An Inquest taken on behalf of our Sovereign Lady the Queen at Adelaide  in the State of South Australia, on the23rd, 24th, 27th and 28th days of April, 1998, 22nd day of May 1998 and 19th day May 2000 , before Wayne Cromwell Chivell, a Coroner for the said State, concerning the death of Brenda Isabel Sowik.

1. Application to re-open inquest

1.1 Following publication of my findings on 22 May 1998 I received further evidence in the form of a letter dated 11 March 1999 from Professor Thierry Vancaillie, Head of the Department of Endogynaecology at the Royal Hospital for Women in Sydney. Professor Vancaillie had been retained after the inquest to provide advice to Mr. Sowik’s solicitors, Angela Bentley & Co., in connection with civil proceedings. In that letter, Professor Vancaillie advised me that he is clearly of the opinion that the primary trocar, and not the Verres needle, was the instrument which caused the damage to Mrs. Sowik’s right iliac artery. He said:-

"I had the opportunity to examine the photographs mentioned in Dr. James’ report. It is beyond doubt, after thorough examination of these photographs, that the vascular injury was due to a triangular tipped trocar and not due to a bevelled Verres needle. This opinion is based upon the fact that the injury to the anterior wall of the vessel has a stellate appearance which is most markedly seen when the vessel is cut open. In addition, the imprint on the posterior wall is markedly seen when the vessel is cut open. In addition, the imprint on the posterior wall is pin-point. A triangular tipped trocar pushed onto a tubular structure would indeed make a stellate imprint on the anterior wall and a punctate imprint on the posterior wall when that tubular structure is positioned against a hard structure, as is the case for the iliac vessels running anterior to the pelvic bone structures".

1.2 In a report to Angela Bentley & Co. dated 15 July 1998, Professor Vancaillie identified further factors which he said supported his conclusion. These factors were:-

"• The recollection by everyone present at the time of occurrence indicates that the vascular collapse was sudden and coincided with the insertion of the laparoscope into the abdominal cavity; that means immediately after insertion of the umbilical trocar.

• The amount of blood loss appears to be rapid, more so than would be expected from a simple needle puncture. The stellate, i.e. three small confluent incisions made by the tip of the Trocar, cause a relatively large defect which could explain the rate of blood loss observed.

• The few descriptions of the ureteric injury failed to indicate that the injury was transfixing as would be expected if the Verres needle had injured both the ureter and the artery.

It is difficult to accept that a Gynaecologist, whether experienced or not in laparoscopic techniques, would insert a Verres needle through the rectus fascia, through the parietal peritoneum, through the posterior peritoneum, through the anterior wall of the ureter, through the posterior wall of the ureter, through the anterior wall of the iliac artery, through the posterior wall of the iliac artery and beyond and not realise that this was not right.

 

The Verres needle is alleged to have been passed through the anterior wall of the iliac artery and the posterior wall of the iliac artery which are separated by approximately one centimetre. It takes, even in the most expert hands, some time for the Verres needle to be mechanically pushed forward through those two walls. It is said in the affidavit by Dr. Scroggs that the Verres needle was inserted in the open position. It is known that the blood pressure of the patient was normal at the time the procedure was started. Although I do not have any nominal figures, I assume that the systolic blood pressure in the patient was at least 100mm of mercury. Assuming that the Verres needle was passed beyond the anterior wall of the iliac artery in the open position, it would literally take milliseconds for a spurt of blood to come out the open end of the Verres needle and literally reach the ceiling of the theatre.

 

Conclusion

The objective and subjective findings overwhelmingly point toward a vascular injury caused by insertion of an umbilical Trocar. It should also be noted that the Trocar used in the case was brand new and most likely a lot sharper than expected and it may have gone in a lot faster and further than Dr. Scroggs had anticipated".

 

1.3 Professor Vancaillie’s opinion was supported by Dr. O.M. Petrucco, Senior Lecturer in Obstetrics and Gynaecology at the University of Adelaide, in a letter to me dated 28 July 1999. Dr. Petrucco pointed out that, on the basis of my earlier findings, the Medical Board of South Australia had issued a warning to the medical profession.

1.4 Dr. A.R. Clarkson, the President of the Medical Board of South Australia, wrote to me on 2 December 1999 confirming this. Dr. Clarkson informed me that he also agreed with Professor Vancaillie’s opinion, and that he was concerned that my findings had been "mirrored" by the Board to the medical profession. However, the warning issued by the Board in its newsletter was general in its terms, and did not rely upon the finding as to whether the Verres needle or the primary trocar was responsible for Mrs. Sowik’s injury.

1.5 I asked Dr. R.A. James, forensic pathologist who supplied an opinion at the first hearing of the inquest, to comment upon Professor Vancaillie’s report, and he replied by letter dated 13 April 1999. Dr. James did not dispute Professor Vancaillie’s views. He said:-

"Apart from identifying the injury and recording it with photographs I have no particular view as to which instrument was causally responsible. I have never used them".

 

1.6 In view of the requests by Professor Vancaillie and Dr. Petrucco that the inquest be re-opened to further examine this issue, I sent copies of Professor Vancaillie’s reports, Dr. Petrucco’s letter and Dr. James’ letter to the solicitors for all the parties given leave to appear at the inquest. I sought advice as to their client’s attitude to a re-opening of the inquest. A re-opening was not opposed by the hospital, or by Mr. Sowik. I received no reply on behalf of Doctors Brooks and Lynch. The solicitors for Dr. Scroggs opposed a re-opening, saying:-

"It was Dr. Scroggs’ view that the coronial findings, Inquest File No. 2336/95 whilst noted by the medical profession had not affected the use of the Verres needle. It was also noted that your findings were made with some hesitation and Dr. Scroggs does not believe it is in the public’s interest and the medical community to reopen the inquest. In his view, if there are any clinical issues involved in the use of the Verres needle, the College of Obstetricians and Gynaecologists is the appropriate body to take up such issues.

 

Dr. Scroggs would therefore request most strongly that you not reopen the inquest as to do so would be to reopen much sadness and grief for Dr. Scroggs and presumably the Sowik family".

 

1.7 Section 28 of the Coroners Act, 1975 (S.A.), provides:-

"(1) A coroner has a discretion to re-open an inquest at any time.

