Watch for Warning Signs of a Missed Diagnosis
By Anne M. Menke, RN, PhD OMIC Risk Manager
Digest, Spring 2004
ALLEGATION Failure to diagnose optic glioma, resulting in delay in surgical removal and blindness in right eye.
DISPOSITION Settled on behalf of defendant ophthalmologist.
Case Summary
A three-year-old was referred to the insured ophthalmologist with a complaint of headaches. The mother reported an out-turning right eye and said the child needed to sit directly in front of the TV to see. The ophthalmologist noted nystagmus, diagnosed hyperopia OU and exotropia, issued a prescription for a full cycloplegic refraction, and instructed the mother to bring the child back in three months or sooner if headaches and/or blurred vision persisted. Four months later, the ophthalmologist noted resolution of the headache, stable exotropia and hyperopia, slow-beating nystagmus, and stable gaze. The patient was to continue wearing the glasses and return in six months. Three months later, the mother brought the child in when he failed his school eye examination and reported trouble with the glasses. VA was felt to be unreliable but measured 20/30 OD, 20/70 OS. A low-grade allergic conjunctivitis was noted and treated. When he returned as requested for a refraction the following month, the child was failing the school eye exam with and without glasses. Refraction was performed with a mild hyper- opic correction; optic pallor was noted on the fundus examination OD. A trial of patching was planned, after which the child was to return for evaluation. When the mother reported problems with the patching exercise a week later, the ophthalmologist referred her to the local children’s hospital. A work-up there revealed HM to LP only, with marked divergent drift and pale optic disc OD. Neuro- imaging studies revealed an optic glioma, which was treated with surgery, radiation, and chemotherapy.
Analysis
In order to prove malpractice, the care rendered must deviate from the standard and be the cause of the patient’s alleged damages. Experts criticized the insured’s failure to refer the child to a specialist for nystagmus, found on the initial exam, and optic pallor, noted seven months later. The validity of the visual acuity measurement was also challenged, given the precipitous change over a one-week period. Defense experts noted, however, that the patient did benefit from the treatment for exotropia and, more importantly, that earlier diagnosis of this slow-growing tumor would not have affected the treatment or the out- come. The insured ophthalmologist agreed with the defense attorney that these shared concerns, coupled with the child’s poor outcome, could lead to a substantial jury verdict. A decision was therefore reached to settle the case.
Risk Management Principles
“Failure to diagnose” claims are common and account for half of OMIC’s top ten indemnity payments. From both a patient safety and liability perspective, it is important to rule out the worst possible diagnosis as part of the diagnostic process. One of the simplest for- mulations of this axiom is the “witty” or “WIT-D” approach.1 Include the worst thing (W) the patient could have in the differential diagnosis; collect the information (I) needed to rule it in or out; tell (T) the patient and other members of the health care team of your differential diagnosis, planned treat- ment, and any symptoms that should be reported to you; and document (D) your care, decision-making process, and instructions. In this case, nystagmus should have prompted a referral (I) to a neuro-ophthalmologist to rule out a CNS process (W); the optic pallor also required further work-up. There are usually many warning signs of a missed diagnosis. These include repeated, ongoing, or worsening complaints (worsening visual acuity); treatment that does not resolve complaints (kept failing school eye exams); and a diagnosis that does not account for the symptoms (neither the nystagmus nor the optic pallor could be attrib- uted to the hyperopia or exotropia). Such warning signs should prompt the physician to start over by reviewing all chart notes, using the WIT-D approach, accounting for all symp- toms, and seeking a consultation or referral.
Misdiagnosis of a Nevus by an Optometrist Insured with Another Carrier
By Ryan Bucsi, OMIC Senior Litigation Analyst
Digest, Summer 2010
ALLEGATION: Failure to diagnose choroidal melanoma resulting in patient’s death.
DISPOSITION: The case settled for $1.5 million with an arbitrator apportioning $500,000 of the settlement to an OMIC insured group.
