Scottish Sheriff Court Decisions

SHERIFFDOM OF GLASGOW AND STRATHKELVIN AT GLASGOW

 

2B2249/08

 

 

 

 

 

 

INQUIRY HELD UNDER THE FATAL ACCIDENTS AND SUDDEN DEATHS INQUIRY (SCOTLAND) ACT 1976, SECTION 1(1)(b)

DETERMINATION by IAN HARPER LAWSON MILLER, Esquire, Advocate, Sheriff of the Sheriffdom of Glasgow and Strathkelvin   following an Inquiry   held at Glasgow on 14, 15 and 16 April, 11 and 14 May and 10 July, all days of 2009   into the death of   MARGARET WESTWATER GILL

 

 

 

 

GLASGOW, 30^th SEPTEMBER 2009. The sheriff, having resumed consideration of the evidence, productions and submissions,

 

 

FINDS AND DETERMINES:

(1) In terms of section 6(1)(a) of the Fatal Accidents and Sudden Deaths Inquiry (Scotland) Act 1976, that Margaret Westwater Gill, whose date of birth was 26 December 1930, and who resided latterly at 6 Solway Drive, Denny, died on 17 November 2005 at 0455 hours within the Western Infirmary, Glasgow;

(2) In terms of section 6(1)(b) of the said Act, that the cause of her death was a massive internal haemorrhage of indeterminate cause;

(3) In terms of section 6(1)(c) of the said Act, that there were no reasonable precautions whereby her death might have been avoided;

(4) In terms of section 6(1)(d) of the said Act, that there were no defects in any system of working which contributed to her death; and

(5) In terms of section 6(1)(e) of the said Act, that there were and are no other facts which are relevant to the circumstances of her death.

 

 

 

 

HAVING MADE THE FOLLOWING

FINDINGS IN FACT

 

Mrs Gill

(1)               Mrs Margaret Westwater Gill was born on 26 December 1930. She resided latterly with her husband at 6 Solway Drive, Denny. She was commonly known as Myra Gill.

(2) As at early November 2005 she was 74 years of age. She was short in stature, being 4 feet 11 inches in height, and suffered from a congeries of medically recognised conditions. Of greatest relevance for present purposes was aortic stenosis, which is a narrowing of the main valve on the left side of the heart. This condition had been diagnosed first in about 2001.

(3) In addition her weight gave her a high body mass index. This placed her firmly within the ranks of the clinically obese. As at early November 2005 her body mass index was stated to be 45. This led to her being described then clinically as morbidly obese.

(4) Moreover, she suffered from several other conditions that did not have an impact upon the circumstances of her death. They were Type 2 diabetes mellitus, for which she was on oral therapy, and polymyalgia rheumatica for which she was prescribed Prednisolone. She also suffered from bilateral lower limb varicose veins and an underactive thyroid gland.

(5) By late 2005 her aortic stenosis had progressed to the point where it was categorised as severe. This made her potentially a candidate for replacement of the aortic valve. She was then under the care of Dr Peter McSorley, a Consultant Cardiologist whom she attended in Falkirk.

 

Mrs Gill's referral to the Golden Jubilee National Hospital, Clydebank

(6) Mrs Gill indicated her wish to be considered for surgical treatment of her aortic stenosis. With that possibility in mind Dr McSorley referred her to Dr Keith Oldroyd, a consultant cardiologist, practising at the Golden Jubilee National Hospital, Clydebank ("the Jubilee") and also at the Western Infirmary, Glasgow ("the Western"). The Jubilee came under the aegis of the National Waiting Times Centre Board and the Western of Greater Glasgow Health Board.

(7) At the material time Dr Oldroyd was, and continues to be, a highly experienced consultant interventional cardiologist. He qualified as a doctor in 1982. He then undertook years of specialist training in cardiology before becoming a clinical lecturer in medical cardiology at the University of Glasgow. He became a consultant in cardiology in 1995 at Hairmyres Hospital, East Kilbride. He transferred from there to the Western in 2002. He assumed responsibility for the cardiac unit at the Jubilee which led to the relocation of cardiology services to that hospital in May 2008. Over many years in practice he has undertaken interventional cardiology including cardiac catheterisation procedures such as angiograms. This is and always has been the predominant focus of his clinical practice. Between about 1999 and April 2009 he had undertaken approximately 500 to 600 cardiac procedures per year of which about one half have been angiograms. That is significantly more than the average consultant cardiologist in the United Kingdom. In addition, inter alia he teaches angiogram procedure to doctors at other hospitals in the United Kingdom.

(8) The referral of Mrs Gill was with a view to examination of her cardiac arteries by means of an angiogram procedure. As at late 2005 no cardiac surgeon would consider performing surgical treatment of aortic stenosis in the case of a patient of the deceased's age and body mass index without the patient first undergoing a cardiac angiogram.

 

What is an angiogram procedure?

(9) A cardiac angiogram is a means whereby the cardiac blood vessels, including their attendant valves, may be examined and visualised radiologically. The condition of those blood vessels does not show up on a plain X-ray and in order to achieve an image a radio-opaque dye has to be injected into them. This injection is achieved by means of a catheter. A cardiac angiogram procedure is a well-established investigative technique, dating back to the 1950's. It is undertaken without general anaesthesia, usually on a day case basis without the need for an inpatient stay.

(10) The procedure is invasive. It is commenced by puncturing with a needle either the radial artery at the wrist or the femoral artery at the groin, and then by inserting a guide-wire into the punctured artery followed by a catheter.

(11) The guide-wire is of small diameter, being 35 thousands of an inch. Its end is "J-shaped". It has a soft curved tip. It is flexible. It is designed for its intended purpose and to avoid incidental trauma to the patient's blood vessels. In particular it is designed so as to deflect if it comes into contact with an obstacle or simply meets resistance. A guide-wire always precedes a catheter when they are both within the body of a patient. To ease the passage of the catheter it is practice to place a sheath in the puncture site partly within the blood vessel.

(12) During the procedure the guide-wire and catheter are directed through the arterial system to the arteries of the heart, and sometimes into the heart. When access is made by way of the femoral artery the guide-wire and catheter require to be passed upwards within the body from the femoral artery into the external iliac artery and from there through the aorta, the lower section of which is known as the abdominal aorta. When the catheter is in an appropriate position a radio-opaque dye is introduced which allows radiological images to be taken of the cardiac arteries, or of the internal structures of the heart. Once the dye has been released, the guide-wire and catheter are withdrawn through the puncture site. Once that is done any bleeding from the puncture site has to be brought to an end by achieving haemostasis.

(13) In some instances the operator may use a vascular closure device at the end of an angiogram procedure to try to ensure that the puncture site has stopped bleeding, or does not begin to bleed. Such devices include angioseals. The use of an angioseal involves the placement of a plastic footplate, some 5 millimetres in length and 2.2millimetres in width on the internal wall of the artery at the point of the puncture. A small piece of collagen is placed on the external wall of the artery over the puncture. The footplate and the collagen plate are then drawn together so that the hole in the artery lies compressed between them.

(14) Angioseals are the most widely used vascular closure devices. More than two million have been used worldwide. The footplate and the collagen plug are both designed to be biodegradable over a period of approximately 90 days. An installed angioseal is an internal implant, lying within the body. It has no external manifestation and cannot be easily removed. Removal of the angioseal prior to it biodegrading would have to be by means of surgery. It should remain apparent upon direct visual inspection of the arterial puncture site for a period in excess of that which occurred between the angiogram procedure and the post-mortem examination of her body.

 

The risks attendant upon an angiogram procedure

(15) All invasive procedures carry a risk. This risk attaches mostly to those who are very elderly or very unwell or both.

(16) The procedure has associated with it certain well known risks. The benefits for the patient outweigh these risks. One of the known risks is of haemorrhage from the arterial puncture site, because the deliberate puncture of an artery gives rise to the possibility of continuing haemorrhage after the conclusion of the procedure. Where haemorrhage occurs this is a complication of the immediate post-surgical period.

(17) Other factors that increase the risk of haemorrhage include gender (the risk is higher in women for an unknown reason) and obesity.

(18) Steps are routinely taken to reduce the risk of haemorrhaging from the puncture site. They begin with the choice of where to puncture. When the puncture site is in the femoral artery the operator seeks to insert the needle at a point below the level of the inguinal ligament and at a point at which the artery passes over the head of the femur. The ideal place to puncture is immediately in line with the midpoint of the head of the femur. This facilitates achieving haemostasis at the end of the procedure because pressure can then be applied to the femoral artery by pressing it against the head of the femur. The use of a puncture site corresponding to the head of the femur is not a guarantee of haemostasis and haemorrhage may still occur post-procedurally.

(19) It is not always possible in practice to achieve this ideal position. All cardiologists who conduct the procedure can expect to have experience of performing a puncture above the inguinal ligament and accordingly into the external iliac artery. For each procedure the operator has to choose an appropriate entry site. Where it is to be the femoral artery, the operator has to be able to palpate the artery and identify its position relative to the head of the femur. In an obese patient this may be particularly difficult.

(20) Where the puncture site is above the head of the femur it may be possible to achieve haemostasis without subsequent haemorrhaging. A puncture site above the head of the femur is not a predictor of haemorrhage but is associated with a higher risk of its occurrence.

(21) The risk of a guide-wire of the type used in an angiogram procedure perforating a vascular structure is approximately zero.

(22) It is unknown in practice for such a haemorrhage to cease post-procedurally and then for a fatal re-bleed to occur from the puncture site some eight days later. Moreover, such an event is not described in the medical literature.

(23) The risk of death from a coronary angiogram is extremely low, at about one in five thousand while the risk of bleeding is between one and two percent.

 

The risk of puncturing the aorta during an angiogram procedure

(24) The accidental puncture or tear of the abdominal aorta is not a known risk or complication of the procedure. It is not recorded as such in the extensive worldwide literature that exists in relation to the procedure.

(25) It would be virtually impossible to puncture the abdominal aorta during the conduct of the procedure. The abdominal aorta has thick elastic walls. It is some 25 to 30 millimetres in diameter. As a major branch of the largest artery in the body it is a particularly robust structure. The equipment used during cardiac angiogram would not be capable of penetrating a healthy aorta.

(26) If an operator were to perforate the aorta during a procedure this would be apparent immediately. The operator would feel resistance to the guide-wire and catheter followed by a release of that resistance as the perforation occurred. Moreover, there would be a sudden loss of blood pressure, followed by a loss of heart rate. Without prompt treatment death would follow soon after.

 

The conduct of the angiogram procedure on Mrs Gill

(27) During the morning of Wednesday 9 November 2005 Mrs Gill was admitted to the Jubilee for an elective angiogram procedure, under the care of Dr Oldroyd. Dr John McDonald, who was then Dr Oldroyd's specialist registrar in cardiology, spoke to her in advance of the procedure. He informed her of what it involved and explained in standard practical terms the risks or complications of the procedure. She then signed the standard form of consent to undergo the procedure as did he. In the form Mrs Gill acknowledged that Dr McDonald had discussed with her specific complications and risks of the procedure including bleeding and death.

(28) At the material time Dr McDonald was in the sixth year of his training in cardiology. In addition to his training in the United Kingdom he had worked for a year in a Canadian centre specialising in interventional cardiology. As a consequence, by November 2005 he was particularly experienced in the conduct of the procedure. He had been undertaking it since 2000. By November 2005 he had carried out some 3,000 diagnostic coronary angiograms. In 2006 Dr McDonald was appointed to be a locum consultant cardiologist. In 2007 he achieved full consultant status.

(29) Dr McDonald carried out the procedure that day on Mrs Gill within the catheter laboratory of the Jubilee. Dr Oldroyd supervised the conduct of that procedure which was performed in his presence in its entirety. The procedure began at 11.39 am and ended at 12.18 pm. Also present was a radiologist who, under the direction of the operator, recorded images of the progress of the procedure.

(30) Dr McDonald decided upon entry by the right radial artery. This proved successful for obtaining the required angiographic images of the right coronary artery, but it was impossible to obtain images of the left coronary artery because he could not pass the guide-wire and catheter to the required area due to the tortuosity of the brachiocephalic vessel.

(31) Dr McDonald was therefore obliged to resort to an alternative entry site so that the catheters could enter the ascending aorta from a different angle. He chose the right groin. Before making any surgical intervention he palpated her femoral artery in the standard way and satisfied himself that he could use it as an entry site. He then effected entry.

(32) He introduced the guide-wire into the artery and followed that with the attendant sheath which enabled the catheter to access the aorta.

(33) The catheter was 5 French, giving it an external diameter of 1.67 millimetres. The sheath was a plastic tube two millimetres in diameter and eleven centimetres in length. He advanced the catheter up the aorta, released the dye where he wanted to and secured the desired angiographic images of the left coronary system and aorta. He encountered no difficulty in passing the guide-wire or catheter through the abdominal section of the aorta or resistance while doing that. The blood pressure and heart rate of Mrs Gill remained stable throughout the procedure.

(34) At the end of the procedure, Dr Oldroyd had the radiologist carry out a femoral angiogram. Its purpose was to check the position of the puncture site. He had adopted this practice prior to November 2005 where access had been by way of the femoral artery. This was not then a routine procedure and was not undertaken at most similar units in the United Kingdom. That is still the case as at spring of 2009. It was an additional precaution adopted by Dr Oldroyd as part of his practice.

(35) The femoral arteriogram showed her puncture site to be in the right external iliac artery, above the crease of the groin and higher than the femoral head. It was about one to two centimetres above the ideal position.

(36) In light of this information, Dr Oldroyd decided that a vascular closure device should be inserted of the type known as an angioseal. Dr McDonald placed that angioseal within the puncture site in the groin and without any technical problems or apparent incident. Once it was in place there were no obvious signs externally of any further bleeding from the wound.

(37) Mrs Gill was thereafter taken to the recovery area, which was a short distance from the catheter laboratory. Dr Oldroyd then dictated a discharge summary with a view to this being typed up and dispatched to Dr McSorley. The summary was typed two days later. It makes no mention of any problems with the conduct of the procedure. In light of the findings obtained as a result of the procedure Dr Oldroyd also dictated a letter to the cardiac surgeons at the Western referring Mrs Gill to them with a request that they consider her for aortic valve replacement, while recognising that she was a high risk case in view of her age, morbid obesity and type 2 diabetes mellitus. It too was typed on 11 November 2005.

