge, are more likely to cause problems.
Doctor McGrath commented to similar effect (T.107.29).
46 Professor Fletcher justified the distinction as follows:
- “Now, for hip and knee surgery, a much more extensive operation, the duration of the surgery is much longer than for instance repairing an Achilles tendon and there is much more damage done to the associated veins, the large veins up around the hip and around the knee. So if a clot does occur it is much more likely to be a significant clot affecting a major vein which could more likely give rise to a significant pulmonary embolus with that clot breaking off. So for an injury requiring surgery in the lower leg and foot the veins are smaller and the overall incidence of a major clot is very much less than with hip and knee surgery. So that is my sort of, they are my reasons for drawing the distinction between risk with hip and knee surgery versus lower limb and ankle and foot surgery.” (T.109.16)
47 I find that insofar as the risk of developing DVT, VTE or PE is concerned, there is a real distinction between hip and knee surgery and that involving the foot and ankle in that the risk is much lower with foot and ankle surgery.
48 The medical experts were unanimous in their opinion that if it were the intention of Dr Newman that a dose of Clexane be given to the deceased post-operatively, it was insufficient for him to simply write the word “Clexane” on the operation chart. As the treating surgeon it was his responsibility to specify the dosage of Clexane and to indicate over what period it should be given. It was his responsibility to ensure, either directly or indirectly, that his directions as to the administration of Clexane were complied with and that the drug was administered to the patient in accordance with that direction. It was the opinion of the medical experts that Dr Newman’s conduct was deficient in that regard.
49 The medical experts also agreed that there had been a failure on the part of the hospital in that there had been no follow up to the entry on the operation chart concerning the administration of Clexane. There should have been a protocol in place in the hospital in relation to such situations so that an explanation would be sought from the treating surgeon as to exactly when and what medication was to be administered to a patient.
50 The medical experts were divided on the question of whether in May 2004 it would have been standard practice for a surgeon performing an Achilles tendon repair to prescribe Clexane or another LMWH by way of prophylaxis to reduce the chance of a DVT or VTE developing. Doctor Benson was unable to comment because this was outside his area of expertise. Doctor Conrad was of the opinion that it was standard practice. He based that on anecdotal evidence and on his own practice of prescribing LMWH after an operation while the patient was in hospital and after discharge for a total of 10 days.
51 The defendants’ medical experts disagreed. Doctor Sullivan said:
- “I think amongst surgeons who are dealing exclusively in this area it wasn't standard practice in 2004 to give Clexane, that is based obviously on a regular practice. I'm dealing with other ankle surgeons attending meetings, both here and overseas, and the literature also in this area, particularly the sort of multi centre surveys of surgeons who are dealing with this on a daily basis who suggest that it is quite the opposite. The majority of surgeons weren't giving prophylaxis in 2004.” (T.107.18-24)
52 Doctor McGrath expressed the same opinion (T.108.47). Professor Fletcher said:
- “The standard practice would be to not use pharmacological prophylaxis, that is with Clexane, because the risk of preventing DVT against the risk of bleeding with your agent always has to be weighed up with individual cases and certainly for this category of injury and the surgery, we would not have recommended routine Clexane prophylaxis.” (T.109.38)
53 Implicit in Dr Conrad’s opinion on this issue was his belief that it was not valid to distinguish between knee and hip surgery and isolated below knee surgery. The defendants’ medical experts justified their opinions by reference to the medical literature and by reference to the risks associated with the administration of LMWH. These risk were an allergic reaction to Heparin and unexpected haemorrhage. There was also a well known but lesser risk of Heparin induced DVT known as thrombocytopaenia.
54 The defendants’ medical experts did not consider that there were any additional DVT/VTE risk factors associated with the deceased undergoing the operation. In that regard they did not regard his age or weight as significant and they had regard to the answers which he had given on his patient history form, particularly his negative answer to whether he had experienced blood clots in the past. The risk associated with lower limb immobilisation was intrinsic to the operation and was balanced by the mobilisation of the deceased on crutches after his discharge.
55 There was debate amongst the medical experts as to the significance of the risks associated with the administration of LMWH as a phrophylaxis. Doctor Benson accepted that haemorrhage was a real risk but was of the opinion that it was not life threatening, especially in the foot and ankle. On the other hand, he thought the risk of a fatal PE, although 1 in 4,500, was still sufficiently real as a matter of general practice to justify the giving of LMWH as a phrophylaxis in this sort of operation (T.110.11).
56 Doctor McGrath did not agree. He pointed out that the risk of a major haemorrhage occurring with the administration of LMWH was 2%, so that with a group of 4,500 individuals there was a potential for 90 patients to suffer a major haemorrhage if they were prescribed LMWH as a phrophylaxis (T.112.10). That had to be balanced against the risk of 1 patient in 4,500 developing a fatal PE. On this issue he said:
- “I want to just reflect back on the risk that we, as clinicians, need to assess when we are looking after our patients. We come back to the anticoagulant use in as DVT prophylaxis we have to keep in mind, inform the patient that if we going to use that, there is at least a 2 per cent risk of major haemorrhage and in 4,500 patients that would be translated to 90 patients. So for each pulmonary embolism we may prevent we may exchange that for 90 cases of major haemorrhage. That is our dilemma with every patient we see, we look after and it is our responsibility then to make a judgment call and I think it comes down to clinician's responsibility to utilise the literature in that way but to look at the patient.” (T.165.36)
57 Professor Fletcher expressed a similar opinion:
- “Just following on from Dr McGrath. If there was an agent we could give that had no risk at all we would give prophylaxis to everybody. But the reality is not that and we do have to weigh up that risk benefit with the approach of Dr McGrath.” (T.165.49)
58 Doctor McGrath explained that the risk of haemorrhage was not restricted to the operation site and that haemorrhage caused in this way was difficult to treat:
- “I just wanted to extend our understanding of haemorrhage here. We are not looking just simply at local haemorrhage but we are looking at haemorrhage involving major organs, major viscera and with anticoagulation we have to anticipate the possibility of haemorrhage in other areas such as the brain, the gastrointestinal tract and retroperitoneal area. We have restricted our understanding of haemorrhage in this situation to the ankle but as a physician I am often involved in caring for patients who have suffered haemorrhage in other regions of the body that are truly life threatening.” (T.117.10)
- “… our ability to reverse the anticoagulant effect of low molecular weight Heparin is compromised, is restricted. We do not have a specific antidote that will normalise the coagulation disturbance. We are probably able to reverse the effect of the low molecular weight Heparin by about 60 per cent with Protamaine but not a hundred per cent.” (T.119.25)
59 I am satisfied that the risk of a haemorrhage or an allergic reaction with the use of LMWH as a phrophylaxis was a real and significant one which had to be taken into account by a surgeon considering the prescription of LMWH as a thromboprophylactic in May 2004.
60 There was no agreement between the experts on what dose of Clexane/LWMH should have been prescribed for the deceased (if it were appropriate to do so) and what effect such a dose would have had on the PE which eventually brought about the deceased’s death.
61 Doctor Conrad relied upon the recommendations of Aventis, the distributors of Clexane, and on the recommendations in the MIMS publication. In the 2004 volume of MIMS the recommendation in the case of high risk and moderate risk patients was for prophylaxis to be continued for 7-10 days or until the risk of thromboembolism had diminished. Doctor Conrad considered the deceased to be a moderate to high-risk patient.
