New South Wales Supreme Court CITATION : Monique Frances King v SESAHS & Anor [2005] NSWSC 305 HEARING DATE(S) : 7/02/05 - 16/03/05 JUDGMENT DATE : 8 April 2005 JUDGMENT OF : Newman AJ DECISION : Paragraph 54 CATCHWORDS : Medical neglience - Standard of care - Breach of duty - Causation - Warning of complications of treatment Albrighton v Royal Prince Alfred Hospital [1982] NSWLR 542 Burnie Port Authority v General Jones Pty Ltd (1994) 179 CLR 520 Chappel v Hart (1998) 195 CLR 232 Commonwealth v McLean (1946) 41 NSWLR 389 Dingle v Associated Newspapers Ltd (1961) 2 QB 163 EM Baldwin & Sons Ltd v Plane (1998) 17 NSWCCR 434 CASES CITED : Rodgers v Whitaker (1992) 175 CLR 479 Rosenberg v Percival (2001) 205 CLR 434 Seltsam Pty Limited v McGuinness (2000) 49 NSWLR 262 Sidway v Governors of Bethlem Royal Hospital [1985] AC 871 Woods v Multi-Sport Holdings Pty Ltd (2002) 208 CLR 460 Wyong Shire Council v Shirt (1980) 146 CLR 40 Monique Frances King (Plaintiff) PARTIES : South Eastern Area Health Service (1st Defendant) Richard O'Gorman-Hughes as Executor of the Estate of the late Professor Darcy O'Gorman-Hughes (2nd Defendant) FILE NUMBER(S) : SC 18475/93 D. Higgs SC with D. Graham (Plaintiff) COUNSEL : D.Davies SC with S.Kalfas (Defendants) Turner Freeman Solicitors (Plaintiff) SOLICITORS : Tress Cocks & Maddox Lawyers (Defendants) LOWER COURT JURISDICTION : IN THE SUPREME COURT OF NEW SOUTH WALES COMMON LAW DIVISION NEWMAN AJ Friday 8 April 2005 18475/93 Monique Frances KING v SESAHS & ANOR JUDGMENT 1 NEWMAN AJ: This is an action in negligence, brought by the plaintiff, against two defendants'. The first defendant is the hospital in which the plaintiff received treatment in 1989 and the second defendant is the late specialist oncologist who had charge of her care whilst hospitalised. The only issue in the case is liability, the parties having agreed damages in the sum of $7,000,000. 2 Before turning to the specific allegations of negligence made by the plaintiff against the defendants' I believe it to be convenient to summarise the treatment the plaintiff received in the year 1989. 3 The plaintiff for some six months before her admission to the first defendant's had been complaining of pain, and subsequently weakness, in her right arm. Eventually she was referred to a neurologist, Dr R Mackenzie, who in turn referred her to Dr Warwick Stenning, neurosurgeon, who first saw her on 30 January 1989. On examination Dr Stenning found weakness in her right triceps muscle and also weakness of pronation and supination of the right arm. At the time, an MRI scan, which she brought to Dr Stenning, showed a swelling on the C7 nerve root on the right side, which was partly in the spinal canal and partly in the para spinal muscles. The intrathecal component of this swelling was in contact with the spinal cord but did not displace it. 4 Dr Stenning made a presumptive diagnosis of neurofibroma (a benign entity). Dr Stenning determined that surgical exploration at the C7 level of the plaintiff's spine was the appropriate course of treatment. 5 On 10 February 1989 Dr Stenning carried out a laminectomy at the C7 level using a posterior approach. Dr Stenning found a grey tumour within the fascicles of the C7 nerve root, extending to make contact with the spinal cord. A component of the tumour was removed and sent for histological examination. That examination discovered that the tumour was, contrary to Dr Stenning's presumptive diagnosis, highly malignant. I should add that that report was received during the course of the operation. Dr Stenning then removed as much of the tumour as he could from the posterior approach he adopted. 6 He estimated that approximately one half to one third of the tumour remained, that part of the tumour being inaccessible from the posterior approach adopted at operation. 7 There was however doubt as to the diagnosis of what type of tumour was present in the plaintiff's spine. The final histological report, emanating from the first defendant's staff specialists, was that the tumour was "probably best regarded as an undifferentiated soft tissue sarcoma". Because there was a doubt about the identification of the tumour, tissue was sent to the Department of Defence Armed Forces Institute of Pathology in Washington DC. That organisation was unable to interpret the materials sent to it. A pathologist, Dr Richard Jaworski, having examined all relevant materials, concluded that the entity was in fact a malignant tumour with features consistent with a primitive neuro ectodermal tumour (PNET). In fact the treatment carried out following operation of the plaintiff was carried out on the basis that she was in fact suffering from an undifferentiated soft tissue sarcoma. However, as far as the issues in the case are concerned the fact that the tumour was in fact a PNET, and not an undifferentiated soft tissue sarcoma, is not a matter of importance in the matter. Indeed, Professor Bleyer, an American paediatric oncologist, expressed the view that if it was in fact a PNET that would explain more easily how it was that in fact the plaintiff was cured of the caner of which she suffered. But, as I have said, the fact that it was a PNET and not a sarcoma is not a matter of importance as far as the issues in the case were concerned. 8 Following the surgical procedure carried out by Dr Stenning the plaintiff then came under the care of the second defendant, the late Professor O'Gorman-Hughes. Professor O'Gorman-Hughes was in charge of her management and the prescription of both radiotherapy and chemotherapy to be applied in the course of the plaintiff's treatment. The chemotherapy which was prescribed and administered involved both systemic and intrathecal chemotherapy. Systemic chemotherapy was chemotherapy affecting the body as a whole, whereas intrathecal means chemotherapy administered to the meninges of the spinal cord. The systemic chemotherapy included the administration of the agent's vincristine (VCR), cyclophosphamide (CPA) and actinomycin D (Act-D), whereas the intrathecal chemotherapy included the administration of methotrexate (MTX), cytosine arabinoside (Ara-C) and hydrocortisone. Tendered in evidence was a table setting out the regime of chemotherapy and radiotherapy administered. That table is as follows: - 3 March – 23 March 1989 Radiotherapy to C2 –T2 23.87 Gy over 21 days. 3 March 1989 Intravenous vincristine 1.8mg and cyclophosphamide 700mg. 6 March 1989 Intrathecal methotrexate 12mg and hydrocortisone 50mg. 10 March 1989 Intravenous cyclophosphamide 700mg. 14 March 1989 Intrathecal methotrexate 12mg, cytarabine 70mg and hydrocortisone 50mg. 16 March 1989 Intravenous vincristine 1.8mg and cyclophosphamide 700mg. 23 March 1989 Intravenous cyclophosphamide 700mg, Intrathecal methotrexate 12mg, cytarabine 70mg and hydrocortisone 50mg. 30 March 1989 – 14 April 1989 Radiotherapy to cervical spine tumour bed 22.13 Gy over 16 days. 30 March 1989 Intravenous vincristine 1.8mg and cyclophosphamide 700mg. 7 April 1989 Intravenous cyclophosphamide 700mg, Intrathecal methotrexate 12mg, cytarabine 70mg and hydrocortisone 50mg. 14 April 1989 Radiotherapy to C5 – T1 boost of 2 Gy in 1 day. 26 April 1989 Intravenous vincristine 1.8mg and oral cyclophosphamide 100mg daily. 