Hall v Petros
[2004] WADC 87
•27 MAY 2004
JURISDICTION : DISTRICT COURT OF WESTERN AUSTRALIA
IN CIVIL
LOCATION: PERTH
CITATION: HALL -v- PETROS [2004] WADC 87
CORAM: MACKNAY DCJ
HEARD: 28-30 APRIL, 1-2 MAY, 18-22, 26-29 AUGUST, 31 OCTOBER 2003
DELIVERED : 27 MAY 2004
FILE NO/S: CIV 1383 of 2001
BETWEEN: MARGARET FRANCES HALL
Plaintiff
AND
PETER EMMANUEL PETROS
Defendant
Catchwords:
Negligence - Medical negligence - Whether sufficient information given to patient prior to operative procedure - Whether informed consent - Whether patient would have undergone procedure in any event - Rogers v Whitaker (1992) 175 CLR 479 - Turns on own facts
Damages - Personal injury - Assessment - Chronic infection and scarring associated with tape inserted in operative procedure - Plaintiff 45 year old female - Award of $136,296
Legislation:
Nil
Result:
Plaintiff entitled to judgment in the sum of $136,296
Representation:
Counsel:
Plaintiff: Mr G R Hancy
Defendant: Mr R Halliday
Solicitors:
Plaintiff: Slater & Gordon
Defendant: Mullins Handcock
Case(s) referred to in judgment(s):
Chappel v Hart (1998) 195 CLR 232
Edith Cowan University v Czatryko [2002] WASCA 334
Lock v Lock [1999] WADC 125
Lock v Lock [2001] WASCA 20
Misiani v Welshpool Engineering Pty Ltd [2003] WASC 263
Naxakis v Western General Hospital (1999) 197 CLR 269
Rogers v Whitaker (1992) 175 CLR 479
Rosenberg v Percival (2001) 205 CLR 434
Van Gervan v Fenton (1992) 175 CLR 327
Zaltron v Raptis [2001] SASC 209
Case(s) also cited:
Nil
MACKNAY DCJ:
Introduction
The plaintiff was born on 4 February 1959 and is thus aged 45 years.
The defendant is a medical practitioner who specialises in gynaecology and in particular in the surgical treatment of female incontinence.
In June 1997 the plaintiff saw the defendant with a complaint of incontinence and on 12 August 1997 the defendant carried out a surgical procedure on the plaintiff which included repair of an enterocele and intra vaginal slingplasty.
The intra vaginal slingplasty was carried out with nylon tape and involved the use of a technique pioneered here and in Sweden by the defendant and a Professor Ulmsten, and used extensively by the defendant in Western Australia.
The plaintiff says that there were inherent risks in the procedure such that it was incumbent on the defendant to inform her of them, that he failed to do so, that had she been aware of the risks she would not have agreed to the procedure, that as a result she has suffered injury and has sustained damage and loss, and that in the premises the defendant was in breach of duty and is liable for that loss.
The defendant acknowledges that he was under a duty to the plaintiff but says she was informed of the relevant risks prior to the procedure, denies that she would not have had the procedure, says that if the plaintiff suffered any injury thereby it was as a result of the materialisation of a risk of which she was aware, that if he was in breach the plaintiff by her later conduct caused or contributed to the injury, and that if the plaintiff had followed his advice any complication of the surgery would have been negligible.
Liability is therefore denied.
Amongst the issues raised by the pleadings are whether all of the risks inherent in the procedure and the magnitude of those risks were then known, what the risk of tape rejection then was, whether on that occurring the tape could be easily and without incident be removed, and whether in any event the plaintiff would have undertaken the procedure.
Plaintiff's evidence in relation to liability
The plaintiff said she is married, but separated in October 2000, and is the mother of three boys Haydon, Joshua and Elliott.
She now lives in Bunbury, she said, and is employed as a supervisor by the ACTIV Foundation.
In 1997 the plaintiff said she and her husband conducted a lawnmowing and landscaping business, to which she contributed work preparing quotes, doing bookwork and carrying out a lot of the landscaping.
She and a friend Mrs Beverley Collett also had a business "Wandering Wild Eco – tours", in which she was involved part‑time.
That business had commenced in 1996 and they had run several weekend or adventure tours and also an extended tour north to Cape Leveque in 4‑wheel drive vehicles.
The plaintiff said that she had at that time been incontinent for "several years", that being brought on by sneezing or coughing, when she would on occasion pass a small amount of urine.
She also had to cross her legs when standing in a line, the plaintiff said.
From the time of its onset any change in the condition had been very marginal the plaintiff said, although it was becoming "a bit of an inconvenience".
At some earlier time the plaintiff said she had been told by an acquaintance, Mrs Marsh, that the latter had an incontinence problem which had apparently been successfully treated by a surgical procedure carried out by the defendant, Mrs Marsh speaking of it in "glowing terms".
The plaintiff said that she later saw her longstanding general practitioner, Dr Tamala Atkinson about the incontinence problem, for the first time, and then obtained a referral to the defendant.
It is common ground that on 9 June 1997 the plaintiff consulted the defendant, Mrs Collett attending the defendant's rooms at the South Perth Surgicentre with her.
There the plaintiff said she completed a questionnaire, given to her by the defendant's staff, prior to seeing the defendant with Mrs Collett.
A questionnaire was identified by the plaintiff, and from that it appears that she responded that she lost a tablespoon or more of urine during sneezing, coughing, exercise or laughing "50 per cent or more" of the time, "sometimes" on stooping, squatting or bending, felt that her bladder did not empty properly, had difficulty starting a urine stream or experienced a slow stream 50 per cent or more of the time, and sometimes had a stream which stopped and started involuntarily, had an uncontrollable desire to pass urine, or wet before arriving at a toilet.
The last symptom occurred twice per day, and involved a few drops of urine, the plaintiff reported.
The plaintiff reported that she was "moist" with urine much of the time, occasionally lost urine in bed at night and sometimes wore a pad or liner on going out.
However, she graded the limitation of activity resulting from her incontinence as, only "2 = mild, no effect on lifestyle", on a scale of 1 to 5.
The plaintiff also reported a pain at the bottom of her abdomen or spine 50 per cent or more of the time.
The plaintiff later said she had at that time experienced incontinence for several years, with only a marginal increase through that period, although such was becoming an inconvenience, it being a little "embarrassing crossing your legs in the Myers line", while at work she was vigilant, and generally may have been "caught short" occasionally.
She had been prompted to see Dr Atkinson about it by her youth and ability to bounce back after surgery, the plaintiff said, and had met Mrs Marsh and learned of the defendant's procedure about 18 months before she underwent it, that also resulting in the attendance.
The defendant had the questionnaire with him during the consultation, the plaintiff said, and told her two tests would be required, whilst she was also examined.
At the consultation the defendant also spoke of the procedure he did, which involved inserting tapes, tissue then growing to support it, the plaintiff said, but nothing was said in relation to any other form of procedure.
In regard to any risk in his procedure the plaintiff said the defendant informed her that too many stitches might be inserted, but those could be removed, and after the procedure she would have to take care getting in and out of a motor vehicle.
She saw the defendant again on 28 July 1997, the plaintiff said, Mrs Collett again being with her, and on this occasion the defendant informed her that he had her test results, that she was a good candidate for his procedure, and that she had a slight prolapse which he could repair at the same time.
The plaintiff said that the defendant also informed her that there was a very high success rate of about 90 per cent, but if the procedure was unsuccessful she could have it re‑done within 12 or 18 months.
Following the provision of some other information a pro forma letter of consent was produced by the defendant, the plaintiff said, and he then made various notations on an anatomical diagram whilst explaining the procedure, and drew a further diagram, before asking her to sign it.
The plaintiff said that she began to read the letter, upon which the defendant, to her embarrassment, began to dictate a letter about another patient, that continuing until she passed it to Mrs Collett, on which the defendant said in a very annoyed tone "it's just a simple form."
The letter of consent, dated 28 July 1997, was then signed by her, the plaintiff said.
The pro forma portion of the letter of 28 July 1997 relevantly reads:
"Dear Patient,
The operation discussed with you has been developed over the last seven years, in association with the world renowned Urogynaecology Department, University of Uppsala, Sweden.
We diagnose specific areas of damage to tissues in the front or back of vagina. By targeting these, it is possible to reduce what was previously a major painful operation, involving up to two weeks hospital stay, to a minor procedure performed through a 1cm incision. If both parts of the vagina need surgery, we recommend repair of only one at a time. Frequently this is sufficient to correct most of the problem. Simultaneous repair may actually worsen symptoms, as may tearing out of internal sutures (in approx 5% of cases). Generally, there is very little pain and you will be able to return to normal activities, often within days. Please note: occasionally, repair in the back part of vagina may be painful if the muscles pull the tissues too tightly after surgery.
It is important to realize that the principal reason for your incontinence is that the tissues around your vagina are damaged and therefore the muscles cannot properly close off the bladder. Repairing damaged tissues is like sewing into frayed cloth. As the tissues are damaged, absolute success rate for surgery cannot be higher than 85% to 90%. If some urine continues to be lost post‑operatively, do not despair. The operation is performed in such a way as to promote further tightening over the next 6‑12 months.
Failure to correct symptoms, though alarming to the patient, can usually be corrected by a very minor procedure.
Please contact me anytime, either at the office 474 1966 or at home l384 8064, should you have any problems."
It is common ground that the defendant retained the letter, without provision of a copy to the plaintiff.
The document discovered by the defendant has, in addition to the sketch and notations already referred to, a hand drawn line around the last sentence of the second paragraph, with the following notation:
"5% rejection rate."
The plaintiff said she did not believe that line and notation were on the letter of consent, when she signed it.
The plaintiff said she decided to have the procedure carried out on 28 July 1997 as it seemed to be very straight forward and simple, whilst the first paragraph of the letter of consent had impressed her when she saw it was a long standing procedure.
The plaintiff later said she could not recall whether she had initially made an appointment to see the defendant but the questionnaire had not been sent to her ahead of the consultation.
She was not able to recall specific material she had provided as to her history or initially as to when she was vaginally examined, the plaintiff stated.
A reference to bedwetting in the questionnaire had not been included by her, and she recalled being "shocked" to see it, the plaintiff said, and telling the defendant she had not told him that.
The plaintiff said she recalled some other matters put to her as to the defendant's version of the history of the pre‑procedure consultations, and said she did not recall some, and disagreed with others.
She did not recall any reference on 28 July to her problem being quite severe or significant, the plaintiff said, and the defendant did not make any reference to pelvic floor exercises or their lack of efficacy in her case.
The defendant at no time referred to the existence of other procedures, the plaintiff confirmed, but did tell her that his procedure had a 90 per cent success rate with 10‑15 per cent of patients not being cured by it.
Reference was made to the history of the procedure, the plaintiff said, and she was told overnight hospitalisation was involved, there was usually little or no pain, and if the procedure failed it could be done again.
The plaintiff said she did not have private health insurance and told someone that, but did not recall further conversation about it, and had in any event not made a final decision on that day, although later agreeing she must have indicated her preparedness to undergo the procedure at the second consultation.
It was not the case that she had asked the defendant to carry out both procedures at the same time because of her lack of insurance, and he had agreed to that, the plaintiff said.
