COURT FILE NO.: CV-14-00000311-00
DATE: 20200831
ONTARIO
SUPERIOR COURT OF JUSTICE
BETWEEN:
THE ESTATE OF JULIA STEVENHAAGEN, DECEASED, BY HER ESTATE TRUSTEE, JOHN STEVENHAAGEN, HOLLY STEVENHAAGEN and BRAD STEVENHAAGEN
Plaintiffs
– and –
KINGSTON GENERAL HOSPITAL, DR. GARY N. BURGGRAF, DR. DOUGLAS R. WALKER, DR. I. SINGH, DR. JOHN D. RICKETTS, DR. LAVALEE, W. TSUI, V. NAIR, DR. ROBERT D. TOMALTY, BRENDA BEATTIE, M. CAMPBELL, KATE SWITZER, B. BRUMH, THE TORONTO HOSPITAL (ALSO KNOWN AS UNIVERSITY HEALTH NETWORK), DR. PETER R. MCLAUGHLIN, DR. RALPH EDWARDS, DR. TIRONE E. DAVID, DR. HAGGIE AND DR. YIP, JANE DOE 2 and DR. YARON STERNBACH
Defendants
Jerome R. Morse and Kevin E. Kemp, for the Plaintiffs
William D. Black and Atrisha S. Lewis, for the Defendants Dr. Peter R. McLaughlin and Dr. Yaron Sternbach
HEARD at Kingston: 12-15, 19, 20, 21, 26 and 28 November 2019, 2-6, 9-12, 17-18 December 2019, 20-21 January 2020.
MEW J.
REASONS FOR DECISION
[1] Many years have passed since 18 October 2002, when Julia Stevenhaagen underwent a balloon angioplasty procedure at Toronto General Hospital. During the course of that procedure, she experienced a rupture of her thoracic aorta, a life-threatening emergency.
[2] Julia Stevenhaagen survived. But she was left with paraplegia, paralysis of the left vocal cord, brain ischemia and left arm pain syndrome. She experienced bladder and bowel dysfunction with frequent urinary tract infections. While she experienced some improvement, these afflictions continued until her death on 21 September 2012.
[3] This case is about whether the decisions and actions that were taken by two physicians met the standard of care owed by them to Julia Stevenhaagen and, if they did not, whether their breaches caused the injuries and losses that she suffered.
[4] The parties have agreed on the issue of damages. They have been unable to agree on whether anyone is legally responsible to pay those damages.
[5] This action was commenced in 2003. Over the years, the number of defendants has been whittled down so that only Dr. Peter McLaughlin, an interventional cardiologist, and Dr. Yaron Sternbach, a vascular surgeon, remain.
[6] A great deal of time, resources, expertise and energies have been devoted to this litigation. The complexity of medical negligence litigation and the lack of court resources to adequately support this case have contributed to the delays in getting this matter to trial. Nonetheless, it is highly regrettable that the parties have had to wait so long for resolution.
[7] Significant preparation and collaboration between counsel before the trial began reduced the amount of court time required. Nevertheless, there were 22 hearing days and 341 pages of written submissions were received.
Overview
[8] Julia Stevenhaagen was born in 1955 with a congenital condition known as a coarctation of the aorta.
[9] This condition was diagnosed in 1975.
[10] The aorta is the large blood vessel that delivers oxygen-rich blood from the heart to an individual’s body.
[11] In very general terms, the aorta consists of four sections. Beginning at the top of the left ventricle of the heart, the ascending aorta rises up from the heart. Next, the aortic arch curves over the heart, a close to 180 degree turn. Three major blood vessels branch off of the aortic arch – the brachiocephalic trunk, the left common carotid (which takes blood to the left side of the brain) and the left subclavian artery (which takes blood to the left arm). The third portion is the descending thoracic aorta, which travels down through the chest. The fourth section is the abdominal aorta, which begins at the diaphragm and is the route for oxygenated blood to travel to most of the major organs of the body.
[12] A typical coarctation of the aorta is an hourglass shaped narrowing in the descending aorta, beyond (distal to) the aortic arch.
[13] In 1975, following diagnosis, Ms. Stevenhaagen underwent an “open patch repair” of her coarctation. This was undertaken by way of a thoracotomy – a form of open surgery – on the left side of her chest.
[14] By 1997, Ms. Stevenhaagen had developed persistent hypertension (high blood pressure). A computerised tomography (“CT”) scan showed that the diameter of her ascending aorta was 3 cm whereas her descending aorta had a diameter of 1.8 cm at the coarctation site. She also had an angiogram (a procedure which uses X-rays taken during the injection of a contrast dye to evaluate blockages in the arterial system), which showed a “pressure gradient” of abnormally high blood pressure before the lesion and low blood pressure below it. In Ms. Stevenhaagen’s case, the peak gradient measured was 76 mmHg (millimetres of mercury). This was despite her use of anti-hypertensive medications.
[15] On 23 March 1999, a procedure called a balloon dilation of Ms. Stevenhaagen’s aortic coarctation was attempted at Kingston General Hospital. The plan was to insert a stent which would dilate the coarctation, but the procedure could not be completed because an appropriately sized stent was not available.
[16] The procedure was repeated on 28 May 1999. On this occasion, an 18 mm x 40 mm “wall stent” was placed. This type of stent is described as covered on the inside with cross-hatching small thin metal fibres. Although the placement was successful, the stent did not fully deploy at one end. As a result, a pressure gradient, albeit a reduced one, remained. Ms. Stevenhaagen continued to be treated for persistent hypertension after this procedure.
[17] In July 2001, Ms. Stevenhaagen’s doctors in Kingston decided to refer her to Dr. McLaughlin at Toronto General Hospital. Correspondence dated 31 July 2001 from Dr. John Smythe in Kingston to Dr. McLaughlin noted that Ms. Stevenhaagen had an arm-to-leg blood pressure gradient of approximately 40 mm Hg.
[18] After consulting with Ms. Stevenhaagen by telephone on 24 January 2002, Dr. McLaughlin developed a plan to place a balloon through the existing stent (sometimes referred to as the “Kingston stent” in these reasons) and use the balloon to open up the end of the stent which had not been fully deployed during the procedure in Kingston.
[19] Dr. McLaughlin discussed the risks of complications arising from this “recoarctation” procedure with Ms. Stevenhaagen. He told her that the risk of death, stroke or the need for cardiac surgery, was up to two percent. He described this as “a relatively low risk”.
[20] An elective recoarctation procedure, to be performed by Dr. McLaughlin at Toronto General Hospital, was scheduled for 18 October 2002, with a planned discharge the following day.
[21] The procedure was undertaken in the catheterisation laboratory (or “Cath Lab”). Ms. Stevenhaagen arrived there at 08:26 and the procedure commenced at 08:44. Dr. McLaughlin was assisted by Dr. James Yip, a resident.
[22] Between 09:51 and 09:54, a low-pressure Owen’s balloon was introduced and inflated. The pressure which it exerted was insufficient to dilate the coarctation. The balloon burst and was withdrawn.
[23] A Mullen’s balloon was then introduced. This was a thicker, shorter, device which could tolerate pressures of up to 14 to 16 atmospheres (by contrast with the Owen’s balloon, which could only be inflated to between four and six atmospheres). The Mullen’s balloon is considered to be a medium pressure balloon. It was inflated in stages. No dilation was achieved at one-third inflation or at two-thirds inflation (10-12 atmospheres). However, at 16 atmospheres, the coarctation was fully dilated.
[24] At 10:08, the Mullen’s balloon burst. The Interventional Report recorded by the haemodynamic nurse noted that this occurred at a pressure of 18 atm (atmospheres). However, Dr. McLaughlin testified that he was operating the dial, and that the inflation only went to 16 atm.
[25] Between 10:10 and 10:12, the Mullen’s balloon was withdrawn. However, an angiogram performed at 10:14 revealed what Dr. McLaughlin described as a “little puff” of contrast, just distal to the aortic arch. It was immediately apparent to Dr. McLaughlin that there had been a rupture of the aorta. He instructed the circulating haemodynamic nurse to page Dr. Sternbach. The interventional report records that Ms. Stevenhaagen complained of pain in her shoulder and arm at this time.
[26] Dr. McLaughlin decided to insert a balloon to tamponade, or block, the tear. As Dr. McLaughlin described it, the rupture was in the worst possible location to straddle with a balloon tamponade. He prepared and inserted a Mullen’s balloon, which was inflated so that the tip of the balloon would cover the tear, but not obstruct the left subclavian or left carotid arteries. Because blood was coming from the ascending aorta under high pressure and pushing against the head of the balloon, it was necessary for Dr. McLaughlin to constantly make adjustments in order to keep the tip of the balloon over the tear.
[27] The interventional report also notes that at 10:14, cardiovascular surgery was paged. The cardiovascular surgeon on call that day was Dr. Anthony Ralph-Edwards. His evidence is that he attended the Cath Lab and presented himself to Dr. McLaughlin within a couple of minutes of receiving the page. It is not known who paged Dr. Ralph-Edwards. He came into the control room area of the Cath Lab and stood in front of lead glass that separates the control room from the area where Dr. McLaughlin and Ms. Stevenhaagen was situated. He says that he inquired whether his help was required and established to his satisfaction that an opinion was not required from him at that time. It is not clear whether Dr. McLaughlin and Dr. Ralph-Edwards communicated with each other directly on this occasion. Regardless, Dr. Ralph-Edwards did not stay. During the course of his brief visit, he does not believe that he was informed that Ms. Stevenhaagen had experienced a ruptured aorta.
[28] Dr. Sternbach was operating on another patient when he was initially advised of the request to attend at the Cath Lab, and responded that he was busy and unavailable. He was then told that there was a significant emergency in the Cath Lab that required his attendance. He hurried over there, arriving at 10:29. Having received a summary of events from Dr. McLaughlin and reviewed the available images, Dr. Sternbach’s observation was that the situation was dire and that Ms. Stevenhaagen was “at risk of precipitous exsanguination”. He told Dr. McLaughlin that it would be feasible to insert a covered stent into the aorta to stop the bleeding.
[29] Dr. Sternbach then left the Cath Lab to try and retrieve an appropriate device. In the meantime, a decision was made to place Ms. Stevenhaagen under a general anaesthetic. At approximately 10:43, she was intubated.
[30] It took Dr. Stenbach a few minutes to get to the storage area where the collection of devices was located. He eventually selected an iliac limb stent manufactured by Cook Medical which was 22 mm in diameter and 55 mm in length (the “Cook” stent). He also took other devices with him in case the selected device turned out not to be suitable. All of these devices were meant for use in the abdominal or aorta or iliac arteries. Dr. Sternbach therefore had to contact Health Canada to try and obtain approval for the proposed “off-label” use. He was able to obtain authorisation and returned to the Cath Lab. Dr. McLaughlin had, in the meantime, been able to maintain control of the bleeding site and was deflating the balloon intermittently to allow some perfusion of the organs and local extremities.
[31] Dr. Ralph-Edwards had also been paged a second time by an unknown party, he believes 30 to 45 minutes following the first page. On this occasion, he recalls seeing both Dr. McLaughlin and Dr. Sternbach. He cannot recall who he spoke to, but he became aware that the choice of treatment was to place a covered stent. Once again, he was not asked to provide an evaluation.
[32] Surgery began at 11:03. At 11:28, Dr. Sternbach deployed the stent graft just beyond the Kingston stent. After the initial placement of the stent, there were further adjustments, using balloons, to manipulate the positioning of the stent graft.
[33] An angiogram image (scene 14) at 12:03 confirmed that there was no bleeding. However, at 12:12, Ms. Stevenhaagen’s blood pressure gradient between the ascending aorta and the descending aorta was measured at 93 (a blood pressure gradient refers to the difference in the blood pressure between two points; a gradient of 93 represents a severe restriction of blood flow). To address this, a lower profile balloon was introduced and inflated within the aortic arch to adjust the stent. By 12:35, a gradient of 18 was recorded (which would be a very satisfactory reading in the circumstances).
[34] At 13:40, Ms. Stevenhaagen was transferred to the coronary care unit (“CCU”) for what was described as “intensive monitoring of her heart condition”. There, she initially came under the care of Dr. Mansur Hussein. However, at approximately 14:20, Dr. McLaughlin, having gone to the CCU, saw that her central venous pressure (“CVP”) was 35 mm Hg, a high reading – and became concerned that Ms. Stevenhaagen had become unstable. Although he thought the most likely cause was the shifting of the haematoma that would have formed in her chest cavity as a result of the earlier bleeding, he could not rule out the possibility of further bleeding. Dr. Ralph-Edwards was contacted for a consultation.
[35] Dr. Ralph-Edwards diagnosed ongoing bleeding from the aortic arch and the mediastinal hematoma resulting in SVG obstruction. In his notes he wrote that Ms. Stevenhaagen was “intubated, ventilated, unresponsive (anaesthetized). His note also records “? neurologic injury”. He subsequently wrote:
The situation was discussed with the family, as well as the plan of surgery and the possibility of pre-existing neurologic injury.
[36] The decision was made to take Ms. Stevenhaagen to the operating room for open heart surgery.
[37] Ms. Stevenhaagen was taken to the operating room emergently. Dr. Ralph-Edwards spoke to his senior colleague, Dr. Tirone David, who was on the premises. Dr. David subsequently came to the operating room and assisted.
[38] Dr. Jane Heggie was the attending anaesthetist. She made a note at 14:45 that upon arrival Ms. Stevenhaagen was “sedated + paralyzed on arrival” and “moving all 4 limbs”. She testified that she would have made this assessment sometime between 14:35 and 14:45. A median sternotomy was performed, and 800cc of haematoma was evacuated from her pleural cavity. Ms. Stevenhaagen was placed on cardiopulmonary bypass, and deep hypothermic circulatory arrest was instituted (the operation was performed using hypothermic circulatory arrest at 20 degrees Centigrade with retrograde perfusion of the distal aorta).
