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.

LASIK, PRK Study Identifiers Malpractice Predictors

Higher surgical volume and a history of prior claims or lawsuits are the primary predictors of whether a refractive surgeon will be sued in the future. Additional medical-legal risk factors for surgeons who perform more than 100 LASIK or PRK procedures a year include advertising use, comanagement with optometrists, preoperative time spent with patient, and physician gender.

These are the findings of a retrospective cohort study presented by Richard L. Abbott, MD, professor of clinical ophthalmology, University of California San Francisco, at the American Academy of Ophthalmology Annual Meeting in Anaheim. Dr. Abbott, who is chairman of OMIC’s Underwriting Commit- tee, compared physician characteristics of 100 consecutive OMIC LASIK and PRK claims and lawsuits to demographic and practice pattern data for all active refractive surgeons insured with OMIC between 1996 and 2002.

The study, which also looked at informed consent issues in LASIK and PRK, found that patients who sued were often presented with informed consent for the first time on the day of surgery and many had no consent note written by the surgeon in the patient record.

These findings, published in Ophthalmology (November 2003), will be useful in improving the quality of care for patients undergoing refractive surgery. In addition, OMIC will incorporate the data in its underwriting criteria and risk management protocols to help insureds who perform refractive surgery manage and reduce their risk of claims and lawsuits.

Coverage for Phakic Implants

In early October, the FDA’s Ophthalmic Devices Advisory Panel recommended approval with conditions for use of the Staar Implantable Contact Lens for the treatment of myopia. It is anticipated that many ophthal- mologists, including those who may have never previously performed refractive surgery, may be interested in offering this procedure to their patients once the lenses have gained final FDA approval.

OMIC is in the process of developing a spe- cial questionnaire and underwriting guidelines, similar to other refractive surgery procedures, so that coverage may be offered to qualified ophthalmologists for their performance of phakic implants. The questionnaire and guide- lines will address training, patient selection criteria, informed consent, operative proce- dures, postoperative care, and advertising. If approved, coverage for phakic implants will be endorsed to the policy at full policy limits. No additional premium will apply.

Please note that OMIC’s standard policy excludes coverage for all refractive surgery procedures unless specifically added by endorsement. Each type of refractive surgery procedure must be separately endorsed for cover- age to apply. While the technique for phakic implants is very similar to that for intraocular lens implants, phakic implants are considered to be refractive surgery and, therefore, are not automatically covered by OMIC. No coverage will extend for any phakic implant procedures performed unless the physician has specifically applied and been approved for coverage and the policy has been amended accordingly.

Other procedures for which coverage is available by endorsement following review and approval of a supplemental questionnaire are radial and astigmatic keratotomy, PRK, LASIK (including LASIK variations such as epi-LASIK, LASEK, IntrLase, and Custom-Cap procedures), CK, LTK, Intacs, and clear lens extraction (refractive lensectomy).

How to Reach OMIC

If you have called the OMIC office recently, you probably noticed that we have a new phone system. While our toll-free 800 number is the same, phone extensions for individual departments have changed. Please remove and save the phone card included with this issue of the Digest. It lists new extensions for the most frequently called OMIC departments and gives contact information to reach OMIC by mail, fax, and email.

Toll-free numbers also are provided for Medical Risk Management Insurance Services and Marsh Affinity Group Services, which are the contacts for information about Academy- sponsored business insurance and life and health insurance programs.

State Medical Board Equates Wrong Powered IOL implant with Wrong Site Surgery

By Ryan Bucsi, OMIC Senior Litigation Analyst

ALLEGATION

Misreading of intraocular lens power calculation, resulting in incorrect lens implantation andaneedfora second surgery.

DISPOSITION

Case was settled between the insured and the state board of medicine. The patient did not pursue a claim.