3 May 1989 Intravenous vincristine 1.5mg and oral cyclophosphamide 100mg daily. 10 May 1989 Intravenous vincristine 1.5mg and oral cyclophosphamide 100mg daily. 24 May 1989 Intravenous vincristine 1.5mg and oral cyclophosphamide 100mg daily. 31 May 1989 Intrathecal methotrexate 12mg, cytarabine 70mg and hydrocortisone 50mg. 14 June 1989 Oral cyclophosphamide 100mg daily. 28 June 1989 Oral cyclophosphamide 100mg daily until 11 July 1989. 17 July 1989 Intravenous vincristine 1.5mg and actinomycin D 2800 g over 5 days (600 g for 4 days and 400 g for 1 day). 9 August 1989 Intravenous vincristine 1.5mg and oral cyclophosphamide 100mg daily. 16 August 1989 Intravenous vincristine 1.5mg. 9 This table was further reduced into diagramic form by Professor Bleyer and I set out that representation (see Schedule 1 attached). As may be seen from Professor Bleyer's representation, the plaintiff was first observed to be exhibiting symptoms of myelopathy late in July of 1989. Myelopathy, for present purposes, means a deterioration of the myelin sheath, which inturn resulted in damage to the plaintiff's spinal cord, which ultimately led to her suffering from quadriplegia emanating from the C6 - C7 level. It is that quadriplegia which has led to the matter now before the court. 10 Prior to radiation and chemotherapy commencing, Professor O'Gorman-Hughes composed a scheme for the plaintiff's treatment. I set out that scheme (see Schedule 2 attached). 11 It is apparent that in fact the dosage of Actinomycin-D administered to the plaintiff by the hospital staff exceeded the dosage prescribed by Professor O'Gorman-Hughes. One very live issue which arose during the hearing was the propensity of Actinomycin-D to enhance the effect of radiotherapy previously administered. I shall refer again to this issue later in these reasons. However, it is relevant at this point to summarise the plaintiff's allegations in this regard. They are :- 1.a) No Act-D should have been administered or 1.b) A lesser dosage should have been administered and/or 1.c) at a later time than it was. 12 Professor Bleyer described Act-D as the archetypal radiosensitizer. Essentially, the plaintiff's case in this regard was that the Act-D administered to her enhanced the effect of the previously given radiotherapy so that myelopathy happened, leading to her quadriplegia. 13 Ultimately, the Defendants' did not dispute that the plaintiff's disability was caused by the treatment she received. In their written submissions counsel for the Defendants' made the concession in the following form :- "there does not seem to be any serious dispute that, overall, it was the combination of radiotherapy, TIT and the administration of Act-D that caused the myelopathy. (TIT being a reference to the intrathecal chemotherapy administered)". 14 The plaintiff's case, as presented, afforded no criticism of the administration of radiotherapy and, with one exception, systemic chemotherapy. The one exception in the plaintiff's case relating to systemic chemotherapy was that the plaintiff alleged that either no dosage of the drug Actinomycin D should have been given or, in the alternative, that the drug, when administered, was overdosed. The prime criticism of the treatment of the plaintiff by the defendants' was that no intrathecal chemotherapy should have been administered. Again, in the alternative, if administered, it should have been administered by way of lesser dosage. The plaintiff's allegations of breach of duty against the defendants' may be summarised as follows:- a) That the second defendant and other paediatric oncologists at the Prince of Wales Children's Hospital failed to fulfil their professional obligation to keep themselves informed in relation to the management of the type of children's cancer suffered by the plaintiff. b) The defendants' negligence resulted in the plaintiff receiving excessive intrathecal chemotherapy. As I have said, the plaintiff's case here was that either TIT should not have been given or alternatively should not have been given at the dose and frequency which the plaintiff received. c) Further that there was a failure on the part of the defendants' to warn her parents fully about the proposed therapy. That failure included an allegation that the defendants' should have warned the plaintiff's parents that there was a risk that the administration of TIT could result in spinal cord damage occurring to the plaintiff. So it was further argued that had they been so informed of that risk they would have then been in a position to obtain a second opinion or seek further information about the proposed course of treatment. d) The plaintiff alleges that she was given excessive doses of Act-D. I have already mentioned this earlier in these reasons. 15 While the defendants', as I have indicated, do not dispute that the plaintiff's disabilities were caused by the treatment she was afforded by them, they contend that, in the light of medical knowledge as it existed in 1989, the treatment afforded to her was reasonable. In particular, the fact that she was suffering from a life-threatening tumour required radical treatment to stop the tumour metastasising and to in fact eradicate it from her system. In carrying out that radical treatment one of the risks that existed was the chance of serious side effects such as that suffered by the plaintiff. Had the radical treatment not been carried out then the plaintiff may well have perished. Furthermore, Professor O'Gorman Hughes has, in a statement, contended that in fact he did give the plaintiff's parents an adequate warning about the risk of serious side effects. The principal reason why intrathecal chemotherapy was administered to the plaintiff was to obviate the risk of the tumour metastasising. Essentially, it was the defendant's case that the treatment afforded to her, by 1989 standards, was reasonable and that the disability that she suffered as a consequence of that treatment was an acceptable risk in the administration of such therapy. 16 I turn first to the plaintiff's allegation that the second defendant, and paediatric oncologists engaged by the first defendant, failed to fulfil their professional obligation to keep themselves informed as to the management of the type of cancer suffered by the plaintiff. There was no dispute in the matter that the scheme of management of the plaintiff's treatment was designed by the second defendant, after consultation with other paediatric oncologists at the Prince of Wales Children's Hospital. Equally, there was no dispute that, at least in part, the scheme of management devised by Professor O'Gorman-Hughes after consultation was based upon a protocol known as IRS-II, which had emanated from a body known as the Intergroup Rhabdomyosarcoma Study Group (IRSG) Committee. That group had been formed in 1972 and involved cooperation between a number of study groups in the United States of America, the United Kingdom and Canada. 