In September 2017, Paul Cahill settled a surgical negligence claim on behalf of a 66-year-old man who was left with significant permanent disability following surgical repair of a left ankle fracture. The patient had been taking anticoagulation medication, a category of drugs that thins the blood to prevent dangerous clots. The standard of care for orthopedic surgery on an anticoagulated patient requires that the anticoagulation be reversed, or that its effect be allowed to dissipate, before the surgery is performed. Reversal protects the patient from excessive intraoperative bleeding and protects the surgeon’s ability to perform a clean, well-visualized, well-fixated repair. In this case, the surgery proceeded before the anticoagulation had been adequately reversed. The result, according to the description published on Paul’s notable-cases page, was a difficult surgery and a suboptimal outcome. The functional disability that followed was permanent.
Perioperative anticoagulation management is a well-established area of clinical practice with detailed published guidance. The Canadian and international literature on the perioperative management of warfarin, direct oral anticoagulants, and antiplatelet agents provides specific recommendations for how long each drug must be held before surgery, what laboratory values must be confirmed, when and how to administer reversal agents in urgent situations, and how to balance the risk of perioperative bleeding against the risk of thromboembolism while the patient is off their anticoagulant. The published guidance is not aspirational. It describes the standard of care, and it has done so since well before 2017.
The civil claim in this case was advanced against the treating orthopedic surgeon and the hospital. The settlement was reached without admission of liability and the terms are confidential. The clinical and legal pattern, however, is one that bears explaining because it recurs across many surgical specialties and many anticoagulation classes, and because the safeguards that would have prevented this outcome are part of the routine pre-operative pathway for any patient on a blood-thinning medication.
The clinical context
Anticoagulation medications are prescribed to prevent the formation or progression of blood clots. The clinical indications include atrial fibrillation (where blood pooling in the heart can produce strokes), prosthetic heart valves, deep vein thrombosis, pulmonary embolism, certain hypercoagulable conditions, and the prevention of recurrent stroke. The most commonly prescribed agents include warfarin (the brand name Coumadin), the newer direct oral anticoagulants such as apixaban (Eliquis), rivaroxaban (Xarelto), dabigatran (Pradaxa), and edoxaban (Lixiana), and the antiplatelet agents such as aspirin and clopidogrel (Plavix). Each agent works on a different part of the coagulation cascade and has different pharmacokinetics, different reversal options, and different perioperative management requirements.
The shared feature of all anticoagulants is that they prolong the time it takes for the blood to clot. That property is desirable for the prevention of pathological clots. It is dangerous during surgery, where the surgeon needs the tissues to hold a hemostatic state long enough for the work of the operation to proceed and for the wound to begin healing. An anticoagulated patient bleeds more during surgery, has a larger area of obscured visualization, has more difficulty achieving stable fixation of fractures, has a higher rate of postoperative hematoma formation, has a higher rate of wound complications, and has a higher rate of infection. The published literature treats these associations as well-established for orthopedic procedures including ankle fixation.
The standard of care for elective and semi-urgent surgery on an anticoagulated patient is to discontinue or reverse the anticoagulation before the surgery is performed. The specific approach depends on the drug.
Warfarin. Warfarin is generally held for five days before elective surgery. The international normalized ratio (INR), which is the laboratory measurement of warfarin’s effect on the coagulation cascade, should be confirmed below 1.5 (and ideally below 1.3 for elective orthopedic procedures, where bleeding produces particularly significant complications) before the patient enters the operating room. Where warfarin reversal cannot wait for the natural drug half-life, options include oral or intravenous vitamin K (which initiates the patient’s own production of the missing clotting factors over twelve to twenty-four hours), prothrombin complex concentrate or PCC (which directly replaces the depleted clotting factors and reverses warfarin within thirty minutes), and fresh frozen plasma (which is slower and carries a larger volume burden).
Direct oral anticoagulants. The DOACs have shorter half-lives than warfarin and a more predictable pharmacokinetic profile. The published guidance calls for the drugs to be held for one to four days before elective surgery, with the specific interval depending on the drug, the patient’s renal function, and the bleeding risk of the procedure. Reversal agents are available for emergency situations: idarucizumab for dabigatran, andexanet alfa for the factor Xa inhibitors apixaban and rivaroxaban. In 2017, when this case settled, idarucizumab was widely available in Canadian hospitals, andexanet alfa had been approved more recently and uptake was still expanding, and PCC remained an accepted alternative for urgent DOAC reversal.
