Medical Board of Australia v Woollard

[2012] WASAT 209

JURISDICTION     :   STATE ADMINISTRATIVE TRIBUNAL

STREAM:   VOCATIONAL REGULATION

ACT: MEDICAL PRACTITIONERS ACT 2008 (WA)

CITATION:   MEDICAL BOARD OF AUSTRALIA and WOOLLARD [2012] WASAT 209

MEMBER:   JUDGE D R PARRY (DEPUTY PRESIDENT)

PROF M KAMIEN (SENIOR SESSIONAL MEMBER)
DR M LEVITT (SENIOR SESSIONAL MEMBER)
MR M WIKLUND (SENIOR SESSIONAL MEMBER)

HEARD:   26 AND 27 JUNE 2012

WRITTEN SUBMISSIONS FILED ON 23 JULY 2012, 1 AUGUST 2012 AND 7 AUGUST 2012

DELIVERED          :   19 OCTOBER 2012

FILE NO/S:   VR 145 of 2011

BETWEEN:   MEDICAL BOARD OF AUSTRALIA

Applicant

AND

KEITH VICTOR WOOLLARD
Respondent

Catchwords:

Vocational regulation ­ Medical practitioner ­ Allegation of disciplinary matter ­ Acting carelessly or incompetently ­ Balloon catheter burst in patient's right coronary artery during coronary angioplasty ­ Whether practitioner caused inflation of balloon to a pressure of 18 atmospheres during angioplasty ­ Whether causing inflation of balloon which has rated burst pressure of 14 atmospheres to 18 atmospheres was unsafe ­ Whether practitioner acted carelessly or incompetently ­ Expert evidence ­ Rules of evidence ­ 'Assumption identification rule' ­ 'Basis rule' ­ Relevance in Tribunal proceedings

Legislation:

Health Practitioner Regulation National Law (WA) Act 2010 (WA), s 14, s 17(2)(b)
Medical Practitioners Act 2008 (WA), s 76(1)(b), s 76(1)(b)(i), s 76(1)(b)(ii)
State Administrative Tribunal Act 2004 (WA), s 32(2), s 60(2)

Result:

Finding that a disciplinary matter exists in relation to the practitioner because the practitioner acted carelessly in the course of his practice as a medical practitioner

Summary of Tribunal's decision:

A balloon catheter that Dr Keith Woollard was using during a coronary angioplasty burst inside the patient's right coronary artery.  The Medical Board of Australia alleged that Dr Woollard acted carelessly or incompetently in the conduct of the angioplasty.
The Tribunal found that Dr Woollard caused the inflation of the balloon to a pressure of 18 atmospheres, which was four atmospheres above its rated burst pressure.  The Tribunal found that this was unsafe in the circumstances, because the over­inflation of the balloon increased the risk of its rupture, particularly in a heavily calcified lesion, which could have devastating consequences, including death.  The Tribunal also observed that, while it may not be uncommon for some interventional cardiologists to exceed the rated burst pressure of a balloon by one or two atmospheres, it is not safe practice to do so.
The Tribunal determined that Dr Woollard acted carelessly in causing the inflation of the balloon to a pressure of 18 atmospheres and in failing to change to a non-compliant balloon, which has thicker walls, with a higher rated burst pressure, before exceeding 16 atmospheres.
However, the Tribunal did not find that Dr Woollard acted incompetently, because, at the relevant time, he was in the final stages of training to be able to perform angioplasties, and performed the angioplasty in question under the supervision of an accredited interventional cardiologist. 
The Tribunal required the parties to file written submissions in relation to penalty and costs.  Subject to any further order, these issues are to be determined entirely on the documents.

Category:    B

Representation:

Counsel:

Applicant:     Mr PD Yovich with Ms J McKenzie

Respondent:     Mr JRB Ley

Solicitors:

Applicant:     MDS Legal

Respondent:     Clayton Utz

Case(s) referred to in decision(s):

Cornish Investments Pty Ltd v Chief Commissioner of State Revenue [2012] NSWADT 204

Medical Board of Australia and Bernadt [2012] WASAT 108

Medical Board of Western Australia and Bham [2006] WASAT 190

Medical Board of Western Australia and Richards [2010] WASAT 94

Medical Board of Western Australia and Wright [2010] WASAT 48

Re Baini and Commissioner of Taxation [2012] AATA 440; (2012) 57 AAR 452

REASONS FOR DECISION OF THE TRIBUNAL: 

Introduction

1. Dr Keith Woollard has been a medical practitioner for over 40 years and a specialist cardiologist for over 30 years.  In 2004, Dr Woollard commenced training to be able to perform coronary angioplasties.  By August 2006, Dr Woollard had performed approximately 250 angioplasties under the supervision of interventional cardiologists.  About two months later, Dr Woollard was accredited to perform angioplasties on his own at the Mount Hospital.

2. During a right coronary angioplasty that Dr Woollard performed on Patient S under the supervision of an interventional cardiologist at the Mount Hospital on 30 August 2006, the balloon catheter that Dr Woollard was using in an effort to dilate or clear a stenosis or lesion (commonly known as a narrowing or blockage) in the patient's right coronary artery, and to thereby open up blood flow through the artery, burst.  When Dr Woollard sought to apply traction to remove the balloon, the shaft of the balloon broke off, dissecting the artery and leaving fragments of the ruptured balloon in the artery.  Patient S then had to undergo emergency open heart coronary repair and bypass surgery which, fortunately, she survived.  She subsequently made a complaint about Dr Woollard to the Medical Board of Western Australia.

3. The Medical Board of Australia has brought an allegation to the State Administrative Tribunal that Dr Woollard acted carelessly or incompetently in the conduct of the angioplasty.  The Board alleged – but Dr Woollard denied – that he caused the balloon to be inflated to a pressure of 18 atmospheres, which was 4 atmospheres above its Rated Burst Pressure (RBP).  Dr Woollard said that he only caused the balloon to be inflated to a maximum pressure of 15 atmospheres, and that, as the balloon did not clear the lesion at that pressure, he instructed the scrub nurse to fully deflate the balloon and then to reinflate it to 15 atmospheres.  Dr Woollard said that when the balloon had been fully deflated and had reached about 10 atmospheres on reinflation, it burst. 

4. The Board also contended – but Dr Woollard denied – that inflating the balloon to 18 atmospheres was careless or incompetent in the circumstances, and that Dr Woollard's failure to withdraw the balloon before inflating it beyond 16 atmospheres and his failure to replace it with a 'non­compliant' type of balloon with a higher RBP was also careless or incompetent in the circumstances.

5. The following four principal issues require determination by the Tribunal:

   1)Whether Dr Woollard caused the balloon to be inflated to a pressure of 18 atmospheres.

   2)Whether the guide­wire that Dr Woollard used to position the balloon became trapped in the lesion before the balloon was inflated.

   3)Whether, if the balloon was inflated to a pressure of 18 atmospheres, it was unsafe to do so in the circumstances.

   4)Whether, if the balloon was inflated to a pressure of 18 atmospheres, Dr Woollard acted carelessly or incompetently.

6. We will consider each of these issues in turn.

Did Dr Woollard cause the balloon to be inflated to a pressure of 18 atmospheres?

1. There are four key items of evidence in relation to whether Dr Woollard caused the balloon to be inflated to a pressure of 18 atmospheres.  These are:

   •the Event Log in relation to the procedure;

   •a letter written by Dr Woollard to the manufacturer of the balloon, Abbott Vascular, on 31 August 2006, the day after the procedure;

   •an undated document entitled 'Coronary Angioplasty Report' which Dr Woollard said he dictated over the telephone to his secretary mid to late afternoon on the day of the procedure; and

   •Dr Woollard's testimony based on what he said was an actual recollection of the procedure and, in particular, the maximum pressure to which he caused the balloon to be inflated.

Event Log

1. An Event Log is a contemporaneous record of matters occurring during an angioplasty (or other procedure) which is compiled during the procedure by the monitoring nurse.  The monitoring nurse compiling the Event Log in relation to the angioplasty in question sat in a small adjoining or ante­room to the Cardiatic Catheterisation Laboratory (commonly referred to as CCL or cath lab) where the procedure was taking place, separated from the cath lab by a glass partition and open doorway.  In addition to the computer screen on which the monitoring nurse was compiling the Event Log, the monitoring nurse also had a second computer screen on her desk on which she monitored the patient's blood pressure and electrocardiograph.

2. The monitoring nurse who compiled the Event Log during the angioplasty procedure on Patient S was Nurse Carole Collins.  Nurse Collins was called to give evidence by the Board.  Nurse Collins has about 8 years' experience in relation to angioplasties, approximately half of that time in cath labs and half in a vascular laboratory.  Nurse Collins worked in the CCL at the Mount Hospital for two to three years.  The angioplasty on Patient S occurred towards the end of that period.  Nurse Collins worked with other nurses in the CCL at the Mount Hospital 'as a team and you rotated[;] one scrubbed, one monitored, one circulated' (T:76.9; 26.06.12).

3. Nurse Collins said that she does not recall the particular procedure on Patient S.  However, she gave evidence, which was not disputed, that the role of the monitoring nurse during an angioplasty includes to 'record [on the Event Log] all aspects of the balloon inflations including the stent, deployment times and placement'.  The Event Log for the angioplasty on Patient S states that at 2.35 pm 'Patient on Table'.  The Event Log has a total of 33 entries between 2.35 pm and 4.40pm.  The Event Log contains the following entry at 2.54pm:

   1. 18 ATM/ 29 SEC/ 2,76 + MM/ SITE PROX RCA BALLOONING (BURST BALLOON.)

4. Nurse Collins explained that this entry:

   indicates to me that a balloon was taken to 18 atmospheres for 29 seconds expanding to 2.76 + mms.  The '+' sign indicates to me that the balloon was taken above the RBP as noted in the package.  (Exhibit 20 [11])

5. Nurse Collins gave evidence, which was not disputed, that there is a compliance chart for each balloon used in angioplasty, stating inflation pressures and the diameter of the balloon inflated to each pressure, both on the box containing the balloon and on a sterile card inside the packaging.  She said that once the consultant conducting the procedure confirms to the circulating nurse that the balloon model selected is correct, the circulating nurse opens the balloon packet from inside the box and gives the box to the scrub nurse.  The scrub nurse takes the box out to the monitoring nurse so that the monitoring nurse has the box in front of him or her during the procedure.  The scrub nurse puts the compliance chart on the sterile card on the table where the procedure is being conducted so the consultant can see it during the procedure. 

6. The compliance chart for the Voyager RX Coronary Dilation Catheter balloon that Dr Woollard used in the angioplasty on Patient S states the diameter in millimetres of the balloon inflated at each pressure from 4 to 15 atmospheres.  The compliance chart  states that the RBP of the balloon is 14 atmospheres and that the diameter of the balloon is 2.72 millimetres at that pressure.  The RBP is the inflation pressure at or below which the manufacturer's laboratory testing has indicated that 99.9% of balloons will not burst.  The compliance chart also states that the diameter of the balloon inflated at a pressure of 15 atmospheres is 2.76 millimetres.  However, whereas the information on the compliance chart is printed black on white for pressures from 4 to 14 atmospheres, the information in relation to 15 atmospheres is printed white on black.

