Personal Injury News: Three Points of Interest -- Stirrett v. Cheema

By Andrew Spurgeon, Ross & McBride 

October 2020

In this edition of the Personal Injury Update I want to consider a case decided by the Court of Appeal in May of this year: Stirrett v. Cheema1 which is fascinating to me on three levels. It involves the death of a man who was in a clinical study of the use of insulin to prevent restenosis of clogged arteries in the heart after angioplasty. He died during a follow-up angiogram procedure to measure the impact of insulin use as a preventative measure against the re-clogging of his arteries. 

My first point of interest arises for me as I am a member of a Research Ethics Board which assesses, approves, defers or denies applications of physicians to do research on human subjects so this piques my interest. The plaintiff’s surviving spouse asserted that the principal investigator in the study was negligent and breached his fiduciary duty to her late husband in inducing him to participate and stay in the study.2 

My second point of interest arises from an interesting question concerning the divergence and overlap of law and equity. The allegations of both negligence and breach of fiduciary duty created some interesting problems in this regard.

My third point of interest in this case comes at its most fundamental level – the issue of factual causation as in a medical malpractice case. Proof of causation in the medical negligence context is a daunting and obscure precinct of law despite regular re-consideration by higher courts.   

The Facts of the Case

Mr. Stirrett was a middle-aged man who was a non-insulin dependent diabetic. He had heart problems and went to hospital to have an angiogram and possible angioplasty. An angiogram is a study of the heart done by inserting a line in the veins up to the heart releasing dye to visually show the circulation and identify blockages in the blood vessels of the heart. Mr. Stirrett’s heart had a 90% blockage at the left circumflex artery. As a result, an angioplasty was done successfully to open up the artery and improve circulation.

When Mr. Stirrett arrived for the angiogram he was asked if he wanted to participate in a study. The study was set to determine whether for non-insulin dependent diabetics the use of insulin could reduce the risk of restenosis (re-blockage) after an angiogram. The subjects would be divided into two groups, one would take insulin and the other would not. After six months subjects would return for a follow-up angiogram to see how much, if any, re-blockage there was in the area of the repaired – reopened artery after angioplasty. Mr. Stirrett was in the control group.  He received no insulin – which was the standard of care and consistent with his diabetic profile.

Unfortunately, the study’s Principal Investigator, Dr. Strauss had difficulty fully enrolling the study and funding was partially curtailed. A Data Safety Monitoring Board was not constituted. Lastly, these changes to the study had not been revealed to Research Ethics Boards overseeing the research. Essentially the study was floundering. None of these facts were revealed in the Consent form signed by Mr. Stirrett at the time he agreed to participate; as well as at the time he underwent the second angiogram.  

Six months post-angioplasty, Mr. Stirrett, who had been suffering from chest pain for approximately one month, attended for the follow-up angiogram. Had Mr. Stirrett not been in the study, he would not have had the second angiogram. He died in the course of having the angiogram. Mr. Stirrett’s autopsy revealed that the area of the previous angioplasty had suffered from very significant restenosis (it had clogged back up again quite badly).

Mr. Stirrett’s wife commenced a claim alleging not only negligence but also breach of fiduciary duty on the part of the investigators in the study. The theory of the plaintiff’s case is if Dr. Strauss had been more up-front and open about the fact that the study was floundering, and had Mr. Stirrett received full and complete disclosure of the facts of the study outlined above, he would not have entered the study or at least not submitted to the second angiography. Alternatively, it was asserted that the Research Ethics Board (had the negative facts been revealed to it) would have shut the study down and the second angiography would not occurred because the study would not have ended.

The Result at Trial

In respect of the allegations of negligence brought in law, the jury determined that the angiogram itself was not done in a manner below standard of care. However, Dr. Strauss, in his capacity as Principal Investigator administering the study, did fall below standard of care in four ways relating to how he administered the study. However, the jury concluded that none of those four breaches of duty caused the injury suffered by Mr. Stirrett, holding that within the tort of negligence no cause in fact was proven linking any of the breaches of duty in the administration of the study to the ultimate outcome of Mr. Stirrett’s death.

But that was not the end of the story at trial. Ms. Stirrett further alleged that Dr. Strauss owed and breached an ad hoc fiduciary duty to Mr. Stirrett.  Fiduciary duty is a concept that arises in equity and determinations of claims for equitable relief are not to be tried by a jury pursuant to s. 108(2) of the Courts of Justice Act.  On this point – the point of equitable relief – Ms. Stirrett won at trial as the trial judge awarded damages to her on the basis that:

“Equity has always held trustees strictly accountable in a way the tort of negligence and contract have not.… The physician is pledged by the nature of his calling to use the power the patient cedes to him exclusively for her benefit. If he breaks that pledge, he is liable”.3

On this basis the trial judge held the defendant physician liable to pay equitable relief to the plaintiff without the plaintiff having to prove a causal connection in fact between a breach of fiduciary duty and the occurrence of injury.