[39] A tear in the inferior aspect of the aortic arch was identified. The Cook stent was found in the distal arch and proximal descending thoracic aorta which was, according to Dr. Ralph-Edwards, partially obstructed. The left subclavian artery was ligated along with the proximal descending thoracic aorta following the removal of both the Cook stent and the “Kingston” stent (a portion of which had been seen protruding through the area of the tear before the aorta was opened up). No evidence of active bleeding was seen.
[40] In addition to the repair and replacement of the ascending aorta and arch, an extra anatomic bypass was constructed between the ascending aorta and the mid-descending thoracic aorta using a 24 millimetre Hemashield graft.
[41] Dr. Ralph-Edwards described the operation as “technically difficult” and following the procedure, it was not possible to close up Ms. Stevenhaagen’s chest owing to haemodynamic compromise. She was therefore returned to the intensive care unit with only the skin closed.
[42] In the days that followed, Ms. Stevenhaagen’s course was complicated by atrial fibrillation and labile haemodynamics.
[43] On 22 October 2002, she was stable enough to be brought back to the operating room for evacuation of a left chest haematoma and wiring of the sternum.
[44] Following the procedure, on 22 October, Ms. Stevenhaagen showed significant neurological impairment, initially, quadriplegia, which subsequently improved to paraplegia. A CT head scan identified areas of low-density in the right and left occipital areas of Ms. Stevenhaagen’s brain.
[45] Ms. Stevenhaagen was discharged from Toronto General Hospital on 19 November 2002 and transferred to Kingston General Hospital.
[46] A further CT head scan performed at Kingston General Hospital on 13 December 2002 identified bilateral occipital lobe infarcts, consistent with “watershed territory” infarcts (brain ischemia that is localised to the vulnerable border zones between the tissues supplied by the anterior, posterior and middle cerebral arteries). There were also infarcts in the right temporal lobe and frontal lobes as well as bilateral parasagittal areas of low density in the frontal lobes. The opinion of the consultant radiologist was that these events were bilateral infarcts in the watershed area in keeping with a hypoperfusion event.
[47] Following her discharge from Kingston General Hospital on 17 December 2002, Ms. Stevenhaagen was transferred to the St. Mary’s of the Lake Hospital where her rehabilitation continued until August 2003. According to her husband, John Stevenhaagen, by the time of her discharge, Ms. Stevenhaagen’s ability to remember things and her awareness seemed to have improved. She underwent day surgery for a laryngeal implant to enable her to speak. However, she could not walk. She required an electric wheelchair, and had enough function in her right arm to operate it. While she ultimately regained much of her cognitive function, she remained wheelchair bound for the rest of her life.
[48] Ms. Stevenhaagen died on 21 September 2012.
Issues
[49] Broadly speaking, there are two issues that must be determined.
a. Did Dr. McLaughlin and Dr. Sternbach exercise the degree of skill and care expected of a normal, prudent physician of comparable training and experience in the same circumstances?
b. Second, if either or both of them fell below that standard of care, did their actions cause or contribute to Ms. Stevenhaagen’s injuries and losses?
[50] I will address these issues in turn, by reference to the submissions made by the parties and the extensive evidence placed before the court and my findings of fact.
[51] Before doing so, I will identify the witnesses and briefly describe what they testified about. I will then describe, in very broad terms, the generally applicable legal principles.
The Witnesses
The Plaintiffs
[52] Julia and John Stevenhaagen got married on 16 August 1975. Their daughter, Holly, was born in 1980; their son, Brad, in 1984. Julia underwent her first heart surgery a couple of months after her wedding.
[53] John Stevenhaagen worked as a Supervisor of Electrical Production Engineering for 29 years. He recounted how, on the day of the 2002 procedure, he, Julia and Holly had walked from their hotel to the hospital.
[54] John Stevenhaagen kept a detailed diary of the events surrounding his wife’s medical events, including those of 18 October 2002 and its aftermath. He made notes of conversations with health professionals that day as well as his own observations.
[55] Holly Budgel described the few moments that she had to see her mother before she was wheeled into the operating room. She said that her unconscious mother was almost unrecognisable due to facial swelling.
The Defendants
(a) Dr. Peter McLaughlin
[56] Dr. Peter Mclaughlin graduated in medicine from the University of Toronto in 1970. He undertook postgraduate training at Stanford, Toronto, and Ottawa. Dr. McLaughlin maintained a clinical practice from 1976 until 2005 at the Toronto General Hospital, where he focused on treating adults with congenital heart disease, primarily working in interventional procedures in the Cardiac Cath Lab. He served as Director of the Cardiac Cath Lab at the Toronto General from 1991 to 1999. From 1993 to 2005, Dr. McLaughlin was also a full professor in the Department of Medicine at the University of Toronto. He has served on the Board of Directors of the Heart and Stroke Foundation, and was formerly the President of the Canadian Cardiovascular Society.
[57] Dr. McLaughlin testified that prior to October, 2002, he had performed approximately 75 balloon angioplasties for aortic coarctation and re-coarctations and 70 treatments with balloon angioplasty and stenting. He has written or co-authored over 100 peer reviewed articles, including on interventional cardiology, endovascular stent graft management of coarctation of the aorta in adults, and diagnosis and management of aortic coarctation.
[58] Since 2005, Dr. McLaughlin has practised in Peterborough, Ontario, where he is currently Chief Executive Officer of the Peterborough Regional Health Centre.
(b) Dr. Yaron Sternbach
[59] Dr. Yaron Sternbach received his medical degree from McGill University in 1991. He did his clinical training in Boston before undertaking a research fellowship in microsurgery in Burlington, Massachusetts. From 1997 to 1998, he undertook in an endovascular fellowship at Southern Illinois University, where he focused on minimally invasive (catheter based) therapies. Dr. Sternbach testified that during that fellowship, he performed hundreds of angioplasty and stent graft placements, as well as approximately 60 to 70 aortic repairs. In 1998, Dr. Sternbach undertook an Accredited Vascular Surgery fellowship at Johns Hopkins University in Maryland, where he acquired experience in complex aortic reconstruction.
[60] From 1999 to 2004, Dr. Sternbach served as an Assistant Professor and Director of Endovascular Surgery at the University of Rochester in New York, where he established a general vascular practice, with a focus on minimally invasive therapy. In 2001, he was recruited to develop “a concerted and cohesive approach to minimally invasive vascular therapies and complex aortic reconstruction” by Toronto General Hospital. Dr. Sternbach’s evidence was that, as of 2002, his endovascular experience included 25 minimally invasive carotid interventions, at least 100 aortic interventions, and assisting with hundreds of other aortic interventions.
[61] Dr. Sternbach moved on to Albany, New York in 2004, joining what was then the largest vascular surgery group in the United States. He is currently the Chief of the Division of Vascular Surgery at St. Peter’s Health Partners in Albany and an attending surgeon at Albany Medical Center Hospital.
Participant Physicians
[62] The court was asked by the plaintiffs to receive opinion evidence from two "participant experts" – Doctors Anthony Ralph-Edwards and Tirone David – both, as already noted, cardiac surgeons at Toronto General Hospital. “Participant experts” are witnesses whose evidence is derived from their observations or involvement with the underlying facts that derives from their knowledge, training and experience. The parties disagreed about the extent to which these witnesses should be able to offer their opinions. I provided a written ruling on the scope of Dr. David’s evidence: see 2019 ONSC 6541.
[63] Each of the non-party participant physicians who testified were served with witness summonses and called by the plaintiffs.
(a) Dr. Anthony Ralph-Edwards
[64] Dr. Ralph-Edwards obtained his medical degree from Queen’s University in 1987. He received specialist certification in general surgery in 1992 and in cardiothoracic surgery in 1995. He has been on the active staff of the cardiac surgery unit at the University Health Network, which includes Toronto General Hospital, since 1996.
[65] Although, by the time of Ms. Stevenhaagen’s surgery, Dr. Ralph-Edwards had been a qualified cardiac surgeon for seven years, he was not, to use his own words, “a senior player” at Toronto General Hospital in 2002. Nevertheless, on 18 October 2002, he was the “on-call” surgeon for the cardiovascular service. As such, he would consult when asked to do so and, if consulted to make assessments about whether cardiac surgery was indicated and, if so, when it should be undertaken.
[66] Dr. Ralph-Edwards had never previously been called upon to repair a ruptured thoracic aorta.
(b) Dr. Tirone David
[67] Dr. Tirone David is currently a Professor of Surgery at the University of Toronto and the holder of the Melanie Munk Chair of Cardiovascular Surgery at the Peter Munk Cardiac Centre in Toronto. He graduated in medicine from the Universidade Federal do Paraná in Brazil in 1968. He completed his surgical internship at SUNY Downstate Medical Center in Brooklyn, New York and his general surgery residency at Cleveland Clinic in Cleveland. In 1975, commenced his training in cardiovascular and thoracic surgery at the University of Toronto. From 1988 until 2011, he was the Head of Cardiovascular Surgery at Toronto General Hospital, and, hence, held that position at the time of Mrs. Stevenhaagen’s surgery. He is a world-renowned specialist and lists thoracic aortic surgery among his clinical interests. He has trained many cardiovascular surgeons, including Dr. Ralph-Edwards.
[68] On 18 October 2002, Dr. David had two scheduled operations. He would typically finish his first case of the day by 11:00, taking a break from 11:00 to 12:00, and then finish his second case by 15:00-16:00. Dr. Ralph-Edwards came to Dr. David’s operating room during Dr. David’s second operation and described a patient with a torn aortic arch who was in shock. Based on what he had been told, Dr. David advised Dr. Ralph-Edwards to get the patient into the operating room and agreed to assist once he had finished his case.
[69] Dr. Ralph-Edwards and Dr. David were previously active defendants in this litigation, but the claims against them were dismissed, on consent and without costs, on 7 January 2010.
(c) Dr. Jane Heggie
[70] Dr. Jane Heggie graduated in medicine from the University of Toronto in 1986. After two years in general practice, she undertook a paediatric residency at the Hospital for Sick Children in Toronto, before moving into anaesthesia in 1991, obtaining her specialist designation as an anaesthetist in 1994. She undertook a fellowship in cardiac anaesthesia from 1995-1997 and spends 80% of her professional time in the care of cardiac patients.
[71] Dr. Heggie had initially responded to a call from the Cath Lab where she came to assist her colleague, Dr. Fedorko, who was already there along with Dr. McLaughlin and Dr. Sternbach. She remained there until Ms. Stevenhaagen’s condition had stabilised. She was then called back later to the CCU, arriving there between 14:15 and 14:25.
[72] Dr. Heggie assisted in the operating room until 17:00, when she handed over to another anaesthetist.
The Experts
[73] As D.A.Wilson J. observed in Tahir v. Mitoff, 2019 ONSC 7298, at para. 40:
Medical negligence cases, along with other professional negligence cases, in the vast majority of cases, require expert evidence to assist the trier of fact to determine the standard of care that is applicable, whether there has been a breach of that standard and whether the damages that result are caused by the negligence. In making these determinations, the trier of fact must necessarily weigh conflicting testimony from similarly qualified experts and assess the proper weight to be given to the expert opinions.
[74] This case was no exception to that practice.
(a) Dr. William Hellenbrand (called by the plaintiffs)
[75] Dr. Hellenbrand was called by the plaintiffs and qualified to provide opinion evidence on the standard of practice of a cardiologist practising interventional cardiology in 2002 for a patient undergoing treatment for coarctation of the aorta, and likely outcomes for patients where the treatment and management of the patient meets the standard of care or does not.
[76] After receiving his medical degree from SUNY Downstate Medical Center in New York, Dr. Hellenbrand did specialist training in paediatrics and cardiology. From 1978 until 1999, he was Clinical Director, Pediatric Cardiology, at Yale-New Haven Hospital in Connecticut. Subsequent to that he moved to Columbia University and the Children’s Hospital of New York – Presbyterian Hospital where his roles included Director of Invasive Cardiology and Director of Pediatric Cardiology. He returned to Yale in 2011 and is currently Professor Emeritus in Pediatrics and Consultant in Pediatric Cardiology at Yale University School of Medicine.
[77] In summary, it was Dr. Hellenbrand’s opinion that while the procedure undertaken by Dr. McLaughlin, including the immediate response to the rupture employing a balloon tamponade, was appropriate:
a. there should have been a plan in place (made in advance) to deal with a rupture;
b. once a tear had occurred there was no reasonable endovascular solution;
c. there should have been a referral to surgery as soon as the tear had occurred;
d. the stent graft could not be considered a permanent solution; and
e. had there been an earlier referral to cardiovascular surgery, it is more likely than not that Ms. Stevenhaagen would have experienced a better outcome.
(b) Dr. Jerry Chen (called by the plaintiffs)
[78] Dr. Chen is a vascular surgeon who graduated in medicine from the University of Manitoba in 1988. After training as a general surgeon, he undertook a vascular research fellowship at the University of British Columbia and subsequently obtained a M.Sc. in 1998. He pursued further fellowships in clinical vascular surgery and endovascular surgery research at U.B.C. and UCLA Harbor Medical Center in California respectively from 1996-1998. Since then, he has held various positions at U.B.C. and its affiliated hospitals, including Head of Division, Vascular Surgery, from 2008-2018. He was the President of the Canadian Society for Vascular Surgery in 2010-2011. His knowledge of stents and stent grafts was advanced during a Clinical Endovascular Fellowship at Pittsburgh University Medical Center in 2007. His expressed areas of interest include endovascular arterial interventions.
[79] Dr. Chen was called by the plaintiffs and qualified to provide an opinion on whether Dr. Sternbach met the accepted standard of care of an endovascular surgeon in 2002 in relation to his treatment of Ms. Stevenhaagen and whether any breach of standard of care by him caused the outcome of her paraplaegia, spinal cord injury, brain injury or cognitive deficits. He was also accepted as an expert in vascular surgery. The defendants, noting that Dr. Chen’s clinical endovascular fellowship was some five years after Ms. Stevenhaagen’s surgery, submitted that his opinions might carry less weight than someone who was qualified in 2002.
