Ординатура / Офтальмология / Английские материалы / Risk Prevention in Ophthalmology_Kraushar_2008

Figure 20.8 Trials involving laser in situ keratomileusis

a buttonhole flap. The surgeon responded correctly by replacing the flap without performing the laser ablation, and the patient had successful repeat LASIK several months later. A buttonhole flap is a known complication of LASIK and would normally be considered a maloccurrence rather than malpractice. A video of the procedure showed that after application of the suction ring, the pupil did not dilate and the tonometer indicated inadequate pressure. The plaintiff’s expert testified that both of these findings were indications of pseudosuction, which should have alerted the surgeon to abort the microkeratome pass. While the patient acknowledged an uncorrected visual acuity of 20/20, he continued to experience glare, halos, and loss of contrast sensitivity. The jury found in favor of the plaintiff and awarded damages of $275,000.

The second trial resulted in OMIC’s highest award in a LASIK case and focused on patient selection. One plaintiff expert suspected the patient had form fruste keratoconus, even though he acknowledged that the corneal topography was within normal limits. The well-qualified defense experts all felt that the topography and pachymetry were normal and that the patient was indeed an appropriate candidate for the procedure, thus confirming the second opinion the surgeon had obtained prior to the procedure from a fellowship-trained corneal specialist and the supportive evaluation of OMIC’s Claims Committee. Despite the absence of indications of preexisting keratoconus, the patient developed ectasia after LASIK. This development is consistent, the defense argued, with the incidence of keratoconus in the general population, which is approximately 1 per 2,000. Indeed, this patient may well have developed keratoconus without LASIK. Some felt that the ectasia in this case may have been related to a thicker than expected flap, which resulted in a postablation residual bed of less than 250 mm. These technical issues were not the basis of the jury’s plaintiff verdict, however. Instead, as they explained in interviews after the trial, the members of the jury felt that the approximately 100 cases performed

by the surgeon did not adequately prepare him to handle this case. They were not swayed by the expert testimony that this known complication could have happened to any surgeon and awarded the plaintiff $944,000, which, after the addition of pretrial interest, resulted in an indemnity payment of $983,772.

Recent Significant Nonophthalmic Mutual Insurance Company Laser In Situ Keratomileusis Awards

Large awards in refractive surgery are usually granted for economic reasons involving lost earnings and significant health care bills, as happened in the OMIC ectasia case just discussed. The jury believed that the plaintiff, an attorney, lost past and future wages despite the fact that visual acuity was near normal with contact lenses following penetrating keratoplasty. There have been at least four recent multimillion dollar awards involving LASIK cases. Two of these focused on the adequacy of the informed consent of patients with large scotopic pupils, and two involved post-LASIK ectasia.

Pupil Size

The first multimillion dollar award involved a commercial airline pilot. Despite obtaining an excellent uncorrected visual acuity, he was initially granted a jury award of $4,000,000 (less $600,000 for the 15% fault attributed to him) based on his contention that he would not have agreed to have the surgery if he realized that night time glare and halos could make it hazardous for him to fly at night. Admitting that the standard informed consent mentioned this as a possibility, the plaintiff questioned the accuracy of the measurements of his scotopic pupils and the size of the optical zone delivered by the laser, which were subsequently found to be larger than the original measurements. The expert witness for the plaintiff initially stated that because the true optical zone of the laser was smaller than the 6.5 mm pupil size measured during his independent medical examination, the patient should have been consented differently. The jury agreed that the pilot should have been informed that his larger than normal pupils increased his risk and might interfere with his ability to fly. The case was appealed. The trial court granted a new trial because the plaintiff’s key expert changed his testimony on the size of the optical zone after the verdict. The Court of Appeals overturned the new trial, and the case was settled pending the appeal.3

The other pupil-related case resulted in a jury verdict for the plaintiff for $3,002,950. The plaintiff’s scotopic pupils were measured by a technician to be 5.5 mm, but subsequent measurements were 7.5 mm. The patient had a non– wavefront-based treatment in 2001 with a 6.5 mm ablation diameter. The plaintiff’s position was that he should have been warned that because of his large pupils he was at increased risk for night vision disturbances.4

Post–Laser In Situ Keratomileusis Ectasia

The plaintiff in the first post-LASIK ectasia case was a stockbroker who claimed loss of past and future earnings despite having adequate visual acuity with hard contact lenses. Preoperative topography in this case showed signs of form fruste keratoconus according to the plaintiff’s expert, who opined that the patient should have been informed that the surgery was contraindicated. The patient’s procedure took place in a commercial laser center; the abnormal topography was apparently not discussed by either the surgeon or the comanaging optometrist. The jury found in favor of the plaintiff and awarded $7,250,000—$4,500,000 in lost wages and $2,750,000 for pain and suffering.5

