High volume a risk factor for LASIK lawsuits, study shows

A study of insurance records outlined risk factors associated with malpractice claims and suits against refractive surgeons.

A 6-year retrospective study identified surgeon practices associated with an increased risk for liability suits.

High surgical volume, a history of previous claims or suits, less time spent with the patient, comanagement with optometrists and advertising are among the risk factors for malpractice claims and suits identified in a review of nationwide insurance records.

Physicians performing high-volume refractive surgery should be aware of these risk factors, said Richard L. Abbott, MD, at the meeting of the International Society of Refractive Surgery of the American Academy of Ophthalmology.

Dr. Abbott said many aspects of refractive surgery practice may attract litigation.

“LASIK is fertile ground for plaintiff attorneys for many reasons: large volumes of cases, the elective nature of the procedure, high expectations of the patients, the potential for pain and suffering and negative economic harm that comes to the patient,” he said.

Although the physician wins in 90% of malpractice cases, the litigation process is taxing both economically and professionally, Dr. Abbott said.

“If you had to imagine what was or could be the worst experience of your professional career, leaving out sudden death, it is overwhelmingly a medical malpractice lawsuit,” Dr. Abbott said in his presentation. “Once you have been sued, you have lost” because of the significant time spent, emotional drain and the cost in defense, he said.

Dr. Abbott said he and his colleagues conducted the study because there had previously been no quantitative analysis of the risk factors for medical malpractice suits related to refractive surgery. The study was published in the November issue of Ophthalmology.

“Our goal was to provide statistically significant data for underwriting criteria and risk management protocols to proactively manage and reduce the risk for claims and lawsuits against refractive surgeons. Our goal also was to improve the quality of care for patients undergoing refractive surgery,” he said.

Methods

In this retrospective cohort study, Dr. Abbott and colleagues examined physician characteristics in 100 consecutive claims and lawsuits for LASIK and PRK procedures performed by surgeons insured by the Ophthalmic Mutual Insurance Company (OMIC) between 1996 and 2002.

Dr. Abbott is a board member of OMIC. He noted that OMIC did not financially support the study, although it does provide travel funds and a stipend for his presentations.

The authors analyzed and compared the demographics and the management records of physicians who had been sued and those who had not.

The authors also surveyed 750 refractive surgeons with OMIC coverage during that time, of whom 708 responded. They analyzed the responses to determine surgeon practice patterns and compared the characteristics of those who had been sued to those who had not. Data were evaluated statistically using logistic regression analysis, odds ratios, confidence intervals and P values.

High-volume risks

The study showed that the highest concentration of refractive surgeons in the United States is found in the Pacific region, Dr. Abbott said. Almost 50% of ophthalmologists insured by OMIC in that region applied for refractive surgery privileges, he said.

Similarly, the risk of a claim or suit was found to be highest in the Pacific region, Dr. Abbott said.

Analysis of the 100 consecutive cases, in comparison to physicians responding to the survey who had not had a lawsuit against them, showed that there was a greater probability of a claim against high-volume surgeons, Dr. Abbott said. Of the 100 cases, about 25% were filed against surgeons who performed 100 cases or fewer per year, while 75% were filed against surgeons performing more than 300 cases per year.

The average number of refractive surgery cases per year in the lawsuit group was 491, while in the no-lawsuit group the average was 162 per year. This difference was “highly significant,” Dr. Abbott said.

At the end of the presentation, session moderator Eric D. Donnenfeld, MD, asked Dr. Abbott if the investigators had looked at their data in another way, the risk per patient encounter.

“When I reviewed your data, it seemed that the highest volume doctors had the least risk per patient, suggesting that the more experienced surgeons have less risk of lawsuit per patient,” Dr. Donnenfeld said.

