Comparison of annual refractive surgical volume and percentage of surgeons insured by OMIC who did or did not have malpractice claims or lawsuits filed against them. (Adapted from abstract of Abbott RL. Medicolegal risk factors for ophthalmologists performing PRK and LASIK surgery. Paper presented at the annual meeting of the American Academy of Ophthalmology, Anaheim, Calif., November 15, 2003.)

What About Incidence of Lawsuits Per Case?

From his perspective as a busy surgeon in a thriving refractive surgical practice in Johnston, N.Y., John Kearney, M.D., saw the Abbott paper and AAO lecture as a purposely skewed view.

"It was not a well-designed study," he said, "and it seems they had a foregone conclusion that they wanted to support." The obvious omission, Dr. Kearney said, was an analysis of the relative risk per case for high-volume vs. low-volume refractive surgeons.

"I was there when the paper was delivered," Dr. Kearney said. "When [session moderator] Dr. Donnenfeld questioned him, Dr. Abbott admitted that he had never really looked at whether there was actually a lower incidence of lawsuits per case for high-volume surgeons. If you're going to do 1,000 refractive procedures vs. 1 procedure, of course your chances of being sued are higher, but your incidence of suits per case may be much lower. And this study didn't look at it from that point of view."

Dr. Kearney also doubted the way that the study connected higher patient volume with less time spent with each patient. "Every surgeon has to spend time counseling their patients personally," he said. "Large practices can also have a surgical counselor to work with patients, and they have videos and printed materials. Those patients are probably better advised than patients who go to a low-volume practice that doesn't have the same resources. I always think of the sister at the first hospital I worked at who said she wouldn't want to be the last one of the 50 patients we operated on that day. I told her I'd rather be number 50 than number 1, and I still believe that today."

Dr. Kearney voiced many of the frustrations expressed by other surgeons who looked to the study for guidance. "Well, you can't easily change from male to female," he joked, "and it's not practical to relocate from one part of the country to another. And if you've made a large capital investment in a surgery center you're not able to downsize to a small refractive surgical volume. The best way to proceed is to keep doing what you do well and pay attention to the details. Dot all the i's and cross all the t's."

Were the Necessary Data There?

When Richard L. Lindstrom, M.D., managing partner of Minnesota Eye Consultants (MEC) in Minneapolis, learned of the Abbott study, he reviewed the records of their high-volume, seven-surgeon anterior segment surgery practice.

"During the time of the Abbott article [1996-2002], seven MEC surgeons performed 30,303 LASIK and PRK procedures," Dr. Lindstrom said. "All seven surgeons fit the paper's definition of a high-volume refractive surgeon, and all seven of our surgeons have significant cataract, corneal, and/or glaucoma surgical practices as well." Dr. Lindstrom said that there are six male and one female surgeons on staff at MEC, and the practice has always advertised and comanaged surgical patients with referring ophthalmologists and optometrists.

The internal case review at MEC found 3 LASIK/PRK claims or lawsuits, for an incidence of approximately 1 per 10,000 refractive surgical procedures. All of those claims and lawsuits involved a single male surgeon who was also involved in legal action initiated by non-refractive surgical patients. One of those claims was from a comanaged patient and two were not. Dr. Lindstrom noted that this ratio matches the 1:2 proportion of comanaged/referred vs. internal surgical patients at MEC. Although there are lessons to be learned from the Abbott study, he said, some of the implicated "risk factors" may well be spurious.

"I encourage all ophthalmologists to review the Abbott et al. article carefully and then to draft a risk management strategy for their individual practices," Dr. Lindstrom said. "A malpractice claim or lawsuit can have a devastating effect on surgeons, their practice, their partners and even their family and friends."

Although the review of practice claims and lawsuit history could be construed to focus special attention on high-volume male surgeons, Dr. Lindstrom points out that the one female surgeon at MEC currently has the highest-volume refractive surgical practice and has not yet been subject to a claim or lawsuit.

The MEC surgeons have decided not to reduce their surgical volume by limiting their marketing and referral/comanagement patterns.

"We have, however, increased our effort to be certain that our marketing pieces are accurate, honest and formulated such that we would not be embarrassed to have them presented to a jury of our patients' peers," Dr. Lindstrom said. "Most importantly, we spend more preoperative time with our patients. As managing partner, I am encouraging this strongly in our practice. A strong doctor/patient relationship is the most powerful risk management tool available to any surgeon."

What Would Your Practice Records Tell You?

Robert Lehmann, M.D., a busy anterior segment surgeon with offices in Nacogdoches and Grapevine, Texas, appreciated the study's focus on the need for risk management, but was dubious about some of the conclusions.

"Data collection and the treatment of the data, as well as any existing bias, can have a great impact on conclusions for any given study," he said. "I don't see where this study actually matches the volume of cases to the occurrence of claims." Rather than establishing a link, the paper aligned data on surgical volume with data on the time spent with patients and the number of malpractice claims in what may or may not be a valid connection

"A low-volume practice can do a good job of screening and counseling patients, and a conscientious high-volume practice can do a good job," Dr. Lehmann said. "But practices that do not take time or aren't well equipped to counsel patients can have a greater incidence of claims, regardless of how many procedures they do. Either way, it's really a question of the number of claims per patients treated in the practice, which is what this study did not seem to address."

He agreed, however, that geography was correctly identified as a risk factor.

"It is a fact that we are in a litigious society," Dr. Lehmann said, "and that LASIK is a leading target for claims. It has been documented that there are certain regions that are more suit-prone." He believes the Abbott study did not have all pertinent data, however, to interpret the connection between surgical volume, surgeon-patient interaction, and the risk of malpractice claims.

"We have been doing a significant volume of laser vision correction cases since 1996," Dr. Lehmann said. During that time, just one claim was made against the practice, and that claim was dropped even before depositions were taken and with no settlement agreement.

"If you keep abreast of the published studies and current standards, if you evaluate Orbscan data, corneal topography, pachymetry, pupil size, and wavefront data, and if you counsel patients regarding expectations and exclude those who are not suitable candidates for surgery, you will definitely limit your potential liability."

In addition, keeping abreast of current technology is critically important. "I began the transition to the Intralase femtosecond laser technology for creation of the LASIK flap one year ago. This has reduced my stress more than any other single factor with regard to the surgery itself."