Hassan v Minister for Health
[2005] WADC 182
•4 OCTOBER 2005
JURISDICTION : DISTRICT COURT OF WESTERN AUSTRALIA
IN CIVIL
LOCATION: PERTH
CITATION: HASSAN -v- MINISTER FOR HEALTH [2005] WADC 182
CORAM: CRISFORD DCJ
HEARD: 6-10, 13-17 DECEMBER 2004, 23-27 MAY 2005
DELIVERED : 4 OCTOBER 2005
FILE NO/S: CIV 2082 of 2002
BETWEEN: TAHANY HASSAN
Plaintiff
AND
MINISTER FOR HEALTH
Defendant
Catchwords:
Torts - Negligence - Breach of duty to warn of risks - Maternal foetal medicine - Drug trial - Alternative procedures - Hysterectomy - Causation
McKenzie Friend - Interest in outcome - Plaintiff's husband - Exceptional case
Legislation:
District Court of Western Australia Act 1969 s 39
Evidence Act 1906 s 121
Legal Practice Act 2003 s 123
Result:
Plaintiff's claim dismissed
Representation:
Counsel:
Plaintiff: In person
Defendant: Mr P P McCann (Dec 2004) & Mr D R Clyne (May 2005)
Solicitors:
Plaintiff: In person
Defendant: Dibbs Barker Gosling
Case(s) referred to in judgment(s):
Chappel v Hart (1998) 195 CLR 232
Gover v South Australia (1985) 39 SASR 543
McKenzie v McKenzie [1970] 3 All ER 1034
Rogers v Whitaker (1992) A Tort Rep 81-189
Rosenberg v Percival (2001) 205 CLR 434
Schagen v R (1993) 8 WAR 410
Sidaway v Board of Governors of Bethlehem Royal Hospital & Maudsley Hospital Board [1984] QB 493
Case(s) also cited:
Bolam v Friern Hospital Management Committee (1975) 1 WLR 582
Briginshaw v Briginshaw (1938) 60 CLR 336
Damjanovic v Maley (2002) 55 NSWLR 149
Hoyts Pty Ltd v Burns (2003) 201 ALR 470
Jones v Dunkel & Anor (1959) 101 CLR 298
Newman v Nugent (1992) 12 WAR 119
Prast v Town of Cottesloe (2000) 22 WAR 474
Royal Perth Hospital Board of Management v Frost, unreported; SC of WA; BC9905687; 26 February 1997
Schellenberg v Tunnel Holdings Pty Ltd (2000) 200 CLR 121
Uzabeager v Town of Cottesloe (2004) Aust Torts Reports 81-739
Van Gervan v Fenton (1992) 175 CLR 327
CRISFORD DCJ: Mrs Tahany Hassan was admitted to King Edward Memorial Hospital (KEMH) on 11 January 1999. The purpose of her admission was for uterine evacuation following foetal death in utero. She had a history of four prior lower uterine segment caesarean sections ("caesareans").
The evacuation was performed by administration of a prostaglandin which induces labour. She did not completely deliver and manual evacuation of the placenta was undertaken under general anaesthetic. The placenta was low lying and had adhered to the scar tissue from the prior caesareans. Removal of it caused abnormal blood loss.
When Mrs Hassan awoke on 12 January 1999 she was in the Adult Special Care Unit. She had undergone an emergency total hysterectomy to stop the ongoing blood loss.
On 30 July 2002 a writ of summons was issued out of the District Court of Western Australia at Perth by Mrs Hassan claiming unspecified damages for personal injuries suffered as a result of negligence of the defendant and the treating physician, Dr Jan Dickinson ("Dr Dickinson").
The plaintiff's claim
Mrs Hassan says at no time did she ever give informed consent for a medical procedure, namely chemical induction of labour, to be performed on her which could result in hysterectomy. Additionally she says she never gave informed consent to being included in a drug trial which could involve her in such heavy blood loss that hysterectomy was an outcome. She says if she had known that hysterectomy was a possibility she would not have consented to be included in a drug trial or to have undergone a chemical induction of labour to evacuate the foetus.
Mrs Hassan says that given her known history of four prior caesareans being included in a drug trial was inappropriate. She was not given a choice of methods by which the foetus could have been evacuated. She was presented with a procedure not knowing the alternatives or the risks. She complains that she was not adequately attended to by the treating medical practitioner when she was experiencing severe blood loss and pain for an extended period. She pleads res ipsa loquitur. These matters she says have caused her the injuries and as a result of the injuries she has suffered loss.
The Minister for Health ("Minister"), incorporated as the Board of Management of KEMH under s 7 of the Hospitals and Health Services Act 1927 (Cth) resists the claim on the basis that full, freely given and informed consent was obtained from Mrs Hassan and her husband, Omar Hassan, in relation to both the induction into a drug trial and also in relation to hysterectomy being a possible outcome of the medical procedure. It says that due to the adherence of the placenta to scar tissue in Mrs Hassan's uterus caused by four prior caesareans an hysterectomy was inevitable no matter how the foetus was evacuated.
A litigant in person with a "McKenzie Friend" (McKenzie v McKenzie [1970] 3 All ER 1034)
Until early 2004 Mrs Hassan was represented by solicitors.
By chambers summons and affidavit in support filed 22 January 2004 she sought to act in person and to have Mr Hassan represent her in all court proceedings. The application was pressed leading up to trial.
The Minister's initial position was that Mr Hassan was not an appropriate person to represent Mrs Hassan at trial and that she was capable of representing herself. Just prior to trial the position changed and the application was no longer opposed. It is a matter that the Court had to consider in any event.
Mrs Hassan said she had consulted more than 12 solicitors but the legal management of her case had been unsatisfactory. She was physically and mentally unable to conduct the proceedings herself. She deposed to having a limited command of the English language. She had spent some $130,000 on legal fees. She and her husband were unemployed and had limited funds to engage further solicitors, even if there was a solicitor willing to take the matter on. The proceedings had been on foot for some years.
Section 123 of the Legal Practice Act 2003 provides, relevantly, that:
"(1)A person must not engage in legal practice unless the person is a certified practitioner.
(2)…
(3)Nothing in subsection (1) is to be construed as preventing a person from –
(a)appearing or defending in person in a court;
(b)…
(c)appearing for a person before a court, or providing advice or other services, if that appearance or the provision of that advice or service, is authorised by written law."
Section 39(1) of the District Court of Western Australia Act 1969 provides that:
"A party to an action, cause or other proceedings may appear before the court in person or by a certified practitioner (within the meaning of the Legal Practice Act 2003) or by any person allowed by special leave of the presiding District Court judge, in any case."
The Court was initially very wary of granting leave to an unqualified person to appear before it especially given the nature of the particular case. Mr Hassan clearly had an interest in the outcome of the litigation. The public interest and the effective disposal of cases is best achieved by the use of qualified lawyers who are skilled in advocacy, experienced, and subject to a disciplinary and ethical code.
The Court was ultimately of the view that Mrs Hassan, as a self‑represented party, should be afforded all reasonable facilities to enable her to exercise her right of audience. On balance it appeared that this was a rare and exceptional case in which a person other than a qualified legal practitioner should be permitted to address the Court and otherwise take an active part in the proceedings (Schagen v R (1993) 8 WAR 410). Not only was the plaintiff's English imperfect but the impact on her both physically and mentally of her stay in hospital in January 1999 had been great. Her ability to question and test the evidence of the treating surgeons, the anaesthetist and other health professionals involved was severely compromised.
