Refractive Claims Up, Payouts Remain Low

By Gregory D. Werre, JD
Mr. Werre is an OMIC defense attorney and partner in the Los Angeles law firm of Bonne, Bridges, Mueller, O’Keefe & Nichols. He represents physicians, hospitals, and other health care providers in professional liability litigation.

[Digest, Winter 2001]

Far from being the “risk free” procedure that some claim, laser refractive surgery can have an adverse outcome even in the hands of the most conservative and experienced practitioner. There has been a significant increase in the number of OMIC refractive surgery cases opened in the last three years, most notably involving LASIK (see figure 1 below). The data collected so far is quite preliminary since the majority of refractive cases are still open; however, we are seeing these two trends:

• Refractive cases are settled with an indemnity payment to the plaintiff more often than other types of ophthalmic claims: 37% versus 22% (see figure 2 below).
• The average indemnity payment is much smaller than the average payout for other types of ophthalmic claims: $43,000 versus $122,000 (see figure 3 below).

That a larger number of claims are settling with a payment to the plaintiff suggests that the standard of care in refractive surgery is reasonably well defined with less disagreement between plaintiffs and defendants than in other subspecialties. The low average indemnity payment suggests that complications resulting from refractive surgery usually are not debilitating and do not lead to significant economic loss (i.e., loss of earnings and/or medical expenses).

There have been exceptions and substantially higher settlements in a few non-OMIC cases. These cases have tended to involve inexperienced physicians and/or physicians utilizing techniques considered experimental by the vast majority of ophthalmologists. In these types of cases, clear-cut liability, profound visual deficits, and loss of earnings drive up the settlement value.

In one large loss case, a series of contact lens masking devices were used during LASIK to treat hyperopia and astigmatism. The 65-year-old patient ended up with irregular astigmatism and monocular diplopia. Glasses failed to correct his double vision and he claimed to be intolerant of contact lenses. Allegedly, he suffered business losses as a result of the surgery. The case settled with a payment in the mid six-figure range.

Informed Consent
Lack of informed consent is often alleged in refractive surgery cases. Substantial personal interaction with the patient preoperatively to establish a positive rapport can be effective in limiting the likelihood of a claim. This includes identifying and discussing any unique circumstances associated with the patient’s case and realistically responding to the patient’s concerns.

The wording of the consent form usually helps the defense, but the accompanying case study below serves as a reminder of the need to periodically scrutinize and update consent forms. Another issue raised in this case study was that corneal ectasia was not specifically referenced in the consent form, which supported the patient’s contention that she did not understand it to be a post-operative complication. It was the defense’s position, however, that corneal ectasia was not a well known risk of surgery in 1997. Many consent forms wisely include a phrase such as “I understand that, since it is impossible to state every complication that may occur as a result of any surgery, the list of complications in this form may not be complete.”

In the large loss case involving the contact lens masking devices, it was alleged that the ophthalmologist failed to inform the patient about his intention to use a masking device. The patient claimed the physician should have indicated that the procedure was experimental and had not been subject to a clinical trial. The physician countered that the procedure was not experimental when performed by him in light of his experience. Additionally, the physician maintained that the patient was apprised of material information and thus gave an informed consent. Finding a supportive defense expert who concurred that the procedure was not experimental required considerable effort.

Patients should be informed of the innovative nature of a new technique, its scientific basis, its benefits, and any possible drawbacks. In certain situations, the physician might even encourage the patient to seek a second opinion before proceeding with an innovative technique. This discussion should be well documented.

Flap Complications
Flap complications account for the largest percentage of LASIK lawsuits. Many flap complications represent nothing more than recognized complications of LASIK and do not lead to permanent significant visual loss. Some cases, however, have been more problematic from a defense standpoint. In one case, the flap made did not provide adequate corneal exposure. The physician, assuming he had adequate corneal exposure, proceeded to complete the laser treatment. Postoperatively, the patient complained of glare and halos. In another instance, the microkeratome met resistance while being passed across the eye. The physician was able to free the microkeratome, complete the pass, and laser the eye, but the patient sustained a loss of best spectacle corrected visual acuity, most likely because the flap was not smooth. It seems quite likely that litigation could have been avoided in each case if the flap had been reseated and treatment postponed. Both cases were settled because convincing a jury to decide in favor of the defense in either case would have been a difficult uphill battle.

