Failure to Treat and Refer Patient with Diabetic Retinopathy

By Ryan Bucsi, OMIC Senior Litigation Analyst

Digest, Winter 2011

ALLEGATION: Failure to refer patient to a retinal specialist and failure to perform a YAG in a timely manner.

DISPOSITION: Case settled for $1,275,000.

Case Summary

A young insulin-dependent diabetic on dialysis presented to an OMIC insured complaining of blurry vision. upon initial examination, the patient was best corrected to 20/80 Ou and diagnosed with bilateral cataracts. The insured performed cataract surgery on both eyes and vision improved to 20/30 Ou. The patient was subsequently examined by the group’s employed optometrist, who documented disc neovascularization and noted that the insured ophthalmologist also examined the patient. This turned out to be the only record of the ophthalmologist’s exam that day. He later told defense counsel he did not agree with the optometrist that the patient had disc neovascularization; however, neither his exam nor decision-making process was documented. The same optometrist examined the patient one month later and documented a stable fundus.

During this time, a non-OMIC insured ophthalmologist wrote a letter on the patient’s behalf to the County Health Department’s Division of Disability Determinations recommending a YAG laser capsulotomy to evaluate the fundus for diabetic retinopathy. A copy of this ophthalmologist’s letter was sent to the insured’s group, but no action was taken. In fact, the patient was again examined by the group’s optometrist and advised to return in four months. The patient did not return until eight months later, by which time vision had deteriorated to NLP OD and CF OS. A different OMIC insured in the same practice diagnosed a questionable retinal detachment OS and performed a paracentesis. He prescribed drops and scheduled a YAG for the following week, but the procedure was later postponed pending approval of the patient’s eligibility by the Division of Blind Services. The second insured finally performed the YAG two months after determining it was needed. He referred the patient to a retinal specialist, who performed two vitrectomies and retinal detachment repairs; however, massive bleeding led to complete visual loss OU.

Analysis

Defense experts voiced some support for each insured’s care but also criticism. They noted that the first insured did not follow up after the cataract surgery even though this patient was highly likely to develop diabetic retinopathy. The second insured ophthalmologist, after diagnosing retinal detachment, did not properly treat it or perform the YAG or refer the patient in a timely manner. Plaintiff counsel alleged that the group delayed this patient’s care due to a dispute over a $15 balance which the patient claimed she could not afford. Since the patient had lost her Medicaid coverage, the County Health Department referred her to the Division of Blind Services to arrange payment for the YAG but not in a timely enough manner. Defense counsel for both insureds felt that the payment issues could alienate jurors and potentially sway them to return a verdict well in excess of the $1 million policy carried by each insured. The insureds demanded that OMIC settle the case within policy limits. The first insured’s case settled for $700,000 and the second for $575,000 for a total of $1,275,000.

Risk Management Principles

The primary risk in this case was not lack of physician knowledge or skill. Familiar with the natural history of diabetes and aware that the disease had already led to renal failure requiring dialysis, both ophthalmologists and the optometrist knew the disease would manifest in the eyes eventually. No one kept this knowledge in mind, however, when treating this patient. Instead, “systems” issues appear to have interfered with proper care. The optometrist noted the early signs of retinopathy, but backed off when the ophthalmologist, who was above him in the group hierarchy, did not agree with the assessment. Both ophthalmologists were employees of the practice and may not have been in a position of authority to determine who should be assigned to high risk patients or to effectively challenge financial policies that delayed acute care. The group’s policies and structure hindered any one provider’s ability to take ownership of the patient and follow the care through to completion. In hindsight, it is easy to acknowledge that emergency treatment should never be delayed due to issues with an account balance or the patient’s inability to pay and that ophthalmologists have a duty to advocate on behalf of the patient.

Charges of Abandonment by Noncompliant Patient

Digest, Spring, 1992

ALLEGATION  Insured ophthalmologist was charged with abandonment by a patient after terminating care due to poor compliance with treatment.

DISPOSITION  Insured wrote off the patient’s bill. No payment was made by the insurance carrier (OMIC).

Background

One of the most difficult things a physician sometimes must do is to terminate the doctor/patient relationship. The decision to terminate a relationship is not only an emotional one but can have medical and legal ramifications as well.

