Informed Consent for Refractive Surgery

By Richard L. Abbott, MD

[Refractive Eyecare for Ophthalmologists, May/June 1998]

We often talk about “the” informed consent as if it were a single document that patients sign prior to undergoing a procedure like refractive surgery. A much more valuable way to envision informed consent is as a process that begins when the patient receives any kind of information about the procedure from the physician’s office. Whatever patients subsequently learn from the practice becomes part of the process of informed consent.

The actual form that the patient signs is just the final step in the process. Most courts will find that all those other pieces of information that patients receive including marketing materials, videos, and patient information brochures are admissible as evidence as part of the informed consent.

The Informed Consent Document

The actual informed consent document that patients sign must cover four basic elements:

• Risks associated with the procedure
• The benefits of the procedure
• The complications of the procedure
• Alternative treatments

In addition, the informed consent should have some background information on the procedure and explain what happens in the procedure. These should all be presented in language that the layperson can reasonably be assumed to understand.

The informed consent document for refractive surgery should include a discussion of the advantages of one procedure vs. another (e.g., laser in situ keratomileusis [LASIK] vs. photorefractive keratectomy [PRK]). Important subsidiary issues like bilateral simultaneous surgery vs. sequential surgery also have to be aired. In each case, the advantages and disadvantages to the patient need to be spelled out clearly. The document should present the kind of factual information that will allow the patient to make as informed a decision as possible.

Risks

In refractive surgery, the greatest risk to the patient is that the results of the surgery will not meet his expectations. The procedure isn’t perfect, and wound healing isn’t perfectly predictable. Therefore, patients must be clearly advised that there is some uncertainty as to the outcome of any refractive surgery.

Even if a high percentage of patients are 20/20 following a procedure, there is no assurance that a given patient will obtain that (or any other) result. Patients must know and accept that outcomes are not guaranteed.

Failure to achieve an expected outcome is the greatest risk of refractive surgery. Some of the other relatively common risks that must be covered in an informed consent document are: undercorrection, overcorrection, fluctuating vision, glare, astigmatism, halos, and loss of perceived contrast in low light. These are all fairly common risks that must be explained.

More devastating outcomes, including loss of vision from infection or scarring, are very rare. It is not necessary to present these relatively unlikely possibilities in a frightening way; but patients do need to be informed that – just as they can be hit by a truck when crossing a street – there is a small, but not zero, chance of serious side effect or bad outcome.

LASIK adds some additional risks – tearing the flap, microkeratome failure, infections under the flap, epithelial ingrowth, etc. These are well known risks that can simply be listed, if the patient is to undergo LASIK.

“Off Label” Procedures

As of this writing, LASIK is still an “off label” procedure, and the patient needs to know that. Usually it is sufficient to include a simple statement to the effect that the doctor believes it is in the best interest of the patients to perform LASIK and that LASIK is allowed although it wasn’t specifically approved in the initial FDA review of the laser. This is not a major issue, but the patient should be made aware of it.

Like LASIK, simultaneous bilateral PRK has not received specific FDA approval. This fact should be made known to PRK patients considering a bilateral procedure. For bilateral PRK patients (and for bilateral LASIK patients as well), the informed consent should cover the advantages and risks of simultaneous bilateral surgery vs. waiting for the first eye to heal before operating on the second eye.

Support for Informed Consent

The informed consent document offers the surgeon some protection, even if it is the only thing that he can muster to show that there was a process of informed consent. But the protection will be greater if there is supporting evidence of a process that went beyond the single document, e.g., notes in the chart documenting a discussion between doctor and patient, or the results of a test taken after watching a video.

The protection offered by the informed consent document can be undermined, sometimes greatly, if the practice’s marketing or patient information materials don’t support it. Marketing materials that are very aggressive, that make claims that can’t be substantiated with facts, detract from the informed consent document. Even if the informed consent document is letter perfect and signed by the patient, its value will be diminished if other materials from the practice seem to contradict it. The refractive surgeon’s best protection is to pay attention to all steps of the process.

Timing

Patients need adequate time to consider the informed consent document. Handing the informed consent document to the patient a few minutes before the surgery isn’t enough. The patient should be able to take the document home, read it, perhaps share it with a spouse or friend, and then have an opportunity to ask the doctor questions about it prior to signing.