[80] Briefly stated, Dr. Chen’s opinion was that Dr. Sternbach had failed to meet the standard of care because:
a. there should have been better planning prior to the procedure being undertaken, including the involvement of cardiac surgery;
b. after the rupture, cardiac surgery should have been called and involved in the decision-making process;
c. Dr. Sternbach was over-confident in his ability to arrest the bleeding using a stent graft;
d. once the decision had been made to effect an endovascular repair, cardiac surgical support should nevertheless have been requested as a backup if the stent did not hold;
e. the stent graft was inappropriately positioned once deployed and hence was not a permanent solution - there should therefore have been a prompt referral to cardiac surgery;
f. the risk of the neurological deficits experienced by Ms. Stevenhaagen would have been significantly reduced if there had not been any delay getting her into open surgery following the balloon rupture.
(c) Dr. Steven Dommann (called by the plaintiffs)
[81] Dr. Dommann is a neurologist. He read medicine at the University of Pretoria, obtaining his MB ChB degrees in 1992 and a master’s degree in neurology from the same university in 2004. He held a succession of positions at hospitals in South Africa and the United Kingdom before undertaking four years of clinical training in neurology in Pretoria. Since then, he has worked and taught in Johannesburg, Townsville (Queensland, Australia) and, since 2010, in Vancouver where he currently serves as the Division Head at Lions Gate Hospital and as a clinical instructor at the University of British Columbia. He received his FRCP(C) designation in neurology in 2014.
[82] Retained by the plaintiffs, Dr. Dommann was qualified as an expert in neurology and on the likely cause of Ms. Stevenhaagen’s neurological injuries and the nature of her spinal cord and brain injury. He explained that he had been asked whether Ms. Stevenhaagen’s neurological injuries had been caused or contributed to by her condition prior to the commencement of her cardiac surgery, and whether she would likely have experienced a better outcome if the cardiac surgery had been performed sooner.
[83] Noting that in the more than four hours prior to Ms. Stevenhaagen undergoing cardiac surgery, she had experienced haemodynamic instability and hypovolemic shock that required inotrope (dopamine) support, Dr. Dommann believed that Ms. Stevenhaagen was already in a significantly compromised state before the surgery began. During that period, she would have been at high risk of watershed infarcts. Dr. Dommann acknowledged that it was difficult to say with exactitude what caused Ms. Stevenhaagen’s neurological injuries. In his opinion, it would have been more likely than not that her outcome would have been significantly better if the surgery had occurred as soon as possible after the rupture had been discovered, or even after the stent was deployed in the endovascular procedure.
(d) Dr. Benoît de Varennes (called by the plaintiffs)
[84] Dr. de Varennes trained at McGill University, where he received his medical degree in 1984 and a M.Sc. degree in 1992. He undertook graduate studies in Experimental Surgery from 1986-87 and received his specialist certification (FRCS(C)) in General Surgery (1989) and Cardiovascular and Thoracic Surgery (1992). Since 1997, he has been an Associate Professor in the Department of Surgery at McGill University. From 2004 – 2013, he was the Chairman of the Division of Surgery at McGill University and since 2009, he has been the Director of McGill’s Fellowship Program in Advanced & Complex Cardiac and Valvular Surgery. He holds admission and surgery privileges at the Montreal General Hospital.
[85] Dr. de Varennes was accepted by the court as an expert witness in cardiac surgery and, as such, qualified to opine on the standard of practice of cardiac surgeons generally, and of all surgeons, including endovascular surgeons, referable to a consulting of a cardio-vascular surgeon, all in the circumstances of the care of Julia Stevenhaagen on 18 October 2000, and the cause of Ms. Stevenhaagen's injuries and the nature of her brain injury and paraplegia.
[86] The following questions were put to Dr. de Varennes:
- Was the cause of Mrs. Stevenhaagen' s neurological injuries due to
a. The length of the cardiac surgery;
b. The need for deep hypothermic circulatory arrest;
c. The need for Factor VII?
Were Ms. Stevenhaagen’s neurological injuries caused (or contributed to) by the delay in consultation with cardiovascular surgery and the deterioration in her condition (shock, hemodynamic instability, SVC obstruction, etc.) before surgery was eventually commenced?
Is it more likely than not that Ms. Stevenhaagen would have experienced a better outcome if cardiovascular surgery had been consulted and surgery performed earlier?
Did the fact that Mrs. Stevenhaagen was hemodynamically unstable and in shock cause or contribute to her injuries?
[87] Briefly stated, his answers to these specific questions were:
a. a. the length of the cardiac surgery did not cause the neurological injuries;
b. the location of the tear required use of deep hypothermic circulatory arrest in order to correct problem and to come up with definitive solution, but the circulatory arrest by itself did not cause her injuries;
c. her injuries were not due to the use of Factor VII (a potent pro-coagulant agent used as a last resort measure when all other measures have failed to stop bleeding).
b. Yes. Ms. Stevenhaagen’s neurological injuries – paraplegia and cognitive disorders – were caused because she came to the operating room with significant episodes of hypotension, metabolic acidosis and need for aggressive resuscitative measures, factors which significantly increased the risk of all complications including neurological complications.
c. Yes. The more stable a patient is, or the less time they are in shock or unstable before they go to operating room, the better is the outcome. Any delay in such an emergent situation will increase risk of all complications including neurological.
d. Yes. Ms. Stevenhaagen was hypotensive and acidocic before her surgery and this instability caused or contributed to her injuries. The length of cardiac surgery usually has no bearing on neurological complications. What does have an effect is the condition of the patient coming in; whether there were complications during the operation; and the adequacy of protection of the various organs.
[88] Further, it was Dr. De Varennes’ opinion that the standard of practice in 2002 required a cardiovascular consultation and to take the patient to the operating room as soon as the rupture of the aorta was recognised, or as soon as possible after that, and that the delay in doing this likely caused Ms. Stevenhaagen’s neurological injuries.
(e) Dr. Lee Benson (called by the defendants)
[89] Dr. Leland (Lee) Benson is a paediatrician and a cardiologist working at the Hospital for Sick Children in Toronto and at Toronto General Hospital. He obtained his M.D. degree from The Chicago Medial School and was a Resident at The Hospital for Sick Children in Toronto and at St. Christopher’s Hospital for Children in Philadelphia. He held Fellowships at the Hospital for Sick Children (Clinical Fellowship in Cardiology) and at UCLA Medical Center in California (Research Fellow).
[90] Until Dr. McLaughlin left Toronto General Hospital, he was a colleague of Dr. Benson’s, although they did not have a social relationship. They have, however, co-authored papers together. Dr. Benson has also co-authored papers with Dr. Hellenbrand. Since 1992, Dr. Benson has been a full professor at the University of Toronto, with a primary focus on interventional cardiology including balloon angioplasties.
[91] Dr. Benson was accepted by the court as an expert witness qualified to opine on the standard of care of an interventional cardiologist practising in 2002.
[92] In Dr. Benson’s opinion, Ms. Stevenhaagen’s procedure was carried out correctly by Dr. McLaughlin and his management of the complication that arose was appropriate. Following the rupture, rapid decision-making was required. It was preferable to attempt to control the bleeding rather than move Ms. Stevenhaagen to the operating room with the balloon tamponade in a precarious position and a high risk of the balloon’s dislodgment. If the balloon had been dislodged while Ms. Stevenhaagen was being transported from the Cath Lab to the operating room, she would have bled to death.
[93] Nor did Dr. Benson regard Dr. McLaughlin’s failure to arrange surgical back-up as a standard of practice issue. In his opinion, the standard of care only required that the procedure be carried out in a hospital with appropriate surgical availability, which Toronto General Hospital had.
[94] Once the placement of the Cook stent had curtailed the bleeding and stabilised Ms. Stevenhaagen’s condition, it was then appropriate for her to be moved to the CCU where she could be observed and assessed. When she subsequently became unstable in the CCU, a referral to surgery was warranted.
(f) Dr. Guy De Rose (called by the defendants)
[95] Dr. Gaetano (Guy) De Rose is a London (Ontario)-based vascular surgeon. After obtaining his medical degree at the University of Western Ontario, he qualified as a specialist in general surgery and, subsequently, vascular surgery. He undertook postgraduate fellowships in vascular surgery at McGill (Royal Victoria Hospital, Montreal) and the University of Toronto (Wellesley Hospital). He is an Associate Professor at Western and has served at the Program Director of the Division of Vascular Surgery, and, subsequently, as Site Chief of Surgery at Victoria Hospital in London. His clinical interests include “complicated aortic endovascular surgery”.
[96] Dr. De Rose was qualified as an expert witness in vascular surgery and, in particular, endovascular management of aortic ruptures and tears including emergency management of thoracic ruptures and tears; and to give opinion evidence relative to standard of care for Dr Sternbach in treating a thoracic aortic rapture in 2002 and whether such endovascular care or treatment caused or contributed to the complications suffered by Ms. Stevenhaagen on or following 18 October 2002.
[97] In short, Dr. De Rose’s opinion was that Dr. Sternbach met the requisite standard of care and that the endovascular treatment received by Ms. Stevenhaagen did not cause or contribute to the complications which she experienced. In his opinion, it was appropriate for Dr. Sternbach to use endovascular sealing of the rupture using a stent graft, and that Dr. Sternbach’s placement of the stent graft was satisfactory in treating the tear.
[98] While Dr De Rose agreed with Dr. de Varrennes that the use of a stent not designed to be used for the management of aortic arch injuries was not the accepted standard in 2002 in all centres across North America, he stated that by October 2002, the use of aortic endografts to treat a traumatic tear of the thoracic aorta had been adapted in centres that were capable of performing the technique and had the resources to do so. He agreed with the proposition that the area of the descending thoracic aorta in the vicinity of the aortic arch is a difficult and challenging area of the anatomy for a vascular surgeon. He agreed too, that with the passage of time more has been learned about how to deal with some of these challenges – “[we] were learning as [we] went”. There was, he said, a lot that was not known in 2002 and a lot is still not known.
[99] Dr. De Rose felt that transporting Ms. Stevenhaagen to the operating room while Dr. McLaughlin was tamponading the rupture with a balloon would have been “quite precarious” and the odds were that it would not have been safe as the balloon would not have remained in place.
[100] In Dr. De Rose’s opinion, it was more likely than not that the neurological injuries suffered by Ms. Stevenhaagen were caused by the open repair that she underwent.
(g) Dr. Daniel Selchen (called by the defendants)
[101] Dr. Daniel Selchen is a neurologist practising in Toronto. For ten years, he was the head of the Division of Neurology at St. Michael’s Hospital. Prior to going to medical school, Dr. Selchen read political philosophy, including two years at Oxford University as a Rhodes Scholar. He obtained his M.D. at the University of Manitoba and completed his neurology training at the University of Toronto. His principal areas of clinical practice are multiple sclerosis and stroke. His practice includes the management of strokes after cardiac surgery.
[102] Dr. Selchen was qualified to give expert evidence as a stroke neurologist to provide opinion evidence on the cause of Ms. Stevenhaagen’s neurological injuries including stroke and spinal cord infarctions and to interpret brain CT scans.
[103] In Dr. Selchen’s opinion, the most likely cause of Ms. Stevenhaagen’s neurological injuries was an embolic infarction, explaining that “an embolus is a clot that comes from a source other than the arteries deep in the brain, but which lodges deep in the brain, and generally comes from an external source, such as the carotid arteries at the front of the brain, or the vertebral or basilar arteries at the back of the brain, or from a central source, that is the heart…”
[104] In Ms. Stevenhaagen’s case, Dr. Selchen thought that the most likely cause of her injuries was either the cardiac procedure “with its attendant complications” or various things that occurred in the post operative period, including atrial fibrillation and “considerable” periods of vascular instability.
Law
[105] To give context to the discussion that follows, I will next set out in general terms, the principles of law and the parties’ positions relating to the issues of standard of care and causation in this case.
Standard of Care
[106] The parties agree that the generally applicable articulation of the standard of care is set out in an often-quoted passage from the judgment of Schroeder J.A. in Crits v. Sylvester, 1956 CanLII 34 (ON CA), [1956] O.R. 132 (CA), at para. 13:
Every medical practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. He is bound to exercise that degree of care and skill which could reasonably be expected of a normal, prudent practitioner of the same experience and standing, and if he holds himself out as a specialist, a higher degree of skill is required of him than of one who does not profess to be so qualified by special training and ability.
[107] The plaintiffs also direct the court’s attention to the subsequent paragraph in Crits, where Schroeder J.A. quoted with approval, from a decision of Lord Hewart C.J. in the Court of Criminal Appeal in Rex v. Bateman (1925), 41 T.L.R. 557, at p. 559, 19 Cr. App. R. 8 (EWCA):
If a person holds himself out as possessing special skill and knowledge and he is consulted, as possessing such skill and knowledge, by or on behalf of a patient, he owes a duty to the patient to use due caution in undertaking the treatment. If he accepts the responsibility and undertakes the treatment and the patient submits to his direction and treatment accordingly, he owes a duty to the patient to use diligence, care, knowledge, skill and caution in administering the treatment ... The law requires a fair and reasonable standard of care and competence.
[108] The plaintiffs submit that the present case, more than most, concerns a failure by the defendants to exercise “due caution”.
[109] An error in clinical judgment is not the same as negligence. “[T]he honest and intelligent exercise of judgment has long been recognized as satisfying the professional obligation”: Wilson v. Swanson, 1956 CanLII 1 (SCC), [1956] S.C.R. 804, at p. 812. The rationale for this principle, which has withstood the test of time, was stated by the Shroeder J.A. in Crits, adopting the language of Denning L.J. in Roe v. Minister of Health:
In approaching a problem such as this it is well for a Court to caution itself, as was done by Denning L.J. in Roe v. Minister of Health et al.; Woolley v. Same, [1954] 2 Q.B. 66 at 83, [1954] 2 All E.R. 131, where that learned jurist stated:
It is so easy to be wise after the event and to condemn as negligence that which was only a misadventure. We ought always to be on our guard against it, especially in cases against hospitals and doctors. Medical science has conferred great benefits on mankind, but these benefits are attended by considerable risks. Every surgical operation is attended by risks. We cannot take the benefits without taking the risks. Every advance in technique is also attended by risks. Doctors, like the rest of us, have to learn by experience; and experience often teaches in a hard way. Something goes wrong and shows up a weakness, and then it is put right.
