LASIK Malpractice

Michael S. Kelton, Esq.
Michael T. Goldstein, M.D., J.D.

INTRODUCTION

LASIK malpractice is like the lottery. Patients have two ways to win. Patients who have successful surgery win by obtaining spectacle independence. Those with unsuccessful outcomes can then enter the malpractice arm of the lottery. As in most lotteries there are a few big winners, with multimillion dollar prizes, a lot of smaller winners and many no winners. Because of several large LASIK verdicts plaintiffs' attorneys are aggressively seeking LASIK cases. Every large verdict attracts more lottery players and enlarges the problem for practicing ophthalmologists. This article will explore the causes of LASIK malpractice and offer suggestions to reduce risk.

BACKGROUND

LASIK surgery accounts for approximately 30% of all ophthalmology malpractice claims.[1] Most cases result in small settlements. In New York, where there is no cap on pain and suffering, the awards can be larger than in other states. LASIK patients tend to be young and employed. A younger patient has many years of future income. If annual earnings are reduced the economic damages are calculated as the reduced annual income multiplied by the number of working years remaining. The greater the annual income that is lost the greater the economic damages. Pain and suffering damages can be significantly greater than economic damages. These include daily pain, discomfort, visual impairment, the constant use of medications and a loss in the enjoyment of life. Combining lost income, pain and suffering damages and long term medical expenses can result in large Lasik malpractice awards.

INTERNET

The internet is loaded with the web sites of plaintiffs' attorneys touting large verdicts won in LASIK malpractice cases. In addition, patients with bad results have their own postings and blogs. Below is an example of what appears on a LASIK malpractice attorney's website:

"Lasik Malpractice

In the past few years alone, our New Jersey malpractice attorneys have had extensive success in Lasik malpractice cases, recovering millions of dollars for our clients. In fact, we won what is believed to be one of the largest Lasik malpractice recoveries in New Jersey history, a $2.1 million Lasik malpractice settlement. The following are other examples of our Lasik recoveries: $850,000 Lasik malpractice settlement, and an $800,000 Lasik malpractice settlement. ...

Often, a person who was not a proper candidate for the surgery to begin with, due to factors such as the shape or condition of the cornea (i.e., keratoconus, pellucid marginal degeneration), high levels of myopia (nearsightedness), or large pupil size, was not carefully evaluated or told the true surgical risks. Poor outcomes can also result from a lack of proper attention to post-surgery issues, such as inflammation, infection, and uneven corneal tissue.

If you or a loved one has been the victim of Lasik malpractice, please contact New Jersey Lasik malpractice attorney... and... he will contact you within twenty-four (24) hours to discuss your Lasik malpractice case.[2]"

OMIC STATISTICS

OMIC is a nationwide malpractice carrier that is associated with the American Academy of Ophthalmology. Their web site posts a large amount of information about LASIK malpractice. OMIC breaks down LASIK malpractice lawsuits into four categories: Clinical Issues, Systems Issues, Provider Issues, and Patient Issues.[3]

CLINICAL ISSUES

Clinical issues were present in 42% of all the claims. Of the clinical issues, 79% involved preoperative issues. These consisted mostly of contraindications to surgery, including, form fruste keratoconus, pellucid corneal degeneration, other corneal problems dry eyes and pupil size.[4]

In fact, according to OMIC 50% of the LASIK settlements in 2006-2007 involved ectasia. This is caused by forme fruste keratoconus, pellucid degeneration or leaving too thin a posterior corneal bed.

An example of an internet posted LASIK malpractice ectasia case appears below:

"Dr. ... Successfully Sued for Medical Malpractice

Westmoreland Man Wins in Eye Surgery Lawsuit
Pittsburgh Post-Gazette

A North Huntingdon man won more than $1 million in a malpractice lawsuit in which he contended his laser eye surgery was botched.

A jury in Allegheny County Common Pleas Court on Wednesday ordered Dr. ..., of Rockville, Md., to pay $850,000 to David N., on whom the doctor performed surgery in 2001 at The Laser Center in Wexford. David N. also received settlements from three other defendants named in the suit --The Laser Center and two optometrists -- bringing the total he is to receive to more than $1 million.

According to the lawsuit, the surgery left David N. with permanent eye damage.