7. Although Nurse Collins does not specifically recall the angioplasty on Patient S, she gave clear evidence of the usual procedure at that time for the inflation of a balloon during an angioplasty, the calling out of information from the table where the procedure was taking place about inflation of the balloon, and her own usual practice of repeating back information called out from the table in relation to the inflation of a balloon before she recorded the information on the Event Log when she was the monitoring nurse. 

8. Nurse Collins gave evidence, which was not disputed, that the interventional cardiologist who is conducting the angioplasty is the person who directs what pressure the balloon is taken to.  She said that the consultant will say something like 'Take it to …' and say the number of the pressure the balloon is to be inflated to.  The scrub nurse will then say 'Going up' and immediately commences inflation of the balloon.  At that moment, the monitoring nurse sets the timer.  When the cardiologist instructs the scrub nurse to deflate the balloon, the scrub nurse says 'Down' or words to that effect, and the monitoring nurse stops the timer.  Nurse Collins gave evidence that:

   In relation to recordings [in the Event Log] concerning balloon inflations, the inflation rate and placement of the balloon/stent is called out from the table over a microphone.  This information is then repeated by the monitoring nurse.

   By repeating the information, the monitoring nurse verifies that she has heard the call from the table correctly.

   On verification the monitoring nurse makes a record of the information.

   I would have followed the above procedure while I was monitoring nurse in this case as I always followed this procedure.  (Exhibit 20 [7] ­ [10])

9. Nurse Collins also gave evidence that:

   It is my usual practice, as a monitoring nurse, to call back the pressure and the length of time at that point [that is, the point at which the scrub nurse says 'Down' or words to that effect and the monitoring nurse stops the timer].  For example, I will call out 'Down at 15 for 30 seconds'.  The table usually repeats the call verifying same. …

   As a monitoring nurse, I have not experienced any difficulty in hearing what a scrub nurse calls out.  (Exhibit 32 [8] and [17])

10. During cross­examination, Nurse Collins remained clear and consistent about the usual procedure for a balloon inflation and her usual practice of repeating back information in relation to a balloon inflation to verify that she heard the call from the table correctly before recording the information in the Event Log.  Under cross­examination, Nurse Collins gave the following evidence:

    Then the consultant instructs the scrub nurse to inflate the balloon if the situation - - -?---If that situation is what is happening, yes, the consultant would tell the nurse to do that.

    When that situation exists you can't necessarily hear what the consultant tells the scrub nurse to inflate to?---There's a microphone system that runs from the table to the room in which the radiographer and the monitoring nurse sits, so you can hear what's being said.

    It's not always turned on though, is it?---It needs to be.  It is always turned on.

    So is it not the case that if the scrub nurse is operating the inflator as opposed to the consultant and that the consultant gives instructions to inflate the balloon, at some point the scrub nurse calls out what she's doing?---As soon as the instructions are given whoever is in control of the indeflator, as soon as they are going up, they shout 'Going up.' The monitoring nurse will immediately flick the timer on.

    Is the monitoring nurse the only one with the timer?---They're the ones that control the timer on the monitor.

    The monitoring nurse is the only one who does that?---Yes.

    The monitoring nurse therefore is the only one who knows eventually how long the balloon has been inflated for?---The timer is also shown on the ECG monitoring screens above the table.

    So when you're told 'Going up' by either the consultant or the scrub nurse, you click the timer on?---That's correct.

    And it shows on the screen - - -?---That's correct.

    That's for the purpose of the people in the laboratory, but you can see the timer yourself as the monitoring nurse anyway?---That's correct.

    You're the only person who actually records what the timer ultimately shows, are you not?---That's correct.

    When I say 'you', I mean the monitoring nurse?---The monitoring nurse.

    It's the case, is it not, that when the pressure reaches the level nominated by the consultant in a situation where the consultant is not actually operating the indeflator, the scrub nurse calls out when she has reached that pressure?---The consultant will tell the person operating the indeflator how long he wants the pressure to - is left.  Like, he'll say, 'Take it up to 15 for 20 seconds.' Once they have been up to 15 for 20 - up at 15 for 20 seconds, it will be down and they will shout 'Down for 20 - 15 for 20'. As soon as you hear that word 'down' the timer is stopped.

    How do you know at the time you hear the word 'down' what the pressure is?---Because they have called out, 'Down at 15 for 20.'  You're documenting that and you're also reiterating or repeating that call.

    So you don't know of your own knowledge what the pressure is?---You don't physically see the dial, no.

    So you don't know. So you rely on them to tell you what it is?---That's correct, and that's why you repeat it so you're repeating the order.

    So they say, '15 for 20 seconds'?---Yes.

    And '15' you would just record, because you have been told that?---That's correct.

    And the '20 seconds' though, wouldn't you be able to independently check that with your timer?---Yes, because you have stopped it, yes.

    Who says '20 seconds'? Is that you or - - -?---The call comes from the table.  '15', that tells me it has gone up to 15 atmospheres for 20 seconds.

    That's from the operator?---That's from whoever is controlling the indeflator.  (T:79.8­81.3; 26.06.2012)

11. The scrub nurse for the angioplasty on Patient S was Nurse Margaret Knowles.  Nurse Knowles was called to give evidence by the Board.  Nurse Knowles commenced working in the CCL at the Mount Hospital in 2002, having previously worked in a cath lab elsewhere.  She worked as part of the nursing team in the CCL at the Mount Hospital for six years, before commencing as a nurse manager.  Since 2010, Nurse Knowles has been a nurse manager at a different hospital. 

12. Nurse Knowles said that, due to the passage of time, she has no recollection of the angioplasty on Patient S, other than that the balloon ruptured while it was inside the patient's coronary artery.  However, Nurse Knowles gave evidence which was consistent with the evidence of Nurse Collins in relation to the usual practice at the time of the procedure for calling out information in relation to a balloon inflation from the table and the recording of that information in the Event Log.  Nurse Knowles gave the following evidence:

    The scrub nurse must be very clear and specific about everything she calls out relating to the type of balloon that is being used, the balloon's pressure and the number of seconds it has been inflated, because it is important that we record all of this information correctly.

    The monitoring nurse can always hear the scrub nurse call out.  If the scrub nurse cannot be heard, a microphone system can be turned on in the control room to transmit the sound.

    There is always the expectation that staff will keep conversations to a minimum and the scrub nurse can ask that anything which impairs hearing be stopped.  When training staff to scrub, they are instructed to call out clear instructions in a loud voice.

    It is not uncommon for the monitoring nurse to call back to the scrub nurse to confirm that the Event Log is accurate.  I have not experienced any difficulty hearing a monitoring nurse calling back to me when I have been the scrub nurse.  (Exhibit 33 [5] ­ [8])

13. Nurse Knowles was cross­examined in relation to this evidence.  She gave the following evidence in cross­examination:

    … You say in one of your statements that there was a microphone system in place in the laboratory?---There's a speaker system. So if there is any background noise we can switch the speaker system on, but quite often the scrub nurse and the monitoring nurse, if there was any background noise, would tell people to just be quite [sic].

    So generally speaking you don't need to use the microphone system?---No.

    In any event, I suppose if somebody couldn't hear what was said or misunderstood what was said, they could ask for it to be repeated?---Yes.

    That happens quite often, doesn't it?---It happens and often the monitoring nurse will call back what you've said just as a counter check.

    If she wants to make sure, but if she's clear on what you've said then there's no need for her to do that. Is that right?---That's correct. (T:108.6­109.1; 26.06.12)

1. Further to her evidence that 'it is not uncommon for the monitoring nurse to call back to the scrub nurse to confirm that the Event Log is accurate' and that 'often the monitoring nurse will call back what you've said just as a counter check', Nurse Knowles gave the following evidence in re­examination in relation to Nurse Collins' practice:

   Now, do you know Caroline Collins?---Yes.

   Did you work with her regularly?­­­Yes.

   Do you know her practice?­­­Yes.

   What was that?­­­Safe.

   What did ­ ­ ­?---Always called back. (T:119.7­119.8; 26.06.12)

2. Although, as noted earlier, Nurse Knowles did not have an independent recollection of the angioplasty on Patient S, consistently with the evidence of Nurse Collins, Nurse Knowles said that, based on the usual practice for this type of procedure, the entry in the Event Log at 2.54 pm indicates that:

   At the instruction of Dr Woollard, at 2.54 pm, I then inflated the balloon catheter to 18 atmospheres for 29 seconds …

3. Dr Woollard gave evidence that the 'usual practice is that, when something significant happens during the angioplasty, the scrub nurse announces what has happened' and 'the monitoring nurse hears what the scrub nurse has said, and makes an entry in the Event Log, describing the event and noting the time it took place' (Exhibit 30 [56] ­ [57]). In cross­examination, Dr Woollard said that 'some [scrub] nurses do, [and] and some [scrub] nurses don't [repeat back the doctor's instructions in relation to balloon inflation]' (T:204.8; 27.06.12). However, Dr Woollard also gave the following evidence under cross­examination:

   But do you say categorically that had the scrub nurse called out an incorrect pressure, you have corrected her?­­­I would have, yes.

   You have no independent recollection of having to do so [in the angioplasty on Patient S]?---No, I do not. (T:205.1; 27.06.12)

4. It was acknowledged in Dr Woollard's submissions that Nurses Collins and Knowles 'were obviously honest witnesses, who did their best to recount the usual procedure in angioplasties at the [Mount Hospital] in about 2006'.  We consider that Nurses Collins and Knowles were each impressive and impartial witnesses with considerable experience as CCL nurses.  Although they did not recall the procedure on Patient S, they gave clear, consistent and compelling evidence about the usual procedure at the time for a balloon inflation during an angioplasty, the calling out of information about a balloon inflation from the table, and Nurse Collins' usual practice as monitoring nurse of repeating back information about a balloon inflation from the table in order to verify that she heard the information correctly before recording it in the Event Log, a practice that Nurse Knowles said that Nurse Collins 'always' followed.  On the basis of their evidence, we find that it is likely that Nurse Collins followed her usual practice of repeating back the information about a balloon inflation to check it before she recorded in the Event Log that the balloon was inflated to a pressure of 18 atmospheres for 29 seconds before bursting during the angioplasty on Patient S.

5. Mr JRB Ley, counsel for Dr Woollard, submitted, correctly, that as the monitoring nurse was sitting in the adjoining or anteroom to the CCL and could not, therefore, see the gauge on the indeflator which the scrub nurse was operating to inflate (and, on Dr Woollard's evidence, to deflate and reinflate) the balloon) 'at no time during the angioplasty would the monitoring nurse have had direct knowledge of the pressure to which the balloon was being inflated' and 'her only knowledge of these pressures would have come from what was called out to her by the scrub nurse'.  However, in light of Nurse Collins' repeat­back practice before recording information about a balloon inflation in the Event Log, the fact that she could not see the indeflator does not cast doubt on the accuracy of the entry in the Event Log that the balloon was inflated to a maximum pressure of 18 atmospheres.