In the other case, the topography, pachymetry, slit-lamp examination, and family history were all normal. The defendant was a fellowship trained, nationally recognized corneal expert, as were the defense experts, who testified that the surgeon had met the standard of care. Nevertheless, the jury awarded the plaintiff $3 million. As in one of the OMIC cases described earlier, this patient may have been the 1 in 2,000 who was destined to develop keratoconus. In both instances, the LASIK surgery may have accelerated the progression.6

Literature Review of Malpractice Issues in Refractive Surgery

Dr. Richard Abbott, OMIC Board Member and Chairman of the OMIC Underwriting Committee, was the lead author of a paper based on his analysis of OMIC’s first 100 PRK and LASIK claims.7 Dr. Abbott concluded in the study2 that

[T]he chances for incurring a malpractice claim or lawsuit correlates significantly with higher surgical volume and a history of a claim or lawsuit. Additional risk factors that increase in importance with high surgical volume include physician gender, advertising use, preoperative time spent with the patient and co-management with optometrists.

Not explicitly stated in the article, but clarified in a subsequent interview, his goal was to obtain data to drive OMIC’s underwriting and risk management protocols so the company could continue to proactively reduce the risk of refractive surgery.7

Associating surgical volume and comanagement with quality of care was challenged in discussions and articles that responded to the study. Some ophthalmologists argued that analyzing the incidence of lawsuits per cases performed would indicate that high volume surgeons had a lower risk of suits given their vast experience with the procedure.7–9 Indeed, low volume surgeons in one study were shown to have a higher number of complications.10 Moreover, they felt that despite the number of surgeries performed, they, along with their staff, did spend adequate “chair time” with each individual patient.

Dr. Abbott clarified that the study did not look at the relative risk per case, but instead the overall higher number of cases when compared with low volume surgeons.7 While he agreed that surgeons with less experience do indeed have higher complication rates, he explained that whether they are sued

depends for the most part on how they handled the complication. Comanagement was associated with higher risk in relation to the volume; it was not an independent variable. The greater risk is due to the complexity of comanagement itself, he stated.

How to Minimize the Likelihood of Refractive

Surgery Lawsuits

A lawsuit is a traumatic experience, both emotionally and financially. To help ophthalmologists avoid claims and their distressing impact, OMIC has developed risk reduction materials and made them available on its website for use by all ophthalmologists. Risk reduction consists of managing patient expectations and proactively comanaging patient care.

Manage Patient Expectations

First, ophthalmologists need to manage patient expectations by careful advertising, prudent patient selection, and patient-friendly informed consent. Advertising, including patient brochures and videos, must be truthful and professional, as well as consistent with the information provided during the informed consent process. An explanation of the rules governing physician advertising and an advertising review form are available in the Risk Management Recommendations section at of OMIC’s website.11,12

Patient Selection: Pupil Size

The importance of the scotopic pupil size in predicting night vision complaints is confusing. Two recent studies by Schallhorn et al.13 and Pop and Payette14 failed to find that large scotopic pupils were predictive of night vision complaints. Other reports15,16 indicate that large scotopic pupils are associated with an increase in higher order aberrations and night vision complaints. Rather than wait for more studies to resolve the issue, manufacturers have opted to advise patients. Thus the latest patient information brochures on wavefront-based surgery from both Visx and Alcon warn of a potential association between large scotopic pupils and night vision difficulty.

From a risk management perspective, if a patient has an unusually large scotopic pupil (greater than 6.5 mm), it would be advisable to discuss the potential increased risk of night vision complaints. Prospective patients should understand that although in most cases these improve with time, some patients have prolonged difficulty and may require drops to reduce pupil size to help alleviate their symptoms.17,18 The patient’s vocation and hobbies may be significant factors to consider. The OMIC’s sample consent form for LASIK includes a discussion of this issue.19

Patient Selection: Ectasia

From a liability perspective, the main issue with post-LASIK ectasia is whether there were any abnormal findings in the preoperative evaluation that could be considered a contraindication to the surgery. In effect, the defensibility of the case can come down to the interpretation of the topography. If the inferior cornea 3 mm below the center of the pupil is more than 1.5D steeper than the superior cornea 3 mm above the pupil, this may indicate form fruste keratoconus. In borderline cases, other tests may be helpful, including pachymetry over the steep area to see if it is thinner inferiorly than centrally, dilated retinoscopy looking for scissoring of the light reflex, and manual keratometry looking for subtle distortion of the mires. The history can also be important. A positive family history of keratoconus or unstable refraction, particularly changes in the amount or axis of astigmatism, can increase the suspicion that the patient may actually have early keratoconus. Findings such as these should be discussed with the patient, and LASIK should not be performed. Photorefractive keratectomy with proper informed consent can be considered as a safer option, but there are also cases of ectasia reported following it as well.20

