Risk Management

Injection of Anecortave Acetate into Globe during ARMD Risk Reduction Trial

Ryan Bucsi, OMIC Senior Litigation Analyst

Digest, Fall 2012

Allegation

Negligent administration of Anecortave Acetate into globe.

Disposition

Drug manufacturer indemnified OMIC insured and settled claim for $500,000.

Case Summary

A 75-year-old female was diagnosed with wet macular degeneration and treated with photodynamic therapy and intravitreal Kenalog. Subsequently, she developed a massive subretinal hemorrhage secondary to age-related macular edema in the right eye. The left eye also had high-risk macular drusen. A non-OMIC-insured ophthalmologist recommended that the patient participate in an age-related macular degeneration risk reduction trial, as he felt there was no other treatment currently available that would be of benefit to the left eye. An OMIC insured performed eight injections of Anecortave Acetate under the trial protocol.

During the last procedure, the insured applied Xylocaine on a Q-tip to the conjunctival surface superotemporally, approximately 8 mm back from the limbus. Xylocaine was then injected about 8mm posterior to the limbus superotemporally. While waiting for the anesthesia to take effect, he pushed the medication through the cannula to the appropriate mark on the syringe. One additional drop of topical anesthetic was applied and the lid speculum was inserted. The insured marked the spot using calipers on the slightly elevated conjunctiva that was 8 mm posterior to the limbus superotemporally. The insured then used grasping forceps to pinch the slightly elevated conjunctiva and make a small snip in the conjunctiva and tenons capsule. A fair amount of scarring was encountered as he tried to dissect down to the sclera surface. The insured was able to insert a cannula but upon withdrawing the tip he noticed a clear strand of material. The insured suspected it was vitreous and realized at this point that the medication had been injected into the globe. A non-OMIC insured retinologist subsequently performed a vitrectomy to remove the Anecortave with silicone oil tamponade and silicone removal OS along with epiretinal membrane peeling. The macula was stable; however, the prognosis for visual recovery was uncertain. The patient’s visual acuity remained at 20/200 OS despite cataract surgery.

Analysis

The OMIC insured was adamant that he did not deviate from the standard of care during the final trial injection. It was the insured’s opinion that the previous injections were responsible for the scarring. The insured reported to his attorney that he had discovered reports of several other patients who experienced similar complications. As discovery progressed, the drug manufacturer abandoned the treatment as it became apparent that it was not beneficial to patients. Prior to the drug trial, the OMIC-insured had obtained a specific indemnification agreement covering this type of incident. OMIC’s defense attorney approached the manufacturer’s attorney about this agreement; however, the attorney for the manufacturer maintained that there was no indemnification since the proposed claim was for alleged negligence by the OMIC insured. Defense counsel reminded this attorney that the agreement specifically spelled out that the manufacturer would indemnify the OMIC-insured in that context. The attorney for the manufacturer continued to disagree but allowed that the manufacturer, for professional relationship reasons, would indemnify the OMIC insured. The manufacturer recommended that defense counsel submit a formal demand for indemnification. The demand was accepted and the insured was dismissed from the claim. The drug manufacturer settled for $500,000.

Risk Management Principles

The insured and the entity he was working for at the time of this incident were extremely thorough in drafting their agreement with the drug manufacturer prior to participating in the trial. By entering into a legally enforceable indemnification agreement with the drug manufacturer, the insured was able to avoid a large settlement. Ophthalmologists should indeed negotiate such agreements before they become involved in surgical and drug studies. Furthermore, the insured applied good technique throughout the trial and thoroughly documented his approach and technique during each injection. This documentation made it very difficult for the drug manufacturer to allege that the insured’s technique was improper.