Obtaining Informed Consent in Team-Based Treatment Plans
Written by Dale V. Orlando, Partner, and Avery Kavanaugh, Summer Student
1. Background
- The central issues underlying the Ontario Court of Appeal’s decision in Denman v. Radovanovic are the nature and extent of a physician’s duty to obtain informed consent for a multi-step course of elective medical treatment. In his decision, Rouleau, J.A. clarified where this duty rests in situations where multiple physicians are involved in providing treatment.
- In 2015, the respondent Michael Denman suffered a catastrophic brain bleed as a result of a medical procedure aimed at curing an anterior ventricle malformation (“AVM”) in his brain. The suggestion is not that the procedure itself, which was part of a multi-step treatment plan, was performed in a negligent manner. Instead, the respondents brought a claim alleging that the appellant doctors at Toronto Western Hospital (“TWH”) failed to obtain Mr. Denman’s informed consent.
- The respondents sued in negligence, alleging that if the appellants had not breached their duty of disclosure, neither Mr. Denman nor a reasonable person in his circumstances would have proceeded with the recommended elective treatment plan.
- The trial judge held that all three appellants were liable based on a failure to obtain informed consent.
- On this appeal, the appellants challenged the trial judge’s judgment and her costs decision. In doing so, they raised a number of issues.
- Upon consideration of the appellants arguments which are reviewed in this summary, Justice Rouleau dismissed the appeal and refused leave to appeal costs.
2. Facts
- On May 10, 2010, Mr. Denman suffered a stroke or seizure. He was taken by ambulance, to hospital where he was diagnosed with an AVM and a flow-related aneurysm. On May 11, 2010, Mr. Denman received treatment which resolved the aneurysm but not the AVM.
- Denman’s underwent stereotactic radiosurgery on March 2, 2011in hopes of resolving the AVM, however this treatment was not successful.
- In May of 2014, Mr. Denman’s case was reviewed at a multidisciplinary AVM case conference at TWH. The multidisciplinary AVM team, which included Dr. ter Brugge and Dr. Radovanovic but not Dr. Pereira (who did not practice at TWH at the time), formulated a plan of treatment including a series of embolizations, followed by a possible microsurgical resection of the AVM, meant to effect a cure of Mr. Denman’s AVM.
- For Mr. Denman to benefit from a reduction of risk of spontaneous bleed, his AVM had to be fully treated. As such, procedures achieving only partial embolization would result in no benefit to Mr. Denman.
2.1. Mr. Denman’s Consent to the Embolizations
- ter Brugge was tasked with conveying the necessary information about the risks and benefits of Mr. Denman’s options following the AVM conference, so that he could make an informed decision about whether to pursue the recommended treatment plan.
- At a meeting in June of 2014, Dr. ter Brugge discussed the risks of a single embolization procedure, the first step of the treatment plan. Dr. ter Brugge testified that he told Mr. Denman that this procedure carried a 3 to 5% risk of stroke or death, and further directed him to a TWH website that reported this treatment to carry a small chance of stroke, about 1 to 3 percent.
- At no point did Dr. ter Brugge discuss the possibility that further treatment would likely be required, nor did he provide Mr. Denman with an estimate of his lifetime risk should he choose to forego treatment.
- The first embolization was conducted on August 19, 2014, by Dr. Pereira. Only partial embolization was achieved.
- Upon recommendation of follow-up treatment, on December 9, 2014, Dr. Pereira performed a second embolization of Mr. Denman’s AVM where, again, only partial embolization was achieved. There was no record that any informed consent discussion took place before this procedure.
- On January 29, 2015, Dr. Pereira and Dr. Radovanovic met with Mr. and Mrs. Denman to propose and discuss what was expected to be the final treatment: a third embolization procedure to be performed by Dr. Pereira, followed by a microsurgical resection of the AVM to be performed by Dr. Radovanovic.
- Pereira explained to Mr. Denman that the risk of an adverse outcome from the combined treatment was 10 to 15 percent, of which 3 to 5 percent would be a severe, life-threatening complication. He further explained that, once the AVM had been removed, Mr. Denman would be cured.