Case Summary

An OMIC insured performed an uncomplicated cataract surgery however on postoperative day one, the patient’s vision was 20/200 OD with a significant hyperopic refractive error that corrected to 20/20. the insured realized that the power of the posterior chamber lens implant had been inadvertently switched with the corresponding power for an anterior chamber lens, resulting in an implant difference of 3.5 diopters. he informed the patient of the error and presented options for treatment, such as wearing glasses, a contact lens, or undergoing an iOL exchange. the patient chose the iOL exchange procedure, which was uncomplicated, and eventually the patient’s uncorrected vision was 20/25 OD.

Analysis

Soon after, the insured received and responded to a letter of investigation from the state medical board. Without contacting OMIC, the insured acknowledged the error that led to the implantation of the wrong iOL. the medical board examiner retained an ophthalmology expert, who opined that the implantation of the incorrect powered iOL was beneath the standard of care. Following this expert’s review, the examiner presented the insured with a settlement proposal, which included a fine, reimbursement of costs of the investigation, a letter of concern from the board, continuing education units, and community service. upon receiving this proposal, the insured reported the matter to OMIC. the case was referred to an attorney, who advised that the insured had put himself at a disadvantage by directly responding to the medical board and not making his response through an attorney. since the board had already conducted an investigation and proposed sanctions, it was significantly more difficult to handle the matter.

OMIC counsel retained two experts who disagreed with the original opinion that the implantation of a wrong powered iOL was beneath the standard of care. While the medical board’s expert did not change his opinion that the insured had violated the standard of care, he disagreed with the board’s finding that wrong powered intraocular lens insertion was tantamount to wrong site surgery and warranted the same fines and penalties. this expert believed that a letter of concern would be sufficient in this case, especially since the insured had taken steps in his practice to ensure that such an error would not recur. the medical board disagreed with its own retained expert and continued to view wrong powered iOL insertion as the equivalent of wrong site surgery.

Risk Management Principles

The insured ophthalmologist should be commended for working with the patient to avoid a claim. Once the error was recognized on postoperative day one, he candidly discussed the error with the patient and the treatment options to address the error. With the insured’s assistance, the patient was able to make a well educated decision on how to proceed. in the event of a medical error, it is wise to withhold billing for the errant surgery and to perform any follow-up procedures at no out-of-pocket cost to the patient. these steps may decrease the likelihood of a patient pursuing a claim or litigation.

As this case illustrates, however, state medical boards have become proactive in response to concerns of patient safety and may take action even if the patient involved is satisfied with the care. Medical board investigations are now often triggered by mandatory reports from surgery centers and hospitals. Once an insured becomes aware that a wrong site surgery or incorrect power iOL insertion has occurred, the incident should be reported to OMIC’s Claims Department or confidential Risk Management hotline at (800) 562-6642, option 2 for Claims or option 4 for Risk Management.

OMIC is collaborating with the American Academy of Ophthalmology and other ophthalmic organizations on a campaign to prevent wrong patient, wrong surgery, and wrong iOL insertion. the Lead and Hotline articles in this Digest provide further insight in to this area of concern.

Twenty Years of Insuring Refractive Surgery

By Anne M. Menke, RN, PhD,

OMIC Risk Manager

Digest, Fall 2008

To view the graphs and tables referred to in this article, go to http://www.omic.com/new/digest/Digest%20Fall%2012-12-08.pdf

For over 20 years, since its founding in 1987, OMIC has insured ophthalmologists who perform refractive surgery procedures while monitoring a key measure of patient safety and satisfaction: professional liability claims (written notices or demands for money or services, including letters, lawsuits, and arbitration proceedings). this spring, we conducted a review of our refractive surgery claims experience to determine if additional measures are needed to ensure that our policy- holders continue to reduce patient safety risks and minimize their—and the company’s—malpractice exposure. this article reports on the frequency and severity of refractive claims and analyzes the issues driving them. this issue’s Hotline article presents risk management recommendations.

