Risk Management

Are Patients Who Chose Premium IOLs a Malpractice Risk?

By Anne M. Menke, RN, PhD

OMIC Risk Manager

Digest, Summer 2011

To view the tables referred to n this article, go to: http://www.omic.com/new/digest/Digest_2011Summer.pdf

Staff in OMIC ‘s Claims and Risk Management Departments field a significant number of calls from ophthalmologists about “premium” intraocular lenses (PIOLs), the name given to those IOLs for which patients are asked to pay extra. Questions range from whether physicians need to inform patients of the availability of PIOLs during the informed consent discussion to whether refunding the extra fees paid for them is an admission of liability. To determine if implantation of PIOLs has led to lawsuits, we conducted our first claims analysis of these lenses.

Thirty-four plaintiffs filed claims involving 47 PIOL implants against 40 OMIC-insured defendants. Thirty-five of these defendants were ophthalmologists, four were associated but separately-insured ophthalmology practices, and one was a separately-insured ambulatory surgery center. Forty-four of the PIOLs were implanted during cataract surgery and three during refractive lens exchange. We compared PIOL claims to cataract and refractive surgery claims; the former share the same procedure and the latter presumably have similar refractive goals and payment issues. Graph 1 on page 4 shows the number and type of PIOLs implanted, while Graph 2 gives the percentage of open, closed, and total claims for PIOL, cataract, and refractive claims. PIOL claims are still very infrequent and there are more open than closed claims, but it is too soon to predict whether claims from these relatively new devices will increase over time.

Many malpractice claims are dropped before a lawsuit is even filed and most close without any money being paid to the plaintiff. Table 1 on page 5 provides three more severity indicators: the median (middle), mean (average), and highest payments for PIOL, cataract, and refractive claims compared to all OMIC claim payments. Premium IOLs have the smallest percentage of claims that close with an indemnity payment, as well as the lowest median, mean, and high payments. In OMIC’s experience to date, PIOL claims are considered very low frequency/very low severity, while cataract claims are high frequency/moderate severity, and refractive surgery claims are low frequency/moderate severity. OMIC does not have data on the prevalence of use of PIOLs, so we cannot draw any conclusions about the relative risk of premium versus monofocal IOLs.

Premium IOL Causation Analysis

OMIC has developed a method of analyzing the primary driving force behind malpractice claims against ophthalmologists. In this analysis, which we call CPSP, we look at four factors: clinical, physician, system, and patient. Clinical issues are areas of controversy or of limits in knowledge or diagnostic/treatment modalities. They are identified during the investigation of a claim and derived in part from the opinions of physician expert witnesses. System issues cannot be attributed to a single individual; instead these are processes in which many individuals and entities are involved. Table 2 shows the primary and secondary causes of claims for premium IOLs in open and closed claims brought by 34 plaintiffs. System issues predominate; patient factors contribute about half as often, followed by clinical and physician ones. While physicians are the least likely contributor to claims against them, there is still much they can do to protect themselves starting with a review of the four contributing factors.

Candidacy issues emerged as the primary clinical issue: experts opined that the appropriateness of premium IOLs was not adequately evaluated for patients with multiple sclerosis, glaucoma, dry eye disease, posterior vitreous detachments, and monfocal IOLs in the fellow eye. Issues frequently seen in monofocal IOL cases were also found, such as when surgery is indicated, how long patients who wore contact lenses must be out of them before the IOL is chosen, and how to determine the dominant eye for monovision.

Experts pointed to faulty physician judgment as the most frequent way that ophthalmologists contribute to claims. An ophthalmologist was criticized by both plaintiff and defense experts for leaving an IOL whose haptic broke during surgery in the patient’s eye, since the defect could lead to the decentration issues the patient later encountered (this elderly patient did not pursue the claim). Plaintiff and some defense experts felt that repositioning a dislocated IOL five times caused the retinal detachment the patient developed (the case settled for $215,000, of which OMIC paid $122,500).

Six system issues were identified (followed by the number of resulting claims): communication among team members (2), the diagnostic process (2), documentation (5), equipment (3), informed consent (20), the litigation process (4), and sterilization (1). Issues are presented for open and closed claims, but specific case examples are only provided for closed claims.

Communication breakdowns are more likely to occur when many physicians are involved in care, and when there are frequent patient hand-offs from one provider to another or from one setting to another. “Wrong” IOL and “wrong” patient errors are the most common examples of these communication breakdowns in ophthalmology, and one case occurred in this series. The ophthalmologist had correctly chosen and ordered the PIOL, but no one on the team had noticed that it was not in the OR. When the physician asked for it, he indicated the correct power but not that it was a PIOL. With the patient’s permission, he immediately exchanged the IOL, and he and the ASC performed the exchange at no charge to the patient (the suit settled for $15,000 on behalf of the physician; the ASC refused to contribute and blamed the physician for the mishap).