...

(3) Where an inquest is re-opened, the coroner may -

(a) confirm any previous finding;

(b) set aside any previous finding;

(c) make a fresh finding that appears justified by the evidence."

 

1.8 In view of the concern expressed by Professor Vancaillie and Doctors Petrucco and Clarkson, and in case the medical profession has been misled by my earlier finding, which I am satisfied was made in error, I have decided to re-open the inquest. I have circulated a draft of this "fresh" finding, as described by Section 28(3)(c) of the Coroners Act to all parties, and they have indicated that they do not wish to have any further oral evidence called. In particular, Dr. Scroggs does not wish to challenge the evidence of Professor Vancaillie.

1.9 I therefore make the following orders:-

(1) Inquest re-opened pursuant to Section 28(1) of the Coroners Act (1975) S.A.;

 

(2) The following documents will be received into evidence and marked:

• C.26: letter from Professor Thierry Vancaillie dated 11 March 1999;

 

• C.26a: copy letter from Professor Vancaillie to Angela Bentley & Associates dated 17 July 1998;

 

• C.26b: copy opinion of Professor Vancaillie dated 15 July 1998;

 

• C.27: letter from Dr. R.A. James dated 13 April 1999;

 

• C.28: letter from Dr. O.M. Petrucco dated 28 July 1999;

 

• C.29: letter from Mouldens Solicitors dated 24 September 1999;

 

• C.30: letter from Wallmans Solicitors dated 30 September 1999;

 

• C.31: letter from Angela Bentley & Associates dated 30 November 1999;

 

• C.32: letter from Dr. R.A. Clarkson dated 2 December 1999 with enclosure (copy newsletter).

 

On the basis of that evidence I set aside the finding I delivered on 22 May 1998 herein, and I make the findings which follow as to the circumstances of Mrs. Sowik’s death.

2. Background

2.1 Mrs. Brenda Isabel Sowik was born on 15 October 1959. On 19 December 1995 she was 36 years old. She was married with two children.

2.2 Mrs. Sowik consulted her general practitioner, Dr. Brian Lynch, in August of 1995 complaining of heavy and painful periods and intermenstrual bleeding. Dr. Lynch prescribed hormonal medication and arranged for an ultrasound examination to be performed, which disclosed the presence of a 3.6cm fibroid on Mrs. Sowik’s uterus. He referred her to Dr. Steven Scroggs, an obstetrician and gynaecologist, who consulted from time to time at Victor Harbor.

2.3 Dr. Scroggs first saw Mrs. Sowik on 11 October 1995. He recommended that a preliminary investigation, in the form of a dilatation and curettage (D & C) and hysteroscopy, be performed, and these procedures were carried out at the Womens and Childrens Hospital.

2.4 Following these investigations, Dr. Scroggs made a diagnosis of dysfunctional uterine bleeding and recommended a laparoscopically assisted vaginal hysterectomy ("LAVH"). Mrs Sowik accepted this advice. Without canvassing the medical evidence in detail, the expert opinions before me at the inquest were unanimous that the procedure was appropriate in the circumstances (see the reports of Dr. Petrucco (Exhibit C.25), and Dr. Michael Cooper (Exhibit C.23) ).

3. The Operation

3.1 The LAVH was arranged for 19 December 1995. The evidence is clear that Mrs. Sowik agreed to have the operation performed at the South Coast District Hospital. She was employed there as an Enrolled Nurse and had assisted in surgery on many occasions. She specifically asked Registered Nurse Fern Hughes to perform the duties of scrub nurse during the operation. It is also clear that Mrs. Sowik understood the procedure to be performed, since she had worked in the operating theatre when Dr. Scroggs had performed a similar operation previously.

3.2 Dr. Lynch assisted Dr. Scroggs at the operation, and the anaesthetic was performed by Dr. Stephen Brooks, a partner of Dr. Lynch, and an experienced General Practitioner-Anaesthetist.

3.3 The anaesthetic commenced at 2.25 p.m., and although Dr. Brooks encountered an initial difficulty with intubation, this was overcome with the use of an instrument known as a Bougie, and the anaesthetic proceeded uneventfully in the initial stages.

3.4 Dr. Scroggs commenced the operation by preparing the relevant areas with Betadine and ensuring that Mrs. Sowik was correctly positioned on the operating table in the lithotomy position (T.224). He then made a small incision in the umbilicus. He did not have a detailed recollection of the initial stages of the operation, but he described the usual procedure as follows:-

• after a check that all the appropriate equipment is present and operating correctly, an incision is made in and immediately below the umbilicus (T.228);

• while the umbilicus is stabilised by either using traction against the skin above the umbilicus, or by grasping and lifting the skin below the umbilicus, an instrument known as a Verres needle is introduced through the incision and then through two layers of muscle (the anterior and posterior rectus sheath), and then through the peritoneum into the peritoneal cavity;

 

• once the needle is within the peritoneal cavity, carbon dioxide (CO2) gas is pumped through it in order to inflate the peritoneal cavity and provide a space in which the surgeon may operate (this process is known as "insufflation");

 

• once the cavity has been insufflated (known as "pneumo peritoneum"), the Verres needle is withdrawn and a trocar and cannula are then introduced into the peritoneal cavity. The cannula is a cylindrical tube within which the trocar, a piercing instrument, is placed. I will refer to this as the "primary trocar";

 

• once in position, the trocar is withdrawn leaving the cannula in place. A laparoscope (an instrument containing a light source and a camera) is then placed into the peritoneal cavity through the cannula. When the laparoscope is connected to the relevant equipment, the space within the peritoneal cavity may be visualised by the surgeon on a television monitor;

 

• once the camera is operational, a second trocar and cannula are introduced into the peritoneal cavity at a point on the right-hand side in the lower abdominal area. I will refer to this as "the second trocar";

 

• depending on the nature of the operation, a further trocar may be inserted on the patient’s left-hand side, but as this stage was not reached in Mrs. Sowik’s case, I will not discuss that further.

