Miscommunication During PRK Leads to Surgical Mix-up
By Randy Morris, JD
OMIC Claims Associate
Digest, Winter 2001
ALLEGATION Improper performance of PRK procedure.
DISPOSTION Case settled on behalf of codefendant ophthalmologist and insured laser center.
Case Summary
A 33-year-old male patient was scheduled to undergo a bilateral PRK procedure at an OMIC-insured laser center. Based upon the surgeon’s preference card maintained at the laser center, the technician added a laser epithelial removal treatment folder to the treatment cards for both eyes before the start of surgery. Upon arriving at the laser center, the surgeon indicated that she intended to perform an alcohol scrape of the epithelium instead of a laser epithelial removal. The technician removed the laser epithelial removal folder for the left eye only. Once the patient was positioned in the laser chair, another technician took over and assisted the surgeon with the PRK on the left eye.
After the left eye had been treated, yet another technician took over for the procedure on the right eye. Both the surgeon and the newest technician looked at the computer monitor to confirm the treatment plan; both failed to realize that a laser epithelial removal folder was still programmed for the right eye. As a result, a laser scrape was performed on the right eye even though an alcohol assisted epithelial scrape already had been performed. Both the surgeon and the technician were mistakenly under the impression that PRK was being performed when in reality a laser epithelial removal of 40 microns was occurring. When the laser stopped after the epithelial removal, the screen showed the pre-programmed PRK treatment. At this point, they both realized the mistake and terminated the procedure without performing the PRK on the right eye. Ultimately, the patient underwent LASIK with an enhancement by a different surgeon. The patient eventually achieved 20/20 vision in the right eye, although he continued to complain of blurry vision. Corneal topography confirmed a central island defect.
Analysis
The codefendant surgeon was relatively inexperienced in the use of the laser and did not recognize the difference in appearance of the epithelial removal screen and the PRK screen. Nor did she distinguish the difference in sound between the full 6.5-mm beam ablating the cornea in the laser epithelial removal mode and the softer sound of the initially small beam ablating the cornea in the PRK mode.
According to the laser’s operating manual, the surgeon is responsible for the treatment plan. Experts for both sides agreed there was liability on the part of the surgeon, but were less certain about the exposure of the laser center. A jury might have found the laser center liable for allowing the technicians to switch in the middle of the two procedures. Additionally, the surgeon was quick to blame the technicians, who were employees of the laser center, for the mix-up. Since the defense did not have any expert support on the standard of care issue, liability would have to be conceded and the case tried solely on the issue of damages. In view of this, the codefendant surgeon and insured laser center agreed to settle rather than go to trial.
Risk Management Principles
This case illustrates the need for all surgical personnel to communicate clearly regarding treatment plans before beginning treatment. While this may be stating the obvious, it is surprising how many times a simple communication breakdown is at the heart of a malpractice suit. A system of checks and double-checks will go a long way toward preventing this type of situation. Additionally, the seemingly random “tag teaming” of technicians that occurred in this case should be avoided by requiring that the same surgical personnel be present for the entire procedure.
Patient Mix-Up in the Laser Suite
By Ryan Bucsi, OMIC Senior Claims Associate, and Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Fall 2003
ALLEGATION Incorrect LASIK procedure per- formed on the wrong patient.
DISPOSTION Case settled on behalf of the ophthalmologist and surgery center.
Case Summary
A44-year-old male truck driver presented at a local eye surgery center for bilateral LASIK correction of hyperopia. He was scheduled to have the second procedure of the day. When the first patient canceled, the truck driver was moved into the first time slot. In the laser suite, staff members addressed him, reportedly more than once, as the patient who had canceled; he did not correct them. He was already positioned for surgery when the insured ophthalmologist entered and was handed the first patient’s medical record, which he used to verify the laser settings.
The next day following surgery, the patient reported significant visual difficulties, which examination revealed were due to high hyperopia and astigmatism. The ophthalmologist realized what had happened, informed the patient of the error, and explained that retreatment alone could not correct the problem. After unsuccessful trials of contact lens and glasses, the patient elected to have clear lens extraction with toric intraocular lens insertion, followed by bilateral LASIK retreatment for residual refractive error, all performed free of charge. The patient’s corrected visual acuity the day after retreat- ment was 20/20 OU. He did not return for additional follow-up.
