Record of Investigation Into Death (Without Inquest)
Coroners Act 1995Coroners Rules 2006Rule 11
I, Rod Chandler, Coroner, having investigated the death of
Judith Louise Allen
WITHOUT HOLDING AN INQUEST
Find :
(a) Judith Louise Allen (“Mrs Allen”) died on 7 July 2009 at the Royal Hobart Hospital in Tasmania, (“the Royal”) aged 49 years;
(b) Mrs Allen was born in Hobart on 27 October 1959. She was married and resided with her husband Simon in Glenorchy. She was not employed at the time of her death.
(c) Mrs Allen died as a result of haemoperitoneum (internal bleeding) complicating laparoscopic gastric band revision surgery.
Background :
Mrs Allen was morbidly obese. In January 2005 she weighed 132kg when she first attended surgeon Mr Stephen Wilkinson to be advised upon lap banding surgery to treat her obesity. In October 2006 Mr Wilkinson carried out this procedure. It was uneventful. Thereafter Mrs Allen had routine follow up visits to Mr Wilkinson and progressive weight loss was recorded. In August 2008 her weight was 97.8kg. However, by May 2009 Mrs Allen was complaining of night time regurgitation. She attended Mr Wilkinson and he reported; “A Gastrogaffin swallow was obtained showing that some of the stomach had slipped through the band making the pouch above the band too big, which was causing the constant regurgitation and chest problems. I explained the need to remove and replace the band into a better position.”
In May 2001 Mrs Allen was baptised a Jehovah Witness and her husband was similarly baptised 12 months later. They both adopted the Jehovah Witness doctrine that the Bible prohibits ingesting blood and that Christians should therefore not accept blood transfusions, even where life was imperilled. It is my understanding that a baptised Jehovah Witness who voluntarily accepts a transfusion is regarded as having disassociated himself from the religion by the abandonment of its doctrines and is subsequently subject to organised shunning by other members.
It seems that Mrs Allen had not informed Mr Wilkinson of her Jehovah Witness status prior to her 2006 lap band surgery but it was recorded in her pre-operative anaesthetic chart that she was a Jehovah Witness and that she declined treatment with red blood cells, platelets and clotting factors. At this time it was also known that Mrs Allen had a previous history of Hepatitis C infection and she had a fatty liver which had to be negotiated in the course of fitting the lap band.
Circumstances Leading to Death :
On 6 July 2009 Mrs Allen attended the Royal for the surgical revision of her lap band to be carried out by Mr Wilkinson as a day procedure. At the time her weight was noted at 109kg. The surgery consent form noted that bleeding was a potential complication which may require a laparotomy. This, as I understand it is a common notation. Mrs Allen’s status as a Jehovah Witness was noted on the anaesthetic assessment sheet.
Professor Anthony Bell reports upon Mrs Allen’s surgery as follows:
“The patient undergoes surgery to remove the lap band, repair a hiatus hernia and insertion of another lap band. The operation report states that there is liver bleeding. Although not specifically stated, the usual cause is because the large liver had become stuck (adhesions) to the area of the previous surgery. In order to gain access to the proximal stomach, the liver would be required to be dissected off the stomach and retracted anteriorly. An attempt was made to control the bleeding from the liver with Floseal. Floseal is a topical agent used to stop bleeding. The manufacturer (Baxter) reports Floseal to be useful in situations where control of bleeding by conventional methods is ineffective or impractical. It contains human thrombin, obtained from human plasma, and bovin derived gelatine matrix. The product information reports that it can cause intravascular clotting and death if injected intravascularly. This product was used with the consent of the patient's husband who had been contacted. Surgical (a haemostatic cloth) and pressure were also used to control the bleeding. The remainder of the operation report suggests a straight forward hiatus hernia repair and reinsertion of a lap band. There is no further mention of the bleeding. The operation finished at approximately 12:15 hours. In the medical notes, written at approximately 18:45 hours, suggests that the blood loss from the operation was approximately 700 ml, not a lot of blood given the redo nature of the operation and liver bleeding that was encountered.”
In recovery Mrs Allen complained of abdominal pain and was hypotensive (low blood pressure). She was treated with adrenaline and metaraminol and then assessed by a surgical team. Because of her persisting low blood pressure and falling haemoglobin it was decided to return her to the operating theatre. This was three hours after the initial operation. Professor Bell describes the events that followed in these terms:
“At the second operation ports were reintroduced for laparoscopy. Blood was aspirated from the peritoneal cavity and collected using a cell saver. A cell saver is a device into which blood can be collected and then reinfused into the patient. Only 750 ml was transfused back to the patient. A welling up of dark blood near the superior pole of the spleen was noted but no definite bleeding source was seen. No other bleeding point was seen. Because the blood continued to well up in the region of the spleen, a decision was made to convert the procedure to an open procedure using an upper midline incision. Packs were placed in the region of the presumed bleeding but on removal of these packs there was very little blood. The remainder of the peritoneal cavity was carefully explored and no other bleeding site identified. In particular, there was no bleeding from the liver which had previously been a problem. After a further period of packing and removal of packs, again no obvious source of bleeding was identified and so the abdomen was closed after two drains had been laced in the peritoneal cavity. The operation commenced at 15:27 hours and finished at 18:15 hours. The patient was transferred to the intensive care unit.”