Frequency of Refractive Surgery Claims

The first refractive claim—for negligent RK—was reported to OMIC in 1989. Claims were infrequent until 1999, four years after OMIC approved coverage for PRK and three after it added LASIK. As of May 2008, OMIC had a cumulative total of 289 refractive claims, of which 58 are still open and under evaluation. Refractive surgery is now the third most frequent area for claims against OMIC insureds, following cataract surgery and general ophthalmology. LASIK claims in particular, and refractive claims overall, represent a significant percent of total open claims (10.41% and 12.31% respectively), although the percentage is lower among total closed claims. LASIK makes up 85% of all open and closed refractive claims, and the number of LASIK claims reported to OMiC has recently increased. When evaluated by the year in which care occurred, however, LASIK incidents peaked in 2000 and have been dropping ever since.

Severity of Refractive Surgery Claims

While a frequency study shows how often a particular type of claim is filed, a severity analysis looks at how often an indemnity payment must be made in order to close the claim and the magnitude of the payment. Compared to OMiC’s overall claims data, refractive claims close more often with an indemnity payment and have higher average and median settlement amounts.

As expected, the majority of the 64 indemnities paid by OMiC for refractive claims were for LASIK and most were under $100,000 (see Table 1). PRK claims occur less frequently, but have a higher average and median payment and more often require an indemnity payment to close. in 2006 and 2007, there was a sharp increase in the average amount and number of refractive settlements, 50% of which involved ectasia; 2008 showed a marked decline (see Table 2).

Causes of Refractive Claims

In our analysis, we divide the cause of claims into four groups: clinical, provider, patient, and systems. two of these— provider and patient—are self-evident. Clinical issues are areas of controversy or of limits in knowledge or diagnostic/ treatment modalities. systems issues cannot be attributed to a single individual; instead these are processes in which many individuals and entities are involved. A much-studied example is medication: the process spans from research and product development, labeling, packaging, distribution, ordering, dispensing, and administering.

Clinical issues predominate in refractive surgery claims, accounting for half of the identified problems in both LASIK and PRK; systems, provider, and patient issues follow (see graphs on page 5). the primary systems issues, in decreasing order of frequency, are equipment, informed consent, and comanagement for LASIK claims; these same three figure in PRK cases as well. Provider problems in LASIK claims center on documentation, failure to perform the preoperative assessment, and knowledge/skill deficits. Ophthalmologists were criticized for treatment decisions and lack of knowledge/skill in PRK. Patient issues were not a significant factor in LASIK, but they slightly outnumbered provider allegations in PRK.

Clinical Issues

Preoperative care was the focus in 83 of 196, or 42%, of LAsiK claims. the primary preoperative clinical issue was the preop assessment (a factor in 71 of 83, or 86%, of claims). in particular, plaintiffs alleged contraindications to refractive surgery, especially clinical and topographical signs of forme fruste keratoconus, pellucid marginal degeneration, and other corneal problems (see Table 3). Other preop issues include candidacy for retreatment, monovision trials and candidacy, and the interval between retreatments. Only 8 of 39, or 20%, of the allegations focused on preop care in PRK claims; preoperative assessment and choice of procedure were the main issues. the Hotline article discusses preoperative assessment in more detail.

Two aspects of care accounted for the majority of the 101 intraoperative LASIK allegations, namely, flap creation (49) and identification of the patient, procedure, and laser settings (18). Corneal injury, decentration, equipment malfunction, anesthesia complications, double carding, ablation zone size, sterilization breakdowns, and power failure accounted for the rest, in decreasing order of frequency. the allegations in PRK intraoperative claims were decentered ablation, wrong nomogram, and wrong procedure.

Not surprisingly, corneal complications led to 72 of 91, or 79%, of postoperative LASIK claims, with negligent diagnosis and treatment of post-LASIK ectasia and inflammation/infection the top allegations (see Table 3). non-corneal issues included retinal complications, dissatisfaction with monovision, diplopia, glaucoma, depression, and pain. in PRK, postoperative problems accounted for 70% of the clinical issues; of these, cornea-related issues predominated (63%), including (in decreasing order) haze, ectasia, central island, abrasion, infiltrate, scarring, and sPK. Other allegations focused on glare, ghosting, night driving, diplopia, headache, and ptosis.

