A 71 -year-old woman suffered a stroke after stopping her anticoagulant medication.
- Adverse outcomes can occur despite appropriateness of the plan of care.
- Documentation in the medical record supports decision-making and care provided at the time of patient encounter.
- Incomplete documentation of patient informed consent and medical risk can weaken the legal defense of a malpractice claim.
A 71-year-old woman was referred to the ambulatory pain clinic for management of ongoing back and leg pain associated with lumbar radiculitis. Her medical history was significant for hypertension, hypercholesteremia, asthma, and coronary artery disease. She had been taking anticoagulation medications (clopidogrel and aspirin) since undergoing coronary artery bypass graft (CABG) surgery five years prior to this visit.
Medical work-up revealed a lumbar disc herniation with extrusion causing nerve root compression. An epidural steroid injection was recommended by the Pain Medicine physician. The patient was scheduled for the injection and advised to stop taking her anticoagulants for the seven days prior to the procedure, which she did. There was no documentation of discussion regarding the risks of discontinuing her blood thinners.
On the morning of the scheduled procedure, the patient presented to the Emergency Department with right-sided weakness, slurred speech, and facial droop, and scored 3/3 on the Cincinnati Prehospital Stroke Scale. She was found to have 60% stenosis, complete occlusion of her left internal carotid artery, and a non-hemorrhagic infarct of her left middle cerebral artery.
The patient was admitted to the hospital for a week and discharged to a rehabilitation facility.
A case was asserted against the Pain Medicine physician for improper medication regimen management.
This case settled in the high range in favor of the plaintiff.
Hospital admission records note the patient stopped taking clopidogrel and aspirin one week prior to her stroke.
The defense expert in this case opined that stroke is rare in a patient whose anticoagulation therapy is paused in preparation for a procedure. That expert also questioned the need for her to be taking clopidogrel five years out from CABG surgery. It was reasoned that the patient had previously exhausted all conservative care and treatment for her back and leg pain, and that the recommended steroid injection was necessary. It was further reasoned that the benefit of treatment outweighed the risk of stopping clopidogrel and aspirin for the week.
Incomplete Documentation of Consent
Document your clinical reasoning and communication with the patient.
Risk of bleeding into the injection site was discussed with the patient, and the patient was advised to stop taking her anticoagulation therapy prophylactically the week prior the procedure. The patient’s risk of embolism from stopping clopidogrel and aspirin, however, was not discussed nor documented in the record. A pre-operative medical evaluation for risk stratification was not obtained and the patient was not fully-informed about her treatment. At this point, her care fell below reasonable standards.
Failure to Meet Standard of Care
A failure to meet the standard of care is a symptom of systemic weakness, not only within the informed consent process itself, but also within the channels of communication between providers and patients. Lack of standard expectations can lead to incomplete communication, knowledge gaps, mismanagement of clinical care, and patient harm.1
The process and documentation of informed consent serves legal, ethical and regulatory purposes and functions as a method to improve trust between providers and patients. As such, enhanced consent processes involve patients, not only in decision-making, but also in prioritization of goals related to medical care and life functions.2
- CRICO Strategies, 2015, Malpractice Risks in Communication Failures: 2015 Annual Benchmarking Report. https://www.rmf.harvard.edu/Malpractice-Data/Annual-Benchmark-Reports/Risks-in-Communication-Failures
- Hall D et al. Informed consent for clinical treatment. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne vol. 184,5 (2012): 533-40. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307558/