 

3.5 Dr. Scroggs said that there was some initial difficulty with insufflation, in that the gas was not flowing. He withdrew the needle between one and two centimetres. This apparently removed the obstruction, and the insufflation process continued normally (T.238). Dr. Scroggs said:-

"In retrospect I can say that the tip of the needle must have passed through the iliac vessel and was on the other side of it, and in an extraperitoneal position, therefore there was tissue around it blocking the end off and raising the pressure".

(T.263)

3.6 When he first inserted the laparoscope, Dr. Scroggs said that he noticed some blood emanating from the pelvic area. He said that it was mainly on the right-hand side of the uterus, and it was dark blood which, he said, "is indicative that it hadn’t just come out of a vessel, that it has been there a short period of time" (T.241). Dr. Scroggs’ initial reaction was that this did not appear "catastrophic" and that it was possibly the result of an ectopic pregnancy, a ruptured cyst or endometriosis (T.242).

3.7 The point at which blood was first seen to be present in the peritoneal cavity is of crucial importance in this case. Dr. Scroggs was insistent that he noticed the presence of blood before he inserted the second trocar (T.242-3). Dr. Lynch supported Dr. Scrogg’s evidence in this regard. In his record of interview with Senior Constable P.C. Gross, Dr. Lynch said:-

"A second trocar was inserted into the right flank. When the camera was connected, blood was noted in the abdomen. Dr. Scroggs said words to the effect that that there was not very much there and it seemed dark in colour."

(Exhibit C.19, p5)

This evidence could be interpreted as suggesting that the camera was not connected until after the second trocar was introduced, which would have been highly irregular. Dr. Lynch said that his evidence should not be interpreted that way. He confirmed in oral evidence that the camera was inserted before the second trocar was introduced (T.167). Ms Hughes, the scrub nurse at the operation, also confirmed that the blood was noted prior to the insertion of the second trocar (T.17).

3.8 On this basis, the second trocar may be discounted as the cause of the damage to the right iliac artery, even though it was inserted at a point much closer to the location of the damage than the other instruments.

3.9 Dr. Scroggs said that he inserted the second trocar with the intention of attempting to locate the source of the bleeding laparoscopically in the hope that it could be dealt with that way. He was unsuccessful in locating the source of the bleeding and so he decided to proceed to laparotomy (an open incision in the abdomen) (T.244).

3.10 At about this time (it is not clear whether before or after Dr. Scroggs commenced the laparotomy), Dr. Brooks noted that there had been a fall in the "end tidal CO2" level as indicated on a capnograph. He also noted that Mrs. Sowik no longer had a recordable blood pressure. He said that this occurred at about 3.00 p.m. He described what happened as follows:-

"At that stage, there is an obvious incident which occurred. Her CO2 was noted to be low, the patient looked pale. I felt for her peripheral radial pulse, it was absent. I felt for the patient’s brachial pulse, it was absent. I tried to do blood pressure on the automatic blood pressure machine, at the same time feeling for the carotid pulse. The carotid pulse is felt in the side of the neck. That was present and it timed with her ECG monitor which was on at 110 beats; 100-110 beats a minute. So that confirmed that she had a carotid pulse, indicating that she had cerebral perfusion, however, the automatic blood pressure machine could not detect the blood pressure. I then proceeded to take her blood pressure manually. This was not able to be obtained. The patient was commenced on 100% oxygen, intravenous fluids were increased. I believe I put the head in the downward tilt and I notified the surgeon that her CO2 was low".

(T.120)

 

3.11 By this time it was apparent that Mrs. Sowik’s condition had deteriorated to a serious extent.

3.12 The laparotomy incision made by Dr. Scroggs was described as a "low transverse incision" which he described as an incision across the patient’s lower abdomen at a point two-fingers breadth above the symphysis pubis (T.245). The location of this incision was criticised by a number of the expert witnesses who gave evidence. I will deal with this issue again later.

3.13 Having performed the incision, Dr. Scroggs sighted what he described as a haematoma, or a collection of blood, outside the peritoneum. It would seem that some of the blood had seeped through a hole that Dr. Scroggs had noticed earlier and that this was the blood he thought was "old blood". When he incised the haematoma, it was readily apparent that Mrs. Sowik was suffering what Dr. Scroggs described as a "torrential haemorrhage", and that an artery rather than a vein had been damaged (T.245).

3.14 Dr. Scroggs attempted to stem the bleeding by the application of a large surgical pack to the general area, and by applying manual pressure. He said that although he was successful to some degree in reducing the blood loss, it remained "moderate" (T.247).

3.15 Ms Hughes said that Dr. Scroggs asked for the name of the vascular surgeon who consults at Victor Harbor. When informed that this was Dr. Larry Ferguson, Dr. Scroggs asked that he be contacted (T.19). Dr. Ferguson spoke to Dr. Lynch. Dr. Lynch has noted the time at about 3.10 p.m. (T.185). Dr. Ferguson clearly understood from his conversation with Dr. Lynch that Mrs. Sowik had suffered a serious haemorrhage, that she was too ill to transfer to a major hospital and that Dr. Scroggs was trying to stem the bleeding with pressure (T.188).

3.16 Dr. Ferguson travelled from his home to St Andrews Hospital where he collected his instruments, and then drove to Victor Harbor in his own car. Having encountered traffic on the way, he did not arrive until just before 5.00p.m.

3.17 At around the same time, Dr. Brooks telephoned Flinders Medical Centre and called for the assistance of a retrieval team. He said that he made the call at between 3.15 and 3.20 p.m. (T.123). There is a disagreement between Dr. Brooks and Dr. Andrew Bersten, a Senior Intensive Care Specialist at Flinders Medical Centre, about whether Dr. Brooks spoke initially to Dr. Bersten or to Dr. David Frankel, a Registrar in the same unit. Although Dr. Bersten said that he did not have the impression that Mrs. Sowik was haemorrhaging (T.83), there were subsequent telephone conversations between Dr. Frankel and Dr. Brooks in which this was made clear. Counsel were agreed that nothing turned on this issue, since it did not affect the outcome.

