ONTARIO SUPERIOR COURT OF JUSTICE
BETWEEN:
ANITA BREBANT FOWLOW, in her Personal Capacity and as Estate Trustee for the Estate of FREDERICK CHESLEY FOWLOW, a Deceased, JONATHAN FEDERICK FOWLOW, and JENNIFER ANNE-MARIE FOWLOW
Plaintiffs
– and –
SOUTHLAKE REGIONAL HEALTH CENTRE and DR. DEEPAK GUPTA
Defendants
Bernie Romano, for the Plaintiffs
Erica J. Baron and Byron Shaw, for the Defendants
HEARD: June 18, 19, 20, and 22, 2012 and by subsequent written submissions
Stinson J.
1This is a medical malpractice lawsuit. It arises from the tragic death of the late Frederick Fowlow, who died on May 1, 2007, four days after undergoing surgery at the Southlake Regional Health Centre in Newmarket.
2The action was discontinued against the defendant hospital. It proceeded to trial as against the defendant Dr. Deepak Gupta, the surgeon who performed the operation. The plaintiffs are Mr. Fowlow's widow and their two adult children.
3Prior to trial the parties settled the quantum of damages. The case proceeded to trial in relation to the issue of liability, only.
facts
Background
4Mr. Fowlow was born in 1942. He and his wife were married in 1980 in Fort McMurray, Alberta, where Mr. Fowlow worked as a plumber. They ultimately relocated to Ontario, where Mr. Fowlow had a successful career as an estimator. By all reports, he loved his job and he worked until the events preceding his death. Unfortunately, Mr. Fowlow had serious health issues. He had a history of high blood pressure and high cholesterol. He suffered a mild stroke that left him blind in one eye, and experienced multiple heart attacks. He suffered from coronary artery disease as well as peripheral vascular disease.
5On January 17, 2007, Mr. Fowlow came to the emergency department at Southlake. He had suffered another heart attack. He underwent a coronary angiography. As a result of that procedure, he was recommended for cardiac surgery.
6Mr. Fowlow was admitted to Southlake as an inpatient on February 6, 2007 for purposes of undergoing coronary artery bypass surgery. His attending physician at the time was Dr. Byung Moon, a cardiac surgeon. Following Mr. Fowlow's admission, but before the cardiac surgery, Dr. Moon sought a consultation from a vascular surgeon at Southlake, Dr. Gupta. In addition to his specialty in vascular surgery, Dr. Gupta practises general surgery at Southlake.
7Mr. Fowlow had undergone previous bypass surgery in his right leg several years previously. That procedure (known as a femoral-popliteal or "fem-pop" bypass) involves the insertion of an artificial artery into the right thigh to connect the upper portion of the femoral artery to the popliteal artery at the knee, in order to bypass a blockage in the artery between those two locations.
8At the time of his admission, Mr. Fowlow was complaining of severe pain in his right leg, a common symptom of peripheral artery disease of the leg, which limits the amount of blood flow that can be delivered to the leg muscles. Dr. Gupta examined Mr. Fowlow and confirmed that the symptoms in his right leg had progressed despite the fem-pop bypass. Dr. Gupta was able to determine, however, that the fem-pop bypass itself was not blocked and that the difficulties being experienced by Mr. Fowlow were caused by a blockage of his right common iliac artery, above his right femoral artery.
9Dr. Gupta concluded that in order to restore circulation to Mr. Fowlow's right leg (and to avoid the possibility of gangrene and the need for amputation) some sort of bypass surgery would be required.
10Dr. Moon and Dr. Gupta consulted with one another and concluded that the appropriate course of treatment was to proceed first with the coronary bypass surgery for which Mr. Fowlow had been admitted to Southlake in the first instance. The problem with his right leg, although serious, was not as serious as the one with his heart that brought him to the hospital in the first place. Mr. Fowlow therefore underwent cardiac surgery and received a triple bypass on February 19, 2007. He was discharged on March 2, 2007.
11Both before and subsequent to his discharge on March 2, 2007, Mr. Fowlow had a series of consultations with Dr. Gupta. In light of the severe arterial blockage in the iliac artery that serviced Mr. Fowlow's right leg, Dr. Gupta recommended bypass surgery. The two options were an aortal-femoral bypass or an axillary-femoral ("ax-fem") bypass. The former involves a connection to the aorta, the largest artery in the body and is a more complex and risky procedure. The ax-fem bypass involves inserting an artificial artery or graft between the axillary artery and the femoral artery. The axillary artery supplies blood to the arm and is located in the vicinity of the shoulder blade. While less risky than the aortal-femoral bypass procedure, the ax-fem procedure also carries risk, with a mortality rate in the order of three percent.
12It is common ground that, in addition to meeting with Mr. Fowlow, Dr. Gupta met with Mr. Fowlow and his two children before he performed the operation. Both his children testified that they remembered the doctor mentioning the three percent mortality risk. Mr. Fowlow decided to proceed with the ax-fem operation.
