Date: 19970312 Docket: GSS-2343 Registry: Charlottetown PROVINCE OF PRINCE EDWARD ISLAND IN THE SUPREME COURT - TRIAL DIVISION BETWEEN: CAROL BRYANT PLAINTIFF AND: NORMAN FENTON DEFENDANT Before: The Honorable Justice David H. Jenkins (Ruling on Defendant’s Motion for Dismissal) Patrick L. Aylward Alan K. Scales, Q.C. Place and Date of Hearing Place and Date of Judgment Counsel for the Plaintiff Counsel for the Defendant Charlottetown, Prince Edward Island December 4 and 6, 1996 January 23-24, and February 14 and 19, 1997 Charlottetown, Prince Edward Island March 18, 1997 GSS-2343 PROVINCE OF PRINCE EDWARD ISLAND IN THE SUPREME COURT - TRIAL DIVISION BETWEEN: CAROL BRYANT PLAINTIFF AND: NORMAN FENTON DEFENDANT Before: The Honourable Justice David H. Jenkins Place and Date of Hearing Charlottetown, Prince Edward Island December 4 and 6, 1996 January 23-24, and February 14 and 19, 1997 Place and Date of Judgment Charlottetown, Prince Edward Island March 18, 1997 PHYSICIANS AND SURGEONS - Informed consent - motion for nonsuit - theory of liability - onus - medical evidence. On a defendant’s motion for nonsuit, the Court held that the plaintiff had not made out a prima facie case as she did not adduce any evidence regarding two essential criteria upon which a jury properly instructed could find for the plaintiff. The plaintiff did not satisfy the onus which rests upon her to adduce evidence, first, that the cause of the condition which resulted from the surgery was a known risk of the procedure, and second, that disclosure of such risk should have been made as part of the physician’s duty to inform. The issue under consideration being the patient’s right to know what risks are involved in undergoing or foregoing surgery or other treatment, evidence of medical experts on scope of disclosure is not conclusive. However, in most cases, including this one, both determination of the cause as a known risk and the scope of the physician’s duty of disclosure must be determined with the assistance of medical evidence. The trier of fact must make the ultimate decision on these criteria based on evidence from physicians, the patient and her family. CASES CONSIDERED: Hyndman v. Jenkins (1980), 18 C.P.C. 303 (P.E.I.S.C.); Salgo v. Leland Stanford Jr. University Board of Trustees (1957) Cal. Ct. Appeals; Kelly v. Hazlett (1976), 75 D.L.R. (3d) 536 (Ont. S.C.); Hopp v. Lepp, [1980] 2 S.C.R. 192 - ii - (S.C.C.); Reibl v. Hughes, [1980] 2 S.C.R. 880 (S.C.C.); Videto v. Kennedy (1981), 125 D.L.R. (3d) 127 (Ont. C.A.); Rayner v. Knickle (1991), 88 Nfld. & P.E.I.R. 214 (P.E.I.S.C.A.D.); Canterbury v. Spence (1972), 464 F. 2d 772; Schanczl v. Singh, [1988] 2 W.W.R. 465 (Alta. Q.B.). TEXTS CONSIDERED: Sopinka, Lederman and Bryant, The Law of Evidence in Canada, Butterworths, 1992; Jay Katz, The Silent World of Doctor and Patient, Free Press, 1984; Gilbert Sharpe, The Law & Medicine in Canada (2 ed.), Butterworths, 1987. Patrick L. Aylward Alan K. Scales, Q.C. Counsel for the Plaintiff Counsel for the Defendant JENKINS J.: [1] Carol Bryant suffered from sinusitis. Because her condition was prolonged and was not responding to medical therapy, her family physician referred her to Norman Fenton, an ENT specialist. After a further period of confronting the condition with medications, substantial symptoms persisted, and Dr. Fenton then recommended a surgical approach. On February 17, 1987, Carol Bryant, then age 41, underwent a nasal septoplasty, bilateral sphenoethmoidectomy, an elective sinus surgery, which Dr. Fenton performed. Complications occurred during surgery and Carol Bryant’s right eye was damaged. [2] The evidence indicates something invaded the orbit of the right eye and caused ocular damage. According to Dr. Fenton’s surgery summary, the procedure was going quite well until the end, when the right sphenoethmoidectomy was being carried out and there was fairly brisk hemorrhaging from the region of the sphenoid or ethmoidal hair cells. Carol Bryant testified that during the weeks following the operation she did not do well. She could not see, could not stop vomiting, and could not understand what was wrong with her. She says Dr. Fenton told her he had cut an artery, and there was nothing to worry about. At first her eye was swollen shut and blackened. When she could open her eye her sight was arterially distorted and she suffered dizziness. This type of condition persisted for two years, until she obtained corrective surgery. Thereafter, she considered her residual condition to be a permanent injury. Her vision is diminished, her eye disfigured, she has dizziness from double vision, she suffers self-consciousness about her appearance and increased psychological problems, and she experiences related functional disabilities. [3] Carol Bryant, as plaintiff, brought this action against Norman Fenton, as defendant, for failure to obtain her informed consent to carry out the sinus operation. She alleges: he presented