Antiplatelet agents. Antiplatelet drugs such as aspirin and clopidogrel inhibit platelet function for the lifespan of the affected platelets. Because platelets cannot be reactivated, the only way to restore platelet function before surgery is to allow new platelets to be produced, which takes approximately seven days. Where surgery cannot wait, platelet transfusion is the available rescue, though its effectiveness is partial.
What the standard of care expects
The standard of care for perioperative anticoagulation management requires a structured assessment before the surgery is scheduled. The published guidance, including the Multi Guideline Expert Insight on perioperative management of anticoagulant and antiplatelet therapy, identifies a small number of steps that are not discretionary.
Identification. The pre-operative assessment must establish what anticoagulation medication the patient is taking, when the last dose was administered, and the indication for the medication. This step also identifies which reversal protocols apply.
Risk stratification. The pre-operative assessment must weigh the thromboembolic risk of holding the anticoagulation against the bleeding risk of proceeding without holding it. Patients with mechanical heart valves, recent strokes, or active venous thromboembolism are at higher thromboembolic risk than patients on anticoagulation for atrial fibrillation alone. The bleeding risk of orthopedic surgery is generally high, with ankle and other lower extremity procedures classified at the higher end of the spectrum.
Timing. The pre-operative assessment must define when the anticoagulation will be held or reversed, when the surgery will be performed, when the laboratory values (INR, drug levels where applicable) will be checked, and when the anticoagulation will be resumed post-operatively. For elective orthopedic surgery, this timing is straightforward: hold the drug for the appropriate interval, confirm laboratory values within target before incision, proceed with surgery, resume the drug post-operatively at an appropriate interval.
Urgency assessment. Where the surgery cannot wait for the natural drug half-life to expire, the assessment must determine whether the urgency justifies active reversal. For most orthopedic procedures, including ankle fracture fixation, the surgery is semi-urgent rather than emergency. The published literature on ankle ORIF identifies windows of days to weeks during which the surgery can be safely performed without affecting the functional outcome. Where the surgery can be delayed long enough for the anticoagulation to be properly reversed or to wear off, the delay is not a clinical compromise; it is the standard of care.
The institutional infrastructure for perioperative anticoagulation management has become more structured since 2017. Most Ontario hospitals operate dedicated pre-operative anticoagulation clinics or pre-admission units, with input from anesthesiology, hematology, the patient’s prescribing physician, and the operating surgeon. The protocols are documented, the laboratory values are reviewed, and the patient’s pathway through the period of held or reversed anticoagulation is supervised. None of this is new.
The patient and the gap in pre-operative management
The patient was 66 years old. He sustained a left ankle fracture and was referred for surgical fixation. He was on anticoagulation medication at the time of the injury, the indication for which is not specified in the public description of the case. The standard pre-operative pathway would have required that his anticoagulation be discontinued for the appropriate interval, that his laboratory values (INR if warfarin, or assessment of residual drug effect if a DOAC) be confirmed within an acceptable range, that any reversal interventions be administered if necessary, and that the surgery be scheduled for a time when his coagulation status was suitable for an operative procedure.
The surgery proceeded before the anticoagulation had been adequately reversed. The operative course was difficult. The clinical sequelae of operating on an anticoagulated patient (excessive bleeding, obscured visualization, increased tissue trauma during the necessary hemostatic manoeuvres, suboptimal reduction and fixation of the fracture, increased post-operative hematoma formation, and the cascade of wound healing and functional complications that follow) all contribute to a higher rate of suboptimal long-term outcome. The patient was left with significant permanent disability.
The specific mechanism by which the suboptimal outcome translated into permanent disability is not detailed in the public description and is appropriately kept confidential. The recognized possibilities, all of which are described in the orthopedic literature on ankle ORIF complications, include malunion or nonunion of the fracture, post-traumatic arthritis from inadequate reduction, chronic pain, restricted range of motion, gait instability, and the secondary effects on the patient’s mobility, independence, and quality of life.
The legal framework
A claim of this kind sits within the surgical-error practice area of medical malpractice litigation. The general elements of a civil malpractice claim are explained in our foundational post on suing for medical malpractice in Ontario. Their application to a case of inadequate perioperative anticoagulation management has a recognizable structure.
