Abstract
Background
Neuro-ophthalmologic conditions are at a higher risk of misdiagnosis compared to other ophthalmic conditions. Increased awareness of the most common diagnostic errors in neuro-ophthalmology that lead to malpractice claims can allow ophthalmologists to further improve their diagnostic workup to reduce delays in diagnosis and management, while also mitigating the risk of litigation.
Methods
Malpractice trials in the Westlaw Legal Database that involved cases of neuro-ophthalmologic diagnostic errors or failures by ophthalmologists were included in this study.
Results
A total of 43 cases were included, all citing failure to diagnose as the main reason for litigation. The most common diagnoses missed were cerebrovascular pathologies (30.2%), intracranial tumours (27.9%) and giant cell arteritis (25.6%). The majority of verdicts were in favour of the defendants (48.8%). After adjusting for inflation, the average amount awarded was $1,952,154.
Conclusion
Nearly half of the cases resulted in a defendant verdict. Settlement and plaintiff verdicts were costly, with average awards of approximately two million inflation-adjusted dollars. Failure to diagnose cerebrovascular pathologies was the most common diagnostic error followed by failure to diagnose intracranial tumours and giant cell arteritis. It is crucial for ophthalmologists to be aware of the most common pitfalls that lead to misdiagnosis or delays in diagnosis of neuro-ophthalmologic conditions.
Introduction
Medical malpractice has been on the rise in the United States (US), and an increasing number of physicians are taking protective measures to mitigate the risk of litigation which has become a tremendous burden on physicians and the healthcare system. Malpractice costs exceed 2% of total healthcare spending, with paid claims greater than $1 million becoming more common. 1 Ophthalmologists, in particular, experience high rates of malpractice suits, with 5–10% experiencing claims annually and mean payments totalling hundreds of thousands of dollars. 2
While missing ophthalmic conditions can lead to vision loss, missing neuro-ophthalmological conditions can lead to vision loss as well as neurologic morbidity and death. Therefore, compared with other ophthalmologic conditions, neuro-ophthalmologic ones tend to be associated with higher levels of risk management, with one study finding that neuro-ophthalmologists had an increased likelihood of receiving first-time unsolicited patient complaints compared to general ophthalmologists. 3 Additionally, it has been reported that neuro-ophthalmologic conditions can have misdiagnosis rates of up to 60%–70%, which ultimately results in needless testing and treatment. 4 All of this suggests that misdiagnosis of neuro-ophthalmologic conditions may be associated with an increased risk of litigation, and while studies have described malpractice claims involving other subspecialties of ophthalmology, no study to our knowledge has investigated neuro-ophthalmology-related claims involving ophthalmologists as defendants using a legal database.
Methods
US medical malpractice civil trials involving ophthalmologists who were sued for neuro-ophthalmology-related claims involving diagnostic errors or failures were retrospectively identified using the Westlaw database (Westlaw, West Publishing Co., St Paul, MN), a legal research database. It contains legal records, jury verdicts, settlements and public records across all 50 state and federal jurisdictions in the US. The database obtains cases from all jurisdictions submitted by attorneys along with cases non-voluntarily submitted from multiple jurisdictions. For the purposes of this paper, cases of misdiagnosis included both diagnostic errors and diagnostic failures.
Cases were searched on 19 September 2021 using keywords including: “neuro-ophthalmology”, “ophthalmology”, “giant cell arteritis”, “stroke”, “tumor”, “papilledema”, “nystagmus”, “intracranial hypertension”, “pseudotumor” and “myasthenia”. This yielded a total of 1,035 jury verdicts and settlements. Three authors (DZ, AW, and PPS) collected information for each case that fell within the scope of this paper, and any issues regarding data acquisition were resolved by the senior author (HDP). Data collected for each case included the gender and age of the plaintiff, the final verdict, the year, the state in which the lawsuit occurred, the number of eyes affected, the reasons behind litigation, and the amounts awarded, asked and offered. The amounts awarded included all disclosures of payment including trial verdicts, settlements and arbitrations. Monetary amounts were adjusted for inflation to 2021 US dollars using the Consumer Price Index (www.bls.gov/data/inflation_calculator.htm) to allow for equitable comparisons.