Giving the informed consent to an unprepared patient on the day of surgery doesn’t give the layperson time enough to grasp its contents. If there is an unsatisfactory result and the patient sues, the hurried circumstances under which the informed consent document was signed will come out in testimony, undercutting the value of the document.

Simply signing the document on the day of surgery is acceptable, if the patient has been given the document for review ahead of time (and this is documented). If the patient is to sign the document on the day of surgery, be sure that the patient is not sedated or dilated until after signing. In general, the patient should not be in any way impaired at the time of signing.

The Surgeon’s Role

Since one wants to be able to rely on it in court, the informed consent document should not be underplayed for the patient. Having a staff person hand the informed consent to the patient with words to the effect of “Please sign this document, it’s just a formality,” will diminish its value. If the risks were glossed over, or if the patient wasn’t given a chance to consider them, the patient may be able to make a credible case that she didn’t know before surgery that her unsatisfactory outcome was possible.

The doctor’s rejoinder that those risks were stated in the informed consent won’t carry much weight if the circumstances in which the document was given to the patient made it seem trivial. Again, informed consent is a process, every step of which should be attended to.

In the last analysis, informed consent is the responsibility of the surgeon. Videotapes, true/false tests, refractive surgery coordinators, and the like can all be important parts of the patient education process. But ultimately there needs to be a face-to-face meeting with the surgeon – even if it’s for a very short period of time. At this meeting the surgeon can ask: “Are there any questions that I can answer?”

Although it may be brief, the patient-surgeon meeting should be a real meeting in which an unsedated patient is free to ask questions. The face-to-face meeting should be documented. A first meeting in the surgery suite with the surgeon peering over the microscope to introduce himself and ask if there are any questions will not bolster the surgeon’s case in court.

Making Your Case

Most of the time nothing goes wrong, and most patients are happy with their result; but it takes just one incident to create a protracted period of difficulty for the refractive surgeon. Since the day-to-day reality is that little goes wrong, it is easy to let one’s defenses down. An ongoing process of informed consent, with clear documentation, should be built into the office routine. Good documentation of an adequate informed consent process makes defense of court cases much easier.

A surgeon’s case will get a strong boost if the chart has notes in the surgeon’s handwriting documenting his part in the informed consent process. This need not be elaborate. All that is required is a few brief sentences such as: “Reviewed informed consent document with patient. Patient understands. All questions were answered to patient’s satisfaction.” That plus a signature provides very useful documentation. If the discussion was more than cursory, a little note on how much time was spent will help, e.g., “15 minutes spent answering questions.”

What Can Weaken a Case?

Just as good documentation will support a case, overly aggressive marketing materials can torpedo it. It is hard to demonstrate that the patient should have been prepared for a less-than-desired result when the practice distributes literature that says things like: “You can throw away your glasses,” or “Guaranteed success.”

It is far easier to mount a good defense when the marketing material is straightforward, honest, and informative, and there is evidence of an educational process that took place over an adequate period of time. The absolute minimum time is probably 2 days. A 2-day process will give the patient at least one night to absorb the material and discuss it with a spouse or a friend. If on the next day the patient has an opportunity to ask questions of the surgeon prior to surgery, and if all this is carefully documented, the process is probably adequate.

Problems happen when the patient feels railroaded through the process with no real chance to understand the surgery or its risks. Unless there is a comanager handling the case, it is especially important that the patient have a chance to meet the surgeon and ask questions prior to the day of surgery.

A poor informed consent process is no liability when the surgical result meets the patient’s expectations. But when a patient’s expectations aren’t met, and the patient feels that there was no real communication with the surgeon, anger and lawsuits can happen. The rule is simple: poor communication leads to anger when there’s a bad outcome.

Comanagement

There are several important points about the comanagement situation. First of all, the patient must understand in advance how care will be divided. The comanaging ophthalmologist (or optometrist) must provide the pre- and postoperative care, but the refractive surgeon will be responsible for the actual procedure. The informed consent documents must clearly identify the participants and delineate their roles.