62 Doctor Benson agreed that 7-10 days was a standard type of time for giving Clexane. He said:
- “I feel the overriding principle is the prophylaxis should be given for the duration of risk and I accept that in the literature at the time, particularly in MIMS, it said seven to ten days. I note that MIMS can be regarded as not much of a journal however it is the licencing documentation that a company goes through to get its licence for that drug that goes into MIMS. So it is based on reputable study to get that far.” (T.121.38)
63 The defendants’ medical experts assessed the deceased as a low risk patient. In reaching that conclusion they took into account the nature of the operation, the fact that the incidence of DVT or VTE was much less frequent in patients with foot and ankle surgery than those having hip or knee surgery and that there were no additional risk factors in his background or health which would predispose him to the development of DVT, VTE or PE.
64 In relation to the recommendation that Clexane as a prophylaxis should be administered for 7-10 days, Dr McGrath said:
- “There is some basis of logic in recommending a seven to 10 day period of prophylaxis after a single traumatic event, be it mechanical or surgical. That is we know from basic medical and physiological studies that the acute phase response of the body, the body's fight or flight if you like, response is active for a period of seven to 10 days after trauma. This acute phase response includes such things as an outpouring of platelets, an outpouring of plasma clotting factors including Fibrinogen and other clotting factors. And when we follow patients after surgery and monitor these factors you find that it peaks in that period of seven to 10 days. So there is some logic in using pharmacological and other forms of prophylaxis in that period of time because you are covering the normal acute phase of response of the body to trauma which is a sort of a function of the host to an injury. It is expected in all circumstances of trauma. “ (T.122.16)
65 Professor Fletcher pointed out that a lot of the studies in the literature, which used the 7-10 day period, came from a time when patients tended to stay in hospital longer. He noted that there were practical difficulties in continuing prophylaxis outside of hospital. It was common ground that had Clexane been administered outside the hospital, it would have involved a self-administered daily injection into the abdomen.
66 Doctor Sullivan did not administer Clexane in every operation which he performed. In the case of an Achilles rupture surgery he did routinely use Clexane while the patient was in hospital. Whether Clexane was to be administered after discharge from hospital was a matter to be discussed with the individual patient and depended upon the specific risk factors associated with that patient. Part of the discussion would routinely involve him advising the patient that by giving Clexane the risk of a pulmonary embolus may not be reduced and that there were dangers associated with its use. (T.126-128)
67 In the course of giving this evidence Dr Sullivan drew a distinction between the risk of DVT, VTE and the risk of a fatal PE. It was his opinion based on recent medical literature that while Clexane might reduce the risk of developing DVT and VTE there was no evidence that it reduced the risk of a fatal PE. Doctor Sullivan said:
- “At the moment pretty much coming from the literature, coming from the hip and knee surgery data where, after a long period of time, routine use of prophylaxis has not reduced the incidence of fatal pulmonary embolism. And the trend at the moment amongst hip and knee surgeons who I work with on a regular basis in the clinic is to move away from prophylaxis for this type of surgery because over the last five or six years they have not actually reduced the incidence of fatal pulmonary embolus by giving prophylaxis. So the trend amongst all the hip and knee surgeons around the world, particularly the US, in the last 18 months has been whilst they may reduce the incidence of clots in the leg they have not actually changed the incidence of people dying after hip and knee replacements of pulmonary embolus.” (T.129.39)
68 Doctor Sullivan set out the difficulties associated with the prescribing LMWH as follows:
- “The problem we have in practice is that you are offering patients this treatment knowing that you may reduce the incidence of a clot, but you also know that the patient can still die from a massive pulmonary embolus despite the use of this drug and at the same time you are exposing them to the risks of the drug. And it is not black and white, it is a very difficult problem. Certainly my practice is to include them in the decision-making process, giving them all the knowledge that I am aware of at the time. And it is a fluid situation. It can change from year to year.” (T.134.01)
69 In relation to dosage, the conclusion which Dr McGrath reached in the case of the usual patient, who would be otherwise immobile, was that one would not take the anti-coagulant treatment beyond the period of hospitalisation. In the case of the deceased Dr McGrath thought there would be some value in a single dose of Clexane to cover his period of immobility whilst in hospital.
- “If it covers a period of immobility a period of perioperative immobility, hospitalisation and thereby confined to bed, that would be, I believe that there is some validity in prescribing that for that circumstance.” (T.138.37)
70 Doctor Sullivan was of the opinion that administering one or two doses of Clexane after an operation while the person was in hospital would have no benefit. His rationale for that conclusion, however, seemed to be based on his doubts as to the beneficial effect of Clexane generally and on the inconclusiveness of the limited number of studies which had been carried out:
- “The answer, the difficulty is your Honour we don't know. If you look at the study that was published recently where they actually, it was a level 1 study, they took group double blind, gave them Clexane for six weeks after the surgery, gave the other group nothing and then they scanned them at three weeks and scanned them at six weeks and the incidence of clot formation was the same in both groups. And this is as recent as in the last twelve months. So this is the difficulty, there were no pulmonary emboli but here you have a group of people given Clexane for six weeks and I think the barrister was trying to indicate why we give it for seven days or ten days, but here is a group of people who got it for the whole six weeks and the incidences of clot formation was no different to the group that got nothing. The problem in practice, we have to make a decision, we still don't have a consensus on what is appropriate.” (T.140.43)
71 In relation to causation, all of the medical experts agreed that the administration of one or two doses of Clexane at the time of the operation and immediately following it would not have prevented the occurrence of the fatal PE 27 days later.
72 As to the effect of the administration of Clexane for 7-10 days following the operation, there was a significant difference of opinion. The final position reached by Dr Conrad was that the administration of Clexane to the deceased for 7-10 days post-operatively would possibly have prevented the development of a fatal PE. In that regard he said that the likelihood was somewhere between a possibility and a probability. Had Clexane been administered for 30 days post-operatively, he thought that the fatal PE would more probably than not have been prevented.
73 Doctor Benson was of the opinion that on general principles the administration of Clexane to the deceased for 7-10 days could have possibly changed the outcome and prevented the PE. He thought it would certainly have provided more protection than if the deceased had one or two doses.
74 Doctor Sullivan said that he did not believe that 7-10 days of Clexane could have prevented a fatal PE in the case of the deceased.
75 Doctor McGrath adhered to what he said in his report of 29 January 2008 that “prophylaxis for a one to two week period would possibly have prevented the pulmonary embolism”. He thought that prophylaxis for one month would probably have prevented it. In his oral evidence, Dr McGrath added the following additional comment:
- “I just want to emphasise the tragic and unexpected complication in this case was the massive pulmonary embolism 27 days after his trauma and surgery. That would have been a very strong prompt for us to look for another cause.”
- “Q. Doctor, I take it that the reason why you say that it was 27 days after you want to look for other causes as a possibility in the occurrence, is that correct?
- WITNESS McGRATH: That's correct, your Honour. Our experience is if - if thrombosis or venous thromboembolism is going to occur after a trauma or surgery, it's most likely going to occur within the first two weeks. If it occurs beyond that time, our experience is that there is likely - there is likely to have been other contributing factors. “ (T.152.4)
76 Professor Fletcher was of the opinion that a 7-10 day course of Clexane in the case of the deceased was very unlikely to have prevented the fatal pulmonary embolism.
