Hassan v The Minister for Health [No 2]
[2008] WASCA 149
•18 JULY 2008
JURISDICTION : SUPREME COURT OF WESTERN AUSTRALIA
TITLE OF COURT : THE COURT OF APPEAL (WA)
CITATION: HASSAN -v- THE MINISTER FOR HEALTH [No 2] [2008] WASCA 149
CORAM: STEYTLER P
MILLER JA
EM HEENAN AJA
HEARD: 1 FEBRUARY 2008
DELIVERED : 18 JULY 2008
FILE NO/S: CACV 130 of 2005
BETWEEN: TAHANY HASSAN
Appellant
AND
THE MINISTER FOR HEALTH
Respondent
ON APPEAL FROM:
Jurisdiction : DISTRICT COURT OF WESTERN AUSTRALIA
Coram :CRISFORD DCJ
Citation :HASSAN -v- MINISTER FOR HEALTH [2005] WADC 182
File No :CIV 2082 of 2002
Catchwords:
Negligence - Medical negligence - Causation - Appeal from judgment dismissing claim for damages for personal injuries and associated losses - Obstetric emergency - Therapeutic hysterectomy - Induced labour following foetal death in utero - Complications associated with abnormal placental adherence and placental detachment - Misoprostal trial to induce labour - Whether informed consent given to participation in Misoprostal trial - Life threatening haemorrhage following placental detachment - Emergency hysterectomy essential to reduce haemorrhage - Risk of haemorrhage because of nature and complications affecting pregnancy
Legislation:
District Court of Western Australia Act 1969 (WA), s 39(1)
Hospitals and Health Services Act 1927 (WA), s 7
Result:
Appeal dismissed
Category: B
Representation:
Counsel:
Appellant: In person - written submissions
Respondent: Mr D R Clyne
Solicitors:
Appellant: In person
Respondent: Dibbs Abbott Stillman
Case(s) referred to in judgment(s):
Beamish v The Queen [2005] WASCA 62
Chappel v Hart [1998] HCA 55; (1998) 195 CLR 232
McKenzie v McKenzie [1970] 3 WLR 472
Mickelberg v The Queen [2004] WASCA 145; (2004) 29 WAR 13
Rogers v Whitaker (1992) 175 CLR 479
Schagen v The Queen (1993) 8 WAR 410
Schellenberg v Tunnel Holdings Pty Ltd [2000] HCA 18; (2000) 200 CLR 121
STEYTLER P: I agree with EM Heenan AJA.
MILLER JA: I agree with EM Heenan AJA.
EM HEENAN AJA:
Introduction
On 8 January 1999, that is, during the 18th week of her sixth pregnancy, an ultrasound examination conducted by a general practitioner confirmed that the appellant had experienced a foetal death in utero. Further investigations confirmed the death of the foetus and, therefore, the appellant was admitted to King Edward Memorial Hospital (KEMH) on 11 January 1999 to undergo an induced labour for uterine evacuation to remove the dead foetus and the associated products of gestation. The clinical method selected for this process was artificial induction of labour and, for this purpose, the appellant was invited to participate in a clinical trial of the use of the prostaglandin, Misoprostal, for the induction of labour. Misoprostal and other prostaglandins are now often used for the induction of labour, particularly in cases of termination or expulsion associated with foetal death, in early stages of pregnancy. This particular trial was designed to test for suitable dosages of the drug in second trimester terminations. The trial was being conducted by a senior obstetrician at the hospital, Dr Jan Dickinson. It had been approved by, and was under the supervision of, the hospital clinical authorities.
I will describe the course of the induced labour in more detail later. For now, it is only necessary to say, that as the labour progressed, difficulties were experienced in the rate of progress. There was maternal bleeding which, at first, was relatively small but, as time went on, increased to a serious degree. This led to a decision to take the appellant to theatre where delivery was eventually achieved but accompanied by much further bleeding.
After the delivery of the foetus and when attempts were being made to detach and remove the placenta, a massive haemorrhage resulted with immediate life threatening consequences. Every effort was made to stem or control the haemorrhage, but it quickly became apparent these efforts would not succeed. Accordingly, as an emergency measure, a total hysterectomy was performed and remaining sources of bleeding were successfully quelled. After a difficult post surgical recovery period the appellant has, fortunately, been restored to reasonable health but, of
course, without her uterus, is incapable of having children and is subject to the other consequences of having had an hysterectomy.
The appellant brought an action in the District Court of Western Australia against the Minister for Health, which is the statutory corporation responsible for the management of KEMH under s 7 of the Hospitals and Health Services Act 1927 (WA). Essentially, the negligence or breaches of duty alleged to support the action fall into the following main categories:
(a)the admission of the appellant into the Misoprostal case study was said to be negligent and in breach of duty because the appellant's history, to the knowledge of Dr Dickinson, should have made it apparent that severe complications could be expected;
(b)the alleged negligent failure of Dr Dickinson and other staff at the hospital to utilise a different method for the induction of labour and, in particular, to use a dilatation and curettage (D&C) or an hysterectomy;
(c)the alleged failure or neglect by medical staff to attend upon and take appropriate action during the course of the induced labour once significant blood loss occurred; and
(d)the alleged failure by Dr Dickinson and other staff to warn the appellant of a material risk, namely, the risk of hysterectomy.
The appellant also relied upon the doctrine of res ipsa loquitur, but this was not pursued with any vigour at the trial or on the appeal. Having regard to the explanation for the causes for the complications which emerged both at the trial and during the course of the appeal, this could not possibly have led to a finding of negligence - see Schellenberg v Tunnel Holdings Pty Ltd [2000] HCA 18; (2000) 200 CLR 121.
The appellant also alleged that, in addition to experiencing an unnecessary hysterectomy, she had suffered further injury, loss and damage, including: injury to the heart, severe and unremitting pain, severe shock, post traumatic stress disorder, other associated consequences and that she has since developed anxiety, a major depressive disorder and related clinical and psychological symptoms.
By its defence, the respondent denied negligence or breach of duty as alleged or at all; pleaded that a real and informed consent was given by the appellant to undergo operative treatment and anaesthetics, including such further alternative operative measures as may in the course of the operation be considered necessary; and that the appellant was expressly advised that there was a risk that she may require an hysterectomy. The respondent also specifically pleaded that a real and informed consent was given by the appellant to participate in the Misoprostal study. Importantly, the respondent also pleaded that the hysterectomy and the resulting disabilities of which the appellant complained were caused or contributed to by previous problems associated with earlier complex pregnancies. These comprised four earlier caesarean section deliveries, the location and adherence of the placenta occurring with this last pregnancy and significant chronic medical conditions rendering the appellant a high surgical risk, including hypertension; deep vein thrombosis (DVT) - thought to be due to a clotting disorder; anxiety and hypothyroidism. By its defence the respondent then identified a series of steps associated with the induced labour and pleaded that appropriate responses were taken by its staff. It is unnecessary to describe these at present because they feature fully in the history which follows later in these reasons of progress in the procedure.
The trial of the action in the District Court before Crisford DCJ took three weeks, and occurred in two segments split by a lengthy adjournment. Her Honour dismissed the appellant's claim and ordered her to pay the respondent's costs. The essential findings made by the learned trial judge were that Dr Dickinson had failed to discharge her duty of care to the appellant by failing to advise her adequately of the risks associated with the evacuation of the foetus and, in particular, in failing to advise her of an alternative available procedure of dilatation and evacuation (D&E). Nevertheless, her Honour concluded that none of these failures caused or contributed materially to the ensuing hysterectomy which, rather, was the result of the appellant's prior obstetric history and associated unavoidable complications with this pregnancy.
A prominent feature of these complications was the condition of placenta praevia, or, although it is an issue of controversy, placenta accreta, in this particular case, compounded by significant intrauterine scarring following the earlier caesarean section deliveries. This made placental detachment difficult and the risk of severe haemorrhage high. Generally speaking, all the consultant medical opinion was to the same effect, namely, that the emergency hysterectomy was essential once the severe haemorrhage developed. Her Honour accepted that, once the severe haemorrhage occurred, then the hysterectomy was inevitable and the only life saving procedure which could be taken.
From that decision, the appellant has appealed to this court on numerous grounds, the more significant of which are that:
•consent for an hysterectomy was not obtained;
•that the use of Misoprostal caused the need for the hysterectomy;
•that one of the other possible procedures to deal with the evacuation of the dead foetus should have been employed and would have avoided the resultant hysterectomy; and
•the failure of Dr Dickinson to give appropriate warnings in relation to the use of the Misoprostal trial and the availability of other alternative methods of delivery was negligent and caused the events which led to the hysterectomy.
I have described these as principal grounds of appeal because, in my view, and with respect, they appear to be the only truly arguable grounds. The appellant, and her then husband, appear to have drafted the grounds of appeal and all the written submissions associated with the appeal. Not having any legal qualifications or experience, they can be pardoned for including other grounds which they, no doubt conscientiously, believe to be tenable but which, in my opinion, cannot survive scrutiny.
Initially, the respondent advanced a cross‑appeal and a notice of contention, the substance of which was to contend that the learned trial judge was in error in concluding that Dr Dickinson had failed to inform the appellant adequately of the risks associated with the Misoprostal trial, and hence to obtain her informed consent to participate in it and, further, that Dr Dickinson had failed to advise the appellant of the availability of an alternative procedure, namely, the D&E procedure, for the evacuation of the uterine contents. However, that notice of appeal and notice of contention was not pursued and was later discontinued.
Specific grounds of appeal
The appellant has formulated 10 grounds of appeal, each of which is supported by extensive submissions and allegations in the notice of appeal. These are in turn elaborated upon at great length by the two sets of written submissions.
At this stage, I shall simply enumerate the various grounds of appeal and make some comments about some of them in order to assign some degree of importance to particular grounds for the overall fate of the appeal. Having done that, I propose to examine the background of the case and the evidence in detail before returning, as necessary, to complete the treatment of individual grounds of appeal in the light of that analysis.
The grounds of appeal raised by the appellant are as follows.
First ground - Consent for hysterectomy was not obtained.
The appellant contends that the trial judge erred in failing to conclude that the respondent did not obtain the appellant's consent to the hysterectomy. This contention misconceives the real issue. The procedure that the appellant underwent was for the evacuation of a foetus that had died in utero; it was not for hysterectomy. Rather, the potential for hysterectomy was a risk; and one which the learned trial judge found the respondent had not adequately conveyed to the appellant. Despite that breach of duty, it was not found to be a cause of the appellant's hysterectomy or subsequent loss and damage.
Second ground - Failure to establish negligence on the balance of probabilities
This ground proceeds on the footing that the treatment given by Dr Dickinson, in particular the Misoprostal trial, caused the hysterectomy and that mere fact that the appellant, a person in good health when she was admitted to the hospital, could emerge afterwards with a loss of uterus and having endured a life‑threatening crisis, is of itself indicative of negligence. It plainly involves, although implicitly, an allegation that this alleged negligent mistreatment caused the hysterectomy.
Third ground - Cause of hysterectomy by the use of Misoprostal
Again, this suggests that it was the use of the drug Misoprostal which caused the hysterectomy. The finding of the learned trial judge was to the contrary.
Fourth ground - Inadmissible evidence
The appellant contends that the learned trial judge wrongfully admitted evidence of the respondent's experts, who, it was alleged, were neither impartial nor independent, and generally favoured the respondent's expert evidence over that of the appellant's.
Fifth ground - Evidence not taken into account
This ground contends that the learned trial judge failed to take into account relevant aspects of the appellant's past medical history and the use of the 'unlicensed drug' Misoprostal which had known risks and that Dr Dickinson did not heed these risks when using the drug on a patient with a history of previous caesarean section deliveries.