An Independent Medical Evaluation (IME) was obtained to evaluate complaints of severe sensitivity to bright light, glare, difficulty focusing, and headaches. UCVA was 20/60 OD, 20/40 OS; pinhole 20/50, 20/30; with refraction, 20/70, 20/60; hard contact lens over refraction, 20/80, 20/100; and near vision 20/25 -2 OU. It was the IME physician’s opinion that the patient could read and see better than the measured UCVA or BSCVA.
Analysis
The surgery center did not have adequate sys- tems in place to prevent this communication breakdown and error. The person who took the cancellation message claimed to have told the technician, but the chart and laser cards for the first patient were not removed from the suite. The facility did not give patients name tags or name bracelets, and this patient was apparently too anxious to notice that he was being addressed incorrectly. Plaintiffs have an easy time winning these cases since wrong patient, wrong procedure, and wrong site outcomes are generally considered to be the result of negligence; claims resolution thus focuses on the amount of damages to be awarded. As in this case, the facility and the surgeon are usually named as codefendants and each contributes to the settlement. Although the insured did not own the surgery center or employ the staff there, he was determined to have the primary responsi- bility for preventing the error and compen- sating the plaintiff.
Risk Management Principles
Excellent protocols exist for preventing errors of this type. The American Society of Ophthalmic Registered Nurses, in cooperation with the American Academy of Ophthalmology, produced Patient Safety Bulletin Number 1: Eliminating Wrong Site Surgery in 2001 (available at www.asorn.org). In July 2003, the Joint Commission on Accreditation of Healthcare Organizations released its Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery (available at www.jcaho.org). Recommendations include a preoperative verification process, marking the operative site, and a “time out” immediately before starting the procedure. The “time out” involves the patient and the entire surgical team; a checklist is used to verify the identity of the patient, the correct site and side, the procedure, the patient’s position, laser settings, and any implants or special equipment.
A second issue raised by this case is the judiciousness of bilateral simultaneous procedures. Advantages to the patient include decreased cost and time off work and increased convenience. However, surgery performed on different days prevents the occurrence of sight-threatening complications in both eyes at the same time and may pro- mote greater accuracy through modification of the treatment plan for the second eye. Further, the patient retains visual function in the unoperated eye while the first eye heals.
Lack of Informed Consent and Failure to Review Topographies
By Ryan Bucsi, OMIC Senior Litigation Analyst
Digest, Fall 2008
ALLEGATION PRK contraindicated by keratoconus.
DISPOSITION Case was settled for $850,000.
Case Summary
During the plaintiff’s first exam, the OMIC insured informed him that he was a good candidate for LASIK. Pachymetry revealed a corneal thickness of 545 OD and 499 Os, and topography was performed. Months later, the patient returned and repeat pachymetry revealed corneal thickness of 475 OD and 443 Os. Topography was also repeated. uncorrected visual acuity was 20/400 OD and 20/200 Os. the patient signed a LASIK consent form and was warned of the risks of operating on both eyes on the same date; however, after considering the options, he decided to proceed with bilateral same day sequential surgery. After initially confirming that the patient was a candidate for bilateral LASIK, the insured telephoned the patient to inform him that he had a thin cornea in the left eye and that he intended to perform PRK OS and LASIK OD. However, when the patient presented for surgery, the insured informed him that PRK would be performed OU since he was not a good candidate for LASIK surgery in either eye. Bilateral PRK was performed.
The patient did well during the initial postoperative period with uncorrected vision ranging from 20/50 to 20/100 OU. however, within a week, his uncorrected vision declined to 20/200 Ou with corneal haze greater OD than OS. His condition did not improve and, less than one month following the bilateral PRK, the insured provided the patient’s disability carrier with a letter stating that the patient was completely disabled due to corneal ectasia. The patient was subsequently fitted with custom contact lenses to help decrease the distortion resulting from the weakened corneas, but he could not tolerate the lenses, which only corrected to 20/200 OU.
Analysis
According to the plaintiff expert, the patient suffered from keratoconus OS based on a preoperative topography that revealed central corneal steepness greater than 50 diopters and corneal thickness of 440 microns. There were also preoperative clinical signs of keratoconus, including an unstable prescription, a best correctible visual acuity of less than 20/20, and increasing irregular astigmatism. Plaintiff expert stated that the patient suffered from forme fruste keratoconus in the right eye as the topographic data revealed inferior steepening and a thin cornea and should have been better counseled on his condition and not allowed to have bilateral PRK performed on the same day. Plaintiff testified that he initially presented to the OMIC insured, not for refractive surgery, but to have his glasses prescription changed. He also alleged that he was never told that the condition of his corneas increased the risk that he might suffer complications.