3.18 A difficulty was then experienced in relation to transport of the retrieval team to Victor Harbor. Although it was intended that Dr. Frankel and his crew would initially travel there in the "Rescue 1" helicopter, this became unavailable because a serious road accident had occurred near Cowell on Eyre Peninsula, and that helicopter was required to evacuate a seriously injured child. Tragically, the child later died. The second helicopter, "Rescue 2", was arranged, and a back-up pilot was called in before the retrieval team could travel to Victor Harbor. This resulted in some delay (see the evidence of Dr. Bersten, T.111). The records indicate that the helicopter left the Flinders Medical Centre at 4.15 p.m., and arrived at the South Coast District Hospital at about 4.45 p.m. (This is reported in the case notes, Exhibit C.18). As things transpired, Dr. Frankel and his team arrived at about the same time Dr. Ferguson did.

3.19 In the meantime, Doctors Scroggs, Lynch and Brooks were attempting to stem the haemorrhage and to transfuse blood and other fluids into Mrs. Sowik in an attempt to keep her alive until Dr. Ferguson’s arrival. A total of 18 units of blood, 16 units of Haemaccel, and 9 units of other fluids were used during this process. This is a very large transfusion, about eight times Mrs.. Sowik’s usual blood volume. Remarkably, the doctors were able to maintain Mrs. Sowik’s blood pressure at a reasonably stable level throughout. In particular, they were able to maintain her carotid pulse which was of critical importance in the avoidance of brain damage.

3.20 Once Dr. Ferguson arrived, he performed a vertical midline incision, located the source of the bleeding, clamped the aorta and the two iliac arteries below the damage, and then repaired the damage by the insertion of two sutures. The notes record that the aorta was clamped at 5.10p.m. Dr. Ferguson said that the hole was between five and ten millimetres in size, about the size of his little finger (See Exhibit C.20, p6).

3.21 Dr. Ferguson described the repair operation as "extremely difficult" (T.191). He said that it took between twenty minutes to half an hour to reveal the site of the damage (T.193). He then described his operation as follows:-

". . . most of the blood coming out of the hole of the artery is coming from the top, coming down. But, there is also bleeding coming back up because, when you clamp an artery, blood comes both ways. It comes mainly down but, also there is back-bleeding. But these two branches you refer to (the external and internal iliac arteries) one going down the leg and one down the pelvis, they were back-bleeding as well. So, having controlled the top, which controlled most bleeding, we then had to control the two vessels below and that takes more time - that is difficult to do".

(T.193)

3.22 When Dr. Ferguson released the aortic clamp, he noted further bleeding, and located the other hole on the underside of the right iliac artery. He inserted a further suture in the underside, and when the clamp was released again, the bleeding had ceased.

3.23 At about the same time, Dr. Ferguson noted that the ureter (the tube which connects the kidney to the bladder) had been damaged and so he repaired that as well.

3.24 Dr. Ferguson then proceeded to close the wound, having removed all of the surgical equipment, and had almost completed that process when Mrs. Sowik suffered a further drop in blood pressure. This is recorded in the case notes as having occurred at 5.55 p.m. Dr. Ferguson re-opened the wound, and established that no further bleeding had occurred.

3.25 Despite frantic attempts to resuscitate her, including the provision of adrenalin and the use of defibrillation equipment, Mrs.. Sowik’s normal heart rhythm could not be restored and she was pronounced deceased at 7.12 p.m.

3.26 Dr. Ferguson explained the process which resulted in Mrs. Sowik’s death as follows:-

"When the vessel has been blocked, the tissue beyond there has been deprived of blood. . . . in this case, the leg and top of the pelvic organs. And, while they are deprived of blood, lots of toxic substances build up in the leg and then, when the blood supply is restored, those toxic substances are brought back into circulation and they can be quite deleterious to the heart . . . that is a major concern we have in our vascular surgery when we have to remove the clamps from the aorta. We are always very concerned at that time that the patient might suffer a heart attack or a cardiac episode, much more so than when we put the clamps on, when we take the clamps off".

(T.195-6)

Dr. James offered a similar explanation (T.68).

4. Issues arising at the inquest

4.1 How was the right iliac artery damaged?

4.1.1 At the post mortem, Dr. James noted that the artery had been "transfixed" front to back, at a point above and very close to where the artery bifurcates into the right external iliac and the right internal iliac arteries (T.62). The hole in the outside wall of the artery was larger than it was on the interior surface (T.69). Dr. James said that, in his opinion, the size of the hole on the interior surface (about two millimetres) gives a better indication of the size of the penetrating instrument (T.75). This evidence is in favour of the proposition that the Verres needle, rather than the primary trocar, did the damage.

4.1.2 The preponderance of medical opinion is in favour of this proposition - see the evidence of Dr. Scroggs (T.261), Dr. Lynch (T.180), and, by implication, Dr. Ferguson (T.210-11), Professor Jamieson (Exhibit C.24), and Dr. Petrucco (Exhibit C.25).

4.1.3 Dr. Michael Cooper was a dissentient from this view, saying that he found it "difficult to imagine if not impossible to imagine" that the Verres needle caused the injury (T.327), having regard to the size of the hole described by Dr. James and Dr. Ferguson.

4.1.4 I have already outlined Professor Vancaillie’s views on this topic, supported as they are by Dr. Petrucco. Taking into account Dr. James’ comments, I find that Dr. Scroggs ruptured Mrs.. Sowik’s right iliac artery with the primary trocar in the early stages of the operation.

 

4.1.5 Was there surgical error or merely misadventure?

Dr. Scroggs openly admits that a surgical error has occurred. He said, when asked about a conversation he had with the husband of the deceased after the operation but before Mrs. Sowik had died:-

"He asked me had I made a mistake, and very clearly I had . . ."

(T.251).

In relation to that conversation, Mr. Sowik made detailed notes the following morning, and his version of the conversation, which was not contradicted by Dr. Scroggs is as follows:-

"Scroggs explained he had punctured the aorta and that it was about five minutes before that was realised. He indicated the needle had passed through the artery and into the ureter and that that was why there were no tell-tale signs of blood back through the instrument. He had then made an incision across the tummy, like for a caesarean to locate the bleeding, and said that he had then followed the standard procedure for bleeding; that is applied pressure until the vascular surgeon arrived. He said that he had to apply this pressure with his hand and then corrected himself and said fist, for nearly two hours. He said that they had not lost blood pressure to the brain and that all signs were there, that there had not been blood flow problems to the brain. I asked how it came to be that he had hit an artery. He replied he had found the needle went in at an odd angle, but that he did not think it would be a problem. I asked him have you made a mistake. He replied, yes, there was an error of judgment on my part, the angle of insertion was unusual, the needle deviated but we didn’t realise there was a problem until some time after".

