Risk Management



Monocular Patient Loses Vision After Vitrectomy

Ryan Bucsi, OMIC Senior Litigation Analyst

This is a recently closed claim study of the Ophthalmic Mutual Insurance Company.

Digest, V24 N1 2014

Allegation

Lack of informed consent of increased risk of bleeding during elective vitrectomy in a patient taking Plavix and aspirin.

Disposition

Case settled for $825,000.

Case Summary

A 77-year-old female patient was referred to an OMIC insured with a history of blindness OS following a stroke several years earlier, as well as diabetes and hypertension. She had previous cataract surgery OD with 20/40 visual acuity and complained of seeing “specks.” The insured diagnosed marked asteroid hyalosis and, although the retina was attached, he recommended a vitrectomy to reduce the floaters. The insured was aware of the patient’s history of stroke and lost vision OS and that she was taking Plavix and aspirin, but he did not have her discontinue these medications prior to surgery. Towards the conclusion of the vitrectomy, the patient developed a bleed that led to a retinal detachment. Unable to isolate the bleed, the insured closed the eye and scheduled a subsequent procedure one week later to remove the blood and reattach the retina using silicone oil. It was noted during this second procedure that there was extensive clotting from the previous procedure.

At this point, the insured consulted with the patient’s primary care physician, who decided to discontinue the Plavix. Two weeks later, a third procedure was performed to remove additional blood. The retina was detached for the removal of blood and reattached at the conclusion of the procedure, again using silicone oil. The insured then consulted with his partner as there was still some blood present in the eye and the retina continued to detach following each surgery. With the insured present, the partner performed a fourth surgery six weeks later in an attempt to remove all the remaining blood and reattach the retina. The surgery was successful in reattaching the retina, but all the blood could not be removed as the patient continued to bleed during the procedure. A final examination revealed a white optic nerve and indicated that blood underneath the retina for a prolonged period of time may have caused damage to the photoreceptors. The patient had nerve atrophy, atrophy of the eye itself, and NLP OD, rendering her completely blind.

Analysis

Our defense experts were split on whether it was within the standard of care to operate on this patient without first consulting her primary care physician about safely taking her off Plavix and aspirin prior to surgery. However, our experts unanimously agreed that a separate informed consent should have been given to the patient specifically detailing the risk of hemorrhage, retinal detachment, and potential loss of sight.

During his deposition, the insured testified that he had no discussions with the patient about an increased risk of bleeding, retinal detachment, and loss of vision because the vitrectomy was done in an avascular area and bleeding was not expected. Our experts disagreed and felt that bleeding was indeed a risk and since the patient had sight in only one eye, there should have been a more thorough review and discussion of all the risks associated with surgery. Indeed, the main weakness of the case was the apparent imbalance between the expected benefit of surgery to remove floaters and the potential risk of blindness in a functionally monocular patient.

Risk Management Principles

The patient history and physical exam were appropriately performed and documented; however, the insured did not take into account that the findings indicated an increased risk for bleeding and retinal detachment, which could lead to blindness in the patient’s remaining good eye. The patient was never informed of these possible complications and did not have the opportunity to make a well-informed decision about moving forward with a procedure that carried significant risks. Additionally, as pointed out by one of OMIC’s defense experts, since this was an elective procedure, a detailed, welldocumented discussion of the risks would have benefited the doctor when complications arose.

OMIC has a sample consent form to use with surgical patients who are taking anticoagulants. See it here.

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