77 Professor Fletcher was asked questions about a genetic predisposition to develop DVT, known as the homozygous V Leiden gene. Approximately 1-2% of the population has that gene which produces a strong predisposition to developing DVT. There was no effective way of determining whether a patient had that gene, except that there was generally a previous history of DVT occurring at an early age, or a very strong family history.
The medical literature
78 The medical literature was relevant to two issues. That which predated May 2004 was relevant to the content of the duty of care and breach. It complemented the opinions of the experts as to whether, and if so in what quantities, LMWH such as Clexane should have been administered to the deceased. All of the medical literature was relevant to the question of causation and in particular whether a failure to administer 7-10 days of treatment with Clexane following the operation made a material contribution to the development of a fatal PE in the deceased.
79 It was agreed by the medical experts that the most authoritative study which existed in May 2004, was in the journal, Chest of that year (exhibit 3, tab 4). It summarised the findings of the seventh American College of Chest Physicians conference on anti-thrombotic and thrombolytic therapy. The study’s importance was that its authors (Geerts and others) reviewed all of the medical literature on the topic up to that time when making their recommendations. Part 3.7 dealt with “isolated lower extremity injuries”.
80 The first point made was:
- “The epidemiology and prevention of VTE after lower extremity injuries have, unfortunately, been poorly studied.”
The risk factors identified by previous studies were:
- “The risk factors for VTE following isolated lower extremity injury include advanced age, presence of fractures rather than soft tissue injuries alone, and obesity. It is not clear whether operative repair itself is a risk factor. The risk of DVT appears to increase with the proximity of the fracture to the knee …”
81 Having reviewed the earlier studies, the conclusion in Chest was as follows:
- “Patients with below-knee injuries have a ten to forty per cent risk of asymptomatic DVT. Prophylaxis with LMWH reduces the frequency of asymptomatic DVT, particularly in those with tendon ruptures. The use of thrombo prophylaxis usually with LMWH, is considered to be a standard of care in some European countries. However, we do not believe that routine thrombo prophylaxis in patients with isolated lower extremity injuries can be recommended, since it is uncertain whether prophylaxis similarly reduces a risk of clinically important VTE, or is cost effective. Pending further data, clinicians may choose to provide no prophylaxis, in-hospital prophylaxis, or prophylaxis that is continued after hospital discharge. We are also unable to generate evidence-based recommendations to help clinicians decide which patients, if any, might benefit from prophylaxis or the type, dose or duration of prophylaxis.”
82 The recommendation made by Chest was:
- “We suggest that clinicians NOT use thrombo prophylaxis routinely in patients with isolated lower extremity injuries (grade 2A).”
83 Doctor Conrad was of the opinion that this paragraph contained an internal contradiction. I do not agree. The distinction which the paragraph is drawing is between asymptomatic DVT and clinically important VTE. It is, of course, the latter which has the potential for serious harm. I am also of the opinion that Dr Conrad misinterpreted the classification “grade 2A” which followed the recommendation. He interpreted it as indicating the existence of a medium risk. It is apparent from the article that the classification indicates the reliability of the studies which support the recommendation. This was explained by Professor Fletcher:
“If I could clarify, as I see it as interpreting the grade A, B and C is based on the level of evidence, so a recommendation that grade A comes from randomised control studies, at least two or more, that are agreed in their results. So that is the highest level of scientific evidence and that is then apportioned a grade A registration.
Grade B comes from randomised control trials that may only be one or come from different categories of surgery or patients and you can extrapolate from different categories.
Grade C recommendations comes from studies that are not randomised control trial, for instance the one which we were discussing earlier was a grade C from lower level of evidence.
So, a 1 A recommendation comes from the strongest scientific evidence which is supported by the whole panel down to a 3 C which would carry much less weight.” (T.144.48)Then the assigning of 1, 2 or 3 with the Chest guidelines comes from a collective opinion based on clinical experience and judgment from the overall panel.
84 Apart from the Chest analysis there was only a limited number of other articles discussing DVT, VTE and PE as complications in foot and ankle surgery.
85 One of the studies (Mizel and others) was entitled “Thromboembolism After Foot and Ankle Surgery” (exhibit 3, tab 1). This article was published in 1998 in “Clinical Orthopaedics and Related Research”. The study stated that for routine prophylaxis to take place in this low risk surgical population, the cost would be substantial. The article concluded:
- “Low dose adjusted Warfarin, designed to keep the prothrombin level at approximately 1.5 times the normal level, has been found to decrease the incidence of thrombo-embolic disease. However, a 0.57% to 0.75% incidence of non-fatal pulmonary emboli remains. Complications remain with this, including an increased incidence of severe post-operative bleeding (1.5% to 4%), and guaiac positive stools, hematuria, epistaxis, skin ecchymosis, hypermenorrhea and hemophtysis. If the entire cohort had received this anti-coagulation, between 41 (1.5%) and 109 (4%) complications could have been expected. Given the low incidence of deep vein thrombosis after foot and ankle surgery and the cost and potential complications involved, the authors of this study think that the risks and costs of thrombo-embolic prophylaxis and screening are not justified for the small gain that may accrue.”
86 The only article which included Australian patients was by Saxby and another (Terrence Saxby was a foot and ankle surgeon practising in Brisbane). This article “Incidence of DVT Following Surgery of the Foot and Ankle” (exhibit 3, tab 2) was published in 2002 in the journal “Foot and Ankle International”.
87 The study was a prospective evaluation of all patients undergoing surgery of the foot and ankle without any DVT prophylaxis. The conclusion of the authors was:
- “In this study, the risk factors found to be associated with DVT formation following foot and ankle surgery were: hind foot surgery with or without immobilisation, increasing age and tourniquet time. Factors found associated with occlusive DVT following foot and ankle surgery were: hind foot surgery with or without immobilisation and increased BMI (body mass index). Age was not found to be associated with occlusive DVT, and BMI was not found to be associated with overall DVT formation, only occlusive DVT. A similar study with larger numbers of patients in the various groups would give more power to the study.
- This study shows that:
- 1. DVT following foot and ankle surgery is rare, but more prevalent than previously suggested.
2. They are mostly asymptomatic, and
3. They do not progress proximally.
- Based on these findings and review of the literature the authors agree with Mizel et al that routine DVT prophylaxis is not indicated in patients undergoing foot and ankle surgery. Even in higher risk patients (hind foot surgery, obese, elderly or increased tourniquet time) the lack of clot progression or symptoms would lead us to believe that prophylaxis is not indicated routinely in these patients.”
88 The second edition of the Australian and New Zealand Working Party Guidelines for the Prevention of Venous Thromboembolism of 2001 provides little assistance. It is expressed in very general terms and does not specifically refer to foot and ankle surgery. Its specific recommendations related to high risk orthopaedic patients, such as those undergoing surgery for hip and knee injuries.
89 On the causation question, more recent studies and research have not greatly assisted. One of the problems is that there have been no studies of symptomatic pulmonary emboli and fatal pulmonary emboli risks in relation to foot and ankle surgery.
90 A 2007 study by Mayle and others entitled “Concepts Review: Venous Thrombo-embolism Disease in Foot and Ankle Surgery” (exhibit 3, tab 7) was published in Foot and Ankle International. The authors concluded in their review of the literature that venous thrombo-embolic disease was less frequent in patients of foot and ankle surgery than those who had hip or knee procedures. They stated that because of the limited number of scientifically valid studies available and the wide range of reported frequencies of venous thrombosis after foot and ankle trauma and surgery, no definite conclusions could be made concerning the risk of DVT or the use prophylactic anti-coagulation.