(T.307)

4.1.6 When questioned about this conversation, Dr. Scroggs did not specifically admit that Mr. Sowik’s version was a verbatim account of the conversation, and in particular did not recall using the words "error of judgment" (T.280-1). Dr. Scroggs was at pains to point out that if he did say to Mr. Sowik that "the needle went in at an odd angle but we did not think it would be a problem", he did not mean to imply that he was aware of the fact that the needle went in at an odd angle at the time it was inserted. He said:-

"It implies that I recognised when the needle was inserted that I put it in at an odd angle and I deny recognising that at any stage".

(T.287)

 

4.1.7 This discussion is clearly predicated on Dr. Scroggs’ belief that the damage was done by the Verres needle, and not the primary trocar.

4.1.8 Regardless of which instrument caused the damage, the fact remains that it was inserted at the wrong angle. The evidence of Dr. James was that the point where the artery was damaged was situated between five and six centimetres to one side of the midline (T.63), which was where the instrument should have been directed. Dr. Scroggs agreed that the location was three to four inches away, although he sought to explain that this is a simplistic evaluation which ignores the fact that he was operating in three dimensions rather than two (T.281).

4.1.9 There is evidence from Dr. James that there was nothing abnormal about the position of the artery that was damaged (T.68), and Dr. Scroggs acknowledged this (T.261).

4.1.10 In defence of Dr. Scroggs, Dr. Cooper said that such an error could have happened "inadvertently". He explained:-

"There’s only a smallish room for error really. As I say, you’ve got perhaps two to three centimetres and in somebody who is reasonably large and if you are talking about perhaps a passage of six centimetres, then it would be possible to veer from what you might imagine is your directed course. To a certain extent this is a blind entry. You can’t see where you’re heading and you can’t see what’s underneath you.

 

. . . but if you compare it to the alternatives, that is, either a laparotomy or using an open technique, the data will again show us that people still sustain bowel injuries and vascular damage, even when they can supposedly see what they’re cutting".

(T.347)

 

Although he suggested that it was possible to be one to two centimetres out and not realise it, he agreed that in this case the error was something in the order of 30° to 40° from the perpendicular (T.365-6), which is much more than one or two centimetres.

4.1.11 I take all that evidence into account, and also have regard to the submissions of Mr. Halliday, counsel for Dr. Scroggs when he said:-

"There are inherent risks in the procedure and one of them materialised, and that can occur without identifying a departure from what is medically recognised as the appropriate standard of care".

(T.402)

 

I should not enter the question of whether there has been a departure from the standard of care expected of Dr. Scroggs. To do so would be to risk contravening Section 26(2) of the Coroners Act. Dr. Scroggs acknowledges that an error has occurred. It is perhaps pointless in view of the limitations placed upon me by that section to embark upon an analysis of the extent of that error. However, I think it is appropriate for me to say that I think the error goes beyond mere misadventure.

4.2 Use of Verres needle/sharp trocars

4.2.1 Having witnessed the death of her friend in the operating theatre, Registered Nurse Hughes said that she asked the other visiting gynaecologists at the South Coast District Hospital to change their method of surgery so that sharp penetrating instruments are not inserted "blind" into the peritoneal cavity (i.e. while the surgeon is unable to see the underlying structures). She explained that she asked them to adopt the technique favoured by general surgeons, whereby an incision is made down through the muscle layers and into the peritoneal cavity with a scalpel, and then a blunt cannula is inserted through the incision. A laparoscope is then inserted into the abdominal cavity through the cannula in the same way. This is known as the Hasson technique. It is only once the laparoscope is in place that sharp trocars are used under direct observation. Ms. Hughes said that she had offered this procedure to Dr. Scroggs before he commenced the previous operation but Dr. Scroggs declined (see her Record of Interview, Exhibit C.14, p3).

4.2.2 Both the Verres needle and primary trocar are sharp, penetrating instruments which are inserted "blind" into the peritoneal cavity. Although the technique involved in handling the two instruments may be different, the risk of damage to underlying structures is similar, since both are sharp. The following discussion about the relative merits of "blind" insertion and the Hasson technique applies equally to both instruments, except where the context otherwise stipulates.

4.2.3 Dr. Cooper said that the Australian Gynaecological Endoscopy Society prepared a series of guidelines on the use of the Verres needle in laparoscopic surgery and these have been described as a "consensus statement". The statement was adopted by the Royal Australian College of Obstetricians and Gynaecologists towards the end of 1997 (T.314). The consensus statement forms part of Exhibit C.23. It makes the following points:-

• the Verres needle has been used by gynaecologists since 1970;

• gynaecological surgeons have been trained in the insertion of a Verres needle "with the same skill and care as for consultants teaching peritoneal entry at laparotomy";

 

• the training includes techniques and guidelines for

(a) intra-umbilical incision,

(b) direction away from major vessels,

(c) modification of the technique or consideration of alternative sites following previous surgery, and

(d) consideration under some circumstances of the use of micro-laparoscopic technology;

 

• because adhesion formation is rare as a result of repeated use of closed laparoscopy, and because laparoscopy may need to be repeated several times over a patient’s life-time, the use of the Verres needle is preferable to the open Hasson technique;

 

• complication rates from the Verres needle insertion are reported to be one in a thousand;

 

• the reported increase in laparoscopic complications has not been associated with the use of the Verres needle in gynaecological practice;

 

• the routine use of the Verres needle to obtain a pneumo peritoneum should not be replaced by the open Hasson technique in other than exceptional circumstances;

 

• the method used to obtain a pneumo peritoneum should remain at the discretion of the surgeon dependent upon skill, individual case judgment and previous training.

(my underlining)

4.2.4 As to the complication rate, Dr. Cooper explained that it has been proven, by retrospective studies involving a large number of patients in several countries including France, United Kingdom, America and Germany, to be about nine per 10,000 cases or just under one per 1,000 of vascular injury to major vessels (T.378). The mortality rate has been established at between four and six per 100,000, and he described this as "underneath that of other medical interventions" (T.378).