A McKenzie Friend in this particular case meant Mrs Hassan was in a position to have her case adequately presented. Special leave was granted to Mr Hassan to actively assist in the presentation of his wife's case.
Evidence by audio link
The matter was further complicated by Mrs Hassan's application to have a number of her expert medical witnesses give evidence by audio link from both interstate and overseas. Audio link by telephone could reasonably be made available. In the circumstances of this particular case the Court was of the view that pursuant to s 121 of the Evidence Act 1906 such a direction was in the interests of justice.
This section is concerned about the manner in which the evidence is to be received – not its relevance or admissibility.
Mrs Hassan lacked the funds to have every one of her experts give evidence either in person or by video link. These witnesses were to give expert opinion only. Evidence of this nature turns more upon the methodology used, relevant literature and contemporary scientific opinion than it does upon the impression made by the witness. Each witness, on questioning by the Court, gave adequate assurances about the environment in which the evidence was to be given and the materials each had available at that time.
Statement of claim
The statement of claim was filed by solicitors for Mrs Hassan on 3 September 2002. Leave was granted for the statement of claim to be amended. This was done by solicitors on 11 December 2003. On 22 January 2004 the plaintiff filed a notice of her intention to act in person. Solicitors were again on the record for the plaintiff in May 2004. On 13 September 2004 the plaintiff filed a notice of her intention to act in person.
Her pleadings were initially drawn and subsequently amended by her solicitors. At trial Mr Hassan indicated acceptance of those pleadings. At the end of the plaintiff's case he stated she did not wish to have the statement of claim altered in any way.
The case was put on the basis that KEMH was vicariously liable for Dr Dickinson.
Background history
I set out the facts relevant to the matters in issue.
Mrs Hassan is now 43 years of age. She was born in Alexandria in Egypt and came to Australia in 1982 at age 20. She met her husband in Egypt and they married in the early 1980's.
She had learnt some English in Egypt. Her English had improved since coming to Australia.
She had done some teaching work in Australia at Arabic schools. She taught Arabic and religious studies. She was paid for this work but stopped working during her first pregnancy.
Her first pregnancy in 1983 resulted in a miscarriage. In 1985, 1987, 1992 and 1997 she gave birth and on each occasion a caesarean was performed. She has a total of five children, the birth in 1985 being twins.
Apart from the four prior caesareans Mrs Hassan had a history of deep vein thrombosis associated with at least two of her pregnancies.
Mrs Hassan again became pregnant in September 1998. Her treating general medical practitioner since early 1997 had been Dr Maysa Abulaban. She attended KEMH at the request of Dr Abulaban on 9 December 1998 due to her history of complicated past pregnancies.
She was seen by the resident medical officer, Dr Adam Roberts. He told her to come back for blood tests and for an ultrasound in a few weeks time. On leaving the hospital, Dr Roberts stopped the Hassans in the car park. Dr Roberts had consulted Dr Dickinson in relation to a prior ultrasound taken privately some time before. Marked foetal abnormality was detected. Dr Roberts requested the Hassans return to the hospital the following day, rather than waiting several weeks to have an ultrasound.
10 December 1998
On 10 December 1998 the Hassans returned to KEMH. An ultrasound was performed by Dr Dickinson who had read and considered Mrs Hassan's previous medical record. This was the first time she had met Mrs Hassan.
The ultrasound report indicated that there was a single live foetus within the uterus. The gestation was 13 weeks and two days by an estimated delivery date of 15 June 1999. The placenta was located posteriorly. It covered the cervix to reside on the anterior uterine wall. The foetus was not well. A termination was indicated and recommended by Dr Dickinson. However, Mrs Hassan wanted to speak with her family and doctor first. She attended Dr Abulaban immediately.
Mrs Hassan's memory of the conversation between herself and Dr Dickinson is that the talk centred on the baby being ill and likely to die. It should be "taken out" quickly. She was aware of a problem with the placenta. This part of the conversation she says was of some five minutes duration.
Dr Dickinson said she told Mrs Hassan that the placenta covered the old caesarean scars.
She said the delivery of the placenta could be difficult, associated with severe haemorrhage and even the loss of the uterus. The hospital notes made by Dr Dickinson on that day support that she had those concerns.
Prior to Mrs Hassan's arrival at Dr Abulaban's surgery, Dr Dickinson had already telephoned and spoken to the GP. She said she did this as Mrs Hassan had an established relationship with Dr Abulaban. The situation was of concern to her as a result of the ultrasound.
Mrs Hassan denied that Dr Dickinson told her there was a risk of hysterectomy or that there were increased risks for her as the pregnancy advanced.
8 January 1999
On Friday 8 January 1999 a further ultrasound ordered by the general practitioner revealed that there had been a foetal death in utero. Mrs Hassan was referred to KEMH Emergency by Dr Abulaban with a letter seeking her admission. She attended mid‑afternoon and was sent to a gynaecology ward.
Dr Dickinson says she saw Mrs Hassan on the ward at KEMH at about 5.00 pm on that day. She had been called back in to the hospital. Her notes written afterwards are marked as 5.40 pm. The Hassans each recall she talked to them for 10 minutes or so.
During the time at the hospital a history was taken from her. This was put in a form titled "Admission, Assessment and Discharge Plan". This form was filled in by an experienced obstetric nurse, Kim Tipper. The form notes Mrs Hassan's religion to be Muslim, her first language to be Arabic but "she speaks English", and her food requirements as halal. As Mrs Hassan did not remain in hospital a discharge summary and clinical coding form was also completed. This is dated 28 January 1999.
A form headed "Consent Form for Operative Treatment and Administration of Anaesthetics" was signed by Mrs Hassan. This related to the evacuation of retained products of conception. It was signed and dated by both Dr Dickinson and Mrs Hassan. The date is 8 January 1999.
Despite Dr Abulaban's view this matter needed to be dealt with urgently as an emergency Dr Dickinson was of a different view.
Dr Dickinson states she discussed medical termination with Mrs Hassan. She did not mention any other possible treatment save to tell Mrs Hassan that due to the size and age of the foetus a suction dilation and curettage was not now possible. She talked about how she would induce the foetus chemically. She did not discuss other possible methods. Dr Dickinson gave evidence that no other options were put simply because none were available at KEMH as first line treatments. She said she discussed the risk of haemorrhage.
The use of a new drug to induce labour was discussed. This new drug was Misoprostol. Mrs Hassan's memory is that she was told, unlike her previous caesareans, she would be home in a few hours. The use of the new drug in a medical induction meant there would be no incision and it would be an easy procedure. Mrs Hassan was happy with this because it meant she would be away from her other children for less time. She did raise with Dr Dickinson her concerns that in a previous pregnancy where drugs had been used to assist she had failed to contract. It was explained that this was a new drug and was likely to make the process very quick and easy.
Mrs Hassan gave evidence that Dr Dickinson did not mention that her situation was one of high risk or that she may need to go to the operating theatre to have the placenta removed. She did not mention the history of the deep vein thromboses, the position of the placenta in her uterus and the actual placement of the placenta being possibly over prior caesarean scars. Her recall was that the procedure as to when and how the drugs were to be taken was explained to her.
Due to the lack of appropriate staffing levels over the weekend it was not possible to carry out the medical evacuation until Monday. She stressed there was no emergency and indeed Mrs Hassan could go home and await a spontaneous delivery if she so desired. Alternatively she could stay in the hospital until Monday when the operation would be carried out at that stage.
Mrs Hassan went home to her children for the weekend. The Hassans returned to the hospital on Monday 11 January 1999.
