Endophthalmitis and Tass: Claims Results and Lessons

By Anne M. Menke, RN, PhD

Anne Menke is OMIC’s Risk Manager.

Digest, Spring 2006

To see the charts mentioned in this article, choose this PDF link: Endophthalmitis and Tass Claims Spring 2006

Uncomplicated cataract surgery was performed on an elderly woman. At the end of the procedure, the ophthalmologist was informed by the nurse that the sterilization indicator on the instruments had not changed. It was feared that the instruments had been washed but not sterilized. The physician and ASC medical director decided not to inform the patient of the potential problem, opting instead to increase the frequency of topical antibiotics. No signs of infection were noted at the first postoperative visit, but two days later, endophthalmitis developed. Ten days after surgery, the two physicians informed the patient and her family that the same strain of pseudomonas aeruginosa had grown in the eye and the ultrasonic bath water at the ASC, leading them to conclude that problems with sterilization were the likely cause of her endophthalmitis and phthisical eye. The patient’s lawsuit was settled on behalf of the ASC for $650,000.

Poor outcomes such as this make infectious endophthalmitis one of the most feared complications of ophthalmic surgery. Recently, a type of inflammatory response known as TASS, or Toxic Anterior Segment Syndrome, has garnered attention and prompted calls to OMIC’s Risk Management Hotline. While not all adverse events can be prevented, there is much ophthalmologists can do to reduce the incidence of endophthalmitis and TASS. In its review of OMIC’s claims experience and the lessons learned from it, this article offers risk management guidance on more effective prevention, recognition, and response to these sight-threatening conditions.

Since OMIC’s inception in 1987, endophthalmitis has accounted for 6% of claims frequency (150 claims out of 2,559 total) and 5% of claims severity ($3,345,964 in paid indemnity out of $63,191,199 total). Of these 150 cases, 25 remain open; of the 125 closed cases, only 8 were taken to trial, and in all but one, the jury returned a defense verdict. A poll of the jury after the sole plaintiff verdict of $735,000 revealed that the award was in response to the defendant group’s practice of locking up medical records on weekends, thus preventing access to key patient information needed to assess the plaintiff’s condition. Since the practice’s name did not appear on the jury’s form, a settlement on its behalf was effected for the amount of the verdict, and the plaintiff award against the ophthalmologist was vacated.

More than three-quarters (78%) of OMIC’s endophthalmitis cases have closed without an indemnity payment. The percentage of cases that have settled (22%) and the median settlement amount ($75,000) are comparable to OMIC’s overall data. Despite the severity of the outcome for the patient, endophthalmitis settlements have ranged from $9,000 to $735,000 compared to a low of $500 and a high of $1.8 million for all settlements. Reflecting the relative novelty of TASS, allegations in all but 3 of the 150 claims involve an infectious rather than an inflammatory process.

Given the estimated 2 million cataract procedures performed annually in the United States, one might anticipate that cataract surgery would account for 61% of all endophthalmitis cases. Surprisingly, however, only 23% of cataract- related endophthalmitis cases resulted in an indemnity payment.

During the informed consent process for cataract surgery, ophthalmologists routinely disclose this rare complication, and most actively try to prevent its occurrence by treating preexisting conditions such as blepharitis, preparing the eye with povidone iodine, and administering antibiotics. Assuming cataract surgery was indicated in the first place and the endophthalmitis was promptly recognized and treated, experts view this complication as a tragic maloccurrence rather than malpractice. On the other hand, cases of endophthalmitis resulting from trauma are rare (5%), but they result in settlement 57% of the time. Clearly, ophthalmologists who do not administer antibiotics and/or carefully monitor the eye for signs of endophthalmitis after trauma are not supported by defense or plaintiff experts.

