Harling v Lauf, 2021 ABQB 235

Court of Queen’s Bench of Alberta Citation: Harling v Lauf, 2021 ABQB 235 Date: 20210326 Docket: 1203 11659 Registry: Edmonton Between: Kevin Harling and Kevin Harling as the Personal Representative of the Estate of Peyton Harling Plaintiffs - and - Dr. George Lauf, Alberta Health Services, Alberta Health Services Owing and Operating the University of Alberta Hospital and the University of Alberta Hospital Defendants _______________________________________________________ Reasons for Judgment of the Honourable Mr. Justice J.S.

Little _______________________________________________________ PART ONE: BACKGROUND .. 3 I. Introduction . 3 II. Overview of Ms. Harling’s Medical History . 3 III. Trial Format, Documentation, and Expert Evidence . 4 PART TWO: BATTERY .. 5 I. Definition . 5 II. Consent Vitiated by Lack of Specific Hospital Privileges? . 6 1. Health Organizations . 6 2. Radiology and MIC Generally . 7 3. Accreditation and Privileges . 7 i. Defects in the Reapplication Process . 9

ii. Delegation to MIC .. 11

a) Partnership Agreement 11

b) Involvement of AHS . 12

c) Conflict of Interest with External Agency . 13

d) Ulterior Motive . 13 iii. Bylaws and Rules . 14

a) Regulation under Hospitals Act 15 II. Permission vs. Privilege . 17 III. Conclusion on Battery . 17 PART THREE NEGLIGENCE . 18 I. Elements . 18 II. Standard of Care . 18 III. Review of the Procedure and Sequelae . 19 IV. Standard of Care respecting Antibiotic Use . 19 1. Conflicting Expert Opinions . 19 2. Venkatesan Report 20 V. Conclusion on the Standard of Care respecting the Use of Antibiotics . 22 VI. Standard of Care Respecting Discharge . 22 1. Vital Signs . 23 2. Pain . 23 VII. Conclusion on Standard of Care respecting Discharge . 25 VIII. Conclusion on Negligence . 26 PART FOUR: CAUSATION .. 26 I.

Test: 26 II. Did the Failure to Use Antibiotics Cause Death? . 27 III. Did Early Discharge Cause Death? . 28 IV. Conclusion on Causation . 30 PART FIVE: CONCLUSION .. 31 PART ONE: BACKGROUND I. Introduction [ 1 ] Ms. Peyton Harling underwent an interventional radiological procedure at the University of Alberta Hospital on August 6, 2010. In advanced stages of liver disease and needing a transplant, she had had a number of these same procedures and other medical interventions in the months leading up to this one.

She was released from hospital after the usual four hour recovery period for this last procedure but returned the following day complaining of unusual discomfort, diagnosed as sepsis. She remained in critical care in the hospital for six weeks. Tragically, and despite extraordinary measures to deal with her condition, she died in hospital on September 22, 2010. [ 2 ] Her widower Mr. Kevin Harling, in his own capacity and as the personal representative of his late wife’s estate, claims that

the doctor who performed the procedure was negligent in failing to use antibiotics during the procedure, failing to recognize and treat symptoms of a known risk of the procedure, namely the perforation of the bowel and resulting infection, and discharging Ms. Harling prematurely after the procedure without conducting a proper diagnosis. [ 3 ] Mr. Harling further claims in battery. The foundation for this claim is that the hospital had not granted the correct privileges to the physician who performed the procedure, and that therefore Ms.

Harling’s consent to the procedure was inoperative. [ 4 ] Because the parties reached agreement on damages, this trial dealt only with liability. II. Overview of Ms. Harling’s Medical History [ 5 ] Ms. Harling’s medical history is complicated. She was born with biliary atresia, which is a problem with the bile duct system [1] which drains bile from the liver into the small bowel. She underwent surgery as an infant for that condition, using a vein from her bowel to replace the defective duct, but it was not successful. In 1983, when she was eighteen months old, she received a liver transplant in the United States.

While the transplant was successful, she developed Hepatitis C, likely from a blood transfusion. [ 6 ] She and Mr. Harling lived in Manitoba, but moved to Edmonton just before their marriage in 2008 when she lost her primary physician and knew that she needed to be in a city with a liver transplant program. By the age of 28, she was being treated at the University of Alberta Hospital. She had frequent episodes of internal bleeding and had undergone frequent blood transfusions, with numerous hospitalizations. She suffered also from cirrhosis and related liver dysfunctions.

One of those dysfunctions was what is called a biliary stricture, which is a constriction of the bile duct which drains bile from the liver to the small bowel. It may be thought of as the same condition she suffered as an infant. Surgery on the bile duct was considered too risky because of her condition – the stricture in the duct forces other vessels to take the load which increases pressure in the organ which increases the risk of uncontrolled bleeding. A liver transplant was really her only hope.

She was a questionable candidate for a transplant because of the number and extent of her medical conditions, but she was put on the wait list in October, 2009 because of her relatively young age. [ 7 ] The treatment chosen to deal with her biliary constriction while waiting for a transplant, and really the only alternative, was biliary drainage, which involved the insertion through the skin and abdominal wall of a drainage tube [2] through the liver to perform the function normally performed by the bile duct.

The tube is perforated [3] where it passes through the liver, so that bile from the liver can enter through those perforations and be directed down the tube. The initial insertion requires that a wire be guided through the liver into the small bowel, with the perforated tube then inserted over the wire and the wire removed. The tube is pulled into a loop where it enters the small bowel, and the other end is taped to the exterior of the abdominal wall. The tube requires periodic replacement as the perforations or the tube itself clogs up.

A wire is inserted in the bad tube which is removed and a new one inserted over the wire which is again removed. Her treatment on August 6, 2010 was the ninth time that that tube had been replaced in the space of months. [ 8 ] Known risks of the procedure include the puncture by the guidewire of a part of the liver or the puncture of another internal organ such as the small bowel. That could occur if the wire is extended too far through the liver or if the end of the tube extends beyond the wire and punctures the small bowel.

In either of these cases, bile could leak from the puncture and cause an internal infection resulting in sepsis. Similarly, if after placement, the tube is dislocated by, for example, being pulled out from where it is taped to the abdomen, the tube itself may rupture the vessels through which it passes, again resulting in bile leakage into the abdominal cavity. [ 9 ] While in recovery at the hospital on the day of the procedure, Ms. Harling complained of abdominal pain. Dr.

Lauf, who performed the procedure, which had appeared to be without complication, examined and discharged her, with instructions to return to the emergency department if her pain persisted or worsened. She returned early the following morning still complaining of abdominal pain. Subsequently diagnosed with sepsis, she remained in the hospital where surgeons, including those from the liver transplant team, performed a number of surgeries in an attempt to get the sepsis under control and, in fact, began the transplant procedure.

But internal scarring due either to the original surgery and transplant as an infant or the sepsis or a combination thereof was too great for a successful transplant. She died in hospital on September 22, 2010. III. Trial Format, Documentation, and Expert Evidence [ 10 ] The entire trial was conducted by WebEx. All counsel and witnesses appeared remotely. [ 11 ] While the trial was conducted remotely, this was not otherwise an electronic trial. Counsel had each prepared extensive hard copy Exhibit books: Exhibit 1 for the plaintiffs and Exhibit 2 for the defendants.

I refer to individual documents in those books by their tab numbers and other exhibits by their respective numbers. [ 12 ] Expert reports were also consolidated in a binder and marked as exhibits as their respective authors testified. Because not all of the witnesses had easy access to the hard copies of Exhibits 1 and 2 or the expert reports, counsel often resorted to “screen-sharing” the document on which they wished the witness to comment.

That process worked well. [ 13 ] By agreement of counsel, statements of fact contained in the documents from the Exhibit books, regardless of who prepared them, were admissible for the prima facie truth of their contents, subject to relevance and the rules of evidence, ie. statements by one person recorded by another were just records of what that first person said to the recorder.

[14] For the purpose of the two step test set out in White Burgess, 2015 SCC 23 at paras 23-24, I found that the evidence of eachexpert was relevant and necessary, and I admitted it on that basis. It would be difficult to understand the procedures Ms. Harlingunderwent and the various complications without medical experts to assist in that process.