the surgery as essentially risk-free; he trivialized the risks; and he inadequately set out the risks, potential consequences from surgery and alternatives for management or treatment. She says he told her the main risk was the anaesthetic and the only way something could go wrong in surgery was if somebody bumped into his arm. The plaintiff does not allege the defendant was negligent in the performance of the operation. Her action is based on lack of informed consent. She submits the defendant as her physician obliterated the risk of sinus surgery and made his patient’s choice for her. [4] The plaintiff presented her evidence and then closed her case. Her evidence contained factual testimony from herself, family members and her family physician, and documentary evidence comprised of medical records of the defendant and the plaintiff’s family physician. Before electing whether to present evidence, the defendant moved for dismissal of the action on the ground that upon the facts and the law no case had been made out. The defendant submits in essence that the plaintiff failed to adduce any evidence of what risk materialized and whether the condition or complication resulted from a risk which the defendant was required to disclose. Nonsuit Page: 2 [5] Under Rule 52.11 it is the right of the defendant to move for dismissal of the proceeding at the close of the plaintiff’s case on the ground that upon the facts and the law no case has been made out. The defendant may move for a nonsuit without being called upon to elect whether he will call evidence. The law is well settled regarding the requirements to be satisfied for a grant of a motion for a nonsuit and regarding the test to be applied in determining whether the requirements are met. If a motion is launched, it is the trial judge’s function to determine whether any facts have been established by the plaintiff from which liability, if it is in issue, may be inferred. The judge decides whether there is any evidence, if left uncontradicted, to satisfy a reasonable person. The judge must conclude whether a reasonable trier of fact could find in the plaintiff’s favour if the trier of fact believed the evidence given in the trial up to that point. If the plaintiff has failed to adduce any evidence in her case in chief and the defendant brings a successful nonsuit motion, then the plaintiff’s action will be dismissed. See Sopinka, Lederman and Bryant, The Law of Evidence in Canada, pp. 130-134. A nonsuit motion will only be granted where no prima facie case is made out. If there is evidence upon which a jury properly instructed could find for the plaintiff, the weight of the evidence is for the finder of fact to determine and the motion ought to be dismissed: Hyndman v. Jenkins (1980), 18 C.P.C. 303 (P.E.I.S.C.), Campbell J. [6] I have concluded that the defendant’s motion must succeed. Upon application of the governing legal principles to the evidence adduced in the trial, the plaintiff has failed to bring any evidence regarding two essential criteria regarding any case which could in the circumstances give rise to liability on the defendant. First, there is no evidence that the cause of the condition which resulted from the surgery was a definite risk of the procedure; indeed, there is no evidence that a particular risk materialized to cause the plaintiff’s condition. Second, there is no evidence that disclosure of that risk should have been made as part of the defendant’s duty to inform. Each criterion needs to be satisfied. The burden of proof for both criteria is on the plaintiff. Such evidence would usually be expected to be found in, or supported by, expert medical testimony. [7] The existence of evidence regarding other criteria essential to a claim based on physician’s breach of duty to obtain the patient’s informed consent, however abundant, does not in the circumstances of this case substitute for evidence, particularly medical evidence, on these criteria. The plaintiff adduced evidence of the plaintiff’s pre-surgery condition and circumstances, of the procedure and it being elective, that the defendant recommended and performed the surgery, of the nature and extent of the defendant’s description or lack thereof of the risks of surgery and lack of advice regarding alternatives to surgery, of the plaintiff’s post-operative medical condition, injury and damages, and that she would have foregone the operation had she been aware of the existence and magnitude of the risk. As well, the Court will not employ a process of elimination and infer, based on the claim and the pleadings being confined to the single issue of consent, that negligence or other possible causes of the plaintiff’s condition are necessarily excluded. Proof of the facts of surgery and unfortunate result does not amount to evidence of physician’s failure to Page: 3 obtain the patient’s informed consent. In judging the evidence I assigned what I conceive to be the most favourable