Neither the defendant nor his receptionist had given her any pamphlet, the plaintiff said.
On 12 August 1997 the plaintiff underwent the procedure, at the South Perth Surgi Centre, after which she said she was in a great deal of pain, such that she was unable to sit up in bed the following morning.
On the defendant being contacted the plaintiff said he did not come to see her but rather she was required to go upstairs to his rooms, where some stitches were removed.
The plaintiff saw the defendant on 10 September 1997 and again on 8 December 1997, and initially said that she then had a little swelling and bloating, and also saw Dr Atkinson, who removed further sutures.
By mid January 1998 the plaintiff said her stomach was distended and she felt off colour, sweaty and feverish, with aching joints and difficulty in passing urine, so that she saw Dr Atkinson who took a swab and prescribed antibiotics.
The plaintiff said her condition worsened rapidly and on seeing Dr Atkinson again she was given more antibiotics and it was suggested she see the defendant.
On 4 February 1998 the plaintiff, again in company with Mrs Collett, saw the defendant, who told her, she said, that he thought she had "a reaction to the tapes and they may be rejecting."
That was, the plaintiff said, the first she had heard of tape rejection.
The defendant had not at any earlier time informed her that sometimes the patient's body rejected the tape, or that if there was a problem it could be removed with tweezers, the plaintiff said, nor had he spoken of surgery risks including infection, haemorrhage, injury to the bladder caused by tape, or deep vein thrombosis.
The plaintiff said the defendant took a swab, and informed her that he would prescribe antibiotics, on which she advised him that she was already taking the same.
The defendant then threw the swab in the bin, saying in a very annoyed and aggressive tone "Well that was a waste of fucking time", the plaintiff said.
In cross‑examination the plaintiff revealed that in September 1997, and following the procedure, she had lost her incontinence, although then saying she was left with a "niggly" left lower abdomen pain.
She agreed she had then said the procedure had been successful.
A questionnaire completed by her at the time of the consultation of 8 December had been noted by her "Cured", the plaintiff agreed.
On 4 February 1998 the defendant had been in an angry and unapproachable mood, and she felt intimidated by his aggression, the plaintiff said, and after her departure she did not want to see him again.
On going to Fremantle Hospital she informed staff of the defendant and the procedure she had undergone and was later told a doctor had communicated with him, the plaintiff said.
When she had seen Dr Atkinson in January 1998 she had a vaginal discharge, "thought" she had a slight discharge on seeing the defendant in February and had a discharge at the time of attending Fremantle Hospital, the plaintiff said.
The plaintiff said that she had attended the hospital after going back to see Dr Atkinson on her condition worsening later in February 1998, and on that doctor advising her that she wanted her to go to the emergency department there.
The plaintiff then underwent an exploratory procedure at Fremantle Hospital in June 1998, when no tape could be located.
Prior to that operation the plaintiff said her symptoms included constant nausea, aches and pains, fever, bloating, inability to concentrate and depression.
The plaintiff had also written to the defendant, apparently in March 1998, and in response to an advice of indebtedness, stating she did not intend to settle the account until she had "some communication from you in full explanation of how and why post‑operative problems have occurred…", and also stating that during the February consultation the defendant's "demeanour suggested that you were unwilling or unprepared to take any responsibility" for her problems.
The plaintiff went on to allege the defendant had discussed her case with another patient, referred to the Fremantle Hospital doctors "in the most derogatory language", and said that on hearing that she had decided there was no point in further discussion with him, although then closing with advice that unless she received a satisfactory explanation she intended "to take the matter of your conduct further."
The defendant responded, by letter to the plaintiff dated 26 April 1998, in which he advised that he had discussed the matter with Dr Yin and Dr Lee of Fremantle Hospital, that it "may be that you have developed a tissue reaction to the tape, and this is something which happens in five per cent to six per cent of patients, and it is something which I have already discussed with you", and that he had informed Dr Yin how to remove the tape.
In his letter the defendant also denied initiating any third party discussion about the plaintiff, although acknowledging such had occurred, expressed regret that the plaintiff had a complication but stated "from my experience, I do not think it will be a serious one", and said the plaintiff would be "most welcome" to return for further treatment.
Following the Fremantle Hospital surgery the plaintiff said her symptoms were discharge, sharp pin prick like sensations in her abdomen, a throbbing sensation in her vagina, bloating and feeling very uncomfortable.
In about November 1998 the plaintiff saw Dr Barry Mendelawitz on referral from the hospital, and he referred her to Professor Con Michael, whom she saw in December 1998, he in turn referring her to Dr John Taylor, who shortly afterwards carried out further exploratory surgery, again without result.
By January 1999 the plaintiff said she was in very poor condition and was extremely depressed.
In April 1999 the plaintiff saw Dr Tamara Walters, who on 27 April 1999 carried out further surgery, some tape being located and removed.
The plaintiff said that following that operation she initially had significant relief, but again to feel ill again and returned to see Dr Walters about September 1999, following which she was referred to Dr Nicholas Tsokos, whom she saw twice, with advice that she should wait until the infection settled.
The plaintiff said she had subsequently improved under her own care, which included garlic tablets, although she still experienced a constant throbbing sensation on the left hand side of the vagina, from whence she believed the tape was removed, and she had also been left with a horizontal scar on the bikini line approximately 6‑7 inches in length.
The last general practitioner she had seen about her vaginal problem was Dr Atkinson, the plaintiff said.
Her marriage had broken up in October 2000 the plaintiff said, the surgery and her consequent inability to work in the family business being contributors to that.
The plaintiff said that if told of a risk of infection she would have returned to her general practitioner to further discuss the matter and perhaps to ask for a second opinion. She was also asked:
"If you have been told that there was a risk of tape rejection before 12 August 1997 what would you have done?---I would have gone back to my general practitioner and asked if there was anything other available or, you know. I couldn't make that decision, I didn't have that information.
If you had been told that there was a risk that tape might not be able to be removed would that have had an effect on your decision whether to proceed on 12 August 1997"?---Yes, it would have.
What effect?---I would have chosen not to have the operation.
If you had been told there was a risk that you might suffer from longer term problems like vaginal discharge or vaginal pain would that have had any effect on your decision whether to proceed?---Yes.
What effect?---I wouldn't have had the procedure.
What would you have done?---I would have weighed up whether my symptoms and what was happening for me, what warranted taking that sort of risk or whether I could just wait and see what happened after that, where it progressed to.
If you had been told that there was a risk of the procedure damaging parts of your body such as your bladder, your urethra or your vagina, would that have had any effect on your decision whether to proceed?---Yes, it would have.
What effect would it have had?---I would have rethought the whole thing. It's fairly important.
If Dr Petros had told you that most urogynaecologists in Australia – most gynaecologists and urologists don't use or recommend his surgery would that have made any difference to you?---Yes, it would have.
What difference?---It would have prompted me to go straight back to my GP and ask for a referral to another specialist doctor.
And if somebody else had told you that rather than Dr Petros would that have made a difference?---Yes.
If Dr Petros had said that most gynaecologists and urologists in Australia perform other procedures, not his, would that have affected your decision?---Yes, it would have.
In what way?---I would have gone to somebody who could tell me about those procedures, gone back to my GP and gone and seen somebody who could inform me about the other procedures that were available."
Medical evidence
Dr Atkinson reported that she saw the plaintiff in March 1997 with a complaint of stress incontinence and referred her to the defendant in June 1997.
On 15 August 1997 the defendant wrote to Dr Atkinson stating he had "performed intravaginal Slingplasty Operation and repair of enterocele." In September 1997 the defendant advised Dr Atkinson the plaintiff had had "a wonderful result" from the procedure and her "stress and urge have been cured and her lower abdominal pain is all but cured", and on 11 December 1997 that to "all intents and purposes she is 100 per cent cured".
Later, at the end of January 1998, the plaintiff again attended Dr Atkinson, on this occasion with symptoms which included a vaginal discharge without odour, sore labia, "a grabbing right iliac fossa pain which…had been niggling for a month", and a "drawing feeling at the end of micturition", and was prescribed antibiotics, the doctor stated.
On 6 February 1998 the defendant then said, in a further letter to Dr Atkinson:
"I am a little bit puzzled with Margaret's symptoms. She describes it as a feeling of 'razor blades' on passing her urine, especially worse on completion of micturition. There is some tenderness on palpation of the urethra vaginally, and clinical diagnosis is consistent with urethritis.
I am not certain of the ultimate bacteriological cause of this, but I concur with your treatment of Doxycycline and Ampicillin as this would eliminate most known causes including ureaplasma etc."
By February 1998 the plaintiff was however not very happy with the defendant's "bedside manner", Dr Atkinson said, and had lost confidence in him, so that the doctor did not consider there was much point in the plaintiff continuing to see him.
After further treatment from her the plaintiff was referred to Fremantle Hospital, later in February 1998, Dr Atkinson said.
Dr Lee, then a resident at Fremantle Hospital, said that it appeared from the hospital record that he saw the plaintiff in February 1998 with complaints which included the presence of a tender lump in the right pelvis around the pubic bone, and following investigation a diagnosis of pelvic abscess and/or urinary tract infection was made, whilst on 13 February he had a telephone conversation with the defendant, was told the plaintiff had undergone an intravaginal slingplasty and uterine prolapse repair, and recorded that it would be better if a registrar or specialist spoke to the defendant personally.
The following day, when the plaintiff was cleared to go home, Dr Lee said he recorded a plan to the effect that she ought remain on antibiotics for a month, return at the end of that period and "If unresolved ‑? remove sling per vaginally."
Dr Jessica Yin was a urology registrar at Fremantle Hospital in 1998 and now practises as a consultant urologist at that and another hospital.
She said she would probably have spoken to the defendant.
The plaintiff had presented to the hospital with a mass in the abdomen, just to the right of the supra pubic joint, Dr Yin said, and it was considered the plaintiff had an infection and that may underlay the mass.
A supra pubic exploration was carried out by Dr Yin on 24 June 1998 at Fremantle Hospital, she said, when neither abscess nor tape was located, but some symptomatic relief was gained by the plaintiff.
Dr Atkinson subsequently referred the plaintiff to Dr Mendelawitz.
Dr Mendelawitz was not called to give evidence but a number of his reports were tendered, from which it appears that after review the plaintiff was indeed referred in October 1998 by him to Professor Michael at the gynaecology outpatient clinic at King Edward Memorial Hospital, with a diagnosis of "chronic infection secondary to unabsorbable suture material", that apparently being a reference to tape.
As stated, the plaintiff was then referred by Professor Michael to Dr Taylor, a urological surgeon, who later reported that on 30 November 1998 he had undertaken a cystoscopy and vaginal examination under anaesthesia of the plaintiff which had revealed a healthy bladder with a well elevated bladder neck and no evidence of tape, the exploration for that occurring after a small incision was made in the anterior vaginal wall. Following that procedure he considered that no further surgical intervention ought occur "until another abscess points" when the plaintiff might require a vaginal and abdominal approach "to rid her of this mesh", he stated.
Dr Walters, who is a gynaecologist, reported that she first saw the plaintiff in April 1999 with a complaint of a "sore lump on the left side of the vagina and a foul smelling discharge."
Four days later, at operation, "tape was visible in the depression where the discharge was noted and was easily removed", the doctor also stated.