Similarly, with respect to the privilegingissue, the expert witnesses provided background that would not otherwise have been available. [15] But while neither party challenged the expertise of the others’ witnesses in their respective areas of expertise, they reservedtheir right to argue that certain witnesses at times strayed beyond their areas of expertise, and I will comment on that as necessary. PART TWO: BATTERY I. Definition [16] I will deal with this aspect of the claim first.

It provides much of the context for the claim in negligence. [17] Battery as a tort is the intentional application of force without consent. In Reibel v Hughes (SCC), [1980] 2SCR 880, the SCC limited its use in cases of medical treatment: In my opinion, actions of battery in respect of surgical or other medical treatment should be confined to cases where surgery or treatmenthas been performed or given to which there has been no consent at all or where, emergency situations aside, surgery or treatment hasbeen performed or given beyond that to which there was consent. (p 890) [18] Mr.

Kirwin for the plaintiffs cites Mohsina v Ornstein, 2012 ONSC 6678, which relies on Reibl v Hughes, for theproposition that medical treatment performed without consent constitutes battery. Insofar as that proposition purports to come fromReibl v Hughes, I would rephrase it as the proposition that one medical treatment performed when consent is given to another constitutesbattery.[4] [19] In Mohsina, a woman gave consent to surgery on a right ovarian cyst.

As a result of bleeding found during the surgery in thearea of the left cornua, which is the cavity in the uterus through which the fallopian tubes pass, the surgeon stitched that cornua. Shethen “clipped”, or sealed, the left fallopian tubes to prevent an ectopic pregnancy, thereby sterilizing the patient. Clearly the surgeon didnot have her patient’s consent for that procedure. That case is simply an example of the second proposition in Reibl v Hughes: surgerywas performed beyond that to which there was consent. [20] Ms.

Harling signed a consent to a biliary tube replacement on August 6, 2010 specifically consenting to Dr. Lauf performingthe procedure: Exh 1, Tab 13. In that consent, she acknowledges that Dr. Lauf had explained the significant risks and alternatives to theprocedure. Dr. Lauf testifed that that is his standard practice. [21] Mr. Harling testified that his wife signed the consent form along with other admission papers before she met with Dr. Lauf. But he conceded on cross-examination that after he dropped Ms. Harling off at the hospital, he would not have known what discussionsshe might have had with Dr.

Lauf. [22] I conclude that the consent form was signed after Dr. Lauf consulted with Ms. Harling. That was his standard practice, andthat is what the consent form states. In any event, the plaintiffs concede that this case is not about informed consent. The plaintiffs’argument here is much more nuanced. It is not alleged that there was no consent in the conventional sense, but instead that the consentwas based on a faulty premise, namely that Dr. Lauf, who performed the procedure, should have had, but did not have, the specificprivilege from the hospital to perform that procedure. II.

Consent Vitiated by Lack of Specific HospitalPrivileges? [23] The plaintiffs argue that the consent given by Ms. Harling is vitiated by the fact that Dr. Lauf as a radiologist did not have thespecific privilege to perform interventional radiological procedures at the UAH. A little background is required to understand thisargument.

1. Health Organizations [ 24 ] Alberta Health Services (AHS) is the provincial organization that resulted from the merger in about 2009 of Capital Health (CH), which was the Edmonton health zone, and several other regional zones in the province. Because the procedure giving rise to this litigation took place a relatively short time after the merger and there seemed to be a bit of a transition period, certain documents and testimony refer to AHS and CH interchangeably. AHS can be considered to be the parent of the University of Alberta Hospital (UAH). 2. Radiology and MIC Generally [ 25 ] Ms.

Harling’s initial biliary tube insertion and all replacement procedures were performed at the UAH by radiologists. Radiology was once the medical discipline that, to paraphrase Dr. Kendel, whom we will meet shortly, involved “reading Xrays in dark rooms”. Like many disciplines in medicine, it has evolved rapidly and dramatically. Radiologists now utilize and interpret the results of a number of different imaging technologies such as fluoroscopy, which was the technology used by Dr. Lauf.

Further, many of what are referred to as invasive procedures, meaning those that involve penetrating the body, are now guided by those medical imaging technologies which allow the physician to see and manipulate an instrument being inserted below the skin. These are called interventional radiology (IR) procedures. [ 26 ] Dr. Lauf is a radiologist. He works in a partnership called Medical Imaging Consultants (MIC), as do most radiologists in Edmonton. MIC contracts its services, meaning its physicians, to the various hospitals in the region. 3. Accreditation and Privileges [ 27 ] The plaintiffs called Dr.

Kendel to testify as an expert in the regulation and accreditation of physicians. While a practicing physician, his administrative roles included serving as the President of Medical Staff at St. Paul’s Hospital in Saskatoon and President of the Saskatchewan Medical Association. After practicing for 14 years, he turned his talents more to the administrative arena. Among other roles, he served as the Registrar/CEO of the College of Physicians and Surgeons in Saskatchewan from 1986 to 2011.

He served on the Medical Council of Canada, the Health Council of Canada, and the Physician Advisory Committee, Accreditation Canada. In those capacities, he has studied the delivery of health care across Canada and investigated how the provinces regulate their processes. [ 28 ] He explained, in broad strokes, that physicians’ Colleges determine initial competency of physicians. Hospitals, or in this case CH and later AHS, determine hospital privileges based on following up on that initial competency and determining the needs of the particular hospital.

The Hospital Act, RSA 2000, c H-12 in s. 17(1) requires that a hospital adopt bylaws “governing the organization and conduct of the medical staff … whereby the medical staff must make recommendations to the board concerning the appointment, reappointment of, and the delineation of hospital privileges of, members of the medical staff.” [ 29 ] In addition to it being a statutorily mandated requirement, Dr.

Kendel emphasized that careful attention to the process of granting privileges is critical to the protection of the public, particularly for high risk procedures such as IR procedures. [ 30 ] As a result of what he testified were instances of harm caused by radiologists and pathologists in Alberta, he was engaged in 2012 by the then Alberta Minister of Health to prepare a Review of AHS Physician Credentialing (the Review). As part of the Review, he noted that there were distinct differences between Edmonton and Calgary on how privileges were granted to radiologists.

In Calgary, for instance, a radiologist could not perform a biliary drainage procedure without a specific privilege granted by the institution. The radiologist would apply for the privilege, the institution would evaluate his or her credentials, and it would then grant or withhold the privilege.

In Edmonton, hospital or health staff in leadership positions made that determination: “privileging historically has always been in the Edmonton area (and many other areas across Canada) for a “General Appointment” and if special training or expertise is needed we relied on specific knowledge of the individual and the integrity of the individual to practice within their expertise in consultation with the site and Zone Medical Leads (such as myself)”. (Exhibit 1, Tab 7, January 30, 2014 letter from Dr. Anderson, AHS Zone Medical Director, Diagnostic Imaging). [ 31 ] Dr.

Kendel was clearly troubled by the Edmonton process. He states in his expert report (Exhibit 6) that: One of the principles for assuring optimal patient safety is that regulatory rigor should escalate in proportion to higher risk of harm associated with specific services. (p.1) To effectively mitigate the risk of harm associated with invasive medical procedures, hospitals must take a rigorous approach to regulating these procedures.

The first, and most critical step in ensuring the safety of invasive medical procedures is regulating which physicians are authorized to perform each specific invasive procedure. [They do so] by requiring each physician to apply for specific practice privileges and then making an informed decision about whether it will or will not grant each of the privileges sought by the applicant (p. 2, parentheses added). [ 32 ] Because so much of the privileging process in Edmonton was verbal and informal, Dr. Kendel testified that he could not offer

an informed opinion about its rigor. [ 33 ] The plaintiffs argue that Dr. Lauf’s situation is illustrative of that lack of rigor, or what we might call transparency, in the granting of hospital privileges. [ 34 ] It is worth noting here that Dr. Kendel offered no opinion on Dr. Lauf’s qualifications either as a radiologist or as a radiologist performing IR procedures. Dr. Kendel knew little about Dr.

Lauf other than what is contained in his curriculum vitae (Exhibit 1, Tab 8) which includes: 1980 MD from University of Alberta 1980-1981 Internship – Edmonton General Hospital 1981-1985 Residency in Diagnostic Radiology, UAH 1985 Certification in Diagnostic Radiology, American Board of Radiology 1985 Fellow in Diagnostic Radiology, Royal College of Physicians and Surgeons of Canada 1987 6 months in-house training in Interventional Radiology, Royal Alexandra 1987-2021 Associate Clinical Professor, University of Alberta [ 35 ] Neither the plaintiffs nor Dr. Kendel argued that Dr.

