Risk Management



Failure to Obtain Informed Consent for Vitrectomy

By Delphine Cherewick, JD

OMIC Claims Associate

Digest, Fall 1999

ALLEGATION  Failure to obtain informed consent for vitrectomy, negligent surgery resulting in endophthalmitis, and negligent postop care.

DISPOSITION  Defense verdict a t trial on behalf of insured.

 

Case Summary

The patient was a 43-year-old woman who had been experiencing flashers and floaters for several months. She consulted a retinal specialist who injected steroids, and although her visual acuity remained good, the floaters continued to progress. For this reason, she sought a second opinion from the insured.

On the initial visit, there was no iris neovascularization in either eye. The fundus examination of the left eye showed 2+ vitreous cells and a very prominent posterior vitreous detachment (PVD). The insured diagnosed uveitis and PVD of the left eye and offered the patient the option of an elective vitrectomy. The insured explained that there could be serious complications associated with a vitrectomy, including the development of cataracts, infection, retinal detachments or hemorrhage, but he did not specifically mention loss of vision and he did not document this conversation in the medical record. The only consent form signed by the patient was a general hospital surgical consent.

The procedure was performed by the insured without apparent complication, and Vancomycin and Aristocort were injected subconjunctivally. The following day, the insured noted mild ptosis, redness, and edema of the eyelid. The patient complained of occasional sharp pains to her left eye. Later that night, the patient began to experience dull aching pain in her left eye and by morning she had greatly diminished visual acuity in her left eye. She was immediately seen by the insured and hospitalized for probable bacterial infection. The insured performed a vitrectomy wash out and injected appropriate antibiotics. Cultures grew out coagulase negative staphylococcus, and despite the insured’s treatment, the patient’s vision continued to decrease. Vision loss progressed to no light perception and the patient was ultimately informed that she would likely require an enucleation.

Analysis

Postoperative infection leading to endophthalmitis is a concern in any surgery involving the eye. It happens to the best of surgeons in the most optimum of circumstances, often with devastating results. Until recently, endophthalmitis cases were extremely difficult to defend because the injury was usually severe and the experts could be counted on to disagree on the administration of antibiotics specifically and postoperative care generally. Presented with conflicting and confusing medical facts, juries generally sided with plaintiffs who had clear evidence of injuries.

This case, on the other hand, benefited from an evolving medical-legal approach to endophthalmitis cases that has been increasingly successful in the courtroom. Citing findings from the 1994 Endophthalmitis Vitrectomy Study commissioned by the National Eye Institute, defense experts were able to support the insured’s course of treatment and show the jury how and why certain approaches to infection are used. This defense tactic also had the effect of discrediting plaintiff experts if they disagreed with the “established” experts who conducted the study.

Risk Management Principles

The most troublesome aspect of this case was the lack of informed consent documentation. It is important to document informed consent in any surgery, but it is imperative in an elective surgery. The decision to have surgery is not as clear cut when it is elective and it is easier for the plaintiff attorney to argue that the plaintiff would not have had the surgery had he or she known of all the risks.

In this case, the insured failed to document his conversation with the patient because of two very common occurrences in the medical office environment: a hectic schedule that does not allow sufficient time for accurate documentation, and complacency with repetitious documentation, such as the risks of surgery. Fortunately, the patient had signed a hospital consent form. This enabled the defense attorney to successfully argue that based on the insured’s usual and customary practice, it was more likely than not that he had instructed the patient on the risks of the procedure.

 

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