meaning which could reasonably be attributed to any ambiguous statements and determined on the whole what tendency the evidence has to establish the matters in issue, and from every fact proved drew legitimate and reasonable inferences and fair deductions as if they were proved directly for the purpose of a prima facie case. I also avoided any consideration of credibility. However, in the absence of either direct evidence or evidence upon which proof of the two mentioned criteria can be inferred, there is no evidence upon which a finder of fact properly instructed could find or infer liability. Consequently, there is no case to send to the finder of fact. Informed Consent: Theory of Liability [8] The legal doctrine of informed consent is a product of conflicting tensions between a patient’s liberty and a physician’s caring custody. The doctrine is relatively new, having emerged from American jurisprudence and had its birth and development from 1957 through 1972. In the 1950's, American judges began to ask whether patients are entitled not only to know what the doctor proposes to do, but also to decide whether an intervention is acceptable in light of its risks and benefits and the available alternatives, including no treatment. Informed consent surfaced in 1957 in the decision of Justice Bray in the California Court of Appeals in Salgo v. Leland Stanford Jr. University Board of Trustees. See Jay Katz, The Silent World of Doctor and Patient, Ch. 3. Canadian jurisprudence evolved from the decision of Justice Morden, then of the Ontario Supreme Court, in Kelly v. Hazlett (1976), 75 D.L.R. (3d) 536 (Ont. S.C.). Application of the law of informed consent involves appreciation of the theory of liability and consideration of material facts. The role of expert medical evidence has evolved, and is now fairly well settled in terms of both policy and precedent. [9] In his text, The Law & Medicine in Canada (2 ed.), pp. 34 ff., Gilbert Sharpe canvasses the legal rationale and the development of the law of informed consent in Canada. According to Sharpe, the nature, amount and quality of information disclosed to a patient about to undergo a medical procedure has emerged as the most important and, in some ways, the most confusing element in the consent forum. A look at first principles reveals that being Ainformed@ is merely one component necessary for a valid consent. Historically, consent served as a defence to the tort battery. The principle of consent, in its simplest form, concerns the patient’s right to know. Over the years, court decisions have required a higher level of disclosure and involved the theory of negligence. The current factors recognized by the courts as important when considering whether a patient has been sufficiently informed emanate from Kelly v. Hazlett and were modified and solidified by the Supreme Court of Canada in two decisions, Hopp v. Lepp, [1980] 2 S.C.R. 192, and Reibl v. Hughes, [1980] 2 S.C.R. 880, and then amplified by the Ontario Court of Appeal in Videto v. Kennedy (1981), 125 D.L.R. (3d) 127. The governing principles were employed and applied at the appellate level in this province in Rayner v. Knickle (1991), 88 Nfld. & P.E.I.R. 214 (P.E.I.S.C.A.D.). Page: 4 [10] As Sharpe mentions (at p. 36), the most interesting aspect of Kelly v. Hazlett is the manner in which the finding of liability was developed. Rather than basing liability in battery, liability for failure to obtain the patient’s informed consent was based on a failure to disclose risks being a breach of the physician’s general duty of care to give reasonable information and advice to the patient. Where the basic nature and character of the operation performed is substantially that which the patient was advised of and agreed to, then there is not an unconsented-to invasion of the person constituting battery, regardless of any failure to disclose collateral risks associated with the operation. An action framed in battery would not succeed. However, such failure, if not justified by reasonable medical considerations, may properly be the basis for a claim in negligence should the procedure result in damage to the patient. In this theory, even where a risk is collateral but still material, if its disclosure is essential to an informed decision to undergo the operation, lack of such disclosure should vitiate the consent. [11] The distinction carries significant implications regarding onus of proof. In the battery analysis the onus is on the defendant physician to prove facts that indicate a valid consent regarding the basic nature of the surgery. In the negligence analysis for breach of duty to inform the plaintiff patient bears a significant burden of proof. Sharpe (at p. 37) states: The learned trial judge [Morden] then adopted the negligence analysis prevalent south of the border wherein the onus rests on the plaintiff to satisfy a number of criteria: first, that the condition that resulted from the surgery