Sixth ground - Other alternatives would not have led to the same outcome
This ground contends that some other alternative method of evacuation would not have led to the outcome of an hysterectomy. It also appears to contend that the learned trial judge erred in finding that the appellant would, in any case, have gone ahead with the procedure even if the risk involved had been adequately disclosed.
Seventh ground - The attending to a high risk patient was negligence
This ground appears to challenge the findings that the nurses who looked after the appellant pre‑operatively were experienced nurses, that the medical notes were accurate and reliable and that Dr Dickinson had informed the appellant's husband at 3.00 am on 12 January 1999 that his wife had had an hysterectomy. In the submissions, however, the ground is enlarged to assert that the appellant was insufficiently or inadequately attended to prior to the hysterectomy and that Dr Dickinson did not attend on her adequately or at all in the ward.
Eighth ground - A finding of failure to warn should lead to establishing of negligence
As developed by the particulars and the submissions, this ground alleges further impropriety by the trial judge in:
•failing to give sufficient weight to the appellant's submissions relating to the credibility and reliability of witnesses, to the KEMH documents and to the case in general;
•that her Honour sought assistance and advice from another judge who had previously acted as counsel for the respondent, attempted to protect the respondent and its witnesses and acted against the interests of the appellant. This amounts to an allegation of direct bias; and
•a specific allegation of biased attitude towards the respondent, its witnesses and its employees.
Ninth ground - Injustice and unfairness to the appellant
This ground advances allegations that the trial judge acted in an unjust manner by generally favouring the respondent in the conduct of the trial and rejected the appellant's case on groundless and unsupported evidence.
Tenth ground - A failure to administer justice
This returns to the previous allegations that the trial judge made an error of law by finding a breach of duty of care but then failing to conclude that the failure to warn must, in one way or another, have contributed to at least the psychological injury suffered by the appellant. This also raises issues of causation.
At this point, I consider it desirable to segregate the various grounds of appeal into two main groups because, with all due respect to the appellant and the disadvantages which she has without formal legal representation, only those grounds which fall within the first category are truly arguable. The second category of grounds, alleging bias, misconduct, failure to take into account evidence, the wrongful admission of evidence and general partisanship, will also be examined but it is abundantly clear that there is no arguable basis for them to be maintained.
In my view, the first category of arguable grounds of appeal can be reduced to four, namely that:
(1)consent for an hysterectomy was not obtained (grounds 1, 3 and 5);
(2)that the use of Misoprostal caused the need for the hysterectomy (grounds 2, 3, 5 and 10);
(3)that one of the other possible procedures to deal with the evacuation of the dead foetus should have been employed and would probably have avoided the resultant hysterectomy (ground 6); and
(4)the finding that Dr Dickinson had failed to give appropriate warnings in relation to the use of the Misoprostal trial and the availability of other alternative methods of delivery was negligence and caused the events which led to the hysterectomy (ground 10).
In relation to the second category of grounds of appeal, which I do not consider give rise to any truly arguable grounds of appeal, these can be reduced to the following groups:
(a)Wrongful admission of evidence from the respondent's experts and general favouring of the respondent's experts to the prejudice of the appellant's case (grounds 4, 8 and 9). It includes submissions that certain of the respondent's witnesses, notably Professor Ellwood and Professor Trudinger, were well acquainted with Dr Dickinson and were her professional colleagues, so that they were not truly independent and should not have been permitted to give expert evidence;
(b)allegations of actual bias by the learned trial judge (grounds 8 and 9). This includes the utterly unsupported allegation that the trial judge improperly took advice from another judge who had been counsel for the respondent in the case; and
(c)failing to attend to a high risk patient (ground 7). This relates to the allegations that the trial judge erred in concluding that the nurses who cared for the appellant in the ward were experienced, that the hospital notes were not fraudulent and that Dr Dickinson had lied in saying that she had informed Mr Hassan, shortly after the hysterectomy, that that operation had, in fact, been performed on his wife because of the emergency which had arisen. All these are simply contrary to the evidence and are without the least support.
Were it not such a dire allegation, it might be possible simply to pass over the unsupported submission that the learned trial judge wrongfully took advice from another judge who had been counsel for the respondent. However, this is such a completely unjustified and extreme allegation that it must be dealt with specifically. It refers to the fact that counsel for the respondent during the early stages of the trial, that is, from 6 December 2004 until the trial was adjourned part‑heard on 17 December 2004 was Mr P P McCann. When the hearing of the trial resumed on 23 May 2005, he had been replaced by Mr D R Clyne of counsel. The reason for this change was that Mr P P McCann, was appointed a judge of the District Court of Western Australia and took up that office on 28 January 2005. This is the only fact relied upon by the respondent to allege improper collusion between the learned trial judge and the respondent's former counsel. For any legal practitioner to make such a serious unsupported allegation would be an act of professional misconduct. It reflects upon the probity of two judges and the District Court and the general administration of justice.
Appointment to the bench of counsel who have been engaged in cases which either continue before the court or come before a court such as this on appeal is a regular and unavoidable part of professional life. All judges and counsel are aware of, and observe strictly, the obligations of refraining to participate judicially in any case in which he or she was, before appointment, professionally retained, and to avoid disclosure about, or comment upon, a case of that nature. It is quite unthinkable that judges of the District Court, or of any court in this country, would behave as is alleged in this ground of appeal and the allegation is rejected as being utterly baseless.
In relation to the contentions that the learned trial judge should not have permitted opinion evidence from highly qualified medical specialists, who gave evidence for the respondent, because they were professionally acquainted with and knew Dr Dickinson, these are also quite groundless. Judicial notice can be taken of the fact that KEMH is the only tertiary obstetric and gynaecological hospital in this State. It is only natural that many of the leading consultants in obstetrics and gynaecology, maternal foetal medicine and neonatology work at KEMH or have close and frequent affiliations with that hospital.
The position is not materially different in other major obstetric and gynaecological hospitals in Australia. The number of specialists in foetal maternal medicine in Australia was revealed to be in the order of about 40. Professional cooperation, continuous professional education, research and professional exchanges all produce the desirable consequence that colleagues in similar fields are aware of each other's work, of developments in their fields and meet in professional venues such as conferences and the like. There is nothing insidious or improper about any of this, quite the contrary. The public interest requires mutual acquaintance and cooperation between specialists of this prominence. The fact that Dr Dickinson is known by Professors Ellwood and Trudinger, among others, is no reason to suggest that either of those persons is unable to give proper, independent, conscientious opinion or is affected by improper degrees of loyalty or sympathy as would give unreliable or distorted evidence. The learned trial judge rejected criticisms of that kind made against the reception of evidence from specialists Professor Ellwood and Professor Trudinger at the trial and was, in my view, undoubtedly right to do so.
Other criticisms that the learned trial judge acted unfairly or improperly amount to no more than dissatisfaction that her Honour, in a number of important respects, decided to accept some, but not all, of the evidence of witnesses who supported the respondent's case and rejected some evidence of witnesses who supported the appellant's case. That her Honour did this is indicative of nothing more or less than the performance of the necessary judicial function of deciding, after careful analysis and review, and with the assistance of full submissions, what conclusions should be drawn from all the evidence in the case having regard to the issues joined and the onus of proof. That in the performance of this task the learned trial judge made decisions which led to the rejection of the appellant's claim is not indicative of any bias, error of law or impropriety but is, rather, the discharge of the duty which her Honour was obliged to perform.
The judicial process of decision after giving detailed reasons by the judge for his or her conclusions enables those conclusions to be examined by a Court of Appeal on a rational basis and in the light of the evidence in the case. This trial and her Honour's reasons for decision proceeded on a conventional basis, with very detailed, considered reasons being given by her Honour. Those allow this court to determine this appeal in the performance of our jurisdiction and to determine appeals according to law. This is a fully transparent process and the case at trial and this appeal has been conducted by an entirely objective examination.
Course of proceedings and submissions
In [8] to [16] of the reasons for decision of the learned trial judge, her Honour described how, although initially represented by solicitors in this litigation, The appellant sought to act in person from January 2004 onwards and sought leave for her husband Mr Hassan, who is not legally qualified, to represent her in all court proceedings. Initially, the respondent opposed that application, but by the time of the trial in the District Court in early December 2004, that opposition was withdrawn and her Honour granted leave under s 39(1) of the District Court of Western Australia Act 1969 (WA) for the appellant to be represented by her husband as a 'McKenzie Friend' (McKenzie v McKenzie [1970] 3 WLR 472 - see also Schagen v The Queen (1993) 8 WAR 410). That course was adopted and Mr Hassan did appear at the trial as an advocate/representative of the appellant, made submissions, called and examined witnesses, cross‑examined the respondent's witnesses and made final submissions.
Although, in the end, this procedure allowed the case to be heard and determined on its merits, it was not without difficulties because, inevitably, the lack of legal knowledge and experience of Mr Hassan resulted in him misunderstanding the law relating to the admissibility of evidence and, to a degree, the significance of the issues in contest in the proceedings. Nevertheless, as Crisford DCJ has set out in her reasons for decision, a very full and adequate examination of the evidence adduced, having regard to the issues joined, was possible, and it is clear that the learned trial judge was at pains to ensure that a fair opportunity was afforded to the appellant and her husband to advance the case desired and to bring to the attention of the court the issues which they wished to have decided.
The institution and prosecution of this appeal has also been conducted by the appellant without the benefit of professional legal representation. The grounds of appeal, the preparation of the appeal books and submissions and other procedural steps were all undertaken by the appellant personally or with the assistance of her husband. Again, the lack of legal professional training and experience is evident in the papers which have been filed but, notwithstanding that, by making due allowances, it is possible to identify and attend to the issues of substance which the appellant desires to have determined by this appeal. However, this lack of familiarity with the rules and legal doctrine meant that there were a series of difficulties and delays in the completion of the papers necessary for the institution of the appeal. Some of these resulted in references to single judges of this court, but it is unnecessary to dwell on the detail. The appeal was eventually listed and came on for hearing before this court on 3 October 2007 before a court comprised of Wheeler JA, Pullin JA and EM Heenan AJA.
When the matter was called on for hearing on 3 October, the court had before it a fax dated 23 September 2007, accompanied by a letter from the appellant (wrongly dated 26 October 2007 rather than 26 September 2007) enclosing her affidavit and an accompanying medical certificate. The medical report from a doctor in Chullora in Sydney certified that the appellant was then suffering from severe depression and was consequently unfit to attend at her court appearance and that she was expected to remain unfit for at least two weeks. The letter concluded with an invitation to contact the doctor for further information. The affidavit also included a 37‑page outline of submissions in support of the appeal verified on oath. Although nothing turns on the authorship of these submissions, the appearances are that they were prepared by Mr Hassan.
Despite this, no leave has been sought or granted by this court for Mr Hassan to act as a McKenzie Friend or in any other capacity on behalf of the appellant for the appeal. On 3 October 2007, the court took up the invitation of speaking to the appellant's medical practitioner by telephone to inquire about the duration of her disability. The court was informed that the appellant's marriage had broken down and that she had separated from her husband and was quite depressed. The doctor indicated that it might be two or three months before she improved significantly. The doctor informed the court that he did not believe that the appellant was then in a position to deal with the appeal at the time or to take any major decisions. The court, therefore, decided that the hearing of the appeal should be adjourned and that the appellant should be notified in writing of this decision and given an opportunity to participate in a later hearing of the appeal by video‑link if possible.
Following that, further documents were sent to the registry of the court, notifying the court that the appellant desired that the appeal should proceed to determination in her absence, but in reliance upon the written submissions which had been filed on her behalf.