Unfortunately, there was no evidence in the insured’s records that he had reviewed the topographies that were taken on two separate occasions. The insured clearly did not suspect that the patient was suffering from either keratoconus or forme fruste keratoconus and did not warn the patient of the increased risk of ectasia. Further complicating the defense was the fact that the patient had not signed a consent form specific to PRK.
Defense experts were unable to support the insured’s care and focused instead on evaluating the plaintiff’s claimed damages. Faced with the probability of a plaintiff verdict exceeding his $1 million policy limits, the insured consented to a settlement and the case was resolved.
Risk Management Principles
Diagnostic tools such as topographies are only useful if they are accurately reviewed and considered in tandem with the clinical picture. no matter how similar the risks and complications, specific informed consent must be obtained for each procedure. This includes a discussion with the patient of the procedure-specific risks, potential complications, and benefits and requires that the patient sign each consent form. If a different procedure is substituted for the original planned procedure, the consent process should begin anew, including obtaining the patient’s signature on a procedure-specific consent form. to avoid an allegation of performing a contraindicated procedure, ophthalmologists should ensure that their preoperative assessment is thorough and well documented in the medical record. See the Hotline article.
Preoperative, Intraoperative, and Postoperative Deficiencies in Care of LASIK Patient
By Ryan Bucsi, OMIC Senior Litigation Analyst
Digest, Fall 2009
ALLEGATION: Failure to examine patient prior to surgery, lack of adequate informed consent, poor surgical technique, and lack of follow-up postoperatively.
DISPOSITION: Case settled for $450,000.
Case Summary
This patient was examined at a laser center by two technicians who informed him that he was a good candidate for LASIK. On the day of surgery, the patient declared that he was too anxious to have the procedure, but he was reassured by an optometrist and decided to proceed. The OMIC insured, whose first contact with this patient was just prior to surgery, claimed that the patient moved his head during surgery causing a thin flap with a central hole OD. The following day, the patient was evaluated but not by the insured. Two days postoperatively, the insured had his second and last contact with this patient when he performed a “refloat” procedure. The patient then sought care at another facility where he was diagnosed with decreased vision due to irregular astigmatism, corneal scarring, and some missing flap OD. The patient corrected to 20/20 OD with a contact lens, but he was unable to tolerate the contact lens. A corneal specialist was consulted and a corneal transplant was recommended, however the patient was unwilling to have the transplant and was left with extreme loss of vision, double vision, and blurriness OD.
Analysis
It was the plaintiff expert’s opinion that the insured was not qualified to perform LASIK as he had only been doing so for two months prior to this incident. This expert testified that the patient should have had PRK due to a corneal thickness of less than 500 microns in both eyes. From the operative note, the plaintiff expert testified that the LASIK surgery was negligently performed because the insured pulled up on the microkeratome, therefore losing suction resulting in a buttonhole complication. Furthermore, the expert said it was inappropriate to remove any part of the flap as the insured did during the refloat procedure.
In addition to these criticisms, several key facts became evident during discovery that led to a decision to settle. There was no documentation in the surgery center records regarding who diagnosed the patient as a LASIK candidate, and the insured did not actually see the patient until the day of surgery. The insured claimed that he wrote a very detailed chart note about the patient jerking his head during the surgery when he examined the patient on postoperative day two. However, this note was never located and members of the surgery center maintained that no such note was written. Furthermore, the patient’s wife had observed the original surgery and testified that her husband did not move his head suddenly during the procedure, which was consistent with the patient’s testimony. The patient and his wife also testified that the insured told them postoperatively that he had pulled up on the microkeratome, lost suction, and a thin flap was created.
The insured was subsequently interviewed on local television where he expressed his displeasure with the microkeratome that was being used and claimed he was promised a different device, but the surgery center never delivered on this promise. The plaintiff used this interview to argue that the insured knew the surgery center was providing substandard care and should have protected the patient by fully informing him of known problems at the center. This interview and the lack of documentation essentially “sealed the deal” as far as settlement was concerned.