- “The incidence of fatal pulmonary embolism is not as well established in foot and ankle surgery as in arthroplasty or trauma, and the overall incidence of asymptomatic DVT also remains elusive.”
91 Doctor Sullivan in his report of 14 October 2008 summarised the findings of a 2008 symposium on this subject:
- “At the recent American Academy of Orthopaedic Surgeons meeting in San Francisco in 2008 a symposium on the speciality day of the American Orthopaedic Foot and Ankle Society concluded that there was no evidence in the literature to suggest that Clexane would reduce the incidence of sudden death from pulmonary embolus. It was recommended that further prospective research be performed. The symposium acknowledged the morbidity associated with deep vein thrombosis in foot and ankle surgery and concluded that at present there is no evidence in the foot and ankle literature to support that Clexane can reduce the incidence of sudden death from pulmonary embolus.”
It was never suggested that Dr Sullivan had wrongly summarised the findings of the symposium.
92 The 2008 edition of Chest at p 417S (exhibit 3, tab 9) summarised its conclusions in the same terms as the 2004 edition [81-82] and made the same recommendation with the same grade 2A classification.
93 A 2008 study by Sharrock and others – “Potent Anticoagulants are Associated with Higher All - Cause Mortality Rate after Hip and Knee Arthroplasty” in the journal Clinical Orthopaedics and Related Research (exhibit 3, tab 10) comprised a review of articles published between 1998 and 2007. Those articles reported upon a total pool of 15,839 patients undergoing elective hip and knee arthroplasty. Within that patient pool it was shown that the group receiving LMWH was associated with the highest incidence of all - cause mortality. As a result the authors concluded that clinical PE occurs despite the use of powerful anticoagulants and that while LMWH could reduce the risk of venographically evident DVT, the literature could not support the use of powerful anticoagulants to prevent PE.
- “The increased risk of bleeding complications has encouraged several experienced surgeons who perform joint arthroplasty to emphasise caution in the use of these anticoagulants. We believe the American College of Chest Physicians should reconsider their guidelines to reflect the fact that PE occurs despite the use of potent anticoagulants and may, in fact, expose patients to increased mortality after surgery.”
Proposed Amendment to Statement of Claim
94 At the conclusion of day four of the hearing, the plaintiffs foreshadowed an amendment to the Statement of Claim. The Court was advised that the plaintiffs wished to rely upon a failure to warn case as well as that already pleaded. The application to amend the Statement of Claim was made on the fifth day of the hearing. The additional particular of negligence sought to be relied upon was alleged against Dr Newman and was expressed in the following terms:
- “Failed to warn the deceased adequately or at all about the prophylactic treatment options available to him and in particular the use and dosage of Clexane when the defendant knew or ought to have known that the deceased was at risk of forming a blood clot or DVT as a result of the operation which could develop into a fatal pulmonary embolus.”
The application to amend was opposed by the defendants.
95 The basis for the application was that evidence had been given by some of the experts that before prescribing Clexane or another LMWH they would discuss the advantages and disadvantages with the patient and involve the patient in the decision making process. It was submitted that this was new material which the plaintiffs were entitled to rely upon.
96 When the application was made I asked counsel for the plaintiffs to take me to the expert evidence which provided the basis for the application. It became apparent from that evidence that the substance of the amendment was not a failure to warn but rather a failure by Dr Newman to explain to the deceased the advantages and disadvantages of using Clexane or some other LMWH. The reason why the plaintiffs tried to express the proposed amendment in terms of a failure to warn was to activate s 5P and thus avoid the operation of s 5O of the Civil Liability Act 2002.
97 A preliminary difficulty for the plaintiffs in the application was that this precise issue had been raised in the joint conference of expert witnesses memorandum, dated 27 October 2008 (exhibit 2), which was available to the plaintiffs’ legal advisers before the commencement of the trial. Question 1 and the comments by the doctors in relation to it, fairly and squarely raised this issue. Accordingly, it was not correct to say that this matter arose unexpectedly at the trial as a result of evidence given by the medical experts.
98 A practical problem with the proposed amendment was that the oral evidence was complete at the time the application was made. Had the amendment been allowed, it would have been necessary to recall Dr Newman, possibly the deceased’s wife, and certainly the five medical experts who had given their evidence concurrently on the fourth day of the hearing.
99 I considered that it was quite unfair to recall Dr Newman. He had already been recalled twice at the request of the plaintiffs. It was also not without significance that on the last occasion that Dr Newman gave evidence, it was clear that the incident had greatly upset and affected him. It would have been extremely difficult to find a convenient date for the five expert medical witnesses to reconvene.
100 My preliminary view was that the application had been made too late and if there were some substance in the failure to warn aspect of the proposed amendment, what was being asked for was the right to present a different case to that which had been thus far placed before the Court.
101 The defendant opposed the application on three bases. The first was that shortly before the commencement of the hearing (27 October 2008) senior counsel for the plaintiffs had expressly disavowed any reliance upon a failure to warn case.
102 The second basis was that the defendants had prepared their case on particular issues, specific questions relating to those issues had been put to the medical experts and the case had been run on that basis. If the amendment were allowed the defendants would be required, potentially at least, to prepare a new case. The costs and inconvenience of further consulting with the medical experts and then reconvening them so that their evidence could be given would be considerable. The defendants submitted that the plaintiffs’ proposed amendment flew in the face of the objects of the Civil Procedure Act 2005 which were directed at proceedings being dealt with cheaply, efficiently and justly.
103 Finally, the defendants submitted that the question of advising as to the advantages and disadvantages of Clexane, or another LMWH, was an obvious matter to be considered by the plaintiffs in preparing their case and no explanation was offered for why that had not been done and why such a significant amendment was being sought after all of the oral evidence had been completed.
104 As indicated, I formed the opinion that the amendment sought did not really raise a failure to warn issue. If I am incorrect in that conclusion, the submissions put on behalf of the defendants have considerable weight and it would be quite unfair for the plaintiffs to be allowed to amend at this late stage in the proceedings, particularly when a failure to warn case had been expressly disavowed shortly before the commencement of the trial.
105 If, on the other hand, the substance of the amendment was a failure on the part of Dr Newman to explain the advantages and disadvantages of Clexane to the deceased to enable the deceased to make an informed decision, the proposed amendment went nowhere and added little to the plaintiffs’ case.
106 It is clear from Dr Newman’s evidence that he was of the opinion that the appropriate dose of Clexane was one dose for every day that the deceased was in hospital, i.e. one dose. Had he explained the advantages and disadvantages of a single dose to the deceased one or two things would have happened; either the deceased would have agreed to have Clexane administered or he would have refused. If he had agreed and Clexane was not given to him, the position is exactly the same as has been already pleaded against Dr Newman.
107 If (as I suspect from the way in which the argument was put to the Court) the plaintiffs’ case on this issue was that Dr Newman should have explained to the deceased the option of Clexane being administered for seven to ten days or more, that again raised the very issue which was already before the Court, i.e. the failure on the part of Dr Newman to properly treat the deceased not only by failing to ensure that he was administered Clexane but by failing to ensure that it was administered for an appropriate length of time.
