Paul v. Miller, 2022 NSSC 255

SUPREME COURT OF Nova Scotia Citation: Paul v. Miller , 2022 NSSC 255 Date: 20220818 Docket: Halifax , No. 498480 Registry: Halifax Between: Andrea Paul Plaintiff v. Robert Miller and Sharon Clarke Defendants DECISION Judge : The Honourable Associate Chief Justice Patrick J. Duncan Heard : June 20, 2022, in Halifax, Nova Scotia Decision : August 18, 2022 Written Decision : September 7, 2022 Counsel : Brian J. Hebert, for the Plaintiff W.

Harry Thurlow and Sian Laing, for the Defendants By the Court: Introduction [ 1 ] Andrea Paul is the proposed representative plaintiff in this action which is subject to a pending certification hearing pursuant to the Class Proceedings Act 2007, c. 28 . In support of the application for certification the plaintiff has given Notice, pursuant to Rule 55, of the intention to admit into evidence the report of Dr. Heather Castleden, sworn in affidavit form on March 30, 2022, and filed May 27, 2022. [ 2 ] The defendants brought a motion to strike the report in its entirety, to disqualify Dr.

Castleden as an expert in this proceeding, and so exclude her from providing expert opinion evidence. The defendants also claim costs on the motion. [ 3 ] In a letter of August 18, 2022, I provided counsel with my disposition of the motion: I have concluded that the motion of the defendants to strike Dr. Heather Castleden's report in its entirety, to disqualify Dr. Castleden as an expert in this proceeding, and to so exclude her from providing expert opinion evidence will be granted in part. Dr. Castleden is a likely fact witness on behalf of the plaintiff.

There are substantial portions of her affidavit which are potentially admissible as facts relevant to the issues in the proceedings. These paragraphs are subject to the usual rules of admissibility. Argument on this motion did not expressly address those portions of the affidavit. If the parties cannot agree on what portions of the affidavit should be considered admissible as non-opinion-based evidence, then I will hear further argument and decide admissibility on a paragraph-by- paragraph basis.

The plaintiff seeks to rely upon the opinion evidence found in paragraphs 43-50 of Dr. Castleden's affidavit. I have concluded that Dr. Castleden will not be permitted to give expert opinion evidence as proposed by the plaintiff and that those paragraphs of the affidavit will be struck. The succeeding paragraphs 51-56 contain information relevant to the determination of her opinions. Paragraph 54, for example, speaks to the certainty Dr. Castleden holds of her opinions.

As with the "fact" paragraphs, I will hear submissions as to whether these paragraphs should be struck in whole or in part. [ 4 ] The following are my reasons for this disposition. Background [ 5 ] The plaintiff is the Chief of the Pictou Landing First Nation (PLFN). She is Mi'kmaq.

The Amended Notice of Action and Claim filed June 25, 2021, states that in 2017 she underwent diagnostic magnetic resonance imaging (MRI), at the QE II Health Sciences Centre in Halifax, Nova Scotia, as part of a medical research project being conducted by the Canadian Alliance for Healthy Hearts and Minds (CAHHM / Alliance study). [ 6 ] She alleges that, unknown to her and without her consent, a second series of MRI scans were taken at the same time. Those scans were intended for use in a study being conducted by the defendants, Drs. Miller and Clarke.

Their study involved MRI elastography of the liver of Indigenous subjects (liver study). The fact of the second scans being taken and the data obtained from them was not shared with CAHHM researchers. [ 7 ] In June 2018 the plaintiff learned of the liver study. By that time the defendants had presented the results of their study to a group of radiologists at a conference in Halifax.

They had also written an unpublished research paper entitled "MRI Findings of Liver Disease in an Atlantic Canada First Nations Population". [ 8 ] It is alleged that approximately 60 other members of the Pictou Landing First Nation who participated in the CAHHM study were also subjected to the liver scans. As such the plaintiff brings the action on behalf of herself and the class of persons who were similarly subjects of the liver study. The claim for damages is framed as arising from: 1. Invasion of Privacy - Intrusion upon Seclusion 2. Unlawful Imprisonment 3. Assault and Battery 4. Negligence 5.

Breach of Fiduciary duty and Breach of Trust 6. Breach of Contract [ 9 ] The motion to certify as a class proceeding is scheduled to be heard October 4, 2022.

The Motion to Strike [ 10 ] The plaintiff seeks to qualify Heather Castleden as an expert in the field of health research involving Indigenous participants and capable of giving opinion evidence on research ethics and the ethical approval requirements for research involving Indigenous participants in Nova Scotia including on the standard of care for obtaining the informed consent of Indigenous participants, and whether the standard has been met. [ 11 ] In support of the plaintiff's position, I have been provided with the: • Affidavit of Andrea Paul sworn March 30, 2022, and filed April 5, 2022; • Affidavit of Jennifer Cameron sworn March 30, 2022, and filed April 5, 2022; and • Affidavit of Heather Castleden, sworn March 30, 2022, and filed April 5, 2022. (Note: The Notice under Rules 55.02 and 55.09 advising that the affidavit was intended to be used as an expert's report was filed May 27, 2022). [ 12 ] Before the court, on behalf of the defendants, are the: • Affidavit of Sian G.

Laing filed June 6, 2022, with three exhibits attached; and • Supplementary affidavit of Sian G. Laing filed June 16, 2022, with transcripts of the Discovery evidence of the Plaintiff, Andrea Paul, and of Jennifer Cameron. Position of the Defendants [ 13 ] The defendants' motion is brought pursuant to Rules 39.04 and 55.10, seeking to have Dr. Castleden disqualified as an expert on the basis that she is unable to provide "fair, non-partisan, and objective assistance to the Court".

Further they submit that she is not qualified to give expert opinion evidence as to "the standard of care for medical doctors conducting themselves in a hospital setting." [ 14 ] The defendants' argument asserts that Heather Castleden, who holds a Ph.D., has a "close, longstanding professional and arguably personal relationship with the plaintiff and prospective Class members." They suggest that a review of the facts demonstrate that Dr.