In the intensive care unit Mrs Allen’s haemoglobin level continued to drop and her blood pressure and cardiovascular status remained critically compromised. She developed a coagulopathy, ie an impaired ability of the blood to clot. Therapy given to Mrs Allen included gelofusine and prothrombinex (in the place of blood products) inotropic medication (to increase and support her blood pressure) and drugs thought to have beneficial effects on blood clotting. However, Mrs Allen remained critically ill. Several times medical staff including Mr Wilkinson explained to Mr Allen the gravity of his wife’s situation and that she would likely only survive if she received a blood transfusion. However, on each occasion Mr Allen refused to consent stating that his wife’s wish that she not have a transfusion should be respected.
Mrs Allen died at 00.35 hours on 7 July 2009.
Mr Wilkinson reports that he had carried out approximately 2100 lap banding operations including many re-do procedures and a blood transfusion had never previously been indicated. He further observes that fatty liver is very common in obese patients and normally does not constitute any increase in risk for patients undergoing lap band surgery.
Investigation and Associated Matters :
Forensic Pathologist, Dr Donald Ritchey, carried out a post mortem examination. He noted; “There was abundant blood tinged watery fluid in the peritoneal space. There was an area of electrocautery on the undersurface of the left lobe of the liver but a definite source of the bleeding was not identified at autopsy.” In Dr Ritchey’s opinion the cause of Mrs Allen’s death was haemoperitoneum (internal bleeding) complicating laproscopic gastric band revision surgery. In his further opinion significant contributing factors were morbid obesity, chronic liver disease, atherosclerotic and hypertensive cardiovascular disease and religious views precluding transfusion of blood products.
The Royal convened a Serious Incident Panel to investigate the circumstances of Mrs Allen’s death. Mr Stuart Walker, a vascular surgeon and the Royal’s Medico Legal Coordinator for Clinical Services reports that the panel made five recommendations as a consequence of Mrs Allen’s death. Those recommendations and Mr Walker’s comments upon each follow:
“1. Standardisation of a consent form for patients who are identified as JW's with specific forms for children and adults.
A consent form for patients who refuse blood products including JW's, has been developed …… This has been a collaborative effort by the Legal Unit Department, the Department of Anaesthetics and the Pathology Department (haematology). This has been a difficult area as there are a number of different and complex blood products that can be given to patients. Unfortunately, there are some products that are acceptable to some JW patients that are not acceptable to others. There are also some products which contain human blood products but this is not obvious. The consent form thus needs to be exhaustive and complete.
2. Standardisation of comprehensive screening tool incorporating review by a haematologist for patients identified as JW with a separate tool for adults and children.
Patients identified as JW's who are admitted for elective surgery will be identified by a modification to the current request for admission form. Once these patients have been identified they will receive a copy of the patient information sheet and consent form covered above….. When patients attend the pre assessment clinic prior to their surgery, they will be categorised into one of three groups:
a. Risk or non-existent risk, e.g. cataract surgery, minor skin lesions, hand surgery under tourniquet. No further action will be required for these patients.
b. Small risk of major bleeding but anticipated blood loss less than 500 ml i.e. major bleeding not likely to occur for that particular surgery, e.g. any intra-cavity procedure such as minor laparoscopic procedures, shoulder surgery, thyroid surgery. These patients will be asked to sign the above consent form. During this consenting process the risks and benefits of blood products will be explained to the patient by the anaesthetist and specific details of what the patient would accept or not will be documented.
c. Anticipated blood loss of 500 ml or more on average for the planned surgery, e.g. major open vascular surgery, laparotomy, thoracotomy, joint replacement surgery. These patients will have review by the haematology team (having been referred by the anaethetists) in order to optimise their condition prior to surgery. A more detailed consenting process will occur, again discussing the risks, benefits and alternatives to blood products with both the anaethetists and haematologist.
3. Standardisation of comprehensive screening tool for patients identified as bariatric.
With respect to this recommendation, the intention was to develop a screening tool to identify inclusion and exclusion criteria for those patients identified as suitable to undergo bariatric surgery. To this end, the Royal Hobart Hospital has undertaken a multidisciplinary internal review of the process for the selection and management of patients for bariatric surgery. This report has now been published.......... This report has been accepted by the Department of Health for state wide implementation. Mechanisms will now be put in place to offer a more comprehensive pre operative multi disciplinary assessment and management pathway for bariatric patients.