The axillofemoral bypass procedure
13In simple terms, the ax-fem procedure requires the surgeon to make two incisions, one near the shoulder and the other in the thigh. The shoulder-level incision allows the surgeon to gain access to the axillary artery, while the thigh incision allows access to the femoral artery below the location of the blockage. Through the shoulder-level incision, the surgeon makes a small longitudinal slice in the axillary artery and attaches the graft or artificial artery by stitching its open end to the area of the slice in the axillary artery. The graft is then routed underneath the patient's skin through the use of a tunneling device until the remaining end of the graft emerges at the thigh incision. The surgeon then cuts a small longitudinal slice in the femoral artery and stitches the open end of the graft to that artery. The net result is that, upon completion of the surgery, blood can flow down the graft from the axillary artery to the femoral artery, bypassing the blockage and restoring circulation to the leg.
14Not surprisingly, there are a number of potential complications that may arise in connection with this type of sophisticated surgery. One concern is that, because the blood flow is now routed through an artificial artery which is placed just below the skin and does not follow normal anatomical passages, care must be taken to ensure that the graft will not be crushed or become kinked. To address these potential problems, the grafts themselves are designed and manufactured with external reinforcement that helps them resist both crushing and kinking. As well, part of the surgical procedure requires the surgeon to measure the actual length between the two incisions and to trim the length of the artificial artery accordingly.
15Another potential complication is the possibility of detachment (or "dehiscence" or "anastomotic disruption") of the graft at either end, where it has been stitched to the existing arteries. Dehiscence can result in the blood flow escaping from the artery or the graft, leading to serious blood loss and even death. This is a greater concern in relation to the connection at the axillary artery since that artery is located in an area of the body that is subject to greater motion (through use of the arm and otherwise) than the attachment at the femoral artery. Patients must therefore take care to avoid strenuous or sudden movement of the arm for 4 to 6 weeks following ax-fem bypass surgery.
Bypass grafts
16A key element in any bypass vascular surgery is the bypass or graft material itself. Over the years manufacturers have succeeded in creating artificial prostheses out of man-made materials that can be introduced into the body to function as artificial arteries. These items come in various materials, designs, and diameters and incorporate various features, suitable or appropriate for different applications. For example, the sort of artificial graft that might be required to accomplish a bypass in an internal area involving a short distance, would likely be different than the one required to accommodate the blood flow necessary for a major artery that needed repair. Where, as in the case of an ax-fem bypass, the graft is to be inserted just below the skin, exposing it to possible external pressure that might crush it (thus preventing blood flow) the graft is designed with reinforced walls to guard against that risk.
17These various prostheses are manufactured by various competing suppliers. Different surgeons may have particular preferences for one kind or another depending on their experience, their surgical techniques and other factors. According to Dr. Gupta, some hospitals use grafts supplied by only one particular manufacturer, for contractual and cost reasons. Given their importance, these are carefully manufactured and sterile items that are fairly expensive, and thus hospitals do not maintain a broad selection in their inventory.
18The graft itself comes from the manufacturer in a cardboard box, which is marked on the outside with a description, serial number and expiry date. Inside the box is a booklet containing information for use (an "IFU"). The box also contains a sealed plastic tray that contains a further sealed sterile plastic tray in which the graft itself sits.
19When the surgeon performing an ax-fem procedure is ready to attach the graft at the axillary artery end, the circulating nurse in the operating room will produce the cardboard box. The surgeon will then verify that the box presented contains the type of graft that the surgeon intends to use for the procedure. Having done so, the surgeon will direct that the box be opened. The graft is then removed and installed as I have described above.
Mr. Fowlow's surgery on April 27, 2007
20Mr. Fowlow's ax-fem bypass surgery was originally scheduled for April 20, 2007. That date had to be postponed, however, because the hospital discovered that the box containing the graft that was intended to be used on that date was no longer sterile and there was no substitute available. The surgery was therefore postponed.
21Mr. Fowlow returned and was re-admitted to the hospital on April 27, 2007. On that date Dr. Gupta performed the ax-fem bypass procedure on Mr. Fowlow during an operation that lasted approximately 2 hours. Based on the evidence before me, and subject to one significant exception that I will mention below, the procedure went as expected and without incident. None of the medical records before me indicate otherwise.
22I am aware that the operative note dictated by Dr. Gupta concerning the procedure was not dictated by him until May 25, 2007, some 4 weeks after the surgery, and over three weeks after he learned about Mr. Fowlow's death. It is therefore by no means a contemporaneous or recent record of the procedure. According to Dr. Gupta, it is not unusual for him to dictate his operative notes several weeks after the actual surgery unless something out of the ordinary occurs during the procedure. Despite the fact that Mr. Fowlow died 4 days after his operation, Dr. Gupta did not consider it necessary to dictate his operative note for Mr. Fowlow's procedure any sooner than he did. Dr. Gupta also testified that he prepared his operative note with the knowledge that Mr. Fowlow had died and with the knowledge that it would likely be read carefully and critically by others. He maintains that he did his best to be objective and precise.
23I am compelled to observe that an operative note prepared in the fashion that Dr. Gupta prepared this one is of little use, for several reasons. First, the passage of time results in a failing of all human memories. Second, especially for someone who is constantly in the operating room, performing numerous, often complex procedures on multiple patients, it cannot be an easy task to recall and recount with precision a procedure on a particular patient that was performed many weeks previously. Additionally, despite Dr. Gupta's assurances that he did his best to be careful and objective, he had to know that his operative note and his conduct of the surgery would likely come under close scrutiny. Given the circumstances under which it was prepared, it is only natural that others may have concerns as to the accuracy of Dr. Gupta's operative note.
