McLean v Valadka: Informed Consent, Cryptogenic Stroke, and the Modified Objective Test

The framework for informed consent in Canadian medical law is one of the most well-developed and well-articulated areas of medical malpractice doctrine. The framework was established in the foundational Supreme Court of Canada decisions of the 1980s, has been refined through subsequent appellate authority, and has been applied in hundreds of trial decisions across the country. The framework operates as a meaningful protection for patient autonomy and as a meaningful cause of action where the physician’s failure to disclose has affected the patient’s decision-making. The framework is also, as cases like McLean v. Valadka illustrate, calibrated to require more than substandard documentation to support a successful claim.

McLean v. Valadka, 2023 ONSC 6803, released by the Ontario Superior Court of Justice on December 1, 2023, is a recent and substantive Ontario application of the informed consent framework in the context of birth control prescribing. The plaintiff, a young woman, suffered a stroke after taking a brand of birth control pill prescribed by her family physician. She alleged that the physician had failed to advise her of the increased risk of stroke associated with the particular brand prescribed (Yaz, a combined oral contraceptive containing drospirenone and ethinyl estradiol). The trial proceeded on the informed consent framework and on the causation framework for the underlying stroke. After hearing extensive expert evidence from family medicine and stroke neurology specialists on both sides, the court dismissed the action.

The case is doctrinally important for several reasons. It is a substantive recent articulation of the informed consent framework in the context of medication prescribing, with the trial judge providing a clear summary of the controlling Supreme Court of Canada authority. It addresses the framework for the “modified objective” component of the causation analysis, including how the framework operates where the patient testifies that she would not have proceeded with the treatment if properly informed. It illustrates the framework’s treatment of substandard documentation as part of, but not dispositive of, the consent inquiry. It provides a worked example of the framework for causation analysis in cryptogenic stroke cases, where the cause of the stroke cannot be definitively established. And it offers a useful reference for the practical reality that informed consent claims, like all medical malpractice claims, require the plaintiff to meet a multi-part framework in which any step can be the basis of dismissal.

The legal framework — informed consent in Canadian medical law

A brief overview of the informed consent framework is useful for the analysis.

The foundational framework. Modern Canadian informed consent doctrine was established in the Supreme Court of Canada’s twin 1980 decisions of Hopp v. Lepp, [1980] 2 SCR 192 and Reibl v. Hughes, [1980] 2 SCR 880. The framework articulated in these decisions has been applied in thousands of subsequent cases and remains the controlling foundation for the doctrine in Canadian law.

The framework includes several core propositions:

• Physicians have an affirmative duty to disclose material information about proposed treatments, without waiting for the patient to ask
• The framework requires disclosure of the nature of the procedure or treatment, its purpose, its material risks (including low-probability risks where they are material), and the available alternatives
• The framework operates on the principle of patient autonomy: every individual has the right to decide what will be done with their body, with the corresponding right to make meaningful decisions based on full understanding
• Informed consent is a distinct cause of action, separate from the standard of care framework for negligence

The framework was substantively confirmed and elaborated in Hollis v. Dow Corning Corp., [1995] 4 SCR 634 (in a slightly different doctrinal context addressing manufacturer duties), which collected the Hopp v. Lepp and Reibl v. Hughes statements of the framework and affirmed their continuing application.

The disclosure component. The first component of the framework addresses what the physician must disclose. The framework requires:

• Disclosure of the nature and purpose of the treatment
• Disclosure of the material risks, with materiality assessed with reference to what a reasonable patient in the position of the specific patient would want to know
• Disclosure of low-probability risks where they are nonetheless material (typically because the consequences if they materialize are severe)
• Disclosure of alternatives, including the alternative of no treatment, with the risks and benefits of each
• The disclosure must be appropriate to the specific patient’s circumstances, education, and stated concerns

The framework is calibrated by the materiality requirement. Not every conceivable risk requires disclosure. The framework operates on what a reasonable patient would want to know in the specific circumstances, with the consequence that the analysis is highly fact-dependent.

The causation framework. Where the plaintiff establishes a failure of disclosure, the framework moves to causation. The causation framework in informed consent operates differently from causation in standard negligence. The framework requires the plaintiff to prove that, had the disclosure been adequate, the patient would not have proceeded with the treatment that caused the harm.

The causation framework includes two components:

The subjective component. The patient must testify, and the court must find as a fact, that she herself would not have undergone the treatment if properly informed. The framework requires credible evidence from the patient about what her decision would have been in the counterfactual world of full disclosure.