In his lawsuit, David N. said he has unusually thin corneas, which makes LASIK surgery, in which the cornea is reshaped by a laser, more risky. The lawsuit contended that doctors knew about David N. thin corneas but never told him of the risk.

Dr. .. is best known for performing laser surgery on golfer Tiger Woods."[5]

Co-management combined with failure to diagnose pellucid degeneration can lead to malpractice litigation. In the case referenced above the patient had multiple visits to an optometrist who performed multiple corneal topographies as part of his evaluation of the patient. The patient was eventually referred to an ophthalmologist for LASIK and the optometrist only sent the last topography. The ophthalmologist performed his own topography and it was normal. Post LASIK ectasia developed and litigation followed. During the discovery phase of the lawsuit the ophthalmologist for the first time became aware of the optometrist's other topographies which, although normal, showed a pattern of progressive steepening of the inferior cornea. Had the ophthalmologist seen all the topographies pre-operatively he would have been able to diagnose pellucid degeneration. [6]

When altered records and a failure to diagnose forme fruste keratoconus are combined, a jury verdict can be substantial:

"$5.6 MILLION LASIK EYE MEDICAL MALPRACTICE VERDICT. On Wednesday, June 10, 2009, a jury in New York City returned a verdict of nearly $5.6 million against.., M.D., for LASIK malpractice. The verdict consisted of an award of: $2,360,000 for the patient's loss of income; $3,100,000 for the patient's pain and suffering, including loss of life's enjoyment; and $120,000 for the patient's wife's claim for loss of her husband's services and consortium. This is the second largest verdict ever for LASIK malpractice...

The plaintiff, J. D., is a pharmacist who lives and works in Queens, New York. On March 25, 2004, Dr. N. concluded that J.D. was a suitable candidate for LASIK surgery. However, plaintiff's medical expert testified that he was not. PD, M.D., an ophthalmologist and cornea specialist from Los Angeles, California, testified that prior to the elective surgery, the plaintiff had a contraindication to LASIK surgery, forme fruste keratoconus...

In addition to Dr. PD, plaintiffs called A. L., Ph.D., from Raleigh, North Carolina. Dr. A. L. is a former federal agent trained in ink dating analysis. Dr. L. testified that Dr. ... intentionally artificially aged a note in his chart concerning his purported conversation with the patient and his wife concerning the risks, benefits, and alternatives to LASIK surgery."

INTRA-OPERATIVE AND POST-OPERATIVE ISSUES

Intra-operative issues are events that occur during the surgery. They include: flap creation issues, wrong settings, decentration and equipment malfunction. The most common intra-operative issues were related to flap creation (49/101 cases) and misidentification or improper laser setting issues ( 18/101 cases). Flap creation can be a technique related problem, or a complication or a result of equipment malfunction. Programming the wrong settings or programming the settings for the wrong patient is the result of carelessness. It is important to remember that, regardless of who enters the operative data into the computer, it is still the surgeon's responsibility to make sure that the information is correct.

Post-operative clinical issues are events that occur after the surgery and include: corneal complications (79%), negligent diagnosis and treatment of post LASIK ectasia, infections and inflammations, flap issues, epithelial defects, epithelial ingrowths and central islands. It is important to emphasize that it is the surgeon's responsibility to ensure that the patient is properly managed post-operatively. If that surgeon delegates post-operative management to someone else the surgeon is still responsible for the damages resulting from the mismanagement of the patient's condition. Surgeons should not release a patient to the care of another until they feel that it is medically, rather than economically, appropriate to do so.

SYSTEMS ISSUES

Systems issues occurred in 159/539 claims. They include: medical device and equipment issues, equipment malfunction during flap creation 30%, informed consent 28%, co-management 23%, and patient misidentification 11%. Flap creation issues can be both intra-operative issues and systems issues. When it is due to malfunction of the equipment it is more likely a systems issue. Obtaining proper informed consent is required before all surgical procedures. It is the responsibility of the surgeon to ensure that proper informed consent is obtained and documented. Surgeons should not be so busy as to not have the time to ensure that proper informed consent is obtained, that the patient's questions are answered and that everything is properly documented.