Despite the advice of Dr Dickinson that there was no emergency and Mrs Hassan could simply go home and await a spontaneous delivery, neither Hassans wanted to await a spontaneous delivery. Mr Hassan gave evidence that he was not happy with that advice, he did not believe it was the right thing to do and he considered it a very dangerous situation and would not accept it. He gave evidence that he had spoken to a doctor in Sydney about it over the weekend.
Mrs Hassan said Dr Abulaban had rung her on Friday night after she returned home to find out what had happened.
11 January 1999
When the Hassans returned to KEMH, just after 8.00 am, a further "Admission, Assessment and Discharge Plan" form was filled in by an experienced obstetric nurse, Audrey Emmett. It was signed at 8.30 am and mirrors the form of 8 January 1999 except her assessment is that Mrs Hassan "speaks good English".
Despite the discharge of Mrs Hassan from hospital on 8 January 1999 a further "Consent Form for Operative Treatment and Administration of Anaesthetics" was not completed on the Monday.
Mr Hassan said that he and his wife saw Dr Dickinson for some 15 to 20 minutes. His recall was that the doctor was running late. Dr Dickinson confirms that she may well have been running late and that she spent some 15 to 20 minutes with the Hassans. Dr Dickinson said she again went over the risks and potential complications of the procedure including haemorrhage, hysterectomy and death. The hospital notes record the risks she says she explained. These were uterine rupture, hysterectomy, infection and haemorrhage. Unusually, these notes are not marked as to the time they were made.
Mrs Hassan was concerned to ensure that the foetus was, in fact, dead and requested a further ultrasound. She was afforded that confirmation. She gave evidence "when I coming back it was a sad day" (sic).
The ultrasound report showed that the placenta was situated on the posterior uterine wall. It covered the cervix to reach the lower anterior uterine wall. This is termed a low lying placenta. Although the pregnancy had progressed 17 weeks 6 days the foetus size was consistent with that of 15 weeks 3 days gestation.
An invitation was extended to Mrs Hassan to participate in a drug trial which was underway and the purpose of which was to ascertain the most suitable dose of the prostaglandin Misoprostol which was already routinely in use at KEMH to induce labour in second trimester pregnancies. Mrs Hassan accepted the invitation and signed a consent form in relation to enrolment in the Misoprostol trial.
Mrs Hassan said she read the form but did not understand it all. She remembered the use of the word "safest". The Hassans did not recall any complications, side effect or risks being discussed. There were none detailed in the form. Mrs Hassan gave evidence that if she had been told hysterectomy was a risk she would not have taken the drug but gone elsewhere, to another doctor, another hospital, another country.
At 10.45 am the procedure of medical induction commenced. Mrs Hassan, accompanied by her husband, was in a single patient room. She was attended by Nurse Emmett. The first dose of Misoprostol from a blind random sample was administered. Nurse Emmett did not record the actual dose but the drug chart signed by Dr Dickinson states that amount as 400 micrograms.
Nurse Emmett had instructed Mrs Hassan to remain still for some 45 minutes after the administration of the first dose. Mrs Hassan's evidence is that some 15 to 20 minutes after its administration she started to bleed and felt the need to go to the toilet, which she did. Her evidence was that her blood was very heavy, continuous and that she had pain.
Nurse Emmett was an experienced nurse. On 11 January 1999 she was working from 7.00 am until 1.00 pm. She had no independent recollection of this day. She had been assigned specifically to Mrs Hassan. She may have had one other patient to deal with but her attention was mostly directed at assisting Mrs Hassan.
The inpatient case notes completed by Nurse Emmett at 12.40 pm record that Mrs Hassan told her she had passed blood into the toilet at 11.45 pm. The blood loss noted at 12.30 pm was of "small dark blood".
Mrs Hassan was experiencing abdominal tightening and crampy pain. Nurse Emmett gave evidence that blood loss was an expected consequence of the procedure. Mrs Hassan was given a hot pack.
The notes indicate that an intravenous bung was to be inserted should fluids be required at a later stage.
Nurse Emmett was relieved by Nurse Kim Tipper, another experienced obstetric nurse. Her shift was from 1.00 pm until 9.30 pm. Again Mrs Hassan was the focus of the nurse's attention.
The hospital notes made by Nurse Tipper show that at 2.00 pm there was a small blood loss but this was increasing when voiding. Pethadine was given for the pain. Dr Dickinson recalls having a conversation by telephone with Nurse Tipper at that time. She was advised that Mrs Hassan was contracting and there was vaginal blood loss. This was pleasing and to be expected. It was about this time that Dr Dickinson asked that the blood loss be accurately measured. Dr Dickinson said that she also requested an intravenous bung be inserted due to the risk of haemorrhage as a result of the placement of the placenta. On Mrs Hassan's admission that day she had arranged for a full blood test to be taken to ensure Mrs Hassan was not anaemic and could sustain anticipated blood loss.
Dr Dickinson saw Mrs Hassan at 4.45pm. She read the notes that had been made. The regular observations indicated that Mrs Hassan was a stable patient, she had a normal pulse, mildly elevated blood pressure, no fever and her temperature was normal. A second dose of 400 mg of Misoprostol was inserted by Dr Dickinson, who examined her generally. She showed all the signs of labour. She directed that Mrs Hassan start fasting and that intravenous fluids be commenced just in case an anaesthetic was required later. The staff were to keep her informed.
Dr Dickinson called the nurse at 8.30 pm. At that time the blood loss measured was 780 ml. The patient was otherwise stable.
At 10.30 pm Dr Dickinson came to the hospital and reviewed Mrs Hassan at 10.45 pm. At 10.15 pm the measured blood loss was 990 ml. She called the operating theatre to ascertain its availability should it be required. It was unavailable at that stage. A review of the medical chart indicated Mrs Hassan was haemodynamically stable and there was no evidence of cardiovascular decompression. Despite the blood loss there was no evidence that this was not being tolerated.
A third dose of 400 mg of Misoprostol was administered by Dr Dickinson at 10.45 pm. A call was made by her to the blood bank to have a cross‑match of blood available.
Her evidence is that some 45 minutes later there was a sudden gush of blood. The loss was, in total, 1200 to 1400 CC. The blood loss prior to 2.00 pm was not measured.
At that stage the operating room became available and Dr Dickinson went to the ward to take her to theatre. Dr Dickinson gave evidence that the operating theatre should have been available ideally, an hour and a half earlier. She said she spoke to Mrs Hassan about what was happening. Neither of the Hassans recall this. She had decided to proceed to the second line treatment of dilation and evacuation under general anaesthetic with ultrasound assistance. This was because of the amount of blood lost and the foetus not yet delivered.
Operating theatre
Dr Michael Bremner was the anaesthetic registrar on call that night. He had been forewarned earlier that evening he may be required in the operating theatre.
His evidence was that whilst Mrs Hassan had lost significant amounts of blood prior to going to theatre her condition was not yet unstable in terms of blood pressure and heart rate.
His understanding was that Mrs Hassan was going to theatre for delivery of a foetus and the placenta. The hysterectomy was not planned prior to the operation commencing.
In the operating theatre at 12.30 am Dr Dickinson was able to remove the foetus manually. She then proceeded to deliver the placenta using a manual removal technique.
She was successful in removing it from the back wall of the uterus. Parts surrounding the cervix and the front wall were very difficult to remove. Her evidence is that she was unable to get a cleavage point and there was an "horrendous" haemorrhage.
She made a clinical diagnosis of placenta accreta, meaning the placenta was morbidly implanted into the uterus. Muscle contractions to stop bleeding could not occur. Dr Helen Wainwright, the anatomical pathologist, concluded that the placenta was implanted into the pre‑existing scar tissue from the caesareans, which left a number of unsupported blood vessels, from which the blood flowed. She stated there was no evidence of placenta accreta.