I also subscribe to the concluding words in his judgment at p. 86 where he says:
But we should be doing a disservice to the community at large if we were to impose liability on hospitals and doctors for everything that happens to go wrong. Doctors would be led to think more of their own safety than of the good of their patients. Initiative would be stifled and confidence shaken. A proper sense of proportion requires us to have regard to the conditions in which hospitals and doctors have to work. We must insist on due care for the patient at every point, but we must not condemn as negligence that which is only a misadventure.
[110] Accordingly, the plaintiffs bear the onus of showing, on a balance of probabilities, that the decisions and actions of the defendants were not those which would have been taken by a reasonable, competent physician in the circumstances: Wilson v. Swanson, 1956 CanLII 1 (SCC), [1956] S.C.R. 804, at pp. 811-812.
[111] It is not enough for the plaintiffs to prove that different decisions would have had a better chance of achieving a more favourable outcome. There may be a number of reasonable options in any given situation. There will often not be an absolutely right or wrong choice. Even a finding that there were better options available than those selected will not necessarily result in a finding of negligence: Connell v. Tanner (2002), 2002 CanLII 44921 (ON CA), 158 O.A.C. 268 (CA), at para. 1.
[112] Unless the chosen course of action was one which a reasonable, competent physician would not have made in the circumstances, the defendants will not be found to have breached the standard of care.
[113] It is also important not to view clinical negligence claims, and in particular the assessment of what standard of care should be applied, through a “retrospectoscope”, that is, with the benefit of hindsight. Rather, they should be evaluated with reference to the knowledge that the defendants had, or ought to have had, at the time the events took place: Lapointe v. Hôpital Le Gardeur, [1992] S.C.R. 351, at para. 28; ter Neuzen v. Korn, 1995 CanLII 72 (SCC), [1995] 3 SCR 674, at para. 34.
[114] In assessing the standard of care, a court will necessarily have regard to the expert evidence that was presented to the court. But it is not the function of the court to decide that one body of opinion is more persuasive than another: Pittman Estate v. Bain (1994), 1994 CanLII 7489 (ON SC), 112 D.L.R. (4th) 257 (Ont. Ct. Gen. Div.) at para. 259.
[115] Ultimately, what must be found is that the courses of action chosen by the defendants would not have been made by a reasonable, competent physician in the circumstances.
Causation
[116] To establish responsibility for Ms. Stevenhaagen’s injuries, the plaintiffs must establish not only that the defendants were negligent but, also, that their negligence (breach of the standard of care) caused her injuries: Clements (Litigation Guardian of) v. Clements, 2012 SCC 32, [2012] 2 S.C.R. 181, at para 37.
[117] The test for showing causation is the “but for” test. As the Supreme Court explained in Clements, at paras. 8-9:
8 The test for showing causation is the "but for" test. The plaintiff must show on a balance of probabilities that "but for" the defendant's negligent act, the injury would not have occurred. Inherent in the phrase "but for" is the requirement that the defendant's negligence was necessary to bring about the injury -- in other words that the injury would not have occurred without the defendant's negligence. This is a factual inquiry. If the plaintiff does not establish this on a balance of probabilities, having regard to all the evidence, her action against the defendant fails.
9 The "but for" causation test must be applied in a robust common sense fashion. There is no need for scientific evidence of the precise contribution the defendant's negligence made to the injury.
[118] The plaintiffs say that the sooner Ms. Stevenhaagen had undergone cardiac surgery, the more likely it is that she would have avoided paraplegia and cognitive deficits. Or, put differently, but for the delay of approximately two-and-a-half to four hours between when the plaintiffs assert that surgery should have taken place, and when it actually took place, Ms. Stevenhaagen would not have suffered paraplegia or cognitive deficits.
[119] The defendants’ position is that the most likely cause of Ms. Stevenhaagen’s strokes was either the cardiac procedure or other events that ensued in the post-operative period and that earlier cardiac surgery would not have changed the outcome. Specifically, the defendants would not be responsible if Ms. Stevenhaagen suffered a stroke while she was haemodynamically unstable following the rupture, i.e. before the deployment of the stent graft (although the defendants also say that Ms. Stevenhaagen likely did not suffer a stroke during that timeframe). Then, following the deployment of the stent, Ms. Stevenhaagen was generally stable until the time of, or shortly before her arrival in the operating room (when all four of her limbs were observed to be moving).
[120] To establish causation, it is not sufficient for the plaintiffs to show that the delay between the rupture occurring and the cardiac surgery would have given Ms. Stevenhaagen a better chance of avoiding her adverse outcome, unless that chance surpasses the threshold of “more likely than not”: Cottrelle v. Gerrard (2003), 2003 CanLII 50091 (ON CA), 67 O.R. (3d) 737 (CA), at para. 25.
Analysis
[121] A recurrent feature of this case is its antiquity. Back in 2002, despite significant advances having been made in endovascular surgical techniques in the preceding decade, the “gold standard” treatment for a torn or ruptured aorta was open cardiac surgery. Both of the defendants acknowledged that.
[122] The world of interventional cardiology has come a long way since 2002. Open surgery would now be the exception rather than the rule. A much wider range of stent grafts is available, including stents that are designed for the architecture of the aorta.
[123] Nevertheless, even back in 2002, if it would have been possible to address the rupture and the threat which it posed to Ms. Stevenhaagen’s life without cardiac surgery, i.e. by deploying an effective endovascular response, most of the experts and participant experts (Drs. David, Ralph-Edwards, Chen, De Rose, Benson and de Varennes) agree that it would have been preferable to have done so.
[124] At the core of the differences between the parties is whether the decision to attempt an endovascular response, rather than refer Ms. Stevenhaagen to the cardiac surgeons sooner, fell outside the accepted standard of practice at the time. And, if so, was the delay in getting her to cardiac surgery more likely than not the cause of her paraplegia and cognitive deficits?
Did the Defendants Breach the Standard of Care?
[125] I would summarise the plaintiffs’ allegations that the defendants breached their duty of care to Julia Stevenhaagen as follows:
a. Preparation for the operation was inadequate. A back-up plan should have been in place before the surgery took place.
b. There should have been a consultation with a cardiac surgeon as soon as the rupture of Ms. Stevenhaagen’s aorta occurred.
c. An endovascular response to the rupture of the aorta was not appropriate because
i. Dr. Sternbach had minimal experience with the procedure that he undertook; and
ii. an appropriate or approved stent was not available.
d. Having deployed the Cook stent, there should have been an immediate consultation with a cardiac surgeon. Instead, valuable time was lost. Ms. Stevenhaagen was transferred to the CCU rather than being moved to the operating room. A cardiac surgical consultation was not obtained until approximately 14:25.
[126] The defendants answer each of these allegations by saying that the decisions taken were reasonable exercises of clinical judgment, when evaluated according to the prevailing standards at the time. Specifically, it was preferable to have attempted an endovascular repair rather than transport her to the operating room which would risk Ms. Stevenhaagen bleeding to death if the balloon tamponade was dislodged. Then, having deployed the stent graft and stabilised Ms. Stevenhaagen, it was reasonable to move her to the CCU for observation.
[127] To frame my analysis of the standard of care issue, I would record that I accept the expert evidence which emphasised that time was of the essence at each stage of the response to the aortic rupture. That should have been an element of the decision making process throughout.
Preparation and Planning
[128] Dr. McLaughlin agreed that part of the preparation for this procedure involves a careful risk assessment and an appreciation of the patient’s anatomy.
[129] Dr. McLaughlin was of the view that Ms. Stevenhaagen’s recoarctation procedure was a relatively low risk one. He quoted to Ms. Stevenhaagen a risk of up to 2% of death, stroke, the need for cardiovascular surgery and other complications associated with heart catheterisation.
[130] Dr. McLaughlin explained that he had recommended a balloon angioplasty for Ms. Stevenhaagen because he believed that it presented a good chance of successfully restoring her aorta to normal diameter, eliminating the 70 mm gradient and making control of her hypertension much easier on much less therapy.
[131] Risk factors to be taken into account in cases such as Ms. Stevenhaagen’s would include a high pre-angioplasty systolic gradient (Ms. Stevenhaagen’s 70 mm gradient was described by Dr. McLaughlin as “very high”). A prior patch repair would be another risk factor.
[132] The balloon needed to impart sufficient pressure to expand the Kingston stent against the fibrous ring of the coaractation. Dr. McLaughlin recognised that if a balloon bursts during the course of an angioplasty, it can exert shearing forces that can not only burst the balloon, but also injure the aorta. A rupture of the aorta would be one of the most catastrophic complications that could occur. It could cause death, and the repair of a rupture could cause stroke.
[133] Dr. Hellenbrand took a different view of the risk. He felt that it was a “very high risk procedure” which required planning, including what to do if a tear occurred. In his opinion, the standard of care required arranging for surgical back-up in advance. Dr. De Rose agreed – to a point – conceding that if Dr. McLaughlin had felt that the potential for complications such as occurred was significant, he should have consulted with cardiac surgery in advance.
[134] While Dr. Benson was not inclined to characterise Ms. Stevenhaagen’s procedure as “high risk”, he acknowledged (by reference to medical literature) the higher risk of aortic dissection and balloon rupture in patients over 40 years of age. Furthermore, when it was suggested to him that the risk of rupture would not be unexpected due to the sharp ends of the existing Kingston stent and the deployment of high pressure within the balloon, Dr. Benson stated that:
Nothing is risk-free and a balloon rupture during the procedure is, in, in this particular instance, is not unexpected. And I think that it was, the rupture of the aortic wall was, obviously, an event that was disappointing at many levels, but it, it, it, it was within the realm of possible complications as is arrhythmias, or a stroke, or a perforation of the heart in any, in any intravascular procedure.
[135] Whereas Dr. Hellenbrand was of the view that there is around an equal risk between a native coarctation and recoarctation procedure, Dr. Benson’s opinion was that in 2002, the risk of disruption of the latter was much lower in recurrent coarctation than native coarctation procedures.
[136] Prior to 2002, Dr. McLaughlin estimated that he had undertaken between 70 and 80 interventions for coarctation of the aorta, using balloon angioplasty or stenting. In only one of those previous cases had the patient experienced a ruptured aorta. That patient, a 65-year-old woman who had undergone catheterisation for angioplasty and stenting of a coarctation of the aorta had, after an apparently successful stent deployment, developed sudden severe circulatory collapse after her return to the recovery area. She was returned emergently to the Cath Lab and a rupture in the aortic wall of the site of the coarctation was identified. Dr. Sternbach and another of his vascular surgery colleagues were consulted. As Dr. Sternbach put it, “there was no cohesive plan” for the patient. He contacted a medical equipment supplier to try and obtain a stent graft. Unfortunately, one could not be obtained in sufficient time. The patient died.
[137] Dr. McLaughlin and Dr. Benson were two of four authors who contributed to an article on their experience: Varma, et. al., Aortic Dissection After Stent Dilatation for Coarctation of the Aorta: A case report and literature review, Catheterization and Cardiovascular Interventions 59:528-535 (2003).
[138] When asked about this previous case, Dr. McLaughlin explained that the patient had an underlying pathological degeneration of the aortic wall from its normal, fairly tough, collagen matrix to a fatty substance called mucopolysaccharide,which weakened the wall and also created a very slippery surface inside the wall of the aorta, which had both allowed the stent to migrate but also made it very difficult to maintain a balloon position over the tear.
[139] Following this experience, there was a discussion between Dr. Sternbach and Dr. McLaughlin. They appeared to have different recollections about that discussion. From Dr. Sternbach’s perspective, it was a casual one. He mentioned to Dr. McLaughlin that it would be nice to have endovascular options available in the future. Dr. Sternbach says that he started looking for appropriate devices that might be used in those situations. He explained that he had a couple of items in mind but that there were not at the time any approved devices in Canada for use in the thoracic aorta. Nevertheless, he did assemble a collection of stent grafts for use with the abdominal aorta. This included a supply of Cook devices in what Dr. Sternbach referred to as “the bail-out box”.
[140] Dr. McLaughlin has a different recollection of his conversation which Dr. Sternbach. He said that they met and agreed that it was essential that they have covered stents on site and immediately available to the Cath Lab. He and Dr. Sternbach had a discussion with the manager of the Cath Lab about where those stents would be stored. It was agreed that they would be located in an area immediately adjacent to the Cath Lab and also close to the vascular surgical operating room, so that Dr. Sternbach or any other vascular surgeon would have immediate access to them.
[141] Dr. Sternbach testified that it was not his understanding from the previous discussion that he had had with Dr. McLaughlin that he had agreed to ensure that there were appropriate stents on board in the event of an aortic rupture for which there was a need to use a stent for a rescue.
[142] Indeed, Dr. Sternbach agreed with the proposition, put to him in cross-examination, that he knew that he would not be able to have a stent immediately available to utilise for the rescue of a patient with the type of aortic rupture experienced by Ms. Stevenhaagen. He has no recollection of a specific conversation with Dr. McLaughlin to inform him of the stents that he did or did not have available. He was asked:
Q. So, do you say prior to October 18, 2002, Dr. McLaughlin understood from you, you did not have Health Canada approval for a stent that could be immediately available and onboard to rescue a patient for an aortic rupture?
A. Not for this aortic rupture, correct.
Q. And you communicated that to Dr. McLaughlin?
A. Yes.
[143] Dr. McLaughlin did not communicate with Dr. Sternbach in contemplation of Ms. Stevenhaagen’s surgery. In fact, Dr. Sternbach knew nothing about Ms. Stevenhaagen until he was summoned to the Cath Lab. Indeed, Dr. Sternbach declined the initial request for assistance and only relented when the urgency of the situation was conveyed to him.
[144] Dr. McLaughlin knew that it was possible that Dr. Sternbach could be unavailable. If that happened, he said he would contact the vascular surgeon on call. Asked about the assistance he might expect to receive in such an event, Dr. McLaughlin said that he assumed that Dr. Sternbach would have made suitable arrangements with other members of the vascular surgical team.
