Executive Summary: Key Legal and Evidentiary Issues

• Central question was whether the gynecologist’s prescription and management of Cyklokapron and oral contraceptives for abnormal uterine bleeding departed from the standard of care of a prudent, diligent specialist in similar circumstances.
• The court scrutinized competing expert opinions in gynecology and hematology on whether combining Cyklokapron with combined oral contraceptives is contraindicated or remains an acceptable, “grey zone” therapeutic choice.
• Causation was heavily contested, especially whether Cyklokapron, allegedly taken in the days before the stroke, probably caused the ischemic cerebrovascular accident versus it being a cryptogenic (unexplained) stroke.
• The evidentiary weight of contemporaneous medical records, laboratory values (hemoglobin levels) and hospital notes on timing of Cyklokapron intake undermined the plaintiffs’ theory of recent heavy bleeding and recent ingestion.
• The court rejected a theory that elevated the mere possibility of drug-related thrombosis into a legal probability in the absence of robust scientific support and in light of strong, specialized hematology evidence to the contrary.
• On costs, the judge applied the usual “loser pays” rule but exercised discretion to cap recoverable expert fees for the successful defendant at CAD 20,000, reducing a significantly higher claimed bill of expertise.

Factual background and medical history

The case arises from a medical liability action brought in the Superior Court of Québec by patient Stéphanie Côté and her spouse, Gilles Jeannotte, against gynecologist Dr. Marie-Yanouk Blain. Ms. Côté suffered an ischemic stroke on 4 December 2018 while on a work trip, leading to aphasia, right upper limb weakness and reduced mobility. She never returned to work and is considered professionally disabled. The parties agreed that if liability were established, damages would total CAD 2,000,000 (CAD 1,950,000 for Ms. Côté and CAD 50,000 for Mr. Jeannotte).

Ms. Côté had long-standing gynecological issues related to heavy menstrual bleeding and intermittent spotting. She first consulted Dr. Blain in 2007 for routine gynecologic review; at that time, examinations were normal, and no particular treatment was required. Over time, particularly from 2012 onward, she experienced abnormal uterine bleeding (menometrorrhagia), including heavier periods and intermenstrual spotting. Investigations included ultrasound, hysteroscopy and endometrial biopsy in 2012, all of which were reassuring and did not reveal malignant or structural pathology.

From 2015, the bleeding became more problematic and symptomatic (fatigue, headaches). In November 2015, Dr. Blain proposed several medical options and, with the patient’s agreement, initiated combined oral contraceptives (COCs), specifically Select 1/35, not for contraception but to stabilize the endometrium and regulate bleeding. The treating internist and family physicians who later assessed Ms. Côté’s hypertension did not object to her continuing COCs. The treatment improved symptoms, and at a March 2016 follow-up, the patient described herself as “very satisfied,” leading Dr. Blain to discharge her from routine gynecologic follow-up, to be seen again as needed.

Evolution of treatment and introduction of Cyklokapron

In August 2017, while Dr. Blain had just returned from a year away, Ms. Côté’s family physician, Dr. Therrien, re-evaluated her for renewed heavy bleeding with clots and fatigue. Dr. Therrien maintained the COCs and, for the first time, prescribed Cyklokapron (tranexamic acid), an antifibrinolytic agent used to control acute heavy bleeding episodes. This was initially for 48 hours, then a further three days as needed, and it helped control the acute bleeding.

On 23 August 2017, Ms. Côté saw Dr. Blain again. In light of recent acute bleeding episodes and the positive response to Cyklokapron, they discussed several therapies: continuing COCs, switching to Depo-Provera, inserting a levonorgestrel intrauterine device (Mirena), or eventually resorting to surgery such as endometrial ablation or, much later, hysterectomy. Given the patient’s age and guidelines emphasising medical rather than surgical management as first-line for abnormal uterine bleeding, surgery was not favoured at that stage. The agreed plan was to continue COCs in continuous regimen and to use Cyklokapron briefly in acute “crisis” bleeding episodes, with Mirena as a next option if medical therapy failed. On 31 August 2017, Dr. Blain herself first prescribed Cyklokapron for up to five days, three times daily as needed, with limited renewals.