Dr Dickinson tried to reduce and ideally stop the extreme blood loss. The anaesthetist administered drugs and Dr Dickinson attempted uterine packing and bi‑manual compression of the uterus.
Dr Bremner arranged for Dr Moira Westmore, a consultant anaesthetist, to be called in to assist. There was an urgent need for massive resuscitation. She arrived shortly after 1.00 am.
Dr Ian Hammond was called at about 1.00 am. He was a senior consultant surgeon in gynaecological oncology. At this stage Dr Dickinson was not successful in reducing the blood loss. Mrs Hassan's blood pressure was then falling. There was a need to take definitive measures to stop the bleeding. At that stage the medical professionals were simply maintaining her life.
Dr Hammond arrived and assessed that an hysterectomy was the only option. There was no other course of action reasonably open. A total abdominal hysterectomy was undertaken by him. This saved her life.
Whilst Mrs Hassan's blood pressure went very low it was then maintained as an acceptable level. Dr Bremner explained the reason for the low blood pressure was the pre‑operation and interoperation blood loss coupled with the drugs used, which routinely drop blood pressure.
After the operation at about 3.00 am Mrs Hassan was taken to the Adult Special Care Unit. She was attended to on a daily basis by Dr Dickinson and was discharged on 21 January 1999.
In July 1999 the Hassans moved to Sydney.
Medical induction of labour ‑ Misoprostol drug trial
Medical induction of labour involves the induction of labour by administration of synthetic prostaglandins. It is a non‑surgical procedure.
Labour proceeds in the usual way in that the cervix dilates and effaces, contractions occur and the foetus and placenta are expelled. However, the placenta or part of it is often retained in the uterus. This then necessitates manual removal in theatre under general anaesthetic. Medical induction of labour procedures have been performed for many years using various chemical agencies.
The main risks in relation to medical induction of labour are haemorrhage, uterine rupture and retained placenta.
Misoprostol and Cervagem are examples of synthetic prostaglandin hormones used to initiate and sustain the early onset of labour. Misoprostol has been the subject of some difference of opinion worldwide.
The drug Misoprostol is licensed in Australia for the treatment of stomach ulcers. However, both in Australia and worldwide it is used in obstetrics, among other things, as a means of cervical priming for inducing labour and termination of pregnancy.
The particular trial utilising Misoprostol conducted by KEMH was designed to test suitable dosing regimes for Misoprostol. Misoprostol 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 of administering one of three different dosage regimes. Firstly, some patients received 400 mg every six hours. Mrs Hassan, 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 & Children's Hospital in Adelaide and a medical expert called by the plaintiff, used Misoprostol in his practice, albeit as a single dose to prime the cervix.
Misoprostol was administrated routinely over that period at KEMH as its first line treatment for the induction of labour. Mrs Hassan would have been administered Misoprostol 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 Misoprostol followed every six hours by intravaginal doses of 200 mg up to a maximum of 48 hours.
The consent form completed by Mrs Hassan had been initially drafted by Dr Dickinson. The form had been approved by the KEMH Scientific Advisory Committee and the Institutional Ethics Committee.
Duty to disclose or advise of risks inherent in the proposed procedure
On 8 January 1999 Mrs Hassan and Dr Dickinson signed a document headed "King Edward Memorial Hospital for Women Consent Form for Operative Treatment and Administration of Anaesthetics". The consent related to the "following operation/procedure – evacuation of retained products of conception the nature, of which has been explained to me by Dr Dickinson." The form goes on to cover "alternative operative measures as may in the opinion of the operating surgeon be found to be necessary during the course of the operation".
On 11 January 1999 Mrs Hassan and Dr Dickinson signed a further document entitled "The Optimisation of Misoprostol Dosing Schedules for Second Trimester Pregnancy Termination".
The plaintiff pleads that despite the signing of the documents referred to, at no time did she:
"19.(a) understand that by her admission it was possible that a hysterectomy would be performed on her;
(b)receive any informed explanation of any likelihood that she would have a hysterectomy performed upon her;
(c)gave any informed consent or voluntary permission for induction into the Misoprostol study; or
(d)gave any informed consent for a hysterectomy to be performed upon her."
It is clear the law imposes on a medical practitioner a duty to exercise reasonable care and skill in the provision of professional advice and treatment. In a particular case this extends to the provision of information. (Rogers v Whitaker (1992) A Tort Rep 81-189, Gover v South Australia (1985) 39 SASR 543 at 551.
The joint judgment of the High Court in Rogers sets out:
"The law should recognise that a doctor has a duty to warn a patient of a material risk inherent in the proposed treatment; a risk is material if, in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it."
Dr Dickinson was under a duty to inform Mrs Hassan of the possible consequences in the event of complications in the evacuation of the foetus, including the possibility of an hysterectomy. That duty was called into existence because of the undisputed foreseeability of that very risk. Here risk of hysterectomy was increased. In particular this related to Mrs Hassan having had prior caesareans which increased the likelihood of the placenta adhering to the previous scars caused by the caesareans and also having a low lying placenta.
The risk did eventuate and Mrs Hassan had a total abdominal hysterectomy.
Was the duty performed?
The question revolves around whether the information given to Mrs Hassan was sufficient to alert her to the serious harm she did suffer.
This depends on the surrounding circumstances particular to each case. The amount of information or advice to be given by a doctor can depend upon a number of factors. These include the nature of the matters to be disclosed, the particular treatment for which the patient is to undergo, the circumstances pertinent to the particular patient, here Mrs Hassan, including her temperament and health.
It is necessary to look at the manner in which the relevant information is communicated to the patient. It is clear that Mrs Hassan, if fully warned of the risk of hysterectomy, would have attached great significance to it especially in view of her culture.
For Mrs Hassan the removal of her uterus presented her with a devastating disability. Her evidence was that she would have preferred death.
Given the significance of the risks no matter how high or low they were it was crucial she knew about them and understood what they were.
(i) Misoprostol study
The relevant form for the drug trial was presented to and signed by Mrs Hassan on 11 January 1999, the day she was to undergo the evacuation. This was in a consultation of some 10‑15 minutes duration. Mr Hassan was present. Mrs Hassan read some of the form but not all of it.
The form sets out information about the purpose of the study – to investigate the most suitable dose of the drug – and it sets out the view that the safest way to interrupt pregnancy during the second trimester is by the use of prostaglandin hormones. It sets out that the drug is not licensed for this purpose in Australia.
The form states that the patient, here Mrs Hassan, has been assessed as eligible to enter the study. Consent is to be given after the information is read and discussed with "your doctor".
The only opportunity to discuss the trial with any doctor was in the 10‑15 minutes on 11 January 1999. Unlike the December 1998 attendance it was not thought appropriate or necessary to involve someone who had an established relationship with Mrs Hassan.
At the time of being presented with the form Dr Dickinson explained the drug procedure and study to Mrs Hassan. She was told that some 130 people had already been given the drug in the course of the study. The drug was more up to date than the drugs Mrs Hassan had previously been given to encourage contractions. Mr Hassan recalls that they were told the procedure was "straightforward". Mrs Hassan states she was told there would be "no cut". Previously, she had been "cut" when undergoing the caesareans in the operating theatre.
The Hassans were not told of any risks of being in the trial. The form sets out no possible risks, complications or side effects of Misoprostol itself or of being in the trial. Given the assurances of Dr Dickinson, Mrs Hassan signed the form.