24Nevertheless, in relation to the procedure itself, there is no direct evidence to suggest that the operation was performed in anything but a routine and standard fashion, but for one exception.
25As mentioned previously, the basic purpose of the procedure is the installation of an artificial artery or graft. As I have further noted, various grafts are manufactured for different purposes by various manufacturers. In the case of Mr. Fowlow's ax-fem bypass, Dr. Gupta installed an IMPRA brand ePTFE vascular graft. More specifically, he used an "IMPRA Flex Thinwall" graft with small beading as external reinforcement. According to Dr. Gupta, this was the only type of graft that he used for this type of procedure and it was the only type available at Southlake Hospital. At the time he used it on the ax-fem bypass for Mr. Fowlow, however, Dr. Gupta was unaware that the manufacturer's IFU for IMPRA Flex Thinwall grafts included a warning that they were not recommended for this type of bypass procedure.
26Specifically, the IFU for the graft used by Dr. Gupta for Mr. Fowlow's ax-fem bypass procedure contained the following express warnings:
Anastomotic or graft disruption has been associated with Axillofemoral, Femoral Femoral, or Axillobifemoral bypass procedures if implanted improperly. Refer to Specific Operative Procedures (Extra-Anatomic Bypass Procedures) for further instructions. Thinwall and IMPRA Flex Thinwall grafts are NOT recommended for these types of bypass procedures.
Axillofemoral, Femoral Femoral, or Axillobifemoral bypass procedures, the patients should be cautioned that, sudden, extreme or strenuous movements should be totally avoided for a period of at least six to eight weeks to allow for proper stabilization of the grafts. Routine activities such as raising the arms above the shoulder, reaching out in front, extended reaching, throwing, pulling, striding or twisting should be avoided.
[Emphasis added.]
27Dr. Gupta admitted that he did not read the IFU for the graft that he used in Mr. Fowlow's procedure. He further admitted that he was unaware that, in the IFU, the manufacturer expressly warned that the IMPRA Flex Thinwall graft that he used was not recommended for the bypass procedure he performed on Mr. Fowlow.
Post-operative care
28Following his operation, Mr. Fowlow was sent to the intensive care unit. Over a course of days, his level of care was stepped down to the point where, on the fourth day following the surgery, May 1, 2007, he was ready to be discharged. Dr. Gupta's evidence (which is confirmed by the hospital records) was that he visited Mr. Fowlow and followed his progress during his rounds on April 28, 29, and 30. Dr. Gupta's note on Mr. Fowlow's chart on April 30 included an order that Mr. Fowlow's IV was to be taken out and he was to go home Tuesday morning (May 1, 2007).
29It is common ground that Mr. Fowlow was discharged from the hospital on May 1. It is also common ground that Dr. Gupta did not see Mr. Fowlow that day. According to Dr. Gupta, he had an early morning meeting followed by surgery, which prevented him from doing his usual rounds. By the time he had completed the surgery, at approximately mid-day, Mr. Fowlow had departed.
30Anita Fowlow, Mr. Fowlow's widow, testified that she went to the hospital to pick him up and take him to the house he was sharing in Barrie, Ontario with their son. She confirmed that she did not see Dr. Gupta that day.
31There is some controversy regarding what discharge instructions, if any, were given to Mr. Fowlow. I will return to this subject when I make my findings of fact.
32After they left the hospital, Mrs. Fowlow drove Mr. Fowlow from Newmarket to his home in Barrie. Their son, Jonathan, met them there and they helped Mr. Fowlow lie down, as he said he was tired and wanted to have a nap. After he was in bed and as directed by Mr. Fowlow, Mrs. Fowlow departed to go to Alliston, leaving Jonathan and his father at the house.
33Mr. Fowlow required prescription medication following his discharge. As a consequence, and because Mr. Fowlow was resting comfortably, Jonathan went to a nearby pharmacy to pick up the medication. Very sadly, upon Jonathan's return to the house after a short absence, he discovered that Mr. Fowlow had suffered a massive external blood loss. Although he attempted mouth to mouth resuscitation, Jonathan was unable to revive his father. Paramedics were summoned, but they, too, were unable to resuscitate Mr. Fowlow.
Post-mortem examination
34An autopsy was performed. It determined that the axillary to femoral bypass tube was completely disconnected at the axillary vessel ridge. There was external blood loss through the overlying scar. It was determined that the distance between the femoral bypass tube that had been installed by Dr. Gupta and the axillary artery was approximately 4.5 centimeters. The tube remained well connected to the right femoral artery.
35The cause of death was determined to be the completely disconnected bypass tube, with secondary localized soft tissue hematoma and external blood loss through the overlying scar, likely complicated by an acute cardiac ischemic event.