The modified objective component. The framework was concerned that subjective testimony given after the harm has occurred (and after the litigation has been commenced) is unreliable on its own. The framework therefore requires that a reasonable person in the patient’s position (with the patient’s relevant characteristics, circumstances, and stated concerns) would also not have undergone the treatment with full disclosure. The framework’s modification of the objective standard is that it considers the patient’s specific circumstances, not the framework of a generic “reasonable person” abstracted from the case.

The framework can dismiss claims at either the subjective or the modified objective step. Where the patient’s own testimony is found not to be credible on the counterfactual decision, the framework fails. Where the patient’s testimony is credible but the framework concludes that a reasonable patient in those circumstances would have proceeded anyway, the framework also fails.

The framework’s policy rationale. The framework’s structure reflects two policy considerations:

• The protection of patient autonomy, which the framework operationalizes through the disclosure requirement and the patient’s standing to bring an informed consent claim
• The protection against retrospective rationalization, which the framework operationalizes through the modified objective component

The framework operates as a meaningful protection in cases where the disclosure failure has actually affected the decision. It does not extend the framework’s protection to cases where the patient would have proceeded with the treatment regardless of the disclosure.

The framework’s relationship to documentation. A specific subset of the framework concerns the relationship between documentation of the consent discussion and the substantive finding of consent. The framework treats documentation as evidence of the consent discussion, but not as the sole determinant. Where documentation is substandard or incomplete, the framework can still support a finding that the discussion occurred and was adequate, based on the credible evidence of the parties about what was said.

This is doctrinally important because it captures the practical reality of clinical practice: physicians often have consent discussions that are not fully captured in the chart, and patients often have memories of those discussions that have been affected by the subsequent harm and litigation. The framework’s response is to assess credibility of all the available evidence rather than to treat documentation as dispositive.

The clinical context — combined hormonal contraception and stroke

A brief clinical overview is useful for the analysis.

Combined hormonal contraception. Combined hormonal contraceptive pills contain an estrogen component (typically ethinyl estradiol) and a progestin component (variably drospirenone, levonorgestrel, norethindrone, and others). The framework for clinical use includes contraception, management of menstrual irregularities, and management of certain hormonal conditions. Combined hormonal contraceptives are among the most widely prescribed medications in clinical practice.

The stroke risk profile. Combined hormonal contraceptives carry a small but real absolute risk of stroke, with the risk varying by:

• The specific estrogen and progestin formulation
• The dose of the estrogen component
• The patient’s individual risk factors (age, smoking, hypertension, migraine with aura, thrombophilic conditions, family history)
• The duration of use

The framework recognizes that the absolute risk in healthy young women is low (in the range of 1 to 2 strokes per 10,000 woman-years of use depending on the specific framing). The relative risk compared to non-users is approximately doubled. The framework treats this as a material risk for informed consent purposes despite the low absolute probability.

The Yaz framework specifically. Yaz is a brand-name combined oral contraceptive containing drospirenone (a progestin) and ethinyl estradiol (an estrogen). Yaz was approved for use in Canada in the mid-2000s. The framework for clinical use is similar to other combined hormonal contraceptives, with some specific considerations:

• The drospirenone component has potassium-sparing diuretic activity, which can be relevant in specific clinical contexts
• The product monograph and subsequent regulatory communications have addressed the framework of risk including stroke risk
• Marketing for Yaz emphasized certain non-contraceptive benefits, which became the subject of regulatory commentary in some jurisdictions

The framework for prescribing Yaz operates on the general framework for combined hormonal contraception, with appropriate disclosure of the risk profile including the stroke risk.

Cryptogenic stroke. A cryptogenic stroke is a stroke for which a definitive cause cannot be identified after appropriate diagnostic workup. The framework for stroke causation includes several recognized categories:

• Atherosclerotic stroke (large or small vessel)
• Cardioembolic stroke
• Stroke from specific identifiable conditions (arterial dissection, vasculitis, hypercoagulable state, paradoxical embolism)
• Cryptogenic stroke (cause unknown after appropriate workup)

The framework for assessing causation in a stroke case operates differently depending on the category. Where the stroke is cryptogenic, the framework treats the cause as unproven, with implications for the legal framework for causation.

The causation question in stroke after hormonal contraception use. Where a stroke occurs in a patient who has been using hormonal contraception, the framework for causation involves several considerations:

• The temporal association (the stroke occurred while the patient was taking the medication)
• The biological plausibility (combined hormonal contraception is associated with stroke risk)
• The framework of recognized stroke risk factors (other than the medication)
• The findings of the diagnostic workup (whether a specific alternative cause was identified)
• The framework of population-level versus individual-level attribution

The framework for the legal question is whether, on the balance of probabilities, the medication caused this specific stroke. Where the workup has not identified a specific alternative cause and the medication is associated with an elevated risk, the framework can support attribution to the medication. Where the workup has identified an alternative cause, the framework typically does not support attribution to the medication. Where the workup is inconclusive (cryptogenic stroke), the framework’s outcome depends on the specific evidence in the case.