(ii) Hysterectomy
The objective evidence is quite clear, hysterectomy was always a possible outcome in a procedure such as this. The risk of an hysterectomy being performed was heightened in Mrs Hassan's circumstances.
The hospital note completed by Dr Dickinson on 8 January 1999 identifies Mrs Hassan as being a high risk patient. It identifies the recurrent deep vein thromboses, the four prior caesareans and the present low lying placenta. The note of 11 January 1999 is more specific in that it identifies the risk of loss of the uterus.
The consent form completed by Mrs Hassan on 8 January 1999 on the ward does not set out any particular risks but leaves the potential for "further alternative operative measures as may be found to be necessary". It does not set out the operation or procedure. It does not set out any alternative procedures.
This form was signed on the Friday. Despite her discharge from hospital on that date it was not re‑signed on the Monday.
Dr Dickinson was certain in her evidence that she had discussed the possibility of hysterectomy with Mrs Hassan. The Hassans were certain that the risks including hysterectomy and haemorrhage were not discussed.
Mrs Hassan's evidence was that she read some of the consent form but her reading was not perfect. I gained the view from her evidence that she considered the form to be a standard admission form. The form was signed in conjunction with assurances given by Dr Dickinson.
(iii) Cultural issues
Both the Hassans are, for the purpose of this part of my reasons, overseas born Arab Australians. (I have used that term broadly to indicate their use of the Arabic language as their first language and that they adhere at least in part to a cultural heritage that can be traced back to Arab speaking countries.)
Mrs Hassan's evidence was that she had learned her English in Egypt. In Australia she had done some work teaching the Arabic language and religious studies at Arabic schools.
The admission forms completed on both 8 January 1999 and 11 January 1999 make it clear that Mrs Hassan was a Muslim and that she ate food prepared in a halal manner. She wore traditional Arabic dress in Court. There was nothing to suggest this was not her habitual attire.
Nurse Tipper noted that Mrs Hassan spoke English but her first language was Arabic. Nurse Emmett made an assessment that she spoke good English. Dr Dickinson was of the view her first language was English.
Dr Dickinson's evidence was that Mrs Hassan seemed to understand English very well. She based this assessment on her prior interactions with Mrs Hassan, the hospital notes completed by other staff and letters she assumed had been compiled by Mrs Hassan. Prior to the induction of labour there had been two occasions on which the pair had spoken. These, by all accounts, were brief.
Mrs Hassan made no request for an interpreter. Mr Hassan, when asked why this was so, said they did not need one. They knew what they were there for. Mrs Hassan, in cross‑examination, said she sometimes understood what had been said to her. Dr Dickinson said Mr Hassan spoke very good English. He certainly spoke better English than his wife. However, during the proceedings, despite the transcript not always reflecting this, he mixed up words and their meanings eg hysterotomy for hysterectomy, hypotensive for hypersensitive in such a way that his understanding of certain medical matters was called into question.
Nurse Tipper gave evidence that Dr Dickinson's practise was to explain procedures thoroughly to patients albeit not necessarily from a language point of view. She said Dr Dickinson's practise for patients who had English as a second language did not differ from patients who had English as a first language.
I had an extended period of time during the course of this trial to observe Mrs Hassan both in the witness box and in the Courtroom generally. It appeared to me that Mrs Hassan had an imperfect understanding of the English language. She had a limited ability to express herself readily and despite being familiar with some aspects of medical terminology was unclear on others. It was not challenged that her presentation in Court was other than how she would normally speak or express herself.
Mrs Hassan presented as a pleasant and accommodating woman. The matters about which she attended Dr Dickinson in late 1998 and 1999 were of a significant emotional and physical nature.
In terms of her ability to understand what was said to her, her evidence was that she did not know the word "hysterectomy" until after that procedure had been performed on her. She was adamant that Dr Dickinson had not mentioned anything like that to her prior to the actual operation.
"… You said, 'what happened'?---She tell me, 'the baby has come. It was a girl.' I had, like – the word – what's it called? Like, I think the – I couldn't understand the word what she said to me. I said, 'what do you mean?' she told me, 'no more babies for you'.
Would that word be 'hysterectomy'?---Yes. I said to her 'what do you mean?' she tell me, 'there's no more babies for you'.
… When I hear it I didn't know exactly what she means. When she tell me I didn't know exactly what's happened to me." (sic)
It is clear that the Hassans were to a certain extent completely guided by and reliant upon everything and anything they were told by the health professionals. Mrs Hassan states:
"When you got doctor is tell you this medicine is good for you, do you take it or not? I take it. She tell me the drug is very good. No anaesthetic, no cut. She's doctor." (sic)
Mr Hassan's evidence also was when he had been told, after the event, his wife had had a hysterectomy he did not fully understand what it meant in a physical sense.
During the course of Mrs Hassan's evidence she sought to exclude her husband from the Courtroom. Some issues had cultural significance. She explained that in her "custom" the womb for the woman was everything and without it she was nothing at all. She expressed the view that it would be better that her life was taken rather than her womb. She had tried to explain to Dr Dickinson, after the procedure, that in her culture – her country and religion, the outcome was extremely difficult for her.
Her treating psychiatrist since 2003, Dr Karima Attia‑Soloman, explained that culturally a woman without a uterus perceives herself as being incomplete. As well as physical disfigurement the scarring is a reminder of her incompleteness. This in turn had an affect on her from a psychiatric point of view. It made her relationship with her husband insecure and it affected her self‑confidence. Physically she had an inability to conceive.
The services of KEMH and the attitudes of some of its staff were clearly designed for Anglo‑Celtic Australians and not necessarily culturally appropriate or sensitive to Arabs and Muslims.
Apart from the hospital night manager who extended some kindness to Mr Hassan days after the event none of the health professionals appear to have used terms readily understandable by the Hassans, "womb" is such an example.
No interpreter was on hand. The critical attendances in relation to the upcoming medical induction of labour were on 8 and 11 January 1999. Each of these attendances with Mrs Hassan was of short duration. Given the possible physical and cultural impact on her, every opportunity for her understanding should have been extended. The fact she was a pleasant and accommodating woman did not mean she understood what was going on.
The State of Western Australia has a multicultural population. It did so in 1999. It is clear there was a lack of understanding by KEMH and its staff of diverse cultures and beliefs. The Hassans came from a culturally and linguistically different background. Scant regard was paid to this.
Findings on duty to disclose and advise of risks
The admission to hospital was not an emergency. It is clear some action was required sooner rather than later, but this was not a medical emergency as at 11 January 1999.
It is not only a question of whether Mrs Hassan had been given all the relevant information in relation to the procedure she was to undergo, but it is a question of whether the relevant information had been communicated to her in terms which were reasonably adequate for that purpose having regard to her apprehended capacity to understand the information.
In Rosenberg v Percival (2001) 205 CLR 434 Kirby J enumerated certain matters of principle which support the continuation of the stringency of the rule stated in Rogers. Relevantly here he states at p 480:
"(2)Whilst it may be desirable to instil a relationship between the health care professional and the patient, reality demands a recognition that sometimes (as in the present case) defects of communication demand the imposition of minimum legal obligations so that even those providers who are in a hurry, or who may have comparatively less skill or inclination for communication, are obliged to pause and provide warnings of the kind that Rogers mandates."
In relation to the issue of whether Dr Dickinson carried out her duty to warn Mrs Hassan of a material risk, I have considered the credibility of both the Hassans and Dr Dickinson. I found each witness tried his or her level best to recount accurately what took place. I formed the view that more was said by Dr Dickinson about the procedure and risks than the Hassans remembered and less was said about the procedure and risks to the Hassans than Dr Dickinson remembered. Some, at least, of her evidence was what she "usually" did. This is understandable and reflects on the reliability of the witness rather than the honesty. However, it goes further than what was actually said.