Another area of potential liability is miscommunication between the surgeon and laser technician, which can lead to adverse results and litigation (see Closed Claim Study). In conclusion, experience gleaned from open and closed refractive cases support the following risk management principles:

• Even the most conscientious, well-trained refractive surgeon can end up facing a lawsuit.
• Careful attention to detail, during the screening process, the informed consent process, and intraoperatively, can serve to limit the risk of a claim down the road.
• Being supportive of a patient who has a complication may reduce the potential for a lawsuit or at least limit damages if one does arise.

Case Study: Corneal Ectasia Following LASIK

In fall 1997, a 35-year-old woman presented to an experienced refractive surgeon for consideration of LASIK. The consent form signed by the patient indicated in part that the second eye is usually treated about six to eight weeks later when the first eye has healed. Following LASIK on the right eye, the patient could see 20/30 uncorrected within the first week. The patient had difficulty wearing a contact lens in the untreated eye and agreed to proceed earlier than the time stated in the consent because she was anxious to return to work. The flap appeared to be healing normally; thus, the physician proceeded with treatment of the left eye seven days after the first eye. Following treatment of the second eye, there was a gradual decrease in the visual acuity of both eyes. Several months later, the patient was diagnosed with corneal ectasia in both eyes, resulting in loss of best spectacle corrected visual acuity. A penetrating keratoplasty was ultimately performed on the left eye.

The patient sued, contending that the preoperative corneal topography deomonstrated evidence of subclinical keratoconus, a contraindication to LASIK, and that a reasonably prudent surgeon would have allowed six to eight weeks to pass following surgery on the first eye before treating the second eye. By waiting, corneal ectasia would have been diagnosed in the first treated eye and the patient would have declined surgery on the second eye. There was also a specific claim for lack of informed consent regarding the risk of corneal ectasia.

For the defense, this case presented several challenges. Opinions differed among defense experts as to whether there was any indication of subclinical keratoconus on the preop corneal topography. One expert thought it was merely artifact. All agreed that if there were indications of subclinical keratoconus, the ophthalmologist should not have proceeded with the operation. However, none of the numerous consultants who saw the patient postoperatively before it was obvious she had an ectasia felt the preop maps were in the least bit suspicious of keratoconus.

As a clinical care issue, it is important to point out that calculations at the time of surgery indicated that a residual bed of over 250 microns would remain after the ablation. However, it was uncommon in 1997 to actually measure flap thickness and residual bed ultrasonically at the time of surgery. Now, especially in borderline cases, this measurement is commonly done and is an excellent way to reduce the risk of corneal ectasia.

The main hurdle for the defense was the plaintiff’s use of the consent form to establish a standard of care for timing treatment of the second eye. The ophthalmologist’s decision to perform surgery on the second eye seven days after the first eye was in conflict with his own informed consent document that indicated a six to eight week waiting period between surgeries. The case settled with a small indemnity payment to the plaintiff.

Orbital Fracture Missed During Eye Exam

By Mary Kasher, MSN, JD

OMIC Claims Manager

Digest, Winter 2002

ALLEGATION  Failure to diagnose orbital fracture in child, resulting in reduced range of motion and double vision.

DISPOSTION  Plaintiff verdict at trial.

Case Summary

A five-year-old boy was referred to the insured ophthalmologist by his pediatrician for a post-trauma eye exam. The child had been fighting with his brother and was pushed to the floor, rubbing his face on the carpet. Examination revealed normal VA in both eyes. The right eye was normal in appearance and movement; the left eye revealed a superficial abrasion to the corneal surface (2+ injection at inner aspect). Palpation elicited no complaints. Observing no restriction of movement, the insured decided not to perform a forced duction test. Antibiotic drops and a firm patch were applied to the left eye, and a follow-up visit was scheduled for the next day.