The other potential risk factor in post-LASIK ectasia is leaving a residual bed of less than 250 mm. During the preoperative evaluation, surgeons should be very aware of the corneal thickness, depth of the planned ablation, and estimated flap thickness. Because the thickness of the actual flap can be considerably thicker than planned, intraoperative subtraction pachymetry should be performed, especially in any case where the corneal thickness and ablation depth might leave a residual bed less than 250 mm. If the intraoperative pachymetry shows that the 250 mm rule could be violated, the flap should be replaced without the excimer ablation. To address the potential patient safety and liability issue of post-LASIK ectasia, OMIC modified its sample LASIK and PRK informed consent documents to address this issue.21

Informed Consent

Two specific issues that may need to be discussed during the informed consent process have just been addressed. This topic is so important that another chapter of this book is devoted to the general subject of informed consent, and we here want to emphasize a few other aspects of the consent process for refractive surgery that deserve special emphasis.

First, the timing of the consent is important. Ideally, the informed consent is initiated by the surgeon, but in reality this rarely happens in a busy refractive surgery practice. During the initial consultation the surgeon or a staff member should emphasize that PRK and LASIK are both surgeries and like all surgeries carry some risk. Many patients feel that because the surgery is performed with a laser it is not “real surgery.” Advertising that refers to “procedures,” excludes any mention of risks, and describes subsequent surgeries as “enhancements” instead of retreatment only reinforces this misconception.

Infection and the rare possibility of significant loss of vision should be mentioned because patients understand that an infection is a possible complication of all surgical procedures. The staff should also explain and demonstrate that underand overcorrections are always possible even if they can usually be improved by a retreatment. If the patient has anything unusual, such as large scotopic pupils, need for a high correction, high astigmatism, or borderline dry eye, the implications of these findings should be discussed and documented in the record. Unusual complications such as buttonhole flaps, haze, and irregular astigmatism are generally covered in the written informed consent. If a retreatment is indicated, informed consent for it should be obtained. See the OMIC sample retreatment consent form.22

The written consent form should be given to the patient to take home well before the surgery. The patient should be encouraged to read it with friends and/or family members and to call with any questions so that misapprehensions can be cleared up. It is also wise to put a note in the record that the risks and benefits of the procedure were discussed with the patient and all questions were answered, especially if the patient has any findings that indicate an increased risk for complications. If necessary, the consent can then be signed on the day of surgery provided (1) the surgeon has already had a consent discussion with the patient and (2) the patient has not received any sedation.

Proactively Comanage Patient Care

Many cataract and refractive surgeons comanage patients. Ophthalmic claims experience indicates that this method of care delivery can increase patient safety and liability risks if not properly performed. “Comanagement of Ophthalmic Patients”22 is a useful resource. It addresses scope of practice issues, how to select and credential comanagers, training and protocols, informed consent for comanagement,23 communication, availability, and supervision. The driving principle should always be patient safety, as determined by the operating surgeon, who has the ultimate responsibility for determining the patient’s candidacy, obtaining the informed consent, and recognizing and managing complications.

Conclusion

Once performed by only a minority of ophthalmologists and greeted with skepticism by doctors and patients alike, LASIK is now a household word, and many cataract surgeons who insert multifocal intraocular lenses are considering performing it for the first time as part of biopic treatment packages. Refractive surgeons can improve patient safety and reduce their liability exposure by keeping their skills current and by adopting the risk management measures gleaned from the claims experiences of their colleagues.

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References

1.ISRS/AAO Survey.

2.Abbott, RL, Ou RR, Bird M. Medical malpractice predictors for ophthalmologists performing LASIK and photorefractive keratectomy. Ophthalmology 2003;11:2137–2146.

3.Post v. University Physicians, Inc.

4.Larson v. Weis, M.D. and N. Refractive Surgery Ctr., 21 Nat. J.V.R.A. 4:C6 (Minn. Dist. 2006).

5.Maggie Haberman. He wins $7.25M In Botched Eye Surgery Suit. New York Daily News (July 31, 2005).

6.$3 million awarded for botched LASIK eye surgery. Lawyers USA, August 14, 2006, citing Gropack v. TLC Laser Eye Centers; June 28, 2006; Nassau County Supreme Court, Mineola, N.Y.; Judge Roy Mahon.

7.Smith SE. Deciphering medical malpractice predictors. Cataract Refract Surg Today 2004;4(2):45–53.

8.Donnenfeld ED. Surgical volume and patient care. Cataract Refract Surg Today 2004;4(2):54–56.