Lauf did not have the requisite training, skill, and experience to perform the tube exchange. By all accounts, he is eminently qualified. [ 36 ] Instead, Dr. Kendel opined that what appears to have been the process for granting privileges to Dr. Lauf at the relevant time was flawed. [ 37 ] Those flaws may be grouped into three broad categories: i. Defects in the Reapplication Process, ii. Delegation by AHS of privileging/qualifying to MIC, and iii. Failure of AHS to follow bylaws and rules. i. Defects in the Reapplication Process [ 38 ] Appointments for hospital privileges require renewal every three years. Dr.

Lauf’s application in 2009 for reappointment to privileges as a radiologist at a number of Edmonton and area hospitals was Exhibit 1, Tab 1. The application is on what appears to be a standard AHS/CH form. Dr. Kendel noted that much of the introductory information on the first page appeared to be pre-populated: name, age, current privileges. There appear to be errors in certain of the dates of Dr. Lauf’s education and training, or at least some confusion about his undergraduate work and post graduate work, also apparently generated by the form itself. And the box is checked that Dr.

Lauf is a Family Physician, when he is not. Dr. Lauf conceded that he could have reviewed the prepopulated portions of the form more carefully. [ 39 ] If the doctor is applying for a change to privileges, that is to be noted on the form. No changes are noted on Dr. Lauf’s form. The

section headed Current Privileges is completed as follows: Site Program

Section Privileges DGH Diagnostic Imaging Radiology Non-Admitting [ 40 ] DGH is the acronym for Devon General Hospital. Seven other hospitals in the Edmonton area are listed, including UAH and Royal Alexandra Hospital (RAH, which is listed as his primary site), all with the same information in the other columns. [ 41 ] Dr. Kendel takes issue with the use of the term Diagnostic Imaging in the Program column and Radiology in the

Section column, arguing that the terms are synonymous: Diagnostic Imaging is a practice domain and Radiology is just a general description of the same thing. He would like to see the term Interventional Radiology in the second column if a radiologist were looking to perform interventional procedures. [ 42 ] He testified as well that he would expect the information under the Privileges column to show details of the procedures that

Dr. Lauf is privileged to perform, and that simply to state Non-Admitting is not relevant information since radiologists typically do not admit patients. With that latter statement, Dr. Lauf agrees. Radiologists are consulted by other physicians and typically do not need to admit patients. [ 43 ] Dr. Lauf’s testimony is that he completed the form provided to him without requesting any additions or deletions and that there was not then any distinction between Radiology and Interventional Radiology.

There was no recognized sub-specialty called Interventional Radiology. [ 44 ] Based upon the expert report and testimony of Dr. Stephen Ho, which I will review in greater detail later in these reasons, I accept Dr. Lauf’s testimony that there was no category of privileges for Interventional Radiology in 2010. That sub-specialty was not recognized by the Royal College of Physicians and Surgeons Canada (RCPSC) until 2016. [ 45 ] On page 8 of the reapplication form, a reviewer is to complete an evaluation. In Dr. Lauf’s case, the reviewer had circled and initialed all of the options/criteria as being Satisfactory.

The initial is not identified, though it appears to match the signature of Dr. Sterling, referred to below. [ 46 ] The following page is entitled

Section III: Recommendation Form. It is signed by Dr. George Sterling, Chief of Service of Dr. Lauf’s primary site RAH, and by Dr. WJ (Bill) Dickout, Site Medical Director of the RAH, both in January, 2010 for a reappointment commencing November 1, 2009. [ 47 ] Dr. Kendel points out that at the top of the form, there are three boxes, one of which is supposed to be checked: Reappointment recommended without alteration to appointment category and privileges. Reappointment recommended, but with the alterations and reasons noted below. Reappointment not recommended for the reasons noted below. [ 48 ] In Dr.

Lauf’s case, no box is checked. [ 49 ] I can agree with Dr. Kendel that the reappointment form in Dr. Lauf’s case was less than perfect. But I can agree as well with Dr. Kendel’s concession that those defects are not material. To quibble about whether all the boxes on the forms were properly checked would amount to an acceptance of the importance of form over substance. ii. Delegation to MIC [ 50 ] In any event, a March 12, 2010 letter (Exhibit 1, Tab 10) on AHS letterhead signed by Dr. Owen Heisler, as Edmonton Zone Medical Director, confirms to Dr.

Lauf that his reappointment to the Medical Staff of Alberta Health Services – Edmonton Zone was recommended by the Zone Medical Advisory Council on January 11, 2010 and had been approved. His privileges at all of the same Edmonton area hospitals are defined as Diagnostic Imaging Program, Non-Admitting. [ 51 ] The letter is copied to Edmonton Zone MIC Group.

a) Partnership Agreement [ 52 ] Medical Imaging Consultants (MIC), as discussed earlier, is a partnership of radiologists. There were then about eighty radiologists in MIC, only about eight of whom, including Dr. Lauf, performed IR procedures. [ 53 ] Relevant portions of the partnership agreement (Exhibit 1, Tab 12) include: s. 1.3(

a) This Agreement is not to be interpreted as fettering any power granted to CH by statute that CH is required to exercise in the public interest; s. 2.1 The Partnership shall in relation to each Facility provide all diagnostic imaging services:

a) Which are required by the Program in place at the Facility from time to time (what is required at any time to be determined by the applicable Patient care related processes/protocols established from time to time at the Facility or in connection with the Program, as the case may be;

b) Which are required to be provided by a duly qualified medical practitioner specializing in those services; and

c) Which are the responsibility of the Operator of that Facility to provide and fund.

s. 5.1 All Radiologists engaged in providing any of the Services shall be required to obtain and maintain appointments and privileges under the Medical Staff Bylaws which are suitable to the performance of the Services in the circumstances; s. 5.2 The process for appointments and renewals and the awarding of privileges and the termination or suspension of either shall be as stipulated in the applicable Medical Staff Bylaws; s. 7.6(

d) Control of the Partnership is and will remain within the control of radiologists resident in Edmonton or surrounding area; s. 10.1 Apart from the retention of Locum Physicians, the Partnership shall not have any right to sub-contract the provision of all or any of the Services without the prior written consent of the Operator(

s) affected; and s. 13.1 The Partnership (and its members) is (are) an independent contractor insofar as its (their) relationship to the Operators; the Partnership and the Radiologists shall not have any authority of any kind to act on behalf of an Operator …); [ 54 ] My reading of the partnership agreement is that it amounts to a consolidation with a quasi-corporate entity of what would otherwise be eighty individual agreements with radiologists who wished to conduct their practices as independent contractors as opposed to employees.

From AHS’s perspective, as well as avoiding individual negotiation of each contract, it avoids certain obligations it might otherwise have as an employer. Further, the individual hospitals are free to determine what procedures are required, and when, but are able contractually to download the scheduling onto the organization comprised solely of those physicians qualified to perform such services. By requiring that control of the partnership always remain with local radiologists, AHS ensures that it does not at some point end up working with a purely corporate entity one step removed from its physician owners.

b) Involvement of AHS [ 55 ] Exhibit 1, Tab 7 is a letter from Dr. Bill Anderson, Zone Medical Director Diagnostic Imaging AHS Edmonton Zone. In it, Dr. Anderson confirms that AHS inherited from CH the contract with MIC to provide medical imaging services (see also s. 21 of the partnership agreement). He refers to interventional procedures being done at only three institutions, including UAH, and that the only radiologists who perform them are those with a dedicated fellowship in interventional radiology or those who are grandfathered due to the length of time they have done them. He refers to Dr.

Lauf as having done a six month fellowship in interventional radiology in 1987 before fellowships became the norm. [ 56 ] Dr. Anderson himself testified, not as an expert but about his role in the process of privileging for radiologists generally and Dr. Lauf specifically. [ 57 ] Dr. Anderson is a radiologist. At the relevant time, he was the Zone Medical Director Diagnostic Imaging AHS for the Edmonton Zone. In that role, part of his job was to ensure that the zone hospitals had adequately trained support staff and radiologists. By virtue of that position, he sat on the executive of MIC, where he was a partner.