Over the following year, Ms. Côté had episodes of chest pain and blood pressure fluctuations, for which internists and family physicians adjusted antihypertensive treatment. Her hypertension was documented as controlled on medication, and repeated cardiovascular investigations were negative. Her bleeding was variably controlled, and by August 2018, at an annual gynecologic follow-up, she reported only occasional spotting, with oral contraceptives renewed for two years.

In September 2018, following removal of a cervical polyp, Ms. Côté reported six weeks of persistent spotting and stated she had taken Cyklokapron without success. On 12 September 2018, without a prior appointment, she was seen by Dr. Blain at the hospital clinic. The patient was exasperated by continuing spotting. They again reviewed alternatives: Depo-Provera (rejected by the patient due to possible weight gain), Mirena, and endometrial ablation. The plan they reached was to insert a Mirena IUD and to continue COCs and Cyklokapron in acute episodes until the Mirena took full effect. On that date, Dr. Blain prescribed 63 Cyklokapron tablets (three tablets three times daily for seven days), with six renewals, for short-term use in crisis bleeding.

Mirena was inserted on 3 October 2018. At that visit, Ms. Côté was told she could stop COCs one week later and use Cyklokapron as needed for heavy bleeding. According to the evidence, she stopped oral contraceptives around mid-October and obtained one further Cyklokapron refill on 6 October 2018. There were no further medical visits until the stroke on 4 December 2018.

The stroke and subsequent investigations

On 2 December 2018, Ms. Côté drove from the Gaspé region toward Brossard for a work meeting, staying overnight en route and then at a hotel near her destination. On the morning of 4 December, she became acutely unwell, noted facial drooping and difficulty functioning, and contacted a hotel employee who drove her to Hôpital Charles-Le Moyne. She was admitted at 10:17 a.m. and diagnosed with an ischemic stroke due to thrombosis of an M2 branch in the left Sylvian valley (within the circle of Willis).

Hospital investigations between 5 and 11 December 2018 (thrombophilia workup, echocardiography, Doppler ultrasound of lower limbs, Holter monitoring) were all negative. Her hemoglobin values in December were normal (above 120), inconsistent with very recent major blood loss. Contemporaneous notes by the emergency physician and hospital pharmacist recorded that her last Cyklokapron use had been about six weeks earlier, although at trial she testified she had taken Cyklokapron on 2 and 3 December 2018. The court viewed this late, litigational revision of the timeline with caution, given the earlier hospital records and the lack of objective evidence of heavy bleeding in the days immediately before the stroke.

On 18 January 2019, after learning of the stroke, Dr. Blain reassessed Ms. Côté, confirmed Mirena was in place by ultrasound, and agreed to proceed, after the medically recommended waiting period of about six months post-stroke, with endometrial ablation. That surgery occurred on 9 July 2019. Functionally, Ms. Côté achieved partial recovery but was left with persistent deficits that precluded a return to her former full-time professional role.

Legal framework for medical liability and causation

The court applied article 1457 of the Civil Code of Québec, which requires proof of fault, damage and a causal link between the two. In medical malpractice, physicians owe an obligation of means rather than result, and their conduct is assessed against the standard of a reasonably prudent and diligent specialist in comparable circumstances, not by hindsight based on the eventual outcome. The analysis also distinguishes scientific from legal causation: while science seeks certainty and precise mechanisms, civil law proceeds on the balance of probabilities (more likely than not), and legal causation cannot rest on mere possibility.

Given the technical nature of the issues, expert evidence in gynecology and hematology was central. The medical records were treated as prima facie evidence of what was done and said, subject to rebuttal, reflecting their contemporaneous and routine nature in clinical practice. Against that legal and evidentiary backdrop, the court framed two main questions: whether Dr. Blain committed a professional fault in her management and prescriptions and whether Cyklokapron probably caused the stroke.