Although the refractive surgeon bears the ultimate responsibility for the surgery, both the surgeon and the comanaging ophthalmologist should have their own informed consent documents. The comanaging ophthalmologist’s document can be less elaborate than the refractive surgeon’s. The comanager’s document can just state his recommendation for the patient, his role in the process, what the procedure entails, and that the patient understands and accepts it.

The refractive surgeon’s document should detail the surgical procedure – including all the basic elements noted above – as well as describe her role and the role of the comanager. The informed consent process can be a joint effort between the refractive surgeon and the comanager. But each should have an informed consent document, and the patient should sign one document in each doctor’s office.

Even in a comanagement situation, the refractive surgeon needs to have a face-to-face meeting with the patient prior to their coming together in the surgery suite. At this meeting, the surgeon can introduce herself, be assured that the patient is adequately prepared, and ask if the patient has any additional questions. This meeting should take place prior to sedation or dilation. The informed consent can be signed at the end of the meeting.

Even though much of the informed consent process took place in the comanaging ophthalmologist’s office, the meeting between the patient and the refractive surgeon is important. The patient has to feel totally at ease with the surgeon, and the surgeon has to know that the informed consent done at the comanager’s office was thorough and well presented.

Conclusion

Informed consent is a very important piece of protection for refractive surgeons and comanaging ophthalmologists. But it is more than that. From an ethical and good practice point of view, as well as from a purely defensive standpoint, it’s important that patients be educated and understand what they are choosing.

A patient who has been brought into the decision process knows the risks and is less likely to believe he has reason to sue. The patients who sue are often the ones who feel abused by an uncaring surgeon who kept them in the dark. The very process of talking to the patients, of taking their concerns seriously, changes the atmosphere and reduces the chance of legal action.

Bilateral LASIK? Not on My Patients!

By James J. Salz, MD

Review of Ophthalmology, January 1998

All the supposed benefits of bilateral simultaneous LASIK surgery rest on big “ifs.” If the surgery and postop course go well, then the operation is more convenient for patients. If the procedure goes well, the surgeon can collect his fee all at once, and the number of follow-up visits is effectively halved. However, if there are complications, there is an excellent chance that those complications will occur in both eyes, not just one. If the patient manifests an unusual response to the surgery, it may well be necessary to perform reoperations in both eyes, not just one. If the patient is dissatisfied with the vision bilateral LASIK provides, he’ll be doubly unhappy and the surgeon could be doubly liable. In my opinion, that’s simply too many “ifs” to ever recommend bilateral LASIK surgery. I think after reviewing the facts, you’ll agree with me.

Complications

The biggest problem with bilateral procedures is the risk of complications. The problem is that if the complication occurs in one eye, there’s a very good chance it will occur in the fellow eye, as well.

Potential bilateral complications include:

• Bilateral infection. Though the risk for an infection with LASIK is probably around one in 1,000, there has already been a documented bilateral infection with the procedure,¹ and it stands to reason that bilateral procedures potentially increase the incidence. If the keratome or blade becomes infected during the first pass, the organisms will most likely be carried over to the fellow eye. This could leave the patient with significant central scars and vision loss in not just one eye, but in both eyes – an infinitely worse outcome.
• Interface haze. Texas surgeon Bobby Maddox and several others have reported cases of bilateral interface haze that begins as mild or moderate levels but worsens over two or three days, resolving only after several weeks of corticosteroids. In one series of 22 cases (most bilateral), all displayed this haze.² These patients’ best-corrected visual acuity varied from 20/25 to 20/200. After a several weeks of steroids, all but one patient returned to 20/20. This remaining patient was overcorrected to +2.00 D, with 20/30 best-corrected acuity. Though most of the haze resolved over time, the etiology and exact incidence of this unusual complication are unknown. Until we know more, it doesn’t seem prudent to put both eyes at risk.
• Retinal complications. LASIK patients can develop vitreous hemorrhage, central retinal artery occlusion, retinal hemorrhage or detachment. In one recent series, one patient out of 700 bilateral, simultaneous LASIK cases developed bilateral sub-macular hemorrhages, and his best corrected acuity deteriorated to 20/400 by the end of the first post-op day.³ Six months later, his best corrected acuity was 20/60 in both eyes. Other complications from this series included a retinal detachment and bilateral iatrogenic keratoconus from an improper thickness plate in the microkeratome.