His compensation for services provided to AHS was paid to MIC while he was a partner there. He is still associated with MIC but not as a partner, so he receives compensation directly from AHS for his continuing administrative role there. [ 58 ] He explained that the process of reappointment involved his having a discussion with the lead radiologist at what he called the lead site/hospital. He conceded that that was a pretty casual conversation.

If no issues were raised, that lead radiologist would sign off, as would the chief medical officer for that lead site, and the application form would then be circulated to the other hospitals for sign off without discussion. All forms would be returned to him, and he would then sign off. [ 59 ] In Dr. Lauf’s case, the reappointment form did not find its way back to Dr. Anderson. As was the case with the missing ticks in the right boxes, and for the same reasons, I find that nothing turns on Dr. Lauf’s reappointment form missing Dr. Anderson’s sign off. Dr.

Lauf’s primary site Chief of Service and Site Medical Director, and their equivalents at all other sites, all of whom were physicians, signed off on this reappointment.

c) Conflict of Interest with External Agency [ 60 ] Dr. Kendel takes issue with what he calls a potential conflict of interest in having an external agency, in this case MIC, determine who does what procedures at what institutions. He testified that this was not the practice anywhere else in Canada. He did not, however, point to any evidence suggesting that this practice led to a reduction in patient safety in Alberta or at UAH. [ 61 ] Nor is Dr. Kendel’s opinion respecting the involvement of an external agency shared by experts in the radiology field itself. [ 62 ] Dr.

Stephen Ho was called by the defendants as an expert on credentialing specifically for radiologists. He is a radiologist: Founder, Interventional Radiology, RCPSC 2017, Fellow, Diagnostic Radiology, RCPSC 1996. Currently he is a Clinical Professor and Director of the Interventional Radiology Fellowship Program at UBC. [ 63 ] He confirmed that “prior to 2016, Interventional Radiology as a distinct subspecialty of Diagnostic Radiology did not exist

and all aspects of Interventional Radiology were incorporated within the parent specialty of Diagnostic Radiology.” (Expert Report, Exhibit 17, p 2) [ 64 ] Dr. Stephen Ho further testified that arrangements such as this, where an external partnership of licenced radiologists provides radiological services to a hospital or health region pursuant to a contract, are common in Canada. Most groups in Alberta and British Columbia, including his own, operate in a similar fashion. He mentioned two groups in Calgary that provide radiological services to hospitals pursuant to similar contracts: Mayfair and EFW.

He further testified that it is the norm for these external practice groups to do the scheduling of radiologists for particular areas or rotations. He testified that this arrangement promotes patient safety and efficiency.

d) Ulterior Motive [ 65 ] Dr. Kendel speculates that there may have been some ulterior motive in this practice of not applying for specific interventional radiology privileges: This raises questions as to why Dr. Lauf did not apply for IR privileges. Was he advised by the partners of MCI [sic] that he was not obligated to do so because they were empowered to mange [sic] informally self-manage the scope of practice of their members at all of the hospitals reference [sic] in the MIC service contract?” (Expert Report, Exhibit 6, p. 5) [ 66 ] There was no evidence of this advice.

The evidence is that the UAH, like the other hospitals where Dr. Lauf performed services, did not offer a specific privilege titled Interventional Radiology. And if the physicians in MIC were self-managing their scopes of practice, the uncontradicted evidence of Dr. Lauf is that there were procedures that would not be assigned to him by MIC or that he would not perform because they were outside of the scope of his experience or training. [ 67 ] Further, Dr. Anderson testified that the professional scheduler at MIC, who is not a physician, has to have the

schedule approved by a radiologist at MIC who then sends it for final approval to each site lead for approval. [ 68 ] In short, while Dr. Kendel may not like the fact that at the time MIC appeared to control who performed interventional radiology procedures, the reappointment process shows that senior medical officers of AHS had the last word on approving which physicians from MIC were permitted to perform these procedures in its hospitals. iii. Bylaws and Rules [ 69 ] Dr. Kendel reviewed the 1997 bylaws and rules for Capital Health (Exh 1, Tabs 9 and 10).

He likened the bylaws to statutes and the rules to regulations. During the relevant period, Capital Health was being absorbed by AHS, and for the purposes of this action these bylaws and rules can be considered to be those of AHS. [ 70 ] The Bylaws define Privileges as: “The clinical services that a member of the Medical Staff may provide in Hospital Facilities and the access to Hospital Facilities granted to a member of the Medical Staff in order to provide specified health care services.” [ 71 ]

Article 5.1 of the bylaws sets out a detailed process for an initial application for appointments and privileges. [ 72 ]

Article 5.1.2 states that all applications shall indicate “the category of appointment desired, the Privileges requested (where applicable) and the nature and extent of Hospital Facilities desired to be accessed and shall include (items a through f). [ 73 ]

Article 5.4.4 of the bylaws states that the “Chief Clinical Officer may approve any renewal requested without following the procedures outlined in

section 5.1”.

Section 3.3 of the Rules sets out the criteria for renewals, though the criteria are statements of qualifications and compliance (eg. with continuing medical education). Dr. Kendel pointed out that there was no evidence of compliance with

section 3.3 of the Rules, though I note that that

section does not require the physician to deliver any additional written material with his or her application for renewal. [ 74 ] Dr. Kendel’s argument appears to be that AHS was obligated to require physicians to apply for a specific privilege to perform interventional radiological procedures, which would be clinical services as defined in the Privileges section. Dr.

Kendel testified that a description on the AHS renewal form of “Diagnostic Imaging Program” was nothing more than a domain or position, and not a privilege; if a physician was part of the Diagnostic Imaging Program he or she could come to work in the radiology department and spend time in a darkened room, but, contrary to Dr. Stephen Ho’s opinion, to perform Interventional Radiology, something more was required. [ 75 ] Yet Dr. Kendel, as stated by Dr. Stephen Ho, acknowledged that in 2010, the RCPSC did not recognize Interventional Radiology as a sub-specialty.

It was evident throughout the course of this trial that the practice of medicine is growing increasingly specialized, but it does not follow that hospitals must recognize specialties not recognized by the physicians’ governing body. [ 76 ] Dr.

Kendel opines that AHS staff would have been aware of the credentialing process in other zones, most particularly Calgary, and that the “only two possible implications is [sic] that the DI credentialing processes are profoundly deficient across Alberta or the DI credentialing process in the Capital Health zone in [sic] markedly different from the process in other zones.” (Expert Report, Exhibit 6, p. 4)

[ 77 ] It may be the case that Edmonton and Calgary dealt with privileging differently, but it does not follow that only one of them was doing it “correctly”. While not tendered as an expert in credentialing, Dr. Chia Sing Ho, a radiologist in Ontario whose testimony I will review in greater detail with respect to the standard of care, states in his report that the situation was similar in Toronto. As an interventional radiologist, he applied for and was granted privileges as a radiologist, and the institution determined which radiologists performed interventional procedures. There was not then nor is there now in Toronto a separate category granting interventional radiology privileges.

a) Regulation under Hospitals Act [ 78 ] The plaintiffs argue that Dr. Kendel’s opinion respecting the granularity of privileges, and the fact that privileges should reflect procedures as opposed to titles, is reflected by Alberta Regulation Reg 247/1990 reproduced below, and particularly s. 33(5). Medical staff 33(1) The board shall delineate the privileges which it grants to each member of the medical staff taking into consideration the needs and facilities of the hospital and physicians’ training and ability and may extend or reduce the privileges.

(2) In the delineation of privileges, the circumstances of practice, the capabilities of the hospital from the standpoint of its physical plant, diagnostic services, medical staff, hospital staff and location shall be taken into consideration.

(3) The board may withdraw privileges that it has granted to a member of the medical staff.

(4) A physician shall have no privileges in a hospital until duly appointed to the medical staff.

(5) Except in an emergency a physician who is not a specialist radiologist shall not be granted privileges to carry out fluoroscopy unless approved by the College of Physicians and Surgeons of Alberta to do so. [ 79 ] I point out that there is no definition of “specialist radiologist” in the Hospitals Act or the above regulation. [ 80 ] I point out as well that this regulation dates back to 1990.