Case Summary
A patient presented to an OMIC insured ophthalmology group for a routine eye examination. The patient was examined by an optometrist who was employed by the group but who maintained separate professional liability insurance with another carrier. During the examination, the optometrist identified a nevus on the patient’s right eye. A diagram of the nevus was drawn in the patient’s chart, and the optometrist instructed the patient to return in one year. The patient returned on an emergency basis about 11 months after the initial exam, complaining of an inability to see out of a portion of the right eye. During this visit, an ophthalmologist examined the patient, diagnosed a choroidal melanoma, and immediately referred the patient to a retinal specialist for a same-day consult. The retinal specialist confirmed the diagnosis and sent the patient to a local specialist for treatment. The melanoma measured 16 x 17 mm with a height of 7 mm. Despite treatment for the melanoma, the patient died approximately three and a half years following the initial examination by the optometrist.
Analysis
The optometrist testified during deposition that although the nevus was not suspicious, she had ordered a fundus photograph. The medical record contained neither a fundus photograph nor a record of a bill for a fundus photograph. Plaintiff experts opined that the optometrist failed to diagnose a suspicious nevus, failed to take a fundus photograph, and failed to advise the patient to return in three months. Plaintiff experts also opined that the group was negligent for failing to properly train and supervise the optometrist. Furthermore, plaintiff experts felt the group fell below the standard of care by not notifying the patient that she was being treated by an optometrist and not an ophthalmologist. There was no formal training program or written protocols at the OMIC insured group office. Physicians there stated that they were comfortable with the competence of the optometrist based on her five years of experience. The defense had trouble finding experts to support the care rendered by the optometrist and the group. In addition, the defendants could not establish a causation argument. Melanoma experts opined that the size of the tumor at the time of diagnosis indicated that it was likely present but missed on the initial exam by the optometrist. Without a fundus photograph, the defense could not argue to the contrary. A settlement of $1.5 million was reached, but OMIC and the other carrier could not agree on how the liability should be apportioned. A binding arbitration was scheduled; the only agreement going into arbitration was that neither carrier would be required to pay over its $1 million policy limit. The arbitrator ruled that the optometrist was 70% liable and OMIC’s insured group was 30% liable. Since 70% of $1.5 million exceeded the co- defendant’s policy limits, the other carrier paid $1 million and OMIC paid the remaining $500,000.
Risk Management Principles
Optometrists and ophthalmologists have different scopes of practice and competencies. While some eye conditions can be managed independently by optometrists, others require consultation with, or management by, an ophthalmologist. Eye conditions that can lead to severe vision loss, systemic disease, or death are best managed in consultation with an ophthalmologist. In this case, the role of the employed optometrist was not well defined by the OMIC insured group and there was no formal training, ongoing evaluation of her competency, or written protocols. The optometrist felt the nevus was non-suspicious so she did not consult with the ophthalmologist during her one and only examination of the patient. As this case demonstrates, communication between a group’s optometrists and ophthalmologists is, at times, critical in order to achieve optimal patient care. Risk management experts at OMIC recommend that the optometrist’s role be defined in writing in terms of what conditions he or she can manage independently, what conditions require consultation with an ophthalmologist, and what conditions require management by an ophthalmologist (see this issue’s Hotline column and “Coordinating Care with Optometrists,” available at www.omic.com, for a more detailed discussion and sample protocol).
Noncompliance Puts Patient and Physician at Risk in Glaucoma Cases
Digest, Summer, 1994
Allegation
Plaintiff alleged that insured ophthalmologist negligently performed unnecessary peripheral iridectomy, resulting in decreased visual acuity in plaintiff’s left eye.
Disposition
Prelitigation screening panel concluded the claim was without merit. Plaintiff did not pursue the case in civil court.
Background
Several states now use prelitigation screening panels to review the merits of a medical malpractice claim before the case can be pursued in civil court. Often these panels include a physician who specializes in the area of medicine involved in the claim. This type of review process can be extremely beneficial to defendant ophthalmologists who can support their treatment choices with sound medical reasoning. If the review panel renders an opinion favorable to the defendant and the plaintiff chooses to continue to pursue the case in court, the favorable panel decision is admissible evidence when permitted by state law. This creates an additional obstacle for the plaintiff to overcome in proving his or her case and can induce the plaintiff to drop the claim short of litigation.
