Risk Management

Lessons from Trials and Settlements of 2004

By Arthur W. Allen, MD, and Anne M. Menke, RN, PhD
Dr. Allen is OMIC’s Chairman Emeritus and is currently serving his final year as Chairman of OMIC’s Claims Committee. Anne Menke is OMIC’s Risk Manager

Digest, Winter 2005

OMIC policyholders have indicated on evaluation forms completed after risk management seminars that they would like to know the outcome of trials and settlements. This article will give an overview of last year’s claims experience. Claims and lawsuits are evaluated by the OMIC Claims Department and the Board’s Claims Committee, as well as by plaintiff and defense attorneys and expert witnesses. The insured ophthalmologist is involved in the process and in the decision to settle a case or take it to trial. Money awarded to plaintiffs as a result of settlements or jury verdicts are called indemnity payments and are reported by OMIC to the National Practitioner Data Bank. As required by state law, some are also reported to the physician’s medical board.

In 2004, there were thirteen trials, which resulted in eleven defense verdicts (85%), one plaintiff verdict, and one mistrial due to a hung jury. One case that resulted in a defense verdict required a payment to the plaintiff based on a pre-trial “high/low” agreement. A jury verdict does not always signal the end of a case. Four of the eleven defense verdicts are being appealed, including one that has already been taken to trial three times. OMIC is appealing the one plaintiff verdict of $500,000. The 56 settlements cost OMIC $6,851,155 in indemnity payments.

All three anesthesia cases involved retrobulbar blocks. In one case, the plaintiff alleged inadequate pain relief during cataract surgery; the other two stemmed from globe perforations, a known complication of the procedure that can occur in the absence of negligence. The cause of the poor outcome in one case was excessive anticoagulation from Coumadin combined with inadequate control of intraoperative bleeding. When a patient is on Coumadin, alternative methods of anesthesia should be considered, and the ophthalmologist should consult with the primary care physician to verify  that the PT level has been recently checked and is in the appropriate range prior to surgery.

The secondary issues in cataract cases were: retinal detachments (5), glaucoma (3), “wrong” IOLs (3), corneal edema (2), endophthalmitis (2), and one each involving informed consent, iritis, retinal toxicity, and payment. Retinal detachments and glaucoma are known complications of cataract surgery, and ophthalmologists who disclosed this information during the informed consent discussion were in a better defense position, especially if the patient had preexisting retinal tears or glaucoma. Failure to diagnose was the main factor in settling these and the iritis case, underscoring the need to determine and treat the cause of visual complaints and to refer patients who do not improve.

“Wrong” cases are considered preventable and are quickly settled. Two were due to using the wrong constant in the A scan, and one from not calculating the effect of pterygium removal on the patient’s astigmatism. Physicians must verify these IOL calculations. Corneal edema developed after intraoperative complications; in one case, the nurse did not note that the phaco machine’s irrigation fluid had run dry, and the anterior chamber collapsed.

Delay in diagnosis is the most common problem we see in endophthalmitis cases. In one case, the infection only developed after a second surgery, later deemed unnecessary, was performed without intraocular antibiotics (see this issue’s Closed Claim Study). In the other case of endophthalmitis, while “telephone treatment” may have contributed to a delay in diagnosis, defense experts successfully argued that the outcome was due to Strep pneumonia, known to be virulent in children. Postoperative cataract patients who call with complications should be evaluated in person by the surgeon or immediately referred to another ophthalmologist if the surgeon is unavailable. Another patient felt his eyes had not been properly shielded during use of the microscope, leading to retinal toxicity; at trial, this was appropriately attributed to his preexisting macular degeneration. Failure to perform surgery due to payment issues led to one lawsuit and settlement. Payment issues should be discussed and handled as part of the preoperative evaluation.

Two unexpected complications led to settlements in chalazion cases. In one, the surgeon cut across the lid margin instead of the lid; the suture required to repair this led to a corneal abrasion. Lack of a signed consent form contributed to the decision to settle. In the second case, a 4×4 gauze pad ignited, burning the patient’s cheek; the fact that the ophthalmologist did not disclose the nature of the injury no doubt influenced the patient’s decision to file a claim.

Six different issues in cornea cases led to settlements. In one, when the extended wear contact lenses ordered were not available, a technician substituted daily wear lenses without consulting the physician or warning the patient, who developed corneal edema. One pediatric contact lens wearer was treated with steroids for a corneal abrasion; the drops masked a pseudomonas infection, which was not discovered in a timely fashion due to inadequate follow-up. This poor outcome reinforces the need to carefully follow abrasions in patients with contact lenses until corneal ulcer is ruled out. Another child needed corneal transplants after he was treated for herpes simplex instead of acanthamoeba. The distinguishing features were not recognized, and the patient was not referred to a corneal specialist when he did not heal promptly.

An eye bank was sued for lack of informed consent when it harvested the corneas of a “John Doe” who remained unidentified after his body was found in a park. A patient receiving corneal transplants developed a choroidal hemorrhage postoperatively, which he attributed to inadequate control of his nausea and vomiting. Defense experts refuted his hypothesis for the cause of this known complication, but venue concerns, high wage loss damages, and a persistent plaintiff contributed to the decision to settle for the cost of defense. In the last case, too much cornea was removed during PTK, requiring corneal  transplants.