17 That group designed and conducted a number of trials. The first trial, which was known as IRS-I, was conducted between 1972 and 1978. The second trial, described as IRS-II, was carried on between 1978 and 1984. The third trial, known as IRS-III, was carried on between 1984 and 1991. Amendments to the protocol established by the IRSG for IRS-III were published on 5 June 1987. 18 Following the cessation of IRS-III in 1991 a fourth protocol, IRS-IV, commenced. All protocols so established stipulated the dosages of chemotherapy agents to be administered and the amounts of radiotherapy patients were to be given. Relevantly, the protocols IRS-II and IRS-III, even as amended, proscribed as part of the treatment to be given to all patients who took part in the study both systemic and intrathecal chemotherapy. The scheme of treatment outlined by IRS-IV abandoned the use of intrathecal chemotherapy, except for patients who suffered from diffuse central nervous system disease combined with either a positive CSF cytology or distant CSF metastases. The object of including intrathecal chemotherapy in the relevant protocols was as a measure to obviate metastases. 19 By 1989 the IRSG was not the only study group in the world investigating the treatment of sarcomas. In Europe intrathecal chemotherapy of the type outlined in IRS-III (even as amended) was not used as routine treatment. Professor Stevens, in his evidence, outlined the reasons why that group, on which committee he was the United Kingdom's representative, determined against its routine use. 20 What is clear from the evidence given by four international paediatric oncologists, Drs' Stevens, D'Angio, Bleyer and Plowman, is, that at the time when the plaintiff's treatment was undertaken in 1989, there was a difference of view between the IRS group and study groups in the United Kingdom and Europe (and apparently elsewhere) as to the use of intrathecal chemotherapy in the treatment of sarcomas. It seems that the IRS Group was the only international group of standing which was then promoting the use of such intrathecal chemotherapy. 21 Indeed experiments carried out by a Dutch based group, using rats as experimental animals and published in 1985, gave a warning as to the use of intrathecal chemotherapy. There van der Kogel and Sissingh introduced their findings as follows :- Introduction "In the therapy of tumours of the central nervous system (CNS), the presence of a blood-brain barrier (b.b.b.) prevents the penetration of most drugs, and therapeutic concentrations in brain tissue can not be obtained. Apart from attempts to temporarily disrupt the b.b.b. (e.g. by hyperosmolar intracarotid infusions [13]), a current method to obtain high local concentrations is the direct intrathecal (i.t.) administration of a drug. The most generally used schedules combine intrathecal chemotherapy (methotrexate, MTX; arabinoside, ara-C) with cranial irradiation and intravenous (i.v.) maintenenance chemotherapy. Unfortunately, this effective schedule is accompanied by a considerable risk of CNS complications, of which the most severe is leukoencephalopathy. The occurrence of these complications could not be attributed to a single component of the treatment, but the combination of radiation with intravenous (i.v.) and intrathecal (i.t.) chemotherapy seems to carry an increased risk as compared to any of the components used as a single agent [4]. For acute lymphoblastic leukemia in children, this treatment is routinely used as a prophylaxis for meningeal relapse [20]. However, with an increasing number of long term survivors, the number of severe late sequelae in the CNS started to rise. Over a time-scale of days to years, the complications range from acute neurotoxic reactions, such as arachnoiditis[19], paraplegia[5,10], somnolence [28], leukoencephalopathy [22,23], microangiopathy [21], and long term intellectual changes [9]. In several reviews, the possible contributions of different components of a therapeutic regimen are discussed [14,19]. Generally observed delayed sequelae appear to be leukoencephalopathy (white matter necrosis, from 4 to 5 months after treatment) and microangiopathy (from about one year after treatment). The time of appearance and the histopathological characteristics of these legions are comparable with the so called early and late delayed radiation-induced damage in the brain [24]. Similar types of early and late delayed damage are observed in the rat cervical spine cord after X-irradiation [26]. The presence of early demyelination and white matter necrosis, as well as late vascular degeneration, indicates the suitability of the rat cervical spine cord as a model to study the tolerance of the CNS to late damage as a result of combined treatments." 22 Not only that, but the IRS Group itself in 1987 began a process of change in its own promotion of intrathecal chemotherapy. As I have already indicated, on 5 June 1987 that group published an amendment to its protocol IRS-III. That amendment took the following form :- "Seven patients have been identified with neurologic complications after treatment for par meningeal sarcoma in IRS-II (1 patient – regimen 26) and IRS-III (6 patients – 5 patients on regimen 36 and 1 on pilot regimen 29). The group consists of 4 males and 3 females ages 6, 13, 14, 15, 16, 17 and 17 years respectively. Five had cranial par meningeal sarcoma and two had par spinal sarcoma, each of the latter with cord compression at diagnosis. Five had Group III disease; 2 had distant metastases in the lung or bone marrow. All received radiation (cranial in 3, cranial + chord in 3, chord in 1) and triple intrathecal chemotherapy. Neurologically, symptoms of lower extremity weakness were noted at 51/2 to 91/2 months after iniation of systemic chemotherapy in 5 of the 7 patients; all 5 apparently had bladder/bowel dysfunction, too, and an ascending polyneuropathy was usually noted. Two of these five patients died, one with a limited autopsy showed aspergillus in the brain plus radiation necrosis. The sixth and seven patients were somewhat different, inasmuch as both had chord compression (and therefore neurologic impairment) at the onset. Both are alive. All seven patients achieved CR status. After a careful review of the patient records and radiation, systemic and intrathecal chemotherapy doses received by these patients it is not apparent what factor(s) caused these complications. However, it is felt that the doses of prophylactic (neg. CSF cytology) intrathecal chemotherapy should be cut back to those now used for CNS leukaemia and that intrathecal therapy should be limited to 4 doses in 20 weeks, after which no further intrathecal chemotherapy is to be given. Patients already on CNS prophylaxis beyond 20 weeks should discontinue intrathecal therapy. Patients with positive CSF cytology or spinal cord involvement should be treated with the amended doses at the frequency called for in the protocol (Sect. 8.72). In addition the 'maximum' tolerance dose of radiation to the spinal cord should be no more than 4140-4200 cGy." Amendments Section 8.72 –(Amended doses for Triple Intrathecal Chemotherapy) Age <1yr(4ml) 1yr(4ml) 2yr(6ml) >3yr(8ml) >9yr(10ml) Mtx 6mg 6mg 9mg 12mg 12mg Hydro- 6mg 6mg 9mg 12mg 15mg cortisone Ara C 12mg 12mg 18mg 24mg 30mg 23 The reference to the amendment made to IRS-III is to be found in an article written by Dr Ruymann in the publication known as Haematology/Oncology Clinics of North America, published in December 1987. This article in fact was a report of the IRS Group itself. At p 634 Dr Ruymann observed as follows :- "The volume of radiotherapy has been significantly reduced in patients with par meningeal tumours without intracranial extension. Brain stem dysfunction in a small number of patients has prompted a new amendment in 1987, which reduced intrathecal chemotherapy. In addition, simultaneous intrathecal chemotherapy and radiotherapy have been avoided. The amended radiotherapy and chemotherapy management of par meningeal tumours on IRS-III is summarized in tables 8 and 9. Patients with a complete chord block by myelogram or MRI may require an immediate decompression laminectomy. A partial cord block should receive immediate radiation to the block if surgery is not elected." 