6. Mr Ley also relied on Nurse Collins' candid response 'that's a probability' to Mr Ley's question in cross­examination that 'but no doubt you have made mistakes in the past, like we all have?' (T:87.1; 26.06.12) and Nurse Collins' concession that 'I guess there's a possibility that I make typing mistakes' to Mr Ley's question 'Well, you do make typing mistakes[,] do you not, like we all do?' (T:87.5; 26.06.12).  Mr Ley submitted that there is, therefore, a possibility that Nurse Collins made an error, either in hearing or in typing the pressure that was reached.  However, in the same passage of cross­examination, Nurse Collins gave the following evidence:

   So you may have misheard it, or may have mistyped the number?---When something is called out from the table, it's repeated by the monitoring person.  If there is any doubt on what's been repeated, the table will correct that call out.

   But I mean you may have thought that you heard something and typed it, and you didn't go back and look at it?­­­But it's repeated twice.  (T:87.2; 26.06.12)

7. In light of Nurse Collins' usual practice of repeating back information about a balloon inflation called out from the table during an angioplasty, it is extremely unlikely that she either misheard or mistyped the maximum inflation pressure of the balloon.  Further, Nurse Collins typed '2,76 + MM' with reference to the diameter of the balloon at its inflation.  The diameter of the balloon is not called out by the scrub nurse, but rather is taken by the monitoring nurse from the compliance chart on the box.  Nurse Collins was cross­examined about her recording of the diameter of the balloon and gave the following evidence:

   Ms Collins, you have written '2.76' which you would normally write, would you not, if you had been told that it had been inflated to 15 atmospheres?---It's written '2.76 plus.'

   You said to the tribunal a moment ago the plus only means that the balloon was taken above the RBP ­ ­ ­?---That's correct.

   ­ ­ ­ noted in the package.  So if that's all the plus means, shouldn't the 2.76 accord with the pressure?---No, because if it was just 2.76 at 15, it would only be 2.76.  What's written on this piece of paper here is '2.76 plus millimetres.'

   So that means more than 2.76?---That's right.  So that means that it went up higher than 15.  (T:86.6-86.8; 26.06.12)

8. As noted earlier, the compliance chart for the balloon states that the diameter of the balloon at a pressure of 15 atmospheres is 2.76 millimetres.  The compliance chart does not refer to any pressure in excess of 15 atmospheres and does not identify the diameter of the balloon at a pressure above 15 atmospheres.  The fact that Nurse Collins typed '2,76 + MM' clearly indicates that she heard and intended to type a pressure greater than 15 atmospheres.  It also shows that Nurse Collins did not mistakenly type '18' instead of '15' atmospheres.  Had Nurse Collins intended to type '15' atmospheres, she would not have added the '+' after '2,76'.

9. Mr Ley submitted that the plus sign does not assist in determining whether there was an error because:

   after the error was made, Nurse Collins would simply have used that pressure [ie '18' which she typed] from the chart.  Therefore, if the pressure was wrong, the diameter would be wrong, but not because Nurse Collins had misread the chart.'

10. This submission is highly conjectural and the substance of it was not put to Nurse Collins.  In any case, the Event Log was compiled progressively during the procedure.  The preceding entry was made two minutes before the entry recording the balloon inflation pressure and the next entry was made four minutes later.  At the time when Nurse Collins added the diameter of the balloon on the basis of the information on the box, the pressure called out from the table is likely to have been fresh in her mind.  It is, therefore, highly unlikely that, if Nurse Collins had heard '15', but had typed '18' by mistake, she would have simply used the mistyped pressure for the diameter from the box, rather than the pressure that was actually called out. 

11. Finally, Mr Ley submitted that because both Nurses Collins and Knowles had ceased working in angioplasties at the Mount Hospital some time ago, 'their recollection of the procedure [in angioplasties at the time] was obviously affected by these passages of time'.  However, as found earlier, the evidence of Nurses Collins and Knowles in relation to the usual procedure for the calling out of information in relation to a balloon inflation from the table, and Nurse Collins' usual practice of repeating back this information, at the time of the angioplasty on Patient S, was clear, consistent and compelling.

12. We, therefore, find that it is extremely unlikely that the Event Log is incorrect when it records that the balloon was inflated to a maximum pressure of 18 atmospheres.

Dr Woollard's letter to Abbott Vascular

1. Dr Woollard gave evidence that on the day of the angioplasty he requested the nurse manager of the CCL at the Mount Hospital to report to Abbott Vascular, the manufacturer of the balloon, 'the difficulties which I had experienced with the balloon catheter during the angioplasty which I had performed on [Patient S]'.  Dr Woollard said that the nurse manager asked him if he would provide her with a letter about the matter which she could send to the manufacturer and that, consequently, the next day, while he was again at the CCL at the Mount Hospital, he dictated a letter to Abbott Vascular to his secretary over the telephone.

2. Dr Woollard gave the following evidence in relation to this:

   When I dictated the letter, the only document to which I would have had access, to refresh my memory of what occurred during the angioplasty, would have been the record, including the Event Log.

   I would not then have had access to the insert, and I cannot remember whether, when I dictated the letter, I could remember the RBP of the balloon.  (Exhibit 30 [191] ­ [192])

3. Dr Woollard said that his secretary typed the letter and provided it to him, and that he signed the letter and gave it to the nurse manager.  Dr Woollard's letter to Abbott Vascular states as follows:

   Dear Leonie

   re:  Voyager 2.5x15 balloon ­ 3806

   As you know, we had difficulties with this balloon.  It was passed over a BMW wire which was placed distally in the right coronary.  It was sited at a calcified severe mid right coronary stenosis.  It was initially inflated but would not disrupt the lesion so it was taken to a pressure of 18 without difficulty.  However, even at that pressure, the lesion did not dilate.  On a second inflation, the balloon ruptured during the process at perhaps about 10.

   I think attempted to withdraw the balloon but it was stuck.  With traction, the markers moved 1­2 cm proximal to the lesion but the catheter would not withdraw any further.  I applied steady very firm traction and after a short period, the catheter came free from the balloon.

   The balloon remained on the wire in the vessel.  The patient was sent for bypass surgery.  The guide catheter and wire were removed at that stage but the balloon was not seen and remains in the coronary artery.

   The patient did not suffer any serious consequences (apart from having bypass surgery).

   Presumably the balloon catheter is designed to disrupt at a particular point so that there is no possibility of the entire catheter being trapped in the patient.

   I would be interested in your comments and inspection of the catheter.  (Emphasis in bold in the first paragraph added)

4. Dr Woollard gave evidence that his statement in the letter that the balloon 'was taken to a pressure of 18 without difficulty' was 'wrong'.  He explained:

   I believe that I made that error because, in dictating the letter, I relied only on the Event Log, which suggested that the balloon had been inflated to 18 atmospheres.

   I would then have thought that the Event Log was accurate. 

   (Exhibit 30 [199] ­ [200])

5. During cross­examination, Dr Woollard also sought to explain that his memory of the procedure was 'certainly less fresh the next day' when he dictated the letter to Abbott Vascular than when he dictated the Coronary Angioplasty Report (discussed below) in the mid to late afternoon of the previous day, because he 'had done several further angioplasty procedures between the two, and that obviously makes it less fresh in your mind' (T:208.1; 27.06.12).

6. However, Dr Woollard conceded in cross­examination that the events that occurred during the angioplasty on Patient S were 'unusual' in one respect and 'unique' in two respects, in his experience.  Dr Woollard said that 'the published data show[s] that [balloon rupture] occurs in 3.6% of balloon use procedures, which is unusual but not outstandingly rare' (T:199.5; 27.06.12).  (Dr Richard Clugston, an interventional cardiologist called by the Board, and Dr Peter Illes, an interventional cardiologist called by Dr Woollard, gave evidence that balloon rupture occurs in only 1 ­ 2% of cases).  Dr Woollard also said that 'the trapping of the balloon and the fact that the catheter could not be withdrawn from the patient, and that she require[d] bypass surgery' were 'really overwhelmingly important aspects of that procedure' and that these circumstances 'really are unique' in his experience (T:200.5; 27.06.12).

7. Given the unusual/unique circumstances in relation to the angioplasty on Patient S, it is highly improbable that Dr Woollard would not have clearly recalled the details of the procedure and, in particular, the maximum pressure to which he caused the balloon to be inflated, when he dictated the letter to Abbott Vascular on the very next day and in the very same place where he carried out the procedure, even if he had performed several angioplasties in between.  Given the circumstances, the events of the angioplasty must have been fresh and clear in his mind when he wrote the letter.  In our view, it is, therefore, highly likely that Dr Woollard's statement to the balloon manufacturer that the balloon 'was initially inflated but would not disrupt the lesion so it was taken to a pressure of 18 without difficulty' is an accurate statement of the maximum pressure to which Dr Woollard caused the balloon to be inflated.

8. As noted earlier, Dr Woollard gave evidence that he 'would not have had access to the insert, and I cannot remember whether, when I dictated the letter, I could remember the RPB of the balloon'.  However, it is highly likely that Dr Woollard would have remembered the RPB of the balloon the day after it burst inside his patient's right coronary artery (an unusual circumstance), part of the ruptured balloon was trapped inside the artery (a unique circumstance, in his experience), and the patient required bypass surgery (a unique circumstance, in his experience).  Furthermore, at the time when he dictated the letter, Dr Woollard had access to the compliance chart of the balloon, because the balloons were located in an unlocked storage area on a wall of the CCL.  Under cross­examination, Dr Woollard conceded that 'if [he] had thought it was important [he] could have' refreshed his memory about the RBP of the balloon (T:231.2; 27.06.12) and that he could have easily found out the RPB if he really wanted to know (T:231.6; 27.06.12).

9. Furthermore, given the unusual/unique circumstances in relation to the angioplasty, the fact that Dr Woollard did not request the amendment of the Event Log the next day is a further indication that it accurately records the maximum pressure to which he had caused the balloon to be inflated. As Dr Clugston said in evidence, if a physician reviews the Event Log and determines that it is inaccurate in any way, 'it is usual practice to request that it be either amended or that a supplementary report be generated' (Exhibit 31 [22]). Given the unusual/unique circumstances in relation to the angioplasty, it is highly likely that Dr Woollard would have independently recalled the maximum pressure to which he had caused the balloon to be inflated a day after the procedure and would therefore have known if the Event Log was inaccurate in that respect.

10. Finally, Mr Ley submitted that as the letter to Abbott Vascular was dictated at the request of the nurse manager and when Dr Woollard 'was doing other things, completely unrelated to this case':

    … it is understandable that he may not have taken the same trouble to be accurate, as he had been when he dictated the Coronary Angioplasty Report [discussed below], and did not cross-check his facts against all the documents.  The letter appears to rely largely on memory, but only one fact is wrong.

11. However, Dr Woollard must have appreciated that the accuracy of the pressure recorded in the letter to Abbott Vascular was critical to the manufacturer in investigating the 'difficulties with this balloon'.  He would, therefore, have reasonably taken care to ensure that the letter, and in particular the maximum pressure referred to in the letter, was accurate.  Furthermore, the circumstances were, as found earlier, unusual/unique in Dr Woollard's experience.  It is highly unlikely that Dr Woollard would not have accurately remembered the maximum pressure to which he had caused the balloon to be inflated when he wrote the letter, given the circumstances of the case.