The facts

The patient. The plaintiff was a young woman in her twenties at the time of the relevant events. She was generally healthy with no significant pre-existing medical conditions of clinical significance.

The prescription. The plaintiff’s family physician prescribed Yaz for contraceptive purposes. The framework of the prescription was a routine combined oral contraceptive prescription consistent with the family practice framework.

The consent discussion. The framework of the consent discussion was contested at trial. The physician’s documentation of the consent discussion was substandard, with the trial judge specifically commenting on the inadequacy of the note-taking. The plaintiff testified that the increased stroke risk associated with Yaz had not been discussed. The physician testified that the increased stroke risk had been discussed. The court was required to make findings about what had been said.

The stroke. Some time after starting Yaz, the plaintiff suffered an ischemic stroke. She required medical treatment and rehabilitation. The framework of her recovery was reasonably good in the circumstances; the trial judge described her recovery as “fairly good”.

The diagnostic workup. The plaintiff underwent an extensive stroke workup designed to identify a specific cause of the stroke. The framework of the workup included cardiac evaluation, vascular imaging, hypercoagulability testing, and other components calibrated to a young patient with stroke. The workup did not identify a definitive cause. The stroke was classified as cryptogenic.

The litigation. The plaintiff commenced an action against her family physician alleging that the physician had failed to obtain informed consent for the Yaz prescription, specifically by failing to advise of the increased stroke risk. The framework of the claim was the informed consent framework rather than a claim based on a breach of the standard of practice in the prescription itself.

The trial. The trial proceeded with expert evidence from both sides on the informed consent question and on the stroke causation question.

The trial judge’s analysis

The informed consent framework summary. The trial judge provided a useful summary of the informed consent framework, drawing on Hollis v. Dow Corning Corp. and the earlier Hopp v. Lepp and Reibl v. Hughes decisions. The framework as summarized in the reasons:

• Physicians have an affirmative duty to disclose material risks, including low-probability risks, without waiting for the patient to ask
• The framework operates on the principle of patient autonomy
• Informed consent is a distinct cause of action separate from breach of the standard of care
• The framework requires a two-part test, with both adequate disclosure and causation
• The causation framework includes a subjective component and a modified objective component
• The framework’s application is highly fact-specific

The trial judge’s summary is a useful and accessible articulation of the framework that can be cited in subsequent informed consent cases.

The disclosure finding. The trial judge found that the physician had advised the plaintiff of the increased risk of stroke associated with Yaz, notwithstanding the substandard documentation of the consent discussion. The framework’s reasoning included:

• The physician’s testimony about the consent discussion, which the court accepted
• The physician’s general practice of discussing risks with patients in this context
• The plaintiff’s testimony, which the court was required to weigh against the physician’s
• The framework’s recognition that substandard documentation does not preclude a finding that the discussion occurred

The framework’s treatment of the documentation question is significant. The trial judge specifically noted that the documentation was substandard while still finding that the consent discussion had occurred and had been adequate. The framework treats documentation as relevant but not dispositive.

The subjective causation finding. Even if the framework had supported a finding that the consent discussion was inadequate, the trial judge found that the plaintiff would have taken the medication anyway. The framework’s reasoning included:

• The plaintiff’s own testimony in the framework of the trial
• The framework of contraceptive options available to the plaintiff
• The plaintiff’s personal circumstances and preferences

The framework’s finding on subjective causation was an alternative basis for dismissal even if the disclosure finding had gone the other way.

The causation analysis on the stroke. Independent of the informed consent framework, the trial judge addressed the framework of causation for the stroke itself. The court preferred the defence expert evidence on stroke neurology over the plaintiff’s expert evidence. The framework’s findings:

• The plaintiff had suffered a cryptogenic stroke
• The extensive stroke workup had not identified a definitive cause
• The framework for legal causation requires more than temporal association
• The framework treats unknown cause as failing to establish that the medication was the cause

The framework’s finding on causation was a further alternative basis for dismissal. Even if the informed consent claim had succeeded, the framework’s failure on stroke causation would have meant no damages were recoverable.