[145] I find it surprising that, having gone to some lengths to arrange for Dr. Sternbach to have an inventory of stents on hand for use if another emergency similar to the one a few months earlier when the patient had died, Dr. McLaughlin was not more proactive in ascertaining whether Dr. Sternbach was available if needed on the day of Ms. Stevenhaagen’s surgery. And if he was not available, whether someone else was who had Dr. Sternbach’s knowledge of the stents on hand and their deployment. “Assuming” Dr. Sternbach would have made suitable arrangements with other vascular surgeons strikes me as suboptimal.
[146] Just as there was no explicit communication from Dr. McLaughlin with Dr. Sternbach or, for that matter, any other vascular surgeon in anticipation of Ms. Stevenhaagen’s surgery, nor was there any express communication with cardiac surgery. Toronto General Hospital did, however, have an on-call cardiovascular service with an operating room on permanent standby if required.
[147] As to what constituted the appropriate standard of care, in terms of preparation, Dr. Benson had the advantage over Dr. Hellenbrand in terms of familiarity with what was and was not appropriate practice in Toronto in 2002.
[148] Nevertheless, both Dr. Hellenbrand and Dr. Benson (and, for that matter, Drs. McLaughlin and Sternbach), agree that the use of an endovascular solution to address a rupture arising during the course of an interventional cardiologic procedure was evolving in 2002. Although these techniques, the availability of appropriate equipment and use of these endovascular solutions, had been going on in Europe for a number of years (and described in the medical literature), things were less advanced in North America.
[149] In Canada, only a limited number of centres were suitably equipped. Toronto General Hospital had not been suitably equipped at the time of the previous incident which Dr. McLaughlin and Dr. Sternbach had experienced (and which Dr. McLaughlin had subsequently coauthored an article about). By the time of Ms. Stevenhaagen’s surgery, Dr. Sternbach had assembled an inventory of stent grafts, albeit that none of these devices was designed for use in the thoracic aorta.
[150] Dr. Benson was of the opinion that the standard of care did not require Dr. McLaughlin to arrange for surgical backup for the Cath Lab intervention. According to him, the standard of care then and now only required that procedures such as the one he undertook on Ms. Stevenhaagen were done in institutions that have surgical availability.
[151] Asked why he had not consulted with cardiac surgery or vascular surgery in anticipation of Ms. Stevenhaagen’s procedure on 18 October, Dr. McLaughlin said:
At the time the patient was referred to me for … consideration, we were doing this type of procedure on quite a significant number of patients … and we had the cardiac surgeons, such as Tirone David, who were very familiar with the work that we were doing and that it was ongoing regularly in the Cath Lab once or twice a month, as was vascular surgery, Dr. Sternbach, and there were very robust backup procedures that were in place and for all of our patients, we proceeded to do the procedure based on the need for the procedure.
[152] Dr. McLaughlin added that, as a practical matter, it would have been difficult for the cardiac surgery and vascular surgery services to have had a consultation in respect of every single patient for whom an intervention for coarctation and re-coarctation was being done. These procedures were, he said, being done regularly at Toronto General Hospital.
[153] In my view, the arrangements in place at the time of Ms. Stevenhaagen’s surgery were incomplete. There was a lack of clarity as to the nature and extent of Dr. Sternbach’s collection of stent grafts and the suitability of their application in the event of a thoracic aorta rupture. There was no certainty that Dr. Sternbach would be available. I did not find Dr. McLaughlin’s assumption that Dr. Sternbach would have made suitable arrangements with his vascular surgical colleagues reassuring. It was Dr. McLaughlin’s good fortune that Dr. Sternbach was, in fact, there on 18 October 2002 and that he eventually responded to the page from the Cath Lab (on the second time of asking).
[154] Furthermore, although Dr. Sternbach may have been well-versed in the theory of using covered stents in such circumstances, he was still at a fairly early stage of his career as a specialist. Importantly, and apparently unbeknown to Dr. McLaughlin, Dr. Sternbach had never previously attempted to repair a ruptured aorta using a covered stent.
[155] I find that Dr. McLaughlin could and should have done better. I prefer Dr. Hellenbrand’s assessment of the risks associated with Ms. Stevenhaagen’s procedure. Given those risks and the resources that were available to him, it would have been prudent for Dr. McLaughlin to have ascertained in advance the actual availability of Dr. Sternbach that day, and to have let Dr. Sternbach know about the procedure he was about to undertake on Ms. Stevenhaagen. He should also have been aware of the extent of Dr. Sternbach’s prior experience.
[156] I would not, however, criticise Dr. McLaughlin for not knowing exactly what sort of inventory Dr. Sternbach had, or that the inventory would not have included stents that were specifically made for use in the thoracic aorta. The simple fact is that at that time, there were no such products licensed and available for use in Canada. However, as Dr. De Rose explained, stent grafts designed for use in one part of the vasculature are not necessarily inappropriate for use in other parts, particularly in a rescue situation. It was appropriate for Dr. McLaughlin to have relied on Dr. Sternbach to determine what stent grafts to have in his “bail-out box” and to know whether any of them would be suitable to use with Ms. Stevenhaagen.
[157] Nor do I find that Dr. McLaughlin should have had an express consultation with cardiac surgery in advance, given the on-call availability of that service on the day of Ms. Stevenhaagen’s surgery.
[158] “Could and should have done better” does not necessarily lead to a finding that the standard of care was not met. While it would have been preferable for Dr. McLaughlin to have better acquainted himself with Dr. Sternbach’s experience and to have liaised with him prior to commencing Ms. Stevenhaagen’s surgery, the fact remains that he did have access to the on-call vascular and cardiac surgery teams.
[159] As a result, I do not find that, despite the deficiencies I have identified, his preparation fell below his duty to exercise the degree of care and skill which could have reasonably been expected of a normal, prudent practitioner of his experience and standing at the time.
Failure to Consult with Cardiac Surgery
[160] The rupture of Julia Stevenhaagen’s aorta was identified at 10:14. Dr. McLaughlin testified that he turned to the circulating haemodynamic nurse and said, “Page Dr. Sternbach”. He says that he did not consider calling cardiac surgery at the time. He explained that he needed to hear from Dr. Sternbach whether a covered stent could be used. He said that if Dr. Sternbach had answered in the affirmative, there would be a chance to save the patient’s life. If the answer was no, cardiac surgery would have to be called and the patient transported to the operating room, with a very high risk that the balloon that he was using to tamponade the rupture would slide off the tear, and the patient would bleed to death.
[161] Although Dr. McLaughlin chose not to call cardiac surgery, an undisclosed person in the Cath Lab did. The Interventional Report recorded that at 10:14 “CV surgery paged”.
[162] The on-call cardiovascular surgeon, Dr. Ralph-Edwards, attended a few minutes later. He explained that it was possible that he had been paged by accident because “our locating does not really distinguish between cardiovascular surgery and vascular surgery”.
[163] The Cath Lab has two parts: an operating area and a control room. Dr. McLaughlin and Ms. Stevenhaagen were in the operating area. It is separated from the control room by a lead glass panel. Dr. Ralph-Edwards did not enter the operating area. To have done so, he would have to have donned a lead vest. Rather, he entered the control room, where the nurses and documenting staff were located, and asked if anyone had called cardiovascular surgery. He says he was told in response that his services were not required. Dr. Ralph-Edwards said at trial that he could no longer recall by whom. However, refreshing his memory from previous occasions when he had been asked the same question, he understood that he had spoken to Dr. McLaughlin who felt that, at the time, cardiovascular surgery was not necessary. Dr. Ralph-Edwards says that he was not apprised of the patient’s condition – specifically that she had suffered a rupture – and, hence, was not asked to render an opinion or deliver any treatment. He acknowledged that he made no inquiries to find out what it was that was going on in the Cath Lab.
[164] Dr. Hellenbrand is highly critical of the decision by Dr. McLaughlin to not even communicate with the on-call cardiac surgeon. As a result, he deprived himself of the benefit of whatever advice Dr. Ralph-Edwards (or, through him, Dr. David) might have had to offer about the emergency he was faced with (Dr. Hellenbrand, as already noted, goes further than that. He says that as soon as the tear was identified, not only should there have been communication with surgery, but that surgery should have been performed right away if possible.)
[165] The defendants were critical of Dr. Ralph-Edwards’ failure to better inform himself of what was going on. Yet Dr. McLaughlin says that even if Dr. Ralph-Edwards had put on a lead vest and joined him at the bedside, he would have thanked him for joining him, explained that the location of the rupture was such that he had to maintain the balloon in that position with great difficulty, and that it would not be safe to transport the patient to the operating room at that time.
[166] In the immediate aftermath of discovering the rupture, Dr. McLaughlin said that his entire focus was on controlling the bleed. He felt that the only hope of Ms. Stevevhaagen surviving was to get a stent to cover the tear. He knew that if he needed cardiac surgery at any time, they would be there in a few minutes and have an operating room ready. He felt that consulting a cardiac surgeon but then telling the surgeon that the patient could not be sent to the operating room safely was not going to improve the risk of the balloon dislodging and the patient potentially dying. He thought it was better to keep his focus on that balloon until Dr. Sternbach could get the stent in place. The balloon tamponade was sliding easily and Dr. McLaughlin was constantly having to adjust it. Any movement of the balloon would cause a large loss of blood which was a risk Dr. McLaughlin felt “we could not afford”.
[167] Dr. Sternbach had arrived at the Cath Lab at 10:29. After a short conversation with Dr. McLaughlin in which it was agreed that an endovascular procedure should be attempted, Dr. Sternbach left the Cath Lab to obtain an appropriate device.
[168] By the time that Dr. Ralph-Edwards responded to being paged for a second time, both Dr. Sternbach and Dr. McLaughlin were in the Cath Lab.
[169] Dr. Heggie, who by this time was also in the Cath Lab, recalled Dr. Ralph-Edwards saying that he had been paged twice and asking if his services were required. While she did not recall the exact words used in response to this inquiry, her evidence was that the communication was clear that Drs. McLaughlin and Sternbach were going to go ahead with a non-operative solution and, consequently, Dr. Ralph-Edwards’ services were declined.
[170] Dr. Ralph-Edwards acknowledges that on the second occasion that he attended, he knew that there had been a rupture of the aorta. He realised that Drs. McLaughlin and Sternbach were dealing with a life- threatening emergency. Although he understood that the plan was to deal with the situation with a covered stent, he believed that open surgery would eventually be required. Given that view, he was asked why he did not insert himself into the mix and make further inquiries.
[171] His answer, and other evidence given about the events of that day, suggest that there may have been some interpersonal issues at play. Dr. Ralph-Edwards said that Dr. McLaughlin was a senior cardiologist and that Dr. Sternbach was a vascular surgeon “who is aggressive and difficult to communicate with and deal with”. It seemed to him that they had the situation under control and that his inserting himself into the process was not going to help anything at that time. He added that once Drs. McLaughlin and Sternbach had decided to go down the route of endovascular repair, they could call him if they decided it was not working out for them.
[172] Dr. Ralph-Edwards also acknowledged that he was frustrated – “miffed” – as a result of being paged twice, but no one coming forward to tell him what they wanted.
[173] Dr. Ralph-Edwards was asked about some testimony that Dr. David had given. Dr. David had said that if it had been him who had been called to the Cath Lab, he would have immediately put on a lead vest and gone in to find out what was going on. Dr. David had speculated that perhaps Dr. Ralph-Edwards was intimidated. Dr. Ralph-Edwards acknowledged that the circumstances were intimidating, adding that if he was to take the patient to the operating room at that time and perform surgery, the outcome would likely have been the same or worse than trying to put in a covered stent. But he also knew that if open surgery was required, it could be arranged very quickly.
[174] Dr. Ralph-Edwards was up front about his experience and abilities at the time. Although a fully qualified cardiac surgeon, he had, as previously indicated, never attempted to repair a ruptured aorta. He was prepared to acknowledge that the circumstances were intimidating. And he also knew that Dr. David was in the building. When Dr. Ralph-Edwards was, ultimately, consulted, he very quickly brought Dr. David in. There is every reason to believe that if Dr. Ralph-Edwards had been consulted sooner, he would have brought Dr. David, with all of his world-renowned skills and experience, into the picture.
[175] The defence experts, Dr. De Rose and Dr. Benson, both subscribed to the view that it was unfortunate that a discussion did not occur amongst the three consultants – Dr. McLaughlin, Dr. Sternbach and Dr. Ralph-Edwards.
[176] Dr. de Varennes was also of the opinion that a cardiovascular surgeon should have been part of the discussion to come up with a plan. He felt that had a cardiovascular surgeon been told that the stent which was going to be used was not designed for such use, the surgeon would have advocated taking the patient to the operating room.
[177] The situation was a fast moving one. It would seem that the second attendance by Dr. Ralph-Edwards occurred some time between Dr. Sternbach returning with some stents and the commencement of the endovascular procedure. By that time, the course had already been set. As Dr. Ralph-Edwards stated, once they had decided what route to go down, it was simply a matter of him waiting to be called, if required.
[178] Dr. Sternbach did not communicate with Dr. Ralph-Edwards when he came to the Cath Lab on the second occasion. Nor did Dr. McLaughlin mention to Dr. Sternbach that a cardiovascular surgeon had presented himself. Furthermore, Dr. Sternbach, who acknowledged Dr. David’s eminence and expertise, said that he had not been aware that Dr. David was in the hospital when he and Dr. McLaughlin were formulating a treatment plan for Ms. Stevenhaagen. He says that he would have welcomed a contribution to the decision-making progress of any appropriately qualified person, which would include a cardiac surgeon. He says that he considered seeking a cardiovascular consultation, but assessed the risks associated with an open surgical intervention as being higher than an endovascular response. He does not believe that he actively decided not to consult with a cardiac surgeon. He therefore decided that it was necessary to proceed on a course of treatment for a very unstable patient.
[179] None of the expert witnesses at trial took the position that it would have been inappropriate for a cardiovascular consultation to have taken place as part of the process of evaluating options.