Case Summary
A 60-year-old female presented to the insured and reported symptoms of headache, eyeache, nausea, vomiting, and blurred and foggy vision three days previously. The insured examined the patient and concluded she had experienced an episode of acute angle closure glaucoma which had spontaneously resolved. The insured ophthalmologist recommended laser peripheral iridectomies OU to avoid another acute episode, as well as a course of treatment for chronic glaucoma. The patient left the insured’s office indicating she would consider the procedure.
Unbeknownst to the insured, the patient sought a second opinion from another ophthalmologist who did not believe the iridectomies were necessary but who advised the patient to be followed for chronic glaucoma. Despite a documented telephone call to the patient and a letter from the insured ophthalmologist urging her to have regular examinations to follow her glaucoma, the patient did not consult another eye professional until two years later. She then returned to the insured for an examination because she felt she needed new glasses. She reported no additional episodes of acute angle closure. The insured reiterated his recommendations for prophylactic surgery and this time the patient agreed.
An iridectomy OD was performed without complications and with good results. After the peripheral iridectomy OS, the patient’s eyes burned, the iris was dilated, and her VA decreased from 20/25 to 20/50. During postoperative visits, the insured noted elevated pressure, vitreous condensation, adherence of the iris to the cornea OS, and increased disc cupping. After two postoperative visits, the patient never returned and subsequently sought eye care from optometrists. Dissatisfied with her decrease in visual acuity OS, the patient filed a written complaint with the Board of Medical Examiners. This complaint prompted a review by the prelitigation screening panel in her state.
Outcome
The litigation screening panel agreed that surgery was an option in 1988 when the insured first recommended it. However, in the absence of intervening problems, the ophthalmologist on the panel did not believe surgery was clearly warranted based on clinical findings alone when the patient returned two years later. In the end, it was the patient’s demonstrated noncompliance in “disappearing” for two years which convinced the panelists that the insured’s treatment plan was justified nonetheless. Documentation by the insured and subsequent treaters specifically indicated that the patient was noncompliant in keeping appointments and taking medications. This documentation laid a firm foundation for the defense’s arguments that it was probably the patient’s own negligence which caused her reduced visual acuity.
Risk Management Principlesand Commentary
The treatment of glaucoma requires vigilance on the part of both the ophthalmologist and the patient. Noncompliant glaucoma patients can jeopardize their own vision and put physicians at risk for litigation. As their condition inevitably worsens, such patients often look for someone else to blame. When it comes to defending a claim, documentation of the patient’s noncompliance and of the physician’s attempts to encourage compliance with medical advice can be as important as documentation of the patient’s clinical progress.
Delayed Diagnosis and Treatment of Glaucoma
Digest, Spring 1997
ALLEGATION
Delayed diagnosis and mismanagement of glaucoma resulting in vision loss in one eye.
DISPOSITION
Claim settled on behalf of insured ophthalmologist.
Case Summary
In July 1990, a 47-year-old female CEO for a regional manufacturing company presented to the office of the insured with complaints of blurred vision and light sensitivity in her right eye over the course of approximately two months. A full eye exam was conducted and all findings were essentially normal. The ophthalmologist diagnosed refractive error in both eyes and successfully corrected the patient’s vision to 20/25 OD and 20/20 OS. The patient was instructed to return in two years unless she experienced a further problem.
A month later, the patient returned with complaints that her right eye had worsened, including light sensitivity and a spot of decreased vision. The Amsler grid test showed a defect in the inferior portion of the visual field of the right eye. The ophthalmologist diagnosed conjunctivitis and corneal abrasion and placed the patient on Vasocidin drops for 10 days. The patient returned after four days, again complaining of blurred vision and irritation from the antibiotic drops. The best corrected vision in her right eye was 20/30-2 and in her left eye 20/20-1. Both funduscopic exams were normal. The antibiotic was changed to Gentacidin and the patient was told to return in a week.