- Radovanovic testified to having informed Mr. and Mrs. Denman that the risk of the combined procedure was around 10%, including deficits ranging from minor disabling.
- At the conclusion of the meeting, Mr. Denman signed the consent form.
- On June 23, 2015, Dr. Pereira performed the third embolization. Post-operatively, Mr. Denman showed signs of complications from the procedure and was taken back to the operating room. Dr. Radovanovic performed emergency surgery to remove the AVM and stop the bleeding causing the complication.
- As a result of the brain bleed, Mr. Denman was left densely hemiplegic (one-sided paralysis) on his left side, fully dependent for all care, and only able to communicate by writing and gesturing.
3. The Law of Informed Consent
- Justice Rouleau reiterated the established duty of a physician to, without being questioned, provide adequate informed to the patient before undertaking the relevant elective treatment. This involves disclosing the nature of the proposed treatment and any material, special, or unusual risks of the treatment.[1]
- Additionally, where there is more than one viable option to manage the patient’s medical condition, the patient is also to be informed of the relative and comparative risks and benefits between the options.[2]
- A patient alleging lack of informed consent must prove that the information provided was inadequate, as well as causation.
- To prove causation, the patient must establish that (1) they would not have undergone the procedure had they been adequately informed, and (2) a reasonable person in the patient’s position would not have undergone the procedure if given adequate information.[3]
- Furthermore, it will also be sufficient for a plaintiff to demonstrate that they would have declined treatment at that particular time, even if only to postpone it to a later date.[4]
4. The Issues on Appeal
4.1. The Trial Judge’s Reasons were Sufficient
- Justice Rouleau concluded that the trial judge reasons were sufficient to permit meaningful appellate review and further clarified that appellate courts “cautioned against…reviewing [a] trial judge’s reasons with an overly critical eye,”.[5]
- The Court of Appeal had recently summarized the principles applied when assessing the sufficiency of reasons in the Levac v James[6]
- In applying those same principles, Justice Rouleau was not satisfied with the appellant’s submission that the trial judge erred in conducting the subjective and modified objective causation analysis.
4.2. The Trial Judge Properly Applied the Law of Informed Consent
- The appellants submitted that the trial judge erred in conducting the subjective and modified objective causation analysis.
- On the issue of what Mr. Denman and a reasonable patient in his circumstances would have done had adequate disclosure been made, the trial judge found the following:
… [H]ad appropriate disclosure been made, neither Mr. Denman nor a reasonable patient in his circumstances would have elected to proceed with medical intervention that was to involve a series of embolizations, possibly and/or likely to be followed by a surgical resection.
- She also found that “neither Mr. Denman nor a reasonable patient in his circumstances would have elected to proceed with the June 23 and 24, 2015 combined procedure.
- In particular, the appellants argued that Mr. Denman’s personal circumstances, (i.e., his eagerness to resolve his AVM) were inadequately addressed by the trial judge. The appellants also took issue with the trial judge imposing a duty to provide exact statistical probabilities to Mr. Denman, and her failure to make a specific finding on what risks were required to be disclosed to Mr. Denman.
4.2.1. Mr. Denman’s Personal Circumstances were Considered
- While the trial judge did not provide a clearly laid out section defining the reasons to support her finding that neither Mr. Denman nor a reasonable person in his circumstances” would have elected to proceed with the various procedures, it was clear that the trial judge was well aware of Mr. Denman’s personal circumstances in applying the law.
- The evidence provided at trial by those who knew Mr. Denman personally disclosed important personal circumstances at the time the plan of treatment was proposed, which Justice Rouleau determined that the trial judge was alive to.
4.2.2. The Trial Judge Did Not Require Particular Statistics
- Rouleau J.A. also disagreed with the appellants and found that the trial judge imposed no requirement to provide a specific calculation of the level of risk or specific statistics in explaining the risk. Rather, the Court clarified what was required for the appellants to have disclosed in this case. Specifically, the appellants were required to disclose an order of magnitude or reasonable range of the risks involved in the proposed treatment.