24 As may be seen from the tables I have set out above and my earlier reference, the dosages of intrathecal chemotherapy administered under the direction of Professor O'Gorman-Hughes were in excess of the dosages recommended in the amendment to IRS-III. 25 It is plain from the statement of Professor O'Gorman-Hughes, tendered in evidence, and his answers to interrogatories, that, at the time when he commenced his treatment of the plaintiff, he was not aware of either the protocol established by IRS-III or its amendment. As I have already mentioned, part of his planned treatment for the plaintiff was based upon the protocol established by IRS-II. 26 It is the fact that neither of the defendant's were full members of the IRS Group. However, the Prince of Wales Children's Hospital was a corresponding member of the IRS Group. Indeed, at the relevant time, the corresponding member of the IRSG at the first defendant was Dr Leslie White, a paediatric oncologist. Dr White deposed that, at the relevant time, namely between 1986 and 1989, he did not receive from the IRS Group the IRS-III protocol, or the amendment made in June 1987. However, in cross-examination Dr White conceded that he had in 1988 possession of minutes of a meeting of the Paediatric Oncology Group (POG) in Orlando Florida in which reference was made to the existence of IRS-III. This resulted in the following exchange taking place in cross-examination :- " Q an I suggest to you, if you just go to p 239 of that document, if I might approach, that there is a summary, would you not agree, of the IRS-III study on one page setting out the various treatment protocols that were current at the time as suggested under IRS-III, in summary form? A That is correct. That is called the schema, yes. Q Can I suggest to you that the schema that was in your possession at the beginning of 1988 revealed that with respect to group II-IV intracranial extension negative CSF patients, the intrathecal medication, methotrexate, Ara-C and hydrocortisone, that was recommended was recommended to be administered at weeks nought, 6, 12 and 20. A That is exactly what it states there. Q Yes. A fair reading of that document would suggest, would it not, that that was, in a schematic form, the current IRS protocol that was in existence with respect to those patients when you had this document during the course of 1988? A That would be true. Q Can I suggest to you that in relation to – and you might not recall the detail of this at the moment – the administration of intrathecal chemotherapy under IRS-II, or IRS-III before it was amended, that with group II-IV patients with negative CSF and intracranial extension, the administration of intrathecal chemotherapy was more frequent than the nought, 6, 12 and 20 weeks that's provided for in this schema – or is that a detail that you now can't remember? A It is a detail I can't remember and I haven't had reason to specifically try and recollect. But, no, I haven't thought about that question. Q In any event, in the beginning of 1989, if Professor O'Gorman-Hughes had asked you as to whether or not you had any documentation in relation to the current IRS protocol, you, on searching through your documents, as you have for the purpose of this case, would have pointed out to him or made available to him this document from POG that you had in your possession at that time; that's so, isn't it? A I think the answer to that is yes. It is also true that I would have normally circulated the document as part of my usual communication with the team. But it was a large document. But certainly it would have been available to all the members of the team. Q Can I just go back. It is not only with respect to intracranial extension patients with negative CSF that the frequency of IT medication is provided for in the way that I have just been over with you – nought, 6,12 and 20 weeks – but, also, the same frequency of TIT is represented as being part of the then current IRS protocol with respect to base of skull erosion and/or cranial nerve group II-IV patients; that's right, isn't it? A That is what it says, yes." 27 As I have already stated, at the time when Professor O'Gorman-Hughes commenced his treatment of the plaintiff he was unaware of the existence of the protocol IRS-III or its amendment. However, Dr White's evidence indicates that, at the relevant time, there was information available at the Prince of Wales Children's Hospital which referred to the existence of the latter protocol. The inference I draw from these circumstances is that there was a breakdown in communication, because, as Professor O'Gorman-Hughes was using an IRS protocol as part of the basis on which he was formulating treatment, he should have been made aware by the corresponding member of the new protocol – which in fact of course had been in existence for some five years at the time when the plaintiff's treatment was commenced. 28 Indeed, it was not until late 1989 that Professor O'Gorman-Hughes became aware of Dr Ruymann's article. He became so aware when, following the complications which had set in to the plaintiff's recovery, he carried out research in order to determine why it was that she was so suffering. Initially the defendant's pointed out that the Prince of Wales Children's Hospital did not subscribe to the journal Haematology/Oncology Clinics of North America in the period 1987 to 1990. However, evidence has now revealed that this journal was in fact available in the medical library of the University of New South Wales (of which institution Professor O'Gorman-Hughes was an Associate Professor at the relevant times). 