Analysis of Risk Issues

It is helpful to analyze the risk issues associated with substandard care by dividing them into four categories. “Clinical” issues include debates in the ophthalmic community on the standard of care and the natural history of the disease or condition. “Systems” issues involve complicated processes of care, such as medications (research, manufacture, distribution, ordering, etc.), equipment, and follow-up and telephone screening methods. Finally, the acts, omissions, and decisions of individual physicians and patients also impact care out- comes. Table 2 indicates the type and frequency of risk issues in OMIC’s endophthalmitis and TASS cases.

Amid ongoing debate of evidence- based guidelines for prevention of endophthalmitis, it is noteworthy that antibiotic administration was not a key issue in any case; nor was patient noncompliance a significant factor. Ophthalmologists have a leadership role to play in addressing the many systems issues that adversely impact care outcomes. In their capacity as users, surgical directors, board members, and owners, they can review equipment maintenance and infection control measures in hospitals and ASCs, focusing particular attention on issues such as flash sterilization, re-use of single-use items, and the ordering, preparation, and use of ophthalmic products, devices, and medications.

Screening Patient Complaints

The two primary issues in OMIC’s endophthalmitis cases—telephone care and the diagnostic process— indicate the need to carefully screen patients who present with ophthalmic complaints, especially postoperatively, and to educate them about which symptoms to report. Each of these identified risks is squarely within physician control and thus can be modified. This issue’s Closed Claim Study illustrates the perils of inadequate screening and failed coordination of care; the Risk Management Hotline advises physicians on how to disclose and investigate sterilization problems or clusters of cases, and prevent TASS. “Telephone Screening of Ophthalmic Problems” provides screening protocols and contact forms for both staff and physicians taking after-hours calls and can be found at www.omic.com.

“A Witty (WIT-D) Approach to Avoiding Mistakes” proposes an easy-to-remember and effective strategy for improving the diagnostic process. Establish a prioritized differential diagnosis in order to rule out the worst case scenario; determine the information you need to obtain during the history and examination, or through studies, to rule that in or out; tell the patient and other healthcare providers to ensure that you are notified of all signs and symptoms that could help establish the diagnosis and determine the treatment plan; and document your decision-making process and follow-up plan.

Endophthalmitis or TASS?

Failure to rule out endophthalmitis has resulted in harm to patients and significant liability exposure for OMIC policyholders. Emerging research indicates that the ophthalmologist should also include inflammatory reactions such as TASS in the differential diagnosis. Indeed, mistaking one for the other could lead not only to a delay in treatment

but may worsen the outcome. Table 3 summarizes some of the distinguishing features. Although this table may be helpful, it can still be difficult or impossible at times to distinguish between endophthalmitis and TASS. For more information see, “Endophthalmitis and TASS: Prevention, Diagnosis, Investigation, Response” at www.omic.com.

1. Carolyn Buppert, “A Witty (WIT-D) Approach to Avoiding Mistakes,” Gold Street 4(6), 2002. See “Risk Management Issues in Failure to Diagnose Cases: A Focus on Traumatic Eye Injuries.”

2. Table compiled from information in Mamalis, Nick et al. “Review/Update: Toxic Anterior Segment Syndrome.” J Cataract Refract Surg Vol 32, February 2006:324-333; Ronge, Laura J. “Toxic Anterior Segment Syndrome: While Sterile Isn’t Clean Enough.” EyeNet, November/December 2002:17-18; and Davis, Brandon L, and Mamalis, Nick. “Averting TASS: Analyzing the Cause of Sterile Postoperative Endophthalmitis Provides Valuable Clues for its Prevention.” Cataract & Refractive Surgery Today, February 2003:25-27.