108 If those matters provide the real basis for the proposed amendment, the amendment did no more than raise matters which were already before the Court and it was unnecessary.
109 For those reasons I refused the plaintiffs’ application to amend the Statement of Claim and the matter proceeded on the existing pleadings.
Submissions and consideration
Duty of Care
110 The plaintiffs did not address the Court on the duty of care and its content. Their submissions related to breach of duty and causation. The defendants, on the other hand, assumed without analysis that the primary issues before the Court were the content of the duty of care and causation. This difference in approach may, to some extent, explain the difficulties which the plaintiffs had when seeking to articulate their case.
111 The following analysis is directed to the case against Dr Newman. If that case is made out, then certain consequences follow for the case against the hospital.
112 The general nature of the duty owed by Dr Newman is set out in Rogers v Whitaker (1992) HCA 58; (1992) 175 CLR 479 at 483:
- “The law imposes on a medical practitioner a duty to exercise reasonable care and skill in the provision of professional advice and treatment. That duty is a "single comprehensive duty covering all the ways in which a doctor is called upon to exercise his skill and judgment"; it extends to the examination, diagnosis and treatment of the patient and the provision of information in an appropriate case. It is of course necessary to give content to the duty in the given case.
- The standard of reasonable care and skill required is that of the ordinary skilled person exercising and professing to have that special skill …".
113 Applying that passage to the facts of this case the standard of reasonable care and skill required of Dr Newman was that of a surgeon specialising in foot and ankle surgery in Australia in May 2004.
114 As the defendants submitted, implicit in the plaintiffs’ case (although never expressed in this way) was the proposition that the duty owed by Dr Newman included an obligation to administer Clexane or other LMWH for an appropriate period following the operation. That was the content which the plaintiffs (had they considered it) sought to give to the general statement of duty in the case which was pleaded.
115 In submissions the plaintiffs’ approach was different. They assumed a duty in general terms without seeking to define it in any way. They submitted that the risk of a PE developing was not only foreseeable but was recognised and acknowledged by Dr Newman. The potential consequences of a PE developing could be fatal and consequently the appropriate response in terms of Wyong Shire Council v Shirt (1980) 146 CLR 40 was to prescribe Clexane/LMWH. As a result the focus of the plaintiffs was upon breach not duty.
116 I have concluded that the approach of the defendants is correct. Accordingly, the first question to be determined is whether the duty of care, which Dr Newman undoubtedly owed to the deceased, included an obligation to administer Clexane or other LMWH.
117 As indicated in my summary of the evidence of the medical experts and the medical literature which was available in May 2004, the opinions of the defendants’ medical experts on this issue are to be preferred to those called on behalf of the plaintiffs. The opinions of Drs Conrad and Benson were based on their understanding of the medical literature. They had read that literature in order to give evidence in the case. The medical experts called on behalf of the defendants practised on a regular basis in this field. It was apparent from their familiarity with the medical literature that this was not something which they had read in order to give evidence, rather it was material with which they had become familiar as part of the practice of their specialities.
118 Their opinion on this issue was unanimous, i.e. it was not standard practice to administer Clexane/LMWH after Achilles tendon surgery in May 2004. They offered sound reasons for that opinion. Whether the risk under consideration was that of a DVT, VTE or fatal PE, they regarded the deceased as a low risk patient. Statistically the risks of DVT or VTE in patients undergoing this sort of surgery were very low. The risks of using Clexane/LMWH outweighed the advantages and the medical literature was unanimous in recommending that LMWH not routinely be administered for this kind of surgery.
119 The dangers of interpreting the medical literature when one does not regularly practise in the field, were amply demonstrated by the two significant errors made by Dr Conrad, i.e. his misunderstanding of the 2A classification in the 2004 Chest study and his failure to appreciate why studies relating to knee and hip surgery provided limited assistance in understanding the incidence of DVT and VTE in foot and ankle surgery. Doctor Benson freely conceded that he was not in a position to express an opinion on this issue.
120 I have concluded that the duty of care owed by the second defendant to the deceased did not include as part of its content an obligation to administer Clexane/LMWH following the surgery.
121 This, however, does not end the matter. On the specific facts of this case, the question of breach still arises and needs to be resolved.
Breach of Duty and Causation
122 The plaintiffs submitted that Dr Newman as a result of his perusal of the medical literature had concluded that Clexane should be administered either before or after Achilles tendon repair surgery and should be continued for as long as the patient was in hospital. This was so even though it might involve the administration of only one or two injections of Clexane. It was Dr Newman’s evidence that Clexane administered in this way was intended to have a prophylactic effect. He followed this practice despite the recommendations in the medical literature. The plaintiffs referred to the similar practice followed by Dr Sullivan.
123 Despite that belief and intention by Dr Newman, no Clexane was administered to the deceased. The reason why that occurred was directly referable to a departure by Dr Newman from proper medical practice. The plaintiffs submitted that the evidence of all the doctors was to the effect that it was insufficient for the second defendant to write “Clexane” on the operation chart without taking steps to ensure that Clexane was in fact administered to the deceased [48]. The plaintiffs submitted that the second defendant’s failure to do this involved a breach of the duty which he owed to the deceased. A similar failure arose from his failure to check whether Clexane had been administered to the deceased before the operation, given the amount of time which had elapsed between the deceased’s admission and the operation.
124 I agree. Dr Newman appeared to concede as much when he agreed that his failure to give clear directions on the medication chart as to the administration of Clexane to the deceased was an “oversight” on his part.
125 The plaintiffs submitted that this failure to ensure that one or two doses of Clexane were administered to the deceased had made a material contribution to the development of his fatal PE on 27 May 2004. The plaintiffs formulated their causation argument in this way.
126 In relation to the risk of developing DVT or VTE, the most dangerous period for a patient was while he or she was in hospital and immobilised. That was the effect of the evidence of the defendants’ medical experts. Accordingly, the most likely time for a clot to have developed in the deceased was while he was in hospital. The risk of that clot developing would have been reduced by the administration of a dose of Clexane while he was in hospital. That did not occur.
127 Once the deceased left hospital, although his foot and ankle remained immobilised, he was using crutches and was more active which significantly reduced the effect of the calf pump not operating in the immobilised foot. The proposition was put in this way:
“We say there is a strong likelihood that as a result of not being administered this dose the DVT developed and took its time over the next 27 days to become a fatal pulmonary embolus. It developed, we say, directly in consequence of the failure to administer Clexane in hospital.” (T.186.25)
128 It was common ground that the Civil Liability Act 2002 applied to this claim. Sections 5D and 5E of the Act deal with causation. They read as follows:
- “ 5D General principles
- (1) A determination that negligence caused particular harm comprises the following elements:
- (a) that the negligence was a necessary condition of the occurrence of the harm ( factual causation ), and
- (b) that it is appropriate for the scope of the negligent person’s liability to extend to the harm so caused ( scope of liability ).
- (2) In determining in an exceptional case, in accordance with established principles, whether negligence that cannot be established as a necessary condition of the occurrence of harm should be accepted as establishing factual causation, the court is to consider (amongst other relevant things) whether or not and why responsibility for the harm should be imposed on the negligent party.
- (3) If it is relevant to the determination of factual causation to determine what the person who suffered harm would have done if the negligent person had not been negligent:
- (a) the matter is to be determined subjectively in the light of all relevant circumstances, subject to paragraph (b), and
- (b) any statement made by the person after suffering the harm about what he or she would have done is inadmissible except to the extent (if any) that the statement is against his or her interest.