The following day, the child presented with increased pain and a “pinching” sensation. He would not allow an examination due to the pain. Suspecting a foreign body and wanting to examine the eye carefully, the insured performed an exam under anesthesia. No foreign body was discovered, but a notation was made that the corneal abrasion was healing. The patient continued to improve until five months later when the pediatrician again referred him to the insured because the left eye was not moving properly. The insured confirmed that the left eye did not elevate properly and referred the child to an oculoplastic specialist.

The specialist noted severely restricted movement OS and ordered a CT scan, which showed a fracture of the orbit. On exam, the upward gaze was almost nonexistent and downward gaze was moderately restricted. The eyeball itself was 2 mm depressed. Surgery to release the entrapped muscle was successful, and improvement in both double vision and movement was noted, although the child continued to experience slight double vision in upward and downward gaze. Neither the child nor his parents reported any problems or restrictions in his activities.

Analysis

The central issue in this case was whether the insured’s examination met the standard of care and whether the delay in diagnosing the orbital fracture affected the outcome. The plaintiff expert and three defense experts stated that with the presenting history and symptoms, they would have suspected an orbital fracture and conducted a forced duction test, either at the office visit or under anesthesia. They also felt it was substandard not to order a CT scan or schedule a follow-up visit after the hospital exam. OMIC was able to find one expert who agreed with the insured that the child did not present with characteristics of an orbital fracture because there were no signs of trauma around the eye and no restriction of movement. Also, the child’s persistent pain was more indicative of a corneal abrasion, which the insured diagnosed, than a fracture. This expert further felt it was not unreasonable that the insured did not perform a forced duction exam under anesthesia since his focus was to examine the cornea and retina. Unfortunately, this expert could not say that the delay in treatment had no effect on the final outcome.

Risk Management Principles

OMIC’s Claims Committee recommended a reasonable settlement to avoid what looked to be an almost certain plaintiff verdict; however, the insured insisted on going to trial because he believed his care was appropriate for the child’s presenting symptoms and that the final result was very good given the injury. Unfortunately, the jury did not agree and came back with a plaintiff verdict.

It is important to remember that when a case goes to trial it is not tried before a jury of the physician’s medical peers but before lay people who have little or no medical knowledge or experience. The jury did not appreciate that the child had an excellent overall result and that the measure of damages was very small, or that the insured’s care was reasonable at the time the child presented. The plaintiff attorney, who had the benefit of hindsight, was able to successfully argue that “if only the doctor had done a duction exam or a CT scan, the child would have better sight today.” It created a scenario in the minds of the jurors that was difficult to overcome.

Early Reporting of Claims Benefits All Insureds

Digest, Fall, 1995

Allegation

The insured ophthalmologist allegedly failed to properly advise a patient of the nature and risks of a surgical procedure and performed surgery to remove a right lower lid lesion in a negligent manner.

Disposition

Claim was dropped by the patient during the prelitigation stage and case was resolved without an indemnity payment.

Background

Early reporting of a claim allowed this OMIC insured to avoid being named as a defendant in a lawsuit. Because the insured gave OMIC the opportunity to respond to the plaintiff attorney before suit was filed, the physician avoided many of the frustrating and time-consuming efforts involved in preparing a full-blown legal defense. At the same time, the insurer was able to avoid expensive defense costs.

Case Summary

The patient was a 77-year-old male referred to the insured for evaluation of a lesion on his right lower lid. The patient reported that the lesion had been growing slowly for approximately a year. Upon examination, the insured described the lesion as a firm, fixed tumor at the lid margin umbilicated with pearly borders. She diagnosed probable basal cell carcinoma and recommended excision.

Several days later, the insured performed an excision of the tumor and reconstruction of the lid defect with a full thickness skin graft. Five days postoperatively the surgical wound completely dehisced. The insured removed all the sutures and offered the patient a Hughes flap reconstruction. The patient agreed to the Hughes flap, and it was performed the next day.

Postoperatively, the Hughes flap took well and the wound was healing nicely. After two postop visits, the patient suddenly informed the insured that he was changing physicians and had decided to be followed by a plastic surgeon rather than an ophthalmologist. The plastic surgeon subsequently performed a division and inset of the flap without complication, but a revision was later required to correct some residual contracture.