No evidence was tendered at the trial as to why this regulation was required for fluoroscopy as opposed to other procedures or how it relates to interventional radiology, which was in its infancy in 1990. [ 81 ] I read nothing into this regulation, which deals only with specialist radiologists, that would require a specific privilege for every procedure conducted by every radiologist. [ 82 ] As a penultimate comment, I point out that Dr. Anderson at the time of preparation of the Review was one of three zone directors for radiology at AHS, the other two being in Calgary and Red Deer. According to Dr.

Anderson, Dr. Kendel did not seek his input for the Review. It is possible that that is one reason Dr. Kendel was unable to comment on the rigor of the process in Edmonton. [ 83 ] Counsel all agreed that this trial was not intended as an inquiry into the privileging process in Alberta, but that notion does call for some commentary. [ 84 ] Dr.

Anderson testified that, while he did not necessarily agree with the conclusions of the Review, in his capacity as Provincial Medical Director Diagnostic Imaging AHS, he is working on what he hopes might be the last draft of a document that will break down the various categories of general and interventional radiology and specify who can perform which of those functions. That process appears to be in response to the Review and Dr. Kendel’s concern that more “granularity” is required in the privileging process.

Admittedly without having heard any expert evidence on this point, it appears that the types of radiological and interventional radiological procedures are limited only by innovations in imaging technologies and the creativity of radiologists to use those technologies to treat an increasing number of conditions. The procedures appear to be growing faster than the ability of a bureaucracy to privilege them. No doubt the field of radiology is not the only medical field that faces this happy problem.

II. Permission vs. Privilege [ 85 ] The Review is a condemnation of the privileging process in place for radiologists at the time: a “profound systemic deficiency in the Diagnostic Imaging credentialing process” (Expert Report, p 4). [ 86 ] Despite his concerns about the process, Dr. Kendel testified that the radiologists performing interventional procedures, including Dr. Lauf, while not having privilege, had permission to do so. [ 87 ] Dr. Lauf testified that he understood hospital privileges to be synonymous with permission to work at that hospital. [ 88 ] In cross-examination, Dr. Kendel agreed that Dr.

Lauf had the only privileges issued for IR procedures. [ 89 ] On an academic level, I defer to Dr. Kendel’s obvious expertise in the regulation and credentialing of physicians. But in my view, it is important to return to first principles. Dr. Kendel in his expert report emphasized the importance to the public of health institutions employing safeguards to ensure optimal patient safety. Those safeguards existed here. AHS had the final say on which radiologists were permitted to perform services in its hospitals. Granted, it did not micro-manage that process. But neither is there any evidence that Dr.

Lauf’s ability to perform this procedure at UAH would have been different had they done so. Based on Dr. Lauf’s education, training, and experience, it is inconceivable that he would not have been given the specific privileges recommended by Dr. Kendel if they had been recognized at the time by AHS. III.

Conclusion on Battery [ 90 ] Returning to Reibl v Hughes : In my opinion, actions of battery in respect of surgical or other medical treatment should be confined to cases where surgery or treatment has been performed or given to which there has been no consent at all or where, emergency situations aside, surgery or treatment has been performed or given beyond that to which there was consent. (at p 890) [ 91 ] I am not prepared to expand that principle to encompass a situation such as this where the plaintiffs claim that the consent itself is vitiated because the institution, although having privileged the physician in accordance with an established regime, did not issue privileges for physicians to the degree that an expert such as Dr.

Kendel, hired by the province to make recommendations for change, would like to see. [ 92 ] For the purposes of whether Dr. Lauf was authorized by or had the permission of AHS in 2010 to perform this particular procedure in this particular institution on this particular patient, I find that Dr. Lauf was authorized by and had permission of AHS to do so. Despite the able arguments of counsel for the plaintiffs, any distinction between privilege and permission is meaningless for the purposes of a claim of battery. [ 93 ] Ms.

Harling’s consent to a procedure performed by a physician who had the only privilege issued by the UAH for that procedure is therefore a full answer to the claim of battery. PART THREE NEGLIGENCE I. Elements [ 94 ] To succeed in this aspect of the claim, the plaintiff must prove that: 1. The defendants owed the plaintiffs a duty of care. 2. The defendants breached the legal standard of care. 3. The plaintiffs suffered an injury. 4. The defendants’ breach of the legal standard of care was the actual and legal cause of the plaintiffs’ injuries.

[ 95 ] The defendants concede the first and third elements. Clearly hospitals and health organizations and physicians owe their patients a duty of care. Clearly, too, Ms. Harling and her husband suffered injuries: she, suffering and death, and he, the loss of her companionship and support. II. Standard of Care [ 96 ] The issue of standard of care is very narrow. There is no dispute that the replacement tube initially was properly placed. But sometime after her discharge, the tube moved and Ms. Harling developed sepsis, which led to complications, which the plaintiffs argue caused her death.

The sepsis, they argue, was the result of either or both of the failure to use antibiotics during the procedure and the failure to diagnose symptoms of sepsis after the procedure and before her release from hospital. The specific questions are: 1. Whether the requisite standard of care required Dr. Lauf to use prophylactic antibiotics during the tube replacement to prevent infection. 2. Whether, as a result of Ms. Harling’s vital signs during her recovery and her complaints of pain while in the recovery room, the requisite standard of care required Dr. Lauf to investigate further before discharging her. III.

Review of the Procedure and Sequelae [ 97 ] It is common ground that the tube exchange itself was uneventful. All evidence suggests that these are not considered by radiologists to be complex procedures and generally take about 30 minutes, which this one did. Dr. Lauf began by injecting contrast dye into the bile duct through the existing tube. It showed obstruction of the tube. He then removed the old tube and replaced it with a new one.

The new tube was properly placed so that bile would drain into the small bowel as shown by the image taken immediately following the procedure marked as Exhibit 13, Fluoroscopy Aug 6, 2010. Dr. Lauf checked the tube for leaks, again using a contrast dye, and none showed. [ 98 ] Ms. Harling was then moved to the recovery room to be monitored for four hours. Her vital signs as recorded by the nursing staff appear unremarkable, though Dr. Chow opines that they indicated a problem. She complained of pain, which Dr. Chow also opines is indicative of sepsis, and the nurses called Dr. Lauf to see her before discharge.

He did so, but he then discharged her. [ 99 ] Mr. Harling brought her back to the emergency department early the following morning when he found her in distress in the bathroom, again complaining of pain. A CT scan showed that the biliary tube had shifted: see Exhibit 13, CT scan Aug 7, 2010. The internal end of the tube where it doubles back (called a Cope Loop) had migrated upward into the liver. Further investigation revealed sepsis in her abdomen. Medical staff performed a number of procedures to attempt to deal with the sepsis including opening up her abdomen twice to drain the infection. IV.

Standard of Care respecting Antibiotic Use 1. Conflicting Expert Opinions [ 100 ] Dr. Lauf had done hundreds of biliary tube replacements since his interventional radiology training in 1987. He uses antibiotics routinely only on initial placement of a tube, reasoning that it is only initial placement that involves piercing of the skin which carries a substantial risk of bacteria to entering the patient’s blood and tissue. During tube replacements, the same orifice is used.

He does not use antibiotics on tube replacements because that is what he was taught, and that is what he teaches his students. [ 101 ] Two medical experts testified respecting the use of prophylactic antibiotics generally. I discuss their evidence here, recognizing that they are not experts in interventional radiological procedures. [ 102 ] Dr. Chow testified as an expert in infectious diseases and infections before, during, and after surgery. He graduated from the University of Manitoba medical school in 1967.

He did his Internal Medicine Residency at the University of Calgary, and received a Fellowship of Infectious Disease in 1972 from Harbor-UCLA Medical Center. He has numerous appointments in his field and currently serves as Professor Emeritus at UBC in Vancouver. His appointments and awards are extensive. He is a prolific author. [ 103 ] Defence counsel recognized Dr. Chow’s expertise in intra-abdominal infections but objected to him opining on the standard of care for radiologists respecting antibiotic use or the recognition and diagnosis by physicians of symptoms of sepsis.

This objection is based on the principle that an expert in one specialty must not comment on the expertise of a different discipline: Malinowski v

Schneider , 2010 ABQB 734 , affd 2012 ABCA 125 . I set out below certain of Dr. Chow’s testimony and opinion on antibiotic use in radiology because it sets out nicely the medical issue, but I give little weight to his opinion respecting the use of antibiotics by radiologists, and I will comment later on his opinion respecting recognition of sepsis symptoms. [ 104 ] Dr. Chow stated that the purpose of prophylactic antibiotics is to prevent germs from the operation site getting into the blood stream and tissues.