The nub of the duty here revolved round the understanding of Mrs Hassan about what could possibly happen to her.
I find that in order for Mrs Hassan 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 much 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 but 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 Mrs Hassan.
A further consent form was not signed and there is nothing to suggest it was drawn to Mrs Hassan's attention on the Monday.
When Mrs Hassan had first met Dr Dickinson in December, Dr Dickinson considered it prudent to have the general practitioner explain matters to her, given she had an established relationship with that practitioner. Dr Dickinson's view that Mrs Hassan understood English is based on scant evidence and some of it is based on what has transpired since 11 January 1999.
Whilst I accept that the words "hysterectomy" and "haemorrhage" were used, I find they were not explained carefully or at all to Mrs Hassan in terms she could understand. They may as well not have been spoken.
Dr Dickinson gave evidence that clinical trials generally were inappropriate for patients who did not understand English.
Whilst I do not agree with the proposition that the form used to recruit patients to the drug trial was generally misleading or inadequate, given Mrs Hassan's particular circumstances, including her high risk status and her language and cultural issues, the contents of the form needed to be explained carefully in conjunction with an explanation about the use of Misoprostol generally, its risks and side effects. It is incumbent upon the doctor to ensure her patient understands the procedures and the trial.
I find that the plaintiff has discharged her onus on the balance of probabilities of proving that there has been a breach of duty to warn of a risk. That risk did eventuate and as a result harm was caused to Mrs Hassan. As was explained by McHugh J in Chappel v Hart (1998) 195 CLR 232:
"Once the plaintiff proves that the defendant breached a duty to warn of a risk, and that the risk eventuated and caused harm to the plaintiff, the plaintiff has made out a prima facie case of causal connection. An evidentiary onus then rests on the defendant to point to other evidence suggesting no causal connection exists. Examples of such evidence are: evidence which indicates that the plaintiff would not have acted on the warning because of lack of choice or personal inclination … Once the defendant points to such evidence, the onus lies on the plaintiff to prove that in all the circumstances a causal connection existed between the failure to warn and the injuries suffered by the plaintiff."
There are a number of matters to further consider.
Alternative methods of evacuating foetus
The plaintiff alleges that the Minister was in breach of its duties in that there was a failure to consider alternative methods of evacuation of the foetus given the particular circumstances of Mrs Hassan. Those alternative methods of evacuation are dilatation and evacuation ("D & E") and hysterotomy.
Medical evidence generally
There was substantial expert and other medical evidence in relation to these procedures and to medical issues generally. Both sides provided the Court with medical journal articles.
In Sidaway v Board of Governors of Bethlehem Royal Hospital & Maudsley Hospital Board [1984] QB 493 Donaldson MR at 513 noted that the requisite standard of care had to be tested in the first instance by reference to the way in which other doctors discharged their duty but that the definition of the duty of care was a matter for the law and the courts. He went on to say at 514:
"The duty is fulfilled if the doctor acts in accordance with a practice rightly accepted as proper by a body of skilled and experienced medical men."
Each of the medical witnesses called, whether by the plaintiff or the defendant, was a highly qualified and experienced practitioner. Each had a particular point of view about the procedure he used or knew about. As was put by Dr Thorolf Nash, a retired consultant obstetrician and gynaecologist from the United Kingdom - it comes down to a difference of experience and a difference of opinion.
The law clearly recognises there is room for difference of opinion. A medical practitioner is not negligent because his or her procedure is not the same as that used by another practitioner.
Overall, I found the evidence given by medical witnesses who currently practice in the area of maternal foetal medicine in Australia to be of most assistance. This is whether he was called by the plaintiff or by the defendant.
Each of the Australian witnesses had experience in the termination of second trimester pregnancies at the relevant time. Dr Nash from the United Kingdom was retired at the time of giving his evidence. He was in practice in 1999. Whilst there was nothing at all to suggest his evidence was not generally reliable, it did not reflect thinking or experience in this country in 1999. This is of some relevance.
Dr Marsden Wagner, an obstetrician, whose current position was that of private consultant in the United States, had not performed any second trimester terminations of pregnancy. He had witnessed one.
Professors David Ellwood and Brian Trudinger called by the Minister were both certified sub‑specialists in maternal foetal medicine. This comprises a small group in Australia. Professor Trudinger was of the view that it comprised 40 sub‑specialists scattered around the whole of the country. The group met on occasions in Australia, and more often overseas. This was for conferences or committee meetings. Dr Dickinson was also a sub‑specialist in maternal foetal medicine.
The plaintiff sought initially to disqualify Professor Ellwood on the ground of bias. This later included Professor Trudinger. The evidence was that Professor Ellwood had known Dr Dickinson on a professional basis for some 15 years. They had discussed medical matters together. Dr Dickinson approached both Professor Ellwood and Professor Trudinger in relation to the provision of reports for the purpose of these proceedings. The same criticism was made generally of the evidence of Professor Hammond and anyone involved with KEMH.
It was clear to me that Professor Ellwood saw his role as that of an expert medical witness to assist the Court. He was a senior specialist in obstetrics and gynaecology and a director of the foetal medical unit at Canberra Hospital. Despite the fact he had professional contact with Dr Dickinson and she had personally sought his involvement in the matter I formed the view that he and the other medical witnesses called by the defendant were impartial. There was nothing to suggest any witness called by the defendant was prepared to compromise independence or integrity.
Hysterotomy
This involves an operation requiring almost complete uterine bisection under general anaesthetic in the operating theatre. The incision occupies most of the anterior wall of the uterus because the lower uterine segment does not form until 20 weeks gestation. It involves the usual risks of surgery including infection, scarring and thrombosis.
Dr Nash was the only expert who spoke in its favour as a first line treatment here. He had obtained his medical qualifications in 1959 in the United Kingdom. He had been a consultant obstetrician and gynaecologist.
He stated that hysterotomy in a mid trimester abortion was not a first choice but given the exceptional circumstances of this case and in balancing the risks it was an appropriate procedure.
He gave evidence that the use of hysterotomy as a first line of treatment would have allowed visualisation of the placental implantation site so as to allow suturing or diathermy of the bleeding vessels. Professors Trudinger and Ellwood rejected this on the basis it was not practical, given the area and number of unsupported blood vessels. They did not agree that there would be good visibility of the site. It was not one or two bleeding blood vessels, but a whole site.
Dr Nash conceded that the procedure may not be widely used in Australia. The overwhelming evidence was that it is rarely used in contemporary medicine. Dr Peat, called by the plaintiff, accepted it was an archaic method of termination and not to be considered here. There was no evidence it was performed in 1999 as a first line treatment anywhere in Australia.
The evidence was that this procedure was not in 1999 and is now not offered at KEMH as a first line treatment. It was rarely performed. It can be used as a second or third line treatment if it is required. Dr Dickinson gave evidence that she had performed the procedure twice. On each occasion there had been a life threatening medical emergency.
Dr Nash stated that any medical practitioner using it needed to be highly trained and experienced in the art of hysterotomy. He further defined a skilled practitioner as someone who had done the procedure before on at least half a dozen occasions.
Dilatation and evacuation ("D & E")
This procedure is performed under general anaesthetic in the operating theatre. Dilation equipment is introduced into the cervix after it has been softened and dilated by a loading dose of a prostaglandin. Forceps are also introduced into the uterus under ultrasound guidance. The foetus is removed in pieces after destruction, in utero, with the forceps.
