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LASIK Malpractice – Who Can Sue?

Candidate for LASIK?

The Focus of LASIK Malpractice Litigation

LASIK eye surgery has replaced tummy tucks and liposuction as America’s number one elective surgery.  The growth has been staggering: LASIK has been performed on 2.5 million people since 1998 and 1.2 million people in 2000 alone.  For seven out of ten patients, the results of this 15-minute procedure are spectacular: improved vision to a normal 20/20 without glasses or contact lenses.

For ophthalmologists, the procedure is extremely lucrative.  The going rate for LASIK is about $2,500 to $4,500 per eye, and some doctors do one procedure almost every half hour, three or four days a week.  With that income, the investment cost for the lasers, about $300,000.00 to $500,000.00, can be soon recouped.

As LASIK has flourished into a $3.3 billion industry, ophthalmologists increasingly use hard sell marketing practices.  Marketing consultant firms now advise doctors on how to best market the procedure to patients.  Unfortunately, this gold rush has its casualties.

An estimated one percent to five percent of patients who have had LASIK suffer serious post-surgery complications.  An additional 10% to 15% of patients must undergo repeat procedures to get their correction right.  The most common problems are over or under correction, diminished contrast, glare, halos, starbursts and blurred vision.  Although the percentage of failed procedures is relatively low, simply by virtue of the number of procedures being done, a substantial proliferation of LASIK malpractice cases can be expected.

This trend has already begun.  In 1999, LASIK related suits represented ten percent of all open claims involving the Ophthalmic Mutual Insurance Company (OMIC).  As of August this year, those claims accounted for almost 20%.  The Review of Ophthalmology recently reported that the LASIK malpractice cases currently being handled by OMIC are as follows:

v     Two overcorrections

v     Two free flaps

v     An incomplete flap

v     LASIK performed on the incorrect axis of astigmatism

v     A wrinkled flap

v     Epithelial ingrowth

v     Equipment malfunction

v     Corneal scarring

v     Haze

v     Failure to treat with monovision

v     Failure to sterilize LASIK equipment

v     Bilateral astigmatism

v     Failure to perform at a later date following a microkeratome

problem during the primary procedure

v     Lack of informed consent

Proof of negligence can be difficult because many complications are accepted risks of the procedure:  infection is always possible; the surgeon may accidentally slice off of the corneal flap or replace it in such a way that it develops wrinkles or striae.  Another frequent complication is the occurrence of central islands — small areas of unablated tissue that the laser has missed and which distort light refraction.  However, while these injuries are known risks, some patients may have been particularly at risk of incurring injury due to their physical characteristics and a claim can be made that a physician’s performance of LASIK despite contraindications constitutes malpractice.  Whether an injured patient was a suitable candidate should therefore be the focus of inquiry.

LASIK, which stands for in-situ keratomileusis, involves reshaping the cornea with a laser so light is refracted at the proper angles.  Using an instrument called a microkeratome, ophthalmologists slice a flap on the cornea’s outmost protective layer, called the epithelium.  They then vaporize some of the underlying tissue using an excimer laser, an instrument originally developed in the 1970’s for the precise etching of silicon chips.  Depending on the correction needed, the laser flattens or steepens the curvature of the cornea.  The surgeon then replaces the flap, which after a few minutes of drying, rebonds with the underlying cornea.

Corneal surgery has been around since the 1950’s.  The earliest procedure, Radical Keratotomy, involved the surgeon reducing the steepness of the cornea using a knife.  Eye surgeons improved on this technique with a procedure called Photorefractive Keratectomy or PRK, which involves using an excimer laser instead of a knife to burn off the epithelium and part of the underlying cornea.  LASIK has the advantage over PRK that trauma to the epithelium is minimal, which reduces pain and healing time.

The parameters for determining a patient’s suitability for LASIK remains a gray area and this indefiniteness has allowed certain physicians eager to promote this lucrative business the latitude to operate on patients who are at an enhanced risk of suffering complications.

A critical factor in evaluating a patient’s candidacy for LASIK is the amount of correction.  The greater the amount of correction needed, the greater the amount of cornea tissue that must be removed.  Too severe a correction and the transitions between the sculpted and unsculpted portions of the cornea are too abrupt, increasing the risk of troublesome haze, glare and halos.  If the cornea is reduced below a minimum threshold amount, the tensile strength of the cornea may be compromised, resulting in iatogenic keratectasia — a bulging forward of the cornea.  A patient’s corneal thickness, therefore, is another critical measurement in determining his or her candidacy.

Another important measurement is the patient’s pupil size under scotopic or low light conditions.  Most lasers can sculpt no wider than a definite area.  Patients whose pupils in the dark are wider than this area will be prone to nighttime vision problems because light can pass through both the sculpted and unsculpted areas of the cornea.

The scotopic pupil measurement also is critical in determining the maximum amount of correction that can be safely performed.  The maximum width of ablation equals the maximum pupil size.  A wider zone of ablation requires deeper ablation than a smaller zone requires to achieve for the same amount of correction.  The maximum correction that can be performed safely, therefore, depends on three variables — the degree of myopia or hyperopia, corneal thickness and scotopic pupil width.  The exact amount is determined using a complex formula which incorporates those variables.

No rules exist for deciding who is a suitable candidate and the decision is left to the individual physician.  Many ophthalmologists refuse to operate on patients with normal sized pupils whose correction is more than minus twelve diopters for nearsightedness and more than plus four diopters for farsightedness.  Other surgeons operate on patients with up to minus 15 diopters.  If the patient has significant astigmatism, large pupils or thin corneas, the degree of myopia or hyperopia that can be successfully corrected is less.

If the patient’s vision is severely impaired, the physician may decide to perform less than the full amount of corrected needed for 20/20 vision and, that way, avoid reducing the cornea below the minimum thickness.  Less than full correction may be appropriate if the physician informs the patient that she will still need to wear contacts or glasses after the surgery.

Handling LASIK Malpractice Cases

One of the more difficult aspects of handling a “suitable candidate” case is trying to find an experienced laser surgeon willing to testify to set parameters for safe treatment.  Most potential experts have their own LASIK practice and will be reluctant to state stringent limits which may come back to haunt them.  In a case that I recently handled in which my client’s degree of myopia was within the disputed range, we were able to obtain a successful outcome after I was fortunate enough to find an eminent eye surgeon and pioneer in the cornea surgery field who was willing to testify that the maximum amount of myopia correction that could be performed safely on my client was minus ten diopters.

The nature of information provided for informed consent can also be fodder for complaint.  Has the physician disclosed that the patient’s measurable aspects of vision put the patient at an enhanced risk of significant pre and post-op complications in light of established contraindications?  Has the physician disclosed the possibility of serious vision loss (including blindness due to macular blowout caused by pressure differential during surgery), permanent starbursts, surgical or equipment failure, complications arising from the unpredictability of the corneal healing response, refractive error, astigmatic error, contrast sensitivity, glare experience, near distance depth perception difficulties, ghosting, halos and haze?  Has the patient been apprised of the probability that after the surgery she may still need contacts and glasses, even if of a lower power?  Does the informed consent form distinguish between risks that are permanent and temporary?

Another important factor is the surgeon’s advertising.  Advertising that make no mention of risks or side effects and that make over optimistic claims of permanent vision improvement could enrage the jury, especially if the advertising casts the doctor in the role of a salesman rather than a professional care giver.

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