Risk Management

Failure to Adequately Inform of Laser Risks

Digest, Fall, 1994

Allegation

Insured ophthalmologist and a retina specialist allegedly failed to warn of the potential danger of total blindness resulting from laser treatment.

Disposition

Charges against the general ophthalmologist were dismissed. The retina specialist settled for an unspecified amount based on the confusion around the informed consent issue.

Case Summary

The patient was a 64-year-old woman who presented to the insured ophthalmologist after experiencing a sudden loss of vision in her right eye. She had a history of hypertension, cataract surgery, and macular degeneration in both eyes. Visual acuity on examination was hand motion at 1 ft. OD, and 20/80+2 OS corrected. Examination of the posterior segment of the right eye revealed an extensive subretinal and subpigment epithelial hemorrhage involving the macula. Both eyes disclosed extensive and severe changes in the macula consisting not only of hemorrhage, but also of drusen and atrophic pigmentary changes. The retinal arterioles were quite narrow in each eye, indicating severe arteriolar sclerosis.

A fluorescein angiogram disclosed the presence of some retinal neovascularization and RPE atrophy in the right eye, but no subretinal blood in the left eye. The recorded diagnosis was huge subretinal hemorrhage OD due to macular degeneration, and beginning subretinal hemorrhage on the left. The insured recommended that the right eye be observed for the next 6 to 12 months and that laser treatment be performed to prevent further breakage and hemorrhaging of the left paramacula. Before referring her to a retina specialist, the insured had the patient sign a fairly general consent form for laser surgery, which listed blurred vision, bleeding, and a hole in the retina as possible complications. The retina specialist also discussed possible complications of surgery with the patient, but since the patient had already signed a release, he did not document the discussion in the record nor did he have her sign a release.

The laser treatment was performed without apparent complication. Three days later, however, the patient noted severe vision loss in the left eye. Examination revealed an extensive subretinal hemorrhage in the left eye similar to that which was present in the right eye. The left eye advanced rapidly from hand movement to no light perception. The patient was left with only light perception in her right eye.

Analysis

The medical experts who reviewed this case were not critical of the technique used during the surgery. They agreed that laser photocoagulation was the appropriate treatment of choice for this patient; however, they were critical of the retina surgeon for failing to adequately document the informed consent process and for relying upon the referring physician’s informed consent. Even though the referring physician had made cursory documentation of the informed consent discussion, it was the surgeon who ultimately was held responsible for ensuring that the patient was adequately informed and for documenting that discussion. Because he did not do this, the plaintiff’s attorney was able to argue that the patient was not adequately warned of the possibility of total blindness following laser treatment. The plaintiff attorney’s final argument was that the patient was not given the pertinent facts to make an intelligent choice about her own vision.

Risk Management Principlesand Commentary

This case illustrates a deviation from one of the primary rules of informed consent: The caregiver who actually performs the procedure is primarily responsible for the adequacy of the informed consent. In the case of a referral, a surgeon cannot make the assumption that the referring physician has discussed the surgery with the patient. Even when the surgeon is certain that detailed information was previously provided to the patient, it is a good practice to review this information, especially in the case of elderly patients, to assist their understanding and allow time for questions.

The issue of adequate consent also comes up under several teaching scenarios where a resident often will secure a timely informed consent prior to a procedure at which the resident is assisting. In such cases, the attending surgeon remains responsible for the quality and completeness of the consent process, and it behooves the surgeon to doublecheck the adequacy of the resident’s consent technique. With the advent of managed care and the interdependence of ophthalmologists, optometrists, physician assistants, nurse practitioners, and others, assuming that another caregiver along the chain of health care has adequately informed or educated a patient is a dangerous practice.