Alleged faults: prescription of Cyklokapron and failure to change therapy sooner

The plaintiffs’ theory of fault evolved over time but crystallised around two allegations. First, that prescribing and renewing Cyklokapron—particularly in combination with COCs—in a patient with obesity, hypertension, a family history of varicosities and other risk factors was negligent and contrary to the product monograph and good practice. Second, that by August 2017, given the recurrent bleeding and risk profile, a prudent gynecologist should have stopped COCs, avoided Cyklokapron and moved earlier to safer alternatives such as Mirena or endometrial ablation.

On the first allegation, the court noted that Cyklokapron had initially been introduced not by Dr. Blain but by the family physician, for very short courses during acute heavy bleeding, and that the drug is a well-known, widely used antifibrinolytic with recognized efficacy in heavy menstrual bleeding. Its use, even in women on COCs, is permitted but must be judicious. The Cyklokapron monograph warns of thrombosis risk, particularly in those with a history or risk of thrombosis, and advises caution when combined with combined hormonal contraception. However, it does not impose an absolute prohibition, instead requiring individualized clinical judgment.

The plaintiffs’ gynecology expert, Dr. Ziegler, testified that he personally never prescribes Cyklokapron and considers the combination with COCs dangerous, especially with higher-estrogen pills such as Select 1/35. He relied on the monograph and limited literature to argue that no prudent gynecologist would have used Cyklokapron in this context. By contrast, the defense gynecologist, Dr. Roberge, and the defense hematology expert, Dr. Séguin, gave evidence that short-term use of Cyklokapron in selected patients, even alongside COCs, is accepted practice within a “grey zone” where guidelines are cautious but do not forbid the combination. They underscored the infrequency of Ms. Côté’s actual Cyklokapron use, the limited number of purchases over more than a year, and the absence of any documented overdose or chronic exposure.

The court was not persuaded that there was an absolute contraindication here. Ms. Côté’s hypertension was medically controlled, she did not smoke, did not have diabetes, had no documented vascular disease or migraines with aura, and the mother’s “thrombosis” history appeared to consist of varicose veins rather than a proven thromboembolic disorder. In that context, the judge concluded that Cyklokapron remained a therapeutic option that a reasonable gynecologist could select for short-term use in acute bleeding, particularly after other conservative measures had been tried and had shown partial benefit. The dose and renewal pattern were within the range contemplated by the monograph, and actual use was limited. On this record, prescribing Cyklokapron, rather than avoiding it altogether, was held not to be a fault.

On the second allegation, the court assessed whether continuing COCs after August 2017, rather than immediately insisting on Mirena or endometrial ablation, fell below the standard of care. Expert evidence showed that COCs are a standard first-line medical therapy for abnormal uterine bleeding and that higher-estrogen formulations may provide better bleeding control. The parties’ experts agreed that Ms. Côté had no clear contraindication to COCs when they were initially prescribed in 2015, and no treating physician had ever stopped them on safety grounds. The contested issue was timing: Dr. Ziegler argued that, by August 2017, given treatment failure and evolving risk factors, a prudent gynecologist would have moved directly to Mirena or ablation and strongly urged the patient to accept this, whereas Dr. Roberge emphasised that the COCs had yielded periods of improvement, that they also helped reduce menstrual-linked migraines, and that guidelines recommend exhausting medical options, including intrauterine devices, before surgery.

The court found that Dr. Blain had, in fact, discussed alternatives, including Mirena, both in 2015 and again in 2017–2018, and that the patient was aware of and at times considered the IUD option. Given the documented clinical improvements, the intermittent nature of the symptoms, the patient’s preferences and the lack of strong evidence demanding immediate escalation, the judge held that it was within acceptable professional judgment to continue COCs with careful follow-up, reserving Mirena and surgical interventions as subsequent steps. The fact that in September 2018 Dr. Blain chose to proceed with Mirena insertion showed an appropriate, staged therapeutic strategy rather than negligence.