The appeal then proceeded on 1 February 2008 in the sense that submissions by counsel for the respondent were heard. The court ordered that a copy of the transcript of the oral hearing on 1 February 2008 should be sent to the appellant and that she be notified that she had an opportunity to make further written submissions in response to the respondent's submissions within a limited period. That was done and further materials have since been received by the court from the appellant. These comprise:
•a letter from the appellant dated 20 February 2008 enclosing 11 pages of written submissions pursuant to the direction of the court given on 1 February;
•a copy of what appears to be a medical report from Dr Robert Gherman MD, head of the division of maternal/foetal medicine at Portsmouth Naval Hospital, Portsmouth, Virginia, USA, dated 23 January 2001 and an accompanying curriculum vitae of Dr Gherman;
•an affidavit of Mr Omar Hassan sworn 20 February 2008 in which he deposes that he is instructed by the appellant to swear this affidavit on her behalf and that he had represented the appellant during the proceedings before the lower court and 'will continue to do so for as long as justice demands'. This affidavit makes a number of assertions about the conduct of the appeal generally and of this court at the hearing of 1 February 2008 and contains a number of serious criticisms in somewhat extravagant terms, suggesting 'serious misconduct of the primary judge, the judges of the appeal'; and
•a further letter from the appellant dispatched by facsimile on 25 February 2008 seeking to make some minor amendments and additions to the written submissions filed on 21 February 2008.
In addition to the materials specifically identified in the above paragraphs, the appellant had filed and served detailed written submissions in support of the appeal as part of the white appeal book before the matter came on for hearing first on 3 October 2007. These comprise 23 written pages and were signed by Mr Hassan.
Despite Mr Hassan's assertion in his affidavit of 21 February 2008 that he is continuing to represent his wife in these proceedings, he has not been granted leave to do so. In view of the information put before the court by the appellant's doctor in October 2007 about a separation, which of course may only have been temporary, there would appear to be serious questions to be addressed before the court could properly grant leave to Mr Hassan to represent the appellant in the current proceedings if that leave were, indeed, sought.
There is little point in pursuing this matter further in the absence of an application for leave for Mr Hassan to act as a McKenzie Friend. In my view, the court can, and should, proceed to deal with the appeal on the basis of all the materials in the appeal books, including the written submissions prepared and filed by Mr Hassan before 3 October 2007 and the subsequent written submissions dated 21 February 2008 signed by the appellant, as amended by the subsequent facsimile transmission of 26 February 2008.
However, the court cannot accept as material for consideration on the hearing of this appeal the letter from Dr Robert Gherman MD of 23 January 2001 or his accompanying CV. That is a report purporting to address the merits of the appellant's case and is in the nature of expert medical evidence which might, perhaps, have been adduced at the trial. It must have been submitted by the appellant or her solicitors to the respondent's solicitors well before the trial because it is the subject of address, comment and attempted refutation by the report of Professor David Ellwood dated 2 June 2004 (exhibit D5, AB 971 at 973 ‑ 934). When Professor Ellwood's report was received into evidence, the learned trial judge expressly excluded from the tender that part of the report which referred to comments of Dr Robert Gherman because that was not a part of the plaintiff's case at trial. No objection was made to that limitation by Mr Hassan on behalf of his wife at the trial and, of course, Dr Gherman was not called. There is no application before us to accept additional evidence at the hearing of this appeal and, even if there were, Dr Gherman's report would not satisfy the tests for fresh evidence - see Mickelberg v The Queen [2004] WASCA 145; (2004) 29 WAR 13, [410] ‑ [439] (Steytler J) 129 ‑ 138, and Beamish v The Queen [2005] WASCA 62 [9] ‑ [15].
I shall, therefore, pay no regard to the contents of the report from Dr Gherman although it is included in the materials submitted by the appellant dated 21 February 2008.
With respect to the affidavit of Mr Hassan of 20 February 2008, I consider that this should be excluded from attention by this court on this appeal. It is argumentative and scandalous, and attributes base motives to members of this court, to her Honour the learned trial judge, to opposing counsel both at the trial and on the appeal, and to the system of justice in this State and in Australia generally. It contains no evidence and is in the nature of submissions in extravagant and insulting terms. It has no place in the determination of the issues arising on this appeal and I shall disregard it.
Background
Although the mass of evidence, the range of specialist expert opinion and the details of the initiation and progress of this induced labour are extremely extensive, it is possible to reduce the areas of importance for the resolution of the litigation and of this appeal to specific areas. The first of these is the significance of the appellant's prior obstetric history and the special complications associated with this last pregnancy. The second is the choice of a clinical or surgical procedure for the evacuation of her uterine contents and the risks and practical difficulties associated with each alternative. The third area is the significance, if any, of the use of Misoprostal as a labour inducing agent for the treatment of the appellant and whether the absence of informed consent to this procedure, as found by the learned trial judge, was in any way causative of the eventual crisis leading to the hysterectomy. The fourth area is whether or not the severe life threatening haemorrhage was an unavoidable risk associated with the treatment of the appellant and whether hysterectomy was the appropriate response when haemorrhage occurred.
Implicit in each of these factual issues are questions about whether or not any of the actions or decisions of the staff for whom the respondent is responsible was negligent and, if so, whether that negligence materially contributed to the need for the eventual hysterectomy. These involve special issues of causation which can only be analysed from the point of view of legal principle once the essential findings of fact have been identified and examined in the light of the challenges raised by the various grounds of appeal.
Appellant's obstetric history
The appellant was born on 27 May 1962 and, therefore, was 36 years and 8 months of age when she was admitted to KEMH for this evacuation on 11 January 1999. Her relevant obstetric history was that, by then, she had given birth to five children, including one set of twins. All of these previous four labours involved deliveries by caesarean section.
Her first pregnancy in 1983 resulted in a miscarriage after 18 weeks. The second pregnancy resulted in the birth of the twins on 25 July 1985. The third pregnancy resulted in the birth of a healthy child on 30 January 1987. The third birth was on 16 September 1992 and the fourth on 13 June 1997.
During the pregnancies leading to the births in 1985, 1987 and 1997 she was diagnosed, on each occasion, as having a deep vein thrombosis (DVT). All of these DVTs were thought to be due to a protein C deficiency. In the 1997 pregnancy, a DVT was thought to have developed at 17 weeks' gestation, but investigations failed to confirm evidence of either a DVT or a pulmonary embolism although she was put on anti‑coagulant prophylaxis. During the pregnancy resulting in the birth on 13 June 1997, she was suspected of being in a prothrombotic state although, in retrospect, it was concluded that the recurrent DVTs were not due to any specific prothrombotic factor (see report of Dr A L Barr, haematologist 9 March 1998 AB 1006).
Therefore, quite apart from this history of repeated DVTs, the four caesarean section deliveries meant that the appellant, inevitably, had scarring, including scarring on the inner surfaces of the uterus. This signified that there could well be problems with adherence of the placenta in any subsequent pregnancy if it was situated at or across the sites of the scarring.
The ultrasound investigations
The appellant had attended her GP on 27 November 1998, who then referred her to the antenatal clinic at KEMH because of recent complaints of severe lower abdominal pains and dizzy spells. He noted the past history of recurrent DVTs, the then recent discovery that she was hypothyroid and that she had stopped her Thyroxin medication over a month ago (AB 1008).
The appellant attended the KEMH antenatal clinic on 9 December 1998 for investigation and review because of her prior history of DVTs. The attending doctor noted that in July 1997 she had been advised by Dr Walters to have a tubal ligation, but that she had not had this procedure and was then 13 weeks pregnant. He recorded that she had recently been diagnosed as being hypothyroid and commenced on Thyroxin but she had not been taking the Thyroxin since discovering she was pregnant. He noted that a foetal ultrasound at 12 weeks showed nuchal thickness at the upper range of normal and that Dr Jan Dickinson had been asked to conduct a further scan the following day. Dr Walters was asked to review the management of the previous DVTs and the history of hypothyroidism (AB 1005).
A further ultrasound was done on 10 December 1998. This confirmed a single live foetus within the uterus consistent with the reported last menstrual period of 10 September 1998 and an estimated date of delivery on 15 June 1999. It reported that the placenta was located posteriorly and covered the cervix to reside on the anterior uterine wall. Further it reported:
The foetus has generalised skin oedema with a nuchal translucency of 9mm. The findings are highly suggestive of a karyotypic abnormality such as Turner's Syndrome or Trisomy 21.
CVS is indicated but [the appellant] wishes to speak with her family and doctor first.
In the antenatal record of 10 December 1998, Dr Dickinson noted that this ultrasound which she had performed demonstrated foetal hydrops and posterioral placenta sweeping over the cervix to the lower part of the uterus anteriorly. She noted a probable karyotypic anomaly and that a CVS was indicated but noted that the appellant wished to speak with her husband and GP first. Significantly, Dr Dickinson noted that concerning the ultrasound in view of her LUSCS (Lower Uterine Segment Caesarean Sections) the appellant could well need an hysterectomy at term because of severe bleeding if the placenta invaded the old scars. She recorded that she discussed the position of the general practitioner and reported her findings, saying that hydrops at this stage of pregnancy is usually lethal for the foetus and a suction D&C then might well be the best option as the morbidity for the appellant would increase as the gestation advances. Dr Dickinson noted that she would await the GP's report and the discussion with the patient.
In these notes, the reference to hydrops is a reference to hydropenia. The nuchal transparency relates to the back or nape of the neck on the foetus and the reference to her karyotypic anomaly is a reference to abnormality in the chromosome normal endowment of individual cells. Turner's syndrome is a reference to an abnormal condition in the foetus and the reference to Trisomy 21 is another reference to an abnormal cellular condition involving an extra chromosome and associated with Down's Syndrome.
A further ultrasound was performed at the direction of the appellant's general practitioner on 8 January 1999, following a fall the previous day and reported vaginal fluid loss. This reported that the uterus contained a single foetus in a longitudinal line with a cephalic presentation, with gross foetal skin oedema and no foetal cardiac pulse. The reported conclusion was a missed abortion (AB 1011). As a result, her GP referred the appellant to the Emergency Department at KEMH advising that she had had previous scans with a grossly abnormal foetus and that the repeated scan this day revealed intro‑uterine foetal death (AB 1010).
At KEMH on 8 January 1999, the appellant was again seen by Dr Dickinson who recorded in the in‑patient progress notes (AB 1012) a case of foetal death in utero. She noted her earlier advice following the ultrasound on 13 December (this evidently refers to the ultrasound of 10 December 1998 - see AB 1007 and 1012) for hydropic foetus with placenta covering the cervix and her recommendation for a CVS and D&C, but noted that the patient did not wish to have that therapy. In view of her history of recurrent DVTs and four LUSCS and the low‑lying placenta, Dr Dickinson thought it best to postpone intervention until the following Monday, that was to 11 January 1999. After further discussion, the appellant decided to return to the ward on the coming Monday and was discharged home that evening.
The appellant returned to the hospital as arranged on 11 January 1999 and was again seen by Dr Dickinson. In the in‑patient case notes (AB 1013), Dr Dickinson noted a Protein C deficiency with a history of DVTs and recorded that the patient would need Heparin post delivery. In particular, Dr Dickinson noted that she had discussed the potential for a loss of the uterus and that the procedure included risks of uterine loss, hysterectomy, infection and haemorrhage. She noted that the appellant agreed to be recruited for the Misoprostal trial. However, before finally submitting to the procedure for the evacuation of her uterine contents, the appellant desired to undergo a further ultrasound scan to verify that the foetus was in fact dead. This was performed at the hospital and confirmed the foetal death in utero. The ultrasound report (AB 1015) noted a single intro‑uterine pregnancy consistent with 15 weeks and 3 days and noted that the amniotic fluid volume was low. The diagnosis was of a foetal death in utero and it was noted that the foetus had marked generalised skin oedema. Again, significantly, the ultrasound report recorded:
The placenta is situated on the posterial uterine wall and sweeps over the cervix to reach the lower anterior uterine wall.