 

Relevant events at the Jubilee post procedure

(38) After she arrived in the Recovery Area Mrs Gill began to feel unwell. She became light headed and complained of nausea. Her blood pressure began to drop. These are non-specific signs and could have had different causes. Despite treatment from the nursing staff her condition did not improvement. Dr Oldroyd attended on her and suspected she was suffering from a haemorrhage. He administered to her a drug that would reverse the anti-coagulant drugs given for the angiogram. He arranged for a transfusion of blood. He then went to the radiology department where he spoke to the consultant radiologist on duty, Dr Grant Baxter, and asked him to undertake an emergency CT scan of her abdomen and pelvis.

(39) Dr Baxter graduated in medicine in 1983. He trained in radiology from 1985 until 1993 when he was appointed to the position of consultant radiologist. As at November 2005 he held the post of consultant radiologist at both the Jubilee and the Western.

(40) The task of the radiologist involves obtaining images of patients and then trying to determine a correct diagnosis and liaising with clinical colleagues in order to decide the best treatment.

(41) Imaging by way of CT scan enables the radiologist to show the volume of tissue in the human body and this allows the medical staff to see an image of the internal organs. As at November 2005 the images were in two dimensions.

(42) The CT scan of Mrs Gill was done at about 2.45 pm. Dr Baxter recorded the images created during the scan. There were some 85 images. He informed Dr Oldroyd that the scan showed active bleeding from a source in the right external iliac artery. That was consistent with the source of the bleeding being the puncture site in the artery.

(43) By this time Mrs Gill's condition had stabilised and she was considered fit for transfer to the Western because the facilities for intervention, should that prove necessary, were available there in a way that was not then the case at the Jubilee. Dr Oldroyd arranged for that transfer by emergency ambulance. Before she left for the Western a blood transfusion was commenced. She arrived at the Western prior to 4.00 pm.

(44) That same day Dr Baxter dictated a report on the CT scan which was typed up subsequently. Within it he referred to there being at least three active bleeding points.

(45) The reference in the report to three bleeding points was not a reference to three sources of bleeding. There was only one source, that being from the right external iliac artery. The bleeding points were the areas to which the blood had tracked from this single source. The blood from the bleeding site travelled in three different directions: (1) into a pseudo aneurysm; (2) into her right flank; and (3) into the right psoas muscle.

Had there been another source of bleeding within the abdomen or pelvis this would have been seen on the CT scan.

(46) The CT scan disclosed no tear in the abdominal aorta and no abnormality within that vessel. If there had been such a tear or abnormality in the aorta with attendant leakage of blood, either would have been seen on the CT scan.

(47) The abdominal aorta was intact and undamaged when the CT scan was performed.

 

The management of Mrs Gill at the Western

(48) On arrival at the Western Mrs Gill was seen by a specialist registrar, Dr Nicola Walker and then admitted to the coronary cardiac unit (CCU). Dr Oldroyd followed Mrs Gill to the Western where he discussed her condition with Dr Walker, with Mr Alan McKay a consultant vascular surgeon and with Dr John Moss a consultant intervention radiologist who was on call at Gartnavel General Hospital. Both Mr McKay and Dr Moss were very experienced in their own fields of expertise.

(49) Mr McKay reviewed Mrs Gill on the ward in the presence of Dr Oldroyd. By this time she was haemodynamically stable. The consensus of opinion made at that time was that any bleeding had stopped. This was reinforced by their empirical experience that retroperitoneal haemorrhage normally stops without surgical intervention.

(50) For a patient in the condition of Mrs Gill, surgical intervention by a vascular surgeon would have placed her at a very high risk of complications due to her aortic stenosis taken together with her recent blood loss, weight and diabetes.

(51) The consensus of opinion on how she should be managed was that it should be conservatively. That decision was taken in the exercise of a clinical judgement involving a balance between the value to her management strategy of further invasive procedure set against the magnitude of the risk to her. That opinion governed her care throughout her time as an in-patient at the Western.

(52) Dr Oldroyd met Mrs Gill's husband, Mr William Gill, her daughter Mrs Ann McGuiness and her son-in-law, Mr Peter McGuiness at the Western. He told them that the angiogram had caused a haemorrhage but that this was under control. Those family members accepted that information at that time.

(53) Later that evening Dr Walker noted that Mrs Gill was vastly improved, with much better blood pressure and colour. The clinical aim was to achieve a haemoglobin level of between 8 and 10.

(54) The clinical system in operation at the Western at the material time was that all patients in the CCU were under the care of one nominated consultant cardiologist for the period from Monday to Friday during normal working hours, and of one on-duty consultant on Saturdays and Sundays.

(55) Mrs Gill was admitted to the CCU on Wednesday 9 November 2005, when the responsible consultant was Professor Stuart Hillis. Over the weekend of 12 and 13 November the responsible consultant was Dr Dunn and for Monday 14 to Friday 18 November it was Dr Mitchell Lindsay. Each of these consultants saw Mrs Gill. In addition, Dr Oldroyd made a point of seeing her in the CCU on both 10 and 11 November.

(56) On Monday 14 November Dr Lindsay arranged for her transfer to a general cardiac ward within the Western when the consultant responsible for her care once again became Dr Oldroyd. He saw her on the ward on Monday 14 and on the morning of Tuesday 15. She was also seen on the ward by Mr Allan Faichney, a consultant cardiac surgeon.

(57) During her time on the ward Mrs Gill was also seen by Dr Alcorn, a consultant radiologist, and by Dr Daly, a nephrologist.

(58) The consensus of opinion of all the doctors who saw her was that conservative management was appropriate for her and that that regime should continue.

(59) Throughout her time at the Western, much of Mrs Gill's care on a daily basis was devolved to doctors below the status of consultant and to nursing staff.

(60) Dr Oldroyd did not see the deceased between the morning of 15 November and her death. Apart from one visit to see Mrs Gill on 10 November Dr McDonald played no part in the deceased's care at the Western.

(61) As a consequence of her resuscitation on 9 November Mrs Gill developed acute renal failure. This was a foreseen and foreseeable consequence of the necessary treatment of her initial haemorrhage. A balancing exercise had to be performed between improving her renal function and her haemologic status. Enough fluid had to be given to protect her renal function without causing heart failure.

(62) By 15 November her renal function was much improved. This was in part the result of administering intravenous colloid fluids into her. A possible effect of such fluids can be to reduce the haemoglobin in the blood due to a dilution effect. A drift downwards in Mrs Gill's haemoglobin levels to 14 November was at the time attributed to this. Although in isolation a decline in haemoglobin can be indicative of internal bleeding her blood pressure and heart rate remained essentially normal. This lent support to dilution being the explanation for her reduced haemoglobin level. As at 14 November her haemoglobin level had declined to 8.6. Dr Oldroyd instructed that if it dropped below 8 then she should be transfused with two units of blood.

(63) On 15 November, test results became available that showed it had declined further to 6.8. The junior doctors on the ward thereupon initiated blood transfusion. They gave her a total of three units of blood: the first on 15 November during the lat afternoon or early evening, the second on 16 November at 2.00 am and the third during the evening of 16 November. The deceased's blood pressure was stable and satisfactory throughout.

(64) Dr Oldroyd was not informed of the drop in the haemoglobin to 6.8. Had he been informed he would have suspected that she could be haemorrhaging once again, even although her blood pressure remained stable and satisfactory and he would have wanted a further CT scan performed on an urgent, but not on an emergency, basis.

(65) As at 15 November, there was no likelihood that she was in immediate danger from a renewed bleed at her femoral access site. There was no reason to think that there might be a sudden catastrophic bleed from the site that would place the deceased's life in danger. There was no reason to suspect a bleed from any other source.

(66) An unnamed junior doctor noted in her hospital records on 16 November: "? angio if haemoglobin continues to fall". In context this is a reference to the type of CT scan necessary to investigate possible internal bleeding. The junior staff was alert to the possibility of haemorrhage.

(67) Had Dr Oldroyd, or anyone else suitably authorised, asked for a CT scan on 16 November it would have been performed on 17 or 18 November. It would not have been performed by the time of Mrs Gill's death.

(68) The only difference in care had Dr Oldroyd been informed of the Haemoglobin reading of 6.8 is that at the time of her death the deceased would have been awaiting a CT Scan.

(69) During 16 November staff made entries in Mrs Gill's hospital records that suggest she looked well, was independently mobile and was uncomplaining.

 

The final collapse and death of Mrs Gill

(70) At about 3.40 am on Thursday 17 November Mrs Gill collapsed. Despite attempts at resuscitation by medical and nursing staff she died at 4.55 am.

(71) Her collapse was the outward sign of a very sudden catastrophic haemodynamic deterioration in her condition that could not have been predicted.

(72) Her death was attributable to that sudden catastrophic deterioration. It took the form of a massive internal haemorrhage.

 

Dr Oldroyd's response to her death

(73) Dr Oldroyd reported the death to the procurator fiscal who instructed a post-mortem examination of Mrs Gill's body. At the time of reporting Dr Oldroyd was uncertain as to what the cause of death might have been. He suspected possible pulmonary embolism brought on by the deceased's immobility. He was aware that persons with aortic stenosis are prone to sudden death. He suspected haemorrhage due to the manner of the deceased's sudden collapse. He was concerned that, if so, the angioseal might have malfunctioned. If the procurator fiscal had decided not to instruct a post-mortem then Dr Oldroyd would have sought the family's permission for a hospital autopsy.

(74) Dr Oldroyd telephoned the deceased's home later on the morning of her death to speak to her family. He spoke to her son-in-law, Peter McGuiness. Dr Oldroyd offered to meet the family and answer any questions that they might have, but his offer was declined by Mr McGuiness. The family did not thereafter seek a meeting with Dr Oldroyd.

 

The concerns of her family

(75) Prior to the death the family had been seeking a meeting with Dr Oldroyd. Their concerns were that they had been unable to meet with Dr Oldroyd after 9 November to discuss their concerns about her despite having requested meetings by way off nursing staff and Mr Faichney.

(76) Neither Dr Oldroyd nor his secretary received messages that family members were seeking a further meeting with him. Had he known that, he would have tried to make arrangements for this even although the system for consultant responsibility for CCU patient care meant that he was not the consultant in charge of her care while she remained in that unit.

 

The post mortem and its recorded findings

(77) The pathologist instructed by the Crown was Dr Tobias Hatter, a Senior Lecturer and Honorary Consultant in the Department of Pathology of the University of Glasgow. He had qualified as a doctor in 1996. Between February 2001 and June 2006 he worked as a forensic pathologist at Glasgow University. He became a senior lecturer in 2003. This post carried with it the status of honorary consultant. He resigned from that post in June 2006 on the ground of ill health. He has not worked in medicine since then.

(78) His post-mortem examination of Mrs Gill's body took place in the Glasgow City Mortuary on 21 November. Dr Oldroyd wanted to attend the examination but was unable to do so. Before it took place he contacted Dr Hatter by telephone before the examination and discussed the case with Dr Hatter. In particular he asked Dr Hatter to look for the angioseal and explained to him what an angioseal was.

(79) After the post-mortem examination Dr Oldroyd again spoke by telephone with Dr Hatter who indicated that he had been unable to locate the angioseal. On Dr Oldroyd expressing surprise at this Dr Hatter undertook to look again for the angioseal and to take tissue blocks for examination. Dr Hatter said that he would get back to Dr Oldroyd but never did so.

(80) Dr Hatter's account to Dr Oldroyd was consistent with a haemorrhage from the puncture site in the right groin. At no time during the conversation did Dr Hatter suggest to Dr Oldroyd that during the examination he had found a tear in the deceased's abdominal aorta. Had that been said it would have rendered irrelevant Dr Oldroyd's concerns about the missing angioseal.

(81) Dr Oldroyd referred to his telephone conversation with Dr Hatter in a letter to Dr McSorley dictated and typed on 24 November 2005. In that letter Dr Oldroyd stated inter alia:

"The Pathologist told me that he thought the haematoma had ruptured into her abdominal cavity and presumably that released the pressure in the peritoneal space and allowed further bleeding from the original problem in the right external iliac artery."

(82) After concluding his post-mortem examination Dr Hatter, as certifying registered medical practitioner, registered the death of Mrs Gill on 22 November 2005 in the district of Falkirk. He gave the cause of death as: "I (a) Massive haemorrhage (b) Catheterisation procedure for angiogram". He also noted her aortic stenosis as a significant condition but opined that it did not cause her death.

(83) On 20 December 2005 Dr Hatter issued a post-mortem report on Mrs Gill to the Procurator fiscal, Glasgow. In that report he stated the cause of death as: "1a Massive haemorrhage due to b Tear in the abdominal aorta due to c Catheterisation procedure for angiogram". He also noted 2: aortic stenosis.

(84) Inter alia he narrated that at post mortem he had found Mrs Gill's peritoneal cavity contained approximately 1.5 litres of fresh blood and clot.

(85) There was no evidence at post mortem that the source of the massive internal haemorrhage that caused the death of Mrs Gill was the catheter insertion site in her right groin.

(86) The tear in the abdominal aorta found at post mortem was not caused by the angiogram procedure conducted on 9 November 2005.

 

My conclusions on various significant decisions taken in respect of her care and treatment between 9 and 17 November

(i) The angiogram procedure

(87) Dr Oldroyd's decision to allow Dr McDonald to carry out the procedure on Mrs Gill was appropriate in the whole circumstances then pertaining and known.

(88) Dr Oldroyd's decision to observe and supervise the conduct of the procedure was appropriate. Had Dr McDonald experienced problems during his conduct of the procedure Dr Oldroyd, as his supervisor, would have been aware of this and could have advised or even assisted as required.

(89) The initial choice of entry by way of the right radial artery was appropriate in the circumstances.

(90) The subsequent choice of entry by way of the right groin was also appropriate.

(91) The fact that the puncture site was higher than the ideal was not a cause for concern over its possible consequences for Mrs Gill, because both Dr Oldroyd and Dr McDonald were highly skilled and experienced in this procedure.

(92) Dr Oldroyd's instruction of a femoral arteriogram at the end of the procedure was appropriate.

(93) Dr Oldroyd's decision to seal the puncture site by means of an angioseal closure device was appropriate.