In evidence Dr Walters said, in answer to a question as to the size of "the piece of tape" removed, that it was "between eight and ten centimetres long and about two centimetres wide", whilst during the procedure she said she had seen erythema to the inside of the vagina, in the vicinity of the tape.
Dr Walters further reviewed the plaintiff in the course of the trial, and in a report of August 2003 stated:
"On examination I was unable to see any tape in the vagina. Some small polyps are seen in the vagina, but are not tender today. She is tender on palpation under the mid to upper urethra and along both vaginal walls anteriorly and laterally. There is pain when the cervix is rocked and the uterus is tender, as are both adnexa. No masses were palpated.
I am unable to give a strong opinion on the cause of the pain. The pelvic tenderness is similar to that I noted when I last saw her and as this was not present before the surgery, it seems likely that it is related to it. The tenderness in the vagina I believe is likely to be related to either the vaginal tapes or scar tissue."
Dr Tsokos, a urogynaecologist, apparently first saw the plaintiff at the end of 1999, and is still a medical attendant.
The doctor gave evidence in circumstances where he said further investigation of the plaintiff was to occur.
The plaintiff's complaints of pain had included pain in the supra pubic region, always anterior to the vaginal wall, around the mid urethra, and also a complaint of there being at times a discharge, Dr Tsokos said.
The possibilities as to the cause were initially said by him to include a deep low grade infection or the effect of scarring, although he later agreed a recurrent prolapse could also be said to be another possibility.
Dr Tsokos said that probably "top of the list" as a possible cause of the plaintiff's pain was the possible presence of tape, because "I don't think anyone believes that they were completely removed in the previous surgery."
There was need of further investigation, Dr Tsokos said.
It was not necessary for the plaintiff to exhibit a raised temperature or white blood cell count, or to have erythema, for there to be an infection, in the doctor's view.
Dr Tsokos had earlier reviewed the plaintiff in May 2003, when he reported that:
"she presented with further pain in the left iliac fossa, pain to the left side of the vagina, increased vaginal discharge and urinary incontinence. She also described a feeling of puffiness in the lower abdomen and a heavy, uncomfortable feeling. At times the pain was sharp and was increased by stretching but there were no relieving factors. She complains of a small amount of stress incontinence, a day time frequency of 4‑5, nocturnal twice, urgency but no urge incontinence as long as she is prompt with toileting. She has post micturition dribbling but no haematuria and no dysuria. She is also complaining of tiredness, lethargy and generalised aching. She has no bowel symptoms.
On examination, she was afebrile. She was tender in the lower abdomen; there was no rebound. On vaginal examination there was a vaginal discharge and a scarred tender area on the left posterior vaginal wall at the junction of the left upper and middle third. Anteriorily there was tenderness on the left and scarring. My impression was that the scarring was not as dense as it had been in the past. I was concerned that there may have been a further infection given our belief that not all the tapes had been removed and therefore arranged for her to have an MRI. Please find enclosed a copy of the MRI which suggests that there is residual tape."
Two further reports from Dr Tsokos were tendered by consent at the end of the trial.
In the more detailed of those Dr Tsokos reported to Dr Hartley of Bunbury on 2 September 2003 that on the same day he and Dr John Taylor had conducted an examination under anaesthetic and a cystoscopy.
The findings included there being a minimal degree of cystocele and rectocele and a minimal degree of cervical descent which would amount to a very early Grade 1 degree of prolapse, the doctor said.
That was entirely consistent with the plaintiff's "parous state", Dr Tsokos said, and he doubted the prolapse was contributing significantly to her symptoms.
Reference was again made by the doctor to scarring of the anterior and posterior vaginal walls. The former being "particularly para urethrally in the region of the mid urethra", more marked on the left, with a pit in the same area, but without evidence anywhere of any tape.
Dr Tsokos concluded by saying that he "would be very reluctant to explore surgically either vaginally or suprapubically in an attempt to removing (sic) the residual foreign body that may remain. I feel that we should persist with the conservative management. It is my opinion that this lady will continue to have some symptoms long term".
Defendant's evidence
The defendant obtained his primary medical degree in 1965 and has since been awarded a doctorate in medical science from Uppsala University and a doctorate in surgery from the University of Western Australia, both related to his work in female incontinence, he said.
In 1997 the defendant said that in the course of his practice he was performing what he described as the "tension free tape" operation or intra vaginal slingplasty, developed by Professor Ulmsten and him.
The form of tape then used was nylon, he said, and it was inserted as a sling from the vagina to the anterior abdominal wall, under the middle of the urethra, the latter placement being a variation on a long standing sling theme, and introduced by the two.
That surgery was based on the "integral theory", the defendant said which had as its premise that female incontinence was chiefly due to laxity in the vagina or supporting ligaments, as a result of altered connective tissue, and which included the proposition that a ligament from the pubic bone to the mid urethra on becoming lax was such a cause.
That was also developed by them, the defendant said, based on earlier work, and was becoming increasingly accepted.
The idea of the tension free tape procedure was then, the defendant said, to tighten that ligament by making a wound with a delivery instrument alongside the mid urethra and then to introduce tape as a template for the formation of scar tissue along its length, the tape being slung under the urethra there, and an "artificial neoligament" being created.
In Australia surgeons who accepted the integral theory formed a body known (variously, it would seem) as the Association of Ambulatory Vaginal Incontinence Surgeons, or Australasian Association of Vaginal and Incontinence Surgeons (AAVIS), at a meeting held in 1997 at Royal Perth Hospital, he said, although there had been an informal group after 1995, when over 40 attended a course in the procedure conducted at the same hospital.
The defendant said the body was essentially a craft group, with courses run from time to time, and most courses and members were outside this State.
Attendance at a course earned a member of the RACOG some continuing education points, he said.
There was no difference between the TVT operation and the IVS operation, the defendant said, apart from the delivery instrument, and in 1999 he commenced using polypropylene tape, which had a lower rejection rate than nylon, of probably around one per cent.
In 1997 nylon was however the best material available, the defendant said.
The delivery instrument invented by and used by him was the "IVS tunneller", that being a J‑shaped stainless steel tube through which the tape was drawn, the defendant said, whilst the TVT, that being a trade name of Johnson & Johnson, consisted of two sharp needles.
In August 1997 the TVT was not available in Australia, the defendant said, and the only available instrument was the IVS tunneller.
The defendant said he received a royalty of about $15 per instrument for the IVS tunneller.
Both the Hospital Benefits Fund and the Health Insurance Commission paid benefits to patients who underwent the IVS operation in 1997, the defendant said.
In 1997 in his practice at the Kvinno Centre the defendant carried out only pelvic floor reconstruction and incontinence work he said, there also being a female doctor who was involved in non‑surgical pelvic floor rehabilitation.
On the plaintiff's first consultation of 9 June 1997, and on seeing she had not completed that portion of the questionnaire where the patient was to describe her symptoms, the defendant said he questioned her and then recorded her answers, such including "wets bed occas.".
A number of tests, as set out in the questionnaire, were then performed by him, the defendant said, including an ultrasound, and on all the material then before him he concluded the plaintiff "had problems in the anterior ligaments and in the posterior ligaments,", recorded in his clinical notes that there was a prolapse, and an enterocele, and said the first was a prolapse of the bladder and the second a prolapse through the rear ligaments.
The defendant said he thought the plaintiff was very enthusiastic, and also thought she had a quite severe problem in relation to her pelvic pain and incontinence.
A 24 hour urinary diary subsequently made by the plaintiff confirmed the significance of the latter, the defendant said, as did a later "cough" pad test, "star jump", and 24 hour pad test.
At the consultation on 28 July 1997, and although he had no recollection of it, the defendant said a protocol he followed would have resulted in him advising the plaintiff of the results of the examination and tests, and that surgery rather than exercises was required.
Notations on the test result form, which he would not ordinarily have seen until the patient came in, supported that, the defendant said, as he would usually engage in an interactive process.
It appeared from his clinical note of 28 July that he said the plaintiff required "repair of the uterine prolapse and … an IVS repair of the anterior ligament", the defendant said, and he also had a note "wants operation" which indicated a preliminary discussion as to that.
The defendant said he did remember the plaintiff being "fairly enthusiastic about having an operation, about being cured," and that "it was a serious problem and I think she was happy to hear that there was hope."
A note was also made that the plaintiff requested going on a waiting list, the defendant said, as he operated at two public hospitals, and he did recall there was also a discussion about cost and the plaintiff then decided to pay for the procedure.
The pro forma letter of consent would then have been procured and discussed, as was his invariable practice and as appeared from it, he said, and he also had a specific memory discussing with the plaintiff that his procedure was a new approach.
The defendant said in 1997 he also told patients where the procedure had been developed, that it was his technology, the differences between it and other procedures, including the nature of the incisions, reduction in risks and "above all because we use a tension free approach, there's very little chance of residual urine at the end of the operation."
The explanation of the procedure would include reference to a "small chance" of perforation of the bladder, he said.
As to the advice in the letter of consent that if "both parts of the vagina need surgery, we recommend repair of only one at a time", and "(s)imultaneous repair may actually worsen symptoms", and his decision in the plaintiff's case to carry out repair of both at the same time contrary to that advice, the defendant said:
"She wasn't insured and it would have been terrible to bring her back and make her pay another $3000 and I felt that I could – you know, I said to her, "Look, I think I can get away with it just by doing both together, as long as you understand that there is this chance that it could be painful.
Do you specifically recall discussing that topic with Mrs Hall?‑‑‑In a general sense I do, in a general sense I do."
Repair of the enterocele could cause pain in about 10 per cent of cases and he circled the relevant part of the letter for that reason, the defendant said.
The note "5 per cent rejection rate" was made during the consultation, and was included, the defendant said, as:
"Well, the main thing wrong with it is that a percentage of patients get tape rejection.
When you speak of tape rejection, what do you mean?‑‑‑I mean it's like a splinter. It's like a foreign body. For whatever reason, and there's a lot of debate as to what the actual mechanism is and people have strong view on it but whatever the mechanism is it's an inflammatory process, in other words, and it's rejected like a splinter. It's a foreign body. We are implanting a foreign body.
What, at that time, did you say to Mrs Hall, if you can recall or if you can't what was your practice?‑‑‑Well, I am very careful about this part of it.
I will do one at a time. Do you remember speaking to Mrs Hall specifically about this?‑‑‑Not specifically, no.
Well, what was your practice or protocol at that stage?‑‑‑My protocol, and it's a protocol that I follow very strictly here because even though it's not harmful to the patient it can be quite frightening, that suddenly they get this thick yellow discharge that can be very smelly and it can be very frightening to a patient. So I make sure that I tell them about it.
What do you say?‑‑‑I say that there's a 5 per cent chance this could be rejected. If it is rejected you'll know about it. It's a thick yellow discharge. Don't be alarmed. We can usually deal with it either by snipping it off or pulling it out but I said this is how the operation works. It works by irritating the tissues to form scar tissues. Sometimes the reaction is more than it should be and that is when it can be rejected.
Are you answering that question from your memory of what you said to Mrs Hall or from your practice at that time?‑‑‑No, I am answering that question from what is my standard practice and that I do emphasise that it is something that I (sic) particular attention to.