It carries the risks of perforation or trauma to the cervix or uterus. This risk of perforation is elevated for a woman with four prior caesareans, due to a thinning of the uterus wall. There is also a risk of infection, retained placenta and haemorrhage.
This is not now offered and was not offered at the relevant time at KEMH as a first line treatment because of the risks KEMH viewed as being greater than the risks associated with the chemical induction of labour. Dr Peat gave evidence it is a technique that requires proper training and skill. Dr Dickinson did not, due to it not often being utilised, have the experience or skill in the execution of the procedure.
The principal witness for the plaintiff of this method of delivering a foetus dead in utero was Dr Peat. He had extensive experience in second trimester terminations and had a particular interest in foetal abnormalities and their management.
His said that a D & E would suit a patient whose foetus was of a gestation period between 13 and 18 weeks. That applied here. The foetus was the size of a 15 week foetus.
His view was that D & E reduced the risk of haemorrhage because the uterus was emptied quickly and early on in the labour process. The labour process was not prolonged and thus the likelihood of heavy bleeding otherwise caused by contractions over a period of time was reduced.
Although he was of the view there were risks associated with both D&E and the chemical induction of labour at the "end of the day an hysterectomy was less likely to have occurred if D & E had been used".
His opinion was that once the haemorrhage started Dr Dickinson did everything she could to prevent an hysterectomy. He also gave evidence that an hysterectomy was possible no matter what procedure was used. He accepted if the placenta was abnormally adherent to the uterus there was going to be bleeding no matter what procedure was used.
Professor Ellwood gave evidence was that he was the only specialist in the ACT and surrounding areas who performed D & E in second trimester terminations. He also supervised second trimester terminations using prostaglandins.
His evidence was that the use of prostaglandins was the method of choice in most tertiary units within Australia.
He identified the specific risks of Mrs Hassan to be, in line with the other experts, the low lying placenta and the four previous caesarean sections. These risks increased the likelihood of severe haemorrhage. His view was that the risks associated with D & E and prostaglandins were the same.
Professor Hammond was of the view that D & E had greater risks associated with it than the risks associated with the use of prostaglandins in induction of labour.
Professor Trudinger who was head of the maternal foetal medicine unit at Westmead Hospital was of the view there was no question that medical induction of labour using prostaglandins was the safest method to use in these circumstances. It was the method he used in his clinical practice on a foetus over 14 weeks gestation.
Cause of the hysterectomy
Massive blood loss or haemorrhage made the hysterectomy performed on Mrs Hassan inevitable. It was performed as an emergency operation. There were two aspects of the blood loss that need to be considered:
(i)Pre-operative blood loss
The blood loss recorded prior to Mrs Hassan's entry into the operating theatre was between 1200 and 1400 ml. This did not take into account any blood loss of Mrs Hassan prior to 2.00 pm.
The blood loss was caused by the contractions which exposed the maternal side of the low lying placenta. The placenta covered the cervix.
Mrs Hassan gave evidence, supported by Mr Hassan that her bleeding commenced at approximately 11.00 am. It was heavy and continuous – "like a river". The nursing notes show small blood loss that increased over the day.
Nurse Tipper explained a lay person's perception that blood loss is very heavy can quite often be wrong in medical terms. Dr Dickinson expected blood loss once the contractions commenced. She was not concerned. There is little evidence to suggest Mrs Hassan was aware there would be any blood loss.
It was Dr Dickinson's ideal position to have had Mrs Hassan in the operating theatre at 10.30 pm. This was impossible due to there only being one operating theatre then available in KEMH. This was being utilised for an emergency caesarean operation. As soon as the operating theatre became available, she was taken there.
Dr Bremner gave evidence that he assessed Mrs Hassan's health and haemodynamic state prior to the operation. He was aware that she had lost approximately one and a half litres of blood during the day. Examination of her heart rate revealed it to be 90 beats per minute, and her blood pressure was 130 Mm Hg. Her blood pressure and sinus rhythm were normal. She was not unstable in terms of her blood pressure and heart rate at that time.
The evidence of Dr Bremner was that if Mrs Hassan had not lost so much blood prior to going into the operating theatre her blood pressure would not have been a problem during the operation. His evidence was that the preoperative blood loss had some effect on the potential for the hysterectomy. However the blood loss during the operation also had a great impact on the end result.
Whether the procedure used to evacuate the uterus is that of D & E or medical induction of labour, there is a need for the cervix to be dilated. The fact that Mrs Hassan's placenta covered the cervix meant that there was blood loss as the cervix dilated and the placenta lifted.
Dr Peat was of the view that because a D & E could have taken place at an earlier stage, the cervix having less need to dilate to the same extent, the blood loss as a result of the contractions would have been less. Professor Ellwood was of the opinion that whether a D & E was performed or labour induced with Misoprostal the blood loss would have been the same.
The evidence of Professors Trudinger and Ellwood was that an earlier entry to the theatre would not have avoided the need for an hysterectomy.
(ii)Operation blood loss
The haemorrhage in the operating theatre was caused by the attempt of Dr Dickinson to remove the placenta. It was morbidly adherent to the previous caesarean scars. The total blood loss in theatre was between 2,500 to 3,000 ml.
Dr Dickinson made a clinical diagnosis of placenta accreta. This diagnosis was not supported by the histopathological diagnosis. Professor Trudinger, when comparing the clinical diagnosis of Dr Dickinson with the pathology report of Dr Wainwright made it clear that no matter whether the placenta was implanted over the scar tissue or morbidly adherent to the uterus uncontrollable bleeding was inevitable.
The placenta had adhered abnormally into the scar tissue of the previous caesareans. The scar tissue, not being muscle, was incapable of contracting on the maternal blood vessels when the placenta was removed. This bleeding was uncontrollable making hysterectomy inevitable.
I accept the correctness of the diagnosis was not the issue here. The outcome would have been inevitably the same.
Dr Peat, having considered the pathology report of Dr Wainwright accepted that the outcome was going to be bleeding no matter what earlier course had been adopted. However, he believed less preoperative blood loss would have been incurred with D & E and this made hysterectomy less likely.
Professors Hammond and Ellwood gave evidence that no matter what method of evacuation was undertaken the outcome would have been the same because of this morbidly adherent placenta.
Dr Nash was unable to assure the court that an hysterectomy would not have been an outcome here given the morbidly adherent placenta.
Dr Wagner was of the view that the source of the haemorrhage was damage to the uterus from the action of Misoprostol. He was extremely critical of the use of Misoprostol and the enrolment of Mrs Hassan in a drug trial. He was also critical of the hospital not having allowed Mrs Hassan the benefit of a spontaneous delivery.
Save and except for his criticism of her enrolment in the drug trial, his other criticisms are not shared by any of the other experts.
I find the cause of the hysterectomy to be as a result of the attempted removal of the placenta in the operating theatre. It was the blood loss in theatre that resulted in hysterectomy. What took place before the attempt to remove the placenta had little impact on the final outcome of hysterectomy.
I make no finding as to whether another procedure would have caused less pre‑operative bleeding as the final outcome of hysterectomy would have resulted in any event, no matter what procedure was used.
Failure to attend upon Mrs Hassan
It is pleaded that having regard to Mrs Hassan'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 Misoprostol, Dr Dickinson or other persons at the hospital failed to attend on or to examine her properly, or at all.
Once on the ward, there is nothing in the evidence which supports this contention. The plaintiff was allocated experienced nurses who had Mrs Hassan as their focus during the day. Observations were regularly taken. These were found to be stable and within acceptable limits. Once blood loss was noted by the experienced nurses to be an issue, it was carefully monitored. Medication for pain was received and general nursing care delivered appropriately.