- (4) For the purpose of determining the scope of liability, the court is to consider (amongst other relevant things) whether or not and why responsibility for the harm should be imposed on the negligent party.
- 5E Onus of proof
- In determining liability for negligence, the plaintiff always bears the onus of proving, on the balance of probabilities, any fact relevant to the issue of causation.”
129 Neither side referred to those sections nor were any submissions made in relation to them. Both sides seemed to assume that the principles embodied in s 5D of the Act were in accord with the common law. That was the approach adopted by the Court of Appeal in Ruddock v Taylor [2003] NSWCA 262; (2003) 58 NSWLR 269 at 286 where Ipp JA explained the section and its purpose:
- “85 As Professor Jane Stapelton has explained in her article "Cause-in-Fact and the Scope of Liability for Consequences" (2003) 119 Law Quarterly Review 388, there are two fundamental questions involved in the determination of causation in tort.
- 86 The first relates to the factual aspect of causation, namely, the aspect that is concerned with whether the negligent conduct in question played a part in bringing about the harm, the subject of the claim. Professor Stapelton argues (at 389) that this inquiry involves determining whether there was, on the part the defendant, "historical involvement in [the plaintiff] suffering actionable damage".
- 87 The second aspect concerns "the 'appropriate' scope of liability for the consequences of tortious conduct" (Stapelton, op cit, at 411). In other words, the ultimate question to be answered when addressing the second aspect is a normative one, namely, whether the defendant ought to be held liable to pay damages for that harm. This inquiry may involve normative issues of a general kind, or issues such as whether the so-called evidentiary gap should be bridged (in the sense explained in Bonnington Castings Ltd v Wardlaw [1956] AC 613), whether the defendant materially increased the risk (in the sense explained in Fairchild v Glenhaven Funeral Services Ltd [2003] 1 AC 32), and whether the damage claimed is too remote.
- …
89 The approach to causation that I have set out forms the basis of s 5D of the Civil Liability Amendment (Personal Responsibility) Act 2002. This Act does not govern the present action but, in my view, the principles it embodies in
regard to causation are in accord with the common law.”
130 Applying those principles, this submission by the plaintiffs fails to meet the test of factual causation. There is no evidence to support the submission. The proposition was never put in terms to any of the doctors. The submission is based on speculation not inference. In that regard, not only is it not known when the clot formed and when it broke off, but it is not capable of being known.
131 On causation questions the focus is a retrospective one and is concerned with what actually happened. The operation took place on 1 May and the fatal PE occurred on 27 May. The medical evidence is all one way. The medical experts say that one or two doses of Clexane given at the time of the operation would not have prevented the development of the fatal PE 27 days later. This evidence was not accompanied by any qualifications. Accordingly, although there was a breach of duty by Dr Newman in failing to ensure that a dose of Clexane was administered following the operation, that breach did not play a part in bringing about the fatal PE. This submission by the plaintiffs fails.
132 The plaintiffs’ alternative submission was that Dr Newman breached the duty of care which he owed to the deceased in that having embarked upon the prescription of Clexane, he should have ensured that it was administered to the deceased for 7-10 days. In oral submissions the argument was put as follows:
- “But the second limb of our argument is this; looked at from a practical point of view, if you decide you are going to do a dose then it has to be something which is based on rationality and dosage intervals. It is insufficient for Dr Newman to say look I went by the guidelines. I didn't have anything else to go by.” (T.190.42)
133 In support of that submission, the plaintiffs relied upon the evidence of Dr McGrath that there was a certain logic in administering Clexane for that period of time [64]. The Court was referred to the distributor’s recommendation and the recommendation of 7-10 days of treatment in the 2004 edition of MIMS. The plaintiffs submitted that having decided that there was a prophylactic benefit to be gained from Clexane in relation to the risk of DVT and VTE, it was illogical of Dr Newman not to have ensured that an appropriate dose was administered to the deceased, i.e. 40 mg per day for 7-10 days.
134 In considering this submission and the question of breach of duty generally, it is useful to have regard to two statements of principle by the High Court.
- “In the way in which litigation proceeds, the conduct of the parties is seen through the prism of hindsight. A foreseeable risk has eventuated, and harm has resulted. The particular risk becomes the focus of attention. But at the time of the allegedly tortious conduct, there may have been no reason to single it out from a number of adverse contingencies, or to attach to it the significance it later assumes. Recent judgments of this Court have drawn attention to the danger of a failure, after the event, to take account of the context, before or at the time of the event, in which a contingency was to be evaluated.” ( Rosenberg v Percival [2001] HCA 18, (2001) 205 CLR 434 Gleeson CJ at [16])
- “Again, because the inquiry is prospective, it would be wrong to focus exclusively upon the particular way in which the accident that has happened came about. In an action in which a plaintiff claims damages for personal injury it is inevitable that much attention will be directed to investigating how the plaintiff came to be injured. The results of those investigations may be of particular importance in considering questions of contributory negligence. But the apparent precision of investigations into what happened to the particular plaintiff must not be permitted to obscure the nature of the questions that are presented in connection with the inquiry into breach of duty. In particular, the examination of the causes of an accident that has happened cannot be equated with the examination that is to be undertaken when asking whether there was a breach of duty of care which was a cause of the plaintiff’s injury. The inquiry into the causes of an accident is wholly retrospective. It seeks to identify what happened and why. The inquiry into breach, although made after the accident, must attempt to answer what response a reasonable person, confronted with a foreseeable risk of injury, would have made to that risk. And one of the possible answers to that inquiry must be “nothing”. ( Vairy v Wyong Shire Council [2005] HCA 62, (2005) 223 CLR 422 Hayne J at [124]).
135 Doctor Newman set out his reasons for prescribing one or two doses of Clexane ([28] – [31]). I have already indicated why I accept Dr Newman as a truthful witness. The reasons why I have found that the content of the duty of care did not include an obligation to administer Clexane to the deceased apply equally to this issue. There are additional reasons.
136 Although Dr McGrath said that there was a certain logic in administering Clexane for 7-10 days, it is clear from other evidence that there was an equally compelling logic in restricting the dosage to the time which a patient spent in hospital. This was the time when a patient’s immobility was at its greatest and therefore the risk of a clot developing was at its greatest. Doctor McGrath said that such a practice had a prophylactic value and it was the practice followed by Dr Sullivan. It also reduced the risk of the development of one of the well-known side effects of Clexane, such as haemorrhage.
137 Apart from the MIMS publication and the recommendations of the distributor of Clexane, Aventis, the medical literature was all one way. It did not recommend the routine administration of LMWH or Clexane for this kind of surgery. Some particular risk factor had to be identified in a patient. None were identified in the deceased. There is no basis for Dr Conrad’s assessment of the deceased as a high-risk patient or of this operation as a high-risk operation. The opinion of the defendants’ medical experts was to the contrary as were the conclusions in the medical literature available at the time. The only specific risk identified in the evidence was that of immobility. This was a risk inherent in the operation itself and one would have thought, inherent in any foot or ankle operation.
138 The medical literature did not specify any particular dosage of Clexane or LMWH. The literature set out the advantages and disadvantages of the administration of LMWH and made recommendations. It was generally acknowledged that the medical literature provided little guidance as to the time over which LMWH was to be administered. Because of this lack of clear guidance and the real risks associated with the administration of LMWH, the consensus of the defendants’ medical experts was that it was for the treating clinician to decide the period over which LMWH should be administered, having regard to the particular circumstances of the patient.