Standard of care. The standard of care for orthopedic surgery on an anticoagulated patient, both in 2017 and today, requires the pre-operative anticoagulation management described above. The published guidance is detailed, the available reversal protocols are well-defined, and the consequences of operating on an inadequately reversed patient are well-known. Where a patient is operated on before reversal has been confirmed by laboratory values or by elapsed time, and the urgency of the surgery did not justify the bleeding risk of proceeding, the conduct falls below the standard of care. The bleeding risk of operating on an anticoagulated patient is the very reason the published guidance exists; the existence of the guidance is what makes proceeding without following it a recognized breach.
The standard of care does not require perfection. There are circumstances in which urgent surgery must proceed despite imperfect reversal, where the thromboembolic risk of further delay outweighs the bleeding risk of proceeding. In such cases, the conduct is acceptable provided the decision is documented, the alternatives have been considered, and active reversal has been attempted to the extent possible. Where the surgery was not urgent and the delay would not have caused harm, the analysis is different.
Causation. Causation in a case of orthopedic surgical bleeding from inadequate anticoagulation reversal is supported by well-established clinical principles. Anticoagulated patients bleed more during surgery. Increased intraoperative bleeding obscures the surgical field. Obscured visualization compromises the surgeon’s ability to achieve anatomical reduction of fractures and to place hardware accurately. Suboptimal reduction and fixation produce poorer functional outcomes. Increased operative time and increased blood loss produce higher rates of wound complications. Each link in the chain is supported by the orthopedic literature. Where a patient with no contributing fracture-related anatomical complexity was left with a significant permanent disability after a difficult surgery performed in the context of inadequate anticoagulation reversal, the causal connection between the breach and the outcome is supported by the available medical evidence.
Damages. The damages in a case of permanent orthopedic disability include general damages for pain and suffering and loss of enjoyment of life, lost past and future income (where applicable), the cost of past and future care including any necessary mobility aids, home modifications, and rehabilitation, and the loss of independence in everyday activities. For a 66-year-old patient, the future-income component may be modest if the patient was already retired or near retirement, but the cost-of-care component can be substantial for a lifetime of impaired mobility, and the general damages for permanent loss of function are typically significant.
How the case resolved
The matter settled on confidential terms before trial. The factors that supported a productive resolution included clear expert evidence on the standard of care for perioperative anticoagulation management, expert evidence on the causal link between the inadequately reversed anticoagulation and the difficult surgery, and well-documented damages reflecting the patient’s permanent disability.
Why this case matters
For patients facing elective or semi-urgent orthopedic surgery while taking an anticoagulant, the lesson of this case is to ensure that the pre-operative anticoagulation plan has been clearly communicated and is being followed. The questions a patient is entitled to ask include: When should I stop my anticoagulation before the surgery? Will I need a bridging medication during the period when I am off my regular drug? Where should I have my INR or my drug level checked before the surgery, and what value are you looking for? If something cannot wait for the normal hold period, what reversal will be used? Is there a hematologist or anticoagulation clinic involved in this pathway? If the answers to these questions are uncertain or inconsistent, the patient is entitled to ask for the surgery to be reviewed by the pre-admission clinic or to be deferred until the questions can be answered.
For surgeons and pre-operative teams, the lesson is that the published guidance on perioperative anticoagulation describes a standard of care that the courts will apply. The protocols are well-defined. The reversal agents are available. The laboratory tests are routinely accessible. The pre-admission infrastructure exists in most Ontario hospitals. The breach in cases of this kind is rarely about technical complexity. It is about following the protocol or not.
For the broader practice of surgical-error litigation in Ontario, this case sits within the smaller but well-recognized category of cases where the breach is in the pre-operative pathway rather than in the operation itself. The surgeon’s intraoperative conduct may be unimpeachable. The breach may be that the patient should not have been on the table at all on the day in question. Cases of this kind are doctrinally distinct from cases involving intraoperative surgical errors and from cases involving post-operative complications. Their analytical structure focuses on the institutional and clinical decisions that should have preceded the incision.
Settlement Date: September 2017
Jurisdiction: Ontario
Counsel for the plaintiff: Paul J. Cahill