CO-MANAGEMENT

Of all the systems issues, co-management is the most problematic. One of the many problems with co-management is that busy surgeons rely on others to do the pre-operative work up. However, regardless of who did the work up the surgeon is still responsible for the misdiagnosis of a pre-existing condition. An example of improper preoperative work up performed by someone other than the surgeon involves Dr. B:

"TLC Pays $900,000 to Settle Malpractice Lawsuit Against Dr. ...

Using assembly-line-like procedures, TLC-employed optometrists oversaw initial testing procedures, pre-qualified patients for surgery, and then lined up surgical candidates upon whom Dr. B. would fly in to operate. Surgery was performed on both of Judge H.'s eyes on the same occasion.

By all accounts, Dr. B's surgical technique was flawless. By Dr. B's own candid admission, however, Judge H. never should have been operated on at all. The screening tests conducted by TLC and provided to Dr. B for review before surgery showed that Judge H. had a condition called keratoconus - irregularly shaped corneas - that disqualified him for LASIK surgery. Instead of improving Judge H's vision, the surgery triggered a series of worsening vision problems that led to legal blindness in one eye that could only be improved - though not completely cured - by a corneal transplant. The need for at least one additional corneal transplant in the other eye is expected.

TLC agreed to pay $900,000 to settle the portion of the case directed against it. Trial preparation for the case against Dr. B. continued until a separate negotiated settlement was reached with Dr. B's liability insurance carrier."[7]

The American Academy of Ophthalmology (AAO) and the American Society for Cataract and Refractive Surgery (ASCRS) have issued a joint position statement on co-management. The ophthalmic surgeon has primary responsibility for the preoperative management and post operative care of his/her patient regardless of the type of surgery performed. The decision to co-manage should be the result of a determination of what is best for the patient, and not economic considerations.[8]>

In the event that the ophthalmologist needs to co-manage with an optometrist the ophthalmologist should verify and document that the optometrist has the appropriate, education, training and skills to follow the patient post-operatively.[9]

This statement is not officially the standard of care but raises important legal considerations. It can be hard to argue that it is in the best interests of the patient not to have his surgeon manage him/her post-operatively but instead to have the care delegated to an optometrist.

In a malpractice trial juries will look at the co-management arrangement. Of concern is the fee arrangement. If the co-management fee is higher than average it could be viewed as an incentive to refer the patient to the higher paying doctor. The staff of both the optometrist and the ophthalmologist can be questioned during discovery. The chart of the co-managing optometrist can be discovered. It is problematic if the ophthalmologist, pre-operatively, was unaware of important information in the optometrist's chart that is later discovered during litigation.

The co-management arrangement could be viewed as a joint venture. The statistics on co-management published by OMIC are summarized in the next table.[10]

CO-MANAGEMENT STUDY PUBLISHED BY OMIC

• 179 Files Of 48 Surgeons In 1998
• Concerns Data Sent to Surgeons
• Patient Histories present in 17/170
• Corneal Topography 71/179. Only 11/179 were more than one month old
• Topographies Sent by Fax in Black and White 61/179, in Color 10/179
• Current and Past Refraction
• Current Refraction 163/179
• Past Refraction 12/179
• Pre- Operative Exam 1/2

In looking at the data from this co-management study published by OMIC, it is apparent that the co-management evaluation process is flawed. Pre-operative histories are lacking. Documentation of stable refractions are lacking. Black and white faxed topographies are of limited value. Recent topographies performed by optometrists, which must be repeated by the surgeon, are of little value. A lack of serial refractions represents a failure to document a history of refractive stability.

According to this study, information provided by referring optometrists is often inadequate, and ophthalmologists relying on this data are in effect relying solely on the findings of inaccurate examinations and patient histories.

According to OMIC, ophthalmologists who co-manage patients should develop protocols to ensure that specific information is obtained from the referral source.[11] OMIC recommends what it describes as the SLEDOG Protocol.[12]

Protocol for Comanagement of Refractive Patients

The following SLEDOG Protocol for comanaging optometrists and refractive surgeons was developed by Callaway & Brennig

Simple mandatory procedures should be followed and shared with the comanaging optometrist. Each comanager should sign off on the following: refraction, central corneal thickness, pupil size (and how it is measured), ocular surface/systemic diseases, and topography. The refractive surgeon must see the patient for the first postop visit and be clear about the subsequent postop care to be provided by the optometrist.

Letters to comanaging optometrists should be written at the time of referral to request all relevant patient information. Such letters document that a system is in place to retrieve patient information.