Systems Issues

Ophthalmology is heavily dependent upon medical devices, and equipment issues account for 30% (48 of 159) of LASIK claims involving systems issues. this was particularly true when there were problems with flap creation. informed consent was a close second at 28%. issues included failure to address ocular and medical comorbidities, the timing of the consent discussion, the surgeon’s role in the consent process, the FDA status of the device, flap complications, and monovision.

Comanagement allegations were found in 23% of claims, most often criticism of the surgeon’s role in the preoperative assessment, informed consent process, and postoperative care. Misidentification of the patient, procedure, or laser settings occurred in 18 cases, accounting for 11% of systems issues.

Claims of false advertising and fraud are becoming more common- place and occurred in 3% of claims. Financial issues, such as refunds, procedure-related costs, and collection efforts, as well as sterilization issues occurred in a few claims. half of the 18 systems issues claims for PRK were due to consent, followed by equipment, comanagement, and advertising.

Provider Issues

The most common provider issue in LASIK claims involved documentation; lack of documentation was the problem 85% of the time. Failure to perform needed tests and evaluations was alleged in 21% of claims. Missing elements in descending order included the preoperative assessment, refraction, topography, pachymetry, and mono- vision trials. Physicians were deemed to lack knowledge and skill in 16% of claims, specifically in topography interpretation, inadequate microker- atome suction, ablation profile, and poor centration. they showed poor judgment when deciding to retreat, performing bilateral procedures the same day, and choosing appropriate flap thickness (11%). Remaining issues, each accounting for 3% of allegations, included poor communication, practice issues (employee, on-call partner, near- ing retirement), personality issues, treatment choices (for abrasion, dry eye, and the use of rigid gas permeable contact lenses with free flaps), and failure to diagnose the cause of decreased and fluctuating visual acuity. Provider issues were the least frequent allegation in PRK; 3 cases involved treatment choices and 2 the physician’s knowledge/skill.

Patient Issues

Defense expert witnesses did not feel patients played a significant role in the outcome of LASIK procedures, pointing to issues in only 25 claims. noncompliance occurred in 9 and personality issues in 8. unsubstantiated complaints and self-inflicted injury (head movement, rubbing, scratching) were found in 4 cases each. As with LASIK, noncompliance was the most frequent patient issue in PRK claims (4 out of 7), followed by individual healing patterns, and self-inflicted injury.

Go to the Hotline article for recommendations on how to reduce the risks associated with refractive surgery.

Why are Dilating Drops in the News?

A medication used routinely by ophthalmol- ogists—dilating drops—was the subject of a recent ruling in the Massachusetts Supreme Court, which in turn occasioned an ASCRS Member Alert. The court opined that if a physician does not warn of the possible side effects of a medication or treatment, he can be held liable not only to his patient but to all those “forseeably put at risk for a failure to warn.”

While this case was triggered by a motor vehicle accident, OMIC has also dealt with mal- practice allegations involving falls after dilation. Indeed, we recently settled such a case, and were already editing articles on risks related to dilating drops for this issue of the Digest (see Closed Claim Study and Risk Management Hotline) when we were contacted by policyholders in response to the ASCRS Alert. It is important to reiterate OMIC’s long-standing recommendations on an ophthalmologist’s duty to warn patients about the effects of dilating drops.

We first suggested such a practice in 1992, when former OMIC committee member Richard A. Deutsche, MD, advised ophthalmologists to “Discuss Potential Side Effects of Eye Drops” in the AAO’s Argus, and we provided a sample consent document for dilating drops in 2002.

At the 2007 AAO Annual Meeting, the OMIC Forum on “Medication Safety and Liability” focused attention on two other high-risk medica- tions that play a role in ophthalmic liability: anticoagulants and steroids. Policyholders who were not able to attend the forum may order a complimentary copy of the CD by calling Linda Nakamura at (800) 562-6642, ext. 652. Insureds are also encouraged to consult “Hemorrhage Associated with Ophthalmic Procedures” and our sample consent form for triamcinolone acetonide (KenalogTM), both available at www.omic.com.