4.2.5 In his report (Exhibit C.24), Professor Glyn Jamieson, the Dorothy Mortlock Professor of Surgery at the University of Adelaide, and one of the pioneers of laparoscopic surgery in this and other Western countries, comments:-

"In the world literature the incidence of major vascular injuries is almost certainly under-reported using such procedures (using a Verres needle sub-umbilically). For instance a paper reported in the American Journal of Surgery in 1995 records only 24 cases, and three deaths. In this paper the vascular injuries were caused by the pneumo peritoneum (Verres needle) in half the cases. My reason for saying this complication is almost certainly under-reported, is that I am aware of two deaths (including the present one) in this State caused by a Verres needle causing a major vascular injury. I am also aware of anecdotal reports from other States in Australia. If no alternative techniques existed for inducing pneumo peritoneum, then the very low incident of death associated with the use of the Verres needle in this location would probably be accepted, and indeed one has to state that gynaecologists around the world continue to accept this very low incidence of mortality from the use of the Verres needle sub-umbilically. However, there are two techniques which obviate death from a major vascular injury during induction of pneumo peritoneum. The first is the so-called Hasson technique, where a blunt cannula is inserted under direct vision into the peritoneal cavity. This is a technique favoured by many general surgeons. The other technique is to use the Verres needle in the left subcostal position. This is a technique which appears to be growing in popularity because any structures damaged by insertion of the needle do not lead to exsanguination and death in the way that occurred in Mrs.. Sowik’s case. This also happens to be the technique which I favour. Therefore my answer to the question is that the sub-umbilical use of the Verres needle is not an acceptable technique. However, it is the technique accepted by the vast majority of gynaecological surgeons in the world".

(Exhibit C.24, p1-2)

4.2.6 Dr. O.M. Petrucco, Senior Lecturer in the Department of Obstetrics and Gynaecology at the Womens and Childrens Hospital, also provided a report (Exhibit C.25). Dr. Petrucco gave figures similar to those proffered by Dr. Cooper, but specifically mentioned that injuries leading to death in gynaecological laparoscopy are most frequently cardiac arrests, major vascular injuries, and bowel injury "which occur most frequently at initial blind insertion of instruments to create a pneumo peritoneum" (p3). He added that cases involving major vascular injury have usually been associated with the use of the Verres needle (p3). He referred to several studies which provided detailed information about complication rates, and in particular referred to a study in New South Wales from January 1988 to September 1993 which disclosed eight cases of major vascular injury, the majority caused by Verres needle or primary trocar injuries. In three of the eight cases the patient died. In contrast, Dr. Petrucco referred to a retrospective study of open or Hasson-type laparoscopies involving 11,000 cases in America as reporting no vascular injuries, but bowel lacerations in six cases. Dr. Petrucco commented:-

"Resolution of the question of safety using closed or open techniques for creation of pneumo peritoneum requires prospective surgical audits to be performed nationally by proponents of each technique. The technique for insertion of the Verres needle described by Dr. Scroggs would be considered by most experienced gynaecologists as an acceptable technique".

(p.4)

4.2.7 Dr. Cooper also referred to reports of lacerations of the aorta, and to other studies where deaths from vascular injuries from open operations have occurred. He agreed with Dr. Petrucco, saying:-

"My belief is that there’s not sufficient statistical evidence to say that the Hasson technique is necessarily safer. It perhaps does have some ... advantages, but it’s certainly not without ... disadvantages".

(T.339).

Indeed, Dr. Cooper pointed out that there was a hospital in another State which banned the use of the Verres needle, and "following that ruling there was an inordinate number of bowel injuries from open entry" (T.379).

4.2.8 Having regard to this divergence of opinion, I am not persuaded that it would be appropriate for me to make a recommendation pursuant to Section 25(2) of the Coroners Act that the use of the blind insertion technique in laparoscopic surgery should be discontinued. However, I think that the issues which have been canvassed in this case raise matters of sufficient concern that the arguments for and against the use of such a technique should, as Dr. Petrucco suggests, be analysed by "prospective surgical audits to be performed nationally by proponents of each technique". When considering the relative safety of each technique, surgeons should not be placed in the situation of relying upon incomplete or misleading statistical information.

4.3 The appropriateness of the reaction to the emergency situation

Dr. Scroggs described his basic approach to the emergency situation as follows:-

"Clearly, it was life-threatening and there was no ideal management plan because the ideal management plan was to have a vascular surgeon there to fix it up immediately, so what we were attempting to do was to make the best of a situation that we could. We had large amounts of blood available and the information I was getting from the anaesthetist was that they were keeping up with the amount of blood loss that I was managing to maintain and I felt quite confident that if I attempted to put any clamps on it, there was going to be copious bleeding whilst I was trying to do that and I had no vision on exactly where the vessel was so whilst attempting to put those clamps on she would’ve lost a lot of blood and it may have been of no benefit. It may have damaged the iliac vein which was adjacent to the artery; it may have torn the artery, for all I knew; and I felt that we had a situation, whilst it wasn’t ideal, it was at least manageable that we were maintaining some degree of vascular filling with the anaesthetist attempts at resuscitation and I was changing a torrential blood flow into a moderate blood flow and that we should continue in that fashion".

(T.270-1)

His actions should be examined in that context, and I will keep these factors in mind in the following analysis.

4.4 The appropriateness of a low transverse incision

4.4.1 The medical opinion before me establishes that the low transverse incision made by Dr. Scroggs, once the fact of a substantial haemorrhage had been established, was inappropriate. Dr. Cooper said:-

"Yes, I think that under these circumstances, a vertical incision would have been more appropriate to gain access to all of the potential vascular structures that might have caused the problem".

(T.334).

He added:-

"In this situation of a sudden drop in blood pressure and a conversion to laparotomy because of the worry of haemorrhage, I think most people would favour a vertical incision".

(T.377)

This was the approach taken by Dr. Ferguson once he arrived.

Dr. Cooper conceded that, since it took 90 minutes or so for a vascular surgeon to arrive, "it may not have made a lot of difference" (T.377).