The Appeal

The defendant appealed asserting two grounds of appeal. 

That there was no ad hoc fiduciary duty owing by the physician to the patient that was breached and consequently, the court erred in finding liability against the defendant, Dr. Strauss; and

If there indeed was a breach of ad hoc fiduciary duty by the physician to the patient, the plaintiff (patient) had not proven that his injury was in fact causally related to such breach of duty and further, the trial judge erred in concluding that no causal connection was necessary to establish liability.

The Court of Appeal only addressed the second ground of appeal. Because of their answer to the second question, the court concluded it did not need to address the first issue.

The Court of Appeal held – assuming a breach of fiduciary duty was proven – that the trial judge erred in concluding that such a breach could result in liability on the part of the defendant without proof that the breach of fiduciary duty in fact caused the injury. In other words, the court concluded, causation-in-fact is a necessary element of proving entitlement to recovery for breach of fiduciary duty.

On this point, the Court of Appeal held that the factual determination by the Jury in the tort (common law) component of the case that there was no causal connection between breaches of duty of care and injury to Mr. Stirrett was controlling. Those breaches of duty of care were the same as the breaches of ad hoc fiduciary duty alleged by the plaintiff in the case. Given that causation had not been proven, it was superfluous and unnecessary to determine whether there indeed was any ad hoc duty of care owed to Mr. Stirrett breached by Dr. Strauss.

My Three Points of Interest

As mentioned above, the particular facts in this case pique my interest on three levels. Let’s look at each.

a. Research Ethics

The Court of Appeal in this case gives a good overview of the legal framework in which research studies on human subjects are undertaken in Canada. It outlines the role of the governing Tri-Council Statement4and the regime in which ethical determinations concerning research on human subjects are made.

Dr. Strauss, the Principal Investigator of the Study in which Mr. Stirrett was enrolled, clearly made errors and was sloppy in observing his obligations to disclose facts to both Mr. Stirrett and to the Research Ethics Board about his study. He failed to disclose the lack of uptake on the study; the withdrawal of funding; the lack of updating the overseeing Research Ethics Board on the status of the study, and the lack of constituting of a Data Safety Management Board (DSMB).5 

The Jury appeared to conclude that none of these breaches of care by Dr. Strauss in point of fact caused Mr. Stirrett’s injury – they did not have any material impact upon whether the second angiography (the one in which he died) would have occurred. The difficulty one has with this conclusion is that it is one drawn by a jury and therefore is without explanation. There is no treatment of the question of materiality and the subjective – objective test for informed consent found in Reibl v. Hughes.6   This essentially is the flaw with jury verdicts, they are conclusions of a group of people with unreported and likely divergent reasons.

b. The Juxtaposition of Law and Equity

I find the continued inter-relationship of Law and Equity fascinating. In this case, there is the vestigial distinction between the two where juries exist in law but not in equity. In a fused court structure like our own, arguably, the decision-maker in a single case – in respect of the facts should be the same for both matters in law and equity. But in this case, that proposition is both true and not true at the same time.  As the Court of Appeal noted, as per the Courts of Justice Act s. 108(2)1.xi. trials may not be conducted by a jury if the remedy sought is: “[o]ther equitable relief”. Fiduciary duties are duties which are recognized not in common law, but in equity. A court may provide equitable relief for the breach of a fiduciary duty. The question is what would that relief be and how would it be determined to be owing? 

In the circumstances of Mr. Stirrett’s case, the trial judge faced with a Jury Notice proceeded with a jury trial in respect of the claims made in the tort of negligence which is a common law cause of action but reserved to himself determination of:

Whether a fiduciary duty was owed to Mr. Stirrett by Dr. Strauss;

If one existed, whether Dr. Strauss breached that fiduciary duty; and

If a fiduciary was breached, what remedy, if any would be provided to Mr. Stirrett.

Such a procedural cleavage between law and equity within the same case invites the prospect of inconsistent findings of fact as between the jury and the judge. As in this case, the duties of care found in the tort of negligence owed by Dr. Strauss to Mr. Stirrett would be similar, if not identical to the fiduciary duties he arguably owed to Mr. Stirrett. The question was however, would the causational requirements for compensation in tort also apply in equity?  If so, how?