Wrong Eye, Wrong IOL, Wrong Patient

By Paul Weber, JD

OMIC Vice President of Risk Management/Legal

Digest, Summer 2008

To view the graphs referred to in this article, go to http://www.omic.com/new/digest/Digest%20Summer%209-12-08.pdf

To err is human, but in medicine, errors can have life and death consequences. nearly a decade after it was published, a 1999 headline from an institute of Medicine report on medical errors is still quoted: “98,000 Americans Dead every Year from Medical errors.” the IOM report, To Err is Human, Building a Safer Health System, shone the media spotlight on the problem of medical errors and raised aware- ness of the shortcomings of the American health care system. Less publicized was a 2000 follow-up article by PBS health correspondent Susan Dentzer in Effective Clinical Practice (vol. 3, no. 6, American College of Physicians). In her article, “Media Mistakes in Coverage of the Institute of Medicine’s Error Report,” Ms. Dentzer notes that “all too frequently, errors in health care were the result of systems problems rather than of individual acts of malfeasance. in other words, to err really is human; at the same time, health care, like any other system in which we operate, is devised by and composed of humans. As a result, like any system that aims to minimize or eliminate error, health care must be designed to compensate for our inevitable human shortcomings.”

All ophthalmologists have heard horror stories of wrong sided, wrong patient, wrong procedure, or wrong IOL cases. Most of us probably haven’t read the iOM report, but we are all aware of the need to reduce systemic errors in health care delivery and improve patient safety. the American Academy of Ophthalmology has made a strong commitment to this problem, and in 2001, published “eliminating Wrong site surgery” and “Minimizing Wrong iOL Placement.” Both documents were revised in 2005 and are on the AAO web site. in addition, two related patient safety documents may also be found on the AAO web site, “suggestions for a Checklist to Verify the Operative eye” and “suggested Multiple iOL Verification Procedures in the Operating Room for Minimizing Wrong IOL Placement.” these documents were first developed by the AAO’s Quality of Care secretariat in collaboration with the American society of Ophthalmic Registered nurses and American Association of eye and ear hospitals and were revised in 2005.

Universal Protocol for Wrong Events

In 2003, the Academy and 50 other professional health care organizations endorsed the Joint Commission’s “universal Protocol for Preventing Wrong site, Wrong Procedure, and Wrong Person surgery.”TM   There are four principal components to the universal Protocol:

1. Completing a preoperative verification process;

2. Marking the operative site;

3. taking a time-out immediately before starting the procedure; and

4. Adapting these requirements to non-operating room settings.

Wrong sided cases continue to occur, however, despite the best efforts of the Academy, the Joint Commission, and others. Current data seems to indicate that wrong site surgery is stubbornly defying solutions to eradicate it. (see Joint Commission and OMIC data, Graphs 1 and 2.)

In 2007, the Joint Commission received 5 to 8 new reports a month of wrong site cases nationally, and recently, wrong site surgery became the most frequently reported sentinel event in the commission’s database (nearly 550 events reported since 1996). (Go to www.jointcommission.org.)

The Joint Commission convened a Wrong Site Surgery Summit in 2007. the organizations represented at the summit, including the Academy, agreed that the universal Protocol is effective if properly implemented and consistently followed. Ophthalmic data support this conclusion. John W. Simon, MD, et al, concluded in a study for the American Ophthalmological society that the universal Protocol would have prevented 85% of the wrong incidents he analyzed had it been implemented (“surgical Confusions in Ophthalmology,” Arch Ophthalmol. 2007; 125(11): 1515-22).

Florida Medical Board Imposes Sanctions Against Violators

State medical boards have also responded to the problem. in Florida, the Board of Medicine requires that:

1. A very detailed mandatory “time- out” needs to occur in all surgeries (surgery is defined as an incision or curettage of tissue) in all settings, including the physician’s office; and

2. All licensed facilities and physicians in their own practice must report wrong site/wrong patient incidents.

Penalties for violating these wrong site regulations and/or the time-out rule include fines, community service, and compulsory CME.