Risk Management Principles
Incomplete or missing documentation compromises the defense of any medical malpractice case, but there were other problems with this patient’s care. First, the surgery center employees overrepresented the patient as a suitable candidate for LASIK. Technicians cannot determine a patient’s surgical candidacy, only the surgeon can. If a patient will not be examined by the surgeon until the day of surgery, other steps should be taken to determine if the planned procedure is appropriate for the patient.
Second, the patient’s concerns about surgery were never relayed to the insured by the optometrist. OMIC expects the surgeon to personally obtain informed consent and to personally address any concerns the patient has. If the surgeon is meeting a patient for the first time on the day of surgery, the consent document must be mailed to the patient beforehand (see OMIC’s refractive surgery guidelines at www.omic.com).
Finally, during the course of active litigation, it is never a good idea to talk with anyone, especially the media, about an open and pending medical malpractice lawsuit.
Insuring Refractive Surgery: Liability Risks
By Richard L. Abbott, MD and Paul Weber, JD
The following article explores the experience of the Ophthalmic Mutual Insurance Company (OMIC) in underwriting refractive surgery. As this surgery becomes more popular, issues such as truth-in-advertising as well as traditional underwriting issues become significant.
Ophthalmic Mutual Insurance Company, A Risk Retention Group, insures approximately 2,300 ophthalmologists nation-wide. Approximately, 40 percent (i.e. 920) perform refractive surgery (i.e. surgical correction of nearsightedness, farsightedness, astigmatism and presbyopia), LASIK being the most widely performed refractive procedure. OMIC also insures ambulatory surgery centers and other entities where the excimer lasers are utilized to perform the refractive procedures.
Underwriting
The standard OMIC insurance policy actually excludes coverage for refractive surgery procedures. OMIC insureds must request coverage and be specifically endorsed for each refractive procedure. The insured must submit a supplemental refractive surgery questionnaire, which will be reviewed and approved prior to the insured being covered. A questionnaire is required for each type of procedure performed. The technology surrounding refractive surgery is developing at a dizzying rate, so OMIC has created questionnaires for not only laser procedures ( ie: LASIK, PRK, AND LASEK), but also clear lens extraction, LTK, Intacs, phakic implants, and RK/AK.
Each of the several questionnaires delves into the following areas: 1) training and experience; 2) patient selection; 3) informed consent; 4) operative procedures; 5) postoperative care (e.g. comanagement); and 6) advertising. Insureds who want to perform bilateral simultaneous procedures must undergo yet another level of underwriting review and approval due to the increased risk of a potential catastrophic bilateral complication.
As a condition of coverage, insureds must agree to comply with OMIC’s standard refractive surgery guidelines and guidelines specific to a particular procedure. These guidelines, based on sensible medical practice and sound risk management principles, were developed by practicing refractive surgeons to reduce the likelihood of claims and to aid in the defensibility of any resulting claims. Furthermore, OMIC requires that insureds submit for review their consent forms, informational videos, patient education literature, and advertisements. At first, a small percentage of OMIC insureds perceived the guidelines as burdensome. Now, with the rapidly increasing frequency of LASIK lawsuits and claims, that perception is even more infrequent.
Risk Management
Our insureds’ advertising and marketing is considered one of the risk exposures we are most concerned about and endeavor to minimize. Both the Federal Trade Commission and Food and Drug Administration have promulgated advisories setting forth guidelines for proper advertising. These federal advisories have also been addressed in American Academy of Ophthalmology publications. OMIC staff reviews the marketing material of our insureds and frequently advises them to delete misleading/untrue statements (“throw away your glasses,” “fast, easy, painless procedure”) and guarantees (“money back,” “life-time”) found in the material. Staff also advises that they must be able to substantiate any claim (“millions satisfied,” “pio- neers in corrective eye surgery”) made in the advertisement.
OMIC regularly provides seminars, articles, and audioconferences to remind our insureds (and the ophthalmic community) about the myriad liability risks associated with refractive surgery and to encourage their participation in minimizing those risks. This risk management information covers informed consent, patient selection, documentation issues, comanagement risks, advertising, and training. OMIC has drafted and distributed model informed consent documents for the various procedures, including bilateral simultaneous consents and consent to comanagement of care. The informed consent documents and articles can be found in the Risk Management sections of the OMIC website at www.omic.com.