36Apart from the foregoing information, the autopsy records contain no detailed description of the mechanism by which the graft and axillary artery became detached. Specifically, there is no evidence (documentary or otherwise) to indicate whether the sutures tore away from the artery itself or from the walls of the bypass graft, or partly from one and partly from the other. The evidence merely establishes that the graft was no longer attached to the axillary artery as it had been at the conclusion of the operation. The specific cause of the detachment was not addressed in the autopsy report nor directly in the evidence at trial.
issues and analysis
The parties' positions
The plaintiffs
37The plaintiffs' position is that the death of Mr. Fowlow was caused by the use by Dr. Gupta of a vascular graft that was not intended for the procedure that Dr. Gupta performed. The plaintiffs submit that Dr. Gupta breached his duty of care to Mr. Fowlow and was negligent in at least the following respects:
(a) he failed properly to inform Mr. Fowlow of the risks associated with the procedure, in particular the fact that the graft he intended to use was not recommended for an ax-fem procedure;
(b) Dr. Gupta failed to read the IFU for the graft that he used, and was thus unaware of the manufacturer's recommendation;
(c) the use of the graft in the face of the manufacturer's recommendation against this particular application, was negligent;
(d) Dr. Gupta failed to ensure that Mr. Fowlow received appropriate instructions when he was discharged from the hospital on May 1; and
(e) Mr. Fowlow's death was caused by Dr. Gupta's negligence.
38In support of their position, the plaintiffs rely on undisputed findings of the coroner and the autopsy report. They also rely on the opinion of their expert witness, Dr. Peter Brown.
The defendant
39The basic position of Dr. Gupta is that the plaintiffs have failed to prove a causal connection between his use of the graft in question and the death of Mr. Fowlow. Simply stated, the evidence fails to establish that the admitted cause of death – the detachment of the graft from the axillary artery – was due to the type or quality of the graft that was implanted. Absent any causal connection, there is no basis for imposing liability.
40In relation to the specific complaints of negligence, Dr. Gupta asserts as follows:
(a) he met the standard of care by disclosing the relevant risks of the surgery and thus Mr. Fowlow gave an informed consent to the procedure;
(b) despite the fact that he did not read the IFU for the graft that he used, in doing so he did not fall below the standard of care;
(c) the use of the thinwall graft was not negligent because thinwall grafts are broadly used in ax-fem procedures;
(d) Mr. Fowlow received adequate discharge instructions and in any event the evidence fails to establish that the cause of the detachment of the graft was non-compliance with instructions he should have received; and
(e) there is insufficient evidence to connect Mr. Fowlow's death to any alleged breach of duty by Dr. Gupta.
41In addition to the factual evidence adduced at trial, Dr. Gupta relies on the opinion evidence of his expert, Dr. Jacques Tittley, and argues that Dr. Tittley's evidence should be preferred to the evidence of Dr. Brown.
Findings of fact
42This is not a case in which there are many disputed facts. The most important fact – the cause of Mr. Fowlow's death – is conceded by Dr. Gupta to be the disconnection of the bypass graft at the point of attachment to the axillary artery. What is not conceded is the mechanism for the detachment or the reason why it occurred.
43The plaintiffs point to the graft that was installed by Dr. Gupta and rely upon the fact that the IFU included a warning that it was not recommended for ax-fem bypasses. The plaintiffs were unable, however, to proffer any direct evidence as to the cause of the disconnection itself. Specifically, there was no evidence describing the condition of the graft itself in the vicinity of the axillary artery; the autopsy report merely stated that it was completely detached and the distance between the open end of the graft and the artery was approximately 4.5 centimeters.
44Neither the coroner's investigation statement nor the post-mortem report made any mention of the mechanism of axillary disruption. Specifically, there is no reference to whether the sutures pulled through the graft, whether the sutures pulled through the artery, whether the graft itself tore, or whether there was some combination of these events. At trial, the plaintiffs did not call any evidence from the coroner or the pathologist. Instead, they relied only on the statements in the printed documents.
45Graft detachment or dehiscence or anastomotic disruption is a known risk of the ax-fem bypass procedure. It can be the result of various causes. For example, a patient with advanced arterial disease may have arteries that are "friable" or particularly fragile. In such cases, the artery walls are weaker and less able to withstand the disruption associated with the bypass procedure, involving as it does having a slice cut into the artery and then attaching the graft by suturing. Mr. Fowlow had advanced arterial disease. It is therefore entirely possible that the detachment of the graft that was installed by Dr. Gupta had nothing to do with the quality of the graft itself, but rather was due to the inability of the patient's axillary artery to maintain the connection.
46Apart from the manufacturer's warning, the plaintiffs were unable to point to any particular evidence to support the conclusion that the disruption was due to the quality of the graft employed. They tendered no evidence from the manufacturer to explain why the warning was included in the IFU or to indicate any history of problems with that particular manufacturer's graft in this type of application. It may be that other problems led to the inclusion of the warning, such as reports of blockages or clotting or kinking in the tube, to name a few. It is noteworthy that thinwall grafts of at least one other manufacturer did not include a warning in the IFU against their use in the ax-fem procedures.
47I further note that in the studies that were tendered in evidence, ax-fem grafts were found to have become detached in a range of circumstances, including while the patient was watching television, sleeping or under unknown circumstances. No systemic problems arising from the use of thinwall grafts in particular were identified. Indeed, as stated in the principal study relied upon by plaintiffs, "[a]lthough multiple steps have been recommended to avoid this complication, occasional cases continue to occur despite observing all precautions." (See Taylor, et al., "Acute disruption of polytetrafluoroethylene grafts adjacent to axillary anastomoses: A complication of axillofemoral grafting", Journal of Vascular Surgery (1994) Volume 20, No. 4, p. 520.) In the present case, the evidence suggests that Mr. Fowlow was asleep in bed when his graft became detached. Unhappily, one of the known risks associated with the ax-fem procedure – detachment of the graft – materialized.