was a definite risk of the procedure; next, that disclosure of that risk should have been made as part of the defendant’s duty to inform. This duty must be determined with the assistance of medical evidence on what would be the proper scope of disclosure in the circumstances. The test is not based on the information a reasonable patient might expect in the circumstances but rather what a reasonable physician would disclose. Finally, the plaintiff must establish the causal link. In this case [Kelly v. Hazlett], she had to show that, had the defendant properly informed her of the risk involved in the osteotomy, she would have foregone the operation. (The basis for the test was modified subsequently by the Supreme Court of Canada.) [12] Reibl v. Hughes at the trial level clarified the distinction between battery and negligence where consent is at issue. According to Sharpe (at pp. 38-39), this enshrined in Canadian law the link between informed consent and a physician’s duty of care. Justice Haines stated: ...The nice point, however, is to determine which instances should properly be treated within the confines of the law of battery, and which should attract the calculus of negligence. The distinction is one of considerable importance... Page: 5 ..... In respect of a claim in negligence, the issue of informed consent to treatment is a concomitant of the physician’s duty of care. A surgeon’s duty to exercise due skill and care in giving his patient reasonable information and advice with respect to the risks specifically attendant on a proposed operative procedure arises out of the special relationship between them. It is a particular case of the duty which is cast on professional persons in a fiduciary position called upon specifically or by implication to give information or advice to a client intending and entitled to rely on his statements to determine his course....That duty does not require warning the patient of the dangers incident to or possible in any surgical procedure, such as the dangers of anaesthesia or the risk of infection, matters which men of ordinary knowledge are presumed to appreciate. It relates to the specific risks within the surgeon’s knowledge peculiar to the contemplated treatment. [13] The Supreme Court of Canada departed somewhat from the traditional negligence analysis of what a reasonable physician would have disclosed in the circumstances and directed consideration instead of what a reasonable patient in a plaintiff’s circumstances would have wanted to know, and what a reasonable patient would have decided. This revision of the issue necessarily affects the role and the diminishes the impact of expert medical evidence. Each case involves particular facts regarding patient and surgery. It is the duty of disclosure to the patient that affects the validity of her consent. Evidence of medical experts of custom or general practice as to scope of disclosure cannot be decisive but is a factor to be considered. In Reibl v. Hughes Chief Justice Laskin stated (at p. 894): ...To allow expert medical evidence to determine what risks are material and, hence, should be disclosed and, correlatively, what risks are not material is to hand over to the medical profession the entire question of the scope of the duty of disclosure, including the question whether there has been a breach of that duty. ...The issue under consideration is a different issue from that involved where the question is whether the doctor carried out his professional activities by applicable professional standards. What is under consideration here is the patient’s right to know what risks are involved in undergoing or foregoing certain surgery or other treatment. The ratio of Reibl v. Hughes on this issue is that in determining whether risks are material, physicians alone cannot make this decision, and the trier of fact must make the ultimate decision based on evidence of physicians, patients and their families. [14] Reibl v. Hughes clearly enunciates that materiality of non-disclosure of certain risks to an informed decision is a matter for the trier of fact, and that it is a matter on which there would, in all likelihood, be medical evidence. Contrary to the plaintiff’s submissions in this case, it does not follow from the proposition that medical evidence is not decisive that medical evidence is unnecessary. The Supreme Court of Canada stated what it characterized as a useful summary of issues on which medical evidence of non-disclosure Page: 6 cases remains significant (at p. 895). It referred to the American case of Canterbury v. Spence: Even Canterbury specifically notes that expert testimony will still be required, in all but the clearest instances, to establish (1) risks inherent in a given procedure or treatment, (2) the consequences of leaving the ailment untreated, (3) alternative means of treatment and their risks, and (4) the cause of the injury suffered by the plaintiff-patient. ... [15] In order