Patient Slip and Fall Following Dilation

By Stacey Meyer
OMIC Assistant Claims Manager

Digest, Spring 2001

ALLEGATION  Failure to provide sunglasses following dilation led patient to fall and hip fracture.

DISPOSITION  Case settled on behalf of insured ophthalmic group.

Case Summary

A 72-year-old male patient was seen by the insured for a routine eye exam during which his eyes were dilated with Neo-Synephrine 2.5% and Mydriacyl 0.5%. Afterwards, as the patient was leaving the office and walking towards his son’s waiting car, he stepped off the curb outside the building and fell down on his right side. He sustained a transverse fracture through the mid-right femoral neck and eventually underwent a bipolar hip replacement. After numerous physical therapy sessions, the patient was ambulating with minimal difficulty.

Analysis

The patient alleged that the insured ophthalmologist was negligent in not providing him with sunglasses or advising him to wear sunglasses after dilating his eyes. He stated that when he left the insured’s office, his eyes were unprotected and blinded by the sun’s glare, which impaired his vision so that he did not see the step from the curb. The plaintiff’s expert opined that it was below the standard of care to allow the patient to leave without providing sunglass protection before the effects of dilation had dissipated.

The insured countered that the technicians in his office who instill dilating drops routinely warn patients that they can cause blurry vision and heightened sensitivity to light, and they keep sunshades at the front desk for patients who request them. However, there was no written office policy or procedure in place regarding this issue. Although the office administrator maintained that she offered the patient sunglasses, there was no documentation to support this, and neither the insured nor other office staff could remember specifically warning the patient of the potential problems associated with dilation. Furthermore, the OMIC Publication Archives advise physicians who administer dilating drops to instruct patients to wear sunglasses and avoid driving or operating dangerous machinery afterwards. In light of this, the defense team and insured agreed it would be difficult to defend the case and settled on behalf of the insured ophthalmic group.

Risk Management Principles
Failure to provide for a patient’s safety has been the basis of many “slip and fall” suits against ophthalmologists. Oftentimes, a slip and fall claim will cross over both a physician’s general liability and professional liability coverage, depending on whether the treatment rendered to the patient contributed to or caused the incident in question. Responsibility for patient safety does not begin and end in the exam chair, but extends to the entire premises, regardless of whether the physician owns or controls the property outside the office

Visual impairment following dilation raises questions of patient safety and establishes a duty on the part of the caregiver to provide for the patient’s safe transport out of the office. Settlements and judgments involving patient falls post-dilation can range a few thousand to tens of thousands of dollars, particularly if the ophthalmologist or office staff are found negligent in supervising an elderly or visually impaired patient.

Providing a safe environment for patients should be a priority in all practices. Conduct periodic audits of the office premises and safety policies. Develop written procedures establishing safety guidelines and practices to be followed by office staff. A routine checklist or mechanism to record that a patient has been warned of potential glare problems and instructed to wear sunglasses can serve to protect the physician and staff from failure to warn allegations.

ROP Case Defines Legal Duty of Care to Patients

By Anne M. Menke, RN, PhD, and Paul Weber, JD

Anne Menke is OMIC’s Risk Manager. Paul Weber is OMIC’s Vice President of Risk Management/Legal.

Digest, Summer 2005

“When does a physician’s duty to a patient end?” It is a question frequently asked by the medical profession and debated by the legal profession. In a retinopathy of prematurity case involving blind twins that initially resulted in a $15 million plaintiff verdict against an OMIC-insured pediatric ophthalmologist, two pediatricians, and one of the pediatricians’ practice group, OMIC learned just how difficult it can be to answer that question. This article provides an overview of the facts of this case and the many legal hurdles faced by the OMIC defense team before an appellate court reversed the plaintiff verdict and made a final determination that the ophthalmologist had no duty to the patient.

In December 1996, twins were born at 30 weeks gestational age in a hospital with a well-established protocol for screening and treating retinopathy of prematurity (ROP). In early February 1997, the hospital’s neonatal intensive care unit (NICU) nurse met with the twins’ mother and told her to schedule an outpatient ophthalmic appointment for both babies. A few days later, before the babies’ discharge, the neonatologist determined that Twin B met the in-hospital screening criteria and asked the OMIC-insured pediatric ophthalmologist to examine the baby. The insured determined that the baby’s retinas were not fully vascularized and noted the presence of Stage I ROP, for which no treatment was indicated. He wrote a follow-up order for a repeat evaluation by a screening ophthalmologist in two weeks to monitor for the development of threshold ROP. The NICU nurse and neonatologist met with the mother at different times to inform her of the results of the ROP examination and to explain the importance of follow-up evaluations; the mother was given a copy of the hospital’s letter to parents explaining ROP (“Dear Parent” letter).