Castleden has a clear self interest in the outcome of the proceeding which manifested itself at a very early stage of this matter by having taken an advocacy position in support of the plaintiff and proposed class members. In that early period of time, she is alleged to

have expressed strongly held views of the ethical wrongdoing by the defendants. In addition, she is said to have exposure to liability for her role in the research study and that, though not a plaintiff now, she sought compensation from the defendants for damages that she alleged their actions caused her to suffer. In sum, they suggest that she has a demonstrable bias rendering her incapable of providing an impartial opinion in the circumstances of this case. Position of the Plaintiff [ 15 ] The plaintiff says that the defendant overstates the nature of the relationship that existed between Dr.

Castleden and the plaintiff and proposed class members. Counsel acknowledges that there was a professional relationship in existence over several years but says that there has been "no continuing contact" among them since 2018. He submits that she is a "...trained academic and researcher.

The facts surrounding her relationship with PLFN does not amount to clear evidence that she is unable to give objective evidence in this matter." [ 16 ] As to her previously stated opinions, counsel argues that there is no evidence "that these opinions were motivated by bias, self interest or other ulterior motives at that time." [ 17 ] The plaintiff says that the evidence is necessary and reliable. No expert evidence has been brought forward on this motion to suggest that she is wrong in her opinions and that the benefits of admitting the evidence outweigh any cost of admission.

It is submitted that the use of the opinion in a certification hearing is different than in a trial - it is a procedural motion with a low evidentiary burden on the plaintiff. It has been suggested that its admission will not unduly extend the time of the hearing and will not usurp the role of the motions judge. The Evidence Plaintiff's Affidavit [ 18 ] Andrea Paul's affidavit describes the relationship that has existed as between her, the members of the Pictou Landing First Nation, and Dr. Castleden. [ 19 ] At some time prior to 2013 (discovery evidence placed it in 2011), Dr.

Castleden was engaged by the PLFN Women's Group to conduct a study of the possible adverse effects of the nearby pulp wastewater facility on the health of the community (Boat Harbour study). [ 20 ] In 2013, Dr. Castleden approached Chief Paul seeking to gain the participation of PLFN members in the Alliance Study. Chief Paul states that she was "open" to this "Because of the relationship of trust that I and other members of the [PLFN], had developed with Dr. Castleden, and her adherence to OCAP principles.", and because of assurances made that it would be subject to appropriate research ethics approvals.

Participation in the Alliance study was agreed to by PFLN October 14, 2014. [ 21 ] Chief Paul outlined the significance of ensuring "ownership, control, access and possession of research data by Indigenous communities" (OCAP principles) which are described in an Exhibit to her affidavit. She set out the chronology of events that give rise to her claim, alleging that the defendants' conduct in taking extra scans for a liver study and presenting a research paper on the results, was done without consent. Relevant to this motion are the following points relating to Dr.

Castleden's participation in the circumstances leading up to and after the liver study scans were taken: • The Alliance study goals, testing procedures and questionnaires were explained to Andrea Paul by Dr. Castleden. • Dr. Castleden informed her of the ethics reviews leading to the approval of the study. • Jennifer Cameron was hired by Dr. Castleden. Her responsibilities were to sign up participants, complete questionnaires with them, and collect the health data of the participants.

It was Jennifer Cameron who reviewed the Consent form with the plaintiff before she signed it in January 2018. • That in March 2018, she attended at the QE ll Health Sciences Centre for blood tests and MRI scans related to the Alliance Study. • That on June 21, 2018, the plaintiff received a phone call from Dr. Castleden who informed her of additional MRI scans having been taken of the PLFN participants. In that call Dr. Castleden is alleged to have said "… the doctors who had done the scans had gone rogue ." • Dr.

Castleden followed this up with an email of the same date, and which was part of a chain of emails attached as Exhibit D to the Affidavit. In it, Dr. Castleden described the defendants' conduct as "…an ethics violation regarding Pictou Landing's MRI data. As you know I am deeply troubled by what has transpired." She closed the email saying: "Please let me know how I can support whatever next steps are taken." [ 22 ] In that chain of emails there is one sent on June 21, 2018, from Dr. Castleden to the defendant Dr. Miller. In it, Dr.

Castleden makes the following comments about the conduct which is the subject of the cause of action in this case: • That her [Dr.

Castleden's] "…relationship of mutual trust and mutual respect with [PFLN]...is now in jeopardy"; • That her "…international reputation for ethical research and advocacy… is now also at risk", and that she was "fairly upset". [ 23 ] She continues: Now I must express my extreme shock, anger, and dismay about the serious breaches in ethical practices that have taken place… even without being well versed in our ethical protocols for Alliance, to be blunt I have no idea how this could have happened when we live in a Truth and Reconciliation era of "nothing about us, without us", in Canada with respect to all Indigenous-settler relationships, but

particularly in research. Plaintiff's evidence on Discovery [ 24 ] The plaintiff was examined for discovery on May 26, 2022. She testified to the relationship that existed between Dr. Castleden and her research students with the PLFN community during the approximately five-year period of the Boat Harbour study. The plaintiff described it this way: • "She [Dr.

Castleden] had a trusted relationship built with the women in the community". • When asked whether it was a "friendship", she characterized it as: …us being able to come together to work with someone who was outside of our community in a trusting way. … there was a friendship. But that was years of Heather, really putting in the effort to understand our Indigenous ways of knowing and to respect our Indigenous ways of knowing. [ 25 ] At the outset of the discussions, Dr. Castleden emailed information about the Alliance Study to the plaintiff who directed her to speak to the PLFN Health Director.

The plaintiff confirmed that Dr. Castleden "assured" her that the Alliance study would be submitted for Ethics Boards' reviews. [ 26 ] The plaintiff testified as to her understanding of the role that Dr. Castleden had in the Alliance study: • that Dr. Castleden was the "principal investigator". • that " we felt that she had a duty to protect us too ". • Q. Did she tell you that part of her responsibility under her agreement was to ensure that what was happening at the MRI site was consistent with the protocol documents and consent forms? • A. Yes. • That she understands that Dr.

Castleden did not carry out site visits to ensure this was done. • Q. Is there some reason that you had not added Dr. Castleden as a defendant to the proceeding? • A. I didn't add her because I felt like she was valuable to share her experience of what happened. So, I don't know. I just saw her as an ally . (Emphasis added) [ 27 ] There was a meeting on July 16, 2018, at PLFN that included the plaintiff, Dr. Castleden, the defendants and others to discuss what happened and the reasons for that. The plaintiff was asked a series of questions about the meeting. In describing Dr.