The intent is to have the highest concentration of the antibiotics in the blood during the operation while tissue is being disturbed. They are effective only for about an hour. They would have little or no effect on an infection resulting from a bile leak. He agreed with Dr. Lauf that the risk is less on a replacement than on an initial placement, but testified that there is still some risk in a replacement because the guide wire is passing through an obstruction. [ 105 ] Dr.

Wuerz was called by the defendants as an expert witness in the field of adult infectious diseases including the management of septic shock and intra-abdominal infections in patients with liver transplants. He, too, graduated from the University of Manitoba medical school. He finished a residency in Internal Medicine at Dalhousie in 2010 before returning to the University of Manitoba to finish a residency in Adult Infectious Diseases in 2012. He worked, apparently part time, on his MSc in Epidemiology at the University of London, graduating with distinction in 2018.

Since 2015, he has worked with the University of Manitoba and the Winnipeg Regional Heath Authority as an Assistant Professor in the Department of Medicine and a consultant on infectious diseases and Internal Medicine. [ 106 ] His evidence respecting the use of prophylactic antibiotics parallels that of Dr.

Chow insofar as their purpose is to mitigate translocation of bacteria from the site where the skin is pierced, that if required, they should be administered about 30 minutes before the procedure, and that they have no benefit after about three hours. [ 107 ] He testified as well that indiscriminate use of antibiotics is a concern in medicine. Dr. Cattrall (Exh 12, para 59) and Dr. Chia Sing Ho (Exh 14, para 35(e)) share that view. Antibiotics develop resistance to bacteria. That resistance leads to higher risk to treat immunocompromised patients. 2. Venkatesan Report [ 108 ] Both Dr. Chow and Dr.

Wuerz were questioned about the content and conclusions of a study published by Venkatesan et. al. titled “Practice Guideline for Adult Antibiotic Prophylaxis During Vascular Interventional Radiology Procedures, 2010” (the Venkatesan Report). [ 109 ] Dr. Chow interpreted the Venkatesan Report as recommending the use of prophylactic antibiotics in all liver and biliary interventions. [ 110 ] Dr. Wuerz pointed out that this recommendation was based on low quality evidence. He noted that on a scale of 1-8 with 1 being the highest (randomized clinical trials), the

article rates its evidence at a 5, meaning case series: patients compiled in serial fashion, lacking a control group. Given his post-graduate degree in Epidemiology which is defined as: … the method used to find the causes of health outcomes and diseases in populations. In epidemiology, the patient is the community and individuals are viewed collectively.

By definition, epidemiology is the study (scientific, systematic, and data-driven) of the distribution (frequency, pattern) and determinants (causes, risk factors) of health-related states and events (not just diseases) in specified populations (neighborhood, school, city, state, country, global). It is also the application of this study to the control of health problems (Source: Principles of Epidemiology, 3rd Edition), Dr.

Wuerz’s opinion respecting the data and science behind the Venkatesan Report is entitled to considerable weight. [ 111 ] I note that the Venkatesan Report states not that the use of prophylactic antibiotics is required but that “antibiotic prophylaxis has become the perceived standard of care for selected procedures (p 1612), that “most of the recommendations presented in this document are intended to guide clinical practice rather than to mandate the use of specific algorithms” (p 1612) and that other factors to consider “include increasing antibiotic resistance” (p 1613). [ 112 ] At best, the Venkatesan Report, which was released after Dr.

Lauf’s procedure, concludes that there is a perceived standard of care requiring the use of prophylactic antibiotics for biliary tube exchanges. I note, however, that Ancef, the antibiotic used by Dr. Lauf’s colleagues, is not one of the antibiotics recommended in the Venkatesan Report and, in fact, there is no consensus in the Venkatesan Report on which antibiotics ought to be used. [ 113 ] Dr. Lauf clearly understood that infection and sepsis can result from an obstructed bile duct, and that the purpose of a biliary tube is to cross that obstruction so that bile can drain properly into the small bowel.

He testified that he was aware of Ms. Harling’s long medical history, biliary atresia, and failing liver. She was well known to MIC as a result of her initial biliary tube placement and a number of exchanges. [ 114 ] He testified that prophylactic antibiotics are used in some medical procedures to reduce the risk of infection.

The initial placement involves piercing the skin and abdominal wall to get to the liver, and that because bacteria can follow the needle/wire from the skin and travel along that pathway, he always used prophylactic antibiotics during that procedure. [ 115 ] He testified that during a tube replacement, there is minimum disruption of tissue, as there is no such piercing of the skin or

abdominal wall. Therefore, prophylactic antibiotics are unnecessary. Further, in his view, there is no greater risk of infection during atube replacement in a known immunocompromised patient such as Ms. Harling than in any other patient. [116] He acknowledged that in six of the eight tube replacements Ms. Harling had in the seven months before his procedure, hispartners in MIC had used prophylactic antibiotics. We do not have the benefit of the evidence from those physicians as to why they usedantibiotics. V.

Conclusion on the Standard of Care respecting the Use of Antibiotics [117] The evidence shows that there was no consensus among radiologists at the time that the standard of care for biliary tubereplacements required the use of prophylactic antibiotics. • Most, but not all, of Dr. Lauf’s colleagues used them on earlier tube replacements for Ms. Harling, though we do not know why orwhy not. • The Venkatesan Report is only a guideline, not a requirement, its scientific foundations are weak, and it was not published at thetime of the procedure on Ms.

Harling. • No evidence was presented that since the time of the Venkatasen Report, its recommendations have been adopted by the radiologycommunity. • Dr. Lauf’s explanation that antibiotics must be used on initial placement makes common sense because the skin is being brokenand a foreign object inserted into the body for the first time and manipulated through the liver.

On a replacement, manipulation of thetube is done within an existing channel with minimal disruption of tissue. • It is common ground among practitioners and experts that indiscriminate use of antibiotics can create resistance of bacteria tothose antibiotics. [118] The plaintiff has not persuaded me on a balance of probabilities that the use of prophylactic antibiotics for an interventionalradiology biliary tube replacement procedure constitutes a standard of care for radiologists and therefore that not using them falls belowthat standard. [119] Nor am I persuaded by the plaintiffs that the standard of care, or the lack thereof, itself may be found negligent by this trier offact as was argued in ter Neuzen v Korn, (SCC), [1995] 3 SCR 674.

During this trial, I listened to and read theevidence of some very intelligent and experienced physicians in the areas of infectious diseases and radiology. They are unable to agreeon the standard, but all have their reasons, which involve a legitimate assessment of the risk of the non-use of antibiotics in one narrowsituation versus the risk that they may be creating down the road by using them in that narrow situation. This is not a situation where alay observer can determine that the standard was inherently negligent: Nattras v Weber, 2010 ABCA 64 at para 40. VI.

Standard of Care Respecting Discharge [120] Following the procedure, Ms. Harling was moved to the recovery room. Her vital signs continued to be monitored as they hadbeen before and during the procedure. Dr. Chow opines that those vital signs, and the pain Ms. Harling described, should have beensignals to Dr. Lauf that something was wrong and that he should have conducted a more thorough diagnosis of those symptoms beforedischarging her. 1. Vital Signs [121] Exhibit 1, Tab 16 is the August 6, 2010 chart for Ms.

Harling recording her respiration, pulse, and blood pressure at regularintervals from 0800 to 1315. [122] Dr. Chow agreed that her vital signs other than blood pressure were unremarkable. Her blood pressure going in was 81/50, at itshighest at 09:45 it was 100/57 and on leaving was 87/46. Dr. Chow opined in his Expert Report that those numbers suggest that she was“relatively hypotensive”, consistent with his testimony in cross-examination that her blood pressure was generally on the low side.

Dr.Chow, it must be remembered, is an expert on infectious diseases and not in post-procedural vital signs of persons with severe liverdysfunction.

[ 123 ] Dr. Lauf testified that nothing about her vital signs jumped out at him. Dr. Cattrall, whom I will introduce shortly, also testified that it is not unusual for liver patients to have low blood pressure. [ 124 ] I note also that Ms. Harling’s blood pressure readings were consistent with those recorded at previous tube exchanges. [ 125 ] I am not satisfied that the blood pressure recordings for Ms.