As part of the hospital’s discharge process, the neonatologist contacted the twins’ pediatrician and told him he was referring two premature infants for outpatient care. At the time of the pediatrician’s first outpatient visit with the mother and infants, he addressed the babies’ numerous medical problems and reviewed the neonatologist’s referral letter with the mother. This letter indicated that the mother had made an appointment with an ophthalmologist.

Soon thereafter, on February 16, 1997, the day before the ophthalmic appointment, the mother contacted the pediatrician’s office and requested insurance authorizations for a circumcision, hernia repair, and tongue clipping. When she came to pick up the authorizations the next day, she asked, for the first time, for an insurance authorization for the ophthalmologist. The pediatrician’s office staff informed her that they could not process her request that day. The authorization form was never sent to the OMIC-insured ophthalmologist. In any event, the mother did not bring the children to the appointment; in her deposition, she claimed that she was told by the insured’s staff that the twins could not be seen without an authorization. The insured denied this.

The mother scheduled another appointment with the insured ophthalmologist for February 28, 1997 but again did not show up, this time because the babies were hospitalized for other health problems under the care of another physician. The twins were scheduled to return to the pediatrician for follow-up after discharge, but were never brought in. Instead, the mother sought treatment from a second pediatrician and told this doctor that there were no concerns about the babies’ eyes. When this pediatrician reviewed the first pediatrician’s records, she noted the concern about ROP and the absence of ophthalmic follow-up; she referred the twins to a different ophthalmologist, not the insured. By that time, June 1997, both babies were blind.

Gaps in the Process of Care

The insured ophthalmologist had only seen Twin B once in the hospital. He had never been asked to see Twin B again in the hospital or in his office and was initially bewildered when he was served with a lawsuit in March 1999 alleging negligent care of twins with ROP whose name he did not recognize. Only after reviewing the complaint did he realize that the plaintiff was the mother of Twin B and that she had scheduled an outpatient appointment with him for both twins in mid-February under a different last name. He checked his appointment records and found that his office had placed a reminder call before the appointment but that the mother did not bring the twins to that appointment or to one that she rescheduled for the end of February. Per office policy, his staff did not follow-up with new, self-referred patients who did not keep appointments, assuming they had decided to seek care elsewhere. The first pediatrician noted that appointments had been made for follow-up of the ROP during the initial visit, but he did not have a system in place to ensure that he received consultant reports. The second pediatrician was given falsely reassuring information by the parents and only later learned of the ROP after asking for and reading the medical records of the first pediatrician.

The Trial and Verdict

Efforts to dismiss the OMIC insured from the case were successful for Twin A since the insured had never examined that infant. OMIC’s Claims Committee and expert witnesses believed the insured had met the standard of care in his treatment of Twin B, and they challenged the existence of an ongoing physician-patient relationship. OMIC and the insured ophthalmologist accordingly decided to take the case to trial. After a five-week trial, the jury awarded the plaintiffs $15 million (plus prejudgment interest) according to the breakdown of fault in the chart on page 5.

The jury assumed that the insured’s relationship with Twin B did not end after his consult in the hospital but followed him after Twin B was discharged. The percentage of fault the jury assigned to the parents ignored the undisputed evidence and the following facts:

• The mother played a significant role in the delay in diagnosis and treatment of ROP by not informing the ophthalmologist of the twins’ name change, not keeping the outpatient appointments with him, and not providing accurate information to the second pediatrician when asked about the condition of the babies’ eyes.

• Her noncompliance occurred despite conscientious efforts to educate her: she was counseled about ROP by the neonatologist and NICU nurse; she received a letter from the hospital about ROP; and she spoke to the first pediatrician about the babies’ health problems. During her testimony, however, she denied understanding the significance of the problem, and her lawsuit blamed the care providers for inadequate follow-up.

Both OMIC and the trial counsel for the insured strongly believed that there was no legally sufficient evidence to support the jury’s finding that an ongoing physician-patient relationship existed between the insured and Twin B. Additionally, when polled after the verdict, the jury cited concern for the infants as