In another series of bilateral LASIKs one patient developed bilateral retinal detachments and another developed extension of lacquer cracks into the macula on the first post-operative day.⁴

Visual Quality

Another problem with bilateral procedures is their inflexibility. We all know that some patients receive a good visual outcome, yet are still unhappy about halos, night glare, or vague visual symptoms. If the surgery is sequential rather than bilateral, the patient retains flexibility. If he’s unhappy with the result in one eye, it’s still possible to opt for glasses or contact lenses until advances like larger ablation zones, phakic IOLs and flying spot lasers are available. I’ve actually heard bilateral proponents say that one reason to do the eyes together is so the patient can’t compare the LASIK eye with a contact lens and be dissatisfied!

Predictability

Most bilateral LASIKs are probably more convenient for the surgeon and patient. However, we all know that different patients can respond differently to refractive surgery. While LASIK helps reduce the variability of the healing response, there’s still the possibility for an unexpected result. Surgeons and researchers are still modifying laser algorithms, and debating the importance of such factors as patient age, amount of myopia and room humidity. Also, individual variations in the cornea’s response to the laser still occur. When surgeons have the ability to modify the surgical plan based on the first eye’s response, better second-eye outcomes can result. This may eliminate the need for reoperations in the second eye, which can save time and effort for everyone involved.

Personal Risk

The final reason I avoid bilateral simultaneous LASIK is a pragmatic one: They increase the exposure to malpractice.

Remember, the typical LASIK patient is successful, with a good career and high earnings. If one of these individuals were to suffer permanent bilateral vision loss and successfully sue the surgeon, the physician would be responsible for the patient’s lost earnings over his or her lifetime. And, if the surgeon’s malpractice insurance didn’t cover the entire award, he would be responsible for the difference. In a California case, for instance, an RK patient who suffered from serious night visual disturbances, glare and visual fluctuations sued and won $5 million. If those same RK cases had been done sequentially, and the patient lost vision only in one eye, the impact on his future earnings would have been judged to be much less and the award would have been lower.

In the end, the decision to perform a bilateral simultaneous LASIK is a question of risk versus reward. The inability to learn from the first eye’s response and evaluate the patient’s satisfaction from the procedure, the potential for bilateral complications, and the possibility for a disastrous malpractice suit far outweigh any gains in efficiency.

For an idea of how the Ophthalmic Mutual Insurance Company views unilateral and bilateral LASIK, informed consent forms for both procedures can be found in the Appendix.

Notes:

1. Watanabe H, Sato Shigeru, et al. Bilateral corneal infection as a complication of laser in situ keratomileusis. Arch Ophthalmol 1997; 115:1593-94.
2. Spivack L. International Society of Refractive Surgery Symposium, Oct. 25, 1997.
3. Luna J. International Society of Refractive Surgery Symposium, Oct. 25, 1997.
4. Dodds R. Annual Meeting of the Argentine Society of Ophthalmology, Summer, 1996.

Refractive Claims Up, Payouts Remain Low

By Gregory D. Werre, JD
Mr. Werre is an OMIC defense attorney and partner in the Los Angeles law firm of Bonne, Bridges, Mueller, O’Keefe & Nichols. He represents physicians, hospitals, and other health care providers in professional liability litigation.

[Digest, Winter 2001]

Far from being the “risk free” procedure that some claim, laser refractive surgery can have an adverse outcome even in the hands of the most conservative and experienced practitioner. There has been a significant increase in the number of OMIC refractive surgery cases opened in the last three years, most notably involving LASIK (see figure 1 below). The data collected so far is quite preliminary since the majority of refractive cases are still open; however, we are seeing these two trends:

• Refractive cases are settled with an indemnity payment to the plaintiff more often than other types of ophthalmic claims: 37% versus 22% (see figure 2 below).
• The average indemnity payment is much smaller than the average payout for other types of ophthalmic claims: $43,000 versus $122,000 (see figure 3 below).

That a larger number of claims are settling with a payment to the plaintiff suggests that the standard of care in refractive surgery is reasonably well defined with less disagreement between plaintiffs and defendants than in other subspecialties. The low average indemnity payment suggests that complications resulting from refractive surgery usually are not debilitating and do not lead to significant economic loss (i.e., loss of earnings and/or medical expenses).