The Court of Appeal’s answer to those questions was “yes”. The factual causational issue of but for a breach of duty “X” occurring, would injury “Y” result – was an issue which applied equally in law and equity. In order for the court to avoid the possibility of inconsistent findings of fact on the causation question, the Court of Appeal held that the Jury’s findings of fact regarding causation in the common law tort of negligence were “controlling” in respect of any potential causational question regarding any possible breach of a fiduciary duty as well.

The question is whether the Court of Appeal is right on this?  If the Courts of Justice Act prohibits jury trials in respect of “other equitable relief” how can findings of fact a jury be controlling in respect of the determination of whether equitable relief ought to be given in light of section 108(2) of the Courts of Justice Act?  I confess, I do not know what the answer to this question is but it is interesting and it suggests that the Court of Appeal in seeking to prevent inconsistent outcomes within a single proceeding are squaring the circle by negating the differences between law and equity.

c. Causation

Causation is an area of law over which “has become complicated, convoluted and confused.”7   This is especially true in respect of how it applied in medical negligence in Ontario.8    The general rule is but for the occurrence of the breach of duty, would the impugned injury have occurred?  Courts are advised to take a common sense, robust and pragmatic approach to assessing whether as a matter of fact, the breach of care and duty proven in fact caused the injury alleged.9 A trier of fact is to ask: but for the wrong committed by the defendant – would the plaintiff’s injury have occurred?  This proposition is one the plaintiff must prove on the balance of probabilities. In the Stirrett case, the Court did not grapple with this question independently.  To avoid an inconsistent finding of fact, the Court of Appeal simply looked to the jury’s factual determination in the common law side of the case and grafted that factual conclusion upon the question of an assumed breach of fiduciary duty. On that basis the court concluded that the case of the plaintiff failed.

Once that decision was made, the court decided it did not need to analyze the question of  whether the trial judge was right in finding an ad hoc fiduciary duty owed by the Principal Investigator of the study to the subject of the study, Mr. Stirrett.

Conclusion

The conclusions of the Court of Appeal in this case were disappointing on three levels. First, in choosing not to grapple with the question of ad hoc fiduciary duty the Court failed to provide guidance to scientific researchers in respect of their duties to the human subjects they study. Second, in the same vein, by choosing not to address the issue of ad hoc fiduciary duty and by simply resorting to the jury verdict on the element of causation in the negligence claim, the Court of Appeal forfeited an opportunity to flush out the contours of the interaction of collateral causes of action in law and equity. Third, in not more fulsomely exploring the issue of factual causation the Court left the law in as confused a state as it found it. Perhaps in a few years another case will come along in which some of these issues will present themselves so that they can be faced squarely.

Andrew J. Spurgeon is a partner at Ross and McBride. He is also an Elected Bencher of the Law Society of Ontario, and the Chairman of the Board of Directors LawPRO, which is the sole insurance company providing primary liability coverage to all 28,000 lawyers in private practice in Ontario.

He can be reached at:
Ross & McBride
1 King St W, Hamilton, ON
L8P 1A4
Tel: 905-572-5810
Email: aspurgeon@rossmcbride.com

Endnotes

1 2020 ONCA 288

2 With Covid-19 and the very public pursuit of a vaccine in the headlines daily, the oversight role of Research Ethics Boards and the management of safety protocols of clinical studies involving human subjects has come into sharp focus for the public of late. There are many concerns and debates about the politicization of scientific inquiry. Research Ethics Boards are a pillar in the edifice of institutions designed to protect the health and well-being of people involved in scientific research and ensure the integrity of the results of research studies.

Norberg v. Weinrib [1992] 2 SCR 226 at paragraphs 95 and 98.

4 The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd edition (TCPS 2 (2018)) is the official human research ethics policy of the federal research granting agencies being:  The Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council (SSHRC).

5 A DSMB is a Board of outside experts whose job is to monitor the overall safety of a study. Many studies are blind or double blinded. A blind study is one where the subject does not know if they are getting the intervention therapy or placebo. A double-blinded study is one where neither the treatment provider nor the subject knows if they are getting the intervention treatment or the placebo. DSMB’s are charged with overseeing the data generated in the study to ensure safety of participants, especially where the investigators do not know which of the subjects are getting what treatment. Studies can be stopped by a DSMB where the data reveals that it would be unethical to continue the study because of negative outcomes for subjects in the study.  

6 [1980] 2 SCR 880.

7 S. Green, Causation in Negligence, Hart Publishing, Oxford (2015) at p. 1.

8 The Court of Appeal in the last few years has come out with two contradictory cases on causation in medical negligence. They are: Surujado v. Melady, 2017 ONCA 41 and Sacks v. Ross, 2017 ONCA 773.

Snell v. Farrell, [1990] 2 SCR 311