One of the potential methods of dealing with the evacuation of the dead foetus was to perform an hysterotomy. As the name suggests, this is a surgical incision into the uterus and generically, includes the performance of a caesarean section delivery through the abdomen, although any surgical cutting into the uterus comes within the term. It is to be distinguished from the procedure of hysterectomy which involves the surgical removal of part or all of the uterus. This latter procedure may be performed via the abdomen or via the vagina.
The induction of labour and the events leading to operative intervention and hysterectomy
In the evidence before the learned trial judge, particularly from the expert witnesses, there were some minor variations of detail in relation to the timing of certain events and, more particularly, in relation to the extent of the maternal blood loss. I am satisfied that, in the end, little if anything turns upon these differences in detail but it is obviously preferable to adopt the most accurate account available. In relation to the evidence of the various expert witnesses, none of these, of course, was present in the hospital on the occasion when the appellant was being treated. Only the hospital medical and nursing staff were then present as was Dr Dickinson at critical phases, although not constantly during the initial processes.
Contemporary hospital clinical notes were being written up during the course of the treatment or immediately afterwards and these appear to be the principal source material for the narrative subsequently obtained from various commentaries, including the summaries of events put to the various experts, upon which they, respectively, based their opinions. Consequently, I regard the contemporary written hospital records as the preferable source material to be supplemented, if and where necessary, by further explanation from Dr Dickinson or medical nursing staff present at the time. To the extent that this record differs from any of the assumptions put to or adopted by the various expert witnesses, it should, in my view, prevail. This was the approach adopted by the learned trial judge except, perhaps, in relation to the extent of the blood loss which will be examined in more detail below.
The hospital records show that there were three doses of Misoprostal administered to the appellant each 400 mcg and administered per vaginam. The first was at 10.45 am on 11 January, the second at 4.45 pm and the third at 10.50 pm (that is at six‑hourly intervals) (AB 1017).
The hospital notes record that at 11.45 am the appellant reported to the nurse that she had passed blood into the toilet. The nurse noted that the PV loss was then small dark blood; the resident was informed and an IV bung was to be inserted (AB 1013). By 2.00 pm the small red blood loss was increasing when the patient voided and at 3.25 pm she was seen by one of the medical staff when an intravenous bung was inserted. By then PV blood loss had increased to moderate. Dr Dickinson herself attended on the patient at 4.45 pm and noted bright PV blood loss and observed that the cervix was beginning to open. She noted that because the placenta was over the cervix she was not surprised by the blood loss but an IV line with IV fluids was commenced. Dr Dickinson noted that if the PV loss continued to concerning levels the patient may need evacuation in the operating room and she asked to be kept informed.
A nursing note at 8.30 pm recorded that the blood loss was continuing and had accumulated to 780 mls to that point. The intravenous line was in place and the patient's observations were stable. Dr Dickinson was informed about the blood loss and directed that the plan of management should continue but that she would review the patient at about 10.30 pm. She instructed the nursing staff that if the blood loss exceeded 1,000 mls, the nursing staff should contact her immediately at home.
The next entry is at 10.50 pm recording a visit to the patient by Dr Dickinson herself. By then the PV loss was about 1,000 ml and there was a steady loss of about 100 mls per hour. Dr Dickinson noted that on vaginal examination she was 100% effaced, 3 cms dilated and that a clot was palpable in the cervix. It was then that the third dose of Misoprostal was given. Significantly, Dr Dickinson recorded in that same note:
No matter what course of action we take she's going to bleed. As there has been good progress since my last VE [vaginal examination] I would prefer to wait and let her deliver spontaneously.
Nevertheless, Dr Dickinson directed that if there was an increasing rate of blood loss or no progress overnight, she would take the patient to the operating theatre and empty the uterus under ultrasound guidance. She noted that a caesarean section delivery was then underway in the operating room. (The only available operating room.) She arranged for a blood cross match to be performed. She asked to be kept informed of the progress and if there was a further blood loss of more than 200 mls she was to be called.
The final entry in the in‑patient progress notes, as put in evidence, was at 11.45 pm and again this was made by Dr Dickinson herself. She noted that the total blood loss was then about 1,200 ‑ 1,400 mls and that the patient needed evacuation in the operating room in view of the ongoing PV loss. She noted that she had told the Hassans that there was a real risk of hysterectomy because the placenta was over the cervix and the previous caesarean section scars.
Although the maternal PV loss before the appellant was taken to theatre was described in this fashion in the in‑patient notes, and finally estimated by Dr Dickinson to be about 1,200 ‑ 1,400 mls by 11.45 pm, there was no complete contemporary record in evidence containing progressive or quantitative record of blood loss during this entire phase. A fluid balance chart was commenced at 5.00 pm on 11 January 1999 when a litre of Hartmanns was put up. That ran until about 11.30 pm when another litre of this solution was commenced. During this time, that is from 5.00 pm until 11.30 pm, the recorded blood loss totalled 1490 mls - this must be regarded as excluding the observed blood losses before 5 pm as recorded in the nurses notes.
The appellant was anaesthetised by Dr Bremner at 12.30 am on 12 January (that is after midnight although the anaesthetic chart records the date as being 11 January (AB 977)). The anaesthetist noted an abnormal foetus with a foetal death in utero (FDIU) and that investigation showed placenta praevia and about 1500 mls blood loss. There was a sharp drop in blood pressure at about 12.40 am and another anaesthetist and a consultant gynaecologist were called in. The operation continued until 3.00 am. The anaesthetists recorded intra‑operative complications comprising sustained hypotension and massive transfusion. The fluid balance chart shows that the patient was commenced on Haemacel at 12.45 am and that blood transfusions commenced at 1.10 am. From 12.45 am onwards the patient received a total of 2,600 mls of Haemacel and 3,000 mls of blood up until 3.40 am.
The operation record forms part of the hospital file (AB 1019) and it appears to have been completed by Dr Dickenson herself, who was assisted by Dr I.G. Hammond. It noted a presumptive diagnosis of foetal death in utero accompanied by placenta accreta. The operation was described as a manual removal of foetus and placenta and a total abdominal hysterectomy with conservation of both ovaries.
After the foetus had been delivered, Dr Dickinson undertook a manual removal of the placenta. She noticed an adherent placenta over the site of the earlier scars. There was a heavy PV loss and falling blood pressure and she proceeded to an abdominal hysterectomy, calling in Dr Hammond at that point. She recorded the findings at operation as a hydropic female foetus in the vagina. The placenta was manually removed and found to be very adherent to the anterior uterine wall in the vicinity of previous caesarean scars. She noted a heavy blood loss despite IV Oxytocin, IV Ergometrine; PGF 2a intramyometrially and packing of the uterus. The patient was hypotensive, which led to the decision made to proceed to an hysterectomy in view of the ongoing blood loss and CVS instability. She noted that the estimated blood loss was 3000 ml and that the patient had been transfused.
A more detailed but consistent account of the events in the operating room was included in a report of the entire incident which Dr Dickinson herself prepared nine days later, on 20 January 1999. At AB 982 Dr Dickinson has there recorded:
In the operating room her initial observations were satisfactory. The haemoglobin was 110gm\dL when checked by the anaesthetist. When anaesthetised and placed in lithotomy there was no significant blood loss on the pad, which was then removed prior to my preparation of the lower genital tract. I could see the foetal lower limbs at the vaginal introitus. The [foetus] was removed from the vagina and inspected by myself: characteristic appearance of Turner's syndrome. I then proceeded to remove the placenta. As I began to remove the placenta there was a severe uterine haemorrhage. The placenta was very adherent anteriorally and appeared to go into the myometrium, such that when I had achieved removal I could feel a defect underneath its location anteriorally (which did not extend through the full thickness of the myometrium). The blood loss was ongoing despite Oxytocin 10 IU intravenously, an Oxytocin infusion, Ergometrine 500, PGF 2 intramyometrially, uterine packing and my manual compression. Blood transfusion was commenced. [The appellant] was hypotensive and it was obvious that the only recourse was to proceed to hysterectomy. With the assistance of Dr Ian Hammond I performed a total abdominal hysterectomy with conservation of the ovaries. There was ongoing blood loss from the uterus until it was removed. There was an estimated 3,000 cc intraoperative loss and massive transfusion with blood and coagulation factors was required.
Relating these descriptions to the anaesthetic chart, it appears that the intrauterine haemorrhage described by Dr Dickinson must have commenced at about 12.45 am and that Dr Hammond was called in at about 12.57 am. Major anaesthetic intervention appears to have commenced at 12.48 am.
Histopathology report
Following the operation, Dr Dickinson sent the uterus and placenta to the hospital's pathology department for a detailed histopathology examination. The report of the pathologist, Dr H Wainwright dated 14 January 1999 (A 975/976) shows marked pathology. Her conclusions were that the uterus revealed a placenta praevia with marked thinning of the scar on the anterior wall of the lower uterine segment due to placental implantation and also haemorrhage from aberrant unsupported vessels with endovascular trophoblast in the lower uterine segment scar. She noted that the placenta showed haemorrhagic endovasculosis secondary to FDIU.
In the body of her report, Dr Wainwright said that examination of the uterus revealed very marked thinning of the uterine wall at the lower uterine segment of the anterior position which, in some places, measured as little as 2 mm. She noted that the placental site involved the lower uterine segment as well as the posterior and anterior walls of the uterus. On microscopic examination sections of the thinned area of the cervix showed lower uterine segment with placental site reaction and no residual myometrium present, indicating the presence of scar tissue with placental implantation. Vessels in the cystic area showed pregnancy associated changes with endovascular trophoblast and included transformed spiral arteries. Some of the vessels were aberrantly located deep to the muscle layer and were thus unsupported by myometrium. The features were reported as being those of placenta praevia with implantation involving the anteriorally situated lower uterine segment scar, the rest of the lower uterine segment and the posterior and anterior walls of the uterus, without any evidence of placenta accreta.
As the learned trial judge found, there cannot be any doubt that in this case the location of the placenta across the mouth of the cervix and, in particular, on the lower anterior uterine wall resulted in the placenta implanting itself in an area where, because of the previous caesarean section deliveries, the myometrium was extremely thin and where there was scar tissue. This meant that the placenta became especially adherent, penetrated through the myometrium and meant that removal after delivery of the foetus would be difficult with an extremely high risk of severe intrauterine haemorrhage, no matter how removal of the foetus and the placenta was attempted.
This became a vital issue in the disposition of the case at trial and remains of major significance for this appeal. As will be described, Dr Wainwright expanded on her report when giving oral evidence and, to a significant degree, the expert opinion evidence depended on the basic histopathology findings or assumptions, some tenuous, about them.
Potential procedures for the removal of the dead foetus
Once the foetal death in utero had been confirmed by the ultrasound performed on 8 January 1999, the obvious question requiring immediate consideration was what, if anything, should be done to remove it. On that Friday evening when Dr Dickinson advised the appellant and her husband that, in her opinion, the evacuation of the uterine contents should be deferred until the following Monday when there would be full medical and surgical cover available at the hospital, as there was a risk of haemorrhage, Mr Hassan initially demanded that the foetus should be delivered immediately because this was an emergency. Dr Dickinson assured the couple that this was not the case and that it would be wiser to wait until the Monday, or that they could even consider waiting for the foetus to deliver spontaneously. According to Dr Dickinson (AB 981) Mr Hassan said that he had been advised that there were dangers with the retention of a dead baby and Dr Dickinson confirmed that in some cases the mother's blood might not clot appropriately if the foetus were retained. It was her opinion that the appellant was in a high risk category and that they should have the foetus delivered by medical intervention on the Monday or, if they chose, on that very Friday evening. After discussing the matter between themselves and acquaintances, the Hassans decided to wait until the Monday.