 

(ii) Post procedure at the Jubilee

(94) Dr Oldroyd's decision to administer a drug to reverse the anti-coagulant drugs to Mrs Gill in the recovery area was appropriate.

(95) Dr Oldroyd's decision to order a CT scan was appropriate.

(96) Dr Oldroyd's decision to refer Mrs Gill to the Western, and have her taken there by ambulance as an emergency, was appropriate.

 

(iii) Her treatment at the Western

(97) The decision taken jointly by Dr Oldroyd, Mr McKay and Dr Moss at the Western on 9 November after examining Mrs Gill, that her care and treatment regime should be one of conservative management, was appropriate in the whole circumstances then known to them.

(98) The course of treatment that Mrs Gill received at the Western from the time she arrived until the early hours of 17 November was appropriate within the context of a conservative management scheme.

(99) The delegation of the responsibility for her day to day care on the ward to junior doctors and to nursing staff was appropriate.

 

 

 

 

 

 

MOREOVER

Continues consideration of the motion made on behalf of both the National Waiting Times Centre Board and the Greater Glasgow Health Board, opposed by the Crown, to find the Crown liable to both Boards in the expenses of the inquiry, Appoints the Boards and the Crown to be heard thereon and Assigns as a diet therefore 28^th October 2009 at 10.00 am within Glasgow Sheriff Courthouse, 1 Carlton Place, Glasgow.

 

 

 

 

 

 

 

 

 

 

 

 

NOTE:

Introduction

[1] This Fatal Accident Inquiry has been convened to inquire into the circumstances of the death of Margaret Westwater Gill ("Mrs Gill") which occurred on 17 November 2005 within the Western Infirmary, Glasgow at the age of 74 years.

 

[2] The duty on me as the sheriff presiding over the inquiry is set out in section 6 of the Fatal Accidents and Sudden Deaths Inquiry (Scotland) Act 1976 ("the Act"). It is to hear all the evidence tendered and any subsequent submissions made on that evidence, and then make a determination setting out the circumstances of the death of Mrs Gill under reference to the five considerations set out in that section, in so far as they have been established to my satisfaction. Had that been the only task facing me I could have accomplished it in relatively short compass. However, I have been given another matter to deal with, a motion at the instance of the two Health Boards represented at the inquiry for an award of expenses in their favour from the Crown. I have still to hear that motion, which is opposed by the Crown, and will do so after issuing this determination, of which this Note forms an integral part, and in conformity with the interlocutor which precedes this Note. That motion, in the terms in which it has been intimated to me, can be expected to cover questions arising out of both the Crown preparation for and presentation of the inquiry.

 

[3] Conscious of that I have felt it right to narrate in this Note far more about that preparation and presentation than would be required by a strict adherence to the statutory dictates for determining the circumstances of the death of Mrs Gill. On one view I could have left this additional task until after hearing the motion but I concluded that it would be much more helpful to both the Crown and the Health Boards if I used the medium of this Note to give in greater detail an account of both preparation and presentation albeit I can do that only from the perspective of the Court. Doubtless at the forthcoming hearing more will have to be said on these matters, additional facts adduced and differing interpretations of events offered, but what I narrate might help both parties in presenting the motion and perhaps have the ancillary benefit of shortening the hearing. The course I have adopted has inevitably lengthened this Note substantially and consequently it has also taken significantly longer to issue this determination.

 

Why this Inquiry?

[4] The Crown have requested this inquiry under section 1(1)(b) of the Act. That provision gives the Crown, in the exercise of their discretion, the right to apply to the sheriff for the holding of such an inquiry where it appears to be expedient in the public interest on the ground that the death was sudden, suspicious or unexplained, or has occurred in circumstances such as to give rise to serious public concern.

 

[5] In this case the Crown have acted because they received information from the pathologist who carried out the post-mortem examination of Mrs Gill that linked her death to the angiogram procedure which she underwent on 9 November 2005 within the Golden Jubilee National Hospital, Clydebank, ("the Jubilee") eight days before her death. That procedure was conducted by Dr John McDonald, then a specialist registrar in cardiology, supervised throughout by Dr Keith Oldroyd, a consultant cardiologist. Shortly after its conclusion her condition deteriorated to the point where Dr Oldroyd arranged immediate palliative treatment for her and an examination by way of CT scan, which was conducted by Dr Grant Baxter, a consultant radiologist. Dr Baxter's report of his findings led Dr Oldroyd to arrange for her immediate transfer to the Western Infirmary, Glasgow ("the Western") where she was admitted initially for examination and then retained as an in-patient initially in the coronary cardiac unit and then on a general cardiac ward. She collapsed on the ward at about 3.40 am on Thursday 17 November and despite urgent medical attention including transferring her to the coronary cardiac unit she suffered a fatal cardiac arrest and was pronounced dead at 4.55 am.

 

[6] The office of the procurator fiscal instructed a post-mortem examination on the body of Mrs Gill because her death was deemed sudden and unexplained. It was conducted by Doctor Tobias Hatter, a senior lecturer and honorary consultant in the Department of Pathology in the University of Glasgow. He conducted that examination on 21 November 2005 and as a result of it, completed a death certificate for her which, as the certifying registered medical practitioner, he duly registered in the district of Falkirk on 22 November 2005. It affirmed that she had died at 04.55 hours on 17 November 2005 within the Western, and narrated as the causes of her death a massive haemorrhage, related to a catheterisation procedure for an angiogram. A further significant condition contributing to her death but not related to the condition he gave as aortic stenosis.

 

[7] Subsequently he prepared a post-mortem report for the procurator fiscal. It is dated 20 December 2005, slightly under one month later than both the examination and the death certificate. That report added the cause of death that was to prove of critical significance for this inquiry. He found as a fact that her peritoneal cavity contained approximately 1.5 litres of fresh blood and clot and went on to say:

"There was a large retroperitoneal bleed associated with a tear in the aorta, approximately 3cm distal to the renal bifurcation."

He took up this finding in his conclusions, which were in the following terms:

"I was informed that the deceased had undergone a catheterisation of her right femoral artery for a coronary angiogram. She had subsequently developed a large retroperitoneal bleed. This was from a tear in the abdominal aorta, most likely caused by the catheter insertion. This is a recognised but rare complication of a catheterisation procedure. There was no evidence that the haemorrhage had occurred from the site of catheter insertion although the angioseal closure device (a device to block the hole that the catheter mde within the right femoral artery) could not be identified. In addition the deceased had severe aortic stenosis which would have compromised her cardiovascular system significantly."

Accordingly he attributed her death to a massive haemorrhage due to a tear in her abdominal aorta which was itself due to the catheterisation procedure for an angiogram. While the certificate attributed her death in a general and in specific way to the catheterisation procedure, the report introduced a previously unexpressed but specific cause.

 

[8] It is that finding and those conclusions that must be held to have prompted the Crown to request this inquiry. If they were correct they could explain why she died suddenly and unexpectedly. Not only had they linked her death to the angiogram procedure in general, they had introduced a specific cause of death, the aortic tear. While both the general and the particular might be said to demand explanation it is the latter that is much more alarming. An angiogram procedure involves invasive surgery, and while any invasive surgical procedure carries within it an inherent and understood risk of consequences and complications of which the most serious is death, in the conduct of this procedure there should be no place for tearing the abdominal aorta. Beyond that in general, the death rate from the procedure is acknowledged in the available literature and in the experience of practicing cardiologists to be very small and usually as a consequence of post procedural haemorrhaging but that was not the conclusion of the pathological report. Indeed it made no link, direct or indirect, express or implied, between the puncture site in the groin and the pool of blood and clot that Dr Hatter found in her peritoneal cavity. Instead it proposed a cause of death that could be attributed to the conduct of the procedure and therefore raised immediately the question of the clinical competence of the two cardiologists involved: Dr McDonald as the operator and Dr Oldroyd as the supervisor. By inference it also raises questions about what should have been done post-procedurally to diagnose and then treat that cause of death between 9 and 17 November, and this introduced consideration of the actions and decisions of Dr Oldroyd made at both the Jubilee and the Western, and the management regime of Mrs Gill at the Western that was decided upon jointly by Dr Oldroyd, Mr McKay and Dr Moss and then implemented throughout her time there as an in-patient by and large by medical staff at a more junior level than consultants and by the nursing staff.

 

The function and purpose of a fatal accident inquiry

[9] All fatal accident inquiries are brought under, and are governed by the provisions of, the Act. It imposes duties on the Lord Advocate, the procurator fiscal for the district with which the circumstances of the death in question appear to be most closely connected and the sheriff to whom application is made for holding an inquiry. It also makes provision for making rules that govern procedure and the payment of fees, and the procedural rules currently in force are the Fatal Accidents and Sudden Deaths Inquiry Procedure (Scotland) Rules 1977 ("the Rules").

 

[10] The primary duty on the sheriff is that enjoined by section 6(1) of the Act: to issue a determination at or as soon as possible after the conclusion of the evidence and any submissions thereon setting out the circumstances of the death in question by reference to the five criteria listed in that subsection so far as they have been established to his satisfaction. Those five are: -

(a) where and when the death and any accident resulting in the death took place;

(b) the cause or causes of such death and any accident resulting in the death;

(c) the reasonable precautions, if any, whereby the death and any accident resulting in the death might have been avoided;

(d) the defects, if any, in any system of working which contributed to the death or any accident resulting in the death; and

(e) any other facts which are relevant to the circumstances of the death.

The scope of all fatal accident inquiries is determined, delineated and circumscribed by this subsection.

 

[11] The function of the sheriff at a fatal accident inquiry in making his determination does not include making any finding of fault or apportioning blame between any persons who might have contributed to the accident. The Act does not empower the sheriff to do that. This was authoritatively stated in the case of Black v Scott Lithgow Limited 1990 SC 322; 1990 SLT 612 in which Lord President Hope, in his opinion, took the opportunity to state the function in the following terms: -

"There is no power in this section to make a finding as to fault or to apportion blame between any persons who might have contributed to the accident. ... It is plain that the function of the sheriff at a fatal accident inquiry is different from that which he is required to perform at a proof in a civil action to recover damages. His examination and analysis of the evidence is conducted with a view only to setting out in his determination the circumstances to which the subsection refers, insofar as this can be done to his satisfaction. He has before him no record or other written pleading, there is no claim or damages by anyone and there are no grounds of fault upon which his decision is required. The inquiry is normally held within a relatively short time after the accident ...It provides the first opportunity to canvass matters relating to precautions which might have avoided the death or any defects in any system of working which contributed to it, at a stage when these issues have not been clearly focused by the parties to any future litigation which may arise. And it is not uncommon ... to find questions being asked about possible precautions or defects which are not the subject of averment in the subsequent action of damages." (p 327 and 615G to H)

 

[12] As Lord President Hamilton observed in the recent case of Global Santa Fe Drilling v Lord Advocate 2009 SLT 597 under reference to Black "[a] fatal accident inquiry is a statutory procedure" .. and "[a]lthough the sheriff presiding at it has judicial duties ...he does not sit to determine the rights or obligations of parties" (paragraph [28] at p 604). It is a fact finding inquiry not a fault finding inquiry. It is inquisitorial in form rather than adversarial. The standard of proof of the circumstances of the death is on the balance of probabilities. The onus of proof rests on the Crown because, by virtue of section 1 of the Act, the duty of investigating those circumstances lies on the Crown.

 

[13] The word "accident" is not defined in the Act. Various views have been expressed as to its meaning and scope. In his Determination following an Inquiry into the death of Alexander Cusker, dated 16 December 2008, Sheriff J K Mitchell sitting at Glasgow Sheriff Court expressed the following views:

"[4] In Mr I H B Carmichael's Sudden Deaths & Fatal Accident Inquiries, third edition, at para 5.69, the learned author states:- 'Accidents can occur anywhere and in almost any context...If a patient died...as the result of an error which occurred in a...therapeutic procedure, that death results from an 'accident'. I respectfully accept the learned author's approach to and interpretation of the term 'accident' as it is used in the 1976 Act. In its common usage, an 'accident' is 'an unfortunate incident that happens unexpectedly and unintentionally, typically resulting in damage or injury': see the New Oxford Dictionary of English."

I respectfully adopt and follow that approach.

 

The procedure in the present application to the start of the inquiry

(i) The application

[14] The Crown in due course, some three years after the death of Mrs Gill, made application to this Court to hold an inquiry under the Act into the circumstances of her death. In it the Crown, as required, gave as a brief narration of the circumstances of her death, and, adopting the conclusions of the post-mortem report, stated that it was caused by a massive haemorrhage due to a tear in the abdominal aorta due to a catheterisation procedure for angiogram and aortic stenosis. Accordingly, from the outset of these proceedings the principal focus of attention was on the tear in the abdominal aorta.

 

(ii) The expert instructed by the Crown

[15] Prior to taking that formal step the Crown investigations had led them to seek the assistance of Dr Kevin Jennings, a consultant interventional cardiologist at Aberdeen Royal Infirmary. The Crown gave him copies of the post-mortem report, the medical notes from the Western Infirmary and a statement given by Dr Oldroyd. This last was not placed before the Inquiry. He was not at that stage given a copy of the CT scan report. Dr Jennings' Report, dated 6 December 2007, is Crown Production no. 3. In it he voiced concerns about three features that potentially concerned events at both the Golden Jubilee Hospital and the Western Infirmary: how the procedure was performed; the post operative treatment; and the presence of the aortic tear.

 

[16] On the first feature he concentrated upon the consequences of entry by the femoral artery, particularly in an obese patient, and stated:

"The presence of considerable obesity by definition increases the difficulty of cardiac catheterisation because it makes vascular puncture more difficult, impairs the ability to visualise the coronary anatomy by imaging and perhaps, of more relevance here, it can serve to mask some of the clinical developments which might have raised the anxiety of the attending clinicians. For example, the ability to examine Mrs Gill's abdomen would have been considerably impeded by her obesity and there would have been little or no prospect of identifying by palpation for example, a collection of blood (a haematoma) whereas this is likely to have been identifiable in a person of normal habitus. Whilst it is true that haemorrhage is a recognised complication of invasive cardiology, this is usually at or near the site of puncture (in the groin) and there is some mention of the puncture being 'high'. The problem with high (too close to the abdomen) punctures is that there is less potential for pressure on the puncture site to stem bleeding. If the puncture is performed correctly in the groin at the level of the inguinal ligament, there is the ability to press on this site to safely achieve haemostasis."