The damages assessment. Despite the dismissal, the trial judge assessed damages in the alternative. The framework included:

• General damages: $75,000
• Past loss of income: $75,000
• Out-of-pocket expenses: $6,887.41
• Future loss of income: $0
• OHIP subrogated claim: $27,871.08
• Loss of interdependent relationship: $0
• Future care costs: $25,000

The framework’s alternative assessment is useful for understanding the value of similar cases where liability is established. The total of approximately $209,000 reflects a young plaintiff with a reasonably good recovery from stroke; cases with more severe sequelae would attract substantially higher damages.

The doctrinal anchors

Several doctrinal anchors emerge from the case.

The informed consent framework as a distinct cause of action. Informed consent is a separate cause of action from breach of the standard of care. The framework requires its own elements (disclosure failure; causation) and produces its own remedy where the framework is met. McLean v. Valadka applies the framework with explicit reference to its independence from negligence claims.

The Hollis / Hopp v. Lepp / Reibl v. Hughes foundation. The Supreme Court of Canada’s foundational decisions establish the framework. The framework’s principles include the affirmative duty to disclose, the materiality standard, the framework for low-probability risks, the framework for alternatives, and the framework for patient autonomy.

The duty to disclose without being asked. The framework imposes an affirmative duty on the physician to disclose material risks. The patient does not have to ask. McLean v. Valadka operates on this framework.

The framework for low-probability risks. The framework requires disclosure of low-probability risks where they are nonetheless material. The framework’s calibration of materiality considers the severity of the consequence if the risk materializes. McLean v. Valadka applies the framework to the stroke risk associated with combined hormonal contraception, which is low in absolute terms but material because of the severity of stroke as a consequence.

The two-part test for informed consent. The framework includes disclosure (was the disclosure adequate?) and causation (would the patient have proceeded with adequate disclosure?). Both components must be satisfied. McLean v. Valadka applies the framework with both components addressed.

The subjective causation component. The framework requires the patient to testify, and the court to find as fact, that she would not have proceeded with adequate disclosure. The framework relies on credible patient testimony about a counterfactual decision.

The modified objective component. The framework requires that a reasonable patient in the position of the specific patient would also not have proceeded. The framework’s “modified” character is that it considers the specific patient’s circumstances rather than applying a generic reasonable person standard.

The “fact-specific” framework. The framework’s application turns on the specific facts of the case. McLean v. Valadka explicitly notes that both steps of the informed consent test are highly fact-dependent. The framework does not produce uniform outcomes across superficially similar cases.

The cryptogenic stroke / unknown cause causation framework. Where the stroke is cryptogenic and no specific alternative cause has been identified, the framework for legal causation requires more than temporal association with a medication. The framework can fail on causation even where the medication is associated with the harm at the population level.

The “substandard documentation does not equal failure of consent” framework. Documentation of the consent discussion is relevant but not dispositive. The framework treats the documentation as one piece of evidence among others (including the physician’s testimony, the patient’s testimony, the physician’s general practice, and the surrounding circumstances). McLean v. Valadka applies the framework to a case with substandard documentation where the consent discussion was nonetheless found to have occurred.

The framework for credibility findings on consent discussions. Where the parties give competing accounts of the consent discussion, the framework requires the trial judge to make credibility findings. The framework’s findings are entitled to substantial deference on appeal absent palpable and overriding error.

The expert evidence preference framework in cryptogenic stroke cases. Where the framework involves contested expert evidence on a cryptogenic stroke, the trial judge’s preference for one side’s expert evidence is entitled to substantial deference. McLean v. Valadka applies the framework with the court preferring the defence stroke neurologist’s evidence.

The birth control / hormonal contraception prescribing framework. Combined hormonal contraception prescribing operates within the general framework for medication prescribing including individualized risk assessment, appropriate disclosure of risks, and ongoing monitoring. The framework includes specific consideration of the stroke risk profile and the patient’s individual risk factors.

The “in any event” framework for causation. Where the framework’s outcome on standard of care is contested, the framework for causation can operate as an alternative basis for dismissal. McLean v. Valadka applies the framework, with both the subjective causation finding and the underlying stroke causation finding operating as alternative bases for the dismissal.

The damages quantification framework in dismissal cases. Even where the framework results in dismissal, the trial judge can assess damages in the alternative. The framework’s alternative assessment is useful for understanding the value of similar cases where liability is established. McLean v. Valadka provides an alternative damages assessment that is informative for comparable cases.

Why this case matters

For patients considering or affected by hormonal contraception decisions. The case is a useful illustration of the framework’s operation in the medication prescribing context.