4.4.2 Should Dr. Scroggs have tried to locate the source of the bleeding?

Once again there was a divergence of medical opinion on this issue. Dr. Andrew Bersten, the anaesthetist and intensive care specialist, suggested:-

"The surgeon needed to do a laparotomy, which I think he did, and then to hold the aorta in his fingers until someone could come down and stop the bleeding, . . . to try to stop the bleeding, and if, if he needed to just put his hand on the aorta".

(Exhibit C.16, p3).

He described this as "almost a first aid measure" (T.91). Dr. Bersten acknowledged the difficulty of locating the bleeding site immediately, but indicated that the appropriate technique was to "try to stop bleeding well above where you thought it was so that you could actually get down to find the source of the bleeding" (T.92).

4.4.3 Dr. Cooper gave some support to Dr. Bersten’s suggestion, saying that he would not have attempted to apply vascular clamps to the area, but:-

"I think it depends where it was. . . . I would have attempted to identify the hole and simply place my hand over it or my finger over it and then it really depends on where you are and who is available as to what you do next".

(T.334)

Dr. Cooper said that Dr. Scroggs would only have been able to identify the bleeding site "with a reasonably considerable amount of difficulty" having regard to the low transverse incision that he had made, and that the task would have been easier with a vertical or midline incision (T.335). Having identified the hole, he said:-

"I would then go backwards from the site of injury to apply pressure, so somewhere, what’s termed proximal, between the heart and the site of injury, to apply pressure at that point and determine exactly what the vessel was that was injured".

(T.335)

 

4.4.4 Indeed, Dr. Cooper pointed out that if the injured vessel had been the right internal iliac artery (in other words below the bifurcation and below where Mrs.. Sowik was injured in this case) then that vessel could have been tied off without major complications. He said:-

"In fact, that’s one of the recommended strategies for massive blood loss in the face of haemorrhage after delivery".

(T.335)

Dr. Cooper said that he thought the location of the bleeding point was within the expertise of a trained gynaecologist. He said:-

"Q. Would you expect a trained gynaecologist to be able to find a hole in an iliac artery which is the size of one’s little finger, if he was minded to look for it?

 

A. Yes, or if they were unable to determine the site, to go proximal and apply pressure at that point".

(T.361)

 

4.4.5 Dr. Scroggs acknowledged that aortic compression was an option, but said that it did not occur to him at the time. He said:-

"The options that I had were limited, I felt that whilst the situation was not optimal, that it was manageable and that help was at hand and that there was more blood at hand, and that we could keep up and that we would be able to save the day".

(T.299)

4.4.6 Dr. Ferguson, the vascular surgeon, was somewhat contemptuous of Dr. Bersten’s suggestion, adding "I’m not surprised that it came from an anaesthetist" (T.202). He added:-

"I thinks that’s fanciful, I really do. I would be interested if any other vascular surgeons would have put forward that hypothesis. It’s very, very difficult to expose blood vessels".

(T.203)

Dr. Ferguson described the difficulties involved as follows:-

"It’s very difficult to envisage the situation here. You have got basically a deep dark hole with blood pouring out of it and, if you put a big bit of pressure on it, that stops the blood. But, you can’t tell exactly where it is coming from so you gradually reduce the area of pressure that you are exerting until hopefully you can get one finger on the bit that is bleeding and then you can try and go above and below, get control of the vessels, and then fix the hole. So, as I recall, when I - and obviously in order to see where the bleeding is coming from, you have got to take the pack off and, as I recall when we took the pack off, the bleeding was so severe that we couldn’t sort of do that. So, I had to go further up in the abdomen and expose the aorta, which is a big artery that divides into two at the umbilicus, to get control above. That was difficult to do. I think that is a very important thing, to get control of the vessel above where the bleeding is".

(T.192)

4.4.7 Dr. Ferguson obviously thinks that a vascular injury should be left to the experts. He said:-

". . . certainly we are very reluctant to encourage general surgeons to try to fix vascular things that look straightforward and then get us if it doesn’t work. We would rather be involved at the outset, because it is difficult and often the first chance is the best chance".

(T.216)

Dr. Cooper acknowledged that the experience of the surgeon was a relevant matter (T.359).

4.4.8 Having regard to the evidence of Dr. Ferguson, particularly as to the difficulties he encountered in identifying the bleeding site, I accept his evidence that Dr. Scroggs should not be criticised for failing to do so. However, I believe that this evidence should be accepted with some limitations. Dr. Cooper obviously feels that there are some measures which can be taken to identify a bleeding site, and even ligate it depending upon the blood vessel involved, which would have proved more effective than the measures taken by Dr. Scroggs in this case.

4.4.9 It seems to me that if a surgeon takes on the responsibility of operating in a regional or country hospital where a vascular surgeon is not immediately available, then the ability to deal with at least some emergency situations where a vascular injury has occurred should be a requirement.

4.5 Should Dr. Scroggs have tried to use the vascular clamps?

4.5.1 Ms. Hughes told me that on two occasions after it became apparent that Mrs.. Sowik was haemorrhaging, she offered Dr. Scroggs the use of special vascular clamps which she had ordered in on the advice of a general surgeon, Mr. Peter Malycha, not long prior to this incident (T.20 and T.31). She told me that she had seen these clamps being used by surgeons other than vascular surgeons on previous occasions (T.32), although she was unable to say whether the surgeon concerned was a gynaecologist (T.41).

4.5.2 Dr. Ferguson, on the other hand, said that he would discourage any surgeon other than a vascular surgeon from using such clamps (T.189). He explained that although the application of a clamp sounds easy, the problem is that the particular blood vessel has to be exposed first and that "we generally discourage non-vascular people from applying vascular clamps" for that reason (T.190). Professor Jamieson made a similar comment, saying that:-

"It is extremely unlikely that without even general surgical experience, let alone vascular surgery experience, that Dr. Scroggs would have been able to alter the course of events by trying to stem the haemorrhage".

(Exhibit C.24, p2)

Dr. Scroggs said that the reason that he did not use the clamps was because:-

"I wasn’t sure whether they were or not (vascular clamps) because I don’t have any experience with them so I was uncomfortable using equipment that I actually wasn’t familiar with. But my principal concern was that I was going to do more harm than good. . . ."