The Statistical Package for the Social Sciences version 28 (SPSS Inc. Chicago, IL, USA) was used to collect data and perform statistical analyses. This present study followed the tenets of the Declaration of Helsinki and was exempted from Northwell Institutional Review Board review because the obtained data was publicly available.
Results
Case characteristics
From the 1,035 malpractice cases, a total of 43 cases, reported from 1986 to 2019, met criteria for misdiagnoses by ophthalmologists resulting in litigation. Of the 18 states represented, New York (20.9%) and California (18.6%) had the greatest number of cases. In terms of case outcomes, 48.8% of cases resulted in a defendant verdict, 25.6% plaintiff verdict, 23.3% settlement, and 2.3% arbitration. In the 22 cases that resulted in a plaintiff award, after adjusting for inflation, the average amount awarded was $1,952,154. The average adjusted amount offered was $82,758 and the average adjusted amount asked was $1,808,389.
Plaintiff characteristics
58.1% of cases involved a female plaintiff, and the average age of the plaintiff, reported in about two-thirds of cases, was 52.9 years. Of the 31 cases that reported the number of eyes affected, 74.2% of cases involved only one eye.
Reasons for litigation
All cases of malpractice reported failure to diagnose as the main reason for litigation. The cases were then further categorised based on the diagnosis missed. Failure to diagnose cerebrovascular pathology was the most commonly cited reason for litigation (30.2%), followed by failure to diagnose an intracranial tumour (27.9%), and failure to diagnose giant cell arteritis (GCA; 25.6%). Other diagnoses not recognised included idiopathic intracranial hypertension (IIH; 9.3%) and optic neuropathy (7.0%).
The most commonly missed cerebrovascular pathology that led to litigation was stroke (76.9%). A failure to recognise transient monocular blindness (TMB) was the most commonly cited reason for misdiagnosing strokes. Other cerebrovascular pathology missed included arteriovenous malformation (7.7%), venous sinus occlusion (7.7%), and aneurysm (7.7%). The specific reasons for failure to diagnose cerebrovascular pathologies are outlined in Table 1.
Breakdown of reasons for failure to diagnose cerebrovascular pathology.
CT: computer tomography; MRI: magnetic resonance imaging; TMB: transient monocular blindness.
aCases cited multiple reasons for allegations, so percentages may not add up to 100%.
Of the 12 cases that cited a failure to diagnose an intracranial tumour, 50% were due to a missed pituitary tumour. Other intracranial tumours included meningiomas (16.7%), pilocytic astrocytoma (8.3%), optic nerve tumour (8.3%), and unspecified benign (8.3%) and malignant (8.3%) brain tumours. The most commonly cited reasons for failing to diagnose an intracranial tumour were failing to order CT/MRI imaging (50.0%) and failing to perform appropriate visual fields and/or colour testing (33.3%). The specific reasons for failure to diagnose an intracranial tumour are listed in Table 2.
Breakdown of reasons for failure to diagnose an intracranial tumour.
CT: computer tomography; MRI: magnetic resonance imaging.
aCases cited multiple reasons for allegations, so percentages may not add up to 100%.
One-quarter of the cases cited a failure to diagnose giant cell arteritis (GCA). This was most commonly due to a failure to recognise clinical signs and symptoms of GCA (45.5%). The specific reasons for failure to diagnose GCA are shown in Table 3. Less common diagnoses missed included IIH and optic neuropathy. The reasons these diagnoses were missed are shown in Tables 4 and 5, respectively.
Breakdown of reasons for failure to diagnose giant cell arteritis.
aCases cited multiple reasons for allegations, so percentages may not add up to 100%.
Breakdown of reasons for failure to diagnose idiopathic intracranial hypertension.
aCases cited multiple reasons for allegations, so percentages may not add up to 100%.
Breakdown of reasons for failure to diagnose optic neuropathy.
aCases cited multiple reasons for allegations, so percentages may not add up to 100%.