 

[17] On the second feature he noted a haemoglobin of 6.8 six days after angiography against an admission haemoglobin of 11.2 and this despite transfusion suggested that there was continued blood loss over this prolonged period of time and went on to state:-

"It is clear that Mrs Gill had a very severe and life-threatening haemorrhage as indicated by her dramatically lowered blood pressure and her continued loss of haemoglobin days after fluid and blood replacement and resuscitation. It is acknowledged that the diagnosis was made and the opinion of a Vascular Surgeon sought. I cannot criticise the decision to manage her conservatively with hindsight, since the Vascular Surgeon had to consider the potential for a per-operative complication had he taken this elderly and very obese lady with advanced aortic stenosis to theatre for vascular repair. It does seem that at the time of this vascular assessment, that Mrs Gill's condition was haemodynamically stable. However, an alternative management strategy for haemorrhage from the iliac artery was for a covered stent to be placed across the bleeding point which is a routine and well tolerated procedure involving a technique similar to the angiographic procedure which Mrs Gill had undergone. If Mrs Gill exsanguinated because of the leak from this site, it is disappointing that this non-surgical approach was not considered in a department with interventional expertise and potential".

 

[18] On the third feature, he observed:

"The post-mortem finding that the cause of Mrs Gill's death was a tear in the abdominal aorta is at variance with the CT evidence of a leak at the level of the right external iliac artery (a branch of the aorta)."

 

[19] He took up this feature in his opinion:

"I have a concern that if the post-mortem and the CT findings are correct that there were two separate bleeding points resulting from cardiac catheterisation in this patient. As an anecdotal contribution in 30 years if invasive cardiological practice I have never perforated the aorta nor has any patient under my care had this complication when procedures were performed by colleagues junior and senior. For perforation of the aorta (the main blood vessel leaving the heart) to occur, the operator would have had to push the interventional device (either a guide wire or a fluid catheter) disturbingly hard against an obstruction (resistance to passage of these devices is usually an indication that the forward passage of the device is obstructed and an alternative path should be sought). I therefore have these concerns: there is a possibility that Mrs Gill had two sites of haemorrhage (in the aorta as identified by the Pathologist) and in the iliac artery as identified by CT scanning)."

 

[20] His conclusion on all matters was in the following terms:-

"Mrs Gill died from a complication of cardiac catheterisation. Although vascular haemorrhage is a recognised complication of cardiac catheterisation, perforation of the aorta is extremely uncommon and is likely to result from careless procedural techniques which would not be expected of a senior trainee. Dr Keith Oldroyd is well known in British cardiology as an extremely experienced and talented interventional Cardiologist but it was not he who was performing the procedure. It is very possible that although he was present he would not have been aware of difficulties in manipulating the cardiac catheter which perforated the aorta and led to the death of Mrs Gill. Thus I am concerned that a Cardiologist practising with ordinary competence should not have perforated the aorta. I am further concerned that consideration of an endo-vascular solution to the vascular haemorrhage was not apparently considered and further that the clear evidence of continued haemorrhage over a period of days appears not to have resulted in a further consideration of how this haemorrhage should be addressed."

 

[21] On receipt of the application the Court pronounced an interlocutor on 19 November 2008 ordering that the inquiry be held and, in conformity with Part IV of the Practice Note dated 5 June 2005, in advance of it a preliminary hearing. After sundry procedure a preliminary hearing was held on 10 March 2009. Those entitled to appear and be represented were the Crown, the family of Mrs Gill, Dr Oldroyd, Dr McDonald and the Health Boards who each had an interest on behalf of one of the two hospitals where Mrs Gill was treated: the National Waiting Times Centre Board for the Jubilee and Greater Glasgow Health Board for the Western. At this hearing the solicitor for the family withdrew from acting. This left the family unrepresented but at the further preliminary hearing on 24 March the procurator fiscal depute indicated very helpfully that the Crown would do what it could to represent their interests.

 

[22] In advance of the inquiry those representing both Dr Oldroyd and Dr McDonald and those representing the two Health Boards separately instructed experts to assess the treatment Mrs Gill received from the time she entered the Jubilee on 9 November 2005 until her death eight days later in the Western. The doctors instructed Dr James Nolan, a consultant cardiologist at the University Hospital of North Staffordshire and the Health Boards inter alia Dr James Spratt, a consultant interventional cardiologist practising at both Stirling Royal Infirmary and the Royal Infirmary of Edinburgh. Both prepared Reports. Neither report was available at the dates of the preliminary hearings held on 10 and 24 March, but they were lodged in process for the inquiry. Dr Nolan's is Production D5 and Dr Spratt's E1. Both are undated but from information given at the preliminary hearing of 10 March it must post-date then, and Dr Spratt's is accompanied by a covering letter dated 10 March. In addition the Crown sought a supplementary opinion from Dr Jennings and this he gave by letter dated 25 March which is lodged as Crown Production number 3A. To assist in the preparation of their reports, both Dr Nolan and Dr Spratt were supplied with a number of relevant documents which included Dr Jennings' report.

 

(iii) The expert instructed by Dr Oldroyd and Dr McDonald

[23] Dr Nolan, in his report, having narrated in detail the sequence of treatment given to Mrs Gill, addressed the conduct of the procedure and the subsequent treatment regime. He began by observing that Mrs Gill clearly had severe progressive symptomatic aortic stenosis. He went on: -

"The patient's multiple co-morbidities and body habitus indicate that the risks of a complication were increased. This increased risk did not preclude cardiac catheterisation and the decision to refer the patient and perform the procedure was appropriate".

 

[24] On the conduct of the procedure he said: -

"The cardiac catheterisation would appear to have been performed with direct supervision and input from Dr Oldroyd. The procedure could not be completed from the chosen radial access site (which would have minimised procedural risk) because of anatomical difficulties, and the decision to complete the procedure by femoral access was appropriate. There is no evidence in the procedural records that supports the view that interventional devices were advanced forcefully or that the procedural technique was careless. The decision to deploy an arterial closure device was appropriate given the problems associated with manual compression in a patient with a BMI of 45. It is important to note that these devices can fail despite technically proficient deployment, and that this can occur after initially successful haemostasis".

 

[25] On her care post-procedurally he said: -

"Early after the procedure the patient developed a major retroperitoneal haemorrhage. Emergency vascular imaging confirmed that the retroperitoneal haemorrhage arose from the access site in the ileo-femoral vasculature.

 

The retroperitoneal haemorrhage was rapidly diagnosed and dealt with by appropriate resuscitation, diagnostic imaging and transfer to a general hospital for further assessment. Given the patient's extensive co-morbidities a decision was made to pursue an initial conservative approach. It is clear from the clinical records that a period of clinical stability resulted, with the patient haemodynamically stable and able to mobilise. On 15.11.05 a low haemoglobin level was noted. There was no evidence of haemodynamic compromise in association with this. Given the large volume of fluid administered to the patient over the preceding days, it is certainly possible that a substantial component of this was haemodilution rather than continued bleeding. An alternative explanation would be re-bleeding, but there was no tachycardia or fall in blood pressure to support this diagnosis. This possibility was considered by the clinical team. Further contrast administration to image the abdominal and lower limb vasculature would have carried a risk of nephrotoxicity. Given this risk and the lack of any haemodynamic evidence of major bleeding, a reasonable decision was made to transfuse and observe."

 

[26] On the events of 17 November he said: -

"The clinical records suggest that a sudden catastrophic haemodynamic deterioration occurred in the early hours of 17.11.05. This suggests that an acute event occurred. The rapid deterioration in association with hypotension and tachycardia suggests acute blood loss as the cause of death."

 

[27] He then reviewed the whole course of her post-procedure treatment: -

"The sequence of events recorded in the clinical record suggest that an initial retroperitoneal haemorrhage occurred in association with the femoral puncture. Retroperitoneal haemorrhage associated with femoral puncture is a rare complication of cardiac catheterisation but is well described in the literature. A retroperitoneal bleed related to femoral artery access can occur despite meticulous and optimal procedural technique. The available literature for this rare complication indicates that it has a high mortality with a 30-50% death rate. The initial resuscitation and investigation were rapid and appropriate. Implanting a covered stent would have required further instrumentation and contrast load. Although this may have sealed the bleeding point in the iliac vessels, there is no doubt that this procedure would also have carried risks to further vascular bleeding and contrast nephropathy. General anaesthesia and open vascular surgical repair would also be associated with a high risk of major peri-operative complications. The decision to pursue a conservative policy, taken in conjunction with vascular surgical and consultant radiology colleagues, was appropriate given the patient's extensive co-morbidity and the additional substantial risk of further interventional procedures.

 

The patient's haemoglobin, haemodynamic measurements and clinical status were stable for six days indicating that the initial resuscitation and management was successful. The terminal event on 17.11.05 was related to an acute catastrophic haemodynamic collapse leading to death from hypovolaemic shock.

 

The clinical records indicate that the clinical team considered the use of further surgery or interventional radiology, and were aware of the possibility of continued or re-bleeding throughout the patient's admission. The conservative strategies adopted were a result of multi-disciplinary consultation and reflect an appropriate response given the patient's clinical stability, extensive co-morbidity and the risks of additional intervention

 

[28] On the question of the aortic tear he began his discussion with the words: -

"The post-mortem findings of two possible bleedings sites involving the ileofemoral vessels and the abdominal aorta are somewhat out of keeping with the clinical picture."

He then suggested four possible scenarios that might explain the sequence of events leading to the death of Mrs Gill.

"There can be no absolute certainty about the sequence of events leadings to the patient's death, but the following explanations are possible:

1 The initial retroperitoneal bleed arose from the puncture site in the ileofemoral vasculature. A large retroperitoneal haematoma resulted. This resulted in haemostasis at the original puncture site due to a pressure effect. On 17.11.05 the haematoma ruptured into the peritoneal cavity relieving pressure at the original puncture site resulting in further catastrophic bleeding and death. The tear in the aorta noted by the pathologist could be related to a post-mortem injury associated with the difficulty of dissection in a patient with such a large haematoma and resultant anatomical distortion.

2 The initial bleed from the ileofemoral puncture site resulted in pressure haemostasis due to haematoma accumulation as described above. Several days later on 15.11.05 re-bleeding from the femoral puncture site occurred. This would explain the fall in haemoglobin. This re-bleeding caused increased pressure within the haematoma resulting in its subsequent rupture with associated catastrophic bleeding and hypovolaemic death. Once again, the aortic tear could be related to a post-mortem injury.

3 The initial bleeding from the ileofemoral puncture produced a haematoma with control of blood loss due to pressure effects as describe above. The catheterisation procedure also resulted in a tear in the aorta as described in the post-mortem findings. If this was the case, rapid exsanguination and death at the time of the catheterisation procedure is the most probable outcome. In addition, no vascular trauma or aortic bleeding was noted at the time of the initial vascular imaging. This is therefore an unlikely scenario.

4 The initial bleeding from the ileofemoral puncture site lead to pressure haemostasis as described above, with clinical stability over several days. A secondary event involving the aorta may have occurred spontaneously resulting in the catastrophic bleeding and rupture of the haematoma that occurred on the 17.11.05. The pathologist noted that there was atheromatous change in the aorta, and this may have lead to an acute aortic syndrome which caused the secondary bleed and would account for the findings at post-mortem."

On balance he concluded on the basis of the evidence available to him that the first or seconds scenarios were more supportable than the third and fourth.

 

[29] In the conclusion of his report he stated:

"The patient's death arose from a rare but recognised complication of cardiac catheterisation resulting in retroperitoneal haemorrhage associated with a femoral artery puncture. After initial clinical stability over several days, a sudden catastrophic event occurred. The most likely explanations for this are detailed above [in the four scenarios]. There is no evidence to suggest that the patient's death was related to careless procedural technique. The patient's death was a result of a rare complication of cardiac catheterisation that is frequently fatal."

 

(iv) The expert instructed by the Health Boards

[30] Dr Spratt in his report narrated what he considered to be relevant facts about Mrs Gill's medical condition at the time of the procedure, the conduct of it and her subsequent care. He gave it as his opinion that:

"It is clear from the considerable documentation prior to the procedure that Mrs Gill represented an increased risk of both morbidity and mortality. The majority of the risk would probably relate to problems with access site. It is unfortunate that she had a congenital anomaly of the right radial artery and that the access site was then switched to the right femoral artery. The main anomaly in this case relates to where the bleeding site arose. All the evidence would point to a retrograde haemorrhage due to an access site complication. Certainly, there is no suggestion that an aortic bleed was the initial causes of her deterioration. The CT scan is unequivocal in this respect and is very much in keeping with both the clinical and angiographic findings. I would agree with Dr Oldroyd's ascertation (sic) that it would be virtually impossible for a 5 French diagnostic catheter to cause an aortic rupture. I would also agree with his ascertation (sic) that such an aortic rupture would have resulted in Mrs Gill's immediate demise. I would contend that the far more likely scenario is that her initial haemorrhage was caused by bleed from an access site complication rather than an aortic bleed. Indeed it is difficult to postulate on why she should then subsequently develop an aortic tear. This would be a most unusual complication particularly in the context of an intravascularly depleted patient with aortic stenosis. Her pulse pressure required to produce such an aortic tear would not therefore be possible to generate. Whilst it is possible to have a spontaneous aortic tear, this would be unlikely in Mrs Gill's case due to the relatively mild amount of atheromatous diseases seen and again the clinical context. One is forced to question the original post-mortem reports. My personal opinion is that the CT scan provides the most likely explanation of Mrs Gill's subsequent demise and initial bleed.

 

Whilst there are ways to ensure safety by a femoral artery access, much of these ways are more challenging in the context of an obese patient. It may be that some form of imaging was performed prior to femoral artery puncture but no documentation of this had been made.

 

With respect to the subsequent decisions made by Dr Oldroyd's team, it is clear that A. The first decision was made to transfer her to a more intensive monitoring environment and this seems entirely appropriate. B. The next decision was made to consult a vascular surgeon to consider whether endovascular repair was warranted or indeed required, again this would be an appropriate consultation. The decision was made in the context of a then stable patient, not to intervene. This would seem in retrospect an appropriate decision.