(T.249)

Having regard to that evidence, I accept that no criticism of Dr. Scroggs is called for in relation to the non-use of vascular clamps.

4.6 Were the efforts of Dr. Brooks effective?

4.6.1 Dr. Brooks told me that Mrs.. Sowik had received a massive transfusion of blood and related fluids while he was trying to maintain her blood pressure during Dr. Scroggs’ attempts to stem the haemorrhage (T.145). At about 4.30p.m. he called in more staff into the operating theatre to stand and squeeze fluid bags in order to get more fluid volume into Mrs.. Sowik (T.157).

4.6.2 Notwithstanding these efforts, Professor Jamieson commented that Mrs.. Sowik still seems to have been under-perfused, "as application of the aortic clamp caused an immediate rise in the patient’s blood pressure". Even so, he commented:-

"I think it is worth stating that the general practitioner and anaesthetist appears to have coped extremely well in these very difficult circumstances".

(Exhibit C.24, p2)

I accept this evidence.

4.7 Availability of retrieval team

4.7.1 Ms. Hughes told me that it usually takes between 30 and 60 minutes for a retrieval team to arrive from the Flinders Medical Centre to the South Coast District Hospital (T.50). Dr. Bersten explained that, subject to the availability of the helicopter and pilot, the minimum time to have the helicopter operational is ten minutes or so (T.79). On this particular day, however, because "Rescue 1" was organised, but then became unavailable making it necessary to recall the pilot for "Rescue 2", an unusual delay occurred (T.80). As a result of these difficulties, the retrieval team was not able to get to South Coast District Hospital until 4.45p.m. or thereabouts. This is just under 90 minutes after 3.20p.m. when Dr. Bersten received the initial telephone call.

4.7.2 As I have said, this seems an excessive time, but was brought about by the unusual circumstances then prevailing. Dr. Bersten explained that this is unlikely to occur now, because there are now two helicopters with the same capacity that "Rescue 1" had in 1995.

4.7.3 I accept Dr. Bersten’s evidence that this issue should also be seen in the context that:-

". . . it is probably arguably the best retrieval service in Australia. It initially evolved from the major hospitals being rung for advice from peripheral hospitals in association with the Flying Doctor Service to bring patients from distant hospitals to these hospitals, and that defacto has become almost something that people believe should be there. It has become more formalised in the form of trauma over the last few years, but I guess it’s important to realise that in some States in Australia there is no medical retrieval service, and if there is one it exists in a very rudimentary form".

(T.110)

4.7.4 In all those circumstances, it seems to me that all those involved did the best they could with the resources available, and that there should be no criticism of the delay which occurred.

4.8 Should laparoscopic surgery have been performed at the South Coast District Hospital at all?

 

4.8.1 When he was interviewed by Senior Constable P.C. Gross on 17 May 1996, Dr. Ferguson was asked whether he considered that such a laparoscopic procedure should be performed in a hospital such as the South Coast District Hospital. He said:-

"Well I think if you’d asked me before this, I would probably say yes but now I say no. . . . I think it was one in a thousand, or one in 10,000 or however, but I think this shouldn’t be . . . I will say that if it had happened in Theatre Four in the Royal Adelaide Hospital when I was in Theatre Five in the Royal Adelaide Hospital . . . it wouldn’t have been a problem. And I must say that that does happen. The very next week there was a gynaecologist put a hole in a big vein in the Royal Adelaide Hospital and he called me in because I was in the next theatre and I was there within a few minutes and we had it controlled within 50 minutes. . . . So I think that . . . I would have to say that . . . it would be unwise to do surgery that clearly has this potential complication in . . . such a remote setting".

(Exhibit C.20, p10-11)

4.8.2 However, at the inquest Dr. Ferguson acknowledged that this may have been "an emotional answer rather than a rational one" and that:-

"Maybe, as your colleague says, you would have to look at the incidence of things over a large number of hospitals and put that down as an acceptable risk, I don’t know".

(T.215)

4.8.3 Dr. Scroggs’ evidence, which I accept, was that Mrs.. Sowik wanted to have the operation at Victor Harbor as it suited her for various reasons (T.252).

4.8.4 Dr. Scroggs told me that he made a "personal decision" not to perform such surgery in regional hospitals since this incident, but that:-

"Advanced endoscopic surgery has happened in peripheral areas now for years, and that unless someone can demonstrate that there is an increased

risk in this sort of vascular injury with advanced laparoscopic surgery, I believe that it should still be done".

(T.256)

4.8.5 There is no doubt that Dr. Scroggs was appropriately accredited to perform this type of surgery at the hospital (see Exhibit C.5e).

4.8.6 The options available to Mrs.. Sowik in these circumstances were a LAVH, a vaginal hysterectomy without laparoscopic assistance, and a conventional abdominal hysterectomy. Dr. Petrucco pointed out that the overall complication rate for the other two options has been demonstrated to be greater than that for LAVH (Exhibit C.25, p3).

4.8.7 Dr. Petrucco also pointed out that since the injury occurred during the insertion of the Verres needle, the fact that this was a LAVH, as distinct from a more minor procedure such as a sterilisation, is irrelevant, since the needle needs to be inserted in each case. He said:-

"In fact, most of the reported cases of similar injuries in the literature were associated with minor laparoscopic procedures".

(Exhibit C.25, p5)

4.8.8 In view of that evidence, a recommendation against the performance of LAVH in regional hospitals would not be appropriate. If the risk of injury is to be completely avoided, laparoscopic surgery in such hospitals would need to be banned altogether. I do not consider this to be a practical suggestion, particularly in view of the incidence of complications and mortality when compared with other forms of surgery.

4.8.9 However, I think this topic needs to be considered in the same context as the debate about whether blind insertion techniques should be used - the use of such surgery should be analysed by properly conducted prospective comparative studies.

5. Recommendations

I recommend, pursuant to Section 25(2) of the Coroners Act, that the use of the blind insertion technique in laparoscopic surgery, and the performance of such surgery in other than major teaching hospitals, with ready access to vascular surgeons, should be examined by properly conducted prospective comparative studies. If such procedures are shown to carry a greater risk of harm than other methods, they should be discontinued.

 

 

 

 

 

……………………………..………