Harling during and after the procedure, before her discharge, would have been a cause for concern for a reasonable radiologist who had just performed a biliary tube exchange on a patient with liver dysfunction. 2. Pain [ 126 ] Dr. Chow opines that Ms. Harling’s complaints of pain should have been a signal to Dr. Lauf that something was wrong. [ 127 ] The nursing notes (Exh 1, Tab 17) for the August 6, 2010 procedure include the following references to pain: 09:55 Procedure finished. Well tolerated by patient… biliary drain placed by Dr. Lauf, secured with drain fix gauze and mefix.

No immediate complications noted at this time. 10:20 Patient reports pain at site 6/10. Morphine given as per doctor’s orders. No nausea or dizziness – resting in bed. 10:45 Patient states morphine is helping, currently resting in bed with eyes closed. 11:15 Denied any symptoms. Putting on lipstick to elevate mood. 12:40 Complained of pain epigastric and near the bladder. Went to washroom ambulatory, apple juice offered, appeared tolerated well. Vitals stable. 13:35 Patient continues to experience abdominal pain and nausea. Dr. Lauf notified.

Gravol and morphine given intravenously as ordered. 14:20 Patient continues to cry and complain of pain in lower abdomen and epigastric. 14:25 Patient’s husband asking questions ++. Dr. Lauf called to speak to patient. Dr. Lauf in discussion with patient. 14:30 Patient discharged. [ 128 ] Mr.

Harling testified that when he arrived to pick up his wife after the procedure: • it was evident that she was in pain, • he had not seen that look on her face before, • she said this was the worst she had felt, • her discharge seemed extremely casual, just pushing her out the door, and • she was told to come back to the hospital if her condition changed. [ 129 ] He then took her from the hospital, and they arrived home at about 4:00 p.m. She lay down in bed and only got up to use the facilities.

He took a sleeping pill but woke up at about 4:00 am to her call for help from the master bathroom where she was trying to vomit and said something was not right. [ 130 ] When taken through some of the Ms. Harling’s medical history, Mr. Harling acknowledged that a report on Sept 28, 2009 showed upper abdominal pain at a constant 10/10, and a note of a September 28, 2009 to October 16, 2009 hospital stay referred to severe upper right abdominal pain before her first biliary drain procedure.

Those observations are not consistent with a conclusion that her pain after this procedure was the worst she had ever experienced. [ 131 ] Nor are the nursing notes from earlier procedures: June 25, 2010, the nursing notes (Exh 1, Tab 48) for the same procedure include:

12:04 Dull pain at tube insertion site 5/10 12:45 Morphine and gravol given for abdominal pain at 6/10. 13:30 Continues to have pain radiating to back 1500 Patient discharged with husband. June 18, 2010 nursing notes (Exh 1, Tab 43) for the same procedure include: 11:30 Crying and in pain 8-9/10. Orders initiated. [5] 11:50 Pain now 3-4/10 11:45 Vomited. 1300 Patient complains of pain 5/10. Denies any nausea. VII. Conclusion on Standard of Care respecting Discharge [ 132 ] Dr.

Chow’s expertise in infectious diseases does not, in my view, extend to diagnosing sepsis from descriptions of abdominal pain in a patient who suffers from liver failure and has undergone a biliary tube replacement. [ 133 ] And from the nursing notes for a number of previous procedures and other hospital visits, it does not appear that the pain of which Ms. Harling complained was out of the ordinary. She was in the advanced stages of liver failure, and abdominal pain would be inevitable: Dr. Cattrall, Expert Report, Exhibit 12, para 56. [ 134 ] What is clear from the evidence is that Ms.

Harling complained of pain after the procedure, and while that was not unique to this procedure, the witnesses found common ground in determining that that can be one symptom of sepsis. Other symptoms described by Dr.

Wuerz are: • low blood pressure, which was not evident on her discharge but was after assessment in emergency the following day; • high respiration rate (though a minor sign), which was not evident on her discharge but was noted after assessment in emergency the following day; • elevated pulse, which was not evident on her discharge but was noted on her arrival in emergency. • higher or lower temperature than usual, which was not evident on her discharge nor in emergency when she first arrived. [ 135 ] The bulk of the symptoms that may cause further investigation into whether the pain was the result of sepsis did not present until Ms.

Harling attended at the emergency department the following morning. [ 136 ] I am unable to conclude that her complaints of pain after this last procedure would have been a signal to a reasonable radiologist that a procedure which appeared to be without incident was giving rise to an infection which would lead to sepsis, such that investigation beyond which Dr. Lauf performed was required. VIII. Conclusion on Negligence [ 137 ] I am not satisfied that the plaintiffs have proven on a balance of probabilities that Dr. Lauf was negligent either in failing to use antibiotics during the procedure or in discharging Ms.

Harling when he did. PART FOUR: CAUSATION I. Test:

[138] If I were able to conclude that the standard of care for interventional radiologists required the use of prophylactic antibiotics forthis procedure and/or that Ms. Harling’s symptoms of pain or vital signs required further investigation such that Dr. Lauf’s actions orinactions therefore fell below one or both of those standards, I would then have to determine whether that was the cause of her death. [139] Causation does not have to be determined by scientific precision. It is, as stated by Lord Salmon in Alphacell Ltd. v.

Woodward, [1972] 2 All E.R. 475, at p. 490: ... essentially a practical question of fact which can best be answered by ordinary common sense rather than abstract metaphysicaltheory. (Snell) [140] In Ediger (Guardian ad litem of) v Johnston, 2013 SCC 18 at para 28, the Supreme Court of Canada confirms that the “butfor” test remains the test for causation: has the plaintiff proven on a balance of probabilities that the injury would not have occurred butfor the defendant’s negligence? [141] The defendants argue that the plaintiffs interpret Snell v Farrell, (SCC), [1990] 2 SCR 311 as shifting theburden of proof on causation from the plaintiff to the defendant.

But the plaintiffs acknowledge that the onus of proof does not shift,only that in certain cases where a plaintiff adduces evidence, an inference may be drawn where a defendant does not adducecontradictory evidence: It is not strictly accurate to speak of the burden shifting to the defendant when what is meant is that evidence adduced by the plaintiffmay result in an inference being drawn adverse to the defendant. Whether an inference is or is not drawn is a matter of weighingevidence. The defendant runs the risk of an adverse inference in the absence of evidence to the contrary.

This is sometimes referred toas imposing on the defendant a provisional or tactical burden. See Cross, op. cit., at p. 129. In my opinion, this is not a true burden ofproof, and use of an additional label to describe what is an ordinary step in the fact-finding process is unwarranted: Guaranty Trust Co.of Canada v Mall Medical Group (SCC), [1969] SCR 541 at 545. [142] The defendants here have adduced contradictory evidence, so I cannot draw an adverse inference. II. Did the Failure to Use Antibiotics Cause Death? [143] In his expert report Dr.

Chow states: Although one could not be 100% certain, preemptive administration of broad-spectrum antibiotics prior to and during her biliary tubeexchange procedure might have mitigated the extent of injury and perhaps averted the onset of septic shock and subsequentcomplications of intraabdominal sepsis and eventual death. (Exhibit 7, p 6) [144] The use of terms such as “might have mitigated” and “perhaps averted” do not come close to the standard necessary to provecausation. [145] Further, on cross-examination, Dr.

Chow testified that Ancef, the antibiotic used by some of the other radiologists for Ms.Harling’s previous procedures, would not likely have been effective against the polymicrobial organisms which resulted in sepsis. [146] In his expert report, Dr.

Wuertz opines: A single dose of prophylactic antibiotic, whether 1 gram of Cefazolin or otherwise, given at the time of the PTC tube exchangeprocedure would not have been sufficient to prevent sepsis from the continuing bile leak and would have had no effect on the abscess,which would require effective surgical correction of the drainage and prolonged antimicrobial therapy. (Exh 15, para 20) [147] A third expert, Dr. Cattrall, surgeon and Director, Living-donor Liver Transplant Program, University Health Network in

Toronto, testified as well. He is not a radiologist. He was called as an expert in liver transplantation and retransplantation and the use of antibiotics. While admittedly not an infectious disease specialist, he testified that he is a specialist on infection within the liver, that transplantation and infectious diseases go together, and that in the early days of transplantation, “we did it all”. He assisted Dr. Kneteman in the first fifteen or so liver transplants in Edmonton in about 1990 and has done 1000 to 1500 liver transplants since.