To a significant degree, the controversies at the trial of this action concerned the choice of method to deliver the dead foetus and, if chemical induction of labour were chosen, the inclusion of the appellant in the Misoprostal trial. It will be necessary to examine the nature, purpose and consequences of the use of Misoprostal in more detail later in these reasons but, for the present, it is necessary to concentrate on the options realistically available in the situation which had arisen. In reality there were four. There was medical termination of the pregnancy with Misoprostal being used to initiate labour ‑ the choice taken. There was dilatation and evacuation (D&E) with pre‑procedure cervical ripening with Misoprostal. There was hysterotomy. Finally, there was an option of doing nothing and to await spontaneous abortion. A fifth possibility of proceeding directly to an hysterectomy was only ever mentioned in hindsight and would not have been offered to or accepted by the appellant.
Dr Dickinson has consistently maintained that she considered all these options and elected the medical termination of pregnancy using Misoprostal as the most appropriate. In doing so she realised that there was always a potential risk regardless of which option was selected. In her view, hysterotomy was the most morbid procedure; the published evidence indicating increased death rates, increased thromboembolic complications and infections with that method. Dr Dickinson said that its principal indication in contemporary medicine was for when other methods of termination failed. The appellant had a high risk of thromboembolic complications and Dr Dickinson said that it had been noted that at her last caesarean section access to the peritoneal cavity was difficult. Dr Dickinson's evaluation was that the performance of a primary hysterotomy was not justified for a 15 to 16‑week size dead foetus in the appellant's case.
Dilatation and evacuation was recognised to be an option, but Dr Dickinson did not select this as the primary treatment known because of the potential risks of maternal injury (perforation of the uterus, cervical trauma). In her view, pre‑procedure cervical ripening (using Misoprostal) is recommended to minimise the risk of injury. She had considered evacuating the foetus if delivery did not occur within a reasonable time.
In retrospect, with the post‑operative knowledge of the uterine pathology, Dr Dickinson said that an elective hysterectomy, leaving the placenta and foetus inside would have been the least morbid procedure, but, of course, one would not initially choose an hysterectomy in such a situation while any hope remained that the patient's uterus could be preserved.
At the trial, the appellant contended that the uterine contents should have been evacuated either by the D&E process or by an hysterotomy. The learned trial judge did not express any final conclusion about those choices because, in the light of her findings, it was unnecessary to do so. Her Honour was satisfied that, whichever method of evacuation had been chosen, the risk of haemorrhage due to complications associated with placental adherence was inevitable and that the risk of a haemorrhage was very high. Once a haemorrhage of that severity occurred, there was no alternative to an hysterectomy. However, her Honour did observe at [217]:
The reality of the position was she [the appellant] wanted the foetus evacuated and the only available option was at KEMH using induction of labour with Misprostal.
And at [221]:
There was no evidence to suggest that these procedures [D&E or hysterotomy] were available in 1999 in [the appellant's] circumstances as a first line treatment anywhere in Western Australia.
And, further, at [223]:
The overwhelming medical expert evidence was that this [an hysterotomy] was not a safe or commonly used procedure. It was termed, variously, archaic and outmoded. But there was no evidence that it was carried out in 1999 as a first line treatment by any surgeon in Australia. Dr Dickinson was not a skilled practitioner in this procedure. It was not performed at KEMH.
And, further, at [225]:
The induction of labour with the use of prostaglandins was the most common method utilised in the major hospitals in Australia.
At [226]:
The alternative procedures were known to and considered by Dr Dickinson. They were not put as options to [the appellant]. I do not find it unreasonable that a hysterotomy was not explained to [the appellant] as a viable option, given the prevailing Australian medical attitude towards it and its availability.
And, finally, at [229]:
My finding as to the cause of the hysterectomy, being the blood loss as a direct result of the implantation of the placenta over the previous Caesarean scarring, supports that the final outcome was inevitable, irrespective of the method of evacuation. I accept Professor Trudinger's evidence that the abnormal implantation of the placenta could not have been detected in advance due to the particular state of gestation.
It will be necessary to revisit the factors which were said to be advantageous or disadvantageous for these various options for the evacuation of the dead foetus a little later. This will entail a review of the expert evidence adduced at the trial on these issues because one group of the appellant's grounds of appeal contends that some option other than the chemically induced labour using Misoprostal should have been selected and that the hospital, by Dr Dickinson, was in breach of duty in not doing so.
The Misoprostal trial
The learned trial judge described the nature and purpose of the Misoprostal drug trial at KEMH in detail in her reasons [84] ‑ [94]. Her Honour recorded that medical induction of labour involves the induction of labour by the administration of synthetic prostaglandins which, essentially, initiate and promote the progression of the process of labour from the first to the following stages. Misoprostal and Cervagem are examples of synthetic prostaglandin hormones used to initiate and sustain the early onset of labour.
Misoprostal has been the subject of some difference of opinion worldwide. The main risks in relation to medical induction of labour are haemorrhage, uterine rupture and retained placenta. Her Honour explained how Misoprostal was licensed in Australia for the treatment of stomach ulcers but both in this country and worldwide it is also used in obstetrics for, among other purposes, a means of cervical priming for inducing labour and termination of pregnancy. Her Honour then observed:
The particular trial using Misoprostal conducted by KEMH was designed to test suitable dosing regimes for Misprostal. Misoprostal was already in use there after earlier clinical trials conducted at KEMH found it to be more effective, inexpensive, easier to use and with fewer side‑effects than other prostaglandins such as Cervagem.
In accordance with appropriate medical practice, KEMH had advised the Commonwealth Therapeutic Goods Administration of its intention to conduct clinical trials with this drug outside its licence. It received a clinical trials notification form from that body.
The method employed by the trial was that of an entirely confidential and random method administering one of three different dosage regimes. Firstly, some patients received 400 mg every six hours. [The appellant], randomly, fell into this category. Others received 200 mg every six hours. Lastly, there was a dose of 600 mg followed by 400 mg every six hours.
The outcome of the trial was that 400 mg every six hours was the optimal dosage.
The Hassans' concerns were the drug was unlicensed, unregistered and lacked approval. It was, the plaintiff said, unsuitable for a woman who had her history. Dr Brian Peat, the director of obstetrics and a specialist in that field at the Women's and Children's Hospital in Adelaide and a medical expert called by the plaintiff, used Misoprostal in his practice, albeit as a single dose to prime the cervix.
Misoprostal was administered routinely over that period at KEMH as its first line treatment for the induction of labour.. [The appellant] would have been administered Misoprostal at KEMH irrespective of whether she consented to join the trial or not. The trial did not relate to the use of the drug only the optimal dosage of the drug. The routine dosage prior to the trial and if a patient was not on the trial was an initial insertion into the vagina of 400 mg of Misoprostal followed every six hours by intravaginal doses of 200 mg up to a maximum of 48 hours. [89] ‑ [94]
(Those references in her Honour's judgment must be read as referring to micrograms, and not to milligrams (mgs) of the drug - 10 micrograms (mcg) = 1 milligram (mg).)
The appellant produced an abstract from an article in the publication Vidyya published on 26 August 2000 (exhibit P8) ‑ AB 943 which contained a warning concerning the unapproved use of Misoprostal. This was to the effect that the use of the drug by any route is contraindicated in women who are pregnant because it can cause abortion. This note mentioned that there were some instances where Cytotec (the trade name for Misoprostal) outside its approved indication, was used as a cervical ripening agent prior to the termination of a pregnancy, or for induction of labour, in spite of the specific contraindications to its use during pregnancy. It mentioned that serious adverse events had been reported following the use of Misoprostal in pregnant women including maternal or foetal death, uterine hyper stimulation, rupture or perforation requiring uterine surgical repair, hysterectomy and other complications. It asserted that the company manufacturing Cytotec had not conducted research concerning the use of the drug for cervical ripening prior to the termination of pregnancy or for the induction of labour.
However, the use of Misoprostal versus the other synthetic hormone Cervagem to initiate or stimulate labour, particularly in the case of terminations, had been common at KEMH before January 1999. As the learned trial judge found, the hospital had sought approval from the TGA (Therapeutic Goods Administration) in January 1998 for the use of the drug. This was sought and granted after prior conditional approval had been obtained from the Hospital Ethics Committee on 23 December 1997 (AB 946) in an approval given for studies over a three‑year period. The application to the TGA on behalf of the hospital had been made by Dr Dickinson herself on 20 January 1998 (AB 948 ‑ 952) and the study was to determine the optimisation of Misoprostal dosing schedules for second trimester pregnancy termination. The approval of the TGA was given by letter of 2 February 1998 (AB 952).
Furthermore, in KEMH Standing Instructions For Resident Medical Officers, Training Registrars And Fellowship Training Registrars 1998 there was a specific protocol for mid‑trimester termination of pregnancy (AB 957). This provided that terminations for foetal anomalies for public patients were to be co‑ordinated through Dr Dickinson and that terminations for foetal death in utero or other non‑anomalous foetal terminations were to be conducted in ward six if the gestation were less than 20 weeks. The protocol then provided:
5. Misoprostal is the current initial prostaglandin of choice in these circumstances. A 200 mcg tablet is inserted into the posterioral vaginal fornix every six hours for 48 hours (or until delivery, whichever occurs first). If delivery has not occurred after 48 hours of Misoprostal therapy, a transcervical Foley catheter is inserted … Misoprostal is not as effective in achieving pregnancy interruption when membranes have ruptured and consideration to the use of oxytocin should be made.
In the same protocol (at AB 959). there are detailed guidelines provided for the use of Misoprostal and again it is stated to be the preferred prostaglandin in the medical management of pregnancy interruption in the second trimester. This part of the protocol contained the instruction:
Misoprostal should be used with caution in women with obstructive airways disease, cardiovascular insufficiency, especially where hypotension may precipitate complications, cervicitis or vaginitis. In all women with previous uterine surgery a very small possibility of scar rupture, and its subsequent management, should specifically be discussed.
The appellant also put in evidence (as exhibit P10 ‑ AB 944 ‑ 944D) a copy of an article published by Dr Jan Dickinson and a colleague, Dr S F Evans in the March 2002 edition of the American Journal of Obstetrics and Gynaecology entitled 'The Optimisation Of Intravaginal Misoprostal Dosing Schedules In Second‑Trimester Pregnancy Termination'. This article described the Misoprostal trial which had been conducted by Dr Dickinson at KEMH under the TGA authority and its results. It referred (944C) to one case of severe complications, which was obviously the Hassan episode. Dr Dickinson and her co‑author wrote in this respect:
There was 1 severe maternal complication in this trial: a woman with 4 previous Caesarean deliveries and an intrauterine foetal death at 18 weeks' gestation who required hysterectomy for intractable post delivery haemorrhage. A pathologic examination of the uterine specimen demonstrated placental invasion of the myometrium at the site of the previous Caesarean deliveries, which was consistent with placenta accreta. We did not exclude women from the trial on the basis of previous uterine surgical procedures, and although the numbers are too small for meaningful analysis, no case of uterine rupture occurred. There was no effect of previous Caesarean delivery on the time to delivery.