Case Summary

The patient was a 30-year-old female who underwent a radial keratotomy of the left eye by another physician. Postoperatively, the eye resulted in a marked overcorrection with a hyperopia in excess of +12. The patient did not want to wear glasses or contact lenses to correct the problem and was referred to the OMIC insured for evaluation. To help correct the problem, the insured performed a procedure whereby he sutured the radial keratotomy incisions to help stabilize the wound. A detailed informed consent was obtained. Although there was noted improvement in the visual acuity, the patient continued to complain of monocular diplopia, fluctuating vision and photophobia. However, the patient failed to keep several post-op appointments despite letters and telephone calls from the insured stressing the need for follow-up. She was also noncompliant about taking prescribed medication.

The patient elected to see a corneal specialist and the insured transferred the medical record to the specialist and advised the patient that he wished to discontinue serving as her ophthalmologist. The patient threatened legal action if the insured stopped seeing her.

Outcome

The OMIC insured wrote off her bill and the patient did not take legal action. OMIC closed the claim without making any payment. The insured ophthalmologist did several things that were instrumental in minimizing the chance of a lawsuit. First, he discussed the procedure and all possible risks, complications and alternative treatments available to the patient. He obtained a detailed consent form and made no guarantees as to the outcome of the surgery. After the procedure, the insured thoroughly documented in the chart when the patient failed to comply with treatment and followed up with several letters expressing concern and disappointment that she had not kept her appointments. The insured also communicated the need for follow up so that the medications could be adjusted and the cornea monitored for continued healing, and he mentioned the adverse consequences of continued noncompliance. Furthermore, the insured wrote to the patient to advise that he was discontinuing his service as her ophthalmologist and to suggest that she select an ophthalmologist who could continue to care for her. Finally, he wrote off the remainder of the patient’s bill without suggesting there was any improper care or liability.

Risk Management Principles and Commentary

Although there is no guarantee that every ophthalmologist who terminates the doctor/patient relationship will have the same result as this insured, there are some guidelines to follow which may protect one against a claim of abandonment.

• Discuss the procedure with the patient thoroughly and document the risks, complications and alternative methods of treatment;
• Document in detail the patient’s noncompliance with treatment and failure to keep follow-up appointments;
• Write or telephone the patient communicating your concern and the consequences of noncompliance and document that communication;
• Suggest that the patient obtain a second opinion;
• Write to the patient noting the reasons why you are terminating the relationship and recommending that the patient obtain another ophthalmologist for continued care.

A note of caution: In this situation, the patient had already sought the care of a corneal specialist and had requested the ophthalmologist forward the medical records to the specialist. Also, the patient’s condition was not critical. Terminating the relationship did not carry any risk to the patient, which may not be the case in other situations. However, in the absence of a critical condition requiring continued medical attention, terminating a doctor-patient relationship may become necessary in some instances.

Delay in Consultation Referral of Post-RK Patient

Digest, Fall, 1996

Allegation

Improper performance of radial keratotomy (RK) surgery, lack of informed consent, and fraudulent concealment of plaintiff’s condition.

Disposition

Case settled with a small indemnity payment.

Case Summary

The patient was a 28-year-old woman who was nearsighted and had worn contact lenses for a number of years without problems. She was interested in having RK surgery after reading about the procedure in a newspaper article. The patient contacted the insured ophthalmologist and was seen by him in August 1986. The insured discussed RK with the patient and had her watch a video showing how the procedure was performed and covering the risks and benefits of RK surgery. The patient’s right eye was scheduled for surgery in November. Prior to surgery, the patient signed a lengthy RK informed consent document, which included information about possible reoperations (enhancements), loss of night vision from “starburst effect,” and the fact that there were no guarantees as to the success of the procedure. During surgery on the right eye, the third incision resulted in a macroperforation and the procedure was terminated. The left eye was operated on later that month and had an initial good result with vision improving to 20/30. In February 1987, the right eye was operated on again with good results. Vision was 20/30 OD and 20/50 OS when tested in March. A repeat surgery of four incisions on the left eye was performed in April. The left eye was still undercorrected and another four-incision reoperation was done in June. Follow-up visits with the insured as late as December of that year showed vision without correction to be 20/25 OD and 20/60 OS.