[180] I would go further. Given the wealth of resources available at Toronto General Hospital, it was inexcusable that such a consultation did not occur. Furthermore, I do not agree with the suggestion made by some of the witnesses, and echoed in the submissions made by the defendants, that Dr. Ralph-Edwards bears responsibility for no such consultation occurring.
[181] Dr. Hellenbrand’s opinion was that it would have been better to have gone to the operating room than find a stent, get approval for a stent and put it in. Nevertheless, he recognised that this was ultimately a decision involving the exercise of clinical judgment and that reputable interventional cardiologists could disagree about judgment decisions. But in circumstances where a decision had been made to not even communicate with the surgeon to help make the judgment with him, Dr. McLaughlin fell below the standard of care.
[182] I accept Dr. Hellenbrand’s criticism of Dr. McLaughlin’s failure to consult. At the end of the day, Dr. McLaughlin was the physician in charge. While he may not have been aware of the first attendance by Dr. Ralph-Edwards, I do not accept his explanation for not summoning the on-call cardiac surgeon. Even if Dr. McLaughlin was unaware that Dr. Ralph-Edwards had come up to the Cath Lab a few minutes after the initial rupture, he should have been actively seeking cardiac surgical input by the time that he discussed the situation with Dr. Sternbach.
[183] In 2002, the “gold standard” for responding to a ruptured aorta was still open surgery. Dr. Hellenbrand acknowledged that transporting a patient in Ms. Stevenhaagen’s situation was potentially hazardous. But, as he put it, it is “what we do” if that is the right choice to be made.
[184] Dr. Chen expressed a similar view. And Dr. Benson was not aware, either up to October 2002 or in the years after, of any adult patient suffering a rupture in the Cath Lab and then bleeding to death en route to surgery.
[185] Interestingly, although Dr. McLaughlin testified that the risk of a “blind” transfer of Ms. Stevenhaagen from the Cath Lab to an operating room while trying to maintain a balloon tamponade in place, was too great, neither the operative notes of Dr. Sternbach or Dr. McLaughlin made any reference to the potential for unsafe transportation to an operating room. Rather, the reason articulated for proceeding with an endovascular approach was stated to be that “in the setting of metal stent, surgical intervention was postulated to be excessively difficult and likely to be more time consuming, therefore, an endovascular solution was sought”. A conclusion reached without having consulted with a cardiac surgeon.
[186] I do not, accordingly, accept the risk of transporting Ms. Stevenhaagen from the Cath Lab to an operating room as a basis for not consulting with cardiac surgery at all. There should have been a communication between the three consultants. A more fully informed decision would then have been made.
[187] I conclude that the failure to consult with cardiac surgery was not just, as Dr. De Rose put it, “unfortunate”. It was a failure that fell below the standard of care owed to Ms. Stevenhaagen in the circumstances, for which Dr. McLaughlin, as the lead physician, was responsible.
Reasonableness of Endovascular Response
[188] As already summarised, contrasting opinions on the appropriateness of an endovascular response have been expressed by Drs. Hellenbrand and Benson, respectively. Dr. Hellenbrand takes the view that there was no reasonable endovascular solution. Specifically, the use of the Cook stent to try and control Ms. Stevenhaagen’s bleeding should not have been attempted and would have had no chance of long-term success.
[189] Dr. Benson saw things differently. He felt that because of the precarious state of the balloon tamponade following the rupture, transporting Ms. Stevenhaagen to the operating room was not a risk that anyone would want to take. An endovascular approach as an alternative then became very attractive. Dr. Sternbach had experience with endovascular devices that Dr. McLaughlin did not. Dr. Sternbach’s advice that the use of a covered stent would be an appropriate strategy was reasonable, and it was reasonable for Dr. McLaughlin as the responsible physician, to accept that advice. The choice of which stent to use and the responsibility for placing it was, appropriately, left to Dr. Sternbach.
(a) Dr. Sternbach’s Abilities
[190] Back in 2002, Dr. Sternbach was a highly trained vascular surgeon who had already acquired experience in complex aortic reconstruction and who was sought out by Dr. Wayne Johnston at Toronto General Hospital to develop a concerted and cohesive approach to minimally invasive vascular therapies and complex aortic reconstruction.
[191] By October 2002, Dr. Sternbach had done about 25 minimally invasive carotid interventions and 100 or more aortic interventions of various types. He had previously repaired aneurysms that had ruptured on approximately eight occasions. None of them, however, involving the aortic arch. He had previously been involved with two procedures dealing with the aortic arch following traumatic ruptures.
[192] Dr. De Rose noted that Dr. Sternbach had been trained in endovascular surgery in the United States. He had presented at meetings that Dr. De Rose had attended. Dr. De Rose felt that Dr. Sternbach had all of the necessary skills.
[193] As Dr. De Rose explained, because of the risks of open surgery to repair aneurysms, the employment of endovascular repairs significantly improved outcomes. However, the endografts were expensive and funding could have been an issue. To some extent, this appears to have been ameliorated by the fact that endografts were available on consignment.
[194] Dr. De Rose considered that it was appropriate for Dr. Sternbach to attempt an endovascular repair using a stent graft. The use of a covered stent at the particular location, where there was already a previously inserted stent, held the possibility of being able to control or even stop the bleeding.
[195] According to Dr. De Rose, all endografts are basically the same – the variables are length and diameter. Of the limited number of grafts available in Canada in 2002, the smallest diameter available was a 23 millimetre or 25 millimetre thoracic endograft.
[196] Dr. Chen did not go as far as saying that the attempt at an endovascular response was wholly inappropriate. He agreed with Dr. David that if a covered stent could be deployed in the Cath Lab to cover the rupture, and to restore blood flow to the descending aorta (and even to the left subclavian artery), that would be a highly preferable option to transporting her blindly with a balloon tamponade to the operating room. And this, despite Dr. Chen’s criticisms of the unsuitability of the device used by Dr. Sternbach.
[197] Notwithstanding the views of Dr. Hellenbrand, who gave his opinion objectively and respectfully, I accept that the judgment calls made by Drs. McLaughlin and Sternbach, which led to the attempt of an endovascular repair, were reasonable in all of the circumstances. Dr. McLaughlin, as the most responsible physician, made the decision to proceed with the endovascular repair. Dr. Sternbach, as the consultant vascular surgeon, selected the device and effected its deployment. While it remains the case that a better informed decision would have been one that had also involved a cardiac surgeon, one can only speculate as to whether that would have had led to different decisions being made. Ultimately, in deciding whether or not the decisions that were made fell below the standard of care, I must be persuaded on a balance of probabilities that those decisions were not those that would not have been taken by reasonable, competent physicians in the circumstances. I find that the election to proceed with an endovascular repair was reasonable.
(b) Use of the Cook Stent
[198] Endovascular repairs of aneurysms only evolved in the mid to late 1990s. Dr. De Rose did the third case in Canada in December 1997.
[199] Dr. Sternbach said that his commitment to Dr. McLaughlin was to look for appropriate devices. He did not commit that he would have stents on hand for use in the case of an aortic rupture. However, he did identify stents that he thought would come close to meeting the needs of a patient experiencing a ruptured aorta. He believes that he communicated to Dr. McLaughlin that he did not have a stent on hand which was designed for that type of rupture, but that he had the next best thing. For that reason, he had to obtain Health Canada approval to use the Cook stent. Once he got the right person on the line, it took a very brief conversation before he received verbal approval.
[200] Dr. Sternbach conceded that he knew that Dr. McLaughlin would be having female patients with coarctations who could well have aortic arches and descending aortic arteries with diameters as small as Ms. Stevenhaagen’s, and that if such a patient experienced a rupture, he would not have a Health Canada approved stent available. But at that time, there were no Health Canada approved devices designed for use in the thoracic aorta.
[201] As already alluded to, because of the limited range of devices available at the time, the “off label” adaptation of the devices that were available was an acceptable practice in appropriate cases.
[202] The evidence satisfies me that the use of the Cook stent was not, per se, negligent. It offered the prospect of addressing the immediate need to stem the escape of blood through the rupture without the need to risk moving Ms. Stevenhaagen to the operating room while attempting to maintain a balloon tamponade in place.
Transfer to the CCU
[203] By approximately noon, there was no bleeding through the ruptured aorta. The stent graft was holding in place. The angiogram taken at 12:03 indicated that there was no bleeding.
[204] It was put to Dr. McLaughlin that if the point of the stent graft was to stop the bleeding, it had seemingly achieved that objective by as early as 12:03 and that Ms. Stevenhaagen could have safely been moved to the operating room at that time. Dr. Chen felt that there should have been a prompt referral to cardiac surgery at that point, because the position of the stent graft was creating a significant obstruction to the flow of blood to the organs downstream and was incompatible with a long-term solution. According to Dr. Chen, the resulting interruption of blood flow would have decreased circulation to those organs, including Ms. Stevenhaagen’s spinal cord, thereby contributing to her paraplegia.
[205] Asked why he did not consult cardiac surgery at or around noon, Dr. McLaughlin said that the decision about a safe time to transfer the patient to the operating room was informed by the belief that Ms. Stevenhaagen’s bleeding had been stopped.
The markers were improving and there was certainly a strong view that the chance to stabilize the patient’s metabolic status would enhance her chance at a successful operation if it were needed and that there was also the possibility that this was a fix, a permanent fix that would last for some time into the future.
We had a stable patient, and the question is, next steps. Now, if Mrs. Stevenhaagen had remained stable, there would not have been the need to rush her to the OR for a complex operation. What we discussed and had planned to do is a CT angio and determine where that hematoma was and what would be the best surgical approach to deal with it, and when we were going to deal with the hematoma. It’s entirely possible that the, the stent could have achieved a seal of that tear for many days, if not weeks or permanently. And the issue here was that… Mrs. Stevenhaagen had been through a very traumatic situation, and all of the tissues and organs in her body had been compromised by lack of blood supply over a period of time. And that in itself increased the risk of any surgical procedure, if we could have given Mrs. Stevenhaagen a few days to allow her body to recover, it would have made safer whatever surgical procedure was decided at the time to be needed. So it was a… risk factor reduction strategy as opposed to rushing her into the OR at that time, and not being clear about what operation she really needed, and also with the higher than normal metabolic risk.
[206] A “pullback” performed at 12:12 measured Ms. Stevenhaagen’s blood pressure gradient at 93 (suggesting a severe restriction of blood flow). An adjustment was therefore required. This involved Dr. Sternbach inflating a compliant balloon within the Cook stent to improve its position. A further pullback performed at 12:35 measured a blood pressure gradient of 18. (Dr. Chen disputes the accuracy of that reading, although his view was not supported by any of the other witnesses, and I am satisfied that Dr. McLaughlin’s recorded gradient was accurate).
[207] Dr. Hellenbrand was of the view that the final placement of the Cook stent was such that it was causing a significant obstruction in the transverse arch impeding most of the flow from the ascending aorta to the descending aorta. Dr. Chen felt that even after the pullback, the extent of the blockage created by the stent was more than 80%. Dr. David interpreted the angiogram cine relied upon by Dr. Chen as showing a blockage of less than 50%.
[208] Whether it was 80% or 50%, what emerges clearly from the evidence is that, despite the hopes of Drs. McLaughlin and Sternbach to the contrary, the Cook stent was at best going to be a short-term solution. As Dr. De Rose conceded, the Cook stent was not capable of accommodating the curvature of the aortic arch. Furthermore, despite Ms. Stevenhaagen having seemingly stabilised, Dr. De Rose also acknowledged that thoracic endografts are subject to forces and stresses that can make accurate deployment and secure fixation technically difficult and extremely challenging.
[209] As already indicated, others, including Dr. David, did not see the obstruction as being as significant as Dr. Chen. And, also as previously discussed, further adjustment of the position of the stent resulted in a relatively satisfactory blood pressure gradient being reported by 12:35, although Dr. Chen disputes the accuracy of that reading.
[210] At 12:12, when the gradient measurement of 93 was taken, there was clearly a decision to be made, and made quickly.
[211] I agree that that would have been a reasonable time to summon cardiac surgery. But I also accept the reality of that situation. Dr. McLaughlin and Dr. Sternbach would not have waited for the arrival of the on-call cardiac surgeon, even if it would only have been a matter of minutes before he arrived. Their immediate reaction was the appropriate one, namely to address the obstruction which, whether it was as significant as Dr. Chen indicates or otherwise, was coincident with a blood pressure gradient of 93. The position of the stent graft was adjusted. By 12:35, the pullback gradient was accurately measured at 18.
[212] Having achieved that, there remained some concerns. There is a notation at 12:37 about Ms. Stevenhaagen’s facial swelling, which, Dr. Dommann explained, would be indicative of superior vena cava obstruction.
[213] Before leaving the Cath Lab, Dr. Sternbach spoke with Dr. McLaughlin and suggested that thoracic surgery ought to be consulted because of the significant accumulation of blood in Ms. Stevenhaagen’s chest. Dr. Yip, the resident, charted “refer to thoracic surgery”.
[214] Dr. McLaughlin explained his decision to have Ms. Stevenhaagen transported to the CCU at the end of the procedure in the Cath Lab:
… We were satisfied with her hemodynamic status. We now had a systolic and diastolic pressure of approximately 150 over 80. We had a pulse rate of 80. We knew we had good urine output. We knew that the acidosis was trending towards normal, and the acidosis was resolving, urine output good, so this was a very satisfactory position and time to transport her to the coronary care unit.
[215] Dr. McLaughlin was nevertheless aware of the possibility that the stent might shift following insertion. Dr. De Rose also confirmed that this was a possibility. Dr. Sternbach, too, agreed that it was possible in the circumstances of the stent being in the position that it was, in proximity to the aortic arch and the left subclavian, that the apposition or seal of the rupture could, possibly, become dislodged. But he added that clinical decisions were made on the basis of facts, not possibilities. And the fact, as Dr. Sternbach and Dr. McLaughlin perceived to be the case at the time, was that Ms. Stevenhaagen’s bleeding had been arrested. Both of them concluded that she should be sent to the CCU.