Florida recorded 33 ophthalmic wrong sided incidents between 2002 and 2006. half of these incidents were related to iOLs. Ninety-two percent of the doctors were fined, all had to pay the cost of the investigations, and all but one had to perform community service. Additionally, these disciplinary actions were reported to the national Practitioner Data Bank and to states where the physicians had inactive licenses. One ophthalmologist faced penalties and sanctions in a state in which he had not practiced since residency, 20 years prior to the incident. Earlier this year, the Florida Board of Medicine surveyed other states to find out what they’re doing about the wrong sided iOL problem. none of the 10 states that responded (AL, ID, MD, NV, NM, NY, OK, TN, WV, and WY) has a separate state statute or medical board rule that addresses wrong site cases. Only new York tracks these incidents, and no new York ophthal- mologist has been sanctioned for a wrong site case in the past 5 years.

Cataract Surgery, IOLs Involved in Most Wrong Cases

With cataract surgery by far the most commonly performed ophthalmic procedure in this country (1.8 million annually), it’s not surprising that most wrong sided cases relate to cataract, and most involve problems with iOLs. indeed, over 80% of wrong sided eye cases reported to OMiC over the course of 20 years have resulted from wrong iOL implantation, wrong power, or wrong measurement (see Graph 3). in 1997, Dean Brick, MD, then chairman of OMiC’s Risk Management Committee, found that 25% of cataract claims involved an iOL. he recommended the following loss prevention strategies, which remain relevant today:

• employ one or two technicians who are well trained to perform keratometry and biometry.

• Review the scans and keratometry data when choosing the iOL.

• use one or two styles of iOLs regularly to prevent confusion about constants or model numbers.

• use a third generation formula for iOL selection.

• Keep a list of iOL choices for that day’s patients on the side of the phaco machine and check it just prior to insertion.

• use a checklist preoperatively to document data, informed consent, and any preop and postop instructions given to the patient.

Zero Tolerance by Joint Commission

At this time, Florida appears to be the only state to strictly penalize wrong site cases. the state’s position is in keeping with the following statement from the Joint Commission’s 2007 Wrong site surgery summit: “there should be ‘zero tolerance’ for failure to follow the universal Protocol as a short term goal and there should be ‘zero tolerance’ for occurrence of these events.”

In the move toward “zero tolerance,” the Joint Commission is changing the universal Protocol to provide more flexibility to hospitals, AsC’s, and health care providers in its implementation. in addition, there will be more details on implementing the ”who, what, when, and how” of the pre-procedure verification process, marking the procedure site, and the time-out. these guidelines are on the Joint Commission’s web site at www.jointcommission.org/Patientsafety/ universalProtocol.

OMIC participates in the AAO’s drive to eliminate wrong site, wrong IOL, and wrong patient surgery. this year’s OMIC Forum at the Annual Meeting in Atlanta will focus on these “never events.” We will review OMiC’s claims and lawsuits, discuss the faulty systems and processes that led to them, discuss state board actions, and review the Joint Commission’s latest Universal Protocol. the panel will include James B. Sprague, MD, a member of OMIC’s Risk Management Committee, and William J. Knauer III, MD, chairman of OMIC’s Marketing Committee. Dr. Simon will discuss his findings and Peter Angood, MD, vice president and chief patient safety officer of the Joint Commission, will review the Universal Protocol. the OMIC Forum will be held Sunday, Nov. 9, at 1:00 pm in the Georgia World Congress Center. Pre-registration is not required, but participants must complete an attendance form on-site to receive CME credit and an OMIC premium discount.

Defense Verdict in Alleged Negligent Placement of Crystalens

Ryan Bucsi, OMIC Senior Litigation Analyst

Digest, Summer 2011

Allegation

Negligent placement of a Crystalens in the sulcus resulting in a lens exchange.

Disposition

Defense verdict.