Thank you. Is there anything about the notes that supports in your own mid the fact that you told Mrs Hall about that 5 per cent rejection rate?‑‑‑I wrote it in at the time.
You have heard what Mrs Hall and Mrs Collett had to say about that not being on the form at a time when they came to sign it, what do you say about that?‑‑‑That is absolutely untrue. It is something I am particularly aware of. I have done a whole lot of research on it. I have done a whole doctoral thesis on it."
A little later the defendant was asked:
"When you mentioned the 5 per cent rejection rate, can you tell the court whether you mentioned what might be the consequence of a rejection – what might happen if there was rejection?‑‑‑Yes. The consequence of a rejection is that the patient develops a thick yellow discharge.
Anything else?‑‑‑It can be quite smelly. That's the bad news. The good news is that – and this is why my practice is to tell the patients not to worry.
Was it your practice in 1997 to do that?‑‑‑Yes.
Carry on?‑‑‑I say, 'Look, don't worry about it. If it happens, just come and see me and I can deal with it as an outpatient procedure.
Did you at that stage explain to them what would be physically done to them to solve the problem?‑‑‑Yes.
Can you tell us what that was?‑‑‑Yes – that if this happens, then it's just a matter of taking the tape and pressing the scissors and cutting it or if it's totally rejected, it just slips out without any trouble at all.
And up to 1997 at least, had you experienced with your patient's tape rejection that required the tape to be removed?‑‑‑You mean surgically?
Yes?‑‑‑No.
When I say surgically, in the fashion that you described?‑‑‑No. The nylon tape had one very wonderful characteristic – that when it was rejected …
Sorry, can I just stop you there and ask you this: whether up until the end of 1997 you had had occasions when you had removed a rejected tape in a patient?‑‑‑Yes. It was a …
On roughly how many occasions?‑‑‑At least 20 times a year. I was doing about 400 operations a year.
For how many years, roughly?‑‑‑8 years, 10 years. You mean in 1997?
Up until 1997?‑‑‑Certainly in volume since about 93 or 94.
And how many times, roughly, in the space of each year, would you come across a tape that had rejected and required removal?‑‑‑At least 20.
And were there any of those tapes that required removal which were not able to be removed by the method you have described?‑‑‑Not with the nylon tape, no.
Can you think of any patients, up until 1997, where the tape was, in your experience, difficult to find?‑‑‑No.
Are you able to tell us of any instances in the established literature up to the end of 1997 where the tape was difficult to find?‑‑‑Are you talking about nylon tape?
Yes?‑‑‑Not that I have read.
And since, with nylon tape?‑‑‑No. You see everybody was moved on to polypropylene and that's a different tape.
I think you've moved on to polypropylene yourself?‑‑‑I have.
But since 1997 is there anything in the literature at all that you are able to direct the court's attention to, which suggests that a nylon tape, inserted in the fashion that you did with Mrs Hall, is difficult to locate and not amenable to removal in the way that you describe?‑‑‑Can I have that question again?
Are there any examples in the literature, since 1997, of the use of nylon tape in the performance of the type of tension‑free procedure that you adopted with Mrs Hall, which record that the tape was difficult to locate or remove?‑‑‑None that I know of.
Had you, up until 1997, had any experience yourself of a patient suffering the type of infection said to have been suffered by Mrs Hall?‑‑‑Can you be more specific?
Have you had any patient who has had a nylon sling inserted, in the type of procedure that Mrs Hall had, who has had the type of infection that Mrs Hall is said to have had?‑‑‑You mean the clinical picture?
Yes?‑‑‑Because I don't think she had an infection.
That is why I said, 'said to have had'?‑‑‑Yes, most certainly.
Who were as sick as Mrs Hall?‑‑‑Some. Some, yes, if you will allow me to elaborate because we need to go into what…
Is that recorded in the literature?‑‑‑Yes. I certainly record it in my doctoral thesis – that different patients react differently to foreign bodies.
And there are instances, in your experience, of people who have been as sick as Mrs Hall, is that right?‑‑‑Yes. Mrs Hall…
Prior to 97?‑‑‑Mrs Hall certainly had what I would call – patients react in three ways to a foreign body such as the tape. 95 per cent of them it's just an annoying discharge but in Mrs Hall's case it was more than that. She had quite an intense reaction. I didn't see her afterwards but I have read the transcripts of the hospital and …
Did you warn her of the risk that something like that might occur?‑‑‑Yes, I did."
The doctoral thesis was not produced.
At the second consultation the defendant said he would not have dictated a letter about another patient in the presence of the plaintiff and Mrs Collett.
In 1997 after a consultation such as that of 28 July the patient would be led by him to the front desk, where his secretary would make arrangements for the surgery, he said.
An "Information Pamphlet for Kvinno Centre" would be given by him to the patient, perhaps when leaving the room, the defendant initially said.
That information pamphlet states "we offer the latest Scandinavian techniques in (inter alia) keyhole surgery".
That procedure is described in the pamphlet as follows:
"KEYHOLE SURGERY: Our surgeons use minimally invasive techniques performed through 1cm incisions. Special instructions are used to help create artificial neoligaments. We strenuously avoid excision of vagina and uterus, as these are vital structural components."
On the reverse side of the pamphlet the need to avoid scarring of the bladder neck and importance of conserving vaginal tissue and the uterus during surgery is set out, and the morbidity associated with the occurrence of the former or failure in relation to the latter described.
A fair reading of the pamphlet leads to the drawing of an inference that the plaintiff's surgery is good, as it avoids that prospect of morbidity.
The following table also appears:
| "COMPARISON OF OLD AND NEW TECHNOLOGY | ||
| NEW | OLD | |
| (Intravaginal Slingplasty) | (bladder neck elevation) | |
| bladder instability | approx 85% | operation contraindicted |
| stress incontinence | equivalent cure | equivalent cure |
| post‑op catheterization | NIL | 7‑10 days |
| hospital stay | 1 day | 7‑10 days |
| incision size | 1 cm | 8‑12 cm |
| post‑op pain | Virtually nil | Significant |
| return to normal activities | 7‑10 days | 6‑8 weeks" |
No reference is made in the pamphlet to any risk of the defendant's procedure.
A further pamphlet, described by the defendant as "very important" was he said given to a patient by his secretary.
The document, entitled "Information for Patients Undergoing Surgery", sets out material under the headings "Pre‑operative Information", "Post‑operative Information", and "follow‑up".
The pamphlet sets out in some detail the procedure before and after the surgery, but from a patient's perspective, with reference to the possibility of post‑operative nausea and vomiting, and to vaginal bleeding, said to be normal, as well as to the need to avoid any tearing of the sutures.
Under "follow‑up" the following appears:
"If you have a yellow vaginal discharge, do not be disturbed. It may be a tape being rejected. This is how the operation works. The tape irritates the tissues to form a scar which acts as an artificial ligament."
Apart from advice to ring the defendant, or if he was on leave Dr Richardson, if concerned, nothing more is said.
There is nothing set out as to the risks of surgery, either general or specific.
It was, however, part of the defendant's protocol to speak of the risks of haemorrhage, infection and thrombosis, he said, but in terms that "because we make smaller incisions there is much less risk of (the same)."
At operation on 12 August 1997 the defendant said he put a tape around the mid urethra, reattached the hammock to the closure muscles, repaired the external urethra ligaments, repaired the enterocele "and approximated the cardinal ligaments and uterosacral ligaments which is really a Manchester – type repair", which was, he said, to repair the front and back ligaments as intended.
On the following morning it had been necessary for the plaintiff to come up to his rooms as he required the use of his examination couch, the defendant said, and he expected that the plaintiff would be brought up in a wheelchair.
At the first post operative follow‑up, on 10 September 1997, the defendant said he noted a complaint from the plaintiff of pain "like a needle" on the left hand side, although she also said she was 100 per cent cured.
On 8 December he noted the plaintiff's backache was cured, she had begun having sexual intercourse, and there was no stress incontinence, the defendant said.
I should record here that at this point in his account in examination in chief the defendant did not appear as scheduled to continue with it, and a psychiatric report was put forward which suggested the defendant might be in some distress and indicated a need for more detailed psychiatric review.
The trial was perforce adjourned until the following day, when a report from another psychiatrist was handed up, which indicated the defendant was able to continue, a finding I accepted.
When, after a lapse of some days the defendant appeared again in the witness box he said that he had no recall of the "last hour or so" of his previous evidence, and that his concentration "was pretty hopeless" on that day, particularly in the afternoon.
His evidence having resumed the defendant then said the information pamphlet personally given by him to the patient would, as part of his protocol, be provided prior to any reference to a letter of consent.
Speaking further of tape rejection, on the return of a patient with early symptoms of such the defendant said he would look for granulation tissue at the mid urethra, that being a precursor to scar tissue, very red and liable to bleed when touched, the tape itself, and a yellow discharge.
The tape would then be pulled out, with the aid of his secretary or a nurse, and the use of a SIMS speculum and sponge holding forcep, the defendant said, and it took five seconds and he had dealt with every nylon rejection in that way.
The defendant said he had "never" had difficulty locating a tape, and he was aided in that by having inserted it himself.
As to the question of pain in relation to tape rejection, and his view of the plaintiff's condition, the defendant was asked:
"Let me just ask you this: have you ever seen a patient on whom you've operated who's having tape rejection or infection who complains of pain?‑‑‑Tape by itself‑‑‑
No, no?‑‑‑No. You mean from the tape itself, just the tape, no.
Is there anything recorded in the literature that would support that a patient suffering from infection or rejection of the tape first complained of pain?‑‑‑I need to clarify your question, Mr Halliday.
Okay?‑‑‑Now, there are two – a tape rejection is essentially a foreign body reaction. Now, if there is what we call a haematoma which is a collection of blood then certainly there can be an infection around the tape but there has to be clinical evidence of it. There are two different things, they are both inflammations. They were described by John Hunter in the 1600's as adhesive inflammations which was a foreign body reaction and infective inflammation. Two different things and this is something I've studied very intensively with reference to John Papadimitriou and with others and written about it in peer review journals and in my doctor of surgery thesis. Now, it is possible to have an infection with a tape but then it's generally associated with pus in the form of a haematoma but that's an acute thing.
Just pausing there, if that condition developed in Mrs Hall would you expect that to show up on imaging in some form?‑‑‑Yes.
What sort of imaging would you expect‑‑‑?‑‑‑Well, firstly, you would have a temperature, secondly, you would have a raised white cell count; thirdly, you'd have a purular discharge which grew bacteria; and fourthly, you would, on CT scan, find a collection of pus in the position of the tape.
On your reading of the hospital notes and apart from one occasion in the Fremantle Hospital where there was a spike in temperature and a period of time where the white cell count was raised in the Fremantle Hospital, have you seen any evidence in the unfortunate course of Mrs Hall's history to suggest the existence of those other conditions that you have referred to?‑‑‑No, I have not. If one looks at the clinical course of Mrs Hall's history the temperature spike and raised white cell count were consistent with a urinary tract infection which was the first admission. Subsequently there has not been a raised temperature recorded. The white cell count has been normal and I think I can only speak indirectly here because I didn't actually examine Mrs Hall at the time but it follows the pattern of, you know, a tape rejection that could have been dealt with 18 months earlier than what it was and I'm sorry that it wasn't. I'm sorry for Mrs Hall, but that's the way it turned out.