Discussion
This study examined neuro-ophthalmology litigation involving failures in diagnosis over the course of 33 years. Overall, 43 cases of malpractice were brought to court with the leading allegations being failure to diagnose cerebrovascular pathologies, intracranial tumours, and GCA. New York was the state with the greatest number of cases, similar to previous malpractice studies; however, this may be secondary to the high density of ophthalmologists and patients in New York. 5 The mean award amount in cases where payments were made was almost two million dollars and defendants won in nearly half of the cases, consistent with prior ophthalmology malpractice literature. 5 With neuro-ophthalmological conditions being associated with more risk management activity and high rates of misdiagnosis, it is crucial to be aware of the reasons behind the most commonly missed diagnoses.3,4
Malpractice claims regarding misdiagnosis of cerebrovascular pathologies
Failure in diagnosing cerebrovascular pathologies was the leading cause of litigation in this study. Strokes were the most frequently missed diagnosis with failure to recognise TMB as the most cited allegation. In patients with significant carotid artery stenosis who present with TMB, there is a 10% three-year risk of subsequent stroke when managed medically. 6 In three cases of misdiagnosed TMB, patients were incorrectly diagnosed with ocular migraines, which can present similarly. A previous case report described a similar scenario and stated that migraines with aura tend to follow a predictable pattern where the aura, which could be transient blindness, will precede a headache. However, if TMB were to follow a headache, then a transient ischaemic attack must be ruled out. 7 Therefore, it is important for ophthalmologists to be aware of this distinction to mitigate the risk of misdiagnosing TMB as a migraine. One case misdiagnosed TMB as acute angle closure glaucoma (AACG). Although both can present similarly, it is critical to differentiate them since both can lead to acute, reversible vision loss. The typical presentation of AACG is conjunctival injection with a fixed mid-dilated pupil and corneal haze along with elevated intraocular pressures. While both ophthalmic migraines and AACG have symptoms that may overlap with TMB, clinicians must be aware of the differences in presentation to avoid misdiagnosing TMB and leaving patients at a higher risk of future strokes.
Malpractice claims regarding misdiagnosis of intracranial tumours
The second leading condition that was misdiagnosed in this study was an intracranial tumour. In a prior study examining missed opportunities to diagnose brain tumours, the authors found that rather than describing specific symptoms, patients tended to describe generalised feelings of “things being not quite right”, which can be vague and difficult to pinpoint. 8 It is thus imperative for ophthalmologists to obtain a detailed medical history, to be aware of such complaints which could present as changes in engagement in activities or decreased ability to carry out responsibilities, and to ask about these symptoms when suspecting a potential brain tumour. The most commonly missed tumour in this study was a pituitary tumour due to failure to order proper testing or interpret results. The most common symptom of patients with pituitary masses is a visual field defect, classically a bitemporal hemianopsia; however, this can vary depending on tumour location relative to the optic nerve, chiasm, or tract. Therefore, if such a diagnosis is suspected, visual field testing must be performed. 9 In one case, a patient with a pituitary tumour who had an abnormal visual field was misdiagnosed as having glaucoma. visual field defects that respect the vertical meridian should raise suspicion for a non-glaucomatous aetiology, as glaucomatous visual field defects are more likely to respect the horizontal meridian. 10 However, in many cases, perimetric visual field results for glaucoma and intracranial tumours can be nearly indistinguishable; therefore it is crucial to perform other testing as well, such as optical coherence tomography (OCT); when OCT and visual field findings do not correlate, a non-glaucomatous pathology is more probable. 11 Additionally, if the visual field loss progresses at a faster rate than would be expected in glaucoma, especially with well-controlled intraocular pressures, that can serve as another red flag of a non-glaucomatous aetiology such as a tumour. 11 With ophthalmologists often being the initial physicians to whom patients with intracranial tumours present, it is important to properly evaluate neuro-ophthalmologic findings and diagnose these tumours in a timely manner. 12
Malpractice claims regarding misdiagnosis of giant cell arteritis (GCA)