4. Department of Surgery undertake an independent review of current processes, elective and non elective bariatric surgery.
The Serious Incident Panel recommends an independent assessment of the current practise regarding bariatric surgery at the Royal Hobart hospital. This would normally involve independent specialists, probably from mainland Australia, coming to Hobart and conducting a thorough review of the current pre operative selection and assessment of patients recommended for bariatric surgery, a review of the procedures performed with documentation of complications and outcomes, and a review of the post operative inpatient and outpatient management of these patients. I am not aware of any plans for such an extensive review. It would appear that the Royal Hobart Hospital have used the proposed and now accepted Careway to cover this recommendation.
5. Cease public funded elective lap band surgery at the Royal Hobart Hospital for up to six months.
This recommendation had been implemented from 2 March 2010. I understand that plans are now well advanced to restart this service in line with the approved careway. Currently, it appears that funding for the allied health aspect of the careway is the hold up. Once this has been resolved, the service will be implemented and lap bands restarted at the Royal Hobart Hospital and the Launceston General Hospital. The careway provides for a significant increase in allied health input to the management of these patients which has created new funding and staffing issues. It must also be acknowledged that there is significant pressure being applied to the Department of Health and specifically to the Royal Hobart Hospital to reinstate this service as quickly as possible as there is a growing waiting list for this procedure and an increasing number of urgent cases to attend to.”
Findings, Comments and Recommendations :
I accept the opinion of Dr Ritchey and find that Mrs Allen died as a result of haemoperitoneum (internal bleeding) complicating laparoscopic gastric band revision surgery. I accept too that significant contributing factors were morbid obesity, chronic liver disease, atherosclerotic and hypertensive cardiovascular disease and religious views precluding transfusion of blood products.
The evidence does not permit me to make a finding upon the source or cause of Mrs Allen’s internal bleeding. It follows that I cannot make any finding, either negative or positive, upon the standard of surgery.
Mrs Allen’s death occurred when Mr Wilkinson and the Royal’s other medical staff were unable to utilise blood products including the transfusion of blood in their treatment of her. Had these treatment options been available then it is, in my opinion, highly likely that the internal bleeding that arose following the lap band revision could have been successfully treated and Mrs Allen’s life saved. In these circumstances Mrs Allen’s death was clearly preventable.
Unintended bleeding can be a complication of most surgical procedures. However, I accept with respect to lap banding and revision of lap banding that the risk of bleeding which necessitates a transfusion is very low. Relevantly, I note and accept the evidence of Mr Wilkinson that in his very extensive bariatric experience he had never previously encountered a case of bleeding which required transfusion following lap banding or lap band revision. Nevertheless, the consequences can be very dire for a Jehovah Witness who experiences bleeding following surgery and it is my opinion that such patients require particular pre-operative attention. This is a matter which the Royal has addressed in the recommendations arising from its Serious Incident Panel review.
No criticism should be made of Mr and Mrs Allen for their choice of religious faith. However, as baptised Jehovah Witnesses they were obligated by their religion to abide by its doctrine that forbid the ingestion of blood or blood products. Their compliance with this doctrine has had the most tragic consequence. I accept that this doctrine has been an entrenched principle of the Jehovah Witness religion since 1945 despite considerable debate and that the prospects of it being abandoned or at least moderated are remote. Nevertheless, Mrs Allen’s death most graphically illustrates the consequence of the rigid adherence to that doctrine and brings me to recommend, perhaps forlornly, that the Jehovah Witness Governing Body and its elders give consideration to a relaxation of its doctrine concerning blood so that any member confronted with an unexpected medical emergency is permitted access to all life saving treatments without breaching the rules of their faith and attracting punishment including shunning.
I have set out above the recommendations made by the Serious Incident Panel arising from Mrs Allen’s death. I support each of them and am confident that, if adopted, they will enhance the safe surgical management of Jehovah Witness patients and bariatric patients generally. I observe that if the recommended screening tool had been in place at the time of Mrs Allen’s presentation it is likely that she would have been assessed as having “a small risk of major bleeding” and thus had explained to her the risks and benefits of the blood product alternatives and her choices (if any) identified. The Panel’s recommendations do not indicate whether, at this stage an autologous blood transfusion (ie. the pre-surgery collection and later re-infusion of a patient’s own blood or blood components) or intraoperative blood salvage would have been identified as options for Mrs Allen. It is my understanding that these two blood collection and re-infusion procedures are accepted by some Jehovah Witnesses as being permissible and it would be my recommendation that they specifically be advised to all Jehovah Witnesses who are assessed as having a small or greater risk of major bleeding at surgery.
I conclude by extending my condolences to Mrs Allen’s family.
DATED : 25 August 2011 at Hobart in Tasmania.