139 Against that evidentiary background, and keeping in mind that the question of breach of duty is a prospective analysis based on the state of knowledge and the circumstances at the time, it was well open to Dr Newman to adopt the compromise which he did, i.e. to administer LMWH in the case of an Achilles tendon operation only while the patient was in hospital. This was his practice if there were no special risk factors associated with the development of a DVT or VTE. The rationale for such a compromise was obvious. While providing a prophylactic benefit during a patient’s period of most immobility, it also reduced the risk of dangerous complications such as haemorrhage. It also avoided the difficulties associated with self-administered Clexane outside the hospital. I am not persuaded that the failure by Dr Newman to administer Clexane or other LMWH for 7-10 days following the operation constituted a failure to comply with the appropriate professional standards.
140 If I am wrong in that conclusion, the evidence clearly establishes the defence in s 5O of the Civil Liability Act 2002.
- “5O Standard of care for professionals
- (1) A person practising a profession ( a professional ) does not incur a liability in negligence arising from the provision of a professional service if it is established that the professional acted in a manner that (at the time the service was provided) was widely accepted in Australia by peer professional opinion as competent professional practice.
- (2) However, peer professional opinion cannot be relied on for the purposes of this section if the court considers that the opinion is irrational.
- (3) The fact that there are differing peer professional opinions widely accepted in Australia concerning a matter does not prevent any one or more (or all) of those opinions being relied on for the purposes of this section.
- (4) Peer professional opinion does not have to be universally accepted to be considered widely accepted.”
141 In relation to the application of s 5O I respectfully adopt the approach of McClellan CJ at CL in Halverson v Dobler [2006] NSWSC 1307, that the section is intended to operate as a defence. This approach was approved by the Court of Appeal in Dobler v Kenneth Halverson [2007] NSWCA 335 at [59] – 60] where Giles JA said:
60 In this sense, s 5O provides a defence. The plaintiff will usually call his expert evidence to the effect that the defendant’s conduct fell short of acceptable professional practice, and will invite the court to determine the standard of care in accordance with that evidence. He will not be concerned to identify and negate a different professional practice favourable to the defendant, and s 5O does not require that he do so. The defendant has the interest in calling expert evidence to establish that he acted according to professional practice widely accepted by peer professional opinion, which if accepted will (subject to rationality) mean that he escapes liability.”“59 Section 5O was amongst the tort law reforms consequent on the Review of Law of Negligence Final Report, September 2002 (“the Review ”). It was intended to introduce a modified Bolam principle. Its importance does not lie so much in questions of onus of proof as in who determines the standard of care. Commonly, as in the present case, there will be expert evidence called by the plaintiff to the effect that the defendant’s conduct fell short of acceptable professional practice and expert evidence called by the defendant that it did not; the expert evidence may or may not recognise that the opposing professional practice is one which has some currency. Apart from s 5O the Court would determine the standard of care, guided by the evidence of acceptable professional practice. It would not be obliged to hold against the plaintiff if the defendant’s conduct accorded with professional practice regarded as acceptable by some although not by others. Section 5O has the effect that, if the defendant’s conduct accorded with professional practice regarded as acceptable by some (more fully, if he “acted in a manner that … was widely accepted … by peer professional opinion as competent professional practice”), then subject to rationality that professional practice sets the standard of care.
142 In accordance with that interpretation of s 5O and applying the “modified Bolam principle” the defendants have established that Dr Newman acted in a manner which as of May 2004 was widely accepted in Australia by orthopaedic surgeons practising in the field of foot and ankle surgery as competent, professional practice.
143 As set out earlier in this judgment, the defendants’ medical experts agreed that in May 2004 the majority of orthopaedic surgeons who specialised in foot and ankle surgery were not administering Clexane as a prophylactic in Achilles tendon repair surgery. The evidence of Dr Sullivan in this regard is particularly compelling given his area of expertise (T.107.23). The basis for that practice was wholly rational as the evidence of the defendants’ medical experts explains and as is set out in the medical literature to which reference has been made. Doctor Benson did not express an opinion on this issue. The only dissent was in the evidence of Dr Conrad. For the reasons previously indicated, I am not satisfied that Dr Conrad had the necessary experience and expertise to express that opinion but in any event I do not accept it. I prefer the opinions of Drs Sullivan, McGrath and Professor Fletcher.
144 Doctor Newman did not administer Clexane to the deceased. I am satisfied that that approach was widely accepted in Australia by peer professional opinion as competent professional practice. To the extent that it was necessary for Dr Newman to establish the “defence” provided by s 5O, he has done so.
145 It follows that I am not satisfied that the plaintiffs have established breach of duty of care on this issue, i.e. the failure to administer Clexane for 7-10 days.
146 Had the plaintiffs been successful in establishing breach of duty on that issue, I am not satisfied that they have established causation.
147 The plaintiffs rely upon the statement of causation principle in Chappel v Hart [1998] HCA 55; (1998) 195 CLR 232 at [27] where McHugh J said:
- “Before the defendant will be held responsible for the plaintiff’s injury, the plaintiff must prove that the defendant’s conduct materially contributed to the plaintiff suffering that injury. In the absence of a statute or undertaking to the contrary, therefore, it would seem logical to hold a person causally liable for a wrongful act or omission only when it increases the risk of injury to another person. If a wrongful act or omission results in an increased risk of injury to the plaintiff and that risk eventuates, the defendant’s conduct has materially contributed to the injury that the plaintiff suffers whether or not other factors also contributed to that injury occurring.”
148 The plaintiffs’ submission based on that statement of principle is as follows. Doctor Newman’s failure to administer Clexane to the deceased increased the risk of the deceased developing DVT, VTE or PE. A fatal PE developed. This was the very eventuality which the administration of Clexane was designed to avoid. The particular risk which had been increased by Dr Newman’s conduct had therefore eventuated and consequently causation was established.
149 In order to evaluate that submission, it is necessary to refer to the evidence on which it is based. The plaintiffs in their submissions have assumed that the operation caused the fatal PE. That is not the effect of the evidence. What Dr McGrath said was:
- “No, clearly there is a relationship between the trauma and surgery and the pulmonary embolism. “ (T.153.1)
That evidence has to be read with that at [75]. The effect of that evidence is that while there is an undoubted association between either or both the trauma and operation on the one hand and the fatal PE on the other, the mechanism by which that occurred is not known. The neutral word “relationship” used by Dr McGrath is clearly something less than the terminology of causation. The part played by the operation and/or trauma in the ultimate development of the fatal PE by comparison with the other factors to which reference is made is unknown and unquantified.
150 It is also necessary to identify the increased risk of injury upon which reliance is placed. It cannot be the risk of a DVT or VTE developing. That risk already existed as a result of the injury. There is nothing in the evidence to suggest that the operation itself, as distinct from the initial injury, increased the risk of a DVT or VTE developing. The increased risk, therefore, upon which the plaintiffs rely can only be any additional risk of developing DVT or VTE which arose as a result of not administering Clexane.
151 The evidence does not establish that the failure to administer Clexane for 7-10 days increased the risk of a fatal PE developing. It is the development of a fatal PE which is the condition which eventuated, not a DVT or VTE.
