Risk Management

FFK Diagnosed on Day of Planned Bilateral LASIK 

Ryan Bucsi, OMIC Senior Litigation Analyst

Allegation

Failure to provide informed consent regarding risk of complications from PRK OS with forme fruste keratoconus.

Disposition

Case settled for $200,000.

Case summary

A 30-year-old female presented to an OMIC insured’s office for a LASIK evaluation. The initial consultation was handled by a technician, who discussed risks such as dry eyes, fluctuation in vision, light sensitivity, and glare with the patient. Upon examination, the insured noted SCVA of 20/800 OU and CCVA of 20/20 OD and 20/30 OS. The corneal examination revealed a pachymetry of 520 in each eye with a decreased tear film OU. The insured’s diagnosis was myopia and tear film insufficiency. The patient agreed to undergo bilateral simultaneous LASIK. Approximately two weeks later, when the patient presented for surgery, the insured diagnosed forme fruste keratoconus (FFK) OS based on the color topography. The patient signed consent forms for LASIK and PRK, and the insured performed LASIK OD and PRK OS. The postoperative course was unremarkable in the right eye; however, the patient complained of poor visual acuity, blurry vision, halos, light sensitivity, and headache in the left eye. Visual acuity fluctuated between SCVA 20/200-20/800 OS with CCVA 20/70 OS. The insured treated the patient’s complaints with Pred Forte and oral Prednisolone. After several months with no improvement, the patient requested and the insured provided a referral for a second opinion. The second opinion was central haze and inferior steepening on topography post PRK. Visual acuity was SCVA 20/200 pinholed to 20/30 OS. The patient was advised by the second ophthalmologist to continue Pred Forte and was fitted with a rigid gas permeable contact lens (RGPCL). The patient returned to the insured, who documented CCVA of 20/30 OS with the RGPCL; however, the patient could not tolerate the lens and a soft contact lens did not improve her vision. The insured noted SCVA of 20/400 OS. The patient self-referred to a third ophthalmologist, who diagnosed inferior steepening and mild corneal haze OS following PRK with FFK. CCVA was 20/80 OS. The third ophthalmologist recommended that the patient continue with the RGPCL. During the insured’s final exam, the SCVA was 20/20+1 OD and 20/400 OS, with CCVA of 20/60 OS. The insured’s diagnostic impressions were corneal haze and FFK OS.

Analysis

A dispute existed between the insured and the patient regarding the informed consent process. The insured informed our defense counsel that he fully discussed the risks of PRK with the patient due to the diagnosis of FFK on the day of surgery. The insured handwrote in the chart that he discussed this with the patient. The patient testified at her deposition that she did not recall the insured having any discussion with her about the risks, benefits, and alternatives to PRK with the diagnosis of FFK. Defense experts retained by OMIC felt that, even though the more conservative PRK procedure was performed on the left eye, the patient deserved more information regarding the specific higher risks she faced postoperatively due to the FFK. Defense counsel estimated a defense verdict chance of 50% with a plaintiff verdict as high as $500,000. With the insured’s consent, the case was settled for $200,000.

Risk management principles

It is important to review key studies like topography before the day of surgery. Even though the ophthalmologist correctly revised the surgical plan from bilateral simultaneous LASIK to LASIK OD and PRK OS, there was no urgency to perform either procedure the same day the FFK OS diagnosis was made. Due to the increased risk of complications following PRK on an eye with FFK, surgery could have been postponed to give the patient more time to reconsider whether to proceed with what are both elective procedures in light of this new information. Since the decision was made not to postpone surgery, the insured should have expanded his handwritten note to include a more thorough description of exactly which risks, benefits, and alternatives were discussed with the patient. Furthermore, a notation should have been made that the patient understood the new diagnosis along with the associated increased risks and still wished to proceed with surgery.