Case Summary

A 45-year-old female patient was diagnosed with cataracts OU and underwent an uncomplicated cataract surgery OD with placement of a Crystalens. The insured ophthalmologist recommended the Crystalens implant because it might allow the patient to be free of glasses and have fewer starbursts and halos. At the first postoperative examination, the patient’s uncorrected vision was 20/20 OD. At the second visit, the patient’s uncorrected visual acuity remained 20/20 OD, but she complained of blurry, tunnel vision, and poor distance vision. At the third follow- up examination, uncorrected visual acuity decreased to 20/50, corrected to 20/25 OD, with complaints of halos and starbursts. The insured recommended a second opinion, which revealed an uncorrected visual acuity of 20/30 corrected to 20/20 OD near, with the Crystalens in good position. The patient self referred to another ophthalmologist whose examination revealed uncorrected 20/30, 20/20 corrected distance vision with J3 at near with the Crystalens in good position. The patient consulted an attorney and was referred to an ophthalmologist he utilized as an expert in medical malpractice cases. This ophthalmologist’s exam revealed 20/50 uncorrected visual acuity and 20/20 OD corrected. The plaintiff expert ophthalmologist performed a lens exchange procedure and placed an AMO model ZA9003 posterior chamber intraocular lens OD. During trial, the plaintiff’s vision was 20/30 uncorrected, corrected to 20/20 at distance OD, with 20/25+1 corrected at close distance.

Analysis

The plaintiff expert testified that he did not recommend a lens exchange; rather, the patient requested it due to continuing complaints of blurry vision from “jiggly lines,” glare, halos, and tunnel vision. The patient reported that the lens exchange procedure improved her visual acuity but did not alleviate the halos and starbursts. The plaintiff expert testified that during the lens exchange the Crystalens was in the sulcus. He opined that the lens must have been incorrectly placed there by the OMIC insured although this expert admitted he did not use and had no experience with Crystalens implants. The OMIC insured and both subsequent treating ophthalmologists maintained that the Crystalens was in the capsular bag when they examined the patient. OMIC’s defense expert testified that it was possible for a lens to move from the capsular bag to the sulcus, and he noted that the plaintiff’s vision was correctable to 20/20 OD postoperatively. OMIC believed the insured’s care was defensible. First, there was support from an expert with significant experience using Crystalens implants and from two subsequent treating ophthalmologists that the lens was properly positioned, while the plaintiff expert was a “hired gun” with no experience using Crystalens. Second, the OMIC insured would relate well to a jury as “an expert” on behalf of his own defense, and the defense counsel had previously and successfully tried cases against this plaintiff attorney. The only hesitation in taking this case to trial was the venue, which had a reputation for plaintiff-oriented juries. Nevertheless, OMIC was confident that a jury would return a defense verdict, and the case proceeded to trial. After two days at trial and 90 minutes of deliberation, the jury returned with a unanimous defense verdict for the OMIC insured.

Risk Management Principles

In addition to a signed written consent form for cataract surgery with a Crystalens, the insured documented his conversations with the patient regarding the Crystalens. The informed consent specifically mentioned double vision or ghost images, shadows in the peripheral vision, floaters or flashes of light, and halos or reflections from lights. The insured’s records were complete and it was easy to follow his thought processes throughout his treatment of this patient. When he could find no objective reason for the patient’s postoperative complaints, he referred the patient for a second opinion, which confirmed a good result and proper positioning of the Crystalens. During litigation, the insured set aside adequate time to meet with defense counsel in preparation for deposition and trial testimony. Although a well-qualified defense expert was hired by OMIC, it was defense counsel’s opinion that the insured’s trial testimony had the greatest impact on the jury. As this case demonstrates, active participation by the insured in defense of a medical malpractice case can significantly contribute to a favorable outcome.

Advertising Premium IOLs

Kimberly Wynkoop, OMIC Legal Counsel

Digest, Summer 2011

Ophthalmologists have both a legal and ethical obligation to truthfully advertise their services. This article will address issues to be aware of in advertising premium IOLs and the implications for coverage when improper advertising occurs. Much of this information was adapted from the American Academy of Ophthalmology 2008 Policy Statement: Guidelines for Refractive Surgery Advertising.

