LASIK mistakes costly, but cheaper - so far - than other errors

Mistakes with LASIK are costing ophthalmologists lots of money, but it could be worse, according to preliminary results of a first-of-its-kind study.

The landmark study, by the world’s largest insurer of ophthalmologists - the U.S.-based Ophthalmic Mutual Insurance Company (OMIC) - has found that LASIK mistakes are costing an average of about $50,000 each.

That figure compares to average pay out of about $130,000 for malpractice claims involving all types of ophthalmic procedures, according to the company, which covers 2,400 members of the American Academy of Ophthalmology.

<“So far, the risk of LASIK has been worse than the reality,”> says Paul Weber, OMIC’s risk manager. “We are not seeing actual losses in LASIK that are any greater than any other procedure being done in the United States. In fact, we are seeing that the average cost of a LASIK claim is actually less than that of more frequently performed procedures, such as cataract and retinal surgery.”

Among the most frequently cited reasons for LASIK malpractice lawsuits are patient complaints of post-operative halos, glare and pain, Mr. Weber adds. As a result, out-of-court settlements and in-court pay outs aren’t generally as expensive as in other surgical procedures where a patient could suffer a catastrophic injury.

“A LASIK injury is a little nebulous,” Mr. Weber says. “It’s not like an ‘eye in the bottle case’ where a lawyer stands up with the patient’s eye in a bottle and points to the ophthalmologist and says, ‘If it were not for the negligence of this doctor, this eyeball would be in the head of the patient before you.”

Despite the relatively good news about the cost of LASIK claims, Mr. Weber isn’t counting any chickens just yet.
Because the study represents only a few years’ worth of malpractice claims, it is difficult to predict whether the trend will continue, says Mr. Weber. In fact, the trend probably will get worse because costlier claims usually take longer to settle or come to court. Of the 55 LASIK malpractice claims filed against the company’s ophthalmologists, only about one-third have been closed, according to the study.

Also, OMIC officials expect increasing numbers of ophthalmologists to use LASIK - thus exposing the company to even more risk of malpractice suits. Currently, the company has certified coverage for about 40 per cent of the OMIC’S ophthalmologists to perform refractive procedures, including LASIK.

So far, the statistics bear out the rise in LASIK malpractice claims. In 1999, LASIK claims accounted for about 10 percent of all of OMIC’s ongoing malpractice claims. In 2000, that figure rose to 13 percent. In the first six months of 2001, LASIK accounted for 19 percent of the company’s ongoing claims.

The company, which covers ophthalmologists across the United States, charges an annual premium that reflects the risk of being sued and the average pay out for such lawsuits in a given geographic area

As a result, an ophthalmologist in some parts of California pays as little as $3,000 a year for the same level of insurance coverage that costs an ophthalmologist in Miami, Florida more than $20,000 a year.

The largest award for LASIK malpractice to date - of just over $1 million - arose after an American ophthalmologist - who was not insured by OMIC - operated on a patient with bilateral hyperopia. (See related story for details.)

Despite the added exposure from LASIK, the company has refused to charge its ophthalmologists any extra premium for performing LASIK or any other refractive procedure, says Jim Holzer, OMIC’s chief executive officer.

“We do not surcharge doctors for doing LASIK because we feel the control isn’t a financial one - it’s a practice management one,” Mr. Holzer says. “And proper practice management entails looking at patient selection, communicating with patients to ensure that they have realistic expectations, and informed consent - which is also about communicating the realities of the procedure.”

In deciding whether to extend coverage for LASIK to an ophthalmologist already covered for traditional procedures, the company also takes into account the number of LASIK procedures that the ophthalmologist usually performs, Mr. Holzer adds.

“We used to be concerned about the cataract mill; now the worry is the LASIK mill,” he says. “Any procedure that is performed at high volume and is the only one of its kind performed in a practice is certainly a red flag for a malpractice underwriter. And, as a result, often we will not underwrite such a practice.”
Detailed results of the LASIK study, which are currently being reviewed by the chairman of the company’s underwriting committee, Richard L. Abbott, MD, are expected later this year,

So far, a preliminary review of the OMIC study indicates that many claims arose because ophthalmologists failed to follow the company’s practice management guidelines. The most common causes for the malpractice claims included:
• Errors in programming the laser, which resulted in overcorrection or astigmatism;
• Improper patient selection, which resulted in intraoperative flap complications and poor outcome;
• Postoperative failure to diagnose or delay in diagnosing complications.

LASIK guidelines can reduce risk of errors - and lawsuits
To obtain malpractice insurance coverage for LASIK from the Ophthalmic Mutual Insurance Company, American ophthalmologists must ensure that they follow a number of rules:
• Surgeon must be certified on the laser to be used as well as be certified for LASIK;
• Patient must be at least 18 years old, with stable refraction without contact lenses;
• Criteria for the degree of patient astigmatism, myopia, or hyperopia, must fall within guidelines set down by U.S. Food and Drug Administration. Off-label treatment of up to 6.0D astigmatism, -15.0D myopia, and +6.0D hyperopia permitted subject to special consent language;
• Surgeon must personally conduct informed consent discussion with patient about LASIK;
• Surgeon must document in medical record that the risks and benefits of LASIK - as well as any alternatives to LASIK - were discussed with the patient as part of the consent process;
• Surgeon must offer each patient a copy of the consent form to take home and consider before agreeing to the procedure;

Bilateral simultaneous LASIK is permitted if the surgeon has previous LASIK experience of at least 10 such cases and the patient signs a special consent form;
Surgeons must follow government guidelines that prohibit ads that mislead the patient about expectations from LASIK or that guarantee results. For example, ophthalmologists should not boast that patients can throw away their glasses after LASIK or that the procedure is always fast, easy, or painless. Also ophthalmologists should not claim that LASIK will last a lifetime or offer patients their money back if it doesn't.

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