- It was apparent to Rouleau J.A. that the trial judge relied on the evidence of Dr. Findlay, who estimated that the cumulative upfront risk of suffering a permanent neurological deficit if Mr. Denman proceeded with the plan of treatment was 30 to 50 percent. This evidence was not disputed at trial.
- According to Dr. Findlay, this up-front risk was to be compared to Mr. Denman’s lifetime risk of spontaneous bleed should he not undergo treatment, which was around 40 to 60 percent, although only a portion of such bleeds would result in serious disability or death.
- Justice Rouleau agreed that, had Mr. Denman been given the appropriate information, he would have weighed an immediate 30 to 50 percent upfront risk of permanent neurological deficit against a 40 to 60 percent risk of spontaneous bleed spread over a lifetime, of which only a fraction would have resulted in serious harm. Had this been the case, it is clear that Mr. Denman nor a reasonable person in his situation would have undertaken the suggested course of treatment.
- A fair reading of the trial judge’s reasons shows that the risks disclosed to Mr. Denman for the third combined procedure were inadequate. Even Dr. Pereira acknowledged that the risk communicated to the Denmans was well understated. As such, the trial judge’s conclusion on this issue was well supported by Justice Rouleau.
4.2.3. Duty to Obtain Consent in Team-Based Treatment Plans
- The appellants also submitted that if the trial judge’s findings regarding a breach of the duty of informed consent and causation were confirmed by the appellate court, that neither Dr. ter Brugge nor Dr. Radovanovic ought to have been found liable, as they did not bear the responsibility to obtain consent for the procedure that resulted in the injury.
- The appellants relied on a text by Gerald B. Robertson & Ellen I. Picard[7], as well as ss. 10(1) and 29(1) of the Health Care Consent Act, 1996 (“HCCA”) to advance the proposition that only the physician who actually administers treatment can be found liable for doing so without informed consent.[8]
- Justice Rouleau disagreed with this submission and confirmed that modern medical treatment may involve a team of doctors working together. Section 13 of the HCCA recognizes the reality of team-based treatment and provides that “[i]f a plan of treatment is to be proposed for a person, one health practitioner may, on behalf of all the health practitioners involved” propose the plan of treatment and obtain consent or a refusal of consent.”[9]
4.2.3.1. Liability of Dr. ter Brugge and Dr. Radovanovic
- As previously mentioned, following the AVM conference, Dr. ter Brugge was tasked with conveying the necessary information about the risks and benefits of the available options to Mr. Denman so that he could make an informed decision. In these circumstances, Justice Rouleau found it difficult to say that Dr. ter Brugge had no responsibility to provide Mr. Denman with adequate.
- Justice Rouleau agreed with the trial judge’s conclusion that Dr. ter Brugge did not adequately disclose the risks involved with the plan of treatment being proposed, or even with a single embolization treatment. Furthermore, Justice Rouleau did not accept the appellants’ argument that it was reasonable for Dr. ter Brugge to disclose only the risks attendant to the first embolization, considering the uncertainty of the success of the plan at the outset.
- In this case, the chain of causation was not broken to omit Dr. ter Brugge from liability. Justice Rouleau clarified that, in order to break the chain of causation, both the reasonably anticipated risks of undergoing the third set of procedures and the risks of deferring treatment should have been disclosed.Had this been done, Mr. Denman would then have been in a position to give his informed consent. The injury he suffered, therefore, would have been incurred after the physicians obtained informed consent for the procedure that caused injury and Dr. ter Brugge’s negligence would, arguably, not have been causal.
- However, Mr. Denman failed to receive adequate disclosure along the way. Meaning that, the chain of causation was not broken and Dr. ter Brugge shares the liability for inadequate disclosure to Mr. Denman. Any of the three doctors were required to provide adequate disclosure and obtain proper informed consent to break the chain.
- Justice Rouleau followed this reasoning to address the liability of Dr. Radovanovic and concluded that while Dr. Radovanovic was not the physician who provided the treatment that caused injury to Mr. Denman, the information provided to him by Dr. Radovanovic was lacking, misleading and inaccurate.