Castleden's role and demeanour during that meeting the plaintiff testified: • She agreed that Dr. Castleden's questioning of the defendants was along the lines of "investigating what had happened". • The plaintiff believes that Dr. Castleden was "upset" with the defendants at the meeting. • When asked whether Dr. Castleden's demeanour suggested that she was angry with the defendants, Chief Paul responded " Yeah, because her reputation was at stake, too ." • She believes that Dr.

Castleden expressed a concern that this incident could negatively impact her ability to do further studies with the Indigenous communities. (Emphasis added) Jennifer Cameron Affidavit Evidence [ 28 ] Jennifer Cameron is a member of Pictou Landing First Nation. She was hired in 2016 as a "community health research coordinator" with the Alliance study. She worked under the supervision of Dr. Castleden, who was the lead local investigator on the Alliance Study in charge of participants from PLFN. [ 29 ] Her role was to recruit volunteers from PLFN to participate in the study.

She then met each interested member in person to explain the study. If they agreed to participate, then she reviewed with them a Consent form that was provided by Dr. Castleden's office. She read the form out loud to them after which she asked the person to sign the Consent form. [ 30 ] Her affidavit outlines various other functions she performed. One of those was to arrange travel and accommodations for participants to attend at the QE II Hospital in Halifax for blood tests and MRI scans.

She also took them to the hospital for the tests. [ 31 ] Before the tests and scans took place, she " …helped them complete the MRI screening forms provided by the QEII and I helped them get set up in the MRI scanner." [ 32 ] In June 2018, she learned of the liver study and the additional MRI scans. She says she was, until that time, unaware that

additional scans were done and so they were not discussed with the participants when she had reviewed the Consent forms. Evidence on Discovery [ 33 ] Ms. Cameron testified that, in 2016, Dr. Castleden interviewed her online for the position and they met in person that summer at the PLFN. [ 34 ] She was taken through her affidavit and expanded on her evidence. This included a description of what occurred during the reading of the Consent form. Her evidence is unequivocal that when reviewing the form provided by Dr. Castleden there was a fulsome opportunity for participants to ask questions and they did.

She noted that the tests were to identify issues related to heart disease and strokes. [ 35 ] She underwent an MRI scan, solely to know what it was like, which enabled her to provide better assurances to nervous participants. During testing of the participants, she noted that a "paddle" was placed on the rib area of participants, which she later learned was associated with the liver scans. It caught her attention because that was not done when she had her scan. She asked the technician about it and was told that they forgot to do it with her.

As far as she knew the scans were of the brain, carotid and heart - not the liver. [ 36 ] She acknowledged that Dr. Castleden's Queens University student attended at one point and conducted the review of the Consent forms with approximately 5 participants, including Ms. Cameron. [ 37 ] Counsel then drew Ms. Cameron's attention to a copy of the "Participant Information and Consent Form". It identifies Dr. Castleden as the "Locally Responsible Investigator" and includes her position at Queens University. Ms.

Cameron was read the following, taken from page 4 of the Consent form: 3) Magnetic Resonance Imaging (MRI) Scan: You will be asked to undergo an MRI scan to measure your abdominal fat, the fat content of your liver, and to assess the functioning of your heart, brain, and carotid. … (Emphasis added) [ 38 ] She was asked a series of questions as to what she said to the participants in relation to " the fat content of your liver" language. Ms. Cameron said: A. I didn't have to do that…. A. I don't recall that piece. I do know it talks about abdomen though… A. … that we went over the word, abdomen…. A.

I don't remember it saying the fatty contents of the liver, but it was about abdomen. No, I don't recall that…. Q. At that time, if it says that there on the form, you would have been aware of it and known it at the time? A. Yes. I would, I would have said, yeah I would have… [ 39 ] Following further questioning, she testified "So, it's more, I really don't remember." [ 40 ] Ms. Cameron was asked if she knew how Dr. Castleden felt about the liver scans.

She replied: … in essence that it was, I guess, um, appalling that this study would go through with, no knowledge…It was mind blowing to her. [ 41 ] She spoke to Dr. Castleden about how she felt - that she [Ms. Cameron] had gained the trust of the participants and had done something wrong because she had not done a good job. She felt she would never be trusted again for "dropping the ball". Dr. Castleden apologized to Ms. Cameron and told her that it would never have happened if the defendants had asked for consent to conduct the liver scans for their own study. Ms. Cameron accepted the apology.

Other evidence in the Motion [ 42 ] Admitted without objection were certain documents submitted as exhibits to the June 6, 2022, affidavit of Sian G. Laing, assisting legal counsel to the defendants. [ 43 ] An investigation and review under the IWK Responsible Conduct of Research Policy in respect of the defendant's actions was conducted commencing in September 2018 and concluding in February 2019. In the lead up to this process Dr. Castleden received an email dated August 24, 2018, from a Dr.

Adam Huber seeking information: I was wondering if there was any additional information about what else Chief Paul, the LCAB [Local Community Advisory Board] or the band council would like? As we have discussed, the Ethics Board and our leadership are available and willing to provide whatever the community feels will be of assistance in moving through this process, whether it is in the form of a written apology, town hall, meetings or what have you. [ 44 ] Dr. Castleden responded in an email dated August 27, 2018, that reads in part:

Specifically, the Chief and LCAB would like to have a detailed written update about the actions that are being taken at the various institutional levels, under the IWK's leadership, to address the academic misconduct and ethical breach by Drs. Miller and Clarke. Particularly, what repercussions - if any- have been activated or are on the table. In other instances where professionals are under investigation for misconduct, they are suspended, suspended without pay, put on leave, and so on, and it seems to our group that this would be a similar response from the institutions involved with Drs.

Miller and Clarke , certainly in the context of doing any research or publishing it/sharing it. (Emphasis added) [ 45 ] This was followed by a letter dated October 23, 2018, from Dr. Castleden to the Interim Vice-President Research, Innovation and Knowledge for the IWK. The letter is signed by Alliance Study Principal investigators as well as representatives of the various Health Institutes and McGill University. Dr. Castleden signed, identifying herself as "Site Principal Investigator" from Queens University. [ 46 ] It is a Demand Letter seeking compensation from the IWK.