“It’s a good point,” Dr. Abbott replied. “We didn’t specifically look at it that way. Having a lot of experience and being a high-volume surgeon doesn’t necessarily mean that you have a poor practice pattern. In other words, you can advertise, comanage, do high-volume surgery; you just have to pay attention to the patient and have the right tools with you to do that.” He said that surgeons must be aware that these types of practice patterns are at a higher risk for a medical malpractice insurance carrier and require closer attention to risk management principles.

Pressure toward high volume

Dr. Abbott noted that economics can spur surgeons to increase their surgical volume.

“There is increasing pressure to do higher volume surgery. Because of the high overhead associated with surgery, many business models often demand higher volume for financial success,” he said.

Additionally, refractive surgery may be viewed by outsiders more as a business than a medical practice, Dr. Abbott said. And because refractive surgery is often considered an elective cosmetic procedure, lawyers may particularly focus on the business practices of a surgeon who influenced a patient to undergo LASIK.

In his study, Dr. Abbott noted that advertising, comanagement arrangements and patient communication all were risk factors for incurring a claim.

“The key element here is that they were all volume-dependent,” he said. “Of physicians in the lawsuit group, 71% actively advertised, compared to only 37.4% who actively advertised in the no claim or suit group. Again, this was statistically significant at over 300 cases per year.”

Comanagement arrangements were also a risk, according to the study, with 55% of surgeons in the lawsuit group comanaging patients as opposed to about 28% in the no-lawsuit group, he said.

Dr. Donnenfeld asked about the data analysis on comanagement arrangements at the end of the presentation. He asked whether the investigators had found a greater risk per patient with comanaging surgeons, or if the higher number of suits was related only to higher patient volume among comanagers.

“I don’t think we have that data yet,” Dr. Abbott said.

Time spent with the patient was also a factor, the study found. Physicians who spent more time with each patient had a lower risk of incurring a claim or suit, Dr. Abbott said.

Other findings of the study suggested that patient communication may have an effect on lawsuit incidence. In 44% of cases, informed consent discussions were done on the day of surgery, Dr. Abbott said, and many took place after patients had been medicated. The surgeon was not involved in 17% of informed consent discussions. Improper performance and informed consent issues accounted for 70% of the claims and suits, he said.

Patient population

The characteristics of patients in the lawsuit group were also analyzed. Most patients were in white-collar professions — accountants, engineers, executives, teachers, lawyers. Average age was 42.1 years. Men and women were almost equally represented, at 49% and 51% respectively.

Dr. Abbott noted that “an inordinate amount” of the plaintiffs suffered from depression or were taking antianxiety medications, “and these problems were all clearly documented in the medical records.”

Two-thirds of the plaintiffs wore contact lenses, which Dr. Abbott said presumably meant that they would have high expectations for their postop vision.

Prevention, precaution

Dr. Abbott closed with a description of the at-risk LASIK surgeon.

“A high-volume, male refractive surgeon who practices in the Pacific region, who advertises, actively comanages and spends little time with his patients is at relatively high risk for subsequent litigation,” he said. “And once the claim is filed, he has an increased chance of incurring additional legal action.”

He offered a word of caution to surgeons in this category. “You need to stop and think. You need to slow down. You need to pay attention to these risk factors,” he said. He advised these surgeons to work with their medical liability companies to reduce their risks for malpractice claims.

For Your Information:

• Richard L. Abbott, MD, can be reached at the University of California at San Francisco, 10 Koret Way, K301, San Francisco, CA 94143-0730; 415-502-6265; fax: 415-502-7418; e-mail: rabbott@itsa.ucsf.edu.
• Eric D. Donnenfeld, MD, can be reached at Ryan Medical Arts Building, Suite 402, 2000 North Village Ave., Rockville Centre, NY 11570; 516-766-2519; fax: 516-766-3714; e-mail: eddoph@aol.com.

Reference:

• Abbott RL, Ou RJ, Bird M. Medical malpractice predictors and risk factors for ophthalmologists performing LASIK and photorefractive keratectomy surgery. Ophthalmology. 2003;110:2137-2146.