The insured did not hear from the patient again for eight months when she appeared with complaints of blurred vision and light sensitivity in the right eye. Visual acuity with correction was 20/30-2 in the right eye and 20/20 in the left. Tension was 30 in the right eye and 28 in the left. Funduscopic exam revealed abnormal cup to disc ratios in both eyes with the worst being 0.8 in the right eye. Visual fields were abnormal on the right and borderline on the left. A diagnosis of bilateral glaucoma was made and the patient was placed on Betagan and instructed to return in 10 days. When the patient returned in 10 days, she reported that the right eye felt better, although visual acuity was essentially the same. Pressure in the left eye had dropped from 28 to 23 but had risen from 30 to 31 in the right eye. The insured placed the patient on a combination of glaucoma medications, which effectively lowered the intraocular pressure to 19 in the right eye.
For the next several months, the patient’s intraocular pressure vacillated from the mid-20s up to 30. The insured noted that intraocular pressure was elevated at some visits because the patient had forgotten to take the glaucoma drops in the morning, resulting in an elevated pressure when the exam took place in the afternoon. The patient also reportedly failed to have her prescription for eye drops filled for a period of three months. Even though the insured continued to monitor the patient’s pressures and adjust her medication every four to six months, this roller coaster pattern of elevated pressures continued throughout most of the next two years.
In September 1993, the patient presented with decreased vision and a change in the appearance of the optic nerve. The cup to disc ratio had now increased to .89 and VA in the right eye was hand motion only. At this point, the insured referred the patient for surgical evaluation and the patient ultimately underwent a laser trabeculoplasty for advanced loss of vision in the right eye. Vision was stabilized but not recovered. The patient sued the ophthalmologist, alleging that vision loss in her right eye was due to delayed diagnosis and mismanagement of glaucoma. The case was subsequently settled before trial.
Analysis
There were two deficits in record keeping that hampered defense of this case. The first was the failure to document ocular pressures on the patient’s second and third visits. Defense experts pointed out that when the patient presented with consistent symptoms of decreasing vision and light sensitivity in the right eye, failure to check pressures would be considered by most to be below the standard. If the pressures were normal and documented, there would be no question regarding the insured’s approach to treatment; however with no pressures recorded, it was left open for the plaintiff to point out that the glaucoma might have been diagnosed earlier. Although the insured stated that his customary routine would have been to check the pressures and that this patient’s must have been normal, there is no mention of this in the chart.
The second record keeping problem was the lack of documentation of patient noncompliance. Over the two years of reported noncompliance, there were very few notations indicating these problems in the medical record. This became critical when the plaintiff attorney interpreted the medical record as showing that the pressures were “just not monitored well” and “adjustments were not timely made” in the medications. The patient testified that she was a model patient who followed all directions. It was very difficult to argue at that point that the variations in treatment patterns were due primarily to patient noncompliance.
Risk Management Principles and Commentary
In recent years, glaucoma cases have developed a significant presence in medical malpractice litigation. A 1996 study of 383 ophthalmology claims from the Medical Liability Mutual Insurance Company of New York found that 15% of the high loss cases (over $250,000) involved the management of glaucoma. The most common problems to appear in litigation were related to failure to diagnose and/or manage chronic glaucoma.1 An earlier study in 1994 specifically analyzed 194 glaucoma claims from the Physician Insurers Association of America (PIAA) and found that four types of problems account for the majority of allegations in glaucoma claims:2
- Diagnostic error (21.7%)
- Improper performance of care (19.1%)
- Medication error (9.8%)
- Failure to monitor patient (8.2%)
Not every case involving these allegations is a case of negligence. In many instances, the injury to the patient is the result of a known complication that can be defended provided the legal facts of the case are not complicated by poor record keeping. When a plaintiff attorney searches the medical records for the cause of vision loss in a glaucoma patient, inevitably the search will analyze evidence of (1) a failure or delay in diagnosis and (2) a delayed or improper treatment pattern. Documentation or lack thereof in the medical record can make or break a case for either side.
Notes
- Kraushar MF, Robb JH. Ophthalmic Malpractice Lawsuits with Large Monetary Awards. Archives of Ophthalmology. March 1996; 114: 333-337.