 

Finally, the continued conservative management of Mrs Gill in the context of her decreasing haemoglobin warrants further review. It may be that at that stage, early endovascular repair might have been contemplated however it is worth considering that Mrs Gill was a patient with considerable comorbidity not least of which acute renal failure which developed as a complication of the initial bleed. Having reviewed her haemodynamic status over this time, it is clear that there was no significant drop in blood pressure. A combination however of critical aortic stenosis and intravascular depletion is potentially lethal and a relatively small bleed can result in significant haemodynamic compromise. It is likely that Mrs Gill had a further bleed in the context of relative intravascular depletion which resulted in her final demise."

 

[31] His conclusion was:

"I can conclude that Mrs Gill died from a complication of cardiac catheterisation. I would suggest that her risk of this complication was considerably higher than average and that her risks of having an adverse event as a result of a bleed were also considerably higher. It is my opinion that there was no negligence involved in the cardiac catheterisation procedure and that the probable cause of the bleed was the puncture related to the procedure but that it is possible that the re-bleed or indeed initial bleed was due to malfunction of the angioseal device used. I believe an appropriate decision was made to treat Mrs Gill conservatively initially and finally that Mrs Gill's continued haemodynamic relative stability was an argument for not pursuing more aggressive intravascular solutions in her situation. I would also conclude that in my opinion it is extremely unlikely that the aorta was perforated as a result of the procedure and there must be some doubt over whether it was perforated at all."

(v) Dr Jennings' supplementary opinion

[32] Dr Jennings wrote his supplementary opinion having seen images which I infer were some if not all of the CT images taken during the procedure. Having reviewed them he commented as follows:

"I can confirm that Mrs Gill had normal epicardial coronary arteries at angiography, the procedure which resulted in her death. My comment is that the arterial puncture site is noticeably high such that the puncture of the artery is within the abdomen (as opposed to being at the top of the leg at the inguinal ligament): this abdominal site of puncture has two potential adverse associations. The first is that it is difficult to identify haemorrhage (because there is the potential for unnoticed bleeding into the abdominal cavity) but also the considerable difficulty of manual pressure stemming haemorrhage which is relatively easy if the puncture is into the artery where it enters the leg and is well-supported by surrounding tissue.

 

As we discussed on the telephone I do not plan to comment on the CT scan (Cardiologists are relatively ill-informed in this regard and rely on radiological reporting). What we can conclude however is that the puncture site was performed where the artery is intra-abdominal with the potential for complications and we have learned from autopsy and imaging that there were more than one perforation in the vascular tree. This should not have occurred in the hands of an interventionist practising with ordinary skill."

 

(vi) The report of the CT scan

[33] The Crown lodged as its production, number 8, the Report dated 9 November 2005 compiled by Dr Grant Baxter of his findings in the course of the CT scan he conducted on Mrs Gill within three hours of the conclusion of the angiogram procedure. Its findings were: -

1. Minor bibasal lung changes. There is a 1.3 cm liver cyst. The gallbladder contains multiple calculi.

2. The right kidney contains a simple 2.5 cm cyst. This is marked displaced anteriorly.

3. There is a large right psoas and extensive right flank haematoma extending from behind the right kidney displacing it anteriorly throughout the lower abdomen and right side of the pelvis into the right groin. There is clear evidence of active bleeding into both the psoas and right flank components. In addition, the right iliac vessels are markedly displaced by the haematoma. Furthermore, there is bleeding from the distal right external iliac artery and appearances would suggest this may be a 3 cm pseudoaneurysm.

 

[34] His considered impression in light of these findings were: -

1. Extensive right psoas/right flank haematoma extending throughout the lower abdomen and right side of pelvis to groin. There are at least three active bleeding points as described above. There is displacement of the right kidney anteriorly by the aforementioned haematoma.

2. Patient discussed and referred to the Western Infirmary.

 

(vii) The consequences of the various reports for the inquiry

[35] Under reference to the reports from Dr Jennings, Dr Nolan and Dr Spratt, none of them took issue with the time and place of the death of Mr Gill as given in both the death certificate and the post-mortem report, and none made any observations that could suggest a finding under (d) or (e) that was anything beyond the formal. The reports did raise questions over whether the entry site in the groin was too high or the arterial closure device failed post procedurally and also whether a covered stent should have been placed across the bleeding point in her groin area, but these were not the critical area of attention. That was the finding of the aortic tear. The problems that it raised for all the experts were not alleviated by the terms of the radiological report. It made no express mention of any tear but, by referring to there being "at least three active bleeding points" it left the source of at least one of these sufficiently unclear as to demand further clarification.

 

[36] An analysis of the expert reports suggests that there were significant areas that were not made the subject of any criticism. They were as follows.

• Notwithstanding reservations about the weight and general medical condition of Mrs Gill no one criticised as inappropriate the decision to carry out the angiogram procedure.
• The same applied to any considerations raised by her age.
• Having taken the decision to proceed, the decision to enter her vascular system by the right wrist was appropriate.
• When it proved impossible to complete the procedure using that entry site alone, the decision to gain entry in the region of her groin was appropriate.
• The decision to obtain a CT scan shortly after the conclusion of the procedure was appropriate.
• The decision to transfer her to the Western Infirmary was appropriate.
• In general terms it was appropriate for the staff at the Western Infirmary to manage her condition conservatively.

 

[37] All of the reports stated a concern about the fact of the existence of the aortic tear and radiated degrees of scepticism about its link to the conduct of the procedure and to the haemorrhage which caused the death of Mrs Gill.

 

[38] It was against this background that all parties prepared for the Inquiry.

 

The inquiry

[39] The inquiry was held over six days: 14, 15 and 16 April, 11 and 14 May and 10 July, all days of 2009. The Crown were represented by Miss Anne Frances Hilley, procurator fiscal depute, Dr Oldroyd and Dr McDonald jointly by Mrs Mary Robertson, solicitor, and the two Health Boards jointly by Mr David Stephenson, Advocate.

 

[40] In the course of the inquiry, the Crown led the evidence of six witnesses: Mr Peter McGuiness, the son-in-law of Mrs Gill; Dr Tobias Hatter; Dr Keith Oldroyd; Dr John McDonald; Dr Grant Baxter; and Dr Kevin Jennings. All the evidence has been transcribed and therefore I do not need to narrate it in detail in this Note beyond those matters that assumed an importance in the inquiry.

 

(i) Mr Peter McGuiness

[41] The first witness was Mr Peter McGuiness. He gave evidence about her state of health in general, her initial reluctance to have an angiogram stemming from her fear of hospitals which was overcome and her important place within her whole family. He then in detailed the direct involvement he, his wife, his father-in-law and his brothers-in-law had had with Mrs Gill over the period from her initial admission to hospital. By the time that started Mrs Gill was on her way to the Western in an ambulance. Dr Oldroyd spoke to Mr McGuiness, his wife and his father-in-law at the Western and said that the angiogram had caused a haemorrhage but it was under control. They accepted that explanation at the time. Thereafter their dealings with hospital staff were confined to junior members with one exception on 14 November when, having asked to see Dr Oldroyd another doctor (subsequently established as being Mr Allan Faichney, the senior consultant cardiac surgeon at the Western) spoke to them and said he would note that the family wished to see Dr Oldroyd. They did not see him before her death, but he telephoned her home during the morning of the day of her death and offered the opportunity to meet the family, but Mr McGuiness declined that offer saying that it was too late for that.

(ii) Dr Tobias Hatter

[42] The next witness was Dr Hatter. He said that he had qualified as a doctor in 1996 and worked for six years as a forensic pathologist at Glasgow University between February 2001 and June 2006. At the time of giving evidence he was not working because he was suffering from ill health. He had not kept up to date for the previous two and a half years.

 

[43] He confirmed that on 21 November 2005 he carried out the post mortem on Mrs Gill and that he was the certifying registered medical practitioner who had prepared the death certificate dated 22 November 2005. He accepted readily that the certificate made no mention of a tear in the abdominal aorta although his subsequent post mortem report did. He accepted that this was unusual, volunteered that to be more accurate the death certificate should have included this information and said he could not really offer an explanation as to why it did not. He was taken through his report and thereafter successively the reports of Doctor Baxter, Dr Jennings, Dr Nolan, Dr Spratt and in addition in cross examination by Mrs Robertson was referred to the letter from Mr Oldroyd to Dr McSorley dictated on 17 November 2005 following upon and reporting on the death of Mrs Gill.

 

[44] From his report he said that the 1.5 litres of fresh blood and clot in the peritoneal cavity was a fatal blood loss. Her liver was pale as were her kidneys, all of which was consistent with death from a large haemorrhage. His findings effectively ruled out that haemorrhage having tracked from the catheter insertion site into the abdomen. He could not say with certainty that the bleed came from the tear in the aorta which was most likely caused by the insertion of the catheter during the procedure. He confirmed that he had been unable to find the vascular closure device that had been fitted at the conclusion of the procedure and suggested that it may have been removed prior to death.

[45] In response to questioning on Dr Baxter's report he said that the reference in that report to right side haematoma was what he described in his post mortem report as right sided retroperitoneal haemorrhage. He did not find three active bleeding points and observed that it did not say what was bleeding.

 

[46] On the report of Dr Jennings he said that at post mortem he had not identified any damage to the right external iliac artery and that the bleeding point was in the distal aorta. Had the bleeding point been within the iliac artery he would have expected to have seen that at post mortem. It would be very unlikely for someone to survive for eight days after developing a tear in the aorta. Death could be expected within hours without treatment. From a consideration of the tear and the nature of the blood in the abdomen he could not say when the tear had occurred. He hazarded that it might have started as a small tear at the time of catheterisation which had become larger later on. He did not know where the normal access point in the groin was for a catheterisation procedure. There were signs of haemorrhage around the access point but that was normal. The post mortem on Mrs Gill was the first one he had performed arising out of an angiogram. It was extremely rare to find lethal complications of such a procedure. He agreed with Dr Jennings that a perforation of the aorta as a consequence of catheterisation was extremely uncommon.

 

[47] While commenting on the report of Dr Nolan, Dr Hatter said that either the tear in the aorta was missed on the CT scan or it was not present at the time of the scan. It was possible that it could have developed in the aorta some eight days after the procedure but he saw no pathological mechanism that would explain that. The catheterisation would not have caused the larger abdominal haemorrhage that he found at post mortem. The clinical picture of an acute catastrophic haemodynamic haemorrhage on 17 November was entirely in keeping with the post mortem findings. The tear in the aorta caused that haemorrhage. The tear that he described as being in the femoral artery did not appear to have tracked through into the abdomen so it did not cause the haemorrhage. Under reference to Dr Nolan's four possible scenarios Dr Hatter he conceded in relation to the first and second that it was possible that the tear in the aorta was a post mortem injury caused by that procedure and that the bleeding point arose from the puncture site. He had seen damage to the aorta occur at post mortem. He had no comment to make on the third and on the fourth he considered that it was unusual for the aorta to rupture as a result of mild atheromatous change to it but it was possible.

 

[48] Dr Spratt's report gave Dr Hatter the opportunity to say that if he accepted that the aortic tear was a post mortem artefact caused by the post mortem procedure then the most likely scenario was, as Dr Spratt said in his opinion, that her initial haemorrhage was caused by bleed from an access site complication rather than an aortic bleed. He agreed with Dr Spratt that it was difficult to postulate on why Mrs Gill should then subsequently develop an aortic tear and that it was unlikely in her case that she would suffer a spontaneous aortic tear. At this point in his examination in chief, Dr Hatter conceded the whole question of the source of the aortic tear when he said in the course of several answers that the three cardiologists whom he described as experts were all saying that the tear was a post mortem artefact, and on that basis he had mistaken a post mortem tear for a bleeding point, it was more likely that that was its source and cause and therefore the most likely bleeding point was the vascular site entry in the groin.

 

[49] In cross examination by Mrs Robertson, Dr Hatter said that he was subject to General Medical Council undertakings regarding his health. He did not remember performing the post mortem on Mrs Gill. He was therefore entirely dependent on his post mortem report. Mrs Gill's height and weight did not cause him any particular difficulty in carrying out that examination. Prior to this post mortem he had not come across a vascular closure device except in textbooks. He understood it to be a pressure device placed externally on to the wound which would have been removed after the catheterisation procedure. He did not know what the one used on Mrs Gill looked like. confirm that he had been unable to find the vascular closure device that had been fitted at the conclusion of the procedure. What the CT scan described as the right external iliac artery was what he described in his report as the right femoral artery. There were often discrepancies between post mortem reports and clinical findings. When Dr Hatter was asked about his concession that the aortic tear was caused at post mortem, he announced that he was finding it hard to give evidence to the inquiry because when he wrote his report he considered himself to be an expert witness but, having not worked for nearly three years he no longer considered himself to be such a witness. He did not feel he was able to comment on other people's reports. He repeated his acceptance that the aortic tear could be a post mortem artefact and that it was more unlikely that it was due to the catheterisation. Accordingly the cause of death 1b in his report, tear in the abdominal aorta, would be wrong but it was still correct to say that her death was caused by a massive haemorrhage due to the catheterisation procedure with the possible source of that haemorrhage being the original bleed site in the right groin which had re-bled. However he could not see how a massive haemorrhage had tracked along the femoral artery up to the kidney when there was only a small amount of haemorrhage present around that artery at post mortem. His conclusion that an abdominal aortic tear was a recognised but rare complication of a catheterisation procedure he took from a cardiac pathology book which he had. He could not recall its name. He had no recollection of a conversation with Dr Oldroyd after completing the post mortem. When taken through Dr Oldroyd's discharge letter to Dr McSorley dated 24 November 2005 Dr Hatter agreed that it made no reference to a bleed from the aorta which in the circumstances seemed unusual.