9.Hoffman J. Study turns up the “volume.” Ophthalmol Manage 2004;Apr:146–148.

10.Stulting RD, Carr JD, Thompson KP, et al. Complications of LASIK for the correction of myopia. Ophthalmology 1999;106:13–20.

11.Menke AM. Advertising medical services. Available at: http://www.omic.com/resources/ risk_man/forms/medical_office/AdvMedServices.rtf.

12.Menke AM. Review of advertisement for medical services. Available at: http://www.omic. com/resources/risk_man/forms/medical_office/AdvReviewForm.rtf.

13.Schallhorn SC, Kaupp SE, Tanzer DJ, et al. Pupil size and quality of vision after LASIK. Ophthalmology 2003;110:1606–1614.

14.Pop M, Payette Y, Risk factors for night vision complaints after LASIK for myopia. Ophthalmology 2004;111:3–10.

15.Chalita MR, Chavalia S, Xu M, et al. Wavefront analysis in post-LASIK eyes and its correlation with visual symptoms, refraction, and topography. Ophthalmology 2004; 447–453.

16.Maguen E, Schlanger J, Wong J, Salz J. Relationship between total aberrations (RMS) and pupil size in ametropic eyes with the LADAR wave system [abstr]. Invest Ophthalmol Vis Sci 2003;44E.

17.Randazzo A, Nizzola F, Rossetti L, et al. Pharmacologic management of night vision disturbances after refractive surgery, results of a randomized clinical trial. J Cataract Refract Surg 2005;31:1764–1772.

18.McDonald JE II, El Moatassem Kotb AM, Decker BB. Effect of brimonidine tartrate ophthal-

mic solution .02% on pupil size in normal eyes under different luminance conditions. J Cataract Refract Surg 2001;27:560–564.

19.Informed consent for LASIK. Available at: http://www.omic.com/products/bus_products/ downloads/forms/LASIKconsent121404.rtf.

20.Malecaze F, Coullet J, Calvas P, et al. Corneal ectasia after photorefractive keratectomy for low myopia. Ophthalmology 2006;113:742–746.

21.Informed consent for LASIK retreatment. Available at: http://www.omic.com/products/bus_ products/downloads/forms/LasikRetreatmentConsent.rtf.

22.Menke, Anne M. Comanagement of ophthalmic patients. Available at: http://www.omic.com/ resources/risk_man/forms/medical_office/Comanagement%20of%20Ophthalmic%20Patient s.rtf.

23.Consent for comanagement after eye surgery. Available at: http://www.omic.com/resources/ risk_man/forms/patient/ComanagementConsent.rtf.

detachment with pseudophakia, endophthalmitis, retained lens fragments after cataract surgery, cystoid macular edema, suprachoroidal hemorrhage, and dislocated intraocular lenses. These patients may understandably harbor some inherent resentment before they encounter the vitreoretinal specialist.1 Some suits may be stimulated by a physician’s attempt to escape from an unfavorable result. This may cause erratic behavior on the part of the physician, varying from hostility to excessive apology.

The litigation may also be comprehensive against all individuals and institutions having contact with the patient during the alleged mishap. Such suits often have the intention of dropping the claim against the vitreoretinal surgeon if during discovery it is demonstrated that he or she was not liable. Unfortunately, such a claim will cost the medical malpractice insurance company money to defend and if the expenses are too great the sum may be added to the vitreoretinal surgeon’s claim total and may thus affect future premiums.

Allegations

Most claims for negligent diagnosis (failure or delay) of vitreoretinal disease are brought against comprehensive ophthalmologists. Although allegations of negligent diagnosis are the most common reason for litigation in other ophthalmic subspecialties and most other specialties,2–5 it is a relatively uncommon cause of litigation against vitreoretinal specialists.1,6 This is probably because of the greater experience of vitreoretinal consultants in the diagnosis of these problems and also because the patient is initially seen by a comprehensive ophthalmologist before the referral is made, thus alerting the consultant to the possible diagnosis. Most allegations against vitreoretinal specialists are for negligent treatment.1,6

Appointments

Office staff must be well educated regarding symptoms of possible emergency situations to ensure that patients complaining of these symptoms are given prompt appointments. When in doubt, the staff should have clear instructions to speak with the physician. If a new or established patient with possible emergent symptoms calls the office and refuses a prompt appointment, the procedure for informed refusal should be followed. This means warning the patient of the risk of not being seen promptly and documenting the warning with a note in the record as well as sending written notice of the risk of not being seen by return receipt mail.

Technically the physician–patient relationship is not established until the patient is seen by the doctor. However, in today’s litigious society, it is not difficult to imagine a clever attorney suing on behalf of a new patient calling about the sudden, recent onset of flashes and floaters, refusing a prompt appointment, and developing