There were six glaucoma cases. A patient with a history of corneal abrasions and corneal erosion suffered another abrasion during pachymetry; failure to warn of the risk of a recurrence was deemed below the standard of care. Two cases involved inadequate diagnostic work-up in patients at risk of developing glaucoma: one had a strong family history and was on nasal steroids; the other was African American. The AAO’s Preferred Practice Patterns for glaucoma should be consulted. In another case, although defense experts supported the care of a noncompliant patient, altered records forced a settlement. Additions to the medical record should be rare, clearly labeled as such, and closely related in time to the care provided. No additions should ever be made after receiving notice of a claim or lawsuit.

Medications were the primary issue in two settlements and the secondary one in seven more. A patient with systemic lupus was referred to an ophthalmologist who failed to appreciate and test for the toxic ocular side effects of Plaquenil. A second physician provided psychiatric medications without an examination or informed consent and also failed to monitor the patient. As described above, excessive levels of Coumadin led to a retrobulbar hemorrhage. Another patient suffered a stroke after being given Procardia to control bleeding during a blepharoplasty. The prescribing information contained a warning about the increased risk of stroke in hypertensive patients on beta blockers; there were also criticisms of the perioperative monitoring and decision to discharge.

Lack of informed consent and failure to monitor and treat the side effects of ocular steroids contributed to settlements in five cases. As part of the informed consent discussion, patients on medications need to understand the risk/benefit ratio, and be carefully educated about the method of administration, follow-up schedule, and symptoms of side effects that should be reported to the physician.

In the sole neuro-ophthalmology case, the ophthalmologist ordered an MRI to rule out a mass or aneurysm in a patient with blurred, double vision and a 3rd motor palsy. Although the report indicated a torturous internal carotid artery and stated that a formal arteriography or CT was needed to rule out ananeurysm, this was not done, and the aneursym ruptured one month later.  The fact that the physician suspected an aneurysm but did not act on the radiologist’s suggestion to rule out this “worst case scenario” was difficult to defend.

Over 16% of the cases come from oculoplastics. Two resulted in settlements with both the ophthalmologist and the surgery center; the first, involving Procardia, was described above. The second illustrates the importance of team communication: the CRNA did not inform the surgeon when the patient moved his head, and the nurse did not confirm the Bovie  settings with the physician and set them too high. The burn caused a corneal perforation. A second equipment-related injury occurred when a patient slid to the floor after a bed malfunctioned. Diagnostic failures led to three settlements, two in patients at risk for their condition. One developed secondary glaucoma from steroids; the other suffered a recurrence of basal cell carcinoma, which might have been diagnosed earlier if tissue had been sent for a biopsy. A third patient reported a significant decrease in visual acuity to the technician involved in the preoperative work-up for ptosis repair. The technician did not report the problem, and the retinal detachment was not diagnosed until after surgery. In addition, the surgeon did not sign the technician’s notes, nor did he personally do a complete preoperative examination. In other cases, the surgical technique and intraoperative decision-making in patients with ptosis, repair of an orbital fracture, and orbital decompression for Grave’s disease were criticized. It is important in complicated cases, such as those that might require non-ophthalmic expertise (e.g., roof decompression and craniotomy), to confer with and, at times, operate with the consultant.

Five cases involved children. Four, discussed elsewhere, stemmed from a corneal ulcer, endophthalmitis following cataract surgery, surgical repair of an orbital fracture, and a traumatic foreign body. In another case, failure to evaluate for an accommodative component and a decision to strengthen the lateral rectus muscle in response to a tight medial rectus caused a poor outcome in strabismus surgery. Three of the five LASIK settlements resulted from “wrong” data. The two wrong laser setting cases could have been prevented by complying with the new JCAHO protocol that includes a “time out” before beginning a laser procedure, while obtaining two axis measurements would have brought the problem in the third case to the surgeon’s attention. Informed consent for the partial, off-label treatment would have helped prepare the patient for the fact that the laser could not treat the amblyopia resulting from her esotropia. A defense verdict was rendered in a free-flap complication case where the patient experienced halos, and in an RK case with macroperforation in which the patient required penetrating keratoplasty and cataract surgery five months later. The only PRK case involved inadequate monitoring of postoperative steroids in a patient with a history of glaucoma and thin corneas.

Failure to diagnose retinal detachment occurred in two cases. Nonclinical, largely preventable problems led to settlements in the remaining retina cases. An ophthalmologist and a medical group were both involved in settling a case of macular pucker. Although the care was defensible, records were altered and there was no consent form for the surgery. Lack of an operative report and failure to obtain and document informed refusal of fluorescein angiography in a patient with AMD treated with photocoagulation led to a settlement, as did performing an incision on the wrong eye.

In addition to the case involving surgical treatment of an orbital fracture, there were two other traumacases. In both of these, undiagnosed foreign bodies led to endophthalmitis and enucleation. In trauma cases, to rule out foreign bodies, the ophthalmologist must obtain a careful history, perform a dilated examination, and order a CT scan. These patients must be carefully followed until the eye heals.

As this article demonstrates, some poor outcomes can be prevented by keeping current with clinical guidelines, conducting a “time out” before surgery, and obtaining and documenting all care, including informed consent. Sometimes, however, patients sue physicians when they experience known complications. When the outcome is less than the patient or ophthalmologist anticipated, the physician needs to use his or her very best communication skills. OMIC policyholders are encouraged to call our Risk Manager for help in these instances. OMIC treats these calls as confidential; only the policyholder has the right to share the information with Claims or Underwriting. Also, see “Responding to  Unanticipated Outcomes” in the Risk Management Recommendations section of our web site as well as an expanded version of this article, with tables summarizing the cases and illustrating the associated nonclinical issues, in the Digest section of the web site (www.omic.com).