48In any case involving disputed facts, one party or the other bears the onus of proof of satisfying the trier of fact on a balance of probabilities regarding the factual conclusion for which it contends. In the present case, the plaintiffs bear the onus of proving, on a balance of probabilities, that the use by Dr. Gupta of the thinwall graft that he chose for Mr. Fowlow's procedure was the cause of the detachment that led to his death. As the preceding analysis shows, there are numerous possible reasons for the detachment that occurred. I am not permitted to speculate regarding what the true cause may have been and on the basis of the evidence before me, I am unable to conclude what the cause was. I am thus unable to make a finding of fact regarding the cause of the detachment of the graft that was discovered during the course of the post-mortem examination.
49Another factual controversy concerns the information provided by Dr. Gupta to Mr. Fowlow regarding the risks of the surgery, when he obtained Mr. Fowlow's consent to the procedure. There were two consultations at which the ax-fem procedure was discussed: one attended by Dr. Gupta and Mr. Fowlow alone, and the second attended by Dr. Gupta, Mr. Fowlow and his children, Jennifer and Jonathan Fowlow. Dr. Gupta alone gave evidence with respect to the former meeting; Jennifer Fowlow, Jonathan Fowlow and Dr. Gupta testified about what transpired at the latter meeting.
50By his own admission, Dr. Gupta has limited independent recollection of his interactions with Mr. Fowlow. In large measure, he relied upon his clinical notes and records, as well as his standard practices. His testimony regarding his dealings with Mr. Fowlow was thus based on a combination of his recollections and his usual practices. That said, it is well-established that the ordinary practice of the professional can be given significant weight by the court: see Bafaro v. Dowd, [2008] O.J. No. 3474, 169 A.C.W.S. (3d) 437 at para. 29 (S.C.J.), affirmed 2010 ONCA 188, 260 O.A.C. 70.
51To my observation, Dr. Gupta was candid and forthright in his testimony. He answered questions on cross-examination in a non-argumentative fashion, offering explanations where appropriate. He conceded points that were fairly made against him. He presented as a compassionate, careful and knowledgeable specialist in vascular surgery.
52Dr. Gupta was challenged in relation to a reference in one of his consultation notes to an "axillobifemoral bypass". I accept that this was either a dictation error or a transcription error. At no time was an axillobifemoral bypass indicated as a necessary course of treatment for Mr. Fowlow. All of Dr. Gupta's other notes refer only to a "right axillofemoral bypass".
53Another criticism leveled at Dr. Gupta was the fact that he did not dictate his operative note concerning Mr. Fowlow's surgery until several weeks after Mr. Fowlow's death. While I have previously commented that this is not a desirable practice for the reasons indicated, there is nothing in the record before me to suggest that the note is inaccurate or was somehow crafted in a fashion to cover up something that had gone wrong during the surgery. Indeed, when Dr. Gupta spoke to the coroner in reporting Mr. Fowlow's sudden post-operative death, he described the procedure as "a smooth operation with no problems". No evidence was adduced to contradict that description.
54Overall, I found Dr. Gupta to be a credible witness and his evidence to be largely reliable.
55The recollections of Jennifer Fowlow and Jonathan Fowlow, the other two witnesses who met with Dr. Gupta and Mr. Fowlow at the pre-operative consultation, were limited. Most of what they remembered about that appointment did not contradict and generally confirmed Dr. Gupta's evidence. Jennifer stated that she did not remember a lot from the meeting and that she did not remember any details. She acknowledged that Dr. Gupta may have discussed options and she simply could not remember whether he used visual aids to describe the procedure. She conceded, however, that Dr. Gupta explained the nature of Mr. Fowlow's problems, the surgery and the risks.
56Jonathan's evidence was very similar. He confirmed that Dr. Gupta explained that he was going to perform a right axillofemoral bypass. He said that he remembered that Dr. Gupta explained the surgery and said there was a three percent mortality risk. He could not recall one way or another whether Dr. Gupta used diagrams to explain the procedure, whether he explained a different surgical option or if he advised that Mr. Fowlow's leg may need to be amputated if he did not have surgery to correct the blockage in the artery.
57Overall, I find little conflict in the evidence regarding the consent discussions with Mr. Fowlow. With respect to the consultation with Mr. Fowlow alone, Dr. Gupta followed up with a consultation note to Mr. Fowlow's family doctor, recording Mr. Fowlow's decision to proceed with the surgery. Although Dr. Gupta did not recall the actual mortality risk of an ax-fem bypass that he quoted to Mr. Fowlow, he believed it was at least three percent, in light of Mr. Fowlow's pre-existing illnesses. In relation to the second consent meeting, attended by Jennifer and Jonathan, once again Dr. Gupta could not recall precisely what he explained in terms of the estimated percentage risk of mortality. When asked about Jennifer and Jonathan's recollections of a three percent mortality risk, Dr. Gupta explained that it would have been at least three percent.
58In relation to the credibility of the testimony of Mr. Fowlow's children, I have no reason to doubt that they did their best to recount accurately their memories of the events in question. Those events occurred, however, more than five years prior to trial. In retrospect, and quite understandably, these are not happy memories for them, given the tragic death of their father. Unlike Dr. Gupta, they have no written records of their discussions. I further cannot dismiss the possibility that their recollections have, over time, been coloured in part by their emotions, particularly in light of their subsequent discovery that the IFU for the graft inserted by Dr. Gupta contained a warning that it was not recommended for an ax-fem bypass.