It should be noted that while the IWK was an original defendant to this action, it has been removed as a defendant by consent. [ 47 ] The letter sets out the circumstances of the alleged wrongdoing by the defendants and states: We consider these actions of IWK's researchers, Drs. Miller and Clarke, to be a breach of scientific/academic, ethical, procedural and legal/contractual obligations. … As a result of the above and without prejudice to their rights and recourses in this matter, the affected entities are each separately seeking the following from IWK: … Dr. Castleden 1.

Costs related to the re-employment of Jenn Cameron and employment of Natalie Denny to work with the PLFN community and deal with the news of additional sequences taken without their informed consent. 2. Costs associated with holding Local Community Advisory Committee meetings, -in person and by teleconference. 3. Travel expenses to date (x3 trips) (June-September) 4. Costs related to the information sharing and decision making processes, to determine what each participant chooses to do with their unauthorised live sequences… 5. Other expenses incurred in Dr.

Castleden's research lab, specifically staff time spent on work related to the breach starting in June 2018, including on-going communication, financial administration and supporting the PLFN staff and LCAB. 6. Any reputational damages related to the collection, presentation, and publication of the unauthorized research by IWK ad Drs. Miller and Clarke ; and 7. All other costs and damages incurred by Dr. Castleden and her advisors (legal and otherwise) and to contain and to minimize the negative impacts resulting from the actions of IWK and Drs. Miller and Clarke. (Emphasis added) Dr. Heather Castleden [ 48 ] Dr.

Castleden's evidence on the motion was presented in affidavit form only. There was no cross examination. [ 49 ] The affidavit has 22 Exhibits attached that include her Curriculum Vitae , various documents relating to the Alliance Study, emails with Chief Paul, Dr. Miller, Dr. Anand, and Dipika Desai (Manager with Hamilton Health Services), and the IWK Investigative Report. [ 50 ] There is significant evidence of her academic standing found in her list of Distinctions, Nominations, Prizes, and as a recipient of numerous Research Awards - with some in dollar amounts that are in 6 and 7 figures.

She remains active in research and is now located at the University of Victoria after periods at Dalhousie and Queens Universities. Her current appointment is as "Professor and Impact Chair in Transformative Governance in Planetary Health". [ 51 ] Dr. Castleden sets out the chronology of her involvement with the PLFN community that began in 2010 with "a community health research project concerning environmental racism". In 2013 she was asked by a lead researcher of the Alliance study whether she would recruit members of PLFN to participate.

She describes, from her experiences, the principles governing ethical research involving First Nations, Inuit and Métis peoples. The philosophy and background that lead to the creation of the OCAP principles mentioned by the plaintiff are set out, as are other aspects of "community based ethics codes". [ 52 ] As part of her responsibilities with the Alliance Study she hired Jennifer Cameron as a "research coordinator" for the Study. She described that Ms.

Cameron's role was "to recruit participants, explain the Alliance Study to participants, explain the Consent form to participants, arrange for participants to sign the Consent form, administer questionnaires, take participants' measurements, and coordinate the taking of blood samples and MRI scans".

[53] Her affidavit speaks to the various communications and meeting attendances in June and July 2018 as described by theplaintiff. [54] The PLFN Alliance Study Agreement, entered into by the PLFN, Queens University, and the Hamilton Health SciencesCorporation in August 2016 specified the conditions for PLFN's control of the data's use and publication rights. [55] Dr. Castleden confirmed that she first learned of the liver study scans by email from Dr. Miller on June 6, 2018, whichinformation "shocked" her and left her "quite concerned". She made inquiries and satisfied herself that there was a failure by Dr.

Millerto comply with certain protocols of the IWK Research Ethics Board (IWK REB) which is the body that would provide oversight of theintended additional scans. [56] She states that Dr. Miller had submitted to the IWK REB copies of two amendments to the Alliance Study which described theMRIs taken of the PLFN participants. [57] At paragraph 42 of her affidavit, she sets out 8 "ethical breaches" committed in the defendants' research, and which are as listedin the IWK Investigative Report. In the following paragraph Dr.

Castleden adopts their statement of "breaches" as being "justified by thefacts as set out in my Affidavit, as well as the affidavits of Chief Andrea Paul and Ms. Jenn Cameron." [58] The ensuing paragraph sets out her opinion as to the relevant standard of care expected of a "reasonably competent healthresearcher when conducting MRI scans on human participants" and concludes that the defendants failed to meet that standard of care in anumber of ways, set out in paragraphs 44-50. [59] The IWK Report characterizes their concern as "research misconduct".

The procedure for their investigation is apparently setout in a document that was not in evidence. It appears that they conducted their work by interview and receipt of written statements.There does not appear to have been a "hearing" nor examination of witnesses in an adversarial process. Their decision reflects anexamination of the facts against a 2014 Responsible Conduct of Research policy adopted by the IWK. [60] The concluding paragraphs of Dr.

Castleden's affidavit set out her compliance with Rule 55, including that she is "providing anobjective opinion" and that she is "100% certain" of the correctness of her opinions. [61] That concludes my review of the evidence. The affidavits and exhibits provide much more detail than set out here. I havefocused on that evidence which speaks to the defendant's objections, being the qualifications of Dr. Castleden and, if she is so qualified,that she has a demonstrated self interest and bias that ultimately renders her evidence inadmissible, notwithstanding her assertion ofobjectivity.

Legal Framework [62] The legal framework for determination of this motion is described in R. v. Mohan, (SCC), [1994] 2 S.C.R. 9and White Burgess Langille Inman v. Abbott and Haliburton Co. 2015 SCC 23. [63] Expert opinion evidence is presumptively inadmissible. The party seeking to adduce opinion evidence bears the burden ofestablishing its admissibility on a balance of probabilities. [64] The inquiry for determining the admissibility of expert opinion evidence is divided into two steps. At the first step, theproponent of the evidence must establish the threshold requirements of admissibility.

These are the four factors set out in R. v. Mohan(relevance, necessity, absence of an exclusionary rule and a properly qualified expert). Evidence that does not meet these thresholdrequirements should be excluded. At the second discretionary gatekeeping step, the trial judge must decide whether expert evidence thatmeets the preconditions to admissibility is sufficiently beneficial to the trial process to warrant its admission despite the potential harm tothe trial process that may flow from the admission of the expert evidence.