[216] Ms. Stevenhaagen was transferred to the CCU, arriving there at approximately 13:45. At that time, her blood pressure had dropped. She received a Dopamine drip, which led to a restoration of her blood pressure. The most responsible physician for Ms. Stevenhaagen when she was in the CCU was Dr. Mansur Hussein. Nevertheless, Dr. McLaughlin went to the CCU shortly after 14:00 because he was concerned about her outcome and wanted to be with her.
[217] At 14:20, it was noted that Ms. Stevenhaagen’s central venous pressure (CVP) was elevated at 35. Dr. McLaughlin was concerned, feeling that the most probable cause was a shift in the haematoma in Ms. Stevenhaagen’s chest during the move to the CCU, and that the haematoma was large enough that she was going to require an immediate thoracotomy or mediastinal approach to drain it. Although Dr. McLaughlin considered the possibility that Ms. Stevenhaagen was bleeding, he thought it to be a low probability. Nevertheless, Dr. McLaughlin advised the staff to contact Dr. Ralph-Edwards.
[218] Was the exercise of clinical judgment by Drs. McLaughlin and Sternbach to transfer Ms. Stevenhaagen to CCU, rather than have her taken immediately to the operating room, reasonable?
[219] From Dr. Hellenbrand’s perspective, there were multiple signs of what he described as “ongoing haemodynamic instability” during the last hour or so that Ms. Stevenhaagen was in the Cath Lab and continuing to the CCU. A pH of 7.15 at 12:36 represented metabolic acidosis, indicative of inadequate perfusion. Facial swelling was noted at 12:37. These and other indicia were suggestive, as Dr. Hellenbrand saw it, of a patient in a severely compromised state, which heightened the risk and predisposed her to more significant injury if there was further delay. In Dr. Hellenbrand’s opinion, therefore, the standard of care required that she be sent to the operating room at that point in time. As he put it:
We had evidence that the stent was not functioning properly. It was causing obstruction. Her [CVP] would’ve been up for a long period of time. All this suggests that she’s very unstable and the anaesthesiologist mentions in his [sic] note, severe swelling of the head and neck. All those things tell me that it’s a continuing problem and that it has not been dealt with.
[220] By contrast, Dr. Benson’s opinion was that Dr. McLaughlin’s decision-making was clinically appropriate. The endovascular procedure had stabilised her clinical status and allowed a safe transfer to the CCU, with time for observation and further assessment, all of which ultimately saved Ms. Stevenhaagen’s life. And if, as appeared to be the case, the bleeding had stopped and Ms. Stevenhaagen’s condition had improved, there was no particular urgency in transporting her to the operation room for further surgery. It was appropriate that she should be taken to the CCU and a plan made there.
[221] The evidence does show that Dr. McLaughlin, in particular, engaged in a process of weighing the advantages and disadvantages of moving Ms. Stevenhaagen to the CCU, rather than the operating room. His judgment was that the Cook stent had done its job, at least for the time being, and possibly longer. While there was ample reason to doubt whether the Cook stent could, in fact, be anything more than a stop-gap solution, the immediate life-threatening situation caused by the aortic rupture appeared to have been averted.
[222] However, with the exception of Drs. McLaughlin and Sternbach, the other medical witnesses saw surgery as inevitable. There was a stent in Ms. Stevenhaagen’s thoracic aorta which was not designed for that part of the anatomy. It did not and could not conform with the curvature in the vicinity of the aortic arch. While there may have been disagreement about the degree of obstruction, there was undoubtedly an obstruction after the Cook stent was placed. There were also still a number of indications that her situation was unstable.
[223] Although the insertion of the stent had achieved its most pressing and urgent need - arresting the life-threatening escape of blood through the rupture in Ms. Stevenhaagen’s aorta - I accept the evidence of the witnesses who say that once that purpose had been achieved, Ms. Stevenhaagen should have been moved immediately to the operating theatre. That was clearly the option which presented the least risk to her. The possibility that she might be able to regain some strength and provide the physicians with the luxury of more time to reflect on what the next steps should be had to be weighed against the risks of doing so.
[224] As a number of the medical witnesses said, time was of the essence. While the decision to insert a stent, rather than transport Ms. Stevenhaagen immediately to the operating theatre was not, in my judgment, an unreasonable one, the decision to send her to the CCU instead of the operating room was, in all of the circumstances, not one which similarly situated reasonable physicians would have made.
[225] I accept the evidence that was imperative to get Ms. Stevenhaagen into surgery as soon as possible. That should have occurred as soon as it was feasible to move her after the repositioning of the stent. So at 12:35 or shortly thereafter, and no later than 1:05 when the procedure in the Cath Lab was recorded as complete. The decision not to so, at the very least, exposed her to unnecessary risk caused by further delay. Her situation remained perilous, and surgery was inevitable.
Conclusions on the Standard of Care Issue
[226] Although Dr. McLaughlin had the opportunity to make more robust preparations for Ms. Stevenhaagen’s surgery, his failure to do so did not fall below the standard of care. The surgery was conducted in a major teaching hospital. On-call cardiac surgery and vascular surgery services were available. As a result of Dr. McLaughlin’s previous discussions with Dr. Sternbach, there was a range of stent graft devices available to address an emergent situation, albeit that the range of devices was limited by what was available in Canada at that time. Although Dr. McLaughlin rated the risk of complications as low, and other physicians who gave evidence viewed the procedure as a high risk one, Dr. McLaughlin’s view was nevertheless one which a reasonable physician could have held.
[227] Dr. McLaughlin should, however, have consulted with a cardiovascular surgeon following the rupture of Ms. Stevenhaagen’s aorta and prior to the commencement of endovascular surgery. While the availability of Dr. Sternbach and his collection of endografts made endovascular intervention an option which would not have been available in many other places, or at an earlier time, the patient was entitled to expect that Dr. McLaughlin would make reasonable use of the resources available to him. On the day of Ms. Stevenhaagen’s surgery, those resources included not only the services of the on-call cardiovascular surgeon, Dr. Ralph-Edwards, but also those of Dr. Tirone David, perhaps the leading specialist in his field in Canada.
[228] Although Drs. McLaughlin and Sternbach might have made a different decision if cardiac surgery had been consulted, the evidence does not lead me to conclude that, on a balance of probabilities, a different decision would (i.e. more likely than not) have been made if cardiovascular surgery had been involved. And, although not a long-term solution, even a stent such as the Cook stent, which was not designed for the architecture of the thoracic aorta, offered the prospect of a lower risk interim solution than a blind transfer of Ms. Stevenhaagen to the operating room while trying to maintain in place a balloon tamponade. The attempt at an endovascular repair, deploying the Cook stent, was a judgment call that reasonable physicians could have made in the circumstances.
[229] Having got Ms. Stevenhaagen to a point where the bleeding seemed to have been arrested and her condition stabilised, she should have been immediately transferred to the operating room. The risk of further injury and complications following the completion of Dr. Sternbach’s endovascular response significantly outweighed any benefit that may have been gained from giving Ms. Stevenhaagen an opportunity to recover. Dr. McLaughlin should have arranged for an immediate consultation with cardiac and/or thoracic surgery following deployment of the Cook stent and initiated the transfer of Ms. Stevenhaagen to cardiac surgery as soon as it was safe to do so. Instead, supported by Dr. Sternbach, it was determined that Ms. Stevenhaagen should be transferred to the CCU. This error breached the standard of care which was owed to Ms. Stevenhaagen.
Causation
[230] The “sooner the better” position of the plaintiffs must be grounded on the court’s findings of breaches of the standard of care.
[231] I have found that Dr. McLaughlin breached the standard of care by (a) not consulting with cardiac surgery between the onset of aortic rupture and the commencement of vascular surgery; and (b) failing to have Ms. Stevenhaagen transferred directly from the Cath Lab to an operating room following the deployment of the Cook stent.
[232] The defendants submit that the “sooner the better” arguments must fail because of the absence of evidence to pinpoint when the damage to Ms. Stevenhaagen may have occurred.
[233] The plaintiffs submit that on the basis of the evidence adduced, while Ms. Stevenhaagen was in the Cath Lab, there were at least four turning points at which the court could reasonably find that the defendants’ failure to meet the accepted standard of practice (by obtaining a cardiac consultation) caused delay that resulted in (or contributed to) Ms. Stevenhaagen’s adverse outcome:
a. At 10:30, when Dr. McLaughlin consulted with Dr. Sternbach. Had the accepted standard of practice been met, the plaintiff argues that this consultation would also have been with a cardiac surgeon, not only with Dr. Sternbach. By 10:44, Ms. Stevenhaagen was intubated and, effectively, the die had been cast. If she had been immediately transferred to the operating room at that point in time, based upon how long it would have taken to get her to the operating room and onto cardiac pulmonary by-pass, Ms. Stevenhaagen could have been haemodynamically stable by 11:19, rather than 15:24.
b. At 12:12, when pullback revealed an unacceptable gradient following the 12:03 angiogram that revealed that bleeding had stopped. The plaintiffs argue that transfer to the cardiac operating room was required since the obstructive nature of the Cook stent could not be solved or remedied. Had that occurred, Ms. Stevenhaagen would have been on cardio pulmonary by-pass by 12:47, so a little over 2.5 hours before she was.
c. At 12:35, after another angiogram was performed, and a reading of 18 registered. If, at that point, she had been transferred to the operating room, she would have been on cardio pulmonary by-pass by approximately 1:10.
d. At 1:05, when the procedure in the Cath Lab was complete. If she had been transferred to the OR then, she would have been on cardio pulmonary by-pass by approximately 1:40, as opposed to 15:24, a delay of approximately an hour and three-quarters.
[234] At 10:08, the balloon inserted by Dr. McLaughlin burst. An angiogram performed six minutes later disclosed the existence of the rupture. At 10:25, a balloon was advanced to the existing Kingston stent and inflation of the balloon began. By this time, seventeen minutes had elapsed since the balloon had burst and eleven minutes since the rupture was detected. The consequences of that in terms of blood loss are not known with any exactitude, but by all accounts, it would have been significant.
[235] The defendants raise the possibility that Ms. Stevenhaagen could have suffered some or all of her neurological injuries immediately in the aftermath of the rupture for which, on any of the plaintiffs’ theories of liability, they would not be responsible.
[236] Certainly, for an hour or more from 10:14 (or shortly thereafter), Dr. McLaughlin was tamponading the rupture with the balloon, and constantly making adjustments to keep the tip of the balloon over the tear. Every two to three minutes, he was deflating the balloon to allow modest blood flow to perfuse the lower organs and extremities and then re-inflating the balloon to prevent significant loss of blood through the rupture.
[237] In my analysis on the standard of care, I came to the conclusion that although the standard of care required Dr. McLaughlin to consult with cardiovascular surgery, it was not negligent for him to have selected the option of having Dr. Sternbach undertake an endovascular repair, despite the absence of cardiovascular surgery input.
[238] Dr. McLaughlin says that he knew that the cardiovascular surgical team was there and could be summoned quickly. Nevertheless, we know from the evidence of Dr. David that if he had been consulted, he would likely have come into the Cath Lab, put a lead vest on, and made his considerable experience and expertise available to Dr. McLaughlin. In saying that, I acknowledge that we do not know for certain whether Dr. David would have ended up in the Cath Lab. What we do know is that when the assistance of Dr. Ralph-Edwards was eventually accepted, he very quickly consulted with Dr. David.
[239] It is purely a matter of speculation as to what would have happened if cardiac surgery had been consulted before the endovascular repair was attempted. The weight of cardiovascular opinions, including Dr. de Varennes and Dr. David, is that if there was, in fact, a viable endovascular approach, it would have been a preferable option to transferring Ms. Stevenhaagen to the operating room, with all of the attendant risks of doing so while maintaining the balloon tamponade in place.
[240] Consequently, there is insufficient basis for concluding, on a balance of probabilities, that but for the failure to involve cardiac surgery between the onset of the rupture and the commencement of the endovascular repair, Ms. Stevenhaagen would have been transported directly to the operating room at, or shortly following, such consultation.
[241] The next turning point suggested by the plaintiffs is 12:12. As I have already explained, I do not find that the standard of care required Ms. Stevenhaagen to have been transferred directly from the Cath Lab to the operating room at that time.
[242] The final turning point submitted by the plaintiffs is 12:35. Based on my finding that Ms. Stevenhaagen should have been moved to the operating room as soon as possible after the adjustment to the stent, the causation inquiry comes down to whether, but for the failure of Dr. McLaughlin to arrange for the immediate transportation of Ms. Stevenhaagen to the operating room between 12:35 and 13:05 when the procedure in the Cath Lab was fully completed, Ms. Stevenhaagen’s neurological injuries have had a better outcome?
[243] At 12:36, Ms. Stevenhaagen’s pH was recorded at 7.15. Dr. Dommann and Dr. Chen both described this reading as demonstrative of severe hypovolemic shock, resulting in inadequate perfusion of her tissues. Dr. David similarly described the low pH as being a consequence of exsanguination or loss of blood.
[244] Despite the note that the procedure in the Cath Lab was completed at 13:05, it was not until 13:40 that Ms. Stevenhaagen was transferred to the CCU.
[245] For the initial stages of Ms. Stevenhaagen’s brief stay in the CCU, Ms. Stevenhaagen was trending in a positive direction. Her pH at 14:08 was 7.34, which Dr. Dommann acknowledged was a “significant” improvement. She was given dopamine to maintain blood pressure (her blood pressure on arrival having been 65/45, a very low reading). However, as already noted, at 14:20 when Dr. McLaughlin went to the CCU, Ms. Stevenhaagen had a CVP of 35. He became concerned that her situation was unstable and consulted cardiac surgery. By 14:30 her CVP was 40. Her systolic blood pressure was 187. The decision was taken by Dr. Ralph-Edwards, in consultation with Dr. David, to get her into surgery. As Dr. David described her status at that time, “the patient was being suffocated internally”.
[246] When Holly Budgel saw her unconscious mother being wheeled into the operating room, she was almost unrecognisable because of her facial swelling. Dr. David explained that this would have resulted from occlusion of Ms. Stevenhaagen’s veins – or superior vena cava syndrome – a medical emergency.