Coronary Angioplasty Report

1. Dr Woollard gave evidence that, within about 15 minutes of the end of the angioplasty on Patient S, during the mid to late afternoon of 30 August 2006, he sat down in the CCL and dictated a document entitled 'Coronary Angioplasty Report', 'outlining what had occurred during my performance of the angioplasty' (Exhibit 30 [157]). Dr Woollard said that the report was typed by his secretary later the same day and was placed on his file for Patient S which was held in his rooms in Murdoch. The Coronary Angioplasty Report refers to the 'Test Date' of 30 August 2006 but is undated and unsigned. The Coronary Angioplasty Report states under 'Procedure Details' as follows:

   Under local anaesthesia via the right femoral a JR4 guide was passed and sat well in the right coronary.  A BMW wire crossed the mid right coronary lesion without difficulty and was located well distal in the vessel.  A Voyager 2.5 x 15 readily crossed the lesion and was inflated up to 15 without successful dilation of the lesion.  A second inflation produced balloon rupture at 10.  The balloon could not be withdrawn more than 2 cm further up the vessel and continued traction led to disruption of the shaft from the balloon.  At this stage there was an obvious large dissection at the site of the lesion.  The patient remained clinically well throughout the procedure.  Multiple guide-wires were passed to try and cross the lesion again but repeatedly chose the dissection lumen and eventually the procedure was abandoned. 

   The patient was transferred for bypass surgery this evening and was maintained on heparin throughout.  (Emphasis in bold added)

2. Mr Ley submitted that the Coronary Angioplasty Report 'should be accepted as a much more reliable account of what took place than the Event Log' for the following six reasons:

   •'The Coronary Angioplasty Report was made by the cardiologist who actually performed the angioplasty, at a time when the events which had taken place during the angioplasty were fresh in his mind, and not by a nurse who was not involved and had no direct knowledge of those events, but simply entered onto a computer information which she heard called out by another nurse in a different room';

   •'As Dr Woollard said [in cross­examination], the Coronary Angioplasty Report was a clinically important document, which was prepared, with great care and attention, for use in the future management of the patient';

   •'The Coronary Angioplasty Report contains a full account of the events which took place during the angioplasty, as opposed to the Event Log, which is a shorthand account of the monitoring nurse, not of the events, but only of what she heard called out';

   •'The Coronary Angioplasty Report requires no interpretation, whereas the Event Log requires considerable interpretation, and interpretations differ';

   •'The Coronary Angioplasty Report is verified by the direct evidence of Dr Woollard, whereas the entries in the Event Log cannot be verified by other evidence'; and

   •'There was only a very faint attempt to discredit the Coronary Angioplasty Report'.

1. The Board's position, expressed in the cross­examination of Dr Woollard and in the case generally, was that Dr Woollard lied in the statement in the Coronary Angioplasty Report, and in the evidence that he gave to the Tribunal when he said, that the balloon was only inflated to a maximum pressure of 15 atmospheres, rather than 18 atmospheres.

2. In our view, while the question for determination is not whether the Coronary Angioplasty Report is a more reliable account of what took place than the Event Log, but rather whether the Tribunal feels an actual persuasion on the evidence before it that Dr Woollard caused the balloon to be inflated to a pressure of 18 atmospheres, we consider that the Event Log is more likely to be correct in relation to the maximum inflation pressure of the balloon for the following five reasons. 

3. First, whereas the Coronary Angioplasty Report is a self­serving statement, the Event Log is unaffected by any potential self­serving motivation. 

4. Second, while the Event Log may require some interpretation, there is absolutely no doubt as to what '18 ATM/ 29 SEC/ 2,76 + MM' means and indeed Dr Woollard accepted in his evidence in chief that this entry 'suggested that the balloon had been inflated to 18 atmospheres' (Exhibit 30 [199]).

5. Third, the Event Log is a truly contemporaneous record of the procedure, whereas the Coronary Angioplasty Report was dictated after the procedure had ended. 

6. Fourth, the submission that the Coronary Angioplasty Report contains 'a full account of the events which took place during the angioplasty' is contrary to Dr Woollard's own evidence.  In particular, Dr Woollard gave evidence that 'the guide­wire and the balloon catheter may have been trapped in the lesion' before he inflated the balloon (Exhibit 30 [99]).  Dr Clugston and Dr Illes agreed that an adverse event such as the entrapment of the guide­wire and/or balloon is something that should go into the consultant's report of the procedure.  However, the Coronary Angioplasty Report does not refer to the possible entrapment of the guide­wire or the balloon.  Furthermore, the Coronary Angioplasty Report does not refer to the lesion as having been heavily calcified, whereas in his Amended Response to the Board's Application to SAT dated 6 March 2012, Dr Woollard said that he performed the angioplasty on Patient S 'in order to dilate a heavily calcified lesion … in the Patient S's right coronary artery'.  Dr Clugston and Dr Illes both considered the degree of calcification of the lesion as very important, because a balloon is more likely to rupture in the presence of a heavily calcified lesion.

7. Finally, as found earlier, in light of Nurse Collins' usual practice of repeating back information about a balloon inflation to check its accuracy before recording it in the Event Log, it is extremely unlikely that the Event Log is incorrect when it records that the balloon was inflated to a maximum pressure of 18 atmospheres.

Dr Woollard's evidence

1. Dr Woollard testified that he recalls being aware, throughout the procedure on Patient S, that the RPB of the balloon was 14 atmospheres.  He said that, in accordance with his usual practice, he believes that he would have instructed the scrub nurse to inflate the balloon to 8 atmospheres, he recalls the pressure in the balloon reaching 8 atmospheres but not clearing the lesion, and that in accordance with his usual practice, he would then have instructed the scrub nurse to inflate the balloon, in stages, up to 14 atmospheres.  Dr Woollard testified that he could see on the screen showing the procedure that the inflating balloon was having no effect on the lesion, and that this continued to be the case when the pressure reached 14 atmospheres.  At that point, Dr Woollard said that he had a discussion with Dr Ajit Menon, the interventional cardiologist who was supervising him, as to the further action to be taken.  Dr Woollard testified that, as a result of the discussion with Dr Menon, he instructed the scrub nurse to inflate the balloon to 15 atmospheres, which, although he was aware was one atmosphere above the RBP of the balloon, he believed was warranted in an endeavour to clear the lesion.  Dr Woollard gave evidence that, after he had given the scrub nurse this instruction, he saw, from the gauge on the syringe, that she had inflated the balloon to 15 atmospheres, and that the scrub nurse then announced to him and to the monitoring nurse that the pressure in the balloon had reached 15 atmospheres.

2. Dr Woollard testified that, as the balloon had still not cleared the lesion, he then had a discussion with Dr Menon as to whether the balloon should be further inflated in an endeavour to dilate the lesion.  Dr Woollard said that, as a result of that discussion, he told the scrub nurse to deflate the balloon, and the scrub nurse followed his instruction.

3. Dr Woollard testified that, after the balloon had been fully deflated, he told the scrub nurse to reinflate the balloon to 15 atmospheres, the scrub nurse began to reinflate the balloon, but the balloon burst when the pressure reached about 10 atmospheres.

4. In his evidence in chief, Dr Woollard said specifically that:

   I did not, at any time during the angioplasty, instruct the scrub nurse to inflate the balloon to 18 atmospheres.

   Nor, at any time during the angioplasty, did the scrub nurse inflate the balloon to 18 atmospheres.  (Exhibit 30 [186] ­ [187])

5. Dr Woollard was cross­examined extensively about this evidence.  He maintained the position that at the time he gave evidence he independently recalled that he only caused the balloon to be inflated to a maximum pressure of 15 atmospheres, and not to a pressure of 18 atmospheres.  Dr Woollard gave the following evidence in cross­examination:

   Although the events happened six years ago, you still remember a great many of them independently?---I do.

   You are confident that you never ordered the inflation of the balloon to 18 atmospheres?---I am confident.

   That is your independent memory?---It is.

   You remember clearly that the scrub nurse never called out '18 atmospheres'?---If she had, that's what I've said in my witness statement, I would have corrected it.

   So she didn't, because there was no correction?---I have no memory of any correction, so yes, that's the inference to be drawn from that, yes. (T:204.2­204.4; 27.06.12)

   …

   So you have a clear and independent recollection of the balloon getting to 14?---Yes.

   Seeing that the lesion was not dilated?---Yes.

   Discussing what to do next with Dr Menon?---I knew there was a discussion, yes.

   And as a result of that discussion, taking it to 15?---Yes.

   Now, those events are not recorded on the CD obviously?---No.

   They are not recorded in your report of 30 August?---No.

   They are not recorded in your letter to Abbott of the next day?---No.

   They are not recorded on the event log?---No. 

   You have no independent memory refresher to help you recall those events?---Nothing from outside, no.

   Those are things that you remember five years nine months and one day after the procedure when you signed your statement?---Yes.

   Including going to 14?---Yes.

   Having the discussion?---Yes.

   Going to 15?---Yes. 

   (T:227.5­228.1; 27.06.12)

   …

   You maintain that the event log recording that the balloon was inflated to 18 atmospheres is wrong?---I do.

   You did not at any stage hear the scrub nurse call out 18?---I did not.

   Or even 17?---No.

   Or 16?---No.

   But 15?---That is, yes, the case, yes.

   At 15 you instructed her not to inflate it further?---Not in those words, but to deflate the ­ ­ ­

   Deflate it?---Deflate the balloon, yes.

   And she obeyed your instruction?---She did. 
   (T:236.9­237.2; 27.06.12)

1. Although Dr Woollard denied the allegation each time, Mr PD Yovich, who appeared with Ms J McKenzie on behalf of the Board, put to him on a number of occasions, and subsequently submitted, that Dr Woollard's evidence in relation to the maximum pressure to which he caused the balloon to be inflated was untrue.

Finding in relation to whether Dr Woollard caused the balloon to be inflated to a pressure of 18 atmospheres

1. As the Tribunal said, referring to the Briginshaw principle or approach, in Medical Board of Western Australia and Wright [2010] WASAT 48 at [31]:

   In approaching disputed issues of fact, we are mindful that the Medical Board bears the burden of proving the material facts on the balance of probabilities, but that by reason of the nature of the allegations, the Tribunal must feel an actual persuasion of the occurrence or existence of the relevant facts in determining whether or not the case against the practitioner is made out: Briginshaw v Briginshaw (1938) 60 CLR 336 at 361 ­ 362; Neat Holdings Pty Ltd v Karajan Holdings Pty Ltd (1992) 110 ALR 449. (see also Medical Board of Western Australia and Bham [2006] WASAT 190 at [44] ­ [46]).

2. We feel an actual persuasion on the evidence, in accordance with the Briginshaw principle or approach, and find it more probable than not, that Dr Woollard caused the balloon to be inflated to a pressure of 18 atmospheres during the angioplasty on Patient S. 

3. As found earlier, having regard to Nurse Collins' usual practice to repeat back information about a balloon inflation to check it before recording it on the Event Log, and Nurse Knowles' corroboration of Nurse Collins' practice, and indeed Nurse Knowles' evidence that Nurse Collins' practice was 'safe' and that Nurse Collins 'always called back', it is extremely unlikely that the Event Log is incorrect when it records that the balloon was inflated to a maximum pressure of 18 atmospheres. 

4. Furthermore, as found earlier, it is highly likely that Dr Woollard's statement in his letter to Abbott Vascular that the balloon was inflated to 18 atmospheres is an accurate statement of the maximum pressure to which he caused the balloon to be inflated. 