One of his current appointments is as Senior Scientist, Toronto General Research Institute with a focus on immunology. Given his credentials, Ms. Harling’s early liver transplant, the fact that she was being looked after by a team of liver transplant specialists in Edmonton, and the fact that that her treatment required biliary duct interventions, I give considerable weight to Dr.

Cattrall’s thoughts on the use of antibiotics during tube exchanges. [ 148 ] His conclusions are summarized in his expert report (Exhibit 12): Para 59 Despite the guidelines regarding the use of prophylactic antibiotics for percutaneous biliary drainage tube exchanges (which were not released in 2010 until after the tube exchange performed by Dr. Lauf), the value of antibiotics in this setting is controversial and many physicians who perform biliary tube exchanges do not use prophylactic antibiotics.

The biliary system is usually colonized with multiple bacterial species, many of which are resistant to commonly used antibiotics. As a result, attempting to choose an antibiotic that will cover everything is virtually impossible. In Ms. Harling’s case, the infection was, as expected, polymicrobial (E.coli, Klebsiella, Clostridium, and Enterococcus). Ancef [6] as a prophylactic antibiotic would not cover all these organisms. Para 60 In my opinion, the infection suffered by Ms.

Harling was not caused by or the result of the transfer of bacteria from the tube….The infection and septic shock caused by the bile leak would not have been prevented by the administration of a prophylactic antibiotic prior to the tube exchange. [ 149 ] Dr. Cattrall acknowledges that while there is a possibility that an infection may be caused by bacteria transfer during the tube exchange, it is a “ virtual certainty that a serious infection will result from an uncontrolled bile and enteric leak in the abdomen as Ms. Harling suffered in this case” (para 60, emphasis added). III.

Did Early Discharge Cause Death? [ 150 ] In its simplest terms, the plaintiff sums up its case for causation by stating that Ms. Harling must have sustained a puncture of some sort as a result of the tube replacement procedure and that that puncture, which was a known risk, led to infection which led to sepsis which could have been prevented by and should have been diagnosed earlier by Dr. Lauf and which caused her death.

This summation amounts to an invitation to draw an adverse inference, which I am not prepared to do by virtue of there being contradictory evidence. [ 151 ] The plaintiffs, in arguing that the only explanation for her death must be that it was the result of the IR procedure, rely on certain observations recorded by Dr. Bigam, an emergency room surgeon and Dr. Kneteman, the head of the liver transplant program who assumed responsibility for Ms. Harling’s care after her emergency surgery, in their operative notes and transplant team meeting minutes following Ms. Harling’s readmission to the hospital on August 7.

Those conclusions or observations include: Bigam: (Operative Notes: Exh 1, Tab 21) August 8, 2010: Over the last few years she has developed jaundice with biliary stricture and has been having PRC stents placed over and over again. She most recently had this performed on 6 August and apparently she had quite significant pain at the time of the PTC tube change unlike any she has ever experienced before, but then she was sent home. [ 152 ] That statement relies on what he may have been told about her pain, but as discussed earlier, I am not satisfied that that was objectively accurate. In any event, Dr.

Bigam goes on in those notes: Unfortunately, this story is much more complicated than that as she also apparently has hepatitis C as well as portal vein thrombosis with cavernous transformation…We knew that the laparotomy would be extremely difficult and so we initially tried nonoperative management in terms of antibiotics, inotropic support, and fluid resuscitation.

She actually improved somewhat throughout the day on Saturday 07 August…the bile that was coming out of her PTC tube initially was quite cloudy apparently and now was crystal clear. [ 153 ] Thus, it appeared that the septic shock diagnosed shortly after her admission to the emergency department was responding to treatment. But her condition deteriorated, and Dr. Bigam was forced to operate. He found that: “Unfortunately, the right upper quadrant

was an absolute disaster” and that the “gallbladder has completely ruptured as we can see down at the hole of this cavity where bile emanating from what appears to be the cystic duct at its junction with the common duct.” Kneteman: Aug 12/10 (Exhibit 2, page 330, Transplant Team meeting minutes) She ran into issues with abdominal sepsis and peritonitis on the weekend after a biliary drain exchange on Friday. She went to the OR and they discovered she had a biliary perforation. Surgeons are concerned because they know it will be a very difficult surgery. She has a portal vein thrombosis and HCV.

She is on hold (on the transplant list) and they feel they need a full forum as to the proper discussion as to a plan for this patient. (parentheses added.) Aug 19/10 (Exhibit 2, page 338, Transplant Team meeting minutes) She had a PTC through her small bowel and went into septic shock…it was thought that this would be the last hit to her liver.

Listed at 2. (Note: Refers to her having had a liver transplant 19 years ago – actually about 26 years ago – and this is reflected on the balance of the entries). [ 154 ] Stating that she ran into issues after a biliary drain exchange is not the same as stating that that exchange was the cause of her distress. [ 155 ] Nor is the statement that she had a PTC through her small bowel backed by any evidence that that was what caused the bile leak. Far more likely is the observation by Dr.

Kneteman earlier in the process: “The percutaneous transhepatic drainage tube has been pulled back and one of its side ports was at the level of the skin explaining the continuous bile leaking and this will have to clearly be replaced in Radiology” (Kneteman operative notes, Aug 8, 2010, Exh 1, Tab 22). [ 156 ] When asked in cross-examination if Ms. Harling passed away from sepsis following her last tube exchange, Dr. Kneteman responded that that was one factor but that she had recovered from sepsis before.

He testified that the major factor in her death was her Hepatitis C, for which non-transplantation treatments were not then available, with gastro-intestinal bleeds being a further factor. In fact, she had largely recovered from sepsis by the time Dr. Kneteman attempted a liver transplant – there was bile in her abdomen but sepsis was not diagnosed.

The reason for the abandonment of the transplant was due to a condition called a cocooned abdomen: the scarring from her first surgery as an infant and her first transplant and, to a lesser extent the abdominal surgeries she underwent at the UAH following her admission to emergency, had so bound her internal organs together that it was not possible to isolate and remove her liver. IV. Conclusion on Causation [ 157 ] Perhaps Dr. Bigam summed it up best in his testimony. He was told to assume that the biliary tube replaced on August 6 had shifted and caused a bile leak before her discharge from hospital that day.

He was then asked whether, if she had been kept in the hospital longer, the course of events would have been any different. He answered in the negative: her fate was sealed in that moment, and antibiotics administered during the process would not have made a difference. [ 158 ] The shifting of the tube was not due to Dr. Lauf’s negligent placement of the new tube: the fluoroscopic images before and after prove that. Even if he or someone else had diagnosed or predicted a shift in the tube or a puncture caused by its replacement and admitted Ms.

Harling to the hospital immediately, as opposed to the following day, the ultimate result would have been the same due to the complexity of Ms. Harling’s underlying conditions. I cannot conclude that anything that Dr. Lauf or the hospital did or did not do caused Ms. Harling’s death. PART FIVE: CONCLUSION [ 159 ] The plaintiffs’ case is dismissed with costs, which may be spoken to if counsel cannot agree. [ 160 ] Mr. Harling, having lost your young wife after too short a time together, you know better than most the fragility of human life and the limits to medical science.

While I have found that the defendants bear no responsibility for your wife’s death, they extended their condolences to you at the beginning of this trial, and I join them now by extending my condolences to you. [ 161 ] Thank you to all counsel for the courtesy and respect they exhibited to each other and the witnesses and who can count themselves among the first to have conducted a trial entirely remotely in our Court. [ 162 ] And I thank our Court Clerk, Ms. Morag O’Sullivan, for her capable handling of the technological challenges presented by this

kind of trial. Heard between February 1-22, 2021. Dated at the City of Edmonton, Alberta this 25 th day of March, 2021. J.S. Little J.C.Q.B.A. Appearances: Patrick D. Kirwin Kirwin LLP for the Plaintiff Kevin Harling Daivd M. Hawreluk Alison Archer Bennett Jones LLP for the Defendant George Lauf Dino McLaughlin Jennifer Janz Field LLP Defendant Alberta Health Services