This article confirmed that Misoprostal was not, at the material time, authorised for use in pregnancy in Australia; and permission to use the prostaglandin for this trial was obtained from the TGA under the Clinical Trials Notification scheme. The study protocol was approved by the Institutional Ethics Committee before commencement. The authors explained that women admitted to KEMH for second‑trimester pregnancy interruption between March 1998 and February 1999 were invited to participate in the study and that no restriction to recruitment was made in terms of the number of foetuses present or a history of previous uterine surgical procedures. In all, 150 women were recruited to the study during the 12‑month period. The conclusion of the authors was that intravaginal Misoprostal 400 mcg at six‑hourly intervals appears to be the preferred regimen for second‑trimester pregnancy termination, with a shorter commencement to delivery interval than the 200 mcg regimen and fewer maternal side‑effects than the 600 mcg loading dose regimen. In the commencement of their article Dr Dickinson and her co‑author wrote:
Termination of pregnancy in the second trimester is most usually effected with prostaglandin agents. These hormones are used to pre‑treat the cervix before dilatation and evacuation or to effect delivery itself. Pre‑treatment with Mifepristone (RU486) is used to accelerate the delivery process in countries that have access to this compound. Techniques such as hysterotomy are associated with increased maternal risks and are rarely required in contemporary medical practice.
We have previously demonstrated Misoprostal (Cytotec; Searle Laboratories, New South Wales, Australia) a synthetic prostaglandin structurally related to prostaglandin E1, to be as effective as the more traditional prostaglandin Gemeprost (Cervagem; Rhone‑Poulenc Rorer, Victoria, Australia) in the medical induction of labour in the second trimester. Since the publication of these data Misoprostal has replaced Gemeprost in our institution as the primary medical therapy for second‑trimester pregnancy interruption. Because of the markedly reduced pharmaceutical costs with the use of Misoprostal, this policy implementation has produced significant budgetary savings.
This practice alteration has produced 2 unexpected occurrences. First, many smaller institutions are now conducting their own second‑trimester pregnancy interruptions, particularly for intrauterine foetal death. Second, a wide variety of dosage regimens are being used by medical staff, as they become more familiar with Misoprostal as an abortifacient. These events prompted this current clinical trial, which has 2 principal aims: to compare the clinical efficacy of 3 doses of intravaginal Misoprostal in producing second‑trimester pregnancy termination and to compare the incidence of maternal side‑effects among these 3 prostaglandin regimens.
The learned trial judge was, therefore, clearly correct in observing that regardless of whether or not the appellant had agreed to participate in Dr Dickinson's Misoprostal clinical trial, as she did, she would nevertheless have been given Misoprostal (albeit at a lower 200 mcg dose and again at six‑hourly intervals) for the induction of labour to evacuate a dead foetus. This was the standard hospital protocol at that date even without the authorised clinical trial.
Accordingly, the issues for close consideration become whether or not recruitment into the trial and the treatment of the appellant with the higher, 400 mcg doses of Misoprostal resulted in any higher or avoidable risk and, if it did, whether the Misoprostal therapy was a material cause of the ultimate hysterectomy. An associated issue became whether or not the use of Misoprostal, whether at the trial dosages or even at the standard protocol dose of 200 mcg every four hours, constituted an increased risk for a patient with the appellant's prior history of uterine surgery and, if it did, whether that caused or materially contributed to the hysterectomy.
It is at this point that the particular allegations made by the appellant in her pleading and the manner in which the trial was contested assume major importance. At paragraph 19 of the statement of claim the appellant had contended that notwithstanding her recruitment into the Misoprostal trial at no time did any officer of the defendant explain to her that as a result of her admission to that trial it was possible that an hysterectomy would be performed upon her; that she was never given any informed explanation as to the likelihood that she would have an hysterectomy performed; that she never gave any informed consent or voluntary permission for induction into the Misoprostal study, nor gave any informed consent for an hysterectomy to be performed. This, so it was alleged by paragraph 20 of the statement of claim, was in breach of the duty of care owed by the hospital and by Dr Dickinson to the appellant and was negligent. Five particulars of negligence were advanced to support that allegation. The first was that it was negligent for the appellant to be included in the Misoprostal clinical trial because of her prior obstetric history, which Dr Dickinson knew or ought to have known, which included the four prior caesarean deliveries and the presentation of the foetus with a placenta praevia. The second particular of alleged negligence was a failure by Dr Dickinson and other hospital staff to consider alternative methods of evacuation which should have been known to be more appropriate for a person with the appellant's history. The third particular of breach of duty was that having regard to the appellant's circumstances, and in particular to her experience and complaint of pain and blood loss in the 13 hours following the first administration of the drug, that is, before being taken to theatre, there was a failure by Dr Dickinson and other hospital medical staff to attend to her or to examine her properly or at all. The fourth particular of negligence was an alleged failure by Dr Dickinson to warn the appellant of a material risk (by implication the risk of hysterectomy) properly or at all. The fourth particular breach of duty was said to be the maxim res ipsa loquitur.
I have already excluded the doctrine of res ipsa loquitur as any basis for supporting the appellant's case in this litigation and no further discussion of that allegation is necessary.
The issue of whether or not Dr Dickinson warned the appellant, adequately or at all, of the risk that she might have to undergo an hysterectomy was an issue of fact for resolution at the trial. There was documentary evidence, including the hospital consent forms (see AB at 924 and 925) that such a warning had been given. As already described, there were repeated entries in the inpatient notes in Dr Dickinson's hand, made long before the crisis developed, that the process of uterine evacuation did involve a risk of hysterectomy although it was then thought to be small.
However, the appellant and her husband asserted that they had not been warned of the risk of hysterectomy, at least not warned in terms which they understood. The learned trial judge considered this issue with care at [114] ‑ [115] and, in doing so, also examined the issue of whether or not informed consent was obtained from the appellant to participate in the Misoprostal trial. Her Honour was satisfied that the standard hospital consent forms had been signed, and that at various points Dr Dickinson had mentioned to the appellant the possibility that she might require an hysterectomy but, nevertheless, concluded that this had not been done in a way which was adequate to achieve comprehending, and therefore informed, consent by the appellant. In this regard, the explicit findings by the learned trial judge were, at [143]:
I find that in order for [the appellant] to understand and fully appreciate what could happen to her required much more than a brief explanation by Dr Dickinson late on a Friday afternoon when she had been called back into the hospital. It required more than a short attendance the following Monday, the morning of the procedure. I find Dr Dickinson was running late on Monday morning. She said she frequently ran late and once she arrived she gave her patients her full attention. In this matter, it was an undesirable way to start the day given the significance it held for [the appellant].
And further [146]:
Whilst I accept that the words 'hysterectomy' and 'haemorrhage' were used, I find they were not explained carefully or at all to [the appellant] in terms she could understand. They may as well not have been spoken.
Dr T G Nash
The third consultant called to support the appellant's case was Dr T G Nash FRCS(E) FRCOG, a consultant obstetrician and gynaecologist, and a consultant in obstetrics and gynaecology to the Hastings and Rother NHS Trust and, at the time he gave evidence, a private consultant in the United Kingdom. Mr Nash provided two written reports, which are exhibits P4A and P4B (AB 929 ‑ 934).
After describing the appellant's prior obstetric history, and the events leading to the admission to KEMH and the uterine extraction, Dr Nash made a series of comments. Firstly, he observed that, with a known low‑lying placenta and four previous caesarean sections, the appellant was not suitable for entry into a trial of a drug. He doubted whether vaginal termination should have been attempted due to a low‑lying placenta and a likely thin lower segment of the uterus but observed that even if vaginal termination had been started the pregnancy should have been terminated surgically as soon as the bleeding became heavy. In the absence of the onset of spontaneous contractions he believed that the safest way to terminate this pregnancy would have been by an hysterotomy as an elective procedure but even then hysterectomy may have been necessary and the patient should have been warned of this possibility.
He regarded the acceptance of the appellant into the Misoprostal trial as misguided. While that might have been acceptable in most cases of foetal death in utero at 18 weeks, her history should have alerted any doctor to the increased risks which would exclude this patient from such a trial. He also commented that the size of the blood transfusion given indicated that the management was allowed to get out of control. He was critical of the persistence with the attempts at vaginal delivery in the presence of heavy bleeding.
His opinion was that the appellant should have been offered an elective hysterotomy and had this been performed it was likely that hysterectomy could have been avoided. He did not accept that hysterotomy would necessarily have led to uncontrollable haemorrhage since the uterus would have been open and the site of bleeding would have been fully visible. That would have allowed control of the haemorrhage by suture and/or diathermy. He emphasised that because of the known problem of the low‑lying placenta early surgical intervention should be employed if bleeding occurs after the use of prostaglandin for cervical ripening even when terminating in the first trimester. He concluded his second report by confirming his opinion that early surgical intervention could probably have avoided hysterectomy but agreed that late surgical intervention makes hysterectomy a strong possibility.
In giving oral evidence by telephone from England during the trial, Dr Nash confirmed the contents of his reports and pointed out that there was another option in the appellant's case; namely, to await the spontaneous onset of a miscarriage. He said that, although this might have led to other complications, namely, an increased risk of coagulation problems, this was an option which should have been explained to her. This is consistent with the observations of Dr Wagner. In Dr Nash's view, an emergency had arisen by the time the appellant had been taken to theatre and that this was, therefore, a case for a surgical removal by hysterotomy. His view of the problems with bleeding in this evacuation appear from his evidence at AB 0200 ‑ 0201 where Dr Nash explained:
[If] you interfere you just by the suggestion in the trial of putting a catheter through the os you're going to start bleeding because that placenta is in the way and if you interfere the bleeding is going to occur regardless. Also the drugs do not necessarily produce the same action of the uterus as a spontaneous onset. Further, the drugs are going to start the cervix dilating. That is going to start separation of the placenta which is over the os and the bleeding is going to continue once it starts and get heavier, so the sooner that uterus is emptied the better. That is why I am against chemical interference with the normal uterine action.
And, as for his choice of hysterotomy, Dr Nash said (at AB 202):
Before the drug's chemical methods of terminating a pregnancy occurs after about 15 or 16 weeks of pregnancy hysterotomy in the UK was the method of choice and the elective procedure does not carry the same risks as an emergency procedure. The risk of infection and so forth are better controlled. The bleeding may start but it is fairly early on and can be dealt with much more effectively.
In cross‑examination, Dr Nash stressed that the appellant was an exceptional case because of her prior obstetric history and the low‑lying placenta. He rejected the suggestion that the risk of complications associated with hysterotomy were greater than with a D&E and said that if it was a proper elective procedure the risks were similar to a caesarean section. He confirmed that the surgical skills of a gynaecologist, rather than the training of an obstetrician, would be needed for such a task. He repeated his opinion that he did not believe that there would have been the catastrophic haemorrhage which occurred in the appellant's case if she had had an elective hysterotomy and that, in that eventuality, any haemorrhage could have been controlled. He was of the view that had an hysterotomy been performed the problem with the adherent placenta over the scar tissue could have been managed because it was not a very large area and bleeding vessels could have been identified and sutured. He was satisfied that there would have been an adequate visualisation of the haemorrhage site for this to occur.
In giving this evidence, Dr Nash spoke from the standpoint of a consultant obstetrician gynaecologist who had conducted many surgical procedures and he stressed that his experience was important in the opinions which he voiced. He acknowledged that even with an hysterotomy there was a problem that excessive bleeding, if it could not be controlled, would have led to an hysterectomy and maintained that he would have warned the patient of this before offering an early elective hysterotomy. When told that the clinicians attending to the appellant may not have had sufficient surgical experience to contemplate performing an hysterotomy on her he said that in that case an elective hysterectomy would have been preferable but, obviously enough, the appellant did not wish to lose her uterus and that option was never discussed.
Expert evidence for the respondent
The independent expert evidence relied upon by the respondent came from two witnesses, Professor D Ellwood and Professor Trudinger. Of course, expert opinion evidence was also adduced from Dr Dickinson herself and from Dr Hammond but, as each of those was directly involved in the treatment of the appellant their evidence should stand in a slightly different category.