5. The Coronary Angioplasty Report, which states that the balloon was only inflated to 15 atmospheres, is a self-serving statement by Dr Woollard and forms part of a document which does not, on Dr Woollard's own evidence, contain a full account of the events which took place. 

6. Having regard to our findings in relation to the documentary evidence, we do not accept the veracity of Dr Woollard's testimony that he only caused the inflation of the balloon to a pressure of 15 atmospheres.  In arriving at this unfortunate finding, we have borne in mind that Dr Woollard is a senior medical practitioner who has been a fellow of the Royal Australasian College of Physicians since 1982, the Chair of the General Cardiology Council of the Cardiac Society of Australia and New Zealand for the past five years, and is a former National and State President of the Australian Medical Association, positions reflecting high trust and confidence in him.  However, in light of the contemporaneous Event Log and Dr Woollard's own letter to Abbott Vascular written when the events of the angioplasty must have been fresh and clear in his mind, we do not accept Dr Woollard's evidence that he did not cause the inflation of the balloon to 18 atmospheres.

Did the guide-wire become trapped in the lesion before the balloon was inflated?

1. In his Amended Response to the Board's Application to SAT filed on 6 March 2012, Dr Woollard contended that:

   …

   4After [he] had fed the uninflated Balloon over the guide­wire, and into the lesion, but before he had caused the Balloon to be inflated, the guide-wire became trapped in the lesion, and could not be manipulated any further.

   …

   12Further, once the guide-wire became trapped in the lesion, as alleged in paragraph 4 above, it was not possible to withdraw the Balloon from the artery, and use instead a balloon with a higher RBP.  …

2. Although Dr Woollard made, and did not withdraw, the allegation that the guide-wire became trapped in the lesion before he inflated the balloon, his evidence in chief did not go that far.  Dr Woollard's evidence was that, before he instructed the scrub nurse to inflate the balloon, he endeavoured to manipulate the guide-wire and the balloon into a position from which he thought the balloon, once inflated, would be more likely to crush the lesion, but found that he could not do so.  Dr Woollard said that the image that he saw on the screen showing the procedure 'indicated that the guide-wire and the balloon catheter might have become trapped in the lesion' (emphasis in bold added) (Exhibit 30 [98]) and that:

   Notwithstanding that the guide-wire and the balloon may have become trapped in the lesion, I considered that the best approach was to inflate the balloon, and attempt to open the artery. (Emphasis in bold added) (Exhibit 30 [99])

3. Nevertheless, paragraphs 4 and 12 of the Amended Response were not amended, and the issue of whether the guide-wire became trapped in the lesion before the balloon was inflated remained an issue before the Tribunal.

4. Given the evidence of Dr Clugston (which we accept below) that, even if the guide-wire had become trapped in the lesion before the balloon was inflated, this would not have justified the inflation of the balloon to 18 atmospheres, the determination of this issue is of no consequence in relation to the first basis on which the Board contended that Dr Woollard acted carelessly or incompetently, namely in causing the balloon to be inflated to a pressure of 18 atmospheres.  However, as this issue is possibly relevant to the contention made by Dr Woollard at paragraph [12] of his Amended Response to the Board's second basis for contending that Dr Woollard acted carelessly or incompetently, namely in failing to withdraw the balloon and use instead a non­compliant balloon which had a higher RBP, we will address the issue.

5. We are comfortably satisfied on the evidence, in accordance with the Briginshaw principle or approach, and find it more probable than not, that the guide-wire did not become trapped in the lesion after the balloon was placed proximate to the lesion and before it was inflated, for the following three reasons.

6. First, Dr Woollard's own evidence was equivocal; he said that the balloon 'might have become' and 'may have been' trapped in the lesion.

7. Second, Dr Clugston gave evidence, with which Dr Illes agreed, that ordinarily, if one can advance a balloon catheter across a tightly narrowed artery, which all the evidence indicates was the case in relation to the angioplasty on Patient S, 'one will also be able to withdraw it'.  As Dr Illes said, it is 'generally a lot easier to withdraw a wire than advance it' (T:329.5; 27.06.12).  Dr Illes said that he has never come across a situation in which a guide­wire and balloon readily crossed a lesion and then became stuck.  He said that 'in my opinion if they pass easily, they generally don't get stuck' (T:337.5; 27.06.12).

8. Third, Dr Clugston also gave evidence, with which Dr Illes agreed, that, if the guide­wire and/or balloon became entrapped in the lesion prior to balloon inflation, that should have been mentioned in the consultant's report and in the letter to Abbott Vascular.  However, Dr Woollard did not mention the entrapment, or even possible entrapment, of the guide­wire or balloon in his Coronary Angioplasty Report or in his letter to Abbott Vascular.

9. In light of the evidence of Doctors Clugston and Illes, we find that it is unlikely that the guide­wire became trapped in the lesion after the balloon was placed proximate to the lesion and before the balloon was inflated.  Having regard to Dr Woollard's own equivocal evidence and the agreed position of the expert witnesses, we find that the guide­wire did not become trapped in the lesion prior to the inflation of the balloon by Dr Woollard.

Was it unsafe to inflate the balloon to a pressure of 18 atmospheres?

1. Dr Clugston and Dr Illes agreed that balloon rupture is a potentially dangerous event, even though some of the risks associated with it are likely to be transient and tolerated by the body.  However, the expert witnesses disagreed in relation to whether inflation of the balloon to 18 atmospheres was unsafe in the circumstances of the case.

2. Dr Clugston considered that it was 'definitely unsafe' (T:261.9; 27.06.12) to inflate the balloon to 18 atmospheres in the circumstances of the case, because the risk of balloon rupture is increased by inflation over the RBP, particularly where the vessel is significantly calcified.  Dr Clugston explained that 'the consequences of balloon rupture inside a coronary artery are potentially devastating', because of the 'extraordinarily high pressures for a balloon inside a vascular structure' (T:262.3­262.4; 27.06.12).  To illustrate the significant pressure released in an artery if a balloon bursts at 18 atmospheres, Dr Clugston compared the pressure in a car tyre, which is two or three atmospheres. 

3. Dr Clugston explained that there are three major potential consequences of balloon rupture.  First, balloon rupture may result in 'massive barotraumas … from the pressure that is generated from what is essentially a sudden explosion inside the coronary artery with contrast material that escapes the balloon' (T:262.5; 27.06.12).  The effect of the barotrauma is that the artery suddenly has no flow of blood.  However, this is 'generally transient, lasting only minutes' (T:264.5; 27.06.12).

4. The second potential consequence of balloon rupture is that 'typically, not infrequently the artery will dissect or tear' (T:262.9; 27.06.12).  Dissection can be very localised and have little consequence or can be very extensive.  If it is very extensive, the 'dissection can extend down the entire artery and … generate a false lumen ­ in addition to the [true lumen]' (T:265.2; 27.06.12).  Dr Clugston explained that:

   If the false lumen fills up with blood and compresses the true lumen, then that artery is no longer functioning and the area of muscle supplied by that artery becomes ­ that's what we call ischaemic, in other words, it's not getting any oxygen and does not work.

   If that cannot be fixed, if it is not fixed, the patient has a heart attack and the area of muscle dies.  If that's a very large area of muscle death then the patient is at risk of death itself.  (T:265.3­265.4; 27.06.12)

5. The third potential consequence of balloon rupture is that 'particulate matter of the balloon can … [become] entrapped within the coronary artery itself and cannot be extracted' (T:263.5; 27.06.12).  Dr Clugston explained that entrapment of balloon fragments is dangerous because:

   If the balloon completely disrupts, then it will have jagged edges and bits and pieces of balloon that will potentially catch on the artery ­ the wall of the artery, particularly if it's calcified, and you may not be able to extract those from the coronary artery at all.  It may be impossible to get the balloon out, or it may be very, very difficult to get the balloon out, so you're left with residual fragments of balloon. …

   If a large segment of balloon and wire is left inside ­ balloon particularly ­ and wire is left inside the artery, then the artery ­ there is a significant risk that the artery will block, or a very high likelihood or expectation that the artery will block and that the patient would have a heart attack, from which they may or may not survive.  (T:267.3, 267.6; 27.06.12)

6. Dr Illes largely agreed with Dr Clugston about the potential consequences of balloon rupture, but expressed the opinion that it was 'not necessarily unsafe' to have inflated the balloon to 18 atmospheres in this case, on the basis of three factual assumptions which he articulated. 

7. Dr Illes' first assumption was that the balloon used by Dr Woollard was undersized in comparison to the artery.  However, Dr Clugston considered that the balloon used by Dr Woollard was 'probably an appropriately sized balloon' for the artery (T:280.6; 27.06.12), and Dr Illes himself ultimately conceded, in response to questions from Mr Yovich, that 'the vessel downstream from the narrowing … would seem about the same size as the balloon, with the balloon inflated' with the consequence that the balloon used by Dr Woollard was 'appropriately sized' for the artery (T:291.3; 27.06.12).

1. Dr Illes' second assumption was that, although 'in a very calcified lesion, I would be reluctant to take it higher or more than one or two atmospheres above rated burst pressure' (T:269.5; 27.06.12), the lesion in this case was not severely calcified, but only 'moderately' calcified.  Dr Illes said that 'in a softer [that is, not severely calcified] lesion, I might take it up a bit, because it's less likely to rupture' (T:269.5; 27.06.12).

2. However, Dr Illes said that his opinion the lesion in this case was only moderately, rather than severely, calcified, was based on his interpretation of the grading of light and shade on the imagery of the lesion captured by Dr Woollard during the angioplasty, and that he is not familiar with the grading settings for the imagery used at the Mount Hospital.  In contrast, Dr Clugston has some familiarity with the settings used at the Mount Hospital and has performed surgery there.  Dr Clugston expressed the opinion that 'there is absolutely no question in my mind that on the angiogram, the lesion was heavily calcified, the artery was significantly calcified, the site of the lesion was heavily calcified' (T:277.9; 27.06.12).

3. Given that Dr Illes is not familiar with the settings used at the Mount Hospital, whereas Dr Clugston has some familiarity with those settings and has performed surgery there, Dr Clugston's strongly expressed opinion that the lesion was heavily calcified, and Dr Woollards's characterisation of the lesion as 'heavily calcified' in his Amended Response to the Board's Application to SAT, we find that the lesion was severely calcified and that consequently Dr Illes' second assumption is not established on the evidence. 

4. Dr Illes' third assumption, on the basis of which he expressed the opinion that it was not necessarily unsafe to inflate the balloon to 18 atmospheres in the circumstances of the case, was that, according to an angiogram for Patient S in 2004, 'there was no right­sided coronary lesion' at that time (T:274.4; 27.06.12).  However, as Dr Clugston responded, and as Dr Illes then conceded, the earlier angiogram could not 'adequately visualise the artery to see whether or not there [was] a blockage there' (T:276.1; 27.06.12), because a catheter could not be placed directly in the artery to obtain a picture of the artery at that time.  Consequently, Dr Illes' third assumption on the basis of which he expressed the opinion that it was not necessarily unsafe to have inflated the balloon to 18 atmospheres is not established on the evidence.