 

[50] Mr Stephenson began his cross examination of Dr Hatter on the theme of his professional experience and certain professional difficulties he had in 2006. Dr Hatter confirmed that he had joined the department of pathology at the University of Glasgow in February 2001 as a lecturer/specialist registrar. In late 2003 he became a senior clinical university teacher which carried with it the post of honorary consultant. His speciality was forensic pathology. He was contracted to undertake post mortems instructed by the Crown. He resigned from his position in June 2006 on the ground of ill-health. For a period of time after that he was subject to certain restrictions imposed by the general Medical Council that enabled the Council to keep his practice under review and required him, if working, to do so under supervision. He had not worked since resigning. He accepted that he had resigned because he was then suffering from depression, some form of mental breakdown and a problem with alcoholism, that these problems had developed over a period of time and that they were present to some extent in late 2005 by which time he was receiving treatment for them. Since resigning he had had no access to any notes he made at the time of Mrs Gill's death. He had no recollection of the case other than by referring to his report and no recollection of the post mortem on her. Before giving his evidence he was unaware of the existence of the reports from Dr Baxter, Dr Jennings, Dr Nolan and Dr Spratt or of the evidence in relation to the CT scan and was not given an opportunity to consider that evidence. He had not given a statement to the Crown in relation to his involvement in the post mortem examination of Mrs Gill and there had been no discussion between him and any representative of the Crown in connection with what his evidence might be to the inquiry. The only contact that he had had with the Crown was when he received a citation to attend the inquiry he asked for a copy of is report. As a consequence it came as a surprise to him when he was asked questions in examination in chief about the reports prepared by other. He agreed with the suggestion that all this had placed him in a rather unfair situation. He also found it quite hard to justify his post mortem report when he no longer considered himself to be an expert pathologist. At the time of the post mortem he thought that he was doing the correct thing but he had no memory of what he had done or not done.

 

[51] Turning to his report he agreed that it gave neither dimensions for nor a description of the aortic tear and that he should have given a description. His evidence that he had referred to a cardiac pathology textbook was based upon a supposition but it would have made sense for him to have checked such a source. If the CT scan demonstrated that the aorta was then intact, Dr Hatter accepted that it was probable that the initial bleed was not the result of any tear in the aorta. Moreover, in light of the reports of the cardiologists, he accepted that it seemed unlikely that the terminal event that caused the death of Mrs Gill was a tear in the aorta but that if it were the cause of that tear was unknown. It was not possible to date a tear in a major blood vessel such as the aorta from histological examination.

 

[52] The Crown did not re-examine Dr Hatter.

 

(iii) Dr Keith Oldroyd

[53] Dr Oldroyd graduated in medicine in 1982 then trained in cardiology. He became a Member of the Royal College of Physicians in the United Kingdom in 1985, graduated as a Doctor of Medicine in 1992, and became a Fellow of the Royal College of Physicians of Glasgow in 1998. He took up the post of clinical lecturer at the University of Glasgow in 1993 and was appointed a consultant cardiologist in 1995, initially at Hairmyres Hospital. He transferred to the Western in 2002. His predominant area of clinical practice is invasive cardiology procedures which includes angioplasty. In an average year in practice over the years 1999 to 2009 he has performed between 250 and 300 angiograms. This is significantly higher than the average in the United Kingdom. In his career he had carried out more than 10,000 cardiological procedures. His annual volume of cardiac investigative procedures was approximately three times the average for the United Kingdom. His unit was in the vanguard in the United Kingdom of the move from femoral to radial entry. He had been involved in training other consultants in this technique as well as more junior medical staff.

 

[54] He recalled Mrs Gill and why she was admitted to the Jubilee. He explained the practice and procedure that was adopted in her case under reference in particular to her medical records. Dr McDonald obtained Mrs Gill's informed consent to undergo the procedure. Dr Oldroyd was present throughout the procedure. Dr McDonald performed it. Dr Oldroyd had no concerns whatsoever about the experience of Dr McDonald, who was then in his final year as a specialist registrar in cardiology and by far the most experienced final year trainee that he had ever had, having already spent a year abroad in a very prestigious unit in Vancouver specialising in invasive cardiology. In order to complete the procedure Dr McDonald had to enter her vascular system twice, first in the right wrist and then in the right groin. The risk of perforation of a vascular structure such as the aorta by a guide wire of the type commonly used in such a procedure was approximately zero. The aorta is the largest artery in the human body and is a strong structure. The required images were obtained.

 

[55] The puncture in Mrs Gill's groin was higher than the ideal by some one to two centimetres. The ideal height was immediately in line with the midpoint of the head of the femur. A high puncture carries with it a higher risk of subsequent retroperitoneal bleeding because it is not possible to press on the entry site to halt the bleeding but even then retroperitoneal bleeding occurs in only a small proportion of cases. For that reason Dr McDonald did a femoral angiogram at the end of the procedure. As a consequence he placed a vascular closure device percutaneously at the entry site in the groin without incurring any technical problems while doing that. The purpose of this angioseal was to seal the puncture. It is biodegradable and that process takes about 90 days to do so fully. It has been used extensively world wide. It ought to be visible to the naked eye.

 

[56] Dr Oldroyd was happy with the way that the procedure had been carried out. There was no sign of any problems at the end of the procedure. He then from the medical records went through the post procedural care and treatment at both the Jubilee and the Western. Shortly after the procedure Mrs Gill displayed signs of being unwell. She did not improve so Dr Oldroyd saw her and he immediately suspected retroperitoneal bleeding. He commissioned an emergency CT scan and discussed its findings with Dr Baxter the radiologist. They confirmed his suspicion and he arranged for her transfer to the Western as an emergency because he thought that she might require further intervention if the bleeding did not stop and at that time the specialist medical services at the Jubilee did not include vascular surgical or interventional radiological.

 

[57] At the Western Dr Oldroyd discussed her condition with the vascular surgical team on call and with the interventional radiologist on call. Their conclusion was to manage her conservatively. Surgical intervention is very rarely required for a retroperitoneal haemorrhage because it almost always stops on its own. Dr Oldroyd had a meeting with members of Mrs Gill's family at which he explained what had happened to her and the likely risks associated with that because of her pre-existing aortic stenosis. She was retained as an in-patient in the Coronary Care Unit.

 

[58] Dr Oldroyd's next direct involvement was early the following morning when he was called at home and advised that she should continue to receive intravenous fluids. He saw her again on 11, 14 and 15 November. On 14 November she was transferred from the Coronary Care unit to the general cardiology ward which brought her back under the supervision of Dr Oldroyd. The medical records suggested consistently that she was continuing to improve. On 15 November Dr Oldroyd found her condition to be stable. He did not see her again before her death. She received at the hands of junior staff three units of transfused blood in furtherance of Dr Oldroyd's instructions that that be done if her haemoglobin went below 8 because it went down to 6.8 although he was not told of this reading.

 

[59] On the question of the drift down of the haemoglobin from 11.1 on 10 November he said that he would not have been concerned until 14 November because it was quite common for a degree of dilution to take effect over the first few days after a patient had lost a lot of intravenous fluid and blood. An alternative explanation for the drift was that she was continuing to bleed but there was no sign of that haemodynamically, such as falling blood pressure, rising heart rate or a continuing deterioration in the kidney function. Had he been made aware of the fall to 6.8 he would have thought of continuing bleeding as a possible explanation. However, her blood pressure looked stable when she received the transfusions and not low which would have been consistent with a continuing bleed. The pattern of her blood pressure readings in the forty eight hours before her death was not one that suggested she was suffering from ongoing bleeding.

 

[60] Of the events of 17 November after Mrs Gill suffered a cardiac arrest Dr Oldroyd said that everything possible that could have been done was done. He opined that whatever happened to her it was a very sudden, catastrophic deterioration which no medical or nursing staff could have predicted.

 

[61] After her death Dr Oldroyd telephoned the family and spoke to Mr McGuiness. Dr Oldroyd offered to meet the family and answer any questions they might have but Mr McGuiness declined that offer.

 

[62] The circumstances of the death of Mrs Gill in presenting with a fatal retroperitoneal bleed seven days after the original procedure were unique both in the experience of Dr Oldroyd and in the extensive available literature on angiograms. To try to avoid this ever happening again Dr Oldroyd has changed his practice to the extent of using X-ray imaging before puncturing the femoral artery to determine the relationship between the proposed puncture site and the head of the femur.

 

[63] Dr Oldroyd spoke to Dr Hatter by telephone both before and after the post mortem. He explained what a vascular closure device looked like because he did not know. After the post mortem, Dr Oldroyd was surprised that Dr Hatter had been unable to find the device. At no point during that conversation did Dr Hatter say that he had identified a tear in the aorta. Accordingly when he saw the post mortem report Dr Oldroyd was surprised and astonished by its findings and conclusion. He tried to speak to Dr Hatter but by then he was no longer in post.

 

[64] Under reference to the post mortem report, Dr Oldroyd said that he had never seen a spontaneous rupture of the aorta in the context of recent catheterisation. He disagreed with Dr Hatter's conclusion that a tear in the abdominal aorta was caused by the procedure or that there was no evidence that the haemorrhage had occurred from the puncture site in the right groin. The CT scan showed clear evidence to the contrary but he accepted that there was no evidence of recent haemorrhage at the time of the post mortem. The findings of that post mortem confirmed his own clinical impression that the bleeding from the original puncture had stopped.

 

[65] Under reference to the two reports prepared by Dr Jennings, Dr Oldroyd agreed that the haemoglobin reading of 6.8 on 16 November despite prior blood transfusions suggested that there may have been ongoing bleeding. At that date he was considering a further CT scan to look for evidence of further bleeding. As for a covered stent, on 9 November he had discussed with a highly experienced interventional radiologist placing one across the bleeding point but decided against because of Mrs Gill's clinical stability at that time.

 

[66] Under reference to Dr Spratt's report, he agreed with the contention that Mrs Gill's initial haemorrhage was not caused by an aortic bleed, and with Dr Spratt's comment that one was forced to question the post mortem report.

 

[67] In cross examination by Mrs Robertson, he confirmed that he had no doubt that Mrs Gill was a suitable candidate for the procedure. He explained that a femoral angiogram was a procedure whereby a dye was injected through the sheath giving access to the artery once the catheter had been removed, in order to see exactly where the puncture was in the femoral artery. With regard to the angioseal closure device, there was no question of it having been removed. Since the death of Mrs Gill he had tried to avoid high punctures. As at 15 November her haemodynamic markers, blood pressure and heart rate did not suggest that she was suffering ongoing bleeding and her haemoglobin reading of 6.8 was attributed to haemodilution. With regard to Dr Nolan's four possible scenarios he said that option one was the likely sequence of events but as to what happened it all came down to the tear in the aorta.

 

[68] In cross examination by Mr Stephenson, he said that up to at least 16 November the standard of management of Mrs Gill was high. While her haemoglobin reading on 16 November might suggest some further bleeding it was of an order quite different from the catastrophic event that led to her death. If on 16 November he had decided to ask for a further CT scan it would have been performed on an urgent basis and that would have meant on 17 or 18 November. Accordingly, it would not have been performed before her death.

 

[69] The Crown did not re-examine Dr Oldroyd.

 

(iv) Dr John McDonald

[70] Dr McDonald said that he qualified in medicine in 1994 and then specialised in cardiology. He finished his training in 2006, worked as a locum consultant cardiologist for one year and then secured appointment as a consultant in September 2007. As at November 2005 he was in his sixth and last year of training. By then he had performed some three thousand angiograms, which gave him experience that was significantly higher than average.

 

[71] He confirmed the evidence of Dr Oldroyd regarding his role in obtaining the informed consent of Mrs Gill in advance of undergoing the procedure, that he conducted that procedure with Dr Oldroyd in attendance throughout, that he encountered no difficulties during it, that he adopted correct procedural techniques, met no obstruction of the catheter while it was being advanced, and that as a consequence of the puncture site in the right groin being high he used an angioseal device on it. After finishing the procedure he was not involved directly in the subsequent care of Mrs Gill although he did see her on 10 November.

 

[72] He agreed that her initial bleed was attributable to a retroperitoneal bleed from and as a result of the puncture in her artery required by the angiogram. He disagreed with Dr Hatter's finding that the source was a tear in the aorta. He considered it unusual that Dr Hatter could not find the angioseal device at post mortem. It ought to have been visible and would not have been removed. Over a time period of approximately ninety days it would be absorbed slowly by the body. He had never heard of a guided diagnostic catheter causing a tear in the abdominal aorta or seen such a case demonstrated or reported as such. A retroperitoneal bleed was a rare but recognised complication of coronary angiography with a significant mortality rate to it.

 

[73] In cross examination by Mrs Robertson he confirmed that it was not inevitable that a high puncture would bleed post-procedurally. There was no re-examination.

 

(v) Dr Grant Baxter

[74] Dr Baxter confirmed that he qualified as a doctor in 1983. From 1985 to 1993 he trained in radiology. In 1993 he was appointed to be a consultant radiologist. As at November 2005 he was a consultant at both the Jubilee and the Western. He explained the role of a radiologist as the imaging of patients and then trying to determine a correct diagnosis and liaising with clinical colleagues in order to decide the best treatment. A CT scan is a method of using X-rays to gather a lot of data from the body. It enables the radiologist to show the volume of tissue in the human body and this allows the medical staff to see an image of the internal organs. As at November 2005 the images were in two dimensions. He went through the numerous images he had recorded while performing the CT scan on Mrs Gill. There were some 85 images tracking from her diaphragm down to her groin, each one horizontally through her body. They showed the presence of the contrast injected intravenously into her blood supply during the angiogram procedure. He explained the importance of that for the scan was that he was looking for a leak of contrast as an indicator of a haemorrhage. Using that method he found evidence for a significant haematoma extending down to her groin becoming more extensive as the images tracked down towards that region with fresh bleeding in the right side of her abdomen and a pseudoaneurysm in the area of the groin. Under reference to his report he clarified one feature of that report, the reference to three active bleeding points, by saying that there was one single source for the bleeding and not three sources. That single source was in the right external iliac artery and the blood from it went to what he described as three active bleeding points: the pseudoaneurysm; the right side of the abdomen; and the right psoas muscle. Dr Baxter said that he had discussed his findings with Dr Oldroyd and their decision was that the best option for Mrs Gill was to transfer her to the Western where there were more support services available than was then the case at the Jubilee. With regard to an aortic tear, Dr Baxter said that he did not see any such injury during the CT scan or any puncture to or leakage from that blood vessel. All the images showed the abdominal aorta to be normal. Had there been an abnormality in the aorta he would have been able to see that during the CT scan.