to establish that a physician’s negligence was a cause of an injury, a patient, as plaintiff, needs to be able to show she has suffered loss as a result of the recommended treatment and that as a reasonable person in her position she would not have consented had required disclosure been made. In the absence of any expert evidence regarding either (i) a known risk having materialized to cause the injury, and (ii) such risk being within the scope of risks which the physician should have disclosed, the finder of fact would have no basis to assess whether any breach of duty by the defendant physician was a cause of the injury. In the case at Bar, the plaintiff adduced some evidence, albeit minimal, of the cause of the injury. However, no evidence was adduced to classify this occurrence as a known risk or that it was a risk which should have disclosed. In Reibl v. Hughes the Supreme Court characterized the evidence of the parties as to what the physician told the patient, rather than the expert medical opinions, as being the crucial evidence; however, that determination was made within the context of a case in which the body of evidence contained expert medical opinions regarding both the risk that occurred and the proper scope of disclosure. [16] In Videto v. Kennedy the Ontario Court of Appeal created an eight-point list regarding the physician’s responsibility for disclosure. Two of the factors point directly to the need for medical evidence: ! The scope of the duty of disclosure and whether it has been breached must be decided in relation to the circumstances of each case. ! The question of whether a particular risk is a material risk is a matter for the trier of fact. It is also for the trier of fact to determine whether there has been a breach of the duty of disclosure. The Court then stated that the plaintiff had the onus of establishing that the physician’s failure to make a proper disclosure amounted to negligence. [17] A canvass of the cases filed by the parties with their pre-trial briefs and on this motion indicates judicial consistency on this issue. There was medical evidence in each case. Depending on the circumstances of the medical procedure and the case, the requirements for proof on liability varied. In Schanczl v. Singh, [1988] 2 W.W.R. 465 (Alta. Q.B.), Marshall J. stated that before deciding what a reasonable patient in the Page: 7 position of the plaintiff would consider to be Amaterial risks@ or Aspecial or unusual risks@ about which he would want to receive information, ...the court will certainly expect to hear medical evidence on the question of what the risks inherent in a particular operation are, how serious these risks are, how frequently these risks may arise, and what information medical practitioners usually transmit to their patients in relation to these risks. But that is not all the Court will have regard to;... In this jurisdiction the analysis of Chief Justice Carruthers, writing for the Court in Rayner v. Knickle, is pertinent to this ruling. First, he noted the risk which caused the injury and then considered whether it needed to be disclosed. He stated that the real question to be decided on the issue of informed consent is whether there is a risk which in the circumstances of the case under consideration requires disclosure. For this, the trial judge must know what particular risk he is dealing with before he can decide whether the risk involved is material as to require disclosure. [18] As counsel for the plaintiff submits, to repel the defendant’s motion she must show just enough evidence to make out a prima facie case on any one basis of liability arising from the pleadings. The plaintiff’s action is based solely in breach of physician’s duty to obtain the patient’s informed consent. In my assessment the plaintiff’s action could not succeed in any of its manifestations, i.e. risks being trivialized, failure to inform or to adequately inform, failure to advise of alternatives, including no surgery. Without medical evidence, there is no evidence upon which in the circumstances of this case a finder of fact could determine an appropriate standard. The plaintiff adduced evidence of what the defendant disclosed, but there is no evidence to serve as a benchmark from which it can be assessed that there is either a risk or an alternative treatment which he either did not disclose or failed to adequately disclose. [19] Counsel for the plaintiff submits there is evidence, including medical evidence, of the risk which materialized. He says the medical records indicate complications occurred, and the medical records and the plaintiff’s testimony provide evidence that she suffered invasion of the orbit and subsequent diplopia. The plaintiff submits the defendant invaded the orbit of the right eye, and that was the risk that materialized. In my view, there are two problems with that analysis. First, whether characterized a condition, complication or injury, this