Risk Management

Risk Management Issues in Medical Retina Disorders

 By Jerome W. Bettman Sr., MD, and Monica L. Monica, MD, PhD

Digest, Fall, 1994

Malpractice suits involving medical disorders of the retina have become more common, specifically those involving diabetic retinopathy and macular degeneration. Informed consent plays a major role in helping retina patients understand the consequences of failing to receive treatment and accept the sometimes less-than-perfect results of treatment. The following case will help illustrate the problem.

Diabetic Retinopathy

Mrs. Jones was a 65-year-old diabetic who presented to an ophthalmologist complaining of a fuzzy spot in her right eye upon reading. She had been an insulin-dependent diabetic for more than 15 years and was well-controlled on medication. On examination, the ophthalmologist discovered metamorphopsia on Amsler grid testing, and exudates and hemorrhages in the perimacular area of the right eye. A fluorescein angiogram was performed which delineated the problem vessels. The ophthalmologist told Mrs. Jones that leaking blood vessels in her eye were causing the blurred spot and explained how a laser could be used to seal off the leaking blood vessels and help her vision.

Laser therapy was successfully performed and eventually the exudates resorbed and the hemorrhage resolved; however, Mrs. Jones still complained about a blurred spot in her right eye upon reading. She was told that the laser had created a scar and that this scar was causing some visual disturbance, but that her initial problem leaking blood vessels had been solved by the laser. Mrs. Jones did not see it that way, and she sued the ophthalmologist.

This case illustrates a few points. One is that disorders of the retina can be complicated and difficult for patients to understand. Videos and patient reading materials may be helpful, but the patient needs to be given ample time to review these materials and to ask questions. Secondly, patients often do not understand the consequences of laser treatment, or they honestly do not recall those complications that might destroy vision. 1,2,3  

For many, the idea of treatment is synonymous with cure. Mrs. Jones was very upset to discover that she still had blurring from macular degeneration. Many patients view the laser as the restorer of perfect eyesight when that may be far from the case. It may be helpful to have the patient write in the chart what he or she understands the possible result of laser therapy to be. This is evidence that cannot be denied in a courtroom.

Retinopathy of Prematurity

For several decades, retinopathy of prematurity (ROP) has been the source of numerous malpractice suits, although there is little doubt that some ROP cases were misdiagnosed and were actually Familial Exudative Vitreoretinopathy, or Coat’s Disease, Eales Disease, macular ectopia, and the like.

Some historical perspective on this problem is instructional. Early ROP claims were based upon the fact that more than 40% oxygen was given to the neonate. At the time, this was the upper limit that was considered appropriate, and any greater concentration constituted malpractice. This arbitrary limit had no basis in scientific fact. As a result, oxygen was severely curtailed and cerebral palsy, respiratory distress syndrome, and death increased in incidence. It was then decided that oxygen should be administered in whatever concentration and duration was necessary for the neonate’s survival. The incidence of malpractice suits increased again. It is now generally concluded that the prematurity itself is the most significant etiological agent. In addition to the oxygen, a number of factors play a role in the development of retinopathy of prematurity, i.e., pH, CO2, prostaglandins, Vitamin E, and others. If oxygen is used only in necessary amounts, it should not be the basis for a suit.

A major catalyst in ROP claims is failure to adequately communicate the potential problems the baby may face even after treatment. Parents are often stressed by the illness of the baby and do not adequately comprehend all the details at the time. This has led to problems with follow-up on the babies, especially for eye checks. It is helpful to involve the entire nursing team in any discussion of the neonate’s problems and the protocol for follow-up. Hearing these messages repeated by the various health personnel involved in their baby’s treatment will reinforce for the family the importance of follow-up care.

Timely Follow-up Crucial in ROP Cases

Progressive retinopathy of prematurity was once an untreatable condition. Cryotherapy to retard the progress of the disease was first proposed in Japan in 1972. Because of the lack of convincing data and complications of treatment in some cases, cryotherapy was not strongly advocated in the United States. The cryo-retinopathy of prematurity study demonstrated an unfavorable outcome in untreated eyes of 43% compared to 21.8% in treated eyes.4

This positive finding reinforced the need for ophthalmologists to detect and carefully follow babies with retinopathy of prematurity changes even after discharge from the neonatal ICU. Babies with so-called threshold disease (defined as five or more contiguous or eight cumulative 30 sectors, or clock hours, of Stage III retinopathy of prematurity in zone one or two in the presence of “plus” disease) are felt to be candidates for cryotherapy. Failure to treat may result in litigation. Timely follow-up of these infants at regular intervals is crucial.

Retinal Tumors

Misdiagnosis of a retinal tumor has accounted for a low proportion of malpractice suits involving medical retina problems. Melanomas are sometimes diagnosed as retinal detachments. Infrequently, claims have arisen because a large subretinal hemorrhage was misdiagnosed as a melanoma and the eye was enucleated. Ophthalmologists should not be afraid to seek second opinions on those cases which do not conform to the usual axioms of diagnosis.

Conclusion

So often, ophthalmologists focus their attention on surgical cases and complications. While surgical incidents do make up a large part of malpractice claims, claims involving medical diagnoses and treatment, especially of retinal disorders, are becoming more common.

Notes:

1. Priluck IA, et al. What Patients Recall of Preoperative Discussion after Retinal detachment. Am J Ophthal. 1979; 87:620.

2. Robinson G and Merav A. Informed Consent: Recall by Patients Tested Postoperatively. Ann Thorac Surg. 1976; 22:209.

3. Leeb D, et al. Observations on the Myth of “Informed Consent.” Plast Reconstr Surg. 1976; 58:280.

4. Tasman W. Threshold Retinopathy of Prematurity Revisited. Arch Ophthal. 1992; 110:623.