 

[75] In cross examination by Mr Stephenson, Dr Baxter said that at some time before giving his evidence he had run a test on the images using a computer programme that was unavailable in 2005 but was in 2009. The programme was able to produce an image in three dimensions rather than two. Using that programme Dr Baxter saw that the resultant image showed no tear in the abdominal aorta. Had there been a tear that image would have shown it. He concluded by saying that his first contact with the Crown had been some two to three months before giving evidence and that a statement had been taken from him within a month of giving evidence but not before.

 

[76] Re-examination was very brief and limited. Of present relevance was Dr Baxter's assurance that he could rely on the findings of a CT scan.

 

(vi) Dr Kevin Jennings

[77] Dr Jennings gave his evidence as a skilled witness speaking to his opinion on relevant events. He began with some features of his experience of cardiology. He qualified as a doctor in 1972, and thereafter trained in cardiology, becoming a consultant in 1983. He was a Fellow of the Royal College of Physicians of Edinburgh and at the time of giving his evidence was an interventional cardiologist at Aberdeen Royal Infirmary and the Vice President of the British Cardiovascular Society. He spoke to his report and supplementary report.

 

[78] He supported the decision made on the admission of Mrs Gill to the Western to treat her conservatively. He opined that with hindsight, she had either continued to bleed continuously over a period of days following the angiogram procedure and then acutely causing her death, or she had experienced several isolated episodes of haemorrhage contributing to the same end point with the last one being irreversible. He also said that the Court required to address what he described as the tension or conflict between the post mortem finding of an aortic tear and the non-invasive pre-mortem imaging taken during the CT scan. In relation to that scan he expressed concern about the existence of what he took from Dr Baxter's report to be three puncture sites. He had no further comment to add to his suggestion in his report that a management strategy alternative to the conservative one adopted was to use a covered stent to occlude the haemorrhage site. The use of such a stent was a routine and well tolerated procedure.

 

[79] Under reference to the post mortem report he was initially asked questions that were predicated on accepting the veracity of the findings and conclusion anent the aortic tear, and in answer to them he suggested reasons that could support that: that the one and a halt litres of fresh blood and clot that Dr Hatter found had moved close to the point of haemorrhage in the abdominal aortic as a result of gravity acting on a patient who was confined to bed, a congruence he described as serendipitous; and that a large haematoma protected a damaged blood vessel such as the aorta but then when it was absorbed by the body the protection ended, thereby permitting a fresh bleed possibly in the form of a traumatic rupture of the aorta. However, it was fanciful to say that the tear developed some eight days after the procedure. On being told of the possibility that the tear was a post mortem artefact, he with all due diffidence because he was not a pathologist, expressed great disappointment that that could have happened. He confirmed that had he been aware of that evidence when compiling his report he would have altered the terms of that report by completely dismissing the aspect of the aortic tear and instead would have concentrated upon the possibility that one of the three puncture sites had haemorrhaged.

 

[80] Turning to that report he concentrated on the existence of those bleeding points. He began by observing that the entry site ought to have been in the right femoral artery rather than in the right external iliac artery and then said that he presumed that the three sites were access attempts to get into the artery. He noted that neither the CT scan nor the post mortem report suggested that the fatal haemorrhage was from these sites. When Dr Baxter's evidence was put to him that there was one source of bleeding and not three, Dr Jennings said that he had acted on the reference in the radiology report to there being at least three active bleeding points. Turning to the conduct of the procedure he said that in thirty years in medicine he had never known a guide wire of the type used to perforate a vascular structure. He was very reassured when told that Dr Oldroyd had been beside Dr McDonald throughout the procedure and that Dr Oldroyd and Dr Baxter had discussed the results of the CT scan and acted on the basis of one bleeding point. Moreover he found it enormously helpful to learn that there was only one entry site in the area of the groin and not three.

 

[81] On the basis that there was only one puncture site Dr Jennings observed that that meant that the procedure had been performed as well as could be expected. He voiced one criticism, and it was a small one, that the puncture site was in the abdomen rather than the leg which led to the reduced possibility of the bleeding site being noticed and identified and also the reduced possibility of it being addressed but he was very reassured on that criticism when told that at the end of the procedure a femoral angiogram confirmed that there was only one puncture site, that Dr Oldroyd had recognised the existence of bleeding right away and had commissioned the CT scan. He was also reassured to learn that Dr McDonald's evidence was that he had experienced no difficulties in advancing the guide wire and catheter. He was not convinced that the drop in Mrs Gill's haemoglobin reading could be attributed entirely to haemodilution because the extent of the drop was too great to support that.

 

[82] On the overall management regime it was only with hindsight that it could be said to have failed Mrs Gill. Had a vascular stent been used then with hindsight the outcome would have been expected to be different. If the fatal bleed came from the puncture site then a timely deployment of a covered stent might have been lifesaving. Had Mrs Gill been given another CT scan that might have altered her management. On the height of the puncture he agreed that that could lead to complications and on the use of an angioseal device that it did not cause him concern that the pathologist could not find it and that it was entirely possible that he overlooked it. Such devices did not always work as intended. In summation he concluded his evidence by saying that she was being looked after in a first class centre by really top people and in light of all that he had been told in the questions put to him his various expressed concerns about the care and management of Mrs Gill were all based on hindsight. Prospectively it was not inappropriate to manage her conservatively given all her problems. Dr Jennings was not cross-examined.

 

(vii) The Crown attitude to the evidence of Dr Hatter

[83] At the close of the Crown evidence, neither Mrs Robertson nor Mr Stephenson led any evidence. All parties then agreed that submissions for the hearing on evidence should be in writing and exchanged in advance of that hearing with the right to make oral submissions in addition to and in light of the written submissions if considered appropriate.

 

[84] It was at this stage in the inquiry and before adjourning the inquiry to that hearing that the Crown made a highly important and momentous statement. The procurator fiscal depute intimated that the Crown no longer relied upon the finding of Dr Hatter in his post-mortem report that the large retroperitoneal bleed which he found during the post-mortem examination was "associated with" a tear in the aorta and his consequential conclusion that the development of that large retroperitoneal bleed was from that tear which he described as having been "most likely caused by the catheter insertion". As a consequence she said that the Crown would not insist on the cause of death in that report of "Tear in the abdominal aorta".

 

[85] This statement was not unexpected. From the moment on the second day of the inquiry when Dr Hatter had finished giving evidence the extent to which the Crown could or should rely on him was a live question. His final position on the aortic tear, elicited in cross-examination and not subjected to any re-examination, was that on balance it was a post-mortem artefact. From that it followed that he was no longer supporting a cause of death that arose out of the conduct of the angiogram procedure.

 

[86] This was a retraction on his part which amounted to a capitulation on this issue of material importance to the inquiry. That it affected the Crown presentation was most immediately signalled by the way in which Miss Hilley conducted her examinations in chief of the next two Crown witnesses, Dr Oldroyd and Dr McDonald respectively. In particular at no point in either did she put to either that Dr McDonald had perforated the aorta while carrying out the procedure. So the question of what reliance the Crown felt able to place on Dr Hatter's evidence remained shrouded in mystery.

 

[87] Eventually Mr Stephenson sought to bring this matter to a head. At the close of Dr McDonald's evidence on the afternoon of the third day of the inquiry, and before I had to adjourn the inquiry for a period of several weeks to 11 May, he asked if the Crown would make clear what reliance they placed on the evidence of Dr Hatter and consequently what the status was of his death certificate and post-mortem report and what could be taken from that report. Mrs Robertson allied herself with that request. Miss Hilley indicated in response that she wanted to reserve her position on that until she had had a chance to read the transcript of the evidence of Dr Hatter which had only been requested the day before and understandably was not then available. Following a discussion parties reached agreement that the Crown would indicate their position on the evidence and the two documents in writing intimated to the court and to the other parties by close of business on 6 May.

 

[88] The Crown did so as agreed in an undated document headed "Comments from Crown with regard to the evidence of Dr Hatter". Their position was that it was inappropriate to comment on the evidence of Dr Hatter until the stage of submissions after all the evidence to the inquiry had been given. The Crown then took this opportunity to raise a new but related matter. They intimated that they had contacted another pathologist "to ascertain whether he would be in a position to consider medical records of Mrs Gill and the post mortem report compiled by Dr Hatter" and that he was willing to undertake this work but would require time to do that which the Crown submitted would have an effect on the completion of the inquiry. Accordingly, the Crown observed, after the evidence of Dr Baxter "the inquiry should be adjourned" to allow that pathologist to give his evidence before Dr Jennings gave his.

 

[89] Nothing was said about the terms of the Crown's letter when the inquiry reconvened until after the Crown had led the evidence of Dr Baxter whereupon Miss Hilley moved to adjourn the inquiry to obtain from the new pathologist a report which would not be available until June 2009. In support of that motion, and without conceding formally that she would not be relying further upon the evidence of Dr Hatter either in whole or in part, she went through a number of difficulties raised by that evidence and said that she wanted an independent forensic pathologist to look at the case notes and consider Dr Hatter's post mortem report and give a critique thereon as to whether Dr Hatter had carried out the post mortem to the required professional standard. This critique, she said, might give an indication of whether the Crown could rely upon the post mortem report and if so to what extent and the Crown proposed then to lead evidence on the basis of that critique.

 

[90] Mrs Robertson said that she did not oppose the motion but observed that it was unfortunate that the Crown had made the motion at the point in time that they had and that what the critique might state was only speculation at this stage. Mr Stephenson opposed the motion. He began by pointing out that the court had a wide discretionary power to adjourn an inquiry under rule 9 of the Fatal Accidents and Sudden Deaths Inquiry Procedure (Scotland) Rules 1977 but that section 3(1)(a) of the Act enjoined that inquiries should be expedited so far as that was reasonably practicable. He then noted that it had taken the Crown over three years from the date of Mrs Gill's death to make the application for an inquiry. He then subjected the evidence of Dr Hatter and his post mortem report to a detailed analysis of what he saw as their many shortcomings, concluding that the Crown position on them was still puzzling and that the Comments of the Crown did not comply with the Court's request to explain their position. He then posed the question what it was that the Crown wanted the new pathologist to do that would assist the inquiry and in answer concluded that it seemed to be to inquire into the actions of Dr Hatter rather than the circumstances of the death of Mrs Gill, thereby running the risk of diverting the inquiry from investigating those circumstances to investigating the professional standing of Dr Hatter. Moreover what the Crown wished to do was investigative in nature and as such was something that ought to have been done before the Crown decided to request an inquiry.

 

[91] In reply the procurator fiscal depute said that the Crown had taken the decision to obtain an independent review of the accuracy of the post mortem report after the third day of the inquiry and during the period of adjournment. They had then contacted the pathologist and he had indicated his willingness to assist but that he would need time to consider the papers, which would not include a transcript of the evidence in the inquiry so far, and then prepare his report.

 

[92] I exercised the discretion that I had and refused the Crown motion. They had not demonstrated cause to grant it at the stage the inquiry had reached. I accepted the soundness of the criticisms made by Mr Stephenson.

 

[93] In light of that refusal the Crown led the evidence of Dr Jennings and then intimated that they would lead no further evidence. At that point I felt it right to become more directly involved in determining the issue of the extent of the Crown's reliance on the question of the aortic tear. It was far from clear to me what the Crown position was and my concern had grown as I had listened to the lines of questioning of Dr Jennings by the Crown. That I was not alone in this feeling may be at least part of the reason why neither Mrs Robertson nor Mr Stephenson cross-examined him.

 

[94] I asked first on what basis under section 1(1)(b) the Crown had convened the inquiry, and was told it was that the death of Mrs Gill had been sudden and unexpected, not that it had been suspicious or in circumstances such as to give rise to serious public concern. I then asked, what was the Crown position on the aortic tear? Initially Miss Hilley said that she wanted to leave that until the stage of submissions and moreover that she wanted, for some undisclosed reason, time to read a transcript of the evidence of Dr Jennings. In light of all that had happened in the inquiry since Dr Hatter had given his evidence it seemed to me that this would not do. It smacked of temporising. In the interests of clarifying the proper scope of the inquiry I indicated that I would allow her to consider her position on this issue until the afternoon sitting. On reconvening for that session she made the statement. The inquiry was then adjourned for the hearing on evidence.

 

(viii) The written submissions

[95] All submissions were lodged in process in advance of the hearing on evidence. Because of that I do not propose to précis them in this Note, but I will refer to their terms wherever necessary to the reasons for my determination.

 

[96] Each of the three submissions included proposed findings concerning the circumstances of the death of Mrs Gill that each wished included in the determination, and each did so by reference to the five headings set out in section 6(1) of the Act. Those proposed findings were grounded in the evidence led at the inquiry that each wished the court to rely upon. The submission for the Health Boards included a motion seeking for each Board an award of expenses against the Crown in respect of the expenses that they had severally incurred in preparing for, and being represented at, the inquiry.

 

[97] Under (1)(a) all three agreed that the finding should be in accordance with the narrative set out in the Crown application to hold the inquiry, namely that Mrs Gill was born on 26 December 1930, lived latterly at 6 Solway Drive, Denny, and died at 04.55 hours on 17 November 2005 in the Western Infirmary, Glasgow.

 

[98] Under (1)(b) the Crown proposed a finding that (1) the cause of death was due to a massive haemorrhage secondary to the catheterisation procedure for an angiogram performed on 9 November 2005, and (2) that aortic stenosis was another significant condition that contributed to her death but did not relate to the disease or condition that caused it. Doctors Oldroyd and McDonald proposed a haemorrhage that was most likely a result of a complication of that procedure. The Health Boards proposed a sudden catastrophic collapse possibly of undetermined cause or in the alternative a massive internal haemorrhage from an undetermined source.

 

[99] Under (1)(c) the Crown proposed a finding that the certain measure that could have been taken which might have resulted in the death of Mrs Gill not occurring was a CT scan at the Western Infirmary. That measure was proposed against what the Crown say was a background of the medical staff there not being alerted to the fact that she continued to bleed after the angiogram procedure and her haemoglobin level continued to fall despite having blood transfusions. The other two submissions proposed a formal finding that there were no reasonable precautions whereby her death might have been prevented.

 

[100] Under (1)(d) all the submissions proposed a formal finding that there were no defects in any system of working which contributed to her death.

 

[101] Under (1)(e) the Crown proposed three facts. All were presented in the negative: that a tear in the aorta did not contribute to her death; that the angiogram procedure did not cause a tear in her aorta; and that the fact that the family were not given an appointment to meet with Dr Oldroyd did not contribute to her death. Doctors Oldroyd and McDonald had no specific submission to make under this sub-section and the Health Boards posed as a question whether there were any other facts which were relevant to the circumstances of her death.