Are you able to tell us how much tape you inserted into Mrs Hall in the operation in terms of length?‑‑‑It's about 10 centimetres.
You heard Dr Tsokos give evidence about the uncertainty of the tape removed by Dr Atkinson – Walters, I'm sorry. I will start talking about 1987 – is the length of the tape that she took, Dr Walters removed, consistent with the length of the tape that you inserted?‑‑‑Yes. I would say‑‑‑
If tape was still present what would – sorry, would it be apparent on imaging?‑‑‑It's possible, yes. It's possible.
Would there be any other sign that would be apparent on any test of the presence of ongoing infection?‑‑‑You would expect to find a collection of fluid in the position of where there tape is. Ultrasound is a very good medium for doing that, transperitoneal ultrasound. I use those quite regularly.
Okay. In your view are the symptoms that she now complains of consistent with infection, a low grade long standing infection, caused by tape rejection?‑‑‑No. No, I think she's had recurrent (sic) of her prolapse, Mr Halliday."
On objection being raised to the last part of the defendant's evidence I indicated that I would receive his evidence as to his stated reasons for that view provisionally, and the defendant went on to say that the plaintiff's symptoms, and in particular cervical excitation pain reproduced and recorded by Dr Walters, demonstrated prolapse, and could be treated appropriately with a Manchester repair, including insertion of a tape.
Having further considered the matter, and in order to ensure I consider the entirety of the defendant's views, as contained in his evidence, I accept it as part of the body of materials before me.
On the return of the plaintiff on 4 February 1998 the defendant said she presented with quite unusual symptoms, and a symptom he had never really seen before, which he recorded in his notes as "razor blades", that being associated with the passing of urine.
On examination on that day the plaintiff was tender over the urethra, the defendant said, and he "thought she had an infection in the urethra which had already been diagnosed by her GP and treatment had been started", and although the possibility of tape rejection occurred to him there was no evidence of it, and in particular no granulation tissue nor any yellow discharge.
His notes revealed that he had taken swabs, and those were not sent on, the defendant said, but he did not use "swear words" with patients.
The defendant said that in his belief in August 1997 the IVS procedure was regarded as an appropriate treatment by a responsible body of medical opinion, and there were three other surgeons in Perth who performed it, and probably about 40 or 50 members of AAVIS interstate, as well as doctors in Scandinavian countries, that the risks of the procedure were known, and there would have been at least 10 publications about it in the medical literature.
He had personally performed at least 1,000 IVS procedures by August 1997, the defendant said.
Approval by the Ethics Committee at Royal Perth Hospital had been given to him to perform the operation as a standard procedure, the defendant said, in 1993.
There was no risk of tethered vagina syndrome in the IVS procedure, he said.
Other letters of consent where he had noted tape rejection were produced by the defendant.
In cross‑examination the defendant agreed reattachment of the hammock which involved making two incisions and reattaching a "loose vagina to the closure muscles" was, in 1997, something he but not Professor Ulmsten did.
That was described by him as a "muscle flap repair" pursuant to an arrangement with the doctor in charge of the HIC, the defendant said.
The procedure developed by Professor Ulmsten and him did not have as potential complications those associated with the other procedures, the defendant said, and for that reason "my procedure is now the gold standard."
Tape rejection was the "main" complication, the defendant said, but that did not mean infection, and he disagreed with the expert called on his behalf, Dr Dwyer, in that regard.
Where the tape was totally rejected it would all slip out, the defendant said, and where it did not slip out when gripped so that scissors were run up to snip it, leaving part of the tape behind, that meant the tape was only partially rejected.
An infection would not "transmigrate" with the tape, due to the growth of granulation tissue and collagen, he said.
The defendant said that he did not in 1977 regard tape rejection as a "hazard" however and still did not do so.
The information pamphlet for patients undergoing surgery provided by the receptionist, which as set out above dealt with a yellow discharge, ought not be read as indicating that such was normal, the defendant said, and it was a complication.
The defendant agreed that in 1997 the majority of specialists who performed surgery to treat urinary incontinence in women did not use the IVS procedure, and those who did constituted a small number of the total.
The defendant was also asked:
"Can you accept as a possibility that because of your personal and financial stake in this procedure that you may perhaps be somewhat blinded as to the adverse elements associated with it?‑‑‑No. I don't accept that proposition in any shape or form, Mr Hancy.
That you see it as your baby and you can't see any bad elements?‑‑‑I think‑‑‑
Do you accept that as a possibility?‑‑‑Absolutely not, Mr Hancy. The role of the scientist is to seek the truth, whether it's good or bad. That's the way it is."
The defendant said that he had sought an evaluation by ASERNIP/S of his procedure, and had served on the Committee as the proposing surgeon.
He did not however agree that, from his perspective at least, in 1997 insufficient was known about the IVS procedure for a reliable conclusion to be formed as to its safety.
However the defendant said he not only agreed with the following portion of the ASERNIP/S report relating to his procedure, there called the "two stage intra vaginal slingplasty", but had actually proposed it.
"The safety and efficacy of the procedure cannot be determined at the present time due to an incomplete and poor quality evidence base. It is recommended that further research be conducted to establish safety and efficacy."
The defendant said that if the relevant criteria were applied as a bar to other surgical procedures no surgery would be carried out.
Expert evidence
Dr Korda is an eminent gynaecologist in practice in New South Wales who practises in the subspecialty of uro‑gynaecology, and has published widely, including in the area of medical ethics.
In 1997 he was an examiner for the RACOG and said that the IVS procedure was not then examined on.
There were no independent studies on the IVS to support it, it had not been extensively reported on, and it was not used by the majority of gynaecologists, Dr Korda said.
The "gold standard" procedure then, Dr Korda said, was culpo suspension.
From 1996 on a development of the IVS, known as the tension free vaginal tape (TVT) procedure, had also been extensively used, he said, that development resulting from problems with the IVS.
The TVT procedure had been performed by him, Dr Korda said, but not the IVS, as he felt the published literature did not support the safety of the latter.
In that regard there had been reports of vaginal tethering and also of rejection of the tape by 8‑9 per cent of recipients, he said, in addition to the other risks of surgery.
Dr Korda said rejection was usually a form of infection, in which bacteria settled in the pores of the tape and the body's defensive mechanisms could not get at the bacteria to effect a cure.
The infection was chronic until the tape was removed, which was difficult, he said, as the tape could be overgrown by connective tissue, and difficult to find, and very frequently only a small amount could be removed at a time, whilst the tape sometimes fractured when grasped.
A change was made in 1997, after the plaintiff's procedure, to the type of tape used in the TVT procedure, Dr Korda said, and mono filament polypropylene tape with large pores of 100 microns introduced, that permitting a more effective attack on the bacteria, whilst there was also a sheath over the tape until the final adjustment.
There had not been a single reported case of tape rejection since then resulting from the TVT procedure, he said.
Tape with a pore of at least 30‑40 microns was required, Dr Korda stated, and the IVS tape had been he thought less than that.
An article by the defendant in which the nylon tape rejection rate was said to be 5.6 per cent after six months had not been considered by him when compiling his report and that period was not long enough to assess the outcome of the procedure, Dr Korda said.
The doctor was asked:
"Although you gave evidence‑in‑chief with respect to the 8 to 9 per cent, would you quibble with 5 per cent as being a view held by a responsible body of urogynaecological surgeons?‑‑‑I would not quibble about that but it's also reasonable to expect that there is a 5 to 9 per cent rejection rate if you look at all the evidence in the literature.
Well, the difficulty I have is that – with that is you're not able to justify that with the literature in court today?‑‑‑Well, I have referenced it and the article can be cited.
I think you also say in one of your reports that you operate or a surgeon should place reliance on his own figures?‑‑‑Yes.
And that's a carbon principle of surgery?‑‑‑That is a good principle of surgery.
But as well as other people's results?‑‑‑Yes.
And if it were that Dr Petros had in his experience elicited a 5 per cent rejection rate in the global sense without digressing into for how long, would it be reasonable in your view for him to rely on that for the purpose of advising patients of the risks and benefits?‑‑‑Yes."
He was also asked:
"Your view is that there may be an 8 to 9 per cent chance of rejection of the tape with IVS but you accept that a 5 per cent chance is a reasonable assessment of the risk of tape rejection?‑‑‑Well, since the published literature is not great on IVS it is very difficult to form any other conclusion [than] what you just said."
Dr Korda said that prior to the procedure being offered in 1997 a responsible surgeon would have spoken of various risks, including a 5 per cent risk of tape rejection, the risk of vaginal tethering and of the fact that the procedure was new or different to that ordinarily offered.
It would not have been enough to express that rate of rejection without further explanation, Dr Korda later said, and a reasonable practitioner ought also to have elaborated on the novelty of the procedure, with references to his own experiences and results, and by reference to the results and complications of the alternative procedure available.
As to an explanation of the risk of rejection Dr Korda said:
"In 1997 if a practitioner were contemplating performing IVS and gave advice to the patient that there was a risk of rejection, in your view would the sufficient discharge of that duty be simply to say there was a risk of rejection without explanation of what that meant?‑‑‑Well, I think you would have to explain what rejection meant, which means that the tape would be rejected by the body and there would be an associated symptom of pain and discharge and the tape may need to be removed.
It was also suggested to you that there could be advice that the risk of rejection was 5 per cent. You have given evidence that there was no independent evidence and no evidence from a randomised controlled study to confirm that percentage figure. In those circumstances, in your view would it be sufficient to simply say that this risk of rejection was only 5 per cent without further explanation?‑‑‑No.
You were also asked about the general risks of surgery. If there was any reason why one of those general risks of surgery might be enhanced with the particular procedure contemplated, would it in your view be reasonable for the practitioner simply to refer to a general risk without reference to the factors that might make it enhanced for that particular procedure?‑‑‑No.
You were also asked about whether it would be a reasonable thing to do to convey words to the effect that the procedure was new and it differed from other procedures and the answer was yes. But would it be sufficient advice from a reasonable practitioner to say that without any further elaboration?‑‑‑No, I think it would have to be elaborated on and you would have to talk about the personal experiences and the results of that procedure."
Dr Korda did state that he agreed the diagnosis of stress incontinence appeared "fairly clear‑cut" and surgical treatment of the plaintiff's stress incontinence was appropriate.
Dr Dwyer is a senior Melbourne urogynaecologist, who has served, inter alia, as chairman of the urogynaecology subspecialty committee and chairman of examiners in that subspecialty for the RACOG, and he has a long list of published material.
He said that he had introduced Prof Ulmsten to the defendant in 1988, as a result of which the professor had come to Perth to see the defendant's work, and the defendant had then gone to Sweden and the IVS procedure had been developed, based on the defendant's original ideas.
Their paths had, however, later diverged, when Prof Ulmsten began to use polypropylene tape, Dr Dwyer said.
Dr Dwyer said that he had never utilised the IVS procedure.
In 1997 the IVS procedure was not the main incontinence procedure being carried out in Australia, he said, but there were about 50 gynaecologists of the AAVIS group who then utilised the procedure.
The Burch colposuspension procedure was the gold standard for Australia at that time, he agreed, although the Murray Cato procedure was popular in Perth.