Analysis

Prior to filing a lawsuit, the patient’s attorney wrote to the insured physician alleging that the insured had provided negligent care and suggesting an out-of-court settlement. The insured promptly notified OMIC of the situation, and the claims representative opened a file and began an investigation accordingly. OMIC consulted with an oculoplastic specialist, who reviewed the pertinent medical records and opined that the surgical technique employed by the insured for both the initial tumor excision and the subsequent Hughes flap was within the standard of care. Armed with this supportive expert opinion, the claims representative was ultimately able to convince the patient’s attorney to drop the case before a lawsuit was filed.

The discussions between the OMIC claims representative and the patient’s attorney did not resolve this case overnight. The attorney had reviewed cases in the medical literature which recommended techniques somewhat different from that employed by the insured, particularly in literature authored by plastic surgeons rather than by ophthalmologists specializing in oculoplastics. Based on this research, the patient’s attorney was initially quite confident about the case and formulated a long laundry list of technical criticisms. It took several months of phone calls and correspondence to convince the attorney that the insured had not deviated from the standard of care and that OMIC was fully prepared to defend the case.

Risk Management Principlesand Commentary

Some physicians mistakenly believe that the only time they should call their insurer is when a Summons and Complaint arrives at their door. While it is true that a lawsuit does not commence until a Complaint has been filed in court and served upon the defendant, the prelitigation stage of a claim should be taken seriously and used as an opportunity to try to avoid litigation.

It is not always possible to derail an impending lawsuit. However, OMIC does have the trained staff and procedures in place to deal with claimants and their attorneys directly in an effort to forestall a lawsuit. For these efforts to succeed, insureds must report potential lawsuits early. When successful, this early intervention benefits all policyholders by reducing defense costs that ultimately impact premiums.

Failure to Diagnose Pseudomonas Infection

By Stacey Meyer

OMIC Assistant Claims Manager

Digest, Spring 2002

Allegation
Delay in diagnosing and treating pseudomonas infection.

Disposition
Case settled on behalf of ER physician with a nuisance amount contributed by insured ophthalmologist.

Case Summary
A 62-year old male with a history of contact lens wear presented to the ER with complaints of pain, redness, and itching in his right eye. The ER physician examined the patient and found a tearful, hyperemic right eye and a central corneal abrasion. He irrigated the eye and treated it with Gentamicin and a patch. The patient was asked to return the following day, at which time he presented with severe pain, discharge, sensitivity to light, and inability to see. The same ER physician performed a slit lamp examination, which revealed that the corneal abrasion had doubled in size. He did not perform a visual acuity exam. The ER physician contacted the on-call ophthalmologist, who gave instructions for the patient to keep the eye patch on for 24 hours and either return to the ER the following day, which was Sunday, or follow up at his office on Monday.

The patient self-referred to another ophthalmologist on Monday and was found to have a severe, advanced inflammation of the cornea and markedly reduced vision. A culture of the eye was positive for pseudomonas. The patient underwent a corneal transplant but subsequently lost all vision in the right eye.

Analysis

The plaintiff alleged that the ER physician performed an inadequate eye examination, failed to suspect corneal infection, and failed to ensure that an ophthalmologist examined him when he returned the following day. His expert opined that the on-call ophthalmologist was equally at faulty for failing to appreciate the seriousness of the patient’s complaint and for not coming into the ER to examine the patient on Saturday when he received the call, regardless of whether the ER physician requested such an examination. According to the plaintiff’s expert, the ophthalmologist should have been suspicious of the corneal ulcer given the history of the patient’s condition, his failure to improve, and the fact that the corneal abrasion had doubled in size overnight.

OMIC’s defense expert countered that the insured ophthalmologist made a reasonable assessment that this was a non-urgent situation based upon the description provided by the ER physician. Further, lack of any evidence of a corneal infiltrate or inflammatory response effectively ruled out a significant infectious or inflammatory process of the cornea and was compatible with a traumatic corneal abrasion. Since the insured was not asked to see the patient but only to make suggestions for the patient’s care, the defense maintained that the insured’s recommendation to continue treatment with cycloplegics and re-patching was reasonable.