Refractive Surgery Litigation
Given the very high volume of refractive procedures, specifically LASIK) over the past 2 – 3 years, OMIC has seen a significant, but not surprising, increase in the frequency of refractive surgery claims and lawsuits. In 1999, LASIK complications represented 10 percent of all open OMIC claims. By 2000, the number had grown to 13 percent, and during the first six months of 2001, 19 percent of open claims involved LASIK. However, this increase does not appear to be disproportionate to the number of individual insureds adding refractive coverage to their policies since 1999 and the increase in the number of entities (ASCs and laser centers) that OMIC covers.
Chart 1
The problems arising in the OMIC claims and lawsuits run the gamut from errors in programming the laser resulting in overcorrection or astigmatism; improper patient selection resulting in intraoperative flap complications and generally poor outcomes; and postoperative failure/delay in diagnosing complications.
At OMIC, refractive procedures, including LASIK, continue to show only low to moderate claims severity when compared with other ophthalmic procedures or overall ophthalmic loss activity. OMIC has opened 55 LASIK cases over the past four years. Of the 18 cases that have closed, seven closed with an indemnity payment averaging $51,142. OMIC’s average indemnity payment for all types of claims is $129,197. On average, refractive surgery claims appear to be no more expensive to defend than other ophthalmic claims.
Chart II
Average Indem nity Paym ent $129,197
$51,142
Refractive Claims
Other Ophthalmic Claims
LASIK settlements outside of OMIC are starting to be reported in the jury verdict reporters. One recently reported LASIK case settled for $1.03 million. The LASIK surgery was performed in 1996 to correct the patient’s slight degree of farsightedness. In 1996, the excimer laser had only recently been approved for PRK correction of nearsightedness. The FDA had not approved the excimer laser for farsightedness. The ophthalmologist had to use a “black box”, a non-FDA approved laser, since the laser manufacturers did not calibrate their lasers for the correction of farsightedness. Further complicating this case, it appears the ophthalmologist tried to correct both eyes simultaneously. The patient ended up with irregular astigmatism in both eyes and a visual acuity of 20/400 left eye and 20/200 right eye. In 1996, it was rare indeed to find an ophthalmologist in the United States providing LASIK for the correction of farsightedness since LASIK for the correction of nearsightedness was still being investigated. It would have been very difficult to find an expert witness to support the care that the ophthalmologist provided in 1996.
Chart III
Percent Settled with Payment
39%
Refractive Claims
22%
Other Ophthalmic Claims
Class Actions
There are reports in the media that the plaintiff’s bar is fine tuning its litigation machinery to sue ophthalmologists and others who perform or are involved in providing LASIK and other refractive procedures. So far, OMIC is aware of two class action lawsuits that have been filed, one in California and one in the state of Washington. Both class actions appear to be utilizing consumer protection statutes as a basis to certify the class. In the California case, the defendants reused the disposable microkeratome blade on several patients, allegedly without properly cleaning it between patients. The plaintiff’s attorney alleged that the ophthalmologists’ advertising, claiming the procedure was “safe,” was a misrepresentation due to the unsterile technique and this misrepresentation triggered the consumer legal remedies statute. The class actions are very expensive to defend and also raise complicated coverage issues since many professional liability insurance policies exclude coverage or only provide a conditional defense for fraudulent acts.
Conclusion
To date, it appears that LASIK and other refractive procedures are no more or less risky than any other type of surgery an ophthalmologist might perform. The lesson from the $1.03 million settlement is that careful underwriting is essential in minimizing the risks of the catastrophic claim. Also, the aggressive marketing of the surgery and concomitant exposure to consumer protection class action lawsuits needs to be dealt with by careful monitoring and ongoing review of marketing material.
It should be pointed out that “off-label” procedures using the excimer laser are not uncommon. The patient should be informed of the innovative nature of such a technique, its scientific basis, its benefits, and any possible drawbacks or criticisms from other practitioners. Other options should be discussed and the patient should be encouraged to seek a second opinion before proceeding with an innovative technique. This discussion should be well documented. Finally, professional liability insurance carriers need advice from consulting ophthalmologists to keep current with “off label” procedures that are standard in the community and should be covered if a claim arises. In addition it is also important for the insurance carriers to know which procedures are still “experimental” and should be specially endorsed or specifically excluded.