29 At the same time it must be borne in mind that the publication in which Dr Ruymann's article appeared was not well known and indeed in its early days at the relevant time. The obscurity of the journal in 1989 was outlined in the evidence of the English paediatric oncologist, Dr P N Plowman, in cross-examination. The following exchange occurred :- " Q You are aware, aren't you, that in late 1989 Professor O'Gorman-Hughes noted a reference to an article by Dr Ruymann in the Haematology/Oncology Clinics of North America publication, entitled, 'Rhabdomyosarcoma in children and adolescents: a review'. Are you aware of that or not? A Yes. I am aware of it now. I was not aware of it then, and I have a copy in front of me. Q I want you to assume that in late 1989, Professor O'Gorman-Hughes unearthed that article. He found a reference to that article by Dr Ruymann. Do you understand? A I understand, yes. I think you would have been quite clever to have found it, but, yes. Q In any event, can I suggest to you that a person with the research skills as to be so clever as to find an article of that type, he is the very type of person that should, if available, have been the type of medical practitioner in charge of the management of Monique, particularly in relation to a decision as to whether or not to administer intrathecal chemotherapy; would you agree with that? A Well, I think that rather reflects on the author, if I may say so. That article is a review article in an unknown journal. It was a new journal with an impact factor of virtually zero. So it is, in our parlance, not accepted as a high-rating paper. Nor would it be one that one would be expected to have seen. So I don't accept that. I don't accept that unreservedly, no." 30 While it is the fact that Professor O'Gorman-Hughes did not read the subject article prior to commencing his regime of treatment of the plaintiff, it is equally true that prior to so commencing he had discussed the treatment of the plaintiff with other oncologists at the Prince of Wales Children's Hospital, including Dr White. In my view, it was entirely reasonable for Professor O'Gorman-Hughes to expect that Dr White would have been in a position, as corresponding member of the IRS group, to advise him of any relevant protocol changes which had occurred since IRS-II. It is apparent from the evidence that he received no such advice. 31 It is of course the plaintiff's case that Professor O'Gorman-Hughes should have :- a) been aware of the existence of IRS-III, and its June 1987 amendment; b) followed it by reducing the amounts of the chemotherapeutic agents used in the patients care and; c) that it would have been prudent in any event, having become aware of the changes made, particularly by the IRS-III amendment, to have discussed the matter with members of the IRS group in North America. 32 The plaintiff's case, in so far as it relied upon Professor O'Gorman-Hughes following the reduced dosages recommended by the 1987 amendment to IRS-III, was starkly brought into relief by the following question and answer in re-examination of Dr Plowman (who had been called by the defendant) : " Q If he had been aware of the 1987 amendment, would it have been unreasonable of him not to have followed it in his clinical judgment? A Yes, I agree with that. If he had been aware of it, he should have followed it, yes." 33 But he was unaware of it. Had he been aware of it I am of the view, on a balance of probabilities, that Professor O'Gorman-Hughes would have sought advice from members of the IRS group as to the problems they had encountered by way of highly undesirable side effects from the administration of the regime of chemotherapy being administered under protocol IRS-III. 34 I so find because of Professor O'Gorman-Hughes' actions after the plaintiff's myelitis became evident. Early in 1990 he contacted a number of members of the IRS group, including Professor Bleyer who gave evidence in this court. This response is indicative to me that, had Professor O'Gorman-Hughes been aware of the existence of IRS-III, and its amendments, he would not only have modified the regime he prescribed for the patient, but also would, in all probability, as he later did, get in touch with relevant members of the IRS group to obtain their advice and assistance. The fact that he did not is, in my view, not attributable to any error on his part but he was not informed, as he should have been, by the corresponding member of the IRS group at Prince of Wales Children's Hospital, Dr White, of the amended protocols. 35 I make these findings in the light of the present common law of Australia in relation to the duty of care owed by medical practitioners. A medical practitioner has a duty to exercise reasonable care and skill in the provision of professional advice and treatment; and the standard expected of a medical practitioner is that of an ordinary skilled person exercising and professing to have that special skill; (see Rodgers v Whitaker (1992) 175 CLR 479 at 483, 487). It follows that Professor O'Gorman-Hughes owed the plaintiff a duty to exercise reasonable care and skill in the provision of paediatric oncology advice and treatment and the standard expected of him was that of an ordinarily skilled paediatric oncologist. A similar duty was cast upon the Prince of Wales Children's Hospital. 36 As far as the scope of the extent of the duty owed by a medical practitioner to a patient is concerned the common law in Australia has departed from that which pertains in England. 37 In England a medical practitioner can not be found in breach of his duty of care if he acts in accordance with the practice accepted at the time as proper by a responsible body of medical opinion, even though other medical practitioners may have adopted a different practice; (see Sidaway v Governors of Bethlem Royal Hospital [1985] AC 871 at 881). In sharp distinction to this statement of principle is what fell from the New South Wales Court of Appeal in Albrighton v Royal Prince Alfred Hospital [1982] NSWLR 542. In particular, Reynolds JA at 562-3 departed from any such notion when he said :- "It is also, in my view, based on a wrong assumption that a jury should be directed that, if what is charged as negligence is shown to have been done in accordance with the usual and customary practice and procedure then prevailing in what was called a particular 'medical community' they cannot find negligence. This, in my opinion, is clearly wrong, because it is not the law that, if all or most of the medical practitioners in Sydney habitually fail to take an available precaution to avoid foreseeable risk of injury to their patients, then none can be found guilty of negligence … though evidence of local practice is admissible as to whether what was done constituted negligence, local practice provides no basis for the exclusion of evidence by experts lacking local experience as to the correct way in which a particular treatment should be performed, or whether a particular treatment should be given at all." 38 The question of whether or not a medical practitioner is in breach of the duty of care imposed upon him will vary from case to case. In Rodgers v Whitaker at 489 it was observed :- "the factors according to which a court determines whether a medical practitioner is in breach of the required standard of care will vary according to whether it is a case involving diagnosis, treatment or the provision of information or advice; the different cases raise varying difficulties which require consideration of different factors." 