See, White Burgess at paras. 23-24. [65] Expert witnesses have a duty to the court to give fair, objective and non-partisan opinion evidence. They must be aware of thisduty and able and willing to carry it out. The expert's opinion must be impartial in the sense that it reflects an objective assessment of thequestions at hand. It must be independent in the sense that it is the product of the expert's independent judgment, uninfluenced by whohas retained him or her or the outcome of the litigation. It must be unbiased in the sense that it does not unfairly favour one party'sposition over another.

The acid test is whether the expert's opinion would not change regardless of which party retained him or her.These concepts, of course, must be applied to the realities of adversary litigation. See, White Burgess at para. 32. [66] Cromwell J. in White Burgess held, at para. 34: A proposed expert's independence and impartiality goes to admissibility and not simply to weight and there is a threshold admissibilityrequirement in relation to this duty.

Once that threshold is met, remaining concerns about the expert's compliance with his or her dutyshould be considered as part of the overall cost-benefit analysis which the judge conducts to carry out his or her gatekeeping role. [67] Imposing this additional threshold requirement is not intended to and should not result in trials becoming longer or morecomplex. It is necessary to determine, having regard to both the particular circumstances of the proposed expert and the substance of theproposed evidence, whether the expert is able and willing to carry out his or her primary duty to the court.

Absent challenge, the expert'sattestation or testimony recognizing and accepting the duty will generally be sufficient to establish that this threshold is met.

However, ifa party opposing admissibility shows that there is a realistic concern that the expert is unable and/or unwilling to comply with his or herduty, the proponent of the evidence has the burden of establishing its admissibility. [68] White Burgess at paras 48-49: 48 Once the expert attests or testifies on oath to this effect, the burden is on the party opposing the admission of the evidence to showthat there is a realistic concern that the expert's evidence should not be received because the expert is unable and/or unwilling to comply

with that duty. If the opponent does so, the burden to establish on a balance of probabilities this aspect of the admissibility thresholdremains on the party proposing to call the evidence. If this is not done, the evidence, or those parts of it that are tainted by a lack ofindependence or by impartiality, should be excluded.

This approach conforms to the general rule under the Mohan framework, andelsewhere in the law of evidence, that the proponent of the evidence has the burden of establishing its admissibility. 49 This threshold requirement is not particularly onerous and it will likely be quite rare that a proposed expert's evidence would beruled inadmissible for failing to meet it. The trial judge must determine, having regard to both the particular circumstances of theproposed expert and the substance of the proposed evidence, whether the expert is able and willing to carry out his or her primary duty tothe court.

For example, it is the nature and extent of the interest or connection with the litigation or a party thereto which matters, not themere fact of the interest or connection; the existence of some interest or a relationship does not automatically render the evidence of theproposed expert inadmissible. In most cases, a mere employment relationship with the party calling the evidence will be insufficient todo so. On the other hand, a direct financial interest in the outcome of the litigation will be of more concern.

The same can be said in thecase of a very close familial relationship with one of the parties or situations in which the proposed expert will probably incurprofessional liability if his or her opinion is not accepted by the court. Similarly, an expert who, in his or her proposed evidence orotherwise, assumes the role of an advocate for a party is clearly unwilling and/or unable to carry out the primary duty to the court.

Iemphasize that exclusion at the threshold stage of the analysis should occur only in very clear cases in which the proposed expert isunable or unwilling to provide the court with fair, objective and non-partisan evidence. Anything less than clear unwillingness orinability to do so should not lead to exclusion, but be taken into account in the overall weighing of costs and benefits of receiving theevidence. (Emphasis added) [69] The concept of apparent bias is not relevant to the question of whether or not an expert witness will be unable or unwilling tofulfill its primary duty to the court.

When looking at an expert's interest or relationship with a party, the question is not whether areasonable observer would think that the expert is not independent. The question is whether the relationship or interest results in theexpert being unable or unwilling to carry out his or her primary duty to the court to provide fair, non-partisan and objective assistance. [70] Examples where courts have held that the expert's interest in the litigation or relationship to the parties resulted in exclusioninclude: • Hutchingame v.

Johnstone, 2006 BCSC 271 (expert stood to incur liability depending on the result of the trial); • Alfano v. Piersanti, 2012 ONCA 297, affirming 2010 ONSC 4853; Kirby Lowbed Services Ltd. v. Bank of Nova Scotia, 2003BCSC 617; and Gould v. Western Coal Corp., 2012 ONSC 5184, 7 B.L.R. (5th) 19 (the expert's stance or behaviour as an advocatejustified exclusion); • Fellowes, McNeil v.

Kansa General International Insurance Co. (1998), (ON SC), 40 O.R. (3d) 456 (Gen.Div.) (proposed expert was the defendant's lawyer in related matters and had investigated from the outset of his retainer the matter of apotential negligence claim against the plaintiff); • R. v. Docherty, 2010 ONSC 3628 (expert was the defence counsel's father); • Ocean v. Economical Mutual Insurance Co., 2010 NSSC 315, 293 N.S.R. (2d) 394 (expert was also a party to the litigation); • Handley v.

Punnett, 2003 BCSC 294 (expert was also a party to the litigation). [71] Civil Procedure Rule 55 requires that an expert's report be signed by the expert, who must make (among others) the followingrepresentations to the court: • that the expert is providing an objective opinion for the assistance of the court; • that the expert is prepared to apply independent judgment when assisting the court; and • that the report includes everything the expert regards as relevant to the expressed opinion and draws attention to anything thatcould reasonably lead to a different conclusion (R. 55.04(1)(a), (

b) and (c)). [72] Dr. Castleden has made that representation to the court. The rule does not affect the rules of evidence by which expert opinionis determined to be admissible or inadmissible. It is consistent however with the common law requirements of the duties of an expertwitness to the court. Analysis [73] The plaintiff proposes that Dr.

Castleden be qualified as an expert: …in the field of health research involving Indigenous participants and capable of giving opinion evidence on research ethics and theethical approval requirements for research involving Indigenous participants in Nova Scotia including on the standard of care forobtaining the informed consent of Indigenous participants, and whether that standard has been met. I will begin with the four threshold requirements for the admissibility of expert opinion evidence as set out in Mohan, supra. They areas follows: 1. Relevance. 2. Necessity in assisting the trier of fact.

3. The absence of an exclusionary rule which would otherwise render the evidence inadmissible. 4. A properly qualified expert. [ 74 ] The first three of these are not in serious contest. [ 75 ] In White Burgess v. Abbott , supra , Justice Cromwell stated that relevance at the threshold stage refers to "logical relevance". To be logically relevant, evidence must have a tendency, as a matter of human experience and logic, to make the existence or non- existence of a fact in issue more or less likely. There is a clear connection between Dr.