152 Some assistance in the application of the Chappel v Hart causation principle is provided by Seltsam Pty Limited v McGuiness and Another [2000] NSWCA 29; (2000) 49 NSWLR 262 at 279 where Spigelman CJ said:
- “107 The starting point of McHugh J's analysis was that it had been established on the balance of probabilities that the conduct did create or increase the risk of injury, "and that risk had eventuated".
- 108 This starting point is the very matter in issue in the present case. Was there evidence on the basis of which the trial judge could conclude, on the balance of probabilities, that there was an increased risk of injury and that that risk had "eventuated" in the specific disease of the respondent?
109 If there was such evidence then, to use the words of both Gaudron J and Callinan J the tribunal of fact was entitled" to find that the conduct which increased risk, materially contributed to the injury - entitled, but not, of course, required to so find. “
153 This was the very point made by Dr Sullivan. He pointed out that whereas the findings in the medical literature as to the effectiveness of LMWH in reducing the incidence of DVT and PE were equivocal at best when applied to foot and ankle surgery, there was no evidence that LMWH had any beneficial effect in relation to the prevention of fatal PE. An analysis of the medical literature tendered in this case indicates that the evidence of Dr Sullivan on this issue is correct.
154 For the causation principle enunciated by McHugh J in Chappel v Hart to apply to this case, the plaintiffs had to establish that the failure to administer Clexane for 7-10 days post-operatively created or increased the risk that the deceased would die as a result of a fatal PE. There is nothing in the medical literature or in the oral evidence in the case to establish that proposition. The only oral evidence specifically on the issue is that of Dr Sullivan and it is against the proposition.
155 The causation question can be approached in another way. On the question of factual causation, the highest at which the evidence can be put is that Drs Conrad, Benson and McGrath thought that the administration of Clexane for 7-10 days might possibly have prevented the development of a fatal PE. The evidence of Dr Sullivan and Professor Fletcher was that it was very unlikely that it would have done so. Leaving aside the opinions of Dr Sullivan and Professor Fletcher, evidence as to possibility does not establish factual causation nor does it provide any basis whereby the Court could assess the degree of contribution or the degree of increased risk to which the deceased was exposed. Mere possibility is not sufficient to establish factual causation.
156 As Spigelman CJ said in Desmond v Cullen [2001] NSWCA 238; (2001) 34 MVR 186 at [13] (a case concerned with whether an intoxicated pedestrian had contributed to his injuries):
- “I also agree with Grove J that the appellant fails on the issue of causation. The evidence relating to the connection between the plaintiff’s state of inebriation and the injury he suffered, never rose above the level of a mere possibility. The fact that he was walking home in a state of intoxication was not shown to have made a material contribution to the injury he suffered. The appellant had to show a material contribution at the level of probability not possibility. (See the authorities collected in Seltsam Pty Limited v McGuiness (2000) 49 NSWLR 262 at [80] to [83]).”
157 I have concluded that on this issue, factual causation has not been established. That being so, I do not see any basis for approaching the matter from the point of view of assessing the “appropriate scope of liability for the consequences of tortious conduct”, i.e. the normative question of whether the defendant ought to be held liable to pay damages for that harm. No submissions were put to that effect and this is not the sort of exceptional case where those considerations would operate.
158 As a fallback position, the plaintiffs submitted that if the Court were not satisfied on the balance of probabilities that causation had been established, the Court would be satisfied that the failure to administer Clexane for 7-10 days had deprived the deceased of the chance of a better outcome and that some percentage should be assessed to give a value for that loss of a chance.
159 The difficulty with that submission is that no evidence was led from the medical experts on the question. The plaintiffs cannot demonstrate on the evidence that a real and quantifiable chance existed. As Hodgson JA said in Rufo v Hosking [2004] NSWCA 391; (2004) 61 NSWLR 678 at [10] any such chance must be “inherent in the circumstances, not merely an artefact of the … evidence”.
160 On the evidence I am not satisfied that a loss of a chance has been established. If it had been a further difficulty would arise in that the medical evidence does not provide any rational basis for assessing that loss of a chance. Such an assessment would involve speculation rather than inference or calculation.
161 For completeness, I should say something about the case which the plaintiffs sought to raise in the proposed amendment to the Statement of Claim. The essence of the amendment was a failure to explain the advantages and disadvantages of the administration of Clexane following the operation so as to allow the deceased to make a decision as to whether the drug should be administered to him.
162 Doctor Newman could not remember whether he had said anything to the deceased on this subject [T39.46]. If he had discussed the matter with the deceased, what he would have explained to the deceased was the advantages and disadvantages of the administration of one or two doses of Clexane. Had Dr Newman provided such an explanation, and had he recommended the administration of one or two doses of Clexane and had the deceased accepted that advice, the plaintiffs’ claim would still fail because of the failure to establish causation previously discussed.
163 If the thrust of the proposed amendment was not to that effect but was directed at establishing that Dr Newman should have explained in detail to the deceased not only his own belief as to the efficacy of Clexane but to have explained to him other options, such as its administration for 7-10 days post-operatively, the plaintiffs’ claim would still have failed. There is no evidence from which the Court could infer, had such an explanation been given, that the deceased would have chosen to undergo such treatment particularly once the dangers of haemorrhage were explained to him. Even if he had, the same problems with causation arise.
164 There is, however, another difficulty with the proposed amendment. Rogers v Whitaker and Rosenberg v Percival recognise that whether a medical practitioner is in breach of the requisite standard of care will vary according to whether it is a case involving diagnosis and treatment on the one hand or the provision of information or advice on the other. Those cases recognise the fundamental difference between the two concepts. In diagnosis and treatment the patient’s contribution is limited to the narration of symptoms and relevant history. Based on that information the medical practitioner provides diagnosis and treatment according to his or her level of skill. The provision of information relates to the patient’s choice to undergo the medical treatment. For the patient’s consent to the treatment to be valid, he or she should be informed in broad terms of the nature of the procedure which is intended.
165 On the facts of this case, the standard of care required of Dr Newman would have been satisfied if he had, in broad terms, explained to the deceased the advantages and disadvantages of the administration of Clexane on the basis of one or two doses post-operatively while the deceased was in hospital. There was no obligation on him to discuss the contents of the medical literature and explain the advantages and disadvantages of 7-10 days of the administration of Clexane post operatively.
166 Given the nature of the medical literature and its complexity, and the problems associated with the administration of Clexane, such an explanation would have been confusing and of little benefit. It would have involved the deceased in the treatment process and an abrogation of responsibility by Dr Newman. It is up to the surgeon to decide upon the treatment with a concomitant obligation to explain the advantages and disadvantages of the recommended treatment. It is not the province of the patient to decide on the treatment when this involves an understanding and examination of complex medical opinion.
167 It follows that even if the Statement of Claim had been amended as sought by the plaintiffs, their claims would still have failed.
Conclusion
168 For the reasons indicated, the plaintiffs’ claim against Dr Newman fails. Since the case against the hospital depended upon liability being found against Dr Newman, the case against the hospital must also fail.
169 The orders which I make are as follows:
(i) There will be judgment in favour of the defendants.
(ii) The plaintiffs are to pay the defendants’ costs of these proceedings.
Key Legal Topics
Areas of Law
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Medical Law
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Tort Law
Legal Concepts
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Duty of Care
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Breach of Contract
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Causation
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Compensatory Damages
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