The TVT procedure had become available in Australia after that time, Dr Dwyer said, and he had commenced using it in 1999, and it was now his main surgery for stress incontinence.
There were differences between the IVS procedure as carried out in 1997 and the present TVT procedure, although the mechanism was similar, he said.
Dr Dwyer said those differences included the type of tape, the "introducer", the making of two vaginal and one abdominal incisions in the IVS as opposed to one vaginal and two abdominal incisions in the TVT, and there being a separate cutting and stitching of the vagina in the IVS which was not usually done in the TVT.
The defendant's proforma consent and information pamphlet for patients undergoing surgery covered the "main aspects", the doctor said, although he thought it would be appropriate to supplement such with an "interactive" process.
In 1997 that would have included pointing out the other alternatives available to a patient, Dr Dwyer said.
As to the question of infection, in the light of the defendant's proforma consent, the doctor was asked:
"What if anything is said in that document, either in its typewritten form or in writing, about infection?---Well, there's nothing – well, there's nothing written on infection but, you know, the concept of rejection or infection I think is one where there is a certain amount, certainly in my mind, of haziness between what is rejection and what was rejection. I mean, what I call infection, from my reading of the literature, they're talking about rejection. I think the two often go together. Obviously if you get infection then you get rejection.
Yes, in your mind?---In my mind.
You agree, don't you, that that form has little on actual complications including tape rejection and infection?---Yes.
Because I'm putting to you what you said in your report?---Yes, yes.
Then further down in 4 you said:
Rejection of the tape is not the primary problem but rather infection developing in the tape that once established cannot be treated with antibiotics and only by removal of the tape?
---Yes.
You agree, don't you, that that form does not give any indication to the reader at all of what is the primary problem. It is:
Infection developing in the tape that once established cannot be treated with antibiotics and only by removal of the tape?
---In my opinion.
You agree?---Yes."
Dr Dwyer had originally reported in relation to the proforma consent that it "does not seem to describe in words the procedure very adequately. The success rate of 85 to 90 per cent is quoted but there is little on actual complications, including tape rejection and infection".
With the IVS procedure, the doctor agreed that "in many cases" tape rejection was associated with infection, which could be chronic unless the tape was removed.
Tape removal was "usually" carried out under general anaesthetic, he stated, as if the tape was adherent it could cause pain, particularly if infection was present.
As to the defendant's statement that the tape could be cut on each side, for the purposes of removal, Dr Dwyer said that "if there is an infection present then I think the whole tape needs to come out and I wouldn't leave any part of it in", which he agreed would entail doing whatever had to be done to remove it.
Dr Dwyer agreed that many patients with an infection had "chronic symptoms of pain and a feeling of unwell", and damage could be caused to tissue and result in "chronic scarring".
As to the likelihood of rejection at the material time, he said that in 1997 there were published papers from the defendant and Prof Ulmsten which put the rate at 5.8 per cent and 9 per cent respectively.
As to the former it would be reasonable for a surgeon to advise a patient on the basis of his own statistics, the doctor said, with advice that they were his own results.
Dr Dwyer said he would have some but not total confidence in the figure of 5 per cent and would say 5‑10 per cent perhaps, based on the existence of limited data which had not been subject to scientific investigation.
The defendant's 1996 publication, which had provided a rejection rate of 5.6 per cent over a period of between three and six months following the IVS procedure, was he agreed based on too short a period, although he considered the "majority of reactions or infections" would occur within that period.
In 1997 there was a responsible body of medical opinion in Australia which considered the IVS procedure to be appropriate treatment for stress incontinence, and that was supported by the Health Insurance Commission, HBF and Royal Perth Hospital approvals, he said.
Dr Dwyer said that he had managed 5‑10 patients with an infection from tape rejection.
It was easiest for the doctor who inserted a tape to find it, he said.
Urologists tended to make an abdominal approach whilst gynaecologists tended to approach through the vagina, Dr Dwyer said, and here he would have made a vaginal examination and removed tape through the vagina, which was reasonably easy in his experience.
However, Dr Dwyer had originally reported in relation to that procedure, that "(s)ometimes this cannot always been effectively performed (sic) and the abdominal or suprapubic route is necessary".
Tapes "can be very difficult to find, especially when there is scarring and infection present", and such were usually incorporated with fibrous tissue, which was difficult to distinguish from the tape, so that it was necessary to know where to look, he said.
If the tape was not protruding into or beyond the vaginal wall an incision would be required, the doctor said.
The tape was easiest to find at the first attempt, the doctor said, and after that it became increasingly difficult to remove.
Dr Dwyer said he thought the plaintiff's symptoms had been due to an infection resulting from the presence of the tape.
In 25 per cent of cases removal of the tape resulted in renewal of the stress incontinence symptoms, Dr Dwyer said, although less was known in that regard in 1997.
Finally, in relation to the defendant's claim that the procedure performed on the defendant would be likely to improve bladder function Dr Dwyer stated:
"5.I cannot see why a suburethral sling should improve her impaired bladder emptying even if it was placed under minimal tension. Nevertheless, prolapse can sometimes contribute to impaired bladder emptying so surgical treatment of her enterocele may have had beneficial effects on bladder emptying. Certainly, there is some evidence of impaired bladder emptying preoperatively which certainly does not seem to have been a problem for her postoperatively.
6.Surgical procedures for stress incontinence either open urethral suspension or suburethral sling do not usually improve bladder emptying and with increased urethral resistance these operations make bladder emptying worse."
Prof Maddern is an Adelaide general surgeon who is a professor of surgery at the Queen Elizabeth Hospital in Woodville, South Australia.
He said that although ideally a new surgical procedure would be evaluated by a prospective randomised controlled trial, in practice with surgery that was very hard to do.
In 1997 the methods available for recognition of a surgical procedure were peer support or approval by a hospital ethics committee, Prof Maddern said.
Approval by the Health Insurance Commission or health funds did not involve any evaluation by an expert committee in 1997, he said.
As to the position of the IVS procedure in 1997 the doctor said he had reviewed that from 1998 as surgical director of the ASERNIP/S project, the report appearing in 2001.
That report, which dealt with both the IVS and TVT procedures, had concluded in each case that:
"There was no peer‑reviewed, good quality evidence available to determine the safety and efficacy of any of the tension‑free urethropexy procedures in comparison to the 'gold standard' surgical procedures for stress incontinence. In the absence of such evidence, the ASERNIP‑S Review Group allocated a level 2 safety and efficacy classification for the two‑stage IVS and TVT procedures, that is:
2. The safety and efficacy of the procedure cannot be determined at the present time due to an incomplete and poor quality evidence‑base. It is recommended that further research be conducted to establish safety and efficacy.
It was recommended that a randomised controlled trial should be conducted to assess the safety and efficacy of the two‑stage IVS. Ideally, the two‑stage IVS should be compared to the TVT procedure, along with the Burch colposuspension as the 'gold standard'.
For the TVT procedure, it was recommended that a randomised controlled trial be conducted, with the Burch colposuspension as the control arm. Such a trial is currently underway in the United Kingdom and full publication of its short and long‑term results are awaited with interest."
Prof Maddern said that 30 ASERNIP/S reviews had now been carried out and the conclusion reached in each was the same as that above in all but a handful.
He agreed that there was also a finding by the review group that only 4 per cent of patients who underwent the Burch colposuspension procedure would have a major complication whereas that figure was about 7 per cent for patients who underwent a pubovaginal sling procedure.
Prof Maddern earlier reported, in relation to the IVS procedure, and the information which he considered ought be given to a patient, that in his opinion the IVS procedure having had RPH ethical committee approval ought to have been regarded as "new" rather than "experimental" and that:
"A patient who is provided with the options of the existing conventional treatment, the new or experimental procedure and the established pros and cons for both approaches is probably gaining sufficient information to make an informed consent."
Dr Richardson is an experienced Perth gynaecologist who, after meeting the defendant in 1992, began to assist him with IVS procedures, and in 1994 began to carry out the same himself, initially with the defendant as an assistant.
In 1995 he then presided over a meeting of gynaecologists from which AAVIS was ultimately formed.
Dr Richardson has in the past provided written material in support of the IVS procedure to various Australian medical journals, in letter form and by way of a short report in one case.
After carrying out the IVS procedure he had experienced patients who returned with a complaint of a yellow discharge, the doctor said, at a rate of 7‑8 per cent, although some doctors had a higher rate and others a lower rate.
Treatment of that discharge was by way of removal of the tape, Dr Richardson said, which could "usually" be done as an office procedure.
There was normally a reddened area about the mid‑urethra and the tape sometimes protruded, he said, and up to the material time he had never found it difficult to locate.
Removal was effected by grasping the tape with forceps, pulling down on it, and then cutting it with scissors, Dr Richardson said, although sometimes the tape was not easily removed.
The doctor said he would then give the patient the option of having an operative procedure carried out, and he did not always get all the tape in the office.
He was still carrying out IVS procedures, Dr Richardson said, but with polypropylene tape, and there was no longer any problem with rejection.
In Dr Richardson's view the IVS procedure was superior to the TVT procedure, the latter being something commercially developed by Johnson & Johnson, and which was more dangerous as there was a risk of vascular perforation.
Other evidence
Mrs Collett gave evidence, and said she had known the plaintiff for about nine years and largely supported her version of events at the consultations of 9 June and 28 July 1997, although not completely and although later conceding her memory was not complete, whilst she was unable to remember various things.
As to the letter of consent she said she did recall the defendant making notations, but "5% rejection rate" was not on it when she signed the document.
Nothing was said about any rejection rate, Mrs Collett said, and the defendant said nothing negative about his procedure and spoke only in positive terms about it.
Mrs Collett said that on 28 July she believed they went away to discuss the matter as they were shocked by the defendant's manner.
After the procedure was carried out the plaintiff was in extreme pain, Mrs Collett said, and the following morning she and a nurse had to carry the plaintiff to the lift and then to the defendant's rooms.
On 4 February 1998 it was the case that the defendant had sworn whilst throwing the swab away, Mrs Collett said, and when he referred to the possibility of tape rejection that "really stunned" her.
Ms Carole Yelas has been the defendant's secretary and receptionist for over 12 years, and agreed there was in place a "series of protocols" for the processing of patients.
A patient saw the defendant by appointment, Ms Yelas said, and would have a completed questionnaire or would complete one prior to seeing the defendant, who would then arrange for her return on another day for testing.
Ms Yelas said that unless a patient was accompanied she would be with the defendant when he conducted the initial examination, and he would never be with a patient "on his own".
The defendant said that to 1997 there was no patient he was able to think of where the tape was hard to find, and no case, with nylon tape, where it could not be removed.
Each of Dr Korda and Dr Dwyer is a medical practitioner of undoubted seniority and expertise in the area of urogynaecology, and, subject to the following, I was impressed with each as a witness.
There were some differences between the evidence of Dr Korda and that of Dr Dwyer, principally as to the view of each concerning the degree to which the IVS procedure had been established in 1997, that being something which it is not necessary for me to resolve.
Further, Dr Dwyer was, I felt, inclined at times in his evidence to be gentle in any criticism and to highlight the positive where it was possible to do so, having no doubt some natural sympathy for a colleague.