59I conclude in the circumstances that, to the extent there may be a material difference between the evidence of the plaintiffs and that of the defendant in relation to the consent consultations with Mr. Fowlow, I prefer and accept that of the defendant.
60Based on the foregoing, I find as follows. At the initial consent consultation (March 27, 2007), Dr. Gupta discussed the surgical options with Mr. Fowlow. He explained that Mr. Fowlow would benefit from either an aortobifemoral bypass or a right axillofemoral bypass. He explained each of the procedures to Mr. Fowlow using a wall chart in his office. He explained the risks and benefits of each surgical option and, in particular, he explained that the plastic grafts used for both bypasses could block off, just like natural arteries although the aortobifemoral bypass would not block off as easily. For Mr. Fowlow, Dr. Gupta recommended an axillofemoral bypass, which had a lower risk when compared with an aortobifemoral bypass. Dr. Gupta explained to Mr. Fowlow there was a risk of death, which he believed was at least three percent.
61Dr. Gupta also explained the course of surgery and the expected recovery. Significantly, he did not inform Mr. Fowlow that the graft that he intended to use – the IMPRA Flex Thinwall graft – was, according to the manufacturer's IFU, not recommended for ax-fem procedures. Dr. Gupta could not have done so, of course, because he was unaware of the manufacturer's warning until after Mr. Fowlow's death.
62Based on Dr. Gupta's explanation, Mr. Fowlow decided to proceed with the surgery. Before scheduling the surgery, Dr. Gupta asked Mr. Fowlow to return to his office for a further consultation with his family. He did so with his children on April 3, 2007. I find as a fact that, on this occasion, Dr. Gupta explained to Mr. Fowlow in the presence of his children the blockage in his right iliac artery. He used the wall chart's diagrams to explain the location of the blockage as well as the surgery that Mr. Fowlow had elected to undergo. He explained the risks and benefits of the surgery, including a three percent mortality risk. Once again, there was no discussion of the specific type of graft that Dr. Gupta intended to use.
Discharge instructions
63A final factual dispute between the parties concerns whether Mr. Fowlow was provided with adequate or even any instructions on his discharge, regarding how he should conduct himself as he continued to recuperate from the surgery. Mrs. Fowlow, who attended at the hospital to pick him up and take him home to Barrie, testified there were no instructions. It was further her evidence that no documents were provided to Mr. Fowlow when he was discharged.
64The nurse who attended on Mr. Fowlow's discharge, Lisa Dol, also testified. She admitted that she had no memory of Mr. Fowlow or her interactions with him. She did, however, identify her signature on a form of patient discharge instructions found in Mr. Fowlow's patient chart at the hospital. According to her, this document is a one-write form, that is prepared in duplicate, with the white copy being kept in the patient's chart and the yellow copy being given to the patient. She confirmed that Mr. Fowlow's chart still contains the white copy and that the second page, the yellow copy, has been detached. Her evidence was that it is her standard practice to review the contents of the form with the patient, then have the patient sign the acknowledgment at the bottom of the form. She then provides the yellow copy to the patient. Mrs. Fowlow confirmed that Mr. Fowlow's signature appears at the bottom of the white copy.
65According to Ms. Dol, she has no express recollection of reviewing the discharge document with Mr. Fowlow or his family, or Dr. Gupta or anyone else. She says that the source of the information was their standard nursing practice. Among other discharge instructions recorded on the form is the following:
Activity level – no strenuous activity 4 – 6 weeks.
The form also directed the patient to make a follow up appointment with Dr. Gupta for May 22, 2007 and that the patient should arrange for the staples and stitches to be removed in Dr. Gupta's office and he should call and book an appointment. Dr. Gupta's evidence was that the instructions regarding the follow up appointment and arrangements for removal of staples and stitches at his office must have been given by him, to be included in the form since the nurse would have no authority to make that type of decision.
66Despite Ms. Dol's lack of express recollection of the events in question, Mr. Fowlow's signature on the document is strong confirmation that he received the document and the instructions that Ms. Dol says were her standard practice. Ms. Dol was unaware that Mr. Fowlow had died. She has no stake in the litigation, nor any connection with the remaining disputants. Although Mrs. Fowlow did not recall these events, her lack of memory may be attributed to the shock of tragic events that unfolded later that day, coupled with the passage of time. It is further conceivable that she was either distracted or not present when the exchange between Mr. Fowlow and Ms. Dol took place. I further note that Ms. Fowlow is also not a disinterested party. In the circumstances, I prefer and accept Ms. Dol's version of what took place when Mr. Fowlow was discharged.
Expert testimony
67Both sides called vascular surgeons who testified as experts qualified to provide opinion evidence. In summary terms, the plaintiffs' expert, Dr. Peter Brown, opined that Dr. Gupta's treatment of Mr. Fowlow did not meet the standard of care. The defendant's expert, Dr. Jacques Tittley, testified that in his opinion Dr. Gupta met the standard of care throughout. For the reasons set out below, I found Dr. Tittley's opinion to be more persuasive in general than that of Dr. Brown, and accordingly worthy of being given greater weight. That said, I am unable to accept all of Dr. Tittley's conclusions.