Castleden's proposed evidence and the circumstances set forth in the pleadings and evidence in this motion. Relevance is established. [ 76 ] The necessity requirement relates to assisting the trier of fact with evidence that is outside the experience of a judge or a jury. Such evidence must be more than merely helpful, yet absolute necessity is not required. The necessity for and understanding of "informed consent" is an issue that is familiar to the court.

The issue of what constitutes informed consent in the circumstances of this claim and the standard of care for obtaining the informed consent of Indigenous participants in medical research is not in the normal experience of a judge or jury. Necessity has been made out. [ 77 ] No exclusionary rule that would render the evidence inadmissible has been identified. [ 78 ] The question of whether Dr. Castleden is a "properly qualified expert" was argued. [ 79 ] The defendants submit that there is a distinction to be made between the ethical obligations that exist for university-based researchers such as Dr.

Castleden and those for a medical doctor conducting health research such as the defendants were doing. [ 80 ] There is no question that Dr. Castleden is a qualified health researcher in university-based research studies. The point of the defendants' argument is that their conduct should not be measured against the standards she employs.

In essence, the issue posed is whether there is a distinction between a "reasonably competent university based health researcher" and a "reasonably competent medical health researcher". [ 81 ] The qualification sought is in "the field of health research" and in the motion materials reference is made to a "reasonably competent health researcher". This is a generic description which neither supports nor undermines the plaintiff's argument to qualify Dr. Castleden. [ 82 ] There is, however, some factual underpinning for the defendants' suggested distinction. [ 83 ] In paragraph 7 of Dr.

Castleden's affidavit she cites "numerous instances where university and government researchers" obtained or used research data in relation to Indigenous peoples which caused harm. This led to the creation of a policy that binds " all university based researchers". [ 84 ] Paragraph 13 of her affidavit refers to the current requirements for obtaining approval for "university based research projects with human participants". [ 85 ] In her June 21, 2018, email to Dr. Miller, in which she expressed her "shock, anger and dismay", Dr.

Castleden questioned how this could happen "…even without being well versed in our ethical protocols for Alliance..." This language seems to concede that the university- based protocols employed in the Alliance study may not have been those which a medical researcher would be aware of or bound by. [ 86 ] So, the standard she uses does seem to focus on the ethical protocols that apply to university and government-based researchers. This does not however exclude the application of those same obligations from applying to the defendants. There was no cross examination of Dr. Castleden that might have clarified this.

I conclude that this is a matter, if it was the sole issue of qualification, that would not exclude her from testifying. It would be a matter of weight to attach to her evidence if the distinction alleged by the defendants was substantiated in further examination. [ 87 ] The second objection is that Dr. Castleden's relationship with the plaintiff and her interest in the results of the litigation render her unable or unwilling to carry out her primary duty to the court to provide fair, non-partisan and objective assistance. [ 88 ] Dr.

Castleden has, in her sworn affidavit, attested to her compliance with Rule 55.04 which states: 55.04 An expert's report must be signed by the expert and state all of the following as representations by the expert to the court: (

a) the expert is providing an objective opinion for the assistance of the court, even if the expert is retained by a party; (

b) the witness is prepared to testify at the trial or hearing, comply with directions of the court, and apply independent judgment when assisting the court; (

c) the report includes everything the expert regards as relevant to the expressed opinion and it draws attention to anything that could reasonably lead to a different conclusion; (

d) the expert will answer written questions put by parties as soon as possible after the questions are delivered to the expert; (

e) the expert will notify each party in writing of a change in the opinion, or of a material fact that was not considered when the report was prepared and could reasonably affect the opinion, as soon as possible after arriving at the changed opinion or becoming aware of the material fact,

[ 89 ] A statement of the proposed expert that asserts their willingness and ability to comply with these duties is generally sufficient to establish that the threshold for admissibility has been met. Dr. Castleden has done that. As such it shifts the burden to the defendants who must show that there is a realistic concern that the expert's evidence should not be received because she is unable and/or unwilling to comply with the duty to provide fair, objective and non-partisan evidence. [ 90 ] I have previously reviewed the evidence in detail. I am satisfied that it does support a "realistic concern" that Dr.

Castleden is unable and possibly unwilling to provide fair, objective and non-partisan evidence. Interest in the litigation [ 91 ] Dr. Castleden's potential exposure for liability to the plaintiff, or of damage to her reputation was engaged by her role as the lead local investigator for a national, multi-site study that was damaged by the allegation that the PLFN participants were subjected to liver scans without their informed consent. She made known from the outset her concerns as to the negative impact the taking of the liver scans would have on her reputation and career. [ 92 ] Dr.

Castleden had the responsibility for ensuring that the Consent forms executed by the participants properly reflected the intended Alliance study testing. She delegated this responsibility to Jennifer Cameron. [ 93 ] Ms. Cameron indicates that she read the Consent forms to each of the participants, except five which were conducted by one of Dr. Castleden's students. In Discovery, she was asked about the inclusion of language in the Consent form pertaining to an MRI scan "to measure your abdominal fat, the fat content of your liver…". Assuming this evidence to be accurate then, as Ms.

Cameron feared, she may not have caught language that described the tests that the plaintiff alleges were conducted without the consent of the participants. This ultimately would provide concern that Dr. Castleden's supervision of Ms. Cameron was contributory to the circumstances that the plaintiff says was causative of damages claimed. [ 94 ] This fact has been recognized by the plaintiff who acknowledged that she could have named Dr. Castleden as a defendant but did not because she sees her as an "ally".

It is also apparent that there is a professional bond, if not personal as well, as a result of the longstanding prior relationship of Dr. Castleden with the PLFN members which developed through the Boat Harbour study. [ 95 ] Counsel for the plaintiff submits that the absence of contact between Dr. Castleden and Chief Paul since 2018 renders any suggestion of self interest moot. I disagree. [ 96 ] In her June 21, 2018, emails, Dr. Castleden made it clear that she had much to lose if blame for this incident rested with her.