5. Section 32(2) of the State Administrative Tribunal Act 2004 (WA) (SAT Act) provides that the Tribunal 'is not bound by the rules of evidence' and is to act 'according to equity, good conscience and the substantial merits of the case without regard to technicalities and legal forms'. However, as was observed in the decision of the Commonwealth Administrative Appeals Tribunal in Re Baini and Commissioner of Taxation [2012] AATA 440; (2012) 57 AAR 452 at [119], '[t]here is, though, a difference between not being bound by the rules of evidence and not having regard to them'. Similarly, as the NSW Administrative Decisions Tribunal said in Cornish Investments Pty Ltd v Chief Commissioner of State Revenue [2012] NSWADT 204 at [31], although it is also not bound by the rules of evidence:

   … in considering an application the Tribunal must, however, not ignore the commonly accepted rules of evidence as was suggested by Evatt J when considering a provision similar to s 73(2) in R v The War Pensions Entitlement Appeal Tribunal and another; ex parte Bott (1933) 50 CLR 228 at 256:

   Some stress has been laid by the present respondents upon the provision that the Tribunal is not, in the hearing of appeals, 'bound by any rules of evidence'.  Neither it is.  But this does not mean that all rules of evidence may be ignored as of no account.  After all, they represent the attempt made, through many generations, to evolve a method of inquiry best calculated to prevent error and illicit truth.  No Tribunal can, without grave danger of injustice, sit then on one side and resort to methods of inquiry which necessarily advantage one party and necessarily disadvantage the opposing party.  In other words, although rules of evidence, as such do not bind, every attempt must be made to administer 'substantial justice'.

6. In Cross on Evidence (8th Australian ed, 2010), Justice JD Heydon summarised the conditions for admissibility of expert opinion evidence under the rules of evidence at common law at [29045] as follows (citations omitted):

   First, there must be a field of specialised knowledge.  Secondly, there must be an identified aspect of that field in which the witness demonstrates that by reason of specified training, study or experience, the witness has become an expert.  Thirdly, the opinion proffered must be wholly or substantially based on the witness's expert knowledge.  Fourthly, the expert must identify the assumptions of primary fact on which the opinion is offered ('the assumption identification rule').  Fifthly, the opinion is not admissible unless evidence has been, or will be, admitted, whether from the expert or from some other source, which is capable of supporting findings of primary fact which are 'sufficiently like' those factual assumptions 'to render the opinion of the expert of ... value' ('the basis rule').  Sixthly, it must be established that the facts on which the opinion is based form a proper foundation for it.  Seventhly, the opinion of an expert requires demonstration or examination of the scientific or other intellectual basis of the conclusions reached. 

7. Justice Heydon observed at [29045] that the 'basis rule':

   … does not require any fact to be proved ­ it requires only that there be evidence, admitted or to be admitted, capable of sustaining findings of fact having some correspondence with the expert's factual assumptions.  A rule that the evidence actually proved the assumptions would be impractical, since it will only be after the whole of the evidence is closed that the court can decide what has been proved.  The actual rule of admissibility, in Wigmore's words, requires only that there be 'a fair possibility of the jury accepting' the evidence tendered.

8. Although the Tribunal is not bound by the rules of evidence, as they were developed over the course of centuries 'to prevent error and illicit truth', it is appropriate to have regard to them in considering evidence presented to the Tribunal.  We do not accept Dr Illes' opinion that it was 'not necessarily unsafe' to inflate the balloon to 18 atmospheres in the circumstances of the case for each of two reasons.  First, it is arguable, having regard to the concessions made by Dr Illes in relation to his first and third assumptions referred to above, that there was ultimately no evidence admitted which is capable of sustaining findings of fact having correspondence with those factual assumptions and that there is not a fair possibility of the Tribunal accepting Dr Illes' initial evidence in support of those assumptions.  Having regard to the basis rule for the admissibility of expert evidence, the absence of evidence capable of sustaining findings of fact corresponding to two of the three factual assumptions upon which Dr Illes based his opinion renders that opinion of little, if any, value.

9. Secondly, in discussing the 'assumption identification rule', Justice Heydon said the following in Cross on Evidence at [29065]:

   … the oral testimony, affidavit, statement or report of the witness giving the expert opinion must identify the facts to which the expert applies specialised knowledge in order to arrive at the expert opinion in question.  Some of these facts may be provable by the expert; some may only be assumed.  But unless those facts (either assumed or deposed to by the expert) bear some relationship with the facts eventually found by the trier of fact, the expert opinion given in relation to the facts assumed or deposed to by the expert will be too remote from the primary facts found by the trier of fact to be capable of useful employment by the trier of fact.  That is what Gleeson CJ meant [in HG v R (1999) 197 CLR 414 at [41]] in saying that an expert must provide 'identification of the facts he [is] assuming to be true, so that they [can] be measured against the evidence'.

10. Although the Tribunal is not bound by the rules of evidence, in order for expert evidence to be of value and accepted by the Tribunal, primary facts sufficiently like the factual assumptions upon which the expert evidence is based must be found by the Tribunal.  As we find that none of the three factual assumptions upon which Dr Illes based his opinion that it was 'not necessarily unsafe' to inflate the balloon to 18 atmospheres in the circumstances of the case are established on the evidence, we do not accept his opinion. 

11. Rather, we accept Dr Clugston's opinion that it was 'definitely unsafe' to inflate a balloon with a RBP of 14 atmospheres to a pressure of 18 atmospheres in the circumstances of the case, because the over­inflation of the balloon increased the risk of its rupture, particularly in a heavily calcified lesion, with the potential devastating consequences he discussed.  We accept Dr Clugston's opinion because he has practised as an interventional cardiologist for the past 20 years, has a number of relevant publications to his name, and gave evidence with which Dr Illes largely agreed in relation to the potential consequences of balloon rupture.  Furthermore, Dr Illes agreed that a balloon is more likely to rupture in the presence of a severely calcified lesion and said that in such a case he would be reluctant to inflate a balloon to a pressure greater than one or two atmospheres above RBP.

12. Dr Illes gave evidence that '[in] real life practice, most cardiologists would go beyond rated balloon pressure by maybe one or two [atmospheres], and sometimes a little higher' (T:271.5; 27.06.12).  Dr Clugston accepted that 'it would be not uncommon for practitioners around the country, some practitioners around the country, to exceed [RBP] by one or two atmospheres' (T:306.6; 27.06.12), although he 'would not endorse them, nor consider it safe exceeding the rated burst pressure by one or two atmospheres' (T:307.2; 27.06.12).  Dr Clugston gave the following evidence:

    I believe that people should stop at the rated burst pressure.  That is what the company product information states.  That is what the text books on interventional cardiology state.  That is what contemporary literature states.  That is what is taught.  (T:306.9­307.1; 27.06.12)

13. For the reasons given by Dr Clugston, and having regard to the serious potential consequences of balloon rupture referred to by Dr Clugston, with which Dr Illes largely agreed, we find that, while it may not be uncommon for some interventional cardiologists to exceed the RBP by one or two atmospheres, it is not safe practice to do so.

14. Furthermore, and in any case, Dr Woollard caused the inflation of the balloon in this case not by one or two atmospheres, but by four atmospheres.

15. Dr Illes also gave evidence that, when he has been on outreach teaching programmes in remote areas of Burma, he has often had to take balloons to very high pressures, up to six to eight atmospheres above RBP, because they use donated balloons and stents and often have no other option when performing angioplasties.  Dr Illes said that 'more often than not they don't burst' (T:324.5; 27.06.12). 

16. However, Dr Illes appeared to accept that his Burma experience was inapposite in the present context, as he said that 'it doesn't perhaps relate to, or doesn't relate to what we do in Australia because we have got a lot of the ­ I have got a lot of the normal equipment'.  Furthermore, the fact that 'more often than not [balloons inflated up to six to eight atmospheres above RBP] don't burst' implies that, less often than not, but still not infrequently, they do burst.  We consider Dr Illes' evidence based on his experience in Burma to be entirely unhelpful.

17. In a letter to the Board, Dr Woollard said that balloon rupture 'has no clinical consequence as the balloon contains only a small quantity of the contrast medium'.  Dr Woollard was cross­examined about this statement.  In re­examination, Dr Woollard said that the statement was based on two journal articles, the first published in the journal Angiology in 1986 and the second published in the Canadian Journal of Cardiology in 1999, which he then produced.  However, Dr Illes gave evidence that the articles do not 'displace the accuracy of Dr Clugston's statement' about the potential consequences of balloon rupture (T:295.3; 27.06.12), although they show that 'in most cases balloon rupture is benign' (T:296.2; 27.06.12), an observation with which Dr Clugston did not disagree.  Dr Clugston explained that, because angioplasty only commenced in the late 1970s, and significant developments have taken place since then, the 1986 article is 'of historical interest only … but of no relevance to what we are dealing with today' (T:299.5; 27.06.12).  Dr Clugston explained that the 1999 article 'is not an article that deals with coronary angioplasty and balloon rupture in coronary arteries alone that have not been stented' and that consequently 'we cannot apply the information that comes from it' to the circumstances of this case (T:299.9; 27.06.12).

18. Furthermore, as noted earlier, Dr Clugston and Dr Illes agreed that balloon rupture can have potentially significant adverse consequences.  We, therefore, do not place any weight on the articles produced by Dr Woollard in re­examination.

19. Finally, we note that, even if, contrary to our finding in relation to issue 2 above, the guide­wire became trapped in the lesion prior to the inflation of the balloon, that would not, in our view, have justified inflation of the balloon to 18 atmospheres in the circumstances of this case.  As Dr Clugston explained:

    Over-inflation against that background, thereby risking balloon rupture, would potentially further complicate the issue of guide-wire and/or balloon entrapment.  Rupture of an already trapped balloon and entrapped wire would be expected to amplify the risk of all or part of the balloon and/or wire being irretrievably trapped in the coronary artery.  In that instance, removal of the balloon and wire or their fragments would require open cardiac surgery. (Exhibit 25 [20])

20. Dr Illes also considered that, if the guide­wire and balloon were trapped, inflation of the balloon would be a 'high­risk' (T:332.9; 27.06.12) and 'nasty' situation (T:333.5; 27.06.12), because 'it usually means there's a firm calcific ridge in the area … [and] things are likely to rupture' (T:333.8; 27.06.12).  Although Dr Illes expressed the opinion that, if the interventional cardiologist has exhausted all other options, the only option may be to inflate the balloon in an effort to free its edges, Dr Illes did not say that the entrapment of the guide­wire would justify the over­inflation of the balloon to 18 atmospheres.

21. We find that it was unsafe for Dr Woollard to have caused the inflation of the balloon to a pressure of 18 atmospheres in the circumstances of the case, because over­inflation of a balloon above the RBP increased the risk of balloon rupture, particularly in the presence of a heavily calcified lesion, which could have devastating consequences discussed by Dr Clugston.

Did Dr Woollard act carelessly or incompetently?

1. Section 76(1)(b) of the Medical Practitioners Act 2008 (WA) (MP Act) provides that the following are 'disciplinary matters' under that Act:

   That a person in the course of his or her practise as a medical practitioner ­

   (i)acted carelessly;

   (ii)acted incompetently;

   …

2. The Board submitted that Dr Woollard acted both carelessly and incompetently:

   a)in causing the inflation of the balloon to a pressure of 18 atmospheres; and

   b)in failing to withdraw the balloon before inflating it beyond 16 atmospheres and failing to replace it with a non­compliant balloon with a higher RBP.