does not describe a risk, but a result. The risk would be the exposure to danger or to mischance (eg. a danger of cutting an artery and blood invading the eye; a risk of catching a cold; a risk of a needle puncture during amniocentesis causing a hypoxicischemic insult, etc.); a hazard. There is no evidence that what happened was a risk. Its occurrence does not necessarily infer it was a known risk of a properly performed surgical procedure. Second, even if there was evidence that a risk materialized and caused the unfortunate result, then another criteria unfulfilled is whether such risk was a material or special or unusual risk requiring disclosure in the circumstances of the case. In Rayner v. Page: 8 Knickle the Court stated (at para. 58) that the failure of the trial judge to decide whether the risk of the needle striking the umbilical cord and causing a haematoma, which in turn reduced the oxygen flow to the fetus, was a risk requiring disclosure was a palpable error which affected his assessment of the facts of the case. [20] Determination of this motion for a nonsuit does not involve consideration of causation, which is a third criteria for liability for which the plaintiff bears the onus of proof. On this issue, the test is what a reasonable person in the patient’s position would have done if the particular risk that developed had been disclosed. Relevant to this point is whether the procedure is necessary and, if so, how necessary. This question is to be determined with medical evidence. One must ask whether a reasonable patient in those circumstances would have proceeded. See Sharpe at p. 46. On application to the facts of the test for a prima facie case the defendant might well succeed on this ground, too. The plaintiff adduced medical evidence that the procedure was elective, evidence from the plaintiff and her family regarding her pre-operative condition, and evidence that she would not have undergone the operation had she known the potential for such adverse collateral consequences. The plaintiff’s family physician responded to a plaintiff inquiry following the operation that just because a procedure is elective A...does not necessarily mean it is not required for your benefit.@ Without entering the purview of weighing the evidence, it appears to me that in the absence of medical evidence beyond the factual evidence which the plaintiff adduced it could reasonably be concluded that while there is some evidence on this criteria, that since there is no medical evidence, which is one of the kinds of evidence which would be required in the circumstances, there is no evidence upon which a jury properly instructed could conclude that a reasonable person in the plaintiff’s position would have foregone the operation. Conclusion [21] Carol Bryant’s condition surely evokes sympathy. There is no doubt she has suffered and that she bears some permanent injury. It is also apparent that damage to her eye occurred during her sinus surgery. However, those circumstances do not automatically imply or give rise to liability on the physician who performed the surgery. For liability to ensue, the plaintiff must show on the balance of probabilities either that the physician was in some way negligent in performance of the surgery, for which the plaintiff did not in this case pursue a claim, or that the physician failed to obtain her informed consent for performance of the surgical procedure. In this case, the plaintiff has not adduced evidence regarding two, and perhaps three, of the criteria for liability on the physician for breach of duty to inform the patient and obtain her consent. The defendant’s motion for nonsuit must succeed. The plaintiff’s action against the defendant is dismissed. Costs [22] The defendant is awarded his costs on the motion for dismissal under Rule 52.11 on Page: 9 a party and party basis to be assessed. Regarding the residual issue of costs on the plaintiff’s earlier motion under Rule 52.10, in which the defendant was awarded his cost of additional work done as a result of that motion, additional costs on the nonsuit motion incurred on the supplementary hearing date of February 19, 1997, were caused by the plaintiff’s motion for leave under Rule 52.10, and so the defendant is also awarded his actual reasonable costs, as opposed to only party and party costs, for that supplementary hearing date. Regarding costs on the action beyond these motions, I expect the usual principles on costs would apply. Costs normally follow the event. On that basis the defendant would be entitled to his costs of the action on a party and party basis. However, I recognize my determination could be affected by submissions from the parties. Therefore, should the parties be unable to agree on the appropriate disposition regarding costs of the action, I would entertain their written submissions on this issue by May 15, 1997. _____________________________________ Justice David H. Jenkins March 18, 1997