Both the Federal Trade Commission Act and the Federal Food, Drug, and Cosmetic Act prohibit false and deceptive or misleading advertising. The FTC has primary jurisdiction over the advertising of health care services, over- the-counter drugs, and devices. The FDA has jurisdiction over product labeling for prescription drugs and medical devices, and advertising of prescription drugs and medical devices that a licensed practitioner must authorize for sale, distribution, or use. Note that patient information brochures, seminars, and videos may be considered advertising.

State licensing authorities also regulate physician advertising and can impose disciplinary action against physicians who engage in false and deceptive advertising. In addition, every state has general laws and rules against false and misleading commercial claims. The American Academy of Ophthalmology has ethics rules which apply to advertising issues as well, most directly, Rule 13. Communications to the Public.

Under FDA regulations, advertising FDA-approved devices by brand name and model is permissible as long as a brief statement of the device’s intended uses and all relevant warnings, precautions, contraindications, and side effects are provided in the advertisement. Ads do not need to incorporate all informed consent disclosures, but they must not contradict them. If the device’s FDA premarket approval orders include requirements that promotional materials contain specific risk information, those must be adhered to.

There are additional precautions to take when advertising FDA- approved premium IOLs that the ophthalmologist may use off-label. While it is legal under the “practice of medicine” exception for physicians to use FDA-approved devices off-label, advertising this use is prohibited.

The FTC requires that advertisers have a “reasonable basis” for advertising claims at the time they are made. This will usually require “competent and reliable” scientific evidence that may include the physician’s own outcomes alone or in combination with other clinical studies, preferably those that have been peer reviewed or replicated in other studies.

If using a testimonial, the particular patient’s experience must be typical or representative of the experiences generally achieved by the physician’s patients, or else a clear and conspicuous disclosure of the results generally achieved by the users of the product or device must be included. Note that some states prohibit the use of patient testimonials.

As with LASIK advertisements, ophthalmologists should avoid ads that begin: “Throw Away Your Glasses” or have images with the same message. Even if the ad text states that the premium IOL “may correct your presbyopia and nearsightedness and may eliminate your need for glasses or contacts,” consumers are still likely to infer from the dramatic opening statement or image that if they select cataract or refractive surgery with use of a premium IOL, they will achieve perfect vision and be free of any need for glasses. Since the surgeon cannot guarantee this outcome, the claim is subject to legal challenge.

Another advertising pitfall is the use of statements such as, “We use premium IOLs so you get the best results.” This implies that premium IOLs produce better results than standard IOLs (or other procedures). Such a statement should be avoided unless the physician has competent and reliable scientific evidence to support it.

A statement that you can legally make is: “The Food and Drug Administration has determined that the premium IOLs we use are safe and effective for cataract surgery.” The Federal Food, Drug and Cosmetic Act was amended to allow references to the FDA-approved status of medical devices in advertisements.

Aside from action by the FDA, FTC, state agency, or the ophthalmologist’s professional society(ies), false or misleading advertising could lead to lawsuits against the physician by patients alleging lack of informed consent or fraud. In turn, this could result in uninsured risk as a result of the denial of the claim or termination of coverage by the ophthalmologist’s malpractice insurer.

Patients may prevail in a claim of lack of informed consent where aggressive advertising has occurred. The patient may allege that the overstated benefits misled him or her into agreeing to undergo the surgery without fully understanding or appreciating the consequences and alternatives. In this way, the advertisement destroys the validity of an otherwise properly executed consent form.

OMIC’s underwriting requirements for refractive surgery (which includes the use of premium IOLs for refractive lens exchange) state that advertisements must not be misleading, and must not make statements that guarantee results or cause unrealistic expectations. Violation of these underwriting requirements may cause termination of the policy or denial of coverage of a claim based on the violation. In addition, Exclusion III.B.1 of the policy provides that OMIC will defend insureds against allegations of medical malpractice that include false, misleading, or deceptive advertising or other fraudulent acts, but not if the claim is based solely on the advertising or fraud claim. Even then, the policy will not cover damages or supplementary payments for such claims.

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.