Malpractice Management
LASIK Referral Leads to Lawsuit
If something doesn't sit right, don't just ignore it. Sometimes a little research pays off big.
BY JERRY SHERMAN, O.D, F.A.A.O.

With surgeons performing about one million LASIK procedures for refractive error correction each year in the United States, the procedure has become rather routine. Hence, many patients and eyecare practitioners consider it nearly risk free.

Most large laser facilities have developed specific guidelines that contain strict contraindications for surgery. The following case will show how adherence to established, reasonable guidelines failed to prevent a disastrous but predictable outcome.

Everybody has a reason

Several years ago, Dr. Miles (not his real name) began offering LASIK co-management to his patients. One 33-year-old male patient decided to have it performed for many reasons, including being tired of having to clean, insert and remove his contact lenses.

Making the referral

Dr. Miles performed his standard LASIK workup, which included a cycloplegic refraction, a peripheral retinal exam and corneal topography. The patient's refraction yielded -2.00 = -4.00 x 80 OD and -4.00 sphere OS with best corrected visual acuity (BCVA) of 20/30+2 OD and 20/20 OS. Corneal topography (CT) revealed the results shown in the figures.

Dr. Miles filled out the LASIK referral form and faxed it, along with a copy of the CT results, to a laser center. The referral form contained a question about whether the patient's refractive error was stable (defined as a maximum of a 0.50D change in sphere or in cylinder) for 12 months. Dr. Miles wrote "Yes."

The LASIK center received the fax and scheduled both a pre-surgical workup and the LASIK procedure on the same day. When the patient presented to the center, the center director (an optometrist who had extensive LASIK experience) checked his refraction, performed a slit lamp exam and obtained and a second CT. The patient signed an extensive informed consent document that included several key points particularly relevant to this case.

The patient initialed a paragraph that stated that he had amblyopia in his right eye and would therefore not achieve 20/20 VA in the that eye after surgery. He also initialed another paragraph that stated that he "must be free of certain eye diseases including keratoconus, glaucoma . . . ." Meanwhile, the center director reviewed the workup but was concerned about the CT results for the patient's right eye.

Unusual CT

The center director had the LASIK surgeon review the patient's CT. He wrote, "CT unusual OD but not keratoconus" on the chart. The center director then called Dr. Miles for additional information on the patient's refractive error history from the past several years. Although Dr. Miles had records dating back 10 years, it appears that he communicated data from only the past several years to the center director. Unfortunately, no evidence exists that anyone ever informed the center director that records for this patient existed for a full 10 years and that the first keratometry reading in his right eye a decade earlier was completely spherical.

It's also unclear whether Dr. Miles ever reviewed the entire chart or realized that he had recorded K readings of 42.00 at 90� OD and 42.00 at 180� on the first exam, 10 years earlier. Also, the old records revealed corrected VAs of 20/20 OD and OS and hence the conclusion that the reduced VA in the right eye was clearly not caused by amblyopia. The surgeon performed the surgery without incident and the patient followed through with post-op visits.

A disappointing outcome

On the one-day post-op visit at Dr. Miles' office, the patient's uncorrected VA was 20/25 OU and the slit lamp exam revealed trace striae and minimal edema OU. Slowly his corneal astigmatism began to return and by the fifth month after the procedure his refraction was +2.00 = -6.00 x 85� OD with 20/25 VA and +.50= -1.50 x 109� OS with 20/20 VA.

The diagnosis on the record for that visit was "abnormal healing response." Several months later, the LASIK center doctors changed their diagnosis to keratoconus OD and mild keratoconus OS. They recommended that the patient wear a GP contact lens and told him that he wasn't a candidate for any additional refractive procedures.

Various opinions

Two years after the procedure, the patient's right eye still demonstrated 6.00D of astigmatism and remarkably, so did the left eye. A review of the records for the 10- year period before LASIK revealed no change in astigmatism in the left eye.

Seeking legal advice

Eventually the patient retained the services of a prominent malpractice attorney and filed a lawsuit that named Dr. Miles, the center director, the LASIK surgeon and the LASIK center as defendants. The patient's (plaintiff's) experts opined that the surgeon should never have performed surgery because the patient's records indicated a spherical refractive error OD progressing to 4.00D of astigmatism over a 10-year period. Such a change can only be caused by keratoconus or a keratoconus-like disorder.

The experts stated their opinions that the patient would eventually require penetrating keratoplasty and that the marked and rapid progression in both eyes was a direct consequence of the LASIK procedure.

Predictably each of the three doctors whom the patient sued blamed the other. The lawyers for the two doctors at the LASIK center blamed Dr. Miles because he made the referral and had evidence of keratoconus buried in his 10 years of records. The plaintiff's experts also criticized the LASIK center's policy of performing the pre-op evaluation on the same day as the surgery. Perhaps a several day delay would have given the doctors at the LASIK center the time to review all of the old records.

Excuses excuses

Dr. Miles' defense was that he referred the patient for a consult only but didn't make the final decision and of course didn't perform the surgery. The defense for the doctors at the center was that the findings of the slit lamp exam that they performed on the day of surgery didn't reveal any signs of keratoconus, that the CT was unusual but not diagnostic of keratoconus and that the refractive error had been stable for roughly one year.

Going by the standards

The doctors at the LASIK center met their own internal established guidelines that included a stable refractive error for one year and thus arguably met the national standard of care. Even if the doctors had met the standard of care, they still could have avoided this tragedy if they had decided to go beyond their own standard and postpone the surgery until they had reviewed all available information.

When it's not enough

Sometimes meeting the existing standard isn't enough. After several depositions were taken from both parties, they reached a settlement for several hundred thousand dollars. (The exact settlement amount cannot be reported.) None of the doctors in this case admitted any wrongdoing. Consider going that extra step to avoid a disaster and malpractice litigation.

Dr. Sherman practices at the Eye Institute and Laser Center in Manhattan and is a distinguished teaching professor at the SUNY College of Optometry.