This is evidenced by her statements that: • her "…relationship of mutual trust and mutual respect with [PFLN]...is now in jeopardy". • her "…international reputation for ethical research and advocacy… is now also at risk. [ 97 ] Similar comments were made on other occasions. [ 98 ] Dr. Castleden's Curriculum Vitae demonstrates that her "international reputation" carries with it significant prestige and awards of research monies, as well as opportunities to conduct academically important research. This is what she saw as being "at risk".

Her interest then is better served if the blame for this event rests solely on the defendants. [ 99 ] Further confirmation of her interest in the litigation is found in the Demand letter she signed and that was sent to the IWK in October 2018, in which she sought "reputational damages", specific damages, and "All other costs and damages incurred by Dr. Castleden and her advisors (legal and otherwise) and to contain and to minimize the negative impacts resulting from the actions of IWK and Drs.

Miller and Clarke." Whether or to what extent she pursued this claim is not the point - it is confirmation of her assessment of how the defendants' actions hurt her reputation, and her desire to affirm their sole responsibility. [ 100 ] I have not observed in the evidence that Dr. Castleden accepted responsibility for failing to ensure that the Consent form executed by the participants complied with her undertaking to the participants. In saying this, I recognize the limited scope of this motion and so that evidence may exist.

As a possible statement against her own interest, it would be understandable that it would not be offered at this time, even if she did feel that to be so. Advocacy on behalf of the Plaintiff/ Partisan Actions [ 101 ] Dr. Castleden took a strong adverse position to the defendants immediately upon finding out what had occurred.

On June 21, 2018, when she called Chief Paul to advise her of what happened, she described the defendants as having "gone rogue". [ 102 ] She expressed her "extreme shock, anger, and dismay about the serious breaches in ethical practices that have taken place…" [ 103 ] The evidence indicates that Dr. Castleden was seen by the plaintiff as advocating for her and the participants. Chief Paul described Dr. Castleden as "angry" with the defendants, when meeting them at the PLFN in July 2018. She noted the risk to Dr. Castleden of the withdrawal of Indigenous participants from future studies. [ 104 ] Dr.

Castleden's correspondence offers support for her affinity to the participants. In her email to Dr. Huber, dated August 27, 2018, she states that "it seems to our group" that the defendants should be disciplined. In doing so, she identified herself as adverse to the defendants and in support of the participants. [ 105 ] The language in the Demand Letter seeking compensation, dated October 23, 2018, from Dr. Castleden to the Interim Vice- President Research, Innovation and Knowledge for the IWK also identifies Dr. Castleden as sharing a common interest with the plaintiff and the participants.

For example, it says that " We consider these actions of IWK's researchers, Drs. Miller and Clarke, to be a breach of

scientific/academic, ethical, procedural and legal/contractual obligations." [ 106 ] In that same letter and listed as demand #8 for compensation sought was reimbursement for "expenses incurred… including… supporting the PLFN staff and LCAB ". [ 107 ] In

summary, Dr. Castleden has, since June 2018, taken a strong partisan position in opposition to the defendants. It is evident that she is genuine in her belief that the defendants are culpable which if untainted by other factors would not exclude her opinion evidence. However, there are other factors. She demonstrated that she has been motivated in part by her support for the plaintiff and participants, and in part by her concern for her own reputation. She sought damages for losses she alleged were incurred as a consequence of the defendants' conduct, and she advocated for the defendants to be disciplined.

Her affidavit states that she is 100% certain of her opinions. It seems clear that she has held that view since early June 2018. While she attests to her ability to be objective and fair, that seems unrealistic when seen against this factual matrix. Her evidence is not independent, in the sense that it is the product of her judgment uninfluenced by the outcome of the litigation.

She has always favored the interests of the plaintiff and prospective class members. [ 108 ] It is for these reasons that I conclude that there is a "realistic concern" as to whether she is able to fulfill the duties of an independent expert witness. Cost Benefit Analysis [ 109 ] Does the cost associated with admitting the report outweigh its benefit? [ 110 ] Counsel for the plaintiff has urged that there is a lower threshold for admitting Dr.

Castleden's opinion evidence since there is a lower threshold of evidence necessary for granting certification of the proceeding as a class action, i.e., the "requirement to show some basis in fact on each of the Certification requirements." [ 111 ] The decision in Wright Medical Technology Ltd v. Taylor 2015 NSCA 68 , at paras. 42 , 43 and 47 is offered in support of this proposition.

Counsel cites Justice Saunders' admonition that "… the judge must not veer into an evaluation of the merits of the claim, or the probative weight of the evidence said to support it, or the potential for success" as standing for this proposition. [ 112 ] With respect I do not read the authorities as suggesting that otherwise inadmissible evidence should be admitted on a certification motion.

There is nothing in White Burgess or other cases that suggests a different test for admission of expert opinion evidence because it is sought to be tendered in a Certification hearing. [ 113 ] The position of the plaintiff is that the benefits of admission outweigh any costs. In

summary counsel submitted that: • the evidence is necessary; • it is reliable; • that it is not for a trial but a "procedural motion"; • that the evidentiary burden in certification hearings is low; • that it will not take much time to have the testimony adduced; • the opinions are not lengthy or complicated; and • it is not a jury trial so there is little risk of usurping the role of the motions judge. [ 114 ] The cost-benefit analysis is the final step in determining the status of Dr. Castleden's opinion evidence. In R. v.

Abbey 2009 ONCA 624 , Justice Doherty discussed this analysis: [87] The "benefit" side of the cost-benefit evaluation requires a consideration of the probative potential of the evidence and the significance of the issue to which the evidence is directed. When one looks to potential probative value, one must consider the reliability of the evidence.

Reliability concerns reach not only the subject matter of the evidence, but also the methodology used by the proposed expert in arriving at his or her opinion, the expert's expertise and the extent to which the expert is shown to be impartial and objective. … [90] The "cost" side of the ledger addresses the various risks inherent in the admissibility of expert opinion evidence, described succinctly by Binnie J. in J. (J.), at para. 47 as "consumption of time, prejudice and confusion".

Clearly, the most important risk is the danger that a jury will be unable to make an effective and critical assessment of the evidence. The complexity of the material underlying the opinion, the expert's impressive credentials, the impenetrable jargon in which the opinion is wrapped and the cross-examiner's inability to expose the opinion's shortcomings may prevent an effective evaluation of the evidence by the jury.