Professor Ellwood gave two written reports (exhibits D4 and D5) AB 966 ‑ 974, and also gave oral evidence and was cross‑examined. He acquired his MBBS at Cambridge in 1981 and his D.Phil at Oxford. He became a fellow of the Royal Australian and New Zealand College of Gynaecologists in 1989 and, at the time of giving evidence, was a senior specialist in obstetrics and gynaecology at the Canberra Hospital, the director of the Foetal Medicine Unit and a sub‑specialist in maternal foetal medicine. He also held the position of professor of obstetrics and gynaecology at the University of Sydney and at the Australian National University.
In his report, Professor Ellwood identified four essential management options for this case, namely:
(1)surgical evacuation of the uterus by dilatation and curettage (described by other witnesses as the D&E procedure);
(2)induction of second trimester miscarriage using various agents, including prostaglandins;
(3)laparotomy and surgical removal of the uterine contents (hysterotomy); and
(4)expectant management (ie, await miscarriage).
He noted that for a woman of the appellant's history there is a significant risk of bleeding and/or a morbidly adherent placenta regardless of the method used. He excluded the fourth option of expectant management because, in her case, once a spontaneous miscarriage commenced there would probably be very heavy bleeding and that would require hospital treatment. A D&E procedure was certainly a possibility and, had it not been for the anterior wall placental site and the previous caesarean sections with scarring, this would have been his preferred option. However, because of that history, it was likely to have been associated with heavy bleeding, which could have been uncontrollable, leading to hysterectomy as definitive management. He rejected hysterotomy as a method of choice because it involves a major surgical procedure and, at that time of gestation, would probably have required an almost complete uterine bisection to achieve delivery of the foetus and placenta. In his view, that was such a major surgical procedure that it was associated with increased risks of bleeding and thromboembolic disease (the appellant's history included previous sustained episodes of DVT). He considered that it was very likely that there would have been bleeding from the placental attachment site through the use of this method, which might also have necessitated an hysterectomy.
The other available option was the induction of a second trimester miscarriage using prostaglandins. He noted that this would be the method of choice in most tertiary units within Australia when faced with a foetal death in utero at 18 weeks' gestation.
Professor Ellwood acknowledged that the history of four previous caesarean sections and the low‑lying placenta were complicating factors for the use of prostaglandins because the degree of bleeding is unpredictable. Nevertheless, he mentioned that Misoprostal was an appropriate form of management for second trimester induction of labour and had been used extensively. He did not believe that in the appellant's case, the use of the prostaglandins contributed in any way to the degree of haemorrhage nor increased the risk of hysterectomy. Accordingly, he concluded that the management of the appellant by KEMH was entirely appropriate. His opinion was that the torrential haemorrhage would have happened regardless of the method of termination of pregnancy.
He interpreted a report of Professor Trudinger of the histological examination of the uterus as describing a case of placental increta so that it would be expected that there would be heavy bleeding and the likely need for hysterectomy regardless of the method of termination of pregnancy. He accepted the views of Dr Peat and Dr Wainwright that there was no placenta accreta but, again, putting aside the precisions of clinical nomenclature, there seems to be no doubt that there was a degree of morbid adherence of this placenta and the critical issue was whether or not detachment could have been managed without producing an uncontrollable haemorrhage.
Professor Ellwood was of the view that the decision to take the appellant to theatre was made when her blood loss reached 1,000 ml. Her total pre‑operative blood loss was estimated at 1,500 ml. He considers that the time at which the appellant was taken to theatre was appropriate because it was expected that there would be some bleeding associated with the attempted induction of labour but once the blood loss approached 1,000 ml the risks were such that surgical intervention was necessary. This decision might have been taken earlier but the induction of labour continued in the belief that delivery of the foetus and placenta would occur relatively quickly and reduce the need for surgical intervention. It is clear that he was mistaken in this respect. The contemporary hospital notes show that the delay in taking the patient to theatre from 10.45 pm until 12.00 midnight was because the operating theatre was already in use for another patient who was undergoing a caesarean section delivery and, accordingly, the delay could not be avoided. This was confirmed by Dr Dickinson in her own evidence.
The possibilities of the use of another theatre or whether there should have been another available were not explored at trial nor raised on this appeal and, therefore, the only inference which might be drawn in favour of the appellant could strengthen the opinions of Dr Nash and Dr Wagner that an earlier planned surgical evacuation should have been undertaken. In this situation, however, it is easier to be wise after the event than to make critical decisions as this difficult case was unfolding and before the unexpected crisis developed.
In his oral evidence, Professor Ellwood confirmed the substance of his written reports. When asked to comment upon the suitability for the appellant's case of the D&E procedure he explained that it would be necessary to perform that under general anaesthetic and that the procedure involved a risk of haemorrhage, trauma to the uterus and/or cervix and the risk of retained tissue which could lead to subsequent infection. With a low‑lying placenta the risk of haemorrhage is considerable because of the risk of placenta accreta or increta.
With regard to chemical induction of labour using prostaglandins, he explained that generally this was done without anaesthetic (so that the risks of anaesthesia are removed). It does not always work. When it does, there is still a risk of haemorrhage and a retained placenta and/or subsequent infection. With a low‑lying placenta and four previous caesarean sections there was a risk of more severe haemorrhage. He also explained that in relation to the haemorrhage there were two aspects; first, that with a low‑lying placenta the process of labour will induce bleeding in the area of the cervix and the second aspect is that there may be haemorrhage at the point of detachment in the area of abnormal adherence. In relation to the latter aspect, he believed that haemorrhage resulting from that factor would have been the same whether the placenta was removed at the time of a D&E procedure or following induction with prostaglandins.
He referred to the hysterotomy as an old procedure which is not now a method of choice. This is because it requires a large surgical incision with associated bleeding that needs to be repaired; the repair to the uterus leaves a much weakened uterus for subsequent pregnancies and the risk of abnormal placentation acreta in future pregnancies. Being a major surgical procedure, it increases the risk of thromboembolic disease such as DVT and subsequent pulmonary embolism. He stated that in 1999 it would not be the method of choice in any of the tertiary hospitals with which he was familiar either in Australia or elsewhere in the world (AB 389). Specifically, Professor Ellwood said that in the appellant's case:
In my opinion, the need for hysterectomy arose once the placenta was removed or attempted to be removed from the implantation site. This was required whatever method of termination of pregnancy was used … including hysterotomy.
When dealing with the histopathological report of Dr Wainwright and the significant issue of whether or not this placenta might have been removed or detached without a massive haemorrhage, Professor Ellwood said (at AB 391):
This is consistent with the view that the placenta is actually implanted on to scar tissue rather than normally implanted on to the maternal decidua and the underlying myometrium. So this is not strictly speaking a placenta accreta because the definition of 'placenta accreta' implies that the placenta is directly attached to the myometrium. In this case, there was no myometrium for it to attach to. It's really attached to scar tissue.
The consequence of this is that there was no natural response to prevent or stop blood flow after the detachment of the placenta because there were no muscle fibres in the scars to contract around the blood vessels. In such a case, it is not possible to stop the bleeding using chemical agents which would cause uterine contractions such as were employed during the moments of crisis in this procedure.
When dealing with the significance of maternal blood loss, Professor Ellwood explained that, generally, a pregnant woman can lose up to about 1,000 ml of blood before there is any significant degree of haemodynamic compromise. However, once more than 1,500 ml is lost there will almost always be haemodynamic compromise, so the point where the patient changes from a relatively stable situation into an unstable one is somewhere between 1,000 and 1,500 ml of blood loss. In his assessment, a timely decision was taken in the appellant's case to go to operating theatre once the blood loss had exceeded 1,000 ml. Regardless of this, however, he was of the opinion that such were the complications associated with this adherent placenta that a haemorrhage would have been inevitable whatever method of evacuation had been employed.
Several points of importance emerged from the evidence of Professor Ellwood which, together with other evidence, formed the basis of significant findings by the learned trial judge.
Firstly, his opinion was that an hysterotomy was not a first line method of treatment for the induction of labour in a second trimester termination in any major teaching hospital in Australia or in other countries of which he was aware and that, in any event, it would be contraindicated in the appellant's case because of the risk of thromboembolic complications which were significant in her case because of her past history of DVTs.
Secondly, he saw a place for the use of prostaglandins, including Misoprostal, for inducing labour in second trimester terminations and had used these methods widely himself and read of their use in many other centres.
Thirdly, in the appellant's case there was obviously a risk of haemorrhage associated with the low‑lying placenta and, before it was clinically demonstrated, there was a known risk that there might be an abnormally adherent placenta. This was because of the ultrasound confirmation that this was a placenta praevia and the history of the four previous caesarean sections and their scarring. This all meant that there could be several sources of haemorrhage, including from the area around the cervical os at the time when the labour and contractions were proceeding with the cervix dilating, and also from the site of placental detachment at the area of abnormal adherence. Although he did not say so expressly, Professor Ellwood strongly implied that the source of the pre‑operative bleeding in the appellant's case did not come from the point of abnormal placental adherence but from elsewhere and was to be expected in such a case.
Fourthly, his interpretation of the histopathological evidence was that, while there may not, strictly speaking, have been the condition of placenta accreta, there was nevertheless abnormal placental adherence penetrating into the scar tissue so that when detachment occurred there was no possibility of muscle contraction, either from natural maternal response or from the injection or application of vasoconstrictor drugs, as was attempted, to reduce the bleeding.
Professor Ellwood's evidence amounted to a strong opinion that this haemorrhage was inevitable whatever means of uterine evacuation had been employed. That was also the opinion of Dr Wainwright and of Professor Trudinger and, while more emphatic, was not really inconsistent with the evidence of Dr Peat. It supported the evidence of the clinicians attending to the case, Professor Hammond and Dr Dickinson, and it provides a rational explanation for the severity of the haemorrhage and why the extreme emergency anaesthetic intervention and the vasoconstrictor drugs given by Dr Bremner and by Dr Dickinson were not able to staunch the haemorrhage.
There was, therefore, every reason for the learned trial judge to accept those opinions as she did and, more importantly for present purposes, it would be quite impossible, in my view, for this court to conclude that the learned trial judge was in error in reaching those conclusions.
The final independent consultant evidence for the respondent was from Professor Trudinger. Professor Trudinger is a professor of obstetrics and gynaecology at the University of Sydney and head of the Maternal Foetal Medicine Unit at Westmead Hospital. His fellowships include the MRCOG, FRCSE and FRANZOG. He has doctoral degrees from the University of Sydney and is a certified subspecialist in maternal foetal medicine. In his report of 10 September 2003 (exhibit D8B AB 984) he set out the obstetric history of the appellant and the details of this induced labour.
Professor Trudinger's interpretation of the histopathological report of Dr Wainwright was that the placenta was implanted in uterine scar tissue which, in his view, equated to placenta increta. For present purposes it is important to note his evidence that:
It is my opinion that haemorrhage was inevitable when the placenta was removed irrespective of the method chosen to evacuate the uterus. If hysterotomy had been performed I believe that the haemorrhage would have been equally uncontrollable and hysterectomy would have been necessary. If dilatation of the cervix and evacuation had been carried out then it is also my opinion that attempted placental removal would have been associated with haemorrhage.
Like Professor Ellwood, he was of the view that hysterotomy was not a primary method of choice for this case. He accepted the opinion of Dr Peat that a D&E as a primary procedure was appropriate as a reasonable view but he did not believe that the outcome would have been any different. He rejected the view of Dr Peat that penetration of the scar tissue by the placental vessels was into muscle. He confirmed these views in his sworn testimony.
He specifically endorsed the use of Misoprostal in obstetrics and referred to endorsement of its use for the augmentation of labour by leading obstetric journals, notwithstanding that the sponsoring drug company had not endorsed it for such purposes. Again he endorsed as reasonable, and as an acceptable alternative, the view of Dr Peat that a D&E would have been an appropriate method to treat the appellant and acknowledged that opinions would differ as to whether or not that process or chemical induction with prostaglandins were appropriate. However, he was quite emphatic that the outcome would not have been different with a D&E.