Causation: was Cyklokapron the probable cause of the stroke?

Having found no fault, the court indicated that causation need not be decided but nevertheless analyzed it fully. The plaintiffs’ case theory was that without Cyklokapron, Ms. Côté would not have had a stroke on 4 December 2018. Their hematology expert, Dr. Moghrabi, opined that in a patient said to be at high thrombotic risk—owing to obesity, hypertension, family history and (as he assumed) recent COC use—adding Cyklokapron tipped the risk from a slim possibility to a probability, and that the absence of any other identified cause after hospital investigations effectively pointed to Cyklokapron as the culprit.

The court weighed this against several considerations. First, Cyklokapron is rapidly cleared from the body, with most of the drug eliminated within about 24 hours and all traces within a few days. For it to plausibly contribute to a thrombotic event, ingestion must be recent. Yet the earliest records from Hôpital Charles-Le Moyne indicated that Ms. Côté reported using Cyklokapron six weeks prior, and there was objective laboratory evidence (normal hemoglobin) suggesting no major bleeding in the days before admission. Her later testimony that she took Cyklokapron on 2 and 3 December 2018 was given years after the event, did not appear in the initial pleadings or demand letter, and was not corroborated by independent data beyond her recollection.

Second, the court examined the quality of the hematology evidence. It found that Dr. Moghrabi’s report was brief, lacked detailed methodology, and rested primarily on a process of elimination: the patient took Cyklokapron, no other cause was found, therefore Cyklokapron was probably responsible. The court considered this insufficient, especially given that approximately one-third of strokes are classified as cryptogenic, meaning no cause is identified even after thorough testing. The fact that no other cause was found did not automatically elevate Cyklokapron from a possible to a probable cause.

Third, the defense hematologist, Dr. Séguin, brought to the court more extensive expertise in thrombosis and cited randomized and contemporary studies indicating no demonstrated increase in thrombotic events attributable to tranexamic acid in the doses and indications at issue. She also clarified that by early December 2018, COCs were no longer contributing to thrombotic risk because they had been discontinued for more than six weeks—long enough for the associated elevated risk to subside. In her opinion, it was highly improbable that either COCs or Cyklokapron were the cause of this arterial stroke and that the event should instead be classified among strokes of unknown origin.

Considering the totality of the evidence, the court ruled that the plaintiffs had not met their burden to establish, on a balance of probabilities, that Cyklokapron caused the stroke. At most, it remained a speculative possibility within a broader field where cryptogenic strokes are common, and the law does not allow judgment on such conjectural foundations.

Decision on liability, damages and costs

Bringing the fault and causation analyses together, the court concluded that Dr. Blain had treated Ms. Côté as a prudent and diligent gynecologist would in a regional hospital context, using accepted medical options for abnormal uterine bleeding, informing the patient of alternatives, adjusting therapy over time and appropriately resorting to Mirena and later endometrial ablation. The unfortunate occurrence of a stroke did not, in itself, prove negligence or defective medical decision-making, nor was the stroke shown to be probably caused by Cyklokapron.

As a result, the action was dismissed. The pre-agreed damages of CAD 2,000,000 were never triggered because the plaintiffs failed to establish liability. On costs, the prevailing rule that the unsuccessful party pays the successful party’s judicial costs was applied, but with a significant reduction in expert fees. Noting that the defense experts’ invoices totalled CAD 56,775—more than double the combined fees of the plaintiffs’ experts—the court exercised its discretion to cap recoverable expert costs at CAD 20,000. Thus, the successful party is the defendant, Dr. Marie-Yanouk Blain, who obtained dismissal of the claim and an order for costs in her favour, including expert fees limited to CAD 20,000, while the precise total of all other taxed costs and disbursements could not be determined from the judgment itself.