Risk Management

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.

Please refer to OMIC's Copyright and Disclaimer regarding the contents on this website