In the area principally under discussion, that of tape rejection and infection, the differences between the two doctors were not great, and I accept the evidence of Dr Korda and generally accept the evidence of Dr Dwyer in relation to the same.
It is not the evidence of either doctor that the problems associated with an infection resulting from tape rejection ceased to exist when the treating doctor also inserted the tape.
In any event, even if that was so, the need to advise would still exist, albeit with additional advice that a continuation in treatment by that doctor might avoid problems that could otherwise arise.
Nothing turns on the defendant's reference to nylon tape, in the context of the pleadings or conduct of the trial.
Dr Richardson is a Perth colleague of the defendant and has been associated with him in the development and use of the IVS procedure and it is worthy of note that his evidence also is quite inconsistent with the defendant's claim as to his own experiences with tape rejection, unless it be the case that for some reason, never sought to be explained, the defendant has an expertise denied to other expert practitioners in the field.
I cannot rely on the defendant's evidence on the point, apart from his admission that he had had patients who experienced tape rejection and then symptoms as severe as those of the plaintiff.
A reasonable uro‑gynaecologist in the position of the defendant, in my view, would have informed the plaintiff the IVS procedure was not a standard procedure in this State and was not employed by a majority of gynaecologists, that there were alternative procedures available, and that the risks of the proposed surgery included haemorrhage, infection and thrombosis, as well as tape rejection and infection.
In addition to any reference to his own recent rate of tape rejection such a doctor would have spoken about the range of rates in the literature, perhaps 5‑10 per cent as Dr Dwyer suggested, would have explained that an infection was likely to be involved, that apart from a discharge there could be symptoms of pain and a lack of well-being, that although removal in the surgery could be attempted a failure to remove all of the tape was a possibility which could result in a need for an operative procedure, whilst tissue damage and chronic scarring were also other possible adverse outcomes, and that in a small number of such cases the reaction would be intense.
Causation
The elements of a cause of action in negligence are threefold; first, the existence of a duty of care, second, breach of that duty, and third, damage as a consequence of the breach.
Dealing firstly with the question whether there is damage, whatever its cause, it is apparent from the evidence of Dr Yin and Dr Lee that the plaintiff had infection related to the presence of the tape on presentation in February 1998, something acknowledged by the defendant in a later letter, albeit as a tape reaction, and that such was still the cause of her difficulties in October 1998 appears from the referral of Dr Mendelawitz.
Dr Taylor was plainly of a like view at about that time, whilst the plaintiff's presentation to Dr Walters in April 1999, and that doctor's findings at surgery, were consistent with an ongoing tape related infection.
The view of each of Dr Walters and Dr Tsokos is that the plaintiff's ongoing vaginal and related symptoms are referable to the ongoing presence of tape or its aftermath, particularly scarring.
That is consistent with the view of Dr Dwyer as to the possible effects of tape related infection.
I note Dr Dwyer also thought the plaintiff's difficulties related to an infection.
The competing possibility, put forward by the defendant, who of course has not examined the plaintiff for many years, that the plaintiff has a recurrent prolapse, is not supported by the evidence of Dr Tsokos or the report of his most recent examination, where as stated he said the degree of vaginal descent was simply consistent with the plaintiff's history of childbearing and was an unlikely contributor to her symptoms.
Nor is it supported by the plaintiff's history since February 1998 and the views of the examining doctors referred to.
I accept those views and that history, and find on the balance of probabilities that the plaintiff had in February 1998 an infection related to the nylon tape inserted by the defendant on 12 August 1997, and that the infection, and/or its aftermath have persisted since that time and have produced the symptoms complained of by the plaintiff and seen by the various doctors who have examined or treated her.
That injury has brought about the symptoms complained of by the plaintiff.
In relation to recent decisions of the High Court of Australia, causation was not a live issue in Rogers v Whitaker (see Mason CJ, Brennan, Dawson, Toohey and McHugh JJ at 492).
It was in issue in Chappel v Hart (1998) 195 CLR 232, also a medical negligence case, and one in which a patient sought damages from a surgeon who had failed to warn her that throat surgery could result in injury to her voice if there was perforation of the oesophagus and infection.
That occurred, despite due care being exercised, and the plaintiff succeeded on proof that had she been warned of the risk the surgery would have been delayed and she would have sought the most experienced surgeon available. Gaudron J said (238/239):
"It was not disputed in this Court that Dr Chappel was under a duty to inform Mrs Hart of the possible consequences in the event of the perforation of her oesophagus and subsequent infection, including the possibility of damage to her voice. The duty was called into existence because of the foreseeability of that very risk. The duty was not performed and the risk eventuated. Subject to a further question in the case of a duty to provide information, that is often the beginning and the end of an inquiry whether breach of duty materially caused or contributed to the harm suffered. As Dixon J pointed out in Betts v Whittingslowe (1945) 71 CLR 637 at 649, albeit in relation to a statutory duty, 'breach of duty coupled with an accident of the kind that might thereby be caused is enough to justify an inference, in the absence of any sufficient reason to the contrary, that in fact the accident did occur owing to the act or omission amounting to the breach'."
McHugh J, who dissented for reasons it is not here necessary to explore, nonetheless expressed the following view (247):
"The onus of proving that the failure to warn was causally connected with the plaintiff's harm lies on the plaintiff. However, 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 that no causal connection exists."
Gummow J said (257):
"Here, the injury to Mrs Hart occurred within an area of foreseeable risk. In the absence of evidence that the breach had no effect or that the injury would have occurred even if Dr Chappel had warned her of the risk of injury to the laryngeal nerve and of the consequent risk of partial or total voice loss, the breach of duty will be taken to have caused the injury.
In those circumstances the task of Dr Chappel was to demonstrate some good reason for denying to Mrs Hart recovery in respect of injuries which she would not have sustained at his hands but for his failure adequately to advise her."
Kirby J expressed the view (273) that:
"Once a plaintiff demonstrates that a breach of duty has occurred which is closely followed by damage, a prima facie causal connection will have been established. It is then for the defendant to show, by evidence and argument, that the patient should not recover damages."
Hayne J also dissented.
Rosenberg v Percival (2001) 205 CLR 434 also concerned a failure to warn of a possible complication in dental surgery, in circumstances where the trial judge found the plaintiff would have undergone the surgery in any event.
Although the circumstances and history of that matter were such that there was little discussion or reference to Chappel v Hart, it is apparent from the reasons of those judges who did refer to the decision that there had been no challenge to it: see Gummow J 462, 464; Kirby J 466, 486.
Reference ought also be made to Naxakis v Western General Hospital (1999) 197 CLR 269, 278-279.
In Edith Cowan University v Czatryko [2002] WASCA 334, a decision of the Full Court of the Supreme Court of Western Australia, Murray J (with whom Wallwork and Templeman JJ agreed) said (at [15]):
"In my opinion, this was a case where the proper conclusion about causation was that to which the trial Judge effectively came; the failure to warn would be regarded as a material cause of the respondent's injuries unless, the evidentiary onus (at least) being on the appellant, it was able to persuade the court of trial that the respondent probably would not have heeded a warning in either of the forms suggested: Nagle v Rottnest Island Authority (1993) 177 CLR 423; Chappel v Hart (1998) 195 CLR 232; and Rosenberg v Percival (2001) 205 CLR 434."
In Misiani v Welshpool Engineering Pty Ltd [2003] WASC 263 Barker J pointed out (at [159]) that appeal courts in a number of other States have followed the same approach.
I might add that in Lock v Lock [1999] WADC 125 I followed Chappel v Hart on that basis, a decision upheld on appeal: see Lock v Lock [2001] WASCA 20.
In the present case counsel for the defendant referred to Zaltron v Raptis [2001] SASC 209, a decision of the Full Court of the Supreme Court of South Australia, in which Chappel v Hart was followed, and invited me to do the same.
Given the above I have no difficulty in so doing.
It follows the defendant having breached the duty of care owed to the plaintiff, an evidentiary onus falls on the defendant to show that the plaintiff would probably not have heeded a warning in the terms set out.
That test is subjective, that is, the question is whether or not this plaintiff, as opposed to a reasonable person in the position of the plaintiff, would have undergone the procedure regardless.
Nonetheless, the reasonableness of such a claim is not without relevance.
In Rosenberg v Percival Kirby J (205 CLR at 486) cited with approval the following:
" 'When determining whether a reasonable patient would attach significance to a risk, the court should bear in mind that reasonable people accept not insignificant risks on a regular basis, eg, driving cars and playing contact sports.
When deciding whether the patient would have undergone treatment if the risk had been disclosed, the court should assess the plaintiff's testimony carefully. Naturally, the reasonableness of refusing treatment is a consideration here. If a reasonable person would have undergone treatment, regardless of disclosure, then in the absence of personal characteristics or circumstances which would explain a refusal, it must be difficult for a court to conclude that the plaintiff would have rejected the treatment no matter what the plaintiff now genuinely believes that he or she would have done. It should be remembered that causation in other areas of negligence presents similar difficulties, eg would an injured employee have used the safety equipment if his or her employer had provided it?'
(Monks, University of Queensland Law Journal, vol 17 at 233.)"
I have no difficulty in finding that the plaintiff honestly holds the belief claimed.
As to the reasonableness of that, there are a number of matters which might be considered.
First, the seriousness of the plaintiff's condition of stress incontinence, and hence the degree of need for the procedure, is plainly relevant.
It is clear that the condition is one which is common amongst middle aged and older women, particularly those in a parous state ie those who have experienced childbirth.
The plaintiff as stated said she had experienced some symptoms of the condition for many years, with only a marginal increase during that time, described the problem as an "inconvenience", and categorised it as a "2 = mild, no effect on lifestyle", on a scale to 5, in her answer to the defendant's questionnaire.
It is of course the plaintiff's belief as to the seriousness of the condition rather than the objective seriousness of such which is relevant.
The plaintiff had seen the defendant almost 18 months after hearing of his procedure, she said.
Apart from her visit to Dr Atkinson to obtain a referral the plaintiff said she had not otherwise consulted her about the matter.
The defendant on the other hand, as stated, said he considered the plaintiff had a severe problem, and she was happy to hear there was hope.
I have already said that I generally prefer the plaintiff's version of what passed between them, and that extends to this topic.
The plaintiff, I find, was not of the view that her condition of stress incontinence was other than as stated by her at any time prior to the procedure being carried out.
Similarly, it follows from the finding already made that the plaintiff also had the belief stated by her, that the defendant's proposed procedure was very straightforward and simple, whilst she was unaware of other mainstream procedures, or of any risk of infection or other morbidity associated with tape rejection arising from the defendant's procedure, including the risk of an unusually severe reaction to tape rejection.
The defendant was of course one of a small minority of medical practitioners engaged in carrying out his procedure.
The question of what a reasonable person might do given a particular set of circumstances is not one which necessarily admits of a single answer.
I consider, given the above, a reasonable person in the position of the plaintiff, once given appropriate advice, might easily have acted as the plaintiff said she would have done had the defendant given her such advice, thought about it some more, returned to her general practitioner, and obtained other advice, and possibly turned to another form of treatment.
Had that occurred and the procedure not taken place at all, or had it even been postponed, on balance the plaintiff would have been unlikely to experience an infection as a consequence of tape rejection.
Given the plaintiff's assertion, and the foregoing, I find the plaintiff would not then have proceeded with the defendant's surgery, and would not have suffered injury.