There have been exceptions and substantially higher settlements in a few non-OMIC cases. These cases have tended to involve inexperienced physicians and/or physicians utilizing techniques considered experimental by the vast majority of ophthalmologists. In these types of cases, clear-cut liability, profound visual deficits, and loss of earnings drive up the settlement value.

In one large loss case, a series of contact lens masking devices were used during LASIK to treat hyperopia and astigmatism. The 65-year-old patient ended up with irregular astigmatism and monocular diplopia. Glasses failed to correct his double vision and he claimed to be intolerant of contact lenses. Allegedly, he suffered business losses as a result of the surgery. The case settled with a payment in the mid six-figure range.

Informed Consent
Lack of informed consent is often alleged in refractive surgery cases. Substantial personal interaction with the patient preoperatively to establish a positive rapport can be effective in limiting the likelihood of a claim. This includes identifying and discussing any unique circumstances associated with the patient’s case and realistically responding to the patient’s concerns.

The wording of the consent form usually helps the defense, but the accompanying case study below serves as a reminder of the need to periodically scrutinize and update consent forms. Another issue raised in this case study was that corneal ectasia was not specifically referenced in the consent form, which supported the patient’s contention that she did not understand it to be a post-operative complication. It was the defense’s position, however, that corneal ectasia was not a well known risk of surgery in 1997. Many consent forms wisely include a phrase such as “I understand that, since it is impossible to state every complication that may occur as a result of any surgery, the list of complications in this form may not be complete.”

In the large loss case involving the contact lens masking devices, it was alleged that the ophthalmologist failed to inform the patient about his intention to use a masking device. The patient claimed the physician should have indicated that the procedure was experimental and had not been subject to a clinical trial. The physician countered that the procedure was not experimental when performed by him in light of his experience. Additionally, the physician maintained that the patient was apprised of material information and thus gave an informed consent. Finding a supportive defense expert who concurred that the procedure was not experimental required considerable effort.

Patients should be informed of the innovative nature of a new technique, its scientific basis, its benefits, and any possible drawbacks. In certain situations, the physician might even encourage the patient to seek a second opinion before proceeding with an innovative technique. This discussion should be well documented.

Flap Complications
Flap complications account for the largest percentage of LASIK lawsuits. Many flap complications represent nothing more than recognized complications of LASIK and do not lead to permanent significant visual loss. Some cases, however, have been more problematic from a defense standpoint. In one case, the flap made did not provide adequate corneal exposure. The physician, assuming he had adequate corneal exposure, proceeded to complete the laser treatment. Postoperatively, the patient complained of glare and halos. In another instance, the microkeratome met resistance while being passed across the eye. The physician was able to free the microkeratome, complete the pass, and laser the eye, but the patient sustained a loss of best spectacle corrected visual acuity, most likely because the flap was not smooth. It seems quite likely that litigation could have been avoided in each case if the flap had been reseated and treatment postponed. Both cases were settled because convincing a jury to decide in favor of the defense in either case would have been a difficult uphill battle.

Another area of potential liability is miscommunication between the surgeon and laser technician, which can lead to adverse results and litigation (see Closed Claim Study). In conclusion, experience gleaned from open and closed refractive cases support the following risk management principles:

• Even the most conscientious, well-trained refractive surgeon can end up facing a lawsuit.
• Careful attention to detail, during the screening process, the informed consent process, and intraoperatively, can serve to limit the risk of a claim down the road.
• Being supportive of a patient who has a complication may reduce the potential for a lawsuit or at least limit damages if one does arise.

Case Study: Corneal Ectasia Following LASIK

In fall 1997, a 35-year-old woman presented to an experienced refractive surgeon for consideration of LASIK. The consent form signed by the patient indicated in part that the second eye is usually treated about six to eight weeks later when the first eye has healed. Following LASIK on the right eye, the patient could see 20/30 uncorrected within the first week. The patient had difficulty wearing a contact lens in the untreated eye and agreed to proceed earlier than the time stated in the consent because she was anxious to return to work. The flap appeared to be healing normally; thus, the physician proceeded with treatment of the left eye seven days after the first eye. Following treatment of the second eye, there was a gradual decrease in the visual acuity of both eyes. Several months later, the patient was diagnosed with corneal ectasia in both eyes, resulting in loss of best spectacle corrected visual acuity. A penetrating keratoplasty was ultimately performed on the left eye.