39 In this case the plaintiff has submitted that there are more rigorous obligations imposed upon a doctor where the nature of the treatment is more risky, or the chances of catastrophic complications are heightened. Furthermore, where there are grave risks involved, the standard demanded of the attending doctor will need to be greater. Reliance was placed upon Mason J's formulation of the test of foreseeability in Wyong Shire Council v Shirt (1980) 146 CLR 40 at 47-8, the majority reasoning of the High Court in Burnie Port Authority v General Jones Pty Ltd (1994) 179 CLR 520 at 54 and what fell from McHugh J in Woods v Multi-Sport Holdings Pty Ltd (2002) 208 CLR 460. At 482 McHugh J said :- "Industry custom and practice can guide but cannot determine whether a person is in breach of a common law duty of care. They are often a good indication of what is reasonable in the conduct of a particular trade, business, profession or activity. But when the risk of injury is high, the effect of injury likely to be serious and the cost of eliminating the risk of the injury small, it is unlikely that industry custom or practice will negate a finding of negligence. Indeed, in Turner v the State of South Australia , Gibbs J said: 'Where it is possible to guard against a foreseeable risk which, although perhaps not great, nevertheless can not be called remote or fanciful, by adopting a means which involves little difficulty or expense, the failure to adopt such means will in general be negligent.'" 40 The Plaintiff rightly submitted that these principles apply to cases such as the present. The plaintiff submitted as follows :- "Here, serious and potentially lethal risks were foreseeable if care was not exercised in the balancing act referred to during the course of the hearing. Additional care and diligence was therefore required to ensure the plaintiff's treatment was based on the best information available at the time. The scope of the defendants' duty of care was to take active steps in the management of the plaintiff's cancer so as to reduce, as far as possible, the prospect of harm to her. It entailed a degree of diligence that, as far as possible, guaranteed the prescription of treatment in accordance with the most current and considered guidelines available in the world. It is submitted that customary professional practice about what was "reasonable" is not enough to avoid a finding that Dr O'Gorman-Hughes breached his duty of care to the plaintiff." 41 However, in relation to the last part of that submission, it follows from my findings of fact that I am of the view that Professor O'Gorman-Hughes, in seeking advice from Dr White, in that latter doctor's capacity as the corresponding member of the IRSG, was utilising a degree of diligence which would guarantee the prescription of treatment in accordance with the most current and considered guidelines available in the world. It was either Dr White's failure to make himself aware of what had fallen from the meeting at Orlando, Florida, in 1988, from whence the relevant minutes referring to IRS-III had emanated, or he had failed to establish a system, perhaps carried out by his delegates, for the proper dissemination of information received from the IRS. It is my view that Professor O'Gorman-Hughes would, as he subsequently did, have sought advice from IRS members had he been aware of the alteration in protocol which occurred in June 1987, particularly as it related to the prescription of dosages of chemotherapeutical agents. On the other hand, the Prince of Wales Hospital, being vicariously liable for the actions of its staff specialist Dr White, is in my view liable for what I regard as a breach of duty to the plaintiff, in that information which should have been made readily available to those charged with the onerous and difficult task of carrying out practice as paediatric oncologists was not provided. Accordingly, in this regard, while I do not regard Professor O'Gorman-Hughes as being in breach of the duty of care imposed upon him I find that the hospital is in breach of its duty. 42 However the matter does not end there. While there was no dispute that the plaintiff's quadriplegia was the result of the treatment that she received at the hands of the defendants' an issue as to causation was raised. 43 Underscoring the raising of this issue is the fact that no expert could positively identify which part of the treatment received by the plaintiff gave rise to her quadriplegia. 44 In determining the issue of causation a courts function is different from that of science. Spigelman CJ put it this way in Seltsam Pty Limited v McGuinness (2000) 49 NSWLR 262 at 286 :- "When assessing expert evidence on causation, the legal concept of causation requires the court to approach the matter in a distinctively different manner from that which may be appropriate in either philosophy or science, including the science of epidemiology. The commonsense approach to causation at common law is quite different from a scientist's approach to causation. An inference of causation for purposes of the tort of negligence may well be drawn when a scientist, including an epidemiologist, would not draw such an inference. (authorities omitted)." See also EM Baldwin v Plane (1998) 17 NSWCCR 434 at 449. Essentially, the question for the court to determine is whether or not the defendants' breach contributed to the plaintiff's damage. If the court so finds, then the fact that the plaintiff might have suffered the injury in any event does not, in any way, militate against the plaintiff succeeding (see Commonwealth v McLean (1946) 41 NSWLR 389 at 410-11). It is trite law that any tortfeasor whose act has been approximate cause of the injury suffered by the plaintiff is liable to compensate the plaintiff for the whole of the injury (see Dingle v Associated Newspapers Ltd (1961) 2 QB 163 at 188). In other words, if a defendant's breach of duty has materially contributed to the damage suffered by the plaintiff the plaintiff will succeed on the issue of causation (see E M Baldwin v Plane at 449). 45 Bearing those principles in mind, I turn to the evidence relating to this issue. 46 The plaintiff's case on causation was pithily stated by Professor Bleyer as early as 15 May 1990 in a letter he wrote to the second defendant. Professor Bleyer, despite extensive cross-examination, did not resile at any stage from the view that he expressed so long ago. In that letter he stated :- "1. Monique has a myelopathy attributable to the combined effects of radiotherapy and chemotherapy. 2. The radiotherapy she received (46Gy in 26 fractions over 6 weeks) would have had a very small probability of causing myelopathy by itself. 3. The intrathecal cytosine arabinoside she received, especially the three doses given concurrently with radiotherapy, enhanced the effect of irradiation on the spinal chord. 4. The actinomycin-D administered after radiotherapy contributed to the myelopathy by inducing a "recall" reaction to the radiotherapy." Similar views were given in evidence by Professor Daphne Hass-Kogan, Professor M Stevens and Dr Martin Berry. 