Whether one adopts the reversal of an evidentiary onus approach or not the plaintiff in my view is able to establish the defendant's breach of duty caused any injury suffered by her as a result of the procedure carried out by him: and see Rosenberg 464‑465 Gummow J.
Contributory negligence
The defendant pleads that when it was possible the plaintiff was suffering from tape rejection she failed to return to the defendant "who had informed her of the need to do so and of the appropriate treatment", and that she engaged other medical advisers and "failed to inform them correctly of the nature and effect of the … operation … and the treatment administered and the advice given to her by the defendant".
Had the plaintiff followed his advice "any complications of his surgery would have been negligible", the defendant also pleads.
It might be observed that the second allegation is contrary to the defendant's own admission made in evidence previously referred to.
As to the first, and also as I have already pointed out, it was not said by the defendant that he informed the plaintiff that it was important that he deal with any post‑operative complication.
Further, not only was the defendant's letter to the plaintiff of 26 April 1998 silent as to that, but the defendant stated that Dr Yin had been informed by him as to how the tape might be removed.
The plaintiff had of course ceased to see the defendant only as a result of his behaviour towards her on 4 February 1998.
The obligation of a person in the position of the plaintiff was to take reasonable care of her own safety.
The plaintiff did not fail in that respect.
Assessment of damages
The plaintiff gave further evidence in relation to her claim, and said that between 1990 and 1995 she and her husband owned retail toy stores.
In January 1995, and after a "fortuitous" lottery win they ceased work for "a couple of years", resuming to commence the lawnmowing and landscaping business, she said.
The plaintiff later agreed she had also had some problems arising from a motor vehicle accident in July 1995, including back problems.
Following the procedure carried out by the defendant in August 1997 the plaintiff was unable to physically work very much in the lawnmowing and landscaping business, she said, and it then dropped off somewhat.
She later said she had worked off and on, doing quotes, some gardening and landscaping jobs and the books, but found in February 1998 she was not well enough to work.
In relation to the business she had commenced with Mrs Collett, they had been "just getting a foothold" in the eco tourism market, but after the procedure she was unable to "put time" into that either, the business involving physical activity, and as a result programmes had had to be cancelled due to her uncertain availability, so that the business was closed on 30 June 1998, the plaintiff said.
Her employment with the ACTIV Foundation began in August 2000, the plaintiff said, and involved the maintenance and care of a facility for three severely disabled people, for which she was paid about $35,500 gross per annum.
In February 1998 her three sons were aged respectively 17, 15 and 13 years, the plaintiff said, and lived with her and her husband at their home in Kardinya.
The plaintiff had been, she said, the home manager, and after February 1998 was unavailable for her family or her businesses.
As a consequence assistance was provided by Mrs Collett, Mrs Patricia Leah‑Shewsbury, and Ms Bernadette Cranfield.
Mrs Collett assisted from January 1998 until April to June 2000, for an average of 7‑10 hours per fortnight, the plaintiff said, and would stay with the family when the plaintiff was unwell and take the plaintiff to appointments, care for the boys, cook meals, walk the dog, do ironing, attend to beds and do general domestic work.
Mrs Leah‑Shewsbury provided assistance for about 23 months from July 1998, the plaintiff said, that amounting to 3½ to 4 hours every three weeks, and involving the provision of transport for the plaintiff's children, picking up shopping and hanging out washing.
The plaintiff said that Ms Cranfield, who had two children attending the same school as those of the plaintiff, assisted with school transport for a "couple" of years from the start of 1998, for about three hours per fortnight, collected foodstuffs, medicine and the like when required, and on occasion brought in washing or vacuumed.
The children also assisted with domestic work, the plaintiff said, whilst the plaintiff's husband, in addition to working longer hours in the business, did more domestic work than hitherto.
Mr John Hall, the plaintiff's husband, said that prior to the procedure in August 1997 the plaintiff had had "an amazing amount of energy", but following the procedure, and initial pain, which seemed to settle after a few months, appeared to become very ill, was unable to do simple jobs, and sometimes spent all day in bed.
As a result he had to take time for taking the children to school, taking washing off the line, cleaning the house and preparing meals, Mr Hall said, although Mrs Collett would help when there.
Mr Hall said that the plaintiff also changed, and became quite distant to her family.
She also spent time at the winery and restaurant property Mrs Collett and her husband owned at Nannup, he said.
The plaintiff had worked with him in the lawnmowing work in the business, Mr Hall said, did quoting for that when he was busy, kept the books, did the customer contact, arranged new parts or equipment, and did some garden "makeovers", the division of work being about 60‑40 in his favour.
He said the plaintiff's work activities ceased after the operation.
From the commencement of the business on 1 July 1996 to the time of the operation it had developed fairly well, Mr Hall said.
Mrs Collett also expressed the view that prior to August 1997 the plaintiff had always been full of life, and was a very fit and strong woman, having been a State athletic, whereas that was not the case afterwards.
Over a two year period from January/February 1998 she assisted with housework, washing, shopping, cooking, school or medical appointment transport, and the like, Mrs Collett said, for three or four days at different times when in Perth.
The eco tourism business the two started in February 1996 had been aimed at a niche market for women only travelling, based on her involvement in the tourist industry for some years, and the availability of accommodation and the restaurant that she had, and the Cape Leveque trip involved a party of 16 women, whilst the two had also gone to India and Thailand to research tours to those places, had a business plan, and had a data base of customers, many of whom were repeat business, Mrs Collett said.
The difficulties arising from the plaintiff's health after the operation resulted, she said, in the closure of the business.
I generally accept the evidence of the plaintiff, and also that of Mr Hall and Mrs Collett as to the above matters, none of which was seriously challenged, as I do the evidence of the treating doctors including Dr Atkinson, Dr Lee, Dr Yin, Dr Walters, Dr Taylor and Dr Tsokos.
I have already found that the plaintiff suffered an infection as a result of the insertion of the nylon sling or tape by the defendant on 12 August 1997.
The injury to the plaintiff has been significant, and one which has had a substantial effect on her life, and in accordance with the views of Dr Tsokos I find that she is likely to experience symptoms related to it over the long term.
The only treatment available to the plaintiff would appear to be conservative management.
The heads of damage which are relevant and my findings in relation to the same are then as follows:
General damages
A reasonable allowance for pain and suffering, loss of enjoyment of life and loss of amenities would be $50,000.
Past loss of economic capacity
The plaintiff, in a schedule dated 18 August 2003 claimed $76,880, for a loss of the "current average weekly wage of $620" for 124 weeks, it being said that the plaintiff was unable to work between February 1998 and approximately 10 July 2000.
I accept the plaintiff was not able to work and will adopt the period of 124 weeks sought, that being slightly less than the evidence might on a competing view suggest.
The plaintiff's net weekly income is in fact valued at $624.70, according to a letter from the ACTIV Foundation Inc.
The plaintiff would have been unlikely to have earned that level of income in 1998, however, given the progress and profitability of the businesses revealed by the tax returns.
I accept that each of the two businesses was in its infancy, was expanding, and had good prospects, and that it was likely that the plaintiff would have benefited from the work she would have done in each.
The plaintiff's income would probably have increased over the period, but precision is not possible, and only a reasonable average income can be utilised.
Doing the best I can I assess the plaintiff's average net weekly loss for the period as one of $300, which results in a total of $37,200.
I note that although a claim was made for loss of wages for following the September 2003 surgical procedure nothing was put forward to indicate there had been such a loss.
Interest on past loss of economic capacity
The plaintiff claims interest at the rate of 6 per cent per annum on the whole of any loss, and without specifying any particular period.
I would allow interest at 3 per cent for the period of 124 weeks on $37,200, and at 6 per cent from 1 August 2000 for 3.825 years, and a total of $11,199 is derived.
Future loss of economic capacity
The plaintiff claimed a loss based on the possibility of an absence from employment each year of three days to age 65 years as a result of a flare‑up of symptoms, and that would appear reasonable.
The net value of the lost days is $375 per annum, or $7.20 per week, and a reasonable multiplier 616, which produces an amount of $4,435, and after a deduction of 5 per cent is made for contingencies a loss of $4,213 is derived.
Past medical expenses
The plaintiff seeks $724 for the claim to costs of various naturopathic remedies, but in the absence of support in the medical evidence I would not allow that, or the amount sought for attendances on the naturopath.
A claim is also made for $4,050, the total cost of attendances and the like on various medical practitioners, including the defendant, identified by the plaintiff as being in connection with the procedure, and I allow that, having regard to the evidence.
Future medical expenses
Given the likely continuance of the plaintiff's symptoms, it now being over six years since such appeared, and in the light of the relevant medical evidence, there is a likelihood that the plaintiff will require medical assistance in the future, and will incur expense in meeting that need.
Only a broad estimate is possible, and I allow $5,000.
Past gratuitous services
It follows from my acceptance of the evidence of the plaintiff and other witnesses that I accept that the plaintiff had a need for assistance at various times.
The hourly rate for any services provided under this head was agreed, I was informed, at $21.50.
Complaint was made by the defendant in his written closing submissions that the evidence did not indicate which services might have been provided prior to the plaintiff's injury.
Although that would be relevant to a claim the subject of statutory modification it was not suggested that is the case here, and at common law the fact that an injured plaintiff has a need for services which had previously been voluntarily provided does not ordinarily result in any reduction of damages: Van Gervan v Fenton (1992) 175 CLR 327, 337‑338 Mason CJ, Toohey and McHugh JJ.
Of greater import is the fact that no real attempt was made in the evidence to distinguish between the provision of services to the plaintiff, and the provision of services to the four other family members required to replace the services previously provided to them by the plaintiff, beyond the description of various activities, something counsel for the plaintiff acknowledged in his closing address.
On the other hand it is the case that there was no challenge to the evidence when given and no comment about it at the conclusion of the trial beyond that referred to, counsel for the defendant in fact not speaking on the topic of the plaintiff's damages at all beyond an allusion to the existence of the written submissions.
The submissions in turn make scant reference to damages.
There is of course often an overlap between the services provided for the benefit of one family member and those which benefit all such as to make any attempt at division somewhat artificial.
In the absence of any suggestion that the plaintiff's schedule misrepresents the evidence as to the work said to have been done by the various actors I adopt the relevant calculations in it.
Again doing the best I can, I would apportion 50 per cent of the services provided to the plaintiff's need created by the procedure and its aftermath, and allow $24,134.
Future gratuitous services
I would not make any separate allowance under this head.
Past travel expenses
There is some overlap between this head and the allowance for past gratuitous services, given the evidence, whilst there would seem no reason why the plaintiff could not have consulted a Bunbury general practitioner after her move there.
I allow $500 for other visits and for any necessary visits to specialists from Bunbury.
In summary, the allowance for each head of damage is:
General damages $ 50,000
Past loss of economic capacity $ 37,200
Interest on past loss of economic capacity $ 11, 199
Future loss of economic capacity $ 4,213
Past medical expenses $ 4,050
Future medical expenses $ 5,000
Past gratuitous services $ 24,134
Future gratuitous services $ Nil
Past travelling expenses $ 500
$136,296
Conclusion
The plaintiff is entitled to judgment against the defendant in the sum of $136,296.
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