- In conclusion, Justice Rouleau found that but for the combined negligence of the appellants, Mr. Denman would not have agreed to the combined procedure and the injury to Mr. Denman would not have occurred.
4.2.4. Justice Rouleau Found No Evidentiary Issues
- The appellants also advanced various evidentiary issues. Particularly, the appellants found issue with the trial judge’s exclusion of Dr. Redekop from testifying because of bias. The appellants argued on appeal that the trial judge made a legal error in failing to apply White Burgess Langille Inman v. Abbott and Haliburton Co.[10], and choosing, instead, to ground her reasons in v. Abbott Laboratories, Ltd.[11], and to apply the factors listed in Wiseas a “strict test”.
- Justice Rouleau reiterated the well-established standard of review of a trial judge’s ruling on the admission of expert evidence. Namely that “Deference is owed to a trial judge’s decision on admitting expert evidence, unless the trial judge commits an error of principle, materially misapprehends the evidence, or reaches an unreasonable conclusion”.[12]
- It was concluded that this threshold for interfering with the trial judge’s decision is not met, and that the trial judge understood and applied the correct legal test. Moreover, the trial judge appropriately considered relevant case law, including Wise, but did not limit her analysis to the application of the Wise
[54] Justice Rouleau further disagreed with the appellants other submissions regarding Mrs. Denman’s and Dr. Findlay’s evidence.
4.3. The Trial Judge Did Not Make an Error in her Cost Awards
[55] The appellants lastly sought leave to appeal the trial judge’s cost order. They argued that the trial judge erred in awarding costs to the respondents “on an enhanced scale” in reliance on extraneous and irrelevant factors.
[56] Justice Rouleau refused to grant leave to appeal the costs award, stating that the trial judge’s award of costs is entitled to a high degree of deference, and that there was nothing to suggest that she directed herself to any irrelevant factors. Additionally, the award of $3 million is not unreasonable in the circumstances.
[57] In conclusion, Justice Rouleau dismissed the appeal.
4.4. Conclusion
[57] Justice Rouleau’s decision holds significant importance as it addresses the importance of obtaining informed consent, particularly in the context of team-based treatment plans, where more than one doctor is involved in providing care. This judgment provides clarification on an important area of the law, and serves as a guide for providing disclosure and obtaining informed consent in modern medical practice
[1] Hollis v. Dow Corning Corp., 1995 CanLII 55 (SCC) , [1995] 4 S.C.R. 634, at para. 24.
[2] Van Dyke v. Grey Bruce Regional Health Centre (2005), 2005 CanLII 18841 (ON CA), 255 D.L.R. (4th) 397 (Ont. C.A.), at para. 67.
[3] Watson v. Dr. Shawn Soon, 2018 ONSC 3809, 50 C.C.L.T. (4th) 83, at para. 82, citing Bollman v. Soenen, 2014 ONCA 36, 315 O.A.C. 90, at paras. 20-23.
[4] Reibl, at p. 928; Felde v. Vein and Laser Medical Centre (2003), 2003 CanLII 19431 (ON CA), 68 O.R. (3d) 97 (C.A.), at para. 14.
[5] R. v. G.F., 2021 SCC 20, 459 D.L.R. (4th) 375.
[6] Levac v. James, 2023 ONCA 73 at para 76.
[7]Gerald B. Robertson & Ellen I. Picard, Legal Liability of Doctors and Hospitals in Canada, 5th ed. (Toronto: Thomson Reuters Canada, 2017), at p. 213.
[8] Health Care Consent Act, 1996, S.O. 1996, c. 2, Sched. A (“HCCA”), ss. 10(1)[3] and 29(1)[4] [HCCA].
[10] White Burgess Langille Inman v. Abbott and Haliburton Co. 2015 SCC 23, [2015] 2 S.C.R. 182
[11] Wise. v. Abbott Laboratories, Ltd., 2016 ONSC 7275, 34 C.C.L.T. (4th) 25
[12] R v. Whatcott, 2023 ONCA 536, 168 O.R. (3d) 81, at para. 34.