The diagnostic process is one of the most complex tasks physicians perform. Certain scenarios frequently lead to allegations of delay in diagnosis, as is the case for some open claims in which multiple providers and specialties tried to find the cause of non-specific symptoms, such as headache or decreased visual acuity.

Documentation issues included omissions and additions. Experts criticized ophthalmologists’ failure to document the specifics of the informed consent discussion, the process of aligning toric IOLs during surgery, and to note complications that occurred during surgery in the operative report. They questioned the accuracy of the medical record when physicians relied heavily upon templates, when scribes documented too uniformly at each visit, and when electronic medical record systems did not individualize the content for each specific patient or visit.

Equipment problems were the primary factor in two PIOL claims. A defective plunger caused a capsular rupture and prevented the ophthalmologist from implanting a Crystalens. The surgeon documented the equipment problem, disclosed it to the patient, reported it to the hospital and the manufacturer, and offered subsequent care at no cost (the plaintiff dropped the suit). A registered nurse who had no prior experience with phacoemulsification equipment caused a corneal abrasion (the non-OMIC ASC settled the case; the physician was dismissed).

An allegation of lack of informed consent accompanies many malpractice claims but rarely turns out to be the pivotal factor. PIOL claims proved to be an exception to this trend, as informed consent issues were the primary factor in eleven cases, and a secondary factor in nine. We concluded that an inadequate informed consent process was the single most important driver of PIOL malpractice claims. See Hotline article for recommendations on how to improve the consent process.

The litigation process itself was the primary factor in three claims and a secondary factor in one. In some cases, expert witnesses appeared to act as an advocate for the attorney who hired them rather than as neutral experts who explain the medicine. One physician accepted a referral from the plaintiff attorney and agreed to examine and treat a patient who was not satisfied with the quality of her vision provided by her Crystalens implant. The plaintiff expert testified at trial that the defendant ophthalmologist had erroneously placed the IOL in the sulcus, despite documented exams by three prior ophthalmologists that the IOL was in the capsular bag (the jury returned a defense verdict). In another case, the plaintiff expert did not carefully review the medical records provided by the plaintiff attorney and certified that the care was substandard; when challenged by the defense attorney during his deposition, the plaintiff expert acknowledged that far from substantiating his criticisms, the medical record demonstrated that the ophthalmologist had met the standard of care (a motion for summary judgment was granted).

Defense expert witnesses can also surprise the attorneys who hire them. A patient in her forties with preoperative visual acuity of 20/40 was offered cataract surgery with a PIOL. The plaintiff expert felt a more careful preoperative exam would have noted a posterior vitreous detachment, which he believed led to an inferior retinal tear. The defense expert was initially supportive and noted that the tear did not impact the patient’s vision. Only during deposition did the defendant and defense attorney learn that their expert was critical of the failure to perform glare testing before recommending cataract surgery (the timing of this reversal of opinion led to a $45,000 settlement).

Patient factors played an important role in PIOL claims, second only to system issues. Accepting an unsatis- factory outcome requires more resiliency than some patients possess or can develop; mental health issues thus were a primary cause in three and a secondary cause in seven claims. One patient had bilateral Crystalens implants but was not satisfied with the quality of her distance vision, so she asked that her distance vision be improved with LASIK at the cost of near vision. Although she acknowledged the need for glasses before she had the refractive procedure, she nonetheless filed a claim and wrote to the medical board when she then had to wear the glasses (the claim was dismissed, and the medical board supported the care). The feeling that the ophthalmologist “must have been done something wrong” was strongest in patients who developed a cascade of complications requiring multiple office visits, medications, consultations, and procedures. A patient with a long eye and a history of prior LASIK surgery experienced a ruptured capsule during surgery to implant a ReSTOR lens; postoperatively, she had a hyperopic surprise and developed bullous keratopathy. Not surprisingly, she was unhappy when her final visual acuity after an IOL exchange and DSAEK was only 20/80 (there was strong defense support for the care and the statute of limitations had expired; the defense motion for summary judgment was granted and the case was dismissed).

As specialists who develop and incorporate new technology at a rapid pace, all ophthalmologists can learn from this early report on malpractice claims related to premium IOLs and implement measures to ensure that patients are carefully selected as candidates for the latest advances and are fully engaged in the decision and care process. The AAO recently published a Focal Points module on MFIOLs and AIOLs in which authors Steven I. Rosenfeld, MD, and Terrence P. O’Brien, MD, provide a systematic approach to determining the cause of the patient’s complaint and how to best address it.1

1. “The Dissatisfied Presbyopia-Correcting IOL Patient.” Focal Points: Clinical Modules for Ophthalmologists. American Academy of Ophthalmology, September 2011.