Did Dr Woollard act carelessly?

1. In Medical Board of Western Australia and Richards [2010] WASAT 94 (Richards) the Tribunal said the following in relation to the meaning of the expression 'acted carelessly' in s 76(1)(b) of the MP Act, at [26] ­ [28]:

   In our view, acting carelessly for the purposes of the MP Act still requires that the carelessness requires that the conduct complained of assumes a scale of gravity which is sufficiently serious to warrant, in the eyes of professional colleagues of good repute and competence, punishment and disciplinary action for the protection of the public.  That is because s 76 is concerned with professional disciplinary proceedings.  The objects identified in s 3 of the MP Act are designed 'for the purpose of protecting consumers of medical services'.  That object is the traditional object of professional regulatory legislation.  The MP Act is not concerned with civil redress.  The notion of carelessness for the purposes of s 76 differs from what is sometimes described as 'mere negligence' - see Pillai v Messiter (No 2) (1989) 16 NSWLR 197 per Kirby P at 200 ­ 201 (Pillai v Messiter).  Acting carelessly involves, for the purposes of the MP Act, not giving sufficient attention or thought to avoiding harm or mistakes or showing no care or interest or effort in the treatment of a patient, but does not include trivial error not warranting disciplinary action.

   In our view, the term 'acted carelessly' does not encompass an error of judgment where the medical practitioner acts with care and diligence, but simply makes a wrong decision unless, to use the words of Kirby P in Pillai v Messiter, the decision involves a departure 'from elementary and generally accepted standards, of which a medical practitioner could scarcely be heard to say that he or she was ignorant'.

   In identifying whether a medical practitioner has acted carelessly, the assessment must be undertaken without the benefit of hindsight, and must be determined from the nature of the conduct and not from its consequences.

2. In this case, in our view, Dr Woollard acted carelessly, within the meaning of s 76(1)(b)(i) of the MP Act, in causing the inflation of the balloon to 18 atmospheres, because, for reasons given in relation to issue 3 above, it was unsafe to do so in the circumstances and Dr Woollard's conduct was of a scale of gravity which is sufficiently serious to warrant, in the eyes of professional colleagues of good repute and competence, punishment and disciplinary action for the protection of the public. In acting in the way he did, Dr Woollard did not give sufficient attention or thought to avoiding harm to Patient S. Dr Woollard's error was not trivial. Moreover, his actions involved a departure from elementary and generally accepted standards from which a cardiologist training to be an interventional cardiologist could scarcely be heard to say that he or she was ignorant. As noted earlier, Dr Clugston gave evidence that manufacturer product information, text books on interventional cardiology, contemporary literature and 'what is taught' are all to the effect that interventional cardiologists 'should stop at the rated burst pressure' (T:306.9; 27.06.12).

3. Furthermore, Dr Clugston and Dr Illes agreed that, 'given that the lesion was heavily calcified … [Dr Woollard] should have withdrawn the balloon and changed to a [non­compliant] balloon with an RBP of more than 14 atmospheres' (joint statement of evidence, Exhibit 29).  As Dr Illes explained, non­compliant balloons are 'thicker walled' (T:286.9; 27.06.12) and 'expand minimally, however much pressure is inside them' (T:286.7; 27.06.12).  Consequently, as Dr Illes said:

   They don't go through lesions as easily.  They can be inflated to higher pressures and are less likely to ­ they don't grow as large, so you maintain the size of the ­ they maintain their size more uniformly, so you're unlikely to overstretch the artery with a balloon, and you can probably inflate them ­ well, you can inflate them to higher rated burst pressures, and higher than the rated burst pressures, the greater safety.  (T:286.9­287.1; 27.06.12)

1. We do not consider that Dr Woollard's proposed undertaking, or a condition to the same effect, that he will not inflate or cause the inflation of any balloon above its rated burst pressure, is adequate without a condition requiring a period of supervision, to protect the public, because of his demonstrated lack of understanding of the consequences of balloon rupture.  However, having regard to his conduct during the angioplasty on Patient S, a condition precluding Dr Woollard from inflating balloons over their rated burst pressure should be imposed for the protection of his patients.

2. We consider that the imposition of a condition is preferable to the provision of an undertaking to the Tribunal and the Board, because, upon the delivery of the Tribunal's decision in relation to penalty, this proceeding will be at an end and, although s 116(1) of the MP Act does not preclude the giving of an undertaking by a practitioner, an undertaking does not have any statutory status.

What is the appropriate monetary penalty in this case?

1. As noted earlier, the Board contended that, if Dr Woollard were not suspended from practice, but the condition requiring supervision were imposed, then the appropriate monetary penalty under s 116(1)(i) of the MP Act is $20,000. Although Dr Woollard conceded that the imposition of a financial penalty is an appropriate disciplinary consequence of the Tribunal's findings, he contended that the penalty should be $10,000.

2. Mr Ley referred the Tribunal to the penalty imposed on 15 August 2012 in proceeding VR 145 of 2010 following the decision in Medical Board of Australia and Bernadt [2012] WASAT 108. In that case, Dr Bernadt, a consultant ear, nose and throat surgeon, was found to have acted carelessly in relation to a single incident concerning a single patient. The penalty imposed by the Tribunal was a reprimand and payment of $7,500. Mr Ley submitted that the case of Dr Bernadt 'has some similarities to this case'. In addition to the fact that the findings of acting carelessly in both cases involved, in substance, a single incident, Mr Ley submitted that the matters are similar because the practitioner in each was very experienced and had practised in the field for many years, without any adverse findings being made against him. Mr Ley noted, however, that as a result of immediate action taken against Dr Bernadt in relation to another matter, at the time of the penalty hearing, he was no longer performing surgery.

3. In relation to the determination of an appropriate penalty in vocational disciplinary proceedings, great care needs to be taken when having regard to penalties imposed in other cases, although general principles can be observed and applied.  A disciplinary tribunal necessarily exercises a broad discretion having regard to the particular circumstances of each case.  Furthermore, in relation to the Bernadt matter, the Tribunal did not publish written reasons for the penalty decision made on 15 August 2012.  We can, therefore, derive little assistance from that assessment of penalty.

4. In Craig, Doyle CJ said the following at [47]:

   In other cases, the protection of the public or the public interest may justify an order intended to bring home to the practitioner the seriousness of the practitioner's departure from professional standards, and intended to deter the practitioner from any further departure.  A fine might well be imposed with this object.  An order imposing a fine might look like a punishment imposed by a court exercising criminal jurisdiction, but in professional disciplinary proceedings it is imposed on a different basis.  An order might also be made in professional disciplinary proceedings to emphasise to other members of the profession, or to reassure the public, that a certain type of conduct is not acceptable professional conduct.  In the latter case[,] the order is made in part to protect the profession, by demonstrating that the profession does not allow certain conduct.  This, in the end, is also in the public interest.

5. In our view, a financial penalty of $20,000 is warranted in light of the seriousness of Dr Woollard's careless conduct and having regard to the other penalties that we are imposing, in particular the condition that Dr Woollard be supervised for a period, which will put him to considerable expense.  In our view, a financial penalty of $20,000 is necessary in order to bring home to Dr Woollard the seriousness of his careless conduct, deter him and other practitioners from acting in a similar way, and to reassure the public that what occurred in this case is not acceptable professional conduct.  Had we not decided that a condition requiring Dr Woollard to be supervised is warranted, we would have imposed the maximum financial penalty of $25,000.  We consider that a reduction of $5,000 from the maximum penalty is appropriate, despite the seriousness of the careless conduct, because of the expense involved in compliance with the condition requiring supervision.

Testimonials and adverse publicity

1. Dr Woollard presented 10 signed testimonials as to his ability and diligence as a cardiologist.  Two of the testimonials are from other cardiologists, one is from a cardiothoracic surgeon, three are from general practitioners (the wife of one of whom is also a patient) and four are from patients.  Mr Ley submitted that 'the referees all speak very highly of [Dr Woollard] and acknowledge their awareness of the adverse findings made against him'.  While the first statement is correct, the second statement is incorrect.  A number of the authors of the testimonials refer to being aware of 'allegations' regarding Dr Woollard's conduct, some in rather vague and one in inaccurate terms.  However, none of the authors of the testimonials appear to be aware of the Tribunal's findings in the earlier reasons.  This greatly reduces the weight that can be given to the testimonials:  Legal Profession Complaints Committee and in de Braekt [2012] WASAT 58 (in de Braekt) at [89] and [91]; contrast Medical Board of Western Australia and Roberman [2005] WASAT 81 (S) at [15].

2. Finally, we note Mr Ley's submission that, as a result of extensive adverse publicity concerning this case, Dr Woollard has had significantly fewer referrals, with his income from angioplasties being reduced by almost half over the year to 31 October 2012, and has suffered the humiliation of long­term patients seeing other specialists.  As the Board accepted, adverse publicity is a matter which the Tribunal may take into account on the issue of penalty.  However, the significance of adverse publicity is subject to the paramount public interest considerations of the protection of the public, the need to maintain the high standards and good reputation of the profession generally in the eyes of the community, and the need to deter other practitioners from acting in a similar way.  In the circumstances of this case, we do not consider that the testimonials and the adverse publicity and its consequences warrant a reduction in the penalty which we are imposing in terms of reprimand, conditions and financial penalty, having regard to the paramount public interest considerations.

What costs order should be made?

1. In Legal Profession Complaints Committee and in de Braekt [2012] WASAT 58 (S) (in de Braekt (S)) at [51], the Tribunal summarised its approach and practice in relation to costs in vocational disciplinary proceedings as follows:

   Although s 87(1) of the SAT Act contemplates that, generally, parties bear their own costs in proceedings before the Tribunal, s 87(2) of the SAT Act confers a discretion on the Tribunal to make an order for the payment by a party of all or any of the costs of another party. The Tribunal's established practice in relation to the exercise of its discretion as to costs under s 87(2) of the SAT Act in vocational disciplinary proceedings is that a successful application by a vocational regulatory body, such as the Committee, will usually result in an order for costs being made in favour of the vocational regulatory body: Medical Board of Western Australia and Roberman [2005] WASAT 81 (S); (2005) 39 SR (WA) 47 (Roberman) at [30] referred to with approval in Paridis v Settlement Agents Supervisory Board [2007] WASCA 97; (2007) 33 WAR 361 at [35]. The policy basis behind this practice is that vocational regulatory bodies 'perform a function which promotes the public interest, and usually with limited resources' and '[t]he financial burden of bringing disciplinary action if the body had no capacity to recover some or all of its costs may be such as to provide a disincentive to bring disciplinary action, or when brought, to ensure that the allegations against the practitioner concerned are properly and thoroughly presented': Roberman at [30].

2. Dr Woollard conceded that there is no reason why, in the circumstances of this case, the Tribunal should depart from its usual practice in relation to costs in vocational disciplinary proceedings.  An order for costs in favour of the Board should therefore be made. 