OMIC’s defense team filed a Motion for Summary Judgment on the legal issue of whether there was in fact a physician-patient relationship between the insured and the plaintiff. Unfortunately, the court denied the motion and held that a factual legal issue did exist. The defense team and the insured agreed this would be a difficult case to argue before a jury and settled on behalf of the ER physician with a nuisance amount contributed by the insured ophthalmologist.

Risk Management Principles
It is common practice for an on-call specialist to rely on the examination of the ER physician. Yet, as this case demonstrates, while the ER physician retains primary responsibility for the patient’s care, the on-call physician also can be held accountable and responsible for the patient’s outcome. It is up to the on-call specialist to elicit enough factual information to ensure that the ER physician has thoroughly examined the patient and that the signs and symptoms reported by the ER physician are complete and accurate.

Often in such cases, a dispute arises over what was said by the two physicians. Documenting the details of a telephone conversation with an ER physician is an important as documenting the findings of an office examination. Recollections of what was discussed weeks and months later are unreliable and open to dispute, especially when the liability of either party depends on these details.

Lack of Informed Consent for Use of Research Drug

By Mary Kasher, MSN, JD
OMIC Claims Manager

Digest, Fall 2000

Allegation

Lack of informed consent for use of investigational drug during cataract surgery.

Disposition

Plaintiff dismissed insured ophthalmologist from suit.

Case Summary

The plaintiff was a 57-year-old woman who had been a patient of the insured for several years during which time her refraction had changed every two or three years. At one visit, she complained of glare and a starburst effect along with a continued decrease in vision. VA OD was 20/70 and OS 20/80. After a discussion of the treatment options available (which included cataract surgery or continuing to adjust her refraction), the patient chose cataract surgery. She also agreed to participate in an ongoing research study on the effects of an experimental drug for cataract surgery after discussing the possible risks and complications of the drug with the ophthalmologist. The consent form was signed and witnessed and the patient was given a copy to take home.

The surgery was uneventful. Intraocular pressure in the surgical eye was normal at the end of the procedure in the surgical eye after the experimental solution was instilled. At the first postoperative visit the following day, intraocular pressure was again normal and vision was improved. Later, the patient recalled going to church and being amazed at how well she could see. About a week after the surgery, the patient began to notice that it took a long time for her eyes to adjust from bright outdoor light to dim indoor light and that her right eye appeared much hazier that the left one. She called the insured’s office the next morning. Upon examination, the insured found peripheral vision in the right eye to be extremely decreased. The patient was experiencing complete darkness or blindness from her outer vision to the center of her vision where she had a small “hole” of vision that appeared to be in focus. The dark area has not improved since this evaluation. The actual cause of vision loss was never determined, although there was conjecture that it was the result of an injury to the retina related to the investigational drug or transport solution.

Analysis

Every medical research project varies in purpose and design, but two areas consistently surface as primary issues under legal analysis: lack of informed consent and any breach in the research protocol. Anytime a procedure involves an experimental substance or process, the patient must be fully informed of the risks involved and sign the “approved” informed consent form for that particular program. Instructions for obtaining informed consent in a research situation must be followed without variation or the consent will be considered flawed and challenged for validity. The research protocol setting out the criteria by which patients are eligible for study and how the procedure is to be conducted also must be followed without exception.

In this case, the insured followed the consent protocol meticulously. All designated forms were signed and placed in the record, and the testimony of the office staff and the patient herself supported all signed informed consent documents. In addition, the insured made an exceptionally strong appearance at his deposition. He was well prepared and presented the facts and circumstances clearly and with appropriate concern. The plaintiff attorney was so impressed with the insured’s performance and clarity of his records that he decided it would be better for the plaintiff’s case to dismiss the insured.

Risk Management Principles

The insured’s dismissal from this legal quagmire demonstrates some sound legal principles for medical practice. When participating in a research study, it is extremely important to follow the protocols with particularity. If any patient harm develops from the study, the entire process will be scrutinized. Medical research study cases present unique documentation challenges since the record can give the plaintiff attorney many avenues for finding noncompliance. It is the completeness of the documentation that will prevail in proving that research protocols were followed as directed.