The nursing staff were in contact with Dr Dickinson when necessary. They were able to contact her at any time, and did so if the situation required. Dr Dickinson was in contact with the hospital and available to insert the second and third doses of Misoprostol.
Dr Dickinson was aware early on of the possibility that the procedure may need to be completed in an operating theatre. To this end, from the morning of 11 January 1999 she carried out measures to ensure this could be done quickly. These measures included taking a full blood count on Mrs Hassan's admission, instructing that an IV bung be inserted, cross matching her blood, alerting the anaesthetist, starting the patient fasting at 4.45 pm and commencing intravenous fluids at 5.00 pm. The operating theatre was alerted. Despite it being in use, as soon as it became available, Mrs Hassan was taken to theatre.
Causation
(i)Duty to inform and advise of risks
Mrs Hassan did not want to await a spontaneous delivery. She wanted the foetus removed as quickly as possible. She had gone to the hospital on 8 January 1999 on an emergency referral from her general practitioner. The Hassans were concerned that the procedure was not going to be carried out immediately. They were concerned that Mrs Hassan was told to go home or wait in hospital but that the evacuation procedure would not commence until Monday. Mr Hassan consulted a medical practitioner over the weekend due to his concern about the delay.
Given Mrs Hassan's high risk factors, hysterectomy was a risk no matter which procedure was used. None of the experts thought it to be out of the question.
Mrs Hassan gave evidence that if she had been made aware of the risk of hysterectomy, she would have gone to another doctor, another hospital, another country. She would have made as many enquiries as were necessary.
However, she also gave evidence that she may still have proceeded but she had wanted a warning.
"… When doctor, she tell me before, 'You are going to caesarean' or he tell me before like 'May be, when you go to the caesarean and they may be take the womb out and no more baby,' before I go and they know when any is a risk to me I do it. But she must tell me." (sic)
Mr Hassan put the position as follows:
"… I cannot recall any of this being said to us and I can assure you, if I can say that, had any of these increased risks been explained to us and we anticipated that to happen, we would not be here today because we are the kind of people, if that was a mistake and the doctor we believed tried to do her best to deal with my wife's case we would have accepted that but our understanding of the whole thing was totally different. We can understand my wife might go to a doctor and say there are such risks, and we accept to go ahead with it and that risk actually become true; we were not going to blame the doctor who warned us. … ." (sic)
I find that if Dr Dickinson had taken the time required to appropriately explain (and by this I mean so that the patient understood) the material risks involved in the procedure of chemical induction of labour using Misoprostol either with or without the assistance of Dr Abulaban or an interpreter then Mrs Hassan would have proceeded in the same manner.
Despite Mrs Hassan's statement that she would have proceeded to another hospital, to another State, or to another country, I view this as a position she has formed in hindsight. Whilst I found her to be generally credible I did not accept her evidence on this point.
This assertion is not based on the practical reality facing the Hassans in January 1999. It is not consistent with what they said and did at the time. No matter where she went she was going to be confronted with the fact of hysterectomy being a risk.
The Hassans wanted the foetus evacuated in a timely fashion. They were concerned at having to wait a weekend. The idea of not having to go to the operating theatre meant Mrs Hassan could be home with her other children a lot quicker. She had five children at home aged between 18 months and 14 years. Mr Hassan was employed part‑time in a bank doing clerical work. Mrs Hassan did not work.
The reality of the position was she wanted the foetus evacuated and the only available viable option was at KEMH using induction of labour with Misoprostol. All that was required was a careful and considered explanation about what would and what could possibly happen.
On the basis of the evidence I also find that it is likely Mrs Hassan would still have consented to be enrolled in the drug trial.
(ii)Failure to consider alternative procedures
There were two alternative procedures put forward by the plaintiff as available. It is pleaded they were not considered.
Dr Dickinson was aware of the two procedures. She had performed each of them irregularly as a second or third line treatment in the termination of second trimester pregnancies. During her time at KEMH, only the medical induction of labour was offered as first line treatment in the circumstances of this case.
There was no evidence to suggest these procedures were available in 1999 in Mrs Hassan's circumstances as a first line treatment anywhere in Western Australia. KEMH was the largest maternity hospital in the State. Mrs Hassan was specifically sent there because of her previous problematic pregnancies and her present heightened risks.
Her evidence was that she would have preferred an hysterotomy rather than any other method of evacuation, including D & E. I formed the view she equated an hysterotomy with a caesarean section. I am not sure that she understood what it really was, its availability and what the risks of it were. Her evidence was given at much the same time as her own expert, Dr Peat, whose oral evidence in relation to hysterotomy did not marry with his medical report in that respect. He said it was not appropriate here.
The overwhelming expert medical evidence was that this was not a safe or commonly used procedure. It was termed, variously, archaic and outmoded. 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.
It would have been possible for her to have had a D & E in another State of Australia. This was not explained to her by Dr Dickinson. The Hassans wanted the foetus removed. They did not want Mrs Hassan to be carrying a dead foetus inside her. Dr Dickinson was made aware of this view on Friday 8 January 1999. They sought some medical advice from a doctor in Sydney over the weekend.
The induction of labour with the use of prostaglandins was the most common method utilised in the major hospitals in Australia.
The alternative procedures were known to and considered by Dr Dickinson. They were not put as options to Mrs Hassan. I do not find it unreasonable that an hysterotomy was not explained to Mrs Hassan as a viable option, given the prevailing Australian medical attitude towards it and its availability.
I am of the view that D & E should have been explained to her on the basis that it was an option available within Australia, although it was not an option that Dr Dickinson saw as being the best available option and would not have recommended it.
Mrs Hassan could not say whether she would have opted for this procedure in any event.
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.
(iii)Drug trial
Whilst the induction of labour using Misoprostol may, if some of the evidence is accepted, have caused more bleeding prior to Mrs Hassan's entry into the operating theatre, there is no evidence which I accept that the uncontrolled bleeding experienced in the operating theatre was directly linked to the use of Misoprostol or her enrolment in the drug trial.
The main view of the experts was that her enrolment in the trial did not affect the final outcome.
A different perspective was put on it by Dr Peat who thought it was a "bit rich to enrol someone in a dose finding study when they had such potential for hazards …it was a bit bold".
Given Mrs Hassan was a high risk patient this may have been so. As it transpired she received the dose later found to be the most appropriate. I have some misgivings about her suitability for enrolment in a clinical trial, given her lack of understanding and high risk factors. However, I find there is no link between the drug trial and the final outcome.
Res ipsa loquitur
In her particulars of negligence Mrs Hassan pleads the doctrine of res ipsa loquitur.
Given my findings and the matters already set out, it cannot be said there is an absence of explanation for the occurrence of the hysterectomy. There was no evidence to suggest an hysterectomy ordinarily occurs or is carried out as a result of negligence. The cause of the hysterectomy here I find, was the uncontrollable blood loss due to the morbidly adherent placenta. It was a complication of the pregnancy. That is not something "under the control of the defendant".
The doctrine of res ipsa loquitur is not applicable to the facts of this case.
Conclusion
I find that Dr Dickinson was in breach of her duty of care towards Mrs Hassan when she failed to advise her of the risks associated with the evacuation of the foetus dead in utero. I find her advice should have included the availability of D & E within Australia as an alternative procedure. However, the plaintiff has not proved that the failure to so advise was legally causative of the hysterectomy. I therefore dismiss the plaintiff's claim.
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