47 Concessions made in cross-examination by certain of the experts called by the defendant, in my view, reinforce the plaintiff's case on causation. For instance Professor Kellie deposed as follows :- "Q . Some evidence was given orally in the case by the plaintiff's experts about the likely outcome for Monique if a different regime of treatment had been given. In the first instance, do you accept, with the knowledge that the medical profession now has, that the TIT did not make a difference to her outcome? (referring to survival) A. I believe that would be the case. Q. Are you able to express an opinion about whether, on the injuries she suffered, that side of things, the administration of 70 mg of Ara-C produced a different result from that which would have been produced by 30mg? A. There is no data on which to base an answer to that question. Q. How does the increased frequency of the dosage of the TIT, over and above that which is contained in the 1987 amendment, make a difference, or are you not able to say? A. Well, we can only answer that by saying that in the Australian experience, using six doses in two weeks, we didn't come across instances like that." Dr D'Angio was cross-examined as follows :- "Q. Do you say that there is sufficient information within the medical profession and learning to determine whether, if Monique had been given 30mg of Ara-C per injection rather than 70, there would have been a difference in the outcome for her? A. I couldn't answer that. There is no information regarding that particular point of which I know. Q. Is there any information there concerning the frequency of the dosage during radiation therapy or not during radiation therapy, for the administration of TIT? A. I am not quite sure I understood. Q. Well, let me put it to you this way. During the course of the radiation, Monique received three doses of triple intrathecal chemotherapy and one dose of methotrexate and hydrocortisone. Had she been treated in accordance with the third IRS protocol as amended, she would have received one course of triple intrathecal therapy during the radiation period. Is there any medical knowledge to say whether the difference in those two frequencies would have made a difference in her outcome? A. Not that I know. Q. In the event of TIT having been administered as recommended by the June 1987 amendment, there would have been significantly less adverse neurotoxic effects upon Monique's spinal chord in the circumstances of the radiation therapy that was provided – that is less than the adverse neurotoxic effects that she was in fact exposed to in view of the course of TIT that was administered? A. The data did bear that out, yes." I should add that Counsel for both parties, during the course of submissions, attacked the credibility of certain of the expert witnesses called by the opposite party. Without dealing with those submissions in detail, I believe it appropriate for me to state that in my view all of the expert witnesses called in this case, whether by the plaintiff or by the defendants', struck me as being witnesses who were doing their level best to give a truthful and honest account of their views on the subject matter they were addressing. 48 When the concessions I have detailed above are read in conjunction with the evidence of the plaintiff's experts, I am of the view that the plaintiff has established, to the requisite degree, the third postulate of causation outlined by Professor Bleyer. 49 I summarise my findings as to both breach and causation in this regard as follows :- That the first defendant, by not advising Professor O'Gorman-Hughes of the existence of IRS III (or indeed its 1987 amendment), caused, at the least, the prescribing and intrathecal administration of overdoses of cytosine arabinoside, which in turn caused the plaintiff's myelopathy and consequent quadriplegia. This finding, as I have stated, results from the utilising of the requisite standard of proof. It is not a finding which I would have made if I had applied the criminal standard of proof – namely proof beyond reasonable doubt. It follows that it would not have been made if my findings had to be based on scientific certainty. 50 A live issue arose in relation to the fourth of Professor Bleyer's postulates in relation to the administration of actinomycin-D. While it was suggested in the plaintiff's case that a longer delay should have been had between the administration of this drug and the cessation of radiotherapy, (to obviate the risk of a "recall" phenomenon), the fact is that the time interval between the two therapeutic modules satisfied the requirements of IRS III, both in its original form and as amended. What is in my view the strength of the plaintiff's case is the quantity of the dosage administered. As may be seen by an examination of the table outlining the therapy actually administered and the amount of Act-D stipulated by the amendment to IRS III to be administered, the amount actually given is in excess of that stipulated by the protocol. Not only that, the amount given by the first defendant's staff was in excess of that prescribed by Professor O'Gorman-Hughes. In these circumstances, again applying the requisite standard of proof, I am of the view that the plaintiff has made out her case in this regard. Accordingly, the plaintiff is entitled, on both limbs of Professor Bleyer's postulates, to succeed against the first defendant. 51 The remaining issue for determination is that of the plaintiff's allegation that the defendants' failed to warn her parents fully about the proposed therapy. In this instance the plaintiff relied on what has fallen from the High Court in Rogers v Whitaker (1992) 175 CLR 479; Chappel v Hart (1998) 195 CLR 232 and Rosenberg v Percival (2001) 205 CLR 434. In Rogers v Whitaker at 490 the majority of the High Court found as follows :- "The law should recognize that a doctor has a duty to warn a patient of a material risk inherent in the proposed treatment; a risk is material if, in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. This duty is subject to the therapeutic privilege." In Rosenberg v Percival, Gummow J at 458 said this :- "Clearly, in cases of a medical practitioner's failure to warn, the extent or severity of the potential injury is of great importance in applying the test in Rogers of "likely to attach significance to", as is the likelihood of the injury actually occurring. These two matters, the extent or the severity of the potential injury and the likelihood of it coming to pass, are to be considered together. A slight risk of a serious harm might satisfy the test, while a greater risk of a small harm might not. It is also important to note that, in considering the severity of the potential injury, that severity is judged with reference to the plaintiff's position. Thus, the risk of blindness in one eye would ordinarily be considered serious; if however, as in Rogers , the patient is already blind in one eye and stands to lose sight entirely, that risk becomes one of an altogether greater magnitude. These considerations need to be weighed against the circumstances of the patient. The patient's need for the operation is important, as is the existence of reasonably available and satisfactory alternative treatments. The patient may be more likely to attach significance to a risk if the procedure is elective rather than life saving. As will be seen, these factors merge with the issue of causation. The second, or subjective, limb of