The patient sued, contending that the preoperative corneal topography deomonstrated evidence of subclinical keratoconus, a contraindication to LASIK, and that a reasonably prudent surgeon would have allowed six to eight weeks to pass following surgery on the first eye before treating the second eye. By waiting, corneal ectasia would have been diagnosed in the first treated eye and the patient would have declined surgery on the second eye. There was also a specific claim for lack of informed consent regarding the risk of corneal ectasia.

For the defense, this case presented several challenges. Opinions differed among defense experts as to whether there was any indication of subclinical keratoconus on the preop corneal topography. One expert thought it was merely artifact. All agreed that if there were indications of subclinical keratoconus, the ophthalmologist should not have proceeded with the operation. However, none of the numerous consultants who saw the patient postoperatively before it was obvious she had an ectasia felt the preop maps were in the least bit suspicious of keratoconus.

As a clinical care issue, it is important to point out that calculations at the time of surgery indicated that a residual bed of over 250 microns would remain after the ablation. However, it was uncommon in 1997 to actually measure flap thickness and residual bed ultrasonically at the time of surgery. Now, especially in borderline cases, this measurement is commonly done and is an excellent way to reduce the risk of corneal ectasia.

The main hurdle for the defense was the plaintiff’s use of the consent form to establish a standard of care for timing treatment of the second eye. The ophthalmologist’s decision to perform surgery on the second eye seven days after the first eye was in conflict with his own informed consent document that indicated a six to eight week waiting period between surgeries. The case settled with a small indemnity payment to the plaintiff.

LASIK, PRK Study Identifiers Malpractice Predictors

Higher surgical volume and a history of prior claims or lawsuits are the primary predictors of whether a refractive surgeon will be sued in the future. Additional medical-legal risk factors for surgeons who perform more than 100 LASIK or PRK procedures a year include advertising use, comanagement with optometrists, preoperative time spent with patient, and physician gender.

These are the findings of a retrospective cohort study presented by Richard L. Abbott, MD, professor of clinical ophthalmology, University of California San Francisco, at the American Academy of Ophthalmology Annual Meeting in Anaheim. Dr. Abbott, who is chairman of OMIC’s Underwriting Commit- tee, compared physician characteristics of 100 consecutive OMIC LASIK and PRK claims and lawsuits to demographic and practice pattern data for all active refractive surgeons insured with OMIC between 1996 and 2002.

The study, which also looked at informed consent issues in LASIK and PRK, found that patients who sued were often presented with informed consent for the first time on the day of surgery and many had no consent note written by the surgeon in the patient record.

These findings, published in Ophthalmology (November 2003), will be useful in improving the quality of care for patients undergoing refractive surgery. In addition, OMIC will incorporate the data in its underwriting criteria and risk management protocols to help insureds who perform refractive surgery manage and reduce their risk of claims and lawsuits.

Coverage for Phakic Implants

In early October, the FDA’s Ophthalmic Devices Advisory Panel recommended approval with conditions for use of the Staar Implantable Contact Lens for the treatment of myopia. It is anticipated that many ophthal- mologists, including those who may have never previously performed refractive surgery, may be interested in offering this procedure to their patients once the lenses have gained final FDA approval.

OMIC is in the process of developing a spe- cial questionnaire and underwriting guidelines, similar to other refractive surgery procedures, so that coverage may be offered to qualified ophthalmologists for their performance of phakic implants. The questionnaire and guide- lines will address training, patient selection criteria, informed consent, operative proce- dures, postoperative care, and advertising. If approved, coverage for phakic implants will be endorsed to the policy at full policy limits. No additional premium will apply.

Please note that OMIC’s standard policy excludes coverage for all refractive surgery procedures unless specifically added by endorsement. Each type of refractive surgery procedure must be separately endorsed for cover- age to apply. While the technique for phakic implants is very similar to that for intraocular lens implants, phakic implants are considered to be refractive surgery and, therefore, are not automatically covered by OMIC. No coverage will extend for any phakic implant procedures performed unless the physician has specifically applied and been approved for coverage and the policy has been amended accordingly.