GCA is characterized by a state of chronic inflammation of medium and large sized vessels, most commonly affecting branches of the carotid artery, that can sometimes lead to irreversible blindness. It has been well established that timely diagnosis and management of GCA is crucial; however, this can be challenging, as evidenced in our study where 25% of litigation involved failure to diagnose GCA. Alarmingly, one study determined that the average delay from presentation to diagnosis of GCA was 9 weeks, and up to 17.6 weeks in patients with extracranial GCA. 13 The clinical picture of GCA is often heterogeneous, with up to two-thirds of patients presenting with new-onset headaches, and approximately half of patients having symptoms of jaw claudication, which can often be misdiagnosed as temporomandibular disorder due to similarities in presentation. 14 The reported incidence of visual manifestations in GCA ranges from 12–70% with about 8–28% of patients reporting premonitory TMB. 15 In addition, about 20% of patients with GCA-induced vision loss do not have any systemic symptoms, further making timely and accurate diagnosis challenging. 15
Serological evaluation of GCA patients can reveal elevations of erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). In our study, two cases of missed GCA occurred because ESR levels were not significantly elevated, which, although uncommon, is not unheard of, with some studies reporting up to 30% of GCA patients having normal ESRs. 16 In another three cases in this study, bloodwork was not ordered. While various imaging modalities have also been explored for the diagnosis of GCA, temporal artery biopsy continues to be the gold standard in diagnosis. Given the grave consequences of missed GCA diagnosis, and potentially heterogeneous clinical findings, physicians should pursue serological testing when the condition is suspected. In situations where serological testing is inconclusive, suspicion for GCA should guide further management and prompt a temporal artery biopsy. It should be noted that the majority of GCA litigation cases included primary care physicians (internists and family practitioners) in the final settlements; consequently, it is not the sole responsibility of ophthalmologists to diagnose and treat GCA.
Malpractice claims regarding misdiagnosis of idiopathic intracranial hypertension
IIH is characterized by the presence of elevated intracranial pressure with no identifiable cause on imaging. Papilledema is a hallmark sign of IIH and, whenever it is suspected, a fundus exam should be performed. 17 One case in this study cited an ophthalmologist who failed to perform a fundus exam, leading to missed visualisation of the swollen optic discs and diagnosis of IIH, ultimately resulting in visual loss. Patients who present with symptoms such as headache, transient visual obscuration, pulsatile tinnitus, and ocular dysmotility should raise suspicion of IIH as a possible aetiology and a thorough workup is necessary. 17
Malpractice claims regarding misdiagnosis of optic neuropathy
In the two cases of litigation involving failure to diagnose optic neuropathy in which the reason behind misdiagnosis was noted, one ophthalmologist failed to order colour vision testing while the other failed to order bloodwork, which would have identified neurosyphilis. Impairment in colour vision is a sensitive marker of optic nerve dysfunction and should be performed whenever optic neuropathies are suspected. 18 In terms of causes of optic neuropathy, neurosyphilis is a relatively rare aetiology and presentations can range from being asymptomatic to having optic neuritis, retinitis, and various other ophthalmologic complications. 19 However, it is still important for physicians to keep neurosyphilis on the differential when patients present with optic neuropathy and order appropriate serologies if indicated.
Major limitations of the study included its retrospective design and relatively small sample size. Similar to other studies using the Westlaw database, this study was also unable to include cases that were confidentially settled before a formal lawsuit. 20 This likely results in an underestimation of the incidence of neuro-ophthalmologic diagnostic error litigation. The level of available information for each case also varied significantly, and in a minority of cases, specifics on how the diagnostic error occurred was not available.
However, despite these limitations, this is the first study that we know of to use the Westlaw legal database to report on neuro-ophthalmologic diagnostic failures by ophthalmologists. It highlights the most common conditions and causes of diagnostic failures which prompt litigation against ophthalmologists. Whereas most prior neuro-ophthalmology diagnostic error studies involve single conditions at one institution, 4 this study included cases with a variety of different conditions from across 18 different states and can serve as a tool to guide ophthalmologists on malpractice trends involving neuro-ophthalmologic diagnostic errors.
Footnotes
Permissions
This work is original, owned by the authors, and is not under consideration for publication elsewhere outside of Medico-Legal Journal.
Acknowledgement
The authors sincerely thank Rita Cinquemani, JD for sharing her expertise with the WestLaw Database.
Declaration of conflicting interests
The authors declare that there are no conflicts of interest or proprietary interests in relation to the submitted work.
Funding
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