[247] Assuming that Ms. Stevenhaagen arrived in the operating room at 14:45 (as noted by Dr. Heggie), the delay resulting from the failure to move Ms. Stevenhaagen straight from the Cath Lab to surgery was at least one hour and forty minutes and, possibly, longer (if she had been moved sometime between 12:35 and 1:05).
[248] At the risk of oversimplifying the evidence and arguments on the subject of causation, I make the following observations.
[249] Appreciating that the experts disagree on when the damage was most likely done, they generally agree that some or all of the following factors could have had a bearing on the outcome:
a. After the initial rupture Ms. Stevenhaagen suffered significant loss of blood until Dr. McLaughlin was able to insert the balloon tamponade;
b. Thereafter, Dr. McLaughlin periodically manoeuvred the balloon to allow some perfusion of the descending aorta and everything that that blood vessel supplies (including the major organs and the spinal cord);
c. Ms. Stevenhaagen was haemodynamically unstable for most of the time between the rupture and being placed on cardiopulmonary by-pass;
d. Ms. Stevenhaagen experienced hypovolemic shock as a result of significant loss of blood;
e. During a period of haemodynamic instability, Ms. Stevenhaagen was at a heightened risk of strokes;
f. The haemodynamic status of a patient before undergoing complex cardiac surgery can play a significant role in the ultimate outcome (Dr. de Varennes, the only cardiac surgeon to testify as a Rule 53 expert witness explained that the longer the period of such instability, the greater the possibility of an adverse outcome);
g. There is a higher risk of neurological injury during or resulting from cardiac surgery than during vascular surgery of the type undergone by Ms. Stevenhaagen;and
h. The use of factor VII – a measure of last resort when everything else has failed to stop bleeding – which was deployed during Ms. Stevenhaagen’s cardiac surgery introduces a very potent coagulant that can cause clotting. The use of factor VII is associated with increased rate of mortality and stroke (although Dr. de Varennes expressed the opinion that factor VII would not have increased the risk of stroke, Dr. Selchen, a stroke neurologist, did: I accept Dr. Selchen’s evidence on that point).
[250] Both of the expert neurologists, Dr. Dommann and Dr. Selchen, acknowledged that Ms. Stevenhaagen’s case is complicated and that it is impossible to be certain about the precise cause of her neurological injuries.
[251] Dr. de Varennes also agreed that it is very difficult to be certain about the cause of Ms. Stevenhaagen’s neurological injuries.
[252] Dr. Selchen, the stroke specialist, concludes that on the balance of probabilities, Ms. Stevenhaagen’s strokes in both the brain and the spinal cord were related to the cardiac surgery procedures, whereas Dr. Dommann, the general neurologist, while recognising that Ms. Stevenhaagen’s injuries were likely due to several factors, concludes that it was more likely than not that the injuries resulted from the delay of cardiac surgery and the deterioration in Ms. Stevenhaagen’s condition prior to surgery.
[253] A number of different studies address the risk of neurological injury resulting from cardiac surgery. Dr. Selchen pointed to studies showing a 10 to 15% risk of complications. Dr. De Rose quoted a similar experience, depending on the magnitude of the procedure. A 2010 article referred to a 0.8% risk of paraplegia with endovascular repair and 2.9% after open repair. Yet another study, referred to by Dr. Selchen, places the overall incidence of stroke after cardiac surgery at 4.6%, with a direct correlation between the increased complexity of the surgery and the incidences of stroke.
[254] Dr. Dommann and Dr. Selchen disagreed on whether the brain and spinal strokes experienced by Ms. Stevenhaagen resulted from watershed infarcts to the brain and spinal cord or from embolic strokes.
[255] Embolic strokes occur when clots or other fragments embolise and occlude blood vessels and, hence, the perfusion of (in this case) parts of the brain or the spinal cord. Embolic infarcts of the spinal cord are rare, yet Drs. Dommann and Selchen disagree on the extent to which an embolic stroke of the spinal cord may have been the cause of Ms. Stevenhaagen's injuries.
[256] The presence, as demonstrated by CT scans of Ms. Stevenhaagen's brain, of bilateral parieto-occipital lobe infarcts demonstrates, according to Dr. Dommann, a typical pattern of watershed infarcts consistent with a hypoperfusion event (i.e. an ischemic as opposed to embolic infarct).
[257] Dr. Selchen draws the opposite conclusion and regards bilateral cortical occipital strokes as far more likely to relate to embolic phenomena. He disputes the notion, articulated by Dr. Dommann, that the infarcts shown in the left and right occipital lobes are symmetrical. In his opinion, the occipital infarcts are cortical and thus, more likely to relate to an embolic event than a hypoperfusion/watershed phenomena.
[258] Regardless of the cause – embolic or hypoperfusion – Dr. Selchen described the observation of Dr. Heggie, recorded at 2:45, that there was evidence of all four of Ms. Stevenhaagen’s limbs moving, as “lynchpin” evidence. He testified that the notation of “limbs moving” provides a level of confidence that the neurological injury – to the spinal cord at least – had not yet occurred at that point. But he also accepted that it was possible Ms. Stevenhaagen could have developed paraplegia between 14:15 and 14:45, but not probable.
[259] Dr. Heggie was unable to recall the movement she observed. She acknowledged that it would not have been purposeful, because Ms. Stevenhaagen was sedated. She was not asked how she could reconcile her observation “moving all 4 limbs” with her adjacent note “sedated + paralyzed on arrival”. Nor was she pressed on the circumstances in which a neurological examination could be undertaken on a fully anaesthetised and intubated patient. In the absence of such explanations, I am unable to share the confidence derived by Dr. Selchen from Dr. Heggie’s annotation.
[260] Dr. Ralph-Edwards evidently recognised the possibility that, by the time Ms. Stevenhaagen was brought to the operating room, neurological injury might already have occurred. He made a point of telling her family.
[261] Although the courts endorse a “robust and pragmatic” approach to the question of evidence, the plaintiffs must be able to prove that Ms. Stevenhaagen’s injuries were caused by the negligence of the defendants.
[262] In Snell, Mr. Justice Sopinka, at p. 336 (S.C.R.) cautioned against finding causation on the basis that the plaintiff had simply proved “that the defendant created a risk that the injury which occurred would occur”.
[263] In Aristorenas v. Comcare Health Services (2006), 2006 CanLII 33850 (ON CA), 83 OR (3d) 282 (CA), a case in which the plaintiff alleged that the delay in treatment had caused or materially contributed to her subsequent contracting of necrotizing fasciitis, the court observed, at para. 66:
The trial judge's causation analysis hinges on his view that it "is a matter of common sense that the negligence or delay on the part of the defendants allowed the wound to reach a complicated state and lead to rapid unpredictable consequences". Despite the use of the phrase "negligence or delay", causation in this case turned on the delay in treatment that resulted from the defendants' negligence. No other theory of causation was offered by the plaintiff.
[264] The Court of Appeal continued, at para. 75:
Even assuming that the plaintiff's theory of the case is correct and that a delay in treatment can cause or materially contribute to the contracting of necrotizing fasciitis, none of the evidence led at trial addresses whether in this case it was the delay in treatment or some other factor that caused the plaintiff to contract necrotizing fasciitis. There are many theories of causation, and the evidence leaves us in a position where we do not know which one is correct or the most probable. None of the evidence provided by the parties provides a link between the negligence of the defendants and the harm suffered by the plaintiff.
[265] In Goodman v. Viljoen, 2012 ONCA 896, Doherty J.A. wrote, at para. 76:
The robust and pragmatic approach takes into account the nature of the factual issues underlying the causation question and the kind of evidence that the parties are reasonably capable of producing on those issues. The approach acknowledges that the causation inquiry is essentially a practical one based on the entirety of the evidence and made with a view to determining whether the plaintiff has established causation on the balance of probabilities and not to a scientific certainty.
[266] As both of the neurologists and some of the other witnesses acknowledged, there is a possibility that neurological damage resulted from what happened in the first two hours following the discovery of the rupture. But as I perceive the evidence, it is more likely than not that the haemodynamic instability which Julia Stevenhaagen experienced from the final deployment of the Cook stent on 18 October 2002 until 15:24, when cardiopulmonary by-pass began, caused or substantially contributed to the neurological injuries that she subsequently suffered.
[267] In coming to this conclusion, I accept that it was Dr. McLaughlin’s instinctive and skillful response when he discovered the aortic rupture that saved Julia Stevenhaagen’s life. Not only that, but his decisive and effective deployment of a balloon tamponade not only sealed (on an intermittent basis) the potentially catastrophic bleed, but also enabled the major arteries to remain perfused, albeit not with the same level of service that they would normally enjoy.
[268] That was the status until Dr. Sternbach’s deployment of the Cook stent which I have found to have been a reasonable response.
[269] There is no question, however, that Ms. Stevenhaagen was in severe hypovolemic shock following the deployment of the Cook stent. She was, as Dr. Hellenbrand explained, in a severely compromised state. Or, as Dr. de Varennes put it, “a ticking time bomb”. While there was a brief lull in the vacillation of the key metrics that were being monitored towards the end of her stay in the Cath Lab, she relapsed into a zone of significant danger within 30 minutes of her transfer to the CCU.
[270] During that time frame, as both neurologists acknowledge, she could have experienced neurological injury to her brain and/or her spine, most likely due to hypoperfusion, or the haemodynamic instability which she experienced.
[271] “Could have” in and of itself does not meet the requirement of probable cause. But the effect of the period of haemodynamic instability which Ms. Stevenhaagen experienced in the hours prior to complex cardiac surgery also increased the possibility of neurological injury during surgery. Dr. de Varennes described the role of a patient’s haemodynamic status before undergoing such surgery as “significant”.
[272] Added to that, the “lynchpin” evidence that Ms. Stevenhaagen was moving all four limbs when she arrived at the operating room – evidence upon which Dr. Selchen seemingly placed considerable weight in forming his opinion that paraplegia occurred during or following surgery – was, in my view, unreliable.
[273] Courts are required to apply the “but for” causation test in a robust common-sense fashion, but to resist the temptation to come to a common-sense conclusion which is not sufficiently grounded to my findings of negligence.
[274] Having carefully considered and weighed the substantial evidentiary record, I am satisfied that the neurological injuries which Ms. Stevenhaagen sustained more likely than not occurred during the period of haemodynamic instability which she experienced between the final deployment of the Cook stent in the Cath Lab and the commencement of surgery in the operating room, and/or that her injuries occurred during or following the cardiac surgery because of her compromised state, resulting from her poor haemodynamic status going into that surgery due to the delay in moving her to surgery following the completion of the procedure in the Cath Lab.
Conclusion and Disposition
[275] Having found that Dr. McLaughlin and Dr. Sternbach fell below the standard of care when they failed to (i) arrange for the transportation of Julia Stevenhaagen directly from the Cath Lab to the operating room, and (ii) make the appropriate and timely cardiac surgical consultations which would have affected that outcome, I am satisfied on a balance of probabilities that, but for this breach of the standard of care, Julia Stevenhaagen would not have suffered the neurological injuries that resulted in her spending the last decade of her life as an invalid.
[276] I come to this conclusion mindful of the dire circumstances which all of the participant witnesses and parties in this lawsuit faced on 18 October 2002. The law of negligence is a blunt and often brutal vehicle for determining what is just in cases such as this. Sentiment cannot play a part in the analysis. As Lord Denning MR observed sixty-five years ago, a balance needs to be struck between, on the one hand, not inhibiting bold medical decisions and initiative, but on the other, recognising the need for due care of the patient at every point. It was accordingly, appropriate for Drs. Sternbach and McLaughlin to apply an innovative and, at the time in Canada, a relatively untried and untested response to the emergent situation that faced them. Their decision to proceed in that manner, even without the benefit of a consultation with a cardiac surgeon, was defensible. But once the stent was in place, perfectly or otherwise, it was time to revert to the gold standard. To get Ms. Stevenhaagen into the operating room sooner rather than later. To mitigate the effect of any damage that might already have been done (repairable or otherwise) and to prevent or at least reduce the risk of further damage. The delay and the circumstances were such that it is more likely than not that Julia Stevenhaagen suffered permanent and life changing injuries as a result.
[277] Judgment will go in favour of the plaintiffs for the agreed-upon amount of damages against Dr. McLaughlin and Dr. Sternbach.
Costs
[278] I am presumptively of the view that costs of the action should be to the plaintiffs on a partial indemnity scale. If the parties cannot agree on costs, or seek a different disposition than the one I have provisionally indicated, they should, within fourteen days of the release of this decision, contact the trial coordinator at Kingston. I will then make such further directions as may be appropriate.
Graeme Mew J.
Released: 31 August 2020
Corrected: 9 September 2020
Paragraph [110]
Third and fourth word in the first sentence changed to “plaintiffs bear” not “defendant bears”.
Paragraph [233b]
Second last word in the first sentence changed to “had” not “at”.
COURT FILE NO.: CV-14-00000311-00
DATE: 20200831
ONTARIO
SUPERIOR COURT OF JUSTICE
BETWEEN:
THE ESTATE OF JULIA STEVENHAAGEN, DECEASED, BY HER ESTATE TRUSTEE, JOHN STEVENHAAGEN, HOLLY STEVENHAAGEN and BRAD STEVENHAAGEN
Plaintiffs
– and –
KINGSTON GENERAL HOSPITAL, DR. GARY N. BURGGRAF, DR. DOUGLAS R. WALKER, DR. I. SINGH, DR. JOHN D. RICKETTS, DR. LAVALEE, W. TSUI, V. NAIR, DR. ROBERT D. TOMALTY, BRENDA BEATTIE, M. CAMPBELL, KATE SWITZER, B. BRUMH, THE TORONTO HOSPITAL (ALSO KNOWN AS UNIVERSITY HEALTH NETWORK), DR. PETER R. MCLAUGHLIN, DR. RALPH EDWARDS, DR. TIRONE E. DAVID, DR. HAGGIE AND DR. YIP, JANE DOE 2 and DR. YARON STERNBACH
Defendants
REASONS FOR JUDGMENT
Mew J.
Released: 31 August 2020