Some practical observations:

Hormonal contraception is associated with a small but real stroke risk. The framework for clinical practice includes disclosure of this risk. The framework’s recognition of the risk does not mean that hormonal contraception is inappropriate; it means that the patient is entitled to know about the risk in making her contraceptive choice.

Individual risk factors matter. The framework for combined hormonal contraception is calibrated to the patient’s individual risk factors including age, smoking status, blood pressure, migraine history, and other clinical features. Where multiple risk factors are present, the framework may support alternative contraceptive approaches.

Documentation of consent discussions matters but is not everything. The framework treats documentation as relevant but not dispositive. The substantive consent discussion is what counts; documentation is evidence of that discussion.

Causation can defeat a claim even where consent was inadequate. McLean v. Valadka illustrates the framework’s structure: even if disclosure had been found inadequate, the case would have failed on causation because the stroke was cryptogenic. Patients and families should understand that the framework for case evaluation includes the causation analysis as well as the standard of care analysis.

Not every adverse outcome supports a claim. McLean v. Valadka is an example of a case that did not succeed despite a serious adverse outcome (stroke in a young patient). The framework for medical malpractice operates on the framework’s elements (standard of care or informed consent; causation; damages) and dismisses claims where any element is not satisfied. For more on the framework for case evaluation, see Why Many Medical Malpractice Cases Are Declined in Ontario. For more on the broader framework for civil claims, see Suing for Medical Malpractice in Ontario: What You Need to Know.

For physicians. A few practical observations:

The duty to disclose is affirmative. The framework does not wait for the patient to ask. Physicians have an obligation to disclose material risks including low-probability risks where they are material.

Documentation matters even if not dispositive. The framework treats substandard documentation as relevant evidence in the analysis. Where the consent discussion has occurred, the framework benefits from clear documentation of what was said. The framework’s protection against substandard documentation through credible testimony is a meaningful but imperfect framework; better documentation is a meaningful protection in itself.

The framework’s causation component is robust. Even where a disclosure failure is established, the framework requires the plaintiff to prove that adequate disclosure would have changed the decision. The framework operates as a meaningful filter against claims where the patient would have proceeded with the treatment regardless.

A final thought

McLean v. Valadka is a useful reference point in the informed consent doctrinal area. The trial judge’s summary of the framework is clear and well-grounded in the controlling Supreme Court of Canada authority. The framework’s application to the facts illustrates how the framework’s multiple components operate in practice, with the alternative grounds for dismissal (subjective causation; cryptogenic stroke) demonstrating how the framework’s protective function operates at multiple levels.

For families thinking about whether something has gone wrong with care involving combined hormonal contraception, the case is a reminder that the framework for evaluation is multi-step and that the framework’s outcome depends on the specific facts. A young stroke patient with serious sequelae is a sympathetic plaintiff, and the framework’s elements are nonetheless required to be proven. Where they cannot be proven, the framework supports dismissal.

For physicians prescribing combined hormonal contraception, the case is a reminder that the framework for informed consent requires affirmative disclosure of the stroke risk among the material risks, regardless of the framework’s complexity and the patient’s apparent low individual risk. The framework supports the patient’s right to make the decision with full information about the risks.

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Decision Date: December 1, 2023

Jurisdiction: Ontario Superior Court of Justice

Citation: McLean v. Valadka, 2023 ONSC 6803 (CanLII)

Outcome: Action dismissed. The trial judge found that the defendant family physician had advised the plaintiff of the increased risk of stroke associated with the Yaz combined oral contraceptive, despite substandard documentation of the consent discussion. In the alternative, the court found that the plaintiff would have taken the medication even with adequate disclosure (subjective causation step failed). Independently, the court found that the plaintiff had suffered a cryptogenic stroke for which no specific cause could be identified after extensive workup, and that the framework for legal causation required more than temporal association with the medication. The framework supported dismissal at multiple steps. The trial judge assessed damages in the alternative at approximately $209,000 (general damages $75,000; past loss of income $75,000; out-of-pocket expenses $6,887.41; future loss of income nil; OHIP subrogated claim $27,871.08; loss of interdependent relationship nil; future care costs $25,000). The trial proceeded with expert evidence from both sides on the informed consent question (family medicine specialists for the plaintiff and defence) and on the stroke causation question (stroke neurology specialists for the plaintiff and defence).

Key authorities: Hollis v. Dow Corning Corp., [1995] 4 SCR 634 (collected statement of the informed consent framework); Hopp v. Lepp, [1980] 2 SCR 192 (foundational SCC authority on the duty to disclose); Reibl v. Hughes, [1980] 2 SCR 880 (foundational SCC authority on informed consent including the modified objective test).