3. The Tribunal summarised its approach and practice in relation to the assessment of costs in in de Braekt (S) at [53] as follows:

   In relation to the amount or quantum of costs, the Tribunal's usual practice is to determine the amount of work which was reasonable and necessary to properly prepare and present the case and then to apply, as a useful guide as to the maximum rates which might be allowed on a party/party basis, the relevant hourly or daily rate specified in the Legal Practitioners (State Administrative Tribunal) Determination 2010 (Determination): J&P Metals Pty Ltd and Shire of Dardanup [2006] WASAT 282 (S) at [9] and Marvelle Investments Pty Ltd and Argyle Holdings Pty Ltd [2010] WASAT 125 (S) at [35] ­ [36] and [47] ­ [48]. The Determination prescribes the maximum amounts which can be charged without a written agreement as to costs with a client under s 282 of the [Legal Profession Act 2008 (WA)]. The Legal Costs Committee has not prescribed a scale of costs for the Tribunal in respect of party/party costs, because the Legal Costs Committee has recognised that 'the overriding philosophy of the Tribunal, as expressed through its enabling legislation, is that parties appearing before the Tribunal are to bear their own costs of proceedings': Legal Practitioners (State Administrative Tribunal) Report 2010 (WA) para 3b.  The Determination is, therefore, not binding in the present case, but rather, is to be used as a guide as to the maximum rates which might be allowed on a party/party basis.

4. The Board presented a detailed schedule of the legal costs and disbursements incurred by it in this proceeding.  The schedule was prepared by collating the electronic entries made in the law firm acting for the Board in relation to time spent working on specific tasks in this matter and adding disbursements, including counsel's fees and Dr Clugston's expert fees.  Three solicitors in the firm, each with over five years' experience (and, therefore, a senior practitioner for the purposes of the Legal Practitioners (State Administrative Tribunal) Determination 2010 (Determination)), were involved in performing the work.  All of their time was recorded at an agreed rate of $351 per hour inclusive of GST, which is just below the maximum amount of $352 per hour which can be charged where there is no written agreement as to costs under the Determination.  It was submitted for the Board that its sophisticated nature ensures that negligible 'solicitor and client work' is performed by its legal representatives.

5. The Board's schedule of legal costs and disbursements adds up to a total of $111,052.02 inclusive of GST, being solicitors' fees of $81,314.49 and disbursements of $29,737.53.

6. Mr Ley submitted that the costs and disbursements incurred by the Board in this proceeding should be discounted in three respects.

7. First, although the Board contended in the proceeding that Dr Woollard 'acted carelessly', within the meaning of s 76(1)(b)(i) of the MP Act, and 'acted incompetently', within the meaning of s 76(1)(b)(ii) of the MP Act, it succeeded only in relation to the first contention. The Board properly conceded that its costs and disbursements should be discounted in respect of that part of its case which was unsuccessful. As the Tribunal has observed, 'a person affected by proceedings instituted by a vocational regulatory body should not have to bear the costs of the proceedings or contribute to the costs of those part of the proceedings which were not successfully maintained': Motor Vehicle Industry Board and Dawson [2006] WASAT 8 at [46].

8. As the Board submitted, the task of presenting evidence against Dr Woollard was identical in respect of the allegations of carelessness and incompetency.  Accordingly, the only discrete costs incurred by the Board as a result of making allegations of incompetency were in the preparation of the application to SAT and its closing submissions.  The Board suggested a discount from $111,052.02 to $105,000 to reflect this work.  Having regard to the proportion of the Board's submissions devoted to the contention of incompetency, this is a reasonable discount to make. 

9. Second, Mr Ley submitted that there should be a discount for amendments made to the grounds of the application during the proceeding.  Mr Ley submitted that this related to costs of approximately $3,000 incurred between 9 November 2011 and 21 February 2012.  The Board conceded that a discount was appropriate for this reason, but argued that the period during which amendments to the grounds of the application were proposed and discussed between the parties relevantly ended on 16 December 2011, when consent orders were agreed, rather than on 21 February 2012.  This argument is sound.  Having reviewed the schedule of costs, it appears that approximately $2,200 was incurred in relation to the amendment to the grounds of the application in November and December 2011.  This further discount reduces the amount of costs and disbursements to $102,800.

10. Third, Mr Ley submitted that the amount of costs and disbursements after the first two deductions is excessive and unreasonable 'for a case in which there were only three or four main issues, the [Board] called two witnesses of fact and one expert, there were relatively few documents, there were no complex legal issues and the hearing occupied two days'.  He submitted that, having regard to the discounts referred to earlier, and the nature and complexity of the case, a reasonable allowance for the Board's costs and disbursements would be $75,000.

11. The Tribunal's main objectives stated in s 9 of the SAT Act include to 'minimise the costs to parties'. As the Tribunal said in J & P Metals Pty Ltd and Shire of Dardanup [2006] WASAT 282 (S); (2006) 45 SR (WA) 242 at [38]:

    … [T]he Tribunal's obligation to minimise the costs to parties will be reflected in the costs assessed by the Tribunal as recoverable.  That approach reflects an expectation that representatives of parties before the Tribunal will approach a proceeding in a way that minimises costs to their clients.  If clients choose to approach proceedings before the Tribunal in a way which substantially increases costs for them, it will be a rare case where that increase in costs will be recoverable through a favourable costs order.

12. The Tribunal assesses costs 'in a relatively robust fashion', consistently with its statutory objectives:  Marvell Investments Pty Ltd and Argyle Holdings Pty Ltd [2010] WASAT 125 (S) at [49]; see, for example, Law and Town of Vincent [2006] WASAT 263 (S). Generally speaking, 'any award should be approached in a broad fashion and should not have to descend into [an] inquiry into small items of expenditure': Perth Central Holdings Pty Ltd and Doric Constructions Pty Ltd [2008] WASAT 302; (2008) 60 SR (WA) 194 at [67].

13. The Board submitted, and we agree, that the disbursements incurred by it are reasonable.  The disbursements comprise principally counsel's fees of $23,100 and Dr Clugston's expert fees of $3,520, inclusive of GST. 

14. Solicitors' fees account for approximately $73,000 of the $102,800 in costs and disbursements after making deductions for the unsuccessful contention of incompetency and amendment of the grounds of the application.  At an hourly rate of $351, this equates to approximately 208 hours of work by senior practitioners in relation to this proceeding.  If this work had been done by a single practitioner working a 40 hour week, it would have fully occupied the practitioner for over five working weeks.  While the hourly rate was reasonable, for the purposes of a costs assessment in this Tribunal, 208 hours of solicitors' time was not reasonable and necessary, having regard to the complexity of the matter, the number of issues, the documentary evidence, the number of witnesses and the length of the hearing.  In short, while the rate charged was reasonable, the number of hours spent was not for the purposes of a favourable costs order in SAT.  Having regard to the Tribunal's objective to minimise the costs to parties, Dr Woollard should not be required to compensate the Board for 208 hours of solicitors' time, even at a rate of $351 per hour.

15. For the purposes of the costs assessment in this case, we consider that the following approximate number of hours of solicitors' time would have been reasonable to properly prepare and present the case:

Expenditure item	Number of hours
Application to SAT	5
Preparation for and attendance at six directions hearings and one three hour mediation	16
Documents, witness statements and general preparation for hearing	60
Documents, witness statements and preparation for hearing in relation to additional issue raised by Dr Woollard as to whether the guide­wire became trapped in the lesion	10
Attendance at hearing	20
Closing submissions	10
Penalty and costs submissions	10
Penalty and costs submissions in reply	4
TOTAL	135

1. The Board referred to the assessment of costs in McClure.  In that case the Tribunal assessed costs in the amount of $113,664.43 for a three day hearing (without written submissions).  The Board submitted that 'that matter was comparable to this in respect of the complexity and importance'.  However, we cannot derive assistance from the assessment in that case.  We are unable to form a view to whether the matter was comparable in terms of complexity and importance.  Furthermore, and, in any case, our task is to determine what work was reasonable and necessary to properly prepare and conduct this case.  We are satisfied that 208 hours of solicitors' time was well in excess of what was reasonable and necessary to properly prepare and present this case in terms of costs recoverable through a favourable costs order.

2. We find that 73 of the 208 hours of solicitors' time was not relevantly reasonable and necessary to properly prepare and present this case. At an hourly rate of $351, this equates to $25,623 which should be deducted from $102,800 to determine the amount of costs and disbursements that should be ordered to be paid by Dr Woollard. Consequently, pursuant to s 87(2) of the SAT Act, Dr Woollard should pay the Board's costs and disbursements of this proceeding assessed at $77,177.

Conclusion

1. We consider that the appropriate disciplinary consequence of our findings that Dr Woollard acted carelessly are that he:

   (a)be reprimanded;

   (b)be required to comply with conditions on his registration:

   (i)that he must not perform any angioplasty or stenting procedure unless he is directly supervised and observed by an interventional cardiologist with at least five years' post­accreditation experience, until he has conducted 75 angioplasties as primary operator, but under supervision, over a 12 month period, and has complied with various reporting requirements in relation to the performance of those procedures; and

   (ii)that he must not inflate or cause the inflation of any angioplasty balloon used when performing angioplasties and stenting procedures above its rated burst pressure; and

   (c)be required to pay a penalty of $20,000 to the Board.

1. Dr Woollard should also be ordered to pay the Board's costs and disbursements of this proceeding assessed in the amount of $77,177.

Orders

1. The Tribunal makes the following orders:

   1.The respondent is reprimanded pursuant to s 116(1)(c) of the Medical Practitioners Act 2008 (WA).

   2.Pursuant to s 116(1)(f) of the Medical Practitioners Act 2008 (WA), the respondent must comply with the following conditions on his registration as a medical practitioner (in addition to any other conditions imposed on his registration by the applicant):

   (i)Dr Woollard must not perform any angioplasty or stenting procedure unless he is directly supervised and observed by an interventional cardiologist with at least five years' post­accreditation experience in percutaneous interventional cardiology who has been approved by the Board as Dr Woollard's supervisor until:

   (a)Dr Woollard has completed within a 12 month period at least 75 angioplasty procedures as the primary operator whilst under such supervision and has submitted to the Board a log book setting out:

   (i)a record of the date of each supervised procedure;

   (ii)the laboratory where each supervised procedure took place;

   (iii)the vessel or vessels in respect of which angioplasty was carried out and details of whether the procedure involved balloon angioplasty and/or stenting; and

   (iv)details of any complications of the procedure that were known at the time of submitting the log book;

   (b)the supervisor has verified that the supervisor provided supervision in according with this condition in respect of each procedure referred to in the log book; and

   (c)the Board has approved the log book and advised Dr Woollard in writing of that approval.

   (ii)Dr Woollard must not inflate or cause the inflation of any angioplasty balloon used when performing angioplasties and stenting procedures above its rated burst pressure.

   3.Pursuant to s 116(1)(i) of the Medical Practitioners Act 2008 (WA), the respondent must pay to the applicant a penalty of $20,000 by 16 January 2013.

   4.Pursuant to s 87(2) of the State Administrative Tribunal Act 2004 (WA), the respondent must pay the applicant's costs of this proceeding assessed in the sum of $77,177 by 16 January 2013.

   I certify that this and the preceding [59] paragraphs comprise the reasons for decision of the State Administrative Tribunal.

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   JUDGE D R PARRY, DEPUTY PRESIDENT