The patient experienced a great deal of difficulty driving at night because of the starburst effect, which the insured tried to treat with a combination of miotics, contact lenses, and spectacles without much success. The patient eventually was referred to a corneal subspecialist by her family’s optometrist. The corneal subspecialist made critical comments about the symmetry, depth, and placement of the incisions in the cornea. Three months later, the patient filed a lawsuit against the insured.

Even though the patient’s VA was 20/20-1 OD and 20/20 OS with contact lenses, the subspecialist proposed corneal transplantation (PKP) as a way of relieving the glare, photophobia, and visual distortion the patient was experiencing at night. After consulting with two other ophthalmologists, the patient agreed to have PKP on the right eye in August 1990. The graft was successful, and the patient claimed the PKP had relieved her glare and star-burst effect in the right eye; however, she did not want PKP on the left eye.

Analysis

The expert for the defense was a corneal subspecialist. At his deposition he testified that the insured’s treatment of the patient was appropriate and countered the other subspecialist’s criticisms regarding the depth and placement of the insured’s incisions. He stated that it was difficult to criticize incision depth since it is impossible to determine with certainty the depth of the incision after it has healed. He also testified that the “symmetry of the incisions” may not be important since many patients have good results with incisions that are irregularly placed or wavy. Finally, he testified that corneal transplant surgery was “way down” on his list of possible treatment options for this patient.

The plaintiff’s expert testified at his deposition that the incisions were not of appropriate depth and were well into the visually significant area of the cornea. The subsequent treating ophthalmologist at his deposition simply confirmed his initial critical comments regarding the depth and placement of the incisions and supported his own recommendation for PKP. Although performing PKP on post-RK patients is controversial, the subsequent treating ophthalmologist was supported by the two other ophthalmologists whom the patient had consulted with prior to PKP.

This case was further complicated by the fact that the patient had begun seeing a psychiatrist for depression and suicidal ideation. The mental health notes stated the depression “… began about four years ago when her corneas were permanently damaged from poorly done surgery on her eyes.”

Defense counsel recommended settlement because this state had a history of high jury awards against ophthalmologists in a number of RK cases even when the patient’s complaints involved relatively minor visual problems. Counsel also felt that if a jury believed the patient’s depression was causally (actually) related to the surgery, the insured could be exposed to a potentially large award. The insured took this advice and agreed to settle.

Risk Management Principles and Commentary

Careful patient selection is a prominent issue in this case. Perhaps there is no way the insured could have detected the patient’s “psychological vulnerability” prior to surgery, but it is still important to point out that often patients who have elective surgery, be it refractive surgery or laser skin resurfacing, have unrealistic expectations and tend to blame the surgery and the surgeon when their lives do not change or the results are not as wonderful as they had hoped. Any patient with a history of psychiatric treatment or substance abuse should be given extra attention by the ophthalmologist. This does not mean that such patients should be summarily denied surgery; however, it may be necessary to spend more time with them to clear up any misconceptions.

The most important risk management issue in this case was the delay in referring the patient to a corneal subspecialist. The delay caused two things to occur. First, the insured lost control of the patient, who went to a subspecialist who held a conservative viewpoint on indications for RK surgery and who had already performed several corneal transplants on post-RK patients. Second, the delay, coupled with the criticism of this subspecialist, raised doubts in the patient’s mind about whether the insured had concealed the fact that she needed a corneal transplant to treat the starburst effect. With refractive surgery patients, and others who have had elective surgery, it is important to consider early consultations to subspecialists or colleagues when the patient complains about some aspect of the care or result. These patients often need reassurance that the treatment rendered has been appropriate and, sometimes, the subspecialist or colleague may have a treatment plan that may help or appease the patient. Any suggested alternative treatment by a colleague should be done so the patient understands it is a joint effort between colleagues to help resolve the problem. Finally, keeping control of the consulting process generally will result in a referral to someone who is less likely to criticize the treatment or surgery. This type of prudent referral is not to be mistaken for a conspiratorial cover-up of a real problem, but rather a commitment to work together in search of a proper resolution to the patient’s complaints.

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.