Emphasize these simple mandatory procedures at meetings with comanaging optometrists.

Document your file. OMIC provides an informed consent form specifically for comanagement situations. The form simply requires the patient to acknowledge the comanagement arrangement.

Office personnel continuity should be maintained at all costs. Not only can a disgruntled former employee significantly strengthen a plaintiff's case, but an office in turmoil is one that makes mistakes.

Give specific persons in your office responsibility for obtaining information about patients who have been referred by comanaging optometrists. While everyone should be generally aware of your simple mandatory procedures, designate one or two employees with specific responsibility for obtaining records. If a lawsuit is ever filed, their testimony will play better before the jury than the testimony of several employees, none of whom is completely familiar with your procedures and process.

LASIK surgeons should develop defensible co-management practices. Heeding the advice of recognized authorities is advisable. The SLEDOG protocol is a good starting point.

PROVIDER ISSUES

The most common error providers make is failure to properly document (85%). This is followed by failure to perform needed tests or evaluation (21%). Problems with physician skill or knowledge account for 16% of provider issues. Finally choosing the wrong flap thickness accounts for 11% of provider issues.

It is interesting that failure to properly document the medical record is the largest provider issue. Doctors need to take the time to ensure that there is proper documentation in the medical record. In malpractice litigation the conventional wisdom is that if it is not documented, it didn't happen. The often used excuse that doctors do not have enough time to diagnose, treat and document the care is unacceptable. All you need to do is loose one major malpractice case and your life will be disrupted far beyond the minor disruption caused by taking the time to properly document the medical record.

The other easily corrected provider issue is performing the proper tests. Proper pre-operative work up is a requirement for all surgery. Proper work up can also eliminate patients who are not candidates for the surgery and further reduce your malpractice risk.

PATIENT ISSUES

Sadly, patient issues are the least common issues in LASIK malpractice litigation. Of the 25 cases involving patient issues, non-compliance accounted for 9/25. Personality issues accounted for 8/25. Finally, unsubstantiated issues of patient self inflicted injuries including head movement, rubbing or scratching accounted for 4/25 cases.

Physicians need to learn to say no to patients. If you have a patient whom you believe will be non-compliant, or who has a personality or expectations that will be problematic, you should simply refuse to operate on that patient. It is better to forgo operating on a patient than lose a major malpractice case. Analyze each patient not only from the medical issues but also from the malpractice issue. If you spot a high risk patient, or one that you simply feel uncomfortable operating on, go with your instincts.

CONCLUSION

Although LASIK is generally a safe procedure with a high percentage of good outcomes, bad results can happen and unhappy patients do exist. Physicians who perform LASIK must practice defensive medicine. Medical work-ups should meet the standard of care. Review of risks, benefits, and alternatives, including no surgery, must be discussed and documented. All possible efforts must be made to avoid operating on patients who are not good candidates for LASIK or for whom the procedure is contraindicated. Surgeons must confirm all pre-operative findings as they are responsible for their accuracy.

Co-management arrangements must be above suspicion and fully disclosed to the patient. Protocols for ensuring that all the necessary information is obtained from the referring optometrist must be implemented and carried out.

LASIK centers should be operated with checks and balances to ensure that the equipment is in proper working order and that the LASIK settings are correct for the patient undergoing the procedure.

Every LASIK patient should be viewed as a ticket holder in the LASIK malpractice lottery. Patients whose medical condition, personality or other factors makes them a bad risk should not have the surgery. One mega million dollar winner whose award exceeds your policy limits could wipe out years of income and savings.

Finally, physicians who expose themselves to the risk of verdicts above their policy limits should consider asset protection strategies well in advance to avoid allegations of fraudulent conveyance of assets in the midst of litigation.

Michael S. Kelton, Esq. is a partner at Abrams, Fensterman, Fensterman, Eisman, Greenberg, Formato & Einiger, LLP, and is the Director of the firm's New York City Litigation Practice, as well as the firm's Medical Malpractice Defense Practice

Michael T. Goldstein, M.D., J.D. is Of Counsel at Abrams, Fensterman, Fensterman, Eisman, Greenberg, Formato & Einiger, LLP. He is an actively practicing Board Certified Ophthalmologist, who is a fellowship trained corneal surgeon.