 

(ix) The discussions over the written submissions

[102] At the hearing on evidence the procurator fiscal depute, Mrs Robertson and Mr Stephenson all adopted their submissions, with minor typographical alterations. The Crown intimated after discussion of the opposition to its proposed determination under (1)(c) mounted by both Mrs Robertson and Mr Stephenson that it was no longer insisting in a determination beyond the formal, and that the motion for expenses was opposed. As for (1)(e) Mrs Robertson said that there was no evidence to support the first of the two facts stated by the Crown and the third was dealt with under other heads. Mr Stephenson was equally critical and submitted that the matters raised might be dealt with in the Note appended to the determination.

 

[103] In respect of (1)(b) Mrs Robertson submitted that the pathological evidence ought to be regarded as unreliable in its entirety with the consequence that the Crown's proposed finding could not stand. Mr Stephenson submitted that the proposed finding lacked a basis in evidence and adopted Mrs Robertson's submissions on this. He analysed the two proposed findings. For the first, he criticised the Crown's use of the word "secondary" as being lacking in specification: was it to be construed as a synonym for "caused by" or was it a correlative to something else and conjunctive with that something else? No causal basis was made to the circumstances of the death of Mrs Gill. Fore the second it was meaningless in context and there was no factual support for it in the Crown submissions. The Crown prayed in aid as support for the reliability of part of Dr Hatter's report his evidence of the weight of Mrs Gill, but that reliance was not borne out by other evidence led, and accordingly there was no scope to use this feature to support the reliability of his evidence. In consequence there was no scope to make a finding under (1)(b).

 

[104] In reply the Crown conceded that what finding to make, if any, depended upon the view taken of the evidence of Dr Hatter. If that were rejected entirely then the inquiry was left with the evidence of Dr Oldroyd to the effect that the death of Mrs Gill was due to a sudden catastrophic collapse but there was no evidence to link that causally to the angiogram procedure. As for the second finding, the reference to aortic stenosis, the Crown included that in the proposed finding to support the death certificate. It was superfluous to include it because aortic stenosis was not a cause of death and Dr Hatter had accepted this in his report.

 

[105] The effect of all this was that the final position of parties in light of the submissions, both written and oral, came down to requesting a determination under (1)(a) that followed the narrative of the application (all three parties); under (1)(b) that either made a causal link between the procedure and the massive haemorrhage (the Crown and Mrs Robertson) or concluded that no such link had been established (Mr Stephenson); under (1)(c) and (1)(d) that was formal (all parties); and under (1)(e) that was either formal (Mrs Robertson and Mr Stephenson) or added one or more of the three findings suggested by the Crown.

 

My determination

(i) My assessment of the evidence

[106] The submissions made no criticism of the reliability of the evidence of five of the witnesses, the exception being Dr Hatter. For those five witnesses I accept their evidence as entirely reliable. Each was patently doing his best to assist the inquiry so far as each was able to do that in their recollection of events and response to the various medical issues raised by the reports and the circumstances. In the event, their respective accounts of the sequence of events that formed the reason for the inquiry did not differ to any extent that was material for my determination and I have therefore been able to use that common ground as the basis of many of my findings in fact.

 

[107] All four medical witnesses, three speaking to fact and one giving opinion evidence, were impressive. All were in truth experts in their chosen disciplines. They had all thought much about the death of Mrs Gill and analysed the sequence of events and their import in light of their own extensive professional experience and skills. To that they had added the findings and conclusion of the post mortem report, and were prepared to work with them and see where that analysis took them. It was apparent as they gave their evidence and also when they were speaking to the various reports that the issue of the aortic tear caused them serious professional unease which they indicated by exhibiting varying degrees of genuine perplexity and respectful scepticism while maintaining throughout a proper professional stance.

 

[108] Mr McGuiness was able to speak only to limited features but he gave valuable information on Mrs Gill's family background and her concerns about undergoing the procedure. Dr Oldroyd in particular was a very impressive witness. He gave his evidence in a measured and restrained manner. He came across as thoroughly professional in all his dealings. When discussing his role in the whole sequence of events from the morning of 9 November he did so with great authority tempered with a genuine concern for what had happened to her. He had clearly thought long and hard about the procedure particularly in light of the post-mortem report and he did not seek to justify the conduct of the procedure or the subsequent care regime adopted for Mrs Gill with the value of hindsight. He was described by Dr Jennings as a "senior highly experienced cardiologist" and "a national expert" in whom he had "complete confidence". It was easy to see why. Dr McDonald was clear and undemonstrative in his evidence and supported what Dr Oldroyd had said about the conduct of the procedure in all material respects. He was supremely well qualified at his stage in his career to carry out that procedure to the required clinical standard. On the basis of what both doctors said I am satisfied that that is exactly what happened. Dr Baxter was of great help in describing how he analysed the source of the original bleed and thereby confirmed the speedy and correct diagnosis made by Dr Oldroyd, and also for satisfactorily explaining that the abdominal aorta was undamaged following the conclusion of the procedure.

 

[109] Dr Jennings brought to his evidence a formidable wealth of knowledge and experience which enabled him to speak with the authority expected of a skilled witness. In giving his evidence he had to indulge in some mental gymnastics because he had prepared his report and supplementary report on the basis of information some of whose premises were challenged in the course of the inquiry. He dealt with each such change of premise with great assurance. In particular he had worked originally with two such features: that the aortic tear had been caused in some way by the conduct of the procedure and that there were three distinct sources of bleeding revealed by the CCT scan. These had clearly caused him great concern. So had his uncertainty about the role Dr Oldroyd had played during the conduct of the procedure. Once it had been explained to him that he should treat the tear as a post mortem artefact, that there was only one source of bleeding and that Dr Oldroyd had supervised the procedure throughout, he was enormously reassured and able to refine his views. That took him to the point where the only criticism of the care of Mrs Gill that he voiced was grounded in hindsight. Viewed prospectively, and in the contemporary context in which it evolved, it was not inappropriate to manage her conservatively given all her problems at the material time. I found the evidence of Dr Jennings of great assistance to me in framing my determination.

 

[110] With regard to Dr Hatter's evidence I have concluded that I must employ it with caution. That is not because he admitted that he could not remember Mrs Gill or performing the post mortem on her body, nor is it because at that time he was receiving treatment for the early stages of a mental illness and also battling alcoholism, the combined effect of which led to his resignation some seven months later. It is because of the circumstances in which he came to give his evidence. He said, and I accept this entirely not least because the Crown did not re-examine him on this information elicited in cross-examination, that in advance of appearing before the inquiry he had no access to any notes he made at the time of Mrs Gill's death and was unaware of the existence of the reports prepared by Dr Baxter, Dr Nolan, Dr Spratt and Dr Jennings and had not been given an opportunity to consider that evidence and therefore had no idea what was expected of him at the inquiry. The first intimation he had of this considerable body of medical fact and opinion, all relevant to the task faced by the inquiry, was when each document was put to him as he gave his evidence.

 

[111] The effect of all this was to handicap him significantly when giving his evidence. Its immediate effect for me was that while still being examined in chief I formed such an adverse impression of his reliability that I almost questioned his credibility. I was able to revise this only when he admitted in cross examination the very limited state of preparation afforded to him. As a result I was able, with some relief, to come to a more judiciously balanced and sympathetic assessment of his evidence. The more profound effect of his lack of preparation for the whole inquiry was that as far as I was concerned his lack of preparation denied him the opportunity to help the inquiry as much as undoubtedly he could or would have wished. This is all the more concerning because looking beyond his initial and obvious nervousness and beyond the uncertainty and occasional lengthy delay that he showed in answering questions on the various medical reports, all of which is readily explicable by reason of his lack of preparation, he gave his evidence in a straightforward, honest and candid way and this, in the whole circumstances in which he did so redounded to his credit.

 

[112] In the course of his evidence he agreed that this lack of preparation had placed him in a rather unfair situation. I would go much further than that. In my opinion it placed him in a position that was both isolated and invidious. This exceedingly unfortunate state of affairs inevitably raised misgivings about whatever he said about the medical features of his involvement with Mrs Gill and that includes his post mortem report. That said, I am not satisfied that I should go as far as the submission that his report in its entirety was either reliable or it was not. It is however, a matter of treating the whole of his evidence with appropriate caution particularly when assessing it against the other evidence that I have accepted. As one example of that, where Dr Hatter had no recollection that Dr Oldroyd had spoken to him both before and after the post mortem I prefer the evidence of Dr Oldroyd and have held that they did speak and the content of what was said was as recalled by Dr Oldroyd.

 

[113] I will not resort to speculation but I think that I can say that had he before the start of the inquiry been precognosced and in addition or in the alternative, if considered appropriate, been given the chance to read the other medical reports and think about what they had to say about his own findings and conclusion about the aortic tear, and had he then indicated what he eventually admitted in court in that regard, it is at least conceivable that the presentation of the inquiry would have followed a very different path and might also have affected the time it took in court.

 

(ii) My determinations under section 6(1)

[114] In light of the evidence on which I have concluded that I can and should rely, and also of the submissions both written and oral I am satisfied to the required legal standard of proof that I can make the findings in fact and the determinations under the five mandatory criteria, all as set out at the start of this determination.

 

Section 6(1)(a)

[115] Under section 6(1)(a) that Margaret Westwater Gill, whose date of birth was 26 December 1930, and who resided latterly at 6 Solway Drive, Denny, died on 17 November 2005 at 0455 hours within the Western Infirmary, Glasgow.

 

[116] This finding echoes the narrative in the application and this in turn is taken from the death certificate. The information for the time of her death comes from the clinical notes in which her time of death is given as 04.55 hours. That remained uncontroverted throughout the inquiry and all witnesses worked with that time without comment or criticism. The only observation I make in addition is that I was not told Mrs Gill's maiden name, it is not given in the death certificate and I could not readily find any reference to it in her medical records.

 

Section 6(1)(b)

[117] Under section 6(1)(b) that the cause of her death was a massive internal haemorrhage of indeterminate cause.

 

[118] Throughout the inquiry the main focus of attention was on this criterion. There was never any dispute that the immediate cause of the death of Mrs Gill was a massive internal haemorrhage. The dispute related to whether that could be linked to the angiogram procedure she underwent on 9 November. There was general acceptance that very shortly after the conclusion of the procedure she suffered a retroperitoneal haemorrhage. That was diagnosed correctly and speedily and as a result she was transferred to the Western as an emergency. There a clutch of highly qualified consultants assessed her and determined that the bleeding had stopped. This was in accordance with normal expectation of that type of haemorrhage. In light of that decision she was thereafter managed conservatively. Her condition over the next few days, and the various readings taken in the unit and then on the ward, seemed to bear out the appropriateness of that exercise of clinical judgement, albeit she remained in need of in-patient care throughout. While the haemoglobin reading from about 14 November onwards might suggest that she was continuing to bleed, there were other indicators that could point validly to a different conclusion, and the source of any such bleeding remains unknown. Her collapse in the early hours of 17 November was unheralded and catastrophic. It is accepted that it was not an aortic aneurysm.

 

[119] The only evidence for where the haemorrhage might have originated is pathological. I discount immediately any suggestion that it was from the tear in the abdominal aorta that Dr Hatter found at post mortem. I do that because of the considerable weight of medical opinion that cast doubt upon it taken together with Dr Hatter's retraction, graciously given, in light of that considerable weight of opinion. I do not need to go so far as to make a finding that the tear was in fact caused in the course of the post mortem and I do not propose to venture an obiter opinion on that. For present purposes it is sufficient if I confirm that I am satisfied that it was not caused to any extent or in any way by the conduct of the procedure. What I am left with is what Dr Hatter says in his report, to which he spoke in his oral evidence, that there was no evidence at post mortem that its source was the puncture site in the right groin. If I reject that evidence then there is nothing else to have recourse to.

 

[120] I have concluded that I should accept Dr Hatter's evidence on this point. When he came to conduct the post mortem, and even having made due allowance for his troubled state of health and the possibility of a lapse in concentration or a failure to observe all that he ought, such as the presence of the angioseal, I think it is going too far to say that he would not have correctly spotted and correctly recorded signs that indicated the massive haemorrhage within her abdomen had tracked from the single puncture site in her groin. In addition this finding is consistent with the evidence of Dr Oldroyd that it confirmed his clinical impression that the bleeding from that site had stopped on 9 November and with the picture of her condition in the Western over the next few days as revealed in her medical records and also the known and recorded features of such a haemorrhage.

 

[121] As a consequence I can reach no conclusion on the source of that final and fatal haemorrhage. Accordingly I have had to make the finding that I have: that her death was due to a massive internal haemorrhage of indeterminate cause.

 

Section 6(1)(c)

[122] Under section 6(1)(c) that there were no reasonable precautions whereby her death might have been avoided.

 

[123] There was no evidence that justified a determination in terms other than the formal.

 

Section 6(1)(d)

[124] Under section 6(1)(d) that there were no defects in any system of working which contributed to her death.

 

[125] There was no evidence that justified a determination in terms other than in the formal.

 

Section 6(1)(e)

[126] Under section 6(1)(e) that there were and are no other facts which are relevant to the circumstances of her death.

 

[127] I am not persuaded that I should do more than make a formal determination under (e). Of the three features urged by the Crown I have dealt with the first two under (1)(b) above which is where I consider they belong. As for the third, it was an understandable desire to speak to the doctor in charge, but that was not an issue that bore on the circumstances of the death of Mrs Gill. I for my part have no other facts that I want to include under (e). As the inquiry proceeded there were two features of the conduct of the procedure that I thought might develop the potential to require a finding: the height of the puncture and the possible use of a covered stent. However, for both I was satisfied by the end of the inquiry that the evidence led had allayed any concerns I had had in that direction for either feature.

The question of expenses

[128] I will hear the Health Boards and the Crown on the motion on behalf of both Health Boards at a hearing yet to be assigned in terms of my interlocutor that precedes this Note. Mrs Robertson made no such motion against the Crown and submitted that neither Dr Oldroyd nor Dr McDonald need be represented at the hearing on expenses. I agree. For that reason I have excluded all reference to them in my interlocutor.