Other procedures for which coverage is available by endorsement following review and approval of a supplemental questionnaire are radial and astigmatic keratotomy, PRK, LASIK (including LASIK variations such as epi-LASIK, LASEK, IntrLase, and Custom-Cap procedures), CK, LTK, Intacs, and clear lens extraction (refractive lensectomy).

How to Reach OMIC

If you have called the OMIC office recently, you probably noticed that we have a new phone system. While our toll-free 800 number is the same, phone extensions for individual departments have changed. Please remove and save the phone card included with this issue of the Digest. It lists new extensions for the most frequently called OMIC departments and gives contact information to reach OMIC by mail, fax, and email.

Toll-free numbers also are provided for Medical Risk Management Insurance Services and Marsh Affinity Group Services, which are the contacts for information about Academy- sponsored business insurance and life and health insurance programs.

Off-Label Use of ICG Dye During Vitrectomy for Floaters

By Ryan Bucsi, OMIC Senior Litigation Analyst

 Digest, Summer 2007

ALLEGATION Lack of informed consent for off-label use of ICG dye during vitrectomy.

DISPOSITION The case settled for $30,000.

Case Summary

A patient with a past history of LASIK OU and floaters OU presented to an OMIC insured complaining that the floaters were worse OD than OS. The insured noted the patient’s vision at 20/20 OU and recommended a vitrectomy. During a preoperative work up the next day, LASIK scars were discovered on both corneas. A fundus exam displayed an unusual vitreous opacity with waves of vitreous material that obscured the view of the posterior pole. The left eye displayed the same abnormal vitreous but was somewhat less significant than the right eye. A vitrectomy was performed that same day. the operative note indicated that the insured used iCg dye on two separate occasions to visualize residual vitreous and then lavaged the eye each time to remove all remaining dye. Immediately following surgery, the patient complained of a large blind spot in the center of vision on the operated eye. He was evaluated by a retinal specialist, who measured the patient’s vision at 20/300 OD with no improvement. There was no other therapy available to improve the patient’s visual acuity.

Analysis

According to the expert witnesses in this case, at the time this care was delivered, the insured’s decision to perform a vitrectomy to treat floaters and use ICG dye to better visualize residual vitreous was a controversial one. Furthermore, the insured did not have a detailed informed consent signed by the patient. Rather, he had a dictated risk/benefit note in the hospital record of a conversation with the patient in which the ophthalmologist explained and the patient understood the risks of surgery, including hemorrhage, infection, retinal detachment, loss of vision, risk of cataract progression, and the visual limitations of pseudophakia. The surgeon was careful to report the patient’s acknowledgment that some individuals are not bothered in the same way he was by vitreous opacities and that the surgery was being performed to address the patient’s unhappiness with the quality of his vision. However, the dictated note did not address the off-label use of ICG dye and the risk of retinal toxicity. Accordingly, the patient not only alleged a lack of informed consent but also contended that the ophthalmologist minimized the risks, stating that the procedure to remove the floaters was “more simple than LASIK” and would not threaten his vision. The patient re- called only the risk of infection and the doctor’s assurance that an infection could easily be treated with antibiotics. it was certainly helpful that the insured had documented the discussion in the hospital record, but the case would have been more defensible if he had also used a procedure-specific consent form signed by the patient. The absence of any documentation on the use of ICG and the patient’s poor outcome supported the decision to settle the case on behalf of the insured.

Risk Management Principles

As this case and the lead article demonstrate, patients often forget or misinterpret what they are told and have a hard time recalling risks that the ophthalmologist disclosed to them during the informed consent discussion. Staff can improve patient understanding by using educational aids such as brochures, handouts, and videos. Having the patient sign a procedure-specific form can also help the defense in several ways. First, it serves as further evidence that the consent discussion took place. Second, patients can be given a copy of the form, and encouraged to read it again at home with their family and to call back if they have any questions. Finally, if patients experience a complication, physicians can use the document to help them come to terms with the outcome. in this case, the insured should have modified a procedure-specific form for vitrectomy to include information about the off-label use of ICG and asked the patient to sign it following a thorough discussion of the risks and benefits of the procedure. OMIC policyholders who need assistance developing forms that are not already available on our web site may call the Risk Management Hotline.