- Craven RE. Risk Management Issues in Glaucoma Diagnosis and Treatment. Ophthalmic Risk Management Digest. Summer 1994: 3-5.
Risks and Benefits of Writing Off a Patient’s Bill
By Ryan Bucsi, OMIC Senior Litigation Analyst
ALLEGATION
Performance of unnecessary cataract surgery and failure to diagnose and treat glaucoma.
DISPOSITION
Case dismissed by plaintiff just prior to trial.
Case Summary
An OMIC insured performed uncom- plicated cataract surgeries one week apart. Following surgery, the patient had uncorrected visual acuities of 20/25+2 OD and 20/25 OS, with increased intraocular pressures of 27 and 28. The insured prescribed Ocuflox in the left eye and Lotemax in both eyes. During subsequent visits, the patient complained of a foreign body sensation, tired- ness, and irritation in both eyes; a throbbing pain and seeing a yellow ring behind the left eye; and glare and light sensitivity. Suspecting migraines, the insured advised the patient to have an MRI, which was normal.
The patient did not return to the insured’s office for three months, against the insured’s advice, but did seek treatment from another ophthalmologist, who documented 20/20 vision without correction bilaterally and diagnosed a posterior vitreous detachment in the right eye. The patient eventually re- turned to the insured complaining of dry eyes, sharp pain, light sensitivity, and headaches. The insured’s impression was a neuralgic pain problem, and he referred the patient to a corneal specialist. The corneal specialist could not find a treatable diagnosis based upon his examinations. A third ophthalmologist treated the patient with punctal plugs and diagnosed chronic open angle glaucoma.
Analysis
The patient did not allege any malpractice against the OMIC insured until a dispute arose over payment of the cataract surgeries. The patient then claimed that she had been informed by the insured’s staff that her health insurance plan would cover all costs of the surgeries; post surgery, however, she learned that only 70% of the costs would be covered. The insured and his staff disputed the patient’s claim but agreed to write off 10% of the costs, leaving the patient responsible for paying 20%. The patient refused to pay and when the insured pursued these costs through litigation, the patient filed a counter suit alleging medical malpractice. Specifically, she alleged that the OMIC insured performed unnecessary cataract surgery on the left eye and failed to diagnose and treat glaucoma.
OMIC retained an attorney on behalf of the insured and had the case reviewed by both cataract and glaucoma experts. Another expert was retained to opine on whether any of the patient’s other health conditions, fibromyalgia, irritable bowel syndrome, or skin cancer, could have caused her ocular complaints. A summary jury trial was held prior to the actual trial dur- ing which jurors heard an abbreviated version of the defendant’s and plaintiff’s arguments and then issued a mock ruling on the case. The jury ruled 6-0 in favor of the defense. When interviewed by the attorneys, the jurors were so overwhelmingly in favor of the OMIC insured that the plaintiff decided to dismiss the case just prior to the start of the actual trial.
Risk Management Principles
When there is an unanticipated outcome followed by a dispute over billing, OMIC insureds are strongly advised to contact OMIC for advice on how to proceed. OMIC staff can help the insured weigh various op- tions, such as setting up a payment plan, waiving or reducing fees, facilitating a second opinion, and offering the patient additional emotional support. In this situation, the pa- tient faced multiple illnesses and hearing that doctors could find no objective reason for her eye complaints may have been more than she could bear. Rather than address the toll that her condition was taking on her, both she and the surgeon focused on the billing issue, which led to an impasse. OMIC certainly supports a physician’s right to be paid for care provided and works vigorously to defend insureds who meet the standard of care, as we did for this ophthalmologist. Our ultimate goal, however, is to avoid litigation entirely because this is gener- ally in the best interests of all parties. Lawsuits are time consuming and stressful and take time away from one’s practice. Some insureds decide fairly readily to waive their fees when it seems a prudent strategy to avoid litigation. Some do so as a compassionate gesture to the patient or to engender or sustain good will in their community. Whatever decision the insured ultimately makes, OMIC wants it to be a well-informed one.