the test in Rogers for material risk requires further discussion. The second limb recognises that the particular patient may not be a 'reasonable' one; he or she may have a number of 'unreasonable' fears or concerns. These will be given full weight under the second limb if the medical practitioner was or should have been aware of them One way of satisfying that condition is if the patient asked questions revealing the fear or concern. However, that is not the only means of satisfying the second limb. There is a multitude of potential circumstances in which a court might find that the medical practitioner should have known of a particular fear or concern held by the patient. Courts should not be too quick to discard the second limb merely because it emerges that the patient did not ask certain kinds of questions. The phrase 'likely to attach significance to' as it appears in both limbs does not present a threshold issue of the same nature as to that presented by the issue of causation. In the authorities, reference has been made to 'information that is relevant to a decision or course of action' and 'matters, which might influence the [decision]'. It is not necessary when determining materiality of risk to establish that the patient, reasonable or otherwise, would not have had the treatment had he or she been warned of the risk in question. The test is somewhat lower than that. However, it is necessary that the reasonable patient or particular patient respectively would have been likely seriously to consider and weigh up the risk before reaching a decision on whether to proceed with the treatment. The authorities referred to above should be read in that way." The plaintiff's case, in this regard, was that Professor O'Gorman-Hughes did not warn the plaintiff's parents that the intrathecal therapy proposed could cause paraplegia or quadriplegia. Mrs King did depose that Professor O'Gorman-Hughes did in fact warn both her late husband and herself of the risk of some very serious side effects, which could result from the administration of that therapy. However, she was adamant that at no time were the risks of paraplegia or quadriplegia raised by Professor O'Gorman-Hughes. Indeed, Mrs King produced a document which she stated her husband had created at the time of the interview during which the possible side effects of the therapy were explained to them both. There was no mention on that document (which was admitted without objection as being a contemporaneous note taken by the late Mr King) of the risks of paraplegia or quadriplegia. Indeed, Professor O'Gorman-Hughes, in his answers to interrogatories and in a document apparently prepared by him called Factual Assumptions, does not specifically deny that he did not tell the plaintiff's parents of that risk, in terms of it being a side effect of intrathecal chemotherapy. In his answers to interrogatories he said this :- "11A. Did the second defendant ever warn the plaintiff that the proposed course of treatment including intrathecal chemotherapy had known toxic consequences, particularly intrathecal methotrexate and Cytosine Arabinoside? 11B. I warned the family of the dangers of the plaintiff developing paraplegia or quadriplegia. I cannot recall specifically discussing this as a risk of intrathecal therapy but did explain what was likely to be the most likely cause of paraplegia or quadriplegia, namely progression of the tumour. I also pointed out the risks of combining radiotherapy with actinomycin D, as such combinations of treatment when given within a close time interval can increase tissue damage within the radiation area. I cannot recall specifically mentioning the risks of neural damage resulting from the use of intrathecal methotrexate or cytosine arabinoside, but had mentioned the above two most likely causes of paraplegia and quadriplegia. I also mentioned to the parents our experiences with a child with a spinal parameningeal soft tissue sarcoma treated by Dr Mameghan (radiotherapist) and me about 18 months previously. Despite treatment with local irradiation and intrathecal methotrexate this child developed meningeal spread, recognised by the detection of malignant cells in the spinal fluid, which progressed despite the use of further intrathecal therapy incorporating cytosine arabinoside and she finally developed paraplegia, and died. The risks of paraplegia were explained to the King family, but it was felt that this would most likely be due to the effects of tumour progression." At paragraph 11 of his statement, which was admitted into evidence, he said this :- "I explained to the parents the high risk of further extension of the sarcoma through the meninges and cerebrospinal fluid, as had occurred in the previously mentioned child, and of even developing paraplegia or quadriplegia mainly due to extension of the tumour. The timing of radiotherapy, intrathecal and systemic chemotherapy was discussed also. On the basis of our pathologist's findings Dr Mameghan and I considered that the above plan should be carried out. Our colleagues at the Paediatric Oncology meeting agreed generally with our recommendations. " Indeed Professor O'Gorman-Hughes, in the document entitled Factual Assumptions, announced his state of awareness of the possibility of paraplegia as follows :- "Professor O'Gorman-Hughes was not aware at the time that there were suggestions that intrathecal therapy with cytosine arabinoside (Ara-C) in association with systemic chemotherapy may cause neurotoxicity or myelitis." 52 The plaintiff's mother stated that had she and her husband been made aware of the risk of paraplegia or quadriplegia arising from this therapy they would have sought a second opinion – even from America. 53 Essentially, what I would understand Professor O'Gorman-Hughes to have done was to advise the plaintiff's parents that she was suffering from a life-threatening tumour and that radical therapy was needed in order to save her life. There is no doubt that he warned the parents that certain catastrophic side effects could accompany that therapy – albeit he did not mention in relation to the therapy the risk of quadriplegia or paraplegia. Mrs King fairly conceded that she and her husband trusted Professor O'Gorman-Hughes. In my view the defendants submission that even if a warning had been given in relation to the therapy that it might cause quadriplegia or paraplegia the plaintiff's parents would have given permission for the therapy to be carried out. In other words, I am of the view that this is not an appropriate case for the applicability of the principles falling from cases such as Rogers v Whitaker. Accordingly, in my view, this part of the plaintiff's claim cannot succeed. 54 It follows in my view that there should be a judgment for the plaintiff against the first defendant in the sum of $7,000,000. There will be a judgment for the second defendant. In my view the plaintiff properly joined the second defendant in the action and accordingly I am of the view that the appropriate costs order is that the first defendant pay the costs of the plaintiff and the second defendant. ********** DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated.