MALPRACTICE MANAGEMENT
Learn from these real-life cases how to protect yourself.

Diabetic Disaster
Some points to consider when treating diabetic patients.

Every time a patient presents with a history of diabetes, remember that diabetic retinopathy is the leading cause of blindness in patients under age 65 in the western world.

To meet the standard of care for these patients, remember to follow the bases.

First base: Does the patient have best corrected visual acuity (VA) of 20/20 to 20/25? If not, why? A mild cataract, common in diabetics, might be responsible, but a maculopathy is of greater concern. Maculopathies caused by so-called clinically significant macula edema (CSME) are often improved with laser treatment, but retinal zones of capillary non-perfusion associated with vision loss aren't amenable to treatment.

Second base: Does the patient have normal pressure? Neovascular glaucoma can cause high pressure in diabetics. This condition can lead to blindness if not recognized and treated in a timely manner.

Third base: Does the dilated fundus exam reveal that the patient has diabetic retinopathy? Findings such as neovascularization of the disc require timely pan-retinal photocoagulation (PRP) to prevent vitreol hemorrhage and traction retinal detachment. In contrast, findings such as mild non-proliferative diabetic retinopathy (NPDR-often still referred to as mild background retinopathy) require no treatment at present but do require appropriate follow-up.

Home plate: Does the patient have a normal visual field? Undetected glaucoma, a retinal vascular occlusion, areas of capillary non-perfusion, diabetic papillopathy and strokes in the brain affecting the visual pathway can all cause field loss.

Patient with mild to moderate non-proliferative diabetic retinopathy. Treatment isn't indicated, but the patient needs to be followed carefully.

The case

A 31-year-old white female in California (who we'll call Jane) presents for an eye exam without any obvious chief complaint. The chart contains the note, "Visual acuity fair, negative diplopia and negative flashes and floaters." The history reveals that Jane has had diabetes for 26 years and has no record of high blood pressure. The only medicine listed is insulin.

Current exam. Dr. Stone's exam reveals corrected VA with a minor refractive error of 20/25+ OU. The pupils, stereo and fusion as well as confrontations were all listed as within normal limits. The anterior filtration angles are judged as open in each eye (grade 4). The intraocular pressures were measured at 19 mm Hg in each eye.

Dr. Stone dilated the patient with the traditional dilating agents and judged that most of the fundus was within normal limits. The exception was the note of mild background diabetic retinopathy but without CSME OU.

The disc-to-cup ratio was .2/.2, the artery-to-vein ratio was 2/3 and Dr. Stone observed a foveal reflex in each eye. The medical diagnosis was listed as mild background diabetic retinopathy.

Dr. Stone prescribed new spectacles and told Jane to return in 6 months or sooner if she noticed any change in her vision. He never saw her again.

Cause for concern. About 1 month later, Jane presented to the emergency room of a major medical center with a 1-week history of fatigue, excessive urination, chronic excessive thirst and vomiting. The hospital staff reported that she was tachycardiac, lethargic, had sluggish speech and coffee ground emesis.

Among her abnormal findings was a blood glucose level of 925 mg/dl and blood pressure of 160/80 mm Hg. The hospital admitted her with a working diagnosis of diabetic ketoacidosis and gastrointestinal bleeding. It appears that her fundus wasn't checked during this 1-week hospital stay.

Jane was evaluated about 1 week after her hospital stay by her diabetologist, who attempted to normalize her blood sugar levels and her blood pressure. When Jane was apparently feeling better, she missed several scheduled appointments with her diabetologist.

Déjà vu. About 8 months after her single eye exam with Dr. X, Jane was hospitalized again, but this time she complained that she had difficulty seeing. In addition to severe proliferative diabetic retinopathy, she also exhibited rubeosis in each eye.

Despite numerous laser treatments to her retinas, the proliferative retinopathy worsened. Glaucoma surgery was also required based on her sky-high IOPs, which were in the 60s. In spite of the best care available, Jane's vision worsened and she's now NLP in each eye. The diabetes has also affected her kidneys and multiple other organs.

	Patient with clinically significant macular edema (CME) in diabetic retinopathy. Laser is indicated.

Standard of care

Based on the Early Treatment of Diabetic Retinopathy Studies (ETDRS), relatively well-documented standards of care guidelines have been established. These guidelines have been adopted and re-printed in many sources, including The AOA Optometric Clinical Practice Guideline, Care of the Patient with Diabetes Mellitus.

These guidelines state that a diabetic patient with normal VA, normal discs and normal pressures with "mild background diabetic retinopathy but without CSME" detected through a dilated pupil requires a follow-up in 12 months -- but doesn't require fundus photography or fluorescein angiography. The same guidelines reveal that such a patient has a 5% chance of progressing to proliferative diabetic retinopathy within 1 year.

Bad news for Dr. Stone?

Jane sued Dr. Stone for missing advanced retinopathy and for failing to refer her to a retinal specialist. The case recently went to a jury trial, and I was pre-pared to testify that Dr. Stone met the standard of care and is hence not culpable of malpractice. His single exam, in my view, covered all the bases.

I believe that the unfortunate and poorly compliant patient displayed only mild non-proliferative diabetic retinopathy at the time of the first exam.

Within 1 month, her general health deteriorated and her newly diagnosed high blood pressure only exacerbated the progression of the diabetic retinopathy.

As noted in the guidelines mentioned earlier, only about 5% of patients with mild NPDR progress to proliferative disease in 1 year. This patient is the one in 20. The guidelines are de-signed for the majority of pa-tients and hence will fail in an occasional case.

Actual fundus photo of Jane at the time of her diagnosis of proliferative diabetic retinopathy.

I could summarize the situation and say that this patient has a bad disease but not a bad doctor and that Dr. Stone went beyond the standard in that he recommended a re-evaluation in 6 months, whereas the published recommended frequency of follow-up is 12 months.

In the middle of the jury trial, and hours before my planned testimony for the defense, the judge dismissed all the charges on technical legal grounds. It's unclear whether the patient will appeal the case.

Beyond the standard

The optometrist in this case isn't culpable of malpractice because he met the existing standard of care. Unfortunately, he experienced the ordeal of being sued, and of knowing that a patient of his went totally blind, and he had to appear at trial to defend himself. Is there anything Dr. Stone could've done differently to have prevented the lawsuit in the first place?

Although not required by the standard, Dr. Stone could've obtained high-quality fundus photos and used them to verify his clinical observation that only mild NPDR was present at the time of his exam. (The plaintiff's experts contend that Dr. Stone must've missed a much more severe retinopathy than what he had noted in his chart.)

If such fundus photos existed, the plaintiff's attorneys would've had great difficulty in finding an expert who would disregard the fundus images. But certain procedures, such as fundus photography, are a "dual-edged sword."

If these photos exist and they document early proliferative disease, then the doctor is culpable because they become part of the evidence and legally become available to the judge and jury.

Dr. Stone also could've re-ferred for a fundus fluorescein angiography. If disc leakage was detected, this would've pointed to early disc neovascularization and led to timely PRP.

If you can't predict it, prevent it

We'll never know if going beyond the standard and obtaining a fluorescein angiography would've changed the outcome and prevented the bilateral blindness. Pay close attention to those important steps I mentioned when treating diabetic patients because you never know when a patient plans to sue, these steps and this example case can prove beneficial in helping you protect yourself against litigation.

The advice put forth in this column shouldn't be miscon-strued as legal advice. This column is based on expert testimony given by Dr. Sherman and reflects his opinions.

Dr. Sherman practices at the Eye Institute and Laser Center in Manhattan and is a distinguished teaching professor at the State University of New York College of Optometry.