68Dr. Brown has extensive academic and professional qualifications. He is an eminent and well respected vascular surgeon and professor. There is no question that he is familiar with the issues in this case.
69Regrettably, I formed the impression that Dr. Brown appeared to have an interest in convincing the parties and the court of the veracity of his opinion. He admitted that he was not specifically aware of his duties as an expert to the court under the Rules. He did not attach a signed Form 53 – Acknowledgement of Expert's Duty – with his report, as required by rule 53.03(2.1)7. Although Dr. Brown signed such a form on the eve of trial, I am concerned that he did not take the time to read and reflect upon the content of the form and his obligation to the court, at the time he prepared his report, well before the trial.
70From time to time, Dr. Brown gave answers that were not entirely responsive to the questions asked on cross-examination. As well, Dr. Brown came to trial with new documents that had not been referenced in his report, in an effort to buttress his opinion. He included an article from a Nursing Journal that was republished by the U.S. Food and Drug Administration in 2009, two years after the surgery in issue. It therefore can have no relevance to the standard of care expected of Dr. Gupta in 2007. These factors lend further support to my concern that Dr. Brown's opinion was not entirely objective.
71Another concern regarding Dr. Brown's opinion arose from his selective reliance on the text book entitled Complications in Vascular Surgery. He relied on part of Chapter 15 of that text in his own expert report and confirmed on cross-examination that he considers it an authoritative work. Despite the foregoing, he disputed as "not evidence based" the statement in Chapter 15 that "the key to avoiding proximal anastomotic disruption is correct and anatomical placement of the axillary anastomosis." However, the authors go on to refer to three separate studies, suggesting there is evidence to support the quoted passage, contrary to Dr. Brown's assertion.
72Overall, despite Dr. Brown's unquestionable familiarity with the subject and expertise as a surgeon, I gained the impression that he misperceived his role in court as being to advocate the plaintiffs' cause.
73I did not have the same concerns in relation to the testimony of the defendant's expert, Dr. Tittley. Under cross-examination his answers were straight forward, non-argumentative and candid. For example, he conceded that if he had read the warning against use of the thinwall ePTFE graft for ax-fem procedure in 2007, he probably would not have used it. Dr. Tittley also candidly conceded that Dr. Gupta's practice of not dictating his discharge summary for Mr. Fowlow twenty-four days after the fact was not ideal. He also agreed that Dr. Gupta's operative report was dictated late. At no time did I gain the impression that Dr. Tittley was trying to defend Dr. Gupta's conduct. I also note that, as required by the Rules, Dr. Tittley completed a Form 53 that accompanied his report. I believe he did his best to discharge the responsibilities acknowledged in that form.
74Although, for the foregoing reasons, I generally prefer the evidence of Dr. Tittley over that of Dr. Brown, this is not to say that I am willing to accept and rely on all his evidence. I will expand on this point as I review each of the principal issues, below.
Specific allegations of negligence
(a) Did Dr. Gupta meet the standard of care in relation to the level of information he provided to Mr. Fowlow when he obtained Mr. Fowlow's consent to the surgery?
75The evidence that I accept establishes that, when he gave his consent to the surgery, Mr. Fowlow was made aware by Dr. Gupta that he faced at least a three percent risk of mortality arising from the operation; he was also told about the consequences of not undergoing the procedure. I largely accept the evidence of Dr. Tittley that the level of disclosure was adequate. I further largely accept Dr. Tittley’s evidence that there was no specific requirement for a surgeon in Dr. Gupta's position to describe in detail the specific brand or type of grafts that the surgeon intended to implant in the patient. But for one material qualification, therefore, I accept that Dr. Gupta met the standard of care when he provided the information he did when obtaining Mr. Fowlow's consent to the procedure, and that Mr. Fowlow’s consent was informed.
76Significantly, Dr. Gupta did not inform Mr. Fowlow that he intended to implant a graft that was expressly not recommended for an ax-fem procedure. In cross-examination, Dr. Tittley conceded that if he had been aware of this warning, he probably would not have used that graft; on this basis he would not have had a discussion with the patient about the fact he intended to use a graft that was not recommended.
77In explaining Dr. Gupta's choice of the graft he used, Dr. Tittley also testified about the practice of so-called "off label" uses of medical devices. He offered as an illustration the common use of a small stent in certain vascular procedures that has FDA approval only for use in bile duct surgery. In my opinion, Dr. Tittley's reference to "off label" use in this context is a conflation of two separate concepts: it is one thing to make appropriate and acceptable use of a product or device in an "off label" application, and something quite different to use it in application for which it is expressly not recommended by the manufacturer. In this respect, I would contrast the comments of Perell J. in Goodridge v. Pfizer Canada Inc. (2010), 2010 ONSC 1095, 101 O.R. (3d) 202 at para. 14 (S.C.J.) regarding "off label" prescribing which he notes is a common practice of physicians. I do not understand those comments of Perell J. to extend to prescribing practices that run contrary to express warnings against such use from the manufacturer.
78I accept as accurate Dr. Tittley's statement that he would never have such a discussion with a patient, because he would likely not use a product for an application for which it was expressly not recommended by the manufacturer. That does not, however, answer the question whether a competent surgeon who intended to use a graft despite a manufacturer's contrary recommendation, had a duty to discuss that fact with the patient. In my view, a surgeon who knowingly intends to use a product or device in a fashion which is contrary to the manufacturer's recommendation, but fails to inform and seek the patient's approval to such use, does not meet the standard of care. Any other conclusion defies logic.
79I therefore conclude that, in failing to inform Mr. Fowlow the he intended to install a graft that was expressly not recommended for an ax-fem procedure, and in failing to obtain his consent to do so, Dr. Gupta fell below the standard of care.
(b) Did Dr. Gupta meet the standard of care when he failed to read the IFU for the graft he used?
80Dr. Tittley testified that the standard of care did not require that Dr. Gupta read the IFU prior to Mr. Fowlow's surgery. He further testified that reading a graft's IFU is something that all surgeons do at some point in the career, early in their training, and that they do not review them on an ongoing basis. By contrast, the plaintiff's expert Dr. Brown testified that it was essential for a vascular surgeon to read IFUs.
81The defendant submits that I should reject the testimony of Dr. Brown and instead accept that the standard of care of a reasonably competent vascular surgeon in 2007 was to read IFUs during training or when a change in the product was brought to the surgeon's attention, by a manufacturer's field representative. I have difficulty with that submission, for two reasons. First of all, it amounts to delegating the responsibility for remaining knowledgeable regarding the suitability of specific prostheses for particular applications to someone other than the surgeon who is responsible for carrying out the procedure. Secondly, if the surgeon is required to read the IFU only when there is a change in the product, that somehow relieves the obligation of the surgeon to stay current with respect to manufacturer's warnings, even when the manufacturer determines that its product is no longer suited for a particular use. Such an approach would create a lacuna of responsibility. Therefore I cannot accept that a surgeon who fails to stay current in relation to such warnings nevertheless meets the standard of care.
82I therefore conclude that, in failing to be aware that the IFU for the thinwall graft that he was customarily using expressly warned against its use for ax-fem surgery, Dr. Gupta fell below the standard of care.
(c) Did Dr. Gupta meet the standard of care when he used the IMPRA Flex Thinwall ePTFE vascular graft in Mr. Fowlow's surgery?
83As Dr. Tittley candidly admitted, had he been aware of the warning issued by the manufacturer, he likely would not have used this graft in Mr. Fowlow's case. In the absence of evidence that the use of a vascular graft in circumstances contrary to the manufacturer's express warning is acceptable, I have no difficulty concluding that, by using the graft he did, Dr. Gupta fell below the standard of care. At the risk of repetition, this is not a case of "off label" use or a non-FDA approved application. Rather, it is the use of a prosthesis for an important and critical application in vascular surgery for which it was expressly not recommended.
(d) Did Dr. Gupta meet the standard of care in relation to Mr. Fowlow's discharge instructions?
84On the facts found by me, the information provided to Mr. Fowlow warned him regarding the risks of over exertion and the need to avoid activity that might compromise his graft. There was no evidence to suggest that Mr. Fowlow's discharge was premature. In any event, there is no evidence that anything Mr. Fowlow did subsequent to his discharge contravened the required instructions such that the graft became detached as a result. I am unable to find that Dr. Gupta fell below the standard of care in relation to Mr. Fowlow's post-operative care.
(e) Did any failure of Dr. Gupta to meet the standard of care cause Mr. Fowlow's death?
85I have concluded that, in several respects, Dr. Gupta's conduct fell below the standard of care. For the plaintiffs to succeed, however, they must establish a causal connection between the conduct of Dr. Gupta and the event that resulted in Mr. Fowlow's death. In my view, they have failed to do so.
86As set out in my recital of the facts above, the autopsy records contain no detailed description of the mechanism by which the graft became detached from the axillary artery. The specific cause of the detachment was not addressed in the autopsy report, nor directly in the evidence at trial. There are numerous possible reasons for the detachment that occurred, and I am unable to conclude what the cause was.
87The potential detachment of a graft from the axillary artery is one of the known potential risks of the ax-fem procedure regardless of the type of graft that is used. As the Taylor study cited by the plaintiffs itself notes, "occasional cases continue to occur despite observing all precautions". In the present case, it would be speculative for me to infer that the detachment of Mr. Fowlow's graft occurred because of the type and manufacturer of the graft used by Dr. Gupta, despite its use for a purpose contrary to the manufacturer's recommendation. It is noteworthy that Dr. Gupta had performed the same procedure on multiple previous occasions using the same graft, without such a complication.
88In the absence of evidence connecting the detachment to the quality of the graft chosen by Dr. Gupta, I am unable to draw a causal link between Dr. Gupta's failure to meet the standard of care and the death of Mr. Fowlow.
conclusion and disposition
89For the foregoing reasons, I find that in several respects the conduct of Dr. Gupta fell below the standard of care. I am unable to find on the evidence, however, that Dr. Gupta's actions or inactions caused Mr. Fowlow's death. As a result, the plaintiffs' claim cannot succeed and the action must be dismissed.
90In the circumstances, having determined in several respects that Dr. Gupta's conduct fell below the standard of care, this would appear to be a case in which there should be no order as to costs. Should either side wish to make costs submissions, however, they should do so within 15 days of the release of these reasons; the opposite party shall have 10 days within which to respond. Costs submissions shall be limited to 3 double-spaced pages, plus a bill of costs.
___________________________ Stinson J.
Released: November 19, 2012