On December 1, 2023, the Ontario Superior Court of Justice dismissed a medical malpractice lawsuit brought by a young woman who suffered a stroke after taking birth control medication provided by her family physician who allegedly failed to advise her of the increased risk of stroke associated with that particular brand of birth control pill (Yaz).

The trial judge found that the patient had provided informed consent relating to the birth control pill despite substandard note taking on the part of the physician. In any event, the trial judge did not agree that the patient’s stroke was related to the birth control medication. The action was dismissed.

DECISION

In their reasons for judgment, the trial judge provided a succinct summary of the law of informed consent in Canada.

As the Supreme Court of Canada observed in Hollis v. Dow Corning Corp., citing its earlier decisions in Hopp v. Lepp, and Reibl v. Hughes:

[P]hysicians have a duty, without being questioned, to disclose to a patient the material risks of a proposed procedure, its gravity, and any special or unusual risks, including risks with a low probability of occurrence, attendant upon the performance of the procedure.

The court in Hollis goes on to explain that the principle underlying “informed consent” is:

[T]he “right of a patient to decide what, if anything, should be done with his body” … The doctrine of “informed consent” dictates that every individual has a right to know what risks are involved in undergoing or foregoing medical treatment and a concomitant right to make meaningful decisions based on a full understanding of those risks.

The case law is clear that informed consent is a distinct cause of action, which is separate from a breach of the standard of care.

To establish a claim based on a failure to obtain informed consent, the plaintiff must satisfy the two-part test. The test requires the plaintiff to prove the following:

• the physician failed to disclose the nature of the procedure (medication) or its material risks such that the patient was uninformed when undergoing the procedure in question;
• the patient herself would not have undergone the procedure (the taking of the medication) in question had she been properly informed; and
• a reasonable person in the patient’s position would not have undergone the procedure in question (the taking of the medication) if fully apprised of the material risks.

The first step of the test relates to adequate disclosure. The latter two parts of the test relate to causation and contain subjective and modified objective components.

In the result, after establishing a failure to disclose material information, the plaintiff must demonstrate on a balance of probabilities that they would not have gone ahead with the operation (medication) on the “modified objective test”.

This analysis, on both steps of the informed consent test, turns on the particular facts of each case.

Based on the facts of the case, the trial judge found that the Plaintiff had failed to prove that there had been a lack of informed consent with respect to the taking of the birth control pill. The Court determined that the physician had advised his patient of the increased risk of stroke. Even if he had not, the Court found that the Plaintiff would have taken the medication anyhow. 

With respect to causation, the Court preferred and accepted the defence stroke neurologist’s evidence. It was accepted that the Plaintiff had suffered a cryptogenic stroke, and even after her extensive stroke work up, the cause of the stroke was not known and therefore not legally related to the use of the birth control pill.

Despite suffering a stroke at a young age, the Court found that the Plaintiff had made a fairly good recovery in the circumstances and would have awarded the following damages (had liability been proven):

• General damages – $75,000
• Past loss of income – $75,000
• Out-of-Pocket expenses – $6,887.41
• Future loss of income – $0;
• OHIP’s subrogated claim – $27,871.08;
• Loss of interdependent relationship – $0;
• Future care costs – $25,000.

EXPERT LIABILITY WITNESSES

Plaintiffs’ Experts

Dr. Geoffrey Morris was qualified as an expert in family medicine and provided opinion evidence on the informed consent issue relating to the prescription of the birth control pill.

Dr. Bryan Young was qualified as an expert in neurology to provide opinion evidence on the likely cause of the patient’s stroke. 

Defence Experts

Dr. Howard Rudner was qualified as an expert in family medicine and provided opinion evidence for the defence on whether the physician had obtained a proper informed consent in this case.

Dr. Daniel Selchen was qualified as a expert in neurology and testified for the defence on the mechanism of the patient’s stroke.

Decision Date: December 1, 2023

Jurisdiction: Ontario Superior Court of Justice

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