There is a risk that a jury faced with a well-presented firm opinion may abdicate its fact- finding role on the understandable assumption that a person labelled as an expert by the trial judge knows more about his or her area of expertise than do the individual members of the jury: J. (J.), at para. 25. [91] In addition to the risk that the jury will yield its fact-finding function, expert opinion evidence can also compromise the trial process by unduly protracting and complicating proceedings.

Unnecessary and excessive resort to expert evidence can also give a distinct advantage to the party with the resources to hire the most and best experts … [ 115 ] I have expressed my serious concerns as to Dr. Castleden's ability to be impartial and objective. Those concerns impact negatively on her reliability. [ 116 ] She has relevant expertise in relation to the existence and application of OPCA principles and in particular with her university-

based research at PLFN. While there could be a benefit in her testimony on that narrow issue, it is not at all clear that she has applied her mind to whether there is a different standard the defendants could or should be held to on the facts of this case. The reliability of her opinion as to breach by the defendants requires an objective and informed assessment of the standard that would apply to the defendants in determining whether there is liability compensable in damages. I return to this example: Dr.

Castleden could not understand the defendants' conduct even "without being well versed in our ethical protocols for Alliance." There is no indication in her report that she gave any consideration to why the doctors should have been, and why they were not, familiar with the Alliance ethical protocols. An open mind and a balanced report would have addressed this. [ 117 ] Plaintiff's counsel asserts that the consistency of Dr.

Castleden's conclusion with those of the IWK committee supports a conclusion that her evidence is reliable. [ 118 ] The report referred to by counsel is dated February 2019 and is entitled "Research Investigation Under the IWK Responsible Conduct of Research Policy". It was prepared by an Investigation Committee established by the IWK. [ 119 ] At paragraph 42 of her affidavit, Dr. Castleden lists what she characterized as the "ethical breaches" the Investigation Committee found to have been committed.

In paragraph 43 she states that these conclusions were "justified" by the evidence in the motion affidavits. [ 120 ] Dr. Castleden did not include the next paragraph of the Report which states, at p. 28: These events of misconduct must, however, be taken in the context of a study that was fully approved by the IWK Research Ethics Board, the body that researchers rely upon to help them navigate the ethical conduct of research.

The IWK REB did have knowledge: • That additional scans were being done • That they would be stored and analyzed locally • Whether an explicit protocol was in place for significant incidental findings • That the local principle investigator acknowledged a lack of experience in dealing with explicit approval of research and co- participation by First Nations participants.

The IWK REB and Research Services inadequately assessed the knowledge and experience of the local research group with regard to research involving First Nations participants and did not sufficiently assist them in acquiring this knowledge. [ 121 ] Nor does her affidavit speak to the Investigative Report's comment on her role in the matter, found at p. 24: With respect to this research breach, there are several ways in which the relationships between those involved are relevant. …It also includes due consideration of the role of Dr.

Castleden as the 'local' Co-Principal Investigator, who was a part of the research project in terms of contacting Pictou Landing First Nations and providing support for the research assistant, Jennifer Cameron. Key considerations include the ability of someone who is not local to provide effective support and supervision at a distance (Dr. Castleden is located in Kingston, Ontario), for a complicated study in a 'high risk' population especially if/as any issues related to the research project arose.

Furthermore, consideration of the potential vulnerabilities of research assistant(s), especially if one is seen to be the community "face" of the project should be reviewed. [ 122 ] Notwithstanding plaintiff counsel's argument to the contrary, resolving a question of reliability of a witness does not depend upon proof of a countervailing opinion. Reliability can be assessed on other available evidence. In this case, Dr.

Castleden's affidavit evidence, while relying upon the IWK investigative report for validation of her conclusions, omits consideration of other salient findings that impact on her role in the matter, and on the context in which the defendants' conduct was seen by the Committee. As such it raises concern as to her impartiality and objectivity, and ultimately to her opinions in relation to the applicable standard and alleged breach of the standard. Cost [ 123 ] I agree that sitting on the motion as a judge alone minimizes the cost of admitting the evidence.

Concerns focused on an expert's opinion overwhelming the trier are mitigated. [ 124 ] I am of the view though that the motion hearing will become unduly protracted by the admission of Dr. Castleden's opinion evidence. She is likely to be an important fact witness for the plaintiff. My findings that question her ability to be objective, non-partisan and independent necessarily mean that the weight to be attached to her opinions will be a significant issue and quite possibly minimize the assistance to the court that she, as an expert, is intended to provide.

In short, her partisanship will become the focus of the examination and distract from the central issues of her fact-based testimony. [ 125 ] It appears that the subjects upon which she was to be qualified are not novel areas. The benefit of her expertise can be found in others. The existence and application of the OCAP principles are apparently well established on a national basis and the PLFN has staff in place to respond to requests for their participation in research projects. As such there is not the same degree of necessity for Dr. Castleden to be the researcher who explains this.

Evidence with respect to the applicable standards of conduct for medical based research would not be novel evidence. [ 126 ] Therefore, I have concluded that the benefit of admitting her opinion evidence would not outweigh the cost. Conclusion [ 127 ] I have concluded that the motion of the defendants to strike Dr. Heather Castleden's report in its entirety, to disqualify Dr.

Castleden as an expert in this proceeding, and to so exclude her from providing expert opinion evidence will be granted in part. The plaintiff seeks to rely upon the opinion evidence found in paragraphs 43-50 of Dr. Castleden's affidavit. I have concluded that Dr. Castleden will not be permitted to give expert opinion evidence as proposed by the plaintiff and that those paragraphs of the affidavit will be struck. [ 128 ] The parties have agreed to a Case Management Conference to be held September 9, 2022, at which time I anticipate scheduling a time to address the admissibility of the remaining paragraphs of Dr.

Castleden's affidavit, on a paragraph-by-paragraph basis. [ 129 ] If the parties cannot agree on costs, then I will also hear submissions of the parties on that issue. [ 130 ] Finally, this decision is not intended to bring into question the ethics or competency of Dr. Castleden as she carries on in her accomplished career. Undoubtedly, she believes that she could provide opinion evidence that would assist the court and that in doing so she could be objective. I do not have reason to question her good faith. As counsel for the defendants acknowledged in argument, Dr.

Castleden could conceivably be qualified to give opinion evidence in her proven expertise in other cases where she was not so intricately and personally involved in the litigation. Patrick J. Duncan Associate Chief Justice