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.

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.

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.

Failure to Coordinate Follow-up Care Results in Missed ROP Diagnosis

Digest, Summer, 1995

Allegation

Failure to communicate responsibility for scheduling a follow-up examination of a premature baby after discharge led to delayed diagnosis and treatment of retinopathy of prematurity (ROP), resulting in bilateral blindness.

Disposition

Joint settlement was reached with indemnity equally divided among the neonatologist, the ophthalmologist, the hospital, and the attending pediatrician.

Background

Communication between attending and consultant physicians is a critical aspect of patient care. When responsibility for follow-up is not clearly defined between specialties, the patient may be lost to follow-up if there is a communication failure within the health care team.

Case Summary

A premature baby boy weighing 1200 grams (2.6 pounds) was delivered by caesarean section at 29 weeks gestation. An ophthalmology consult was called and the eye examination was noted on the chart as “ROP I nasal and temporal retina, zone 2 to 3, mild. Should resolve. Recheck 4 weeks.” The ophthalmologist used an older staging system in which Stage I refers to abnormal vessel configuration, rather than a pre-demarcation line condition. He later explained that his examination of the infant revealed a pre- Stage I or Stage O condition, which has no staging description according to the “new” classification system for ROP, which became the standard of care in 1984-four years before this baby was born-Stage I ROP is characterized by a demarcation line. Thus, under the newer classification system the findings from this exam would not have qualified for a staging classification. The ophthalmologist later stated that the four-week follow-up recommendation was based on the “lack of a demarcation line” on exam and that he would have set an earlier recheck date had there been a clearer line of demarcation.

It was the policy at this neonatal unit for the neonatologist to make arrangements for any scheduled follow-up visits for patients while they were in the unit. But once a patient was transferred, the individual consultants were expected to follow up on recommended care. No arrangements were ever made for the four-week ophthalmology recheck, and the child was discharged one week before he should have been seen for the recheck. Additionally, the neonatal unit, which usually completed a discharge planning form to check off whether all consults were done and confirm that follow-up was scheduled, never completed a form for this baby so the ophthalmology recheck exam was never scheduled.

Upon discharge, the infant was followed by a pediatrician, who did not examine the baby for ROP and thus was unaware of the condition until she received the hospital’s discharge summary at her office three months later. She then discovered this ophthalmology reference: “It should be noted that the baby was seen by ophthalmology to rule out ROP and that exam was noted as Stage I, although I cannot at this time find the consult note. He should probably follow up with this infant after discharge.” The attending physician immediately referred the baby to the ophthalmologist who diagnosed Stage V ROP. Referral was made to a retina specialist who confirmed the diagnosis and performed two surgeries on the left eye and one on the right. None of the surgeries were successful, and the infant became totally blind.

Analysis

Each institution has its own rules and policies regarding delegation of duties and responsibility for referral and follow-up of patient care. In this case, there was confusion between the ophthalmologist and the neonatologist over who was responsible for the baby’s follow-up care. The referral pattern established between the attending neonatologist and the consulting ophthalmologist was one of the major issues raised by the experts who reviewed this case. The ophthalmologist stated at his deposition that the neonatologist had not wanted him to contact the parents and that she would contact him to request all consultations with the patient. The neonatologist testified that she considered herself responsible for arranging follow-up appointments with consultant physicians while an infant remained in the hospital, but it was the consultant’s responsibility to follow through with a charted follow-up appointment once the infant was discharged. It was not difficult for the plaintiff’s attorney to convince the jury that each of the caregivers in this case had failed in their responsibility to coordinate follow-up care, and that this failure prevented a timely diagnosis of ROP.

Defense of the case against the ophthalmologist was further hampered by reference to both an “old” staging system and a “new” system in his report of the baby’s first eye exam. It was not clear what the ophthalmologist meant by this until he explained his peculiar reference system at his deposition. Even more damaging to the credibility of the recorded findings was expert testimony that the first ophthalmic exam is often inaccurate due to the difficulty of examining a squirming infant. For this reason, a follow-up exam is generally completed within one to two weeks to confirm the initial findings. This set the stage for the plaintiff to allege that the consulting ophthalmologist not only failed to accurately examine the infant and diagnose ROP on the first exam, but also failed to do a timely follow-up.

Risk Management Principlesand Commentary

With all pre-term infants, a careful delineation of the responsibilities of the hospital, the neonatal ICU, the neonatologist, and the ophthalmologist must be developed. This case points out the need for communication between the ophthalmologist and the parents during the first examination of an infant for ROP. Parents should be educated about the possibility of blindness in their pre-term infant and a reexamination appointment should be made at the time of the first exam. If this appointment is not kept, the ophthalmologist’s office should contact the parents with a timely phone call and registered letter reminding them of the missed appointment and the need for follow-up care.