Avoiding Malpractice in Refractive Surgery Means Taking Informed Consent Seriously

Refractive Surgery: Malpractice Litigation Outcomes

Custer BL, Ballard SR, Carroll RB, Barnes SD, Justin GA
Cornea. 2017;36:1243-1248

Study Summary

The authors of the current study looked at jury verdicts and settlements in cases regarding corneal refractive surgery (from 1988 to 2014) in the WestlawNext legal database. Per the authors, this database "collects jury verdicts that commercial vendors have deemed important either because of precedence or content," and that are "publicly available in federal and state court records." They acknowledge that the cases in this database do not represent all malpractice cases in the United States.

Not surprisingly, 76% of the cases were related to LASIK. Also not surprisingly, given that the cases go back to 1998, 15% were related to radial keratotomy. About half of the plaintiff allegations involved lack of informed consent.

Following adjustment for inflation, plaintiffs were awarded an average of $1,287,872, with jury verdicts and settlements resulting in mean awards of $1,604,801 and $826,883, respectively.

Viewpoint

Looking at malpractice claims and trial data is a little like morbidity and mortality rounds. Such reviews highlight problems, allow analysis of what might have gone wrong, and identify ways to prevent similar problems in the future.

An important question is: How representative is this database of all malpractice cases?

My sense is that it probably contains a higher percentage of unusual, more severe, or higher award cases than average. One reason I say this is that during a recent educational session^[1] offered by the Ophthalmic Mutual Insurance Company (OMIC), which insures about half of private practice ophthalmologists in the United States, it was stated that from 2011 to 2016 the company had 14 settlements regarding refractive surgery cases, where the average settlement was approximately $107,000, much lower than the average settlement found in this study.

Even so, the authors identify some interesting trends, among which I found the numbers surrounding the lack of informed consent particularly distressing. Many underlying reasons that precipitated the malpractice cases in this study (eg, postoperative complications, machine malfunction) are not under total control of the physician. On the other hand, the informed consent process is 100% determined by the surgeon. The authors cite a study^[2] of ophthalmology residents in which only 18% said that they felt comfortable obtaining informed consent, 56% that they had received previous training in the informed consent process, and 81% that training had occurred in medical school. Apparently, we need to be doing a much better job training our residents.

I find this article especially timely as the Pennsylvania Supreme Court recently handed down a ruling (Shinal v. Toms, 2017) stating that the doctor who will perform the medical procedure has the nondelegable duty to obtain informed consent. This means that the physician cannot use an assistant or a technician (or anyone else) to provide the information required for a patient to make an informed decision regarding a procedure.

OMIC suggests that this ruling also means that any follow-up questions regarding the procedure, including its risks and benefits, must be answered by the physician and appropriately documented in the chart.

While I firmly believe that the majority of surgeons discuss what they consider to be the most important aspects of the proposed surgery, alternatives, risks, and benefits directly with the patient, they also delegate what they consider "less critical" aspects of this discussion to an assistant or a technician. Given the results of this study, that may not be the best way to convey this information to our patients—and, for those of us practicing in Pennsylvania, that process now appears to be "against the law."

Abstract

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