At the completion of his evidence, the learned trial judge asked Professor Trudinger about the significance of the appellant's earlier pre‑operative blood loss of 1,500 ml and whether it contributed to the inevitability of the hysterectomy. His answer was (AB 545):
No, I don't think so at all. I think that it's quite correct to say that the more blood loss then the more resuscitation that's necessary but the inevitability of the hysterectomy was there by virtue of the nature of the placental implantation and the placenta relationship to the scar. It wasn't altered by the procedures. In other words, the relationship of the placenta to the scar tissue wasn't changed by the fact that the uterus might have contracted for six or eight or 10 hours before that. It was still the same relationship between the placenta and the scar tissue in the uterus and that's why I make the comment that I don't see that a hysterectomy was avoidable.
Evidence of Dr J Dickinson
Dr Dickinson qualified in medicine at the University of Western Australia, taking the degrees of Bachelor of Medicine and Bachelor of Surgery in 1981. She became a fellow of the Royal Australian College of Obstetricians and Gynaecologists in 1991 and obtained a doctorate in medicine from the University of Western Australia in 2003. In 1996 she was an honorary adjunct associate professor of the Department of Medical Imaging at Curtin University in this State. From 1992 onwards she was a maternal foetal medicine specialist at KEMH and from 1997 was a clinical senior lecturer at the University of Western Australia at the Department of Obstetrics and Gynaecology. She has written and published extensively in this field alone and with other consultants. At the time of giving evidence at this trial in December 2004 Dr Dickinson was an associate professor in maternal foetal medicine at the University of Western Australia and director of maternal foetal medicine at KEMH.
Reference has already been made to the lengthy written statement about this incident prepared by Dr Dickinson on 20 January 1999 (AB 980 ‑ 983).
In her statement, exhibit D8A, in relation to the methods of dealing with the appellant's case Dr Dickinson wrote (AB 983):
The available therapeutic options in this particular case were medical termination of pregnancy with Misoprostal, a dilatation and evacuation with pre‑procedure cervical ripening with Misoprostal, or hysterotomy. A further option would be to do nothing and await spontaneous abortion. I had carefully considered all options and elected the medical termination of pregnancy route as the most appropriate, accepting that there is always a potential of risk regardless of which option was selected. Hysterotomy is considered the most morbid procedure: published evidence indicates increased death rates, increased thromboembolic complications, and infections with this technique. Its principal indication in contemporary medicine is when other methods of termination fail. [The appellant] was at high risk of thromboembolic complications and it had been noted that her last Caesarean section access to the peritoneal cavity was difficult. I did not feel it was justified to perform a primary hysterotomy for a 15‑16 week size dead foetus in her case. Dilatation and evacuation was also an option. I did not select this as the primary treatment mode because of the potential risks of internal injury (perforation of the uterus, cervical trauma). Pre‑procedure cervical ripening is recommended to minimise the risk of injury and I certainly had considered evacuating the foetus if delivery did not occur in a reasonable time. Indeed, at the second Misoprostal insertion I had considered taking [the appellant] to the operating room and delivering her vaginally but the cervix was only 1 cm and I felt the risks would be too great. No matter what procedure was employed in this case she was going to require a hysterectomy, and now knowing the outcome of the uterine pathology, an elective hysterectomy, leaving the foetus and placenta inside, would have been the least morbid procedure for her.
In her oral evidence Dr Dickinson elaborated on the history of the patient, the pre‑operating room treatment and then, when dealing with the events in the operating room, described how the foetus was delivered manually quite quickly, within four to five minutes, at the most, after the commencement of anaesthesia (AB 0605). Then describing the attempt to remove the placenta Dr Dickinson explained how it was very difficult to come off the front wall of the uterus and as she was attempting to achieve this a horrendous haemorrhage started (AB 0606). She felt the placenta was very adherent to the front wall of the uterus. This coincided with the severe haemorrhage, which was bright red blood, indicating that it was fresh (oxygenated) blood coming directly out of the vessels and not from some older haemorrhage which had pooled elsewhere for some time. Dr Dickinson formed the opinion that the blood loss was coming from the morbidly adherent placental implementation site over the cervix and the anterior wall of the uterus and made a clinical diagnosis of placenta accreta.
Dr Dickinson then described the efforts to control and reduce the haemorrhage and how the anaesthetist was advising her that the patient's blood pressure was falling very rapidly and was getting really low. She decided that the patient needed an hysterectomy and called Professor Ian Hammond, who came quickly and performed the procedure.
In relation to the nature of the morbid adherence of the placenta, Dr Dickinson said (at AB 622), when asked about the findings in the histopathology report of Dr Wainwright:
They are somewhat consistent with my clinical observations, but not exactly. They show that the front wall of the uterus didn't have any myometrium in it. They showed that the placenta was still attached despite all my efforts to remove the placenta; again, consistent with morbid adherence. I had made a clinical diagnosis of placenta accreta, but on reading Dr Wainwright's review she couldn't find any villi coming into the myometrium which is the pathology diagnosis of it which I accept is sometimes at variance with the clinical diagnosis.
The substance of this answer was repeated and confirmed in cross‑examination at AB 0644.
In cross‑examination Dr Dickinson confirmed (AB 666) that in 1999 KEMH had only one operating theatre available during night‑time. That was the reason for the delay in taking the appellant to the operating room from 10.50 pm onwards, because the only available theatre was occupied for an emergency caesarean section. This resulted in a wait of about an hour and a half more than Dr Dickinson's ideal estimate of time (AB 667). Despite losing about 500 ml of blood during this interval of delay the appellant's haemodynamic and cardiovascular observations were stable at the commencement of the operation so there was no evidence of significant compromise. She also confirmed in cross‑examination (AB 691) that it was her opinion that no matter what technique was undertaken to deliver the appellant, that once attempts were made to remove her placenta she would have experienced catastrophic haemorrhage and needed an hysterectomy.
Accordingly, in the light of all the medical evidence, both from independent experts and from the clinicians involved in the procedure, there was unanimity of view that, once the haemorrhage occurred following the attempt to remove this placenta an hysterectomy was inevitable. The appellant's expert's evidence, with slightly differing degrees of emphasis, maintained that either a D&C procedure or an hysterotomy should have been employed and that to use Misoprostal or other prostaglandins for a woman with the appellant's obstetric history, was most inappropriate, and that it was even more inappropriate to persist with that treatment once significant bleeding began. This set of opinions acknowledged that even with one or other of their preferred procedures there was still a risk of massive haemorrhage and ensuing hysterectomy but that, on balance, there was a better than even chance of avoiding hysterectomy by the earlier and more rapid intervention which those other procedures offered.
To a great extent, that assessment of the prospect of avoiding or controlling a large haemorrhage without proceeding to hysterectomy depended on the significance which these doctors attached to the histopathological report and the degree of abnormal adherence of this placenta and, in Dr Peat's case, upon the observation by Dr Wainwright that this was not a placenta accreta. However, the evidence of Dr Wainwright, Professor Ellwood and Professor Trudinger has the effect of changing this balance because of their descriptions that, while the condition was not that of placenta accreta, the spiral arteries from the placenta had penetrated the scar tissue, which was not composed of maternal muscle, so that, on detachment, there could no spontaneous or chemically induced contraction and occlusion of the blood vessels. In effect, this made the haemorrhage unmanageable and, this being the case, the hysterectomy inevitable.
That conclusion effectively determined the fate of the case and, with respect, there was every reason for the learned trial judge to come to that decision on all the evidence. There was certainly a great deal of evidence to support it. Once the significance of the histopathology had been more closely examined, one readily sees why her Honour concluded that the hopes entertained by Dr Peat and Dr Nash were regarded by her Honour as unsustainable.
The learned trial judge's essential finding at [195], [196], [202], [215] and [229] was that the cause of the hysterectomy was the blood loss directly resulting from the attempt to detach the placenta and that this outcome was inevitable irrespective of the method of evacuation.
Despite the breadth of issues covered by the grounds of this appeal and in the written submissions by the appellant, nothing has been demonstrated to cast any doubt about the correctness of that essential finding by the learned trial judge, still less to demonstrate that it was affected by any error or omission which would justify this court taking a different view of the facts. Sadly, in this case, the very extensive forensic reviews of this tragic episode have demonstrated emphatically that the appellant's prior obstetric history and the particular complications associated with this pregnancy made the hysterectomy unavoidable. It was essential in order save the patient's life when confronted with the massive haemorrhage following the attempts at placental detachment. This would have occurred no matter what method of evacuation had been attempted.
Informed consent
A large part of the appellant's case at trial, and on this appeal, contended that the defendant was liable in damages for the appellant's hysterectomy and its associated consequences because no proper informed consent had been obtained from the patient before the Misoprostal induced evacuation was commenced. The learned trial judge did conclude that there had been a failure to obtain adequate informed consent but concluded that this did not cause or contribute to the hysterectomy. As described in detail in the foregoing examination, this is because the evidence satisfied her Honour that any form of evacuation would have led to torrential bleeding at the point when efforts were made to separate the placenta which was abnormally adhering to the scar tissue in the lower anterior uterine segment.
Her Honour also found that, situated as she was, the appellant really had no alternative but to proceed with evacuation at KEMH and would have done so even if she had been better informed of the risks. Her Honour also decided that even if another procedure had been followed it would have led to the same outcome.
There were cogent reasons for reaching those conclusions. The Hassans desired to have the dead foetus removed and were unwilling to wait in hope of a natural spontaneous abortion which, itself, would have been associated with significant and similar risks. Any such second trimester termination of the dead foetus in Western Australia would have been performed at KEMH. There was no credible basis for concluding that the appellant, had she been differently informed, would have gone elsewhere and had the procedure undertaken. She had four young children at home and was in no position to travel interstate. Both she and her husband desired to have the dead foetus evacuated. KEMH was the major obstetric hospital in Western Australia and she had attended there previously because of complications in this pregnancy. It was the natural and obvious place for any procedure to be performed and, in my respectful opinion, the learned trial judge was plainly correct in concluding that, one way or another, the appellant would have submitted to an evacuation of this dead foetus at that hospital even if she had been given more information which would have enabled her better to understand all that was involved.
This has an important secondary effect which was not examined at the trial or on the appeal but which nevertheless should be noticed. It was never intended that the appellant should have an hysterectomy. Indeed, despite the complications and the risks, Dr Dickinson did not believe that an hysterectomy was a real possibility until after the foetus was delivered and the massive haemorrhage commenced. The haemorrhage which followed was in the nature of a major clinical emergency. No consent could be obtained at that point from the patient to proceed to conduct an hysterectomy nor was it necessary. At that point, the prime consideration was the conservation of the patient's life. In those circumstances, where there is no opportunity to avoid the procedure, consent of that kind is not necessary ‑ see Rogers v Whitaker (1992) 175 CLR 479, 489, 493 ‑ 494. The significance of the life‑threatening emergency on the issue of consent was not dealt with at the trial, no doubt because it was obvious that at that point no other course could have been taken. However, implicit in that recognition is the assumption that, even had the appellant been aware of some risk of eventual hysterectomy in any one of a variety of procedures to produce the evacuation of the dead foetus which she underwent, it is clear from all the circumstances and from the learned trial judge's finding that she would still have submitted to the evacuation. There was really no feasible alternative course available.
Once this is realised, the significance of the issue of lack of informed consent diminishes. In concluding, as her Honour did, that the hysterectomy was not caused by any failure to obtain fully informed consent the effect of that decision can equally be described as being that the ultimate hysterectomy was inevitable once the risk of major haemorrhage materialised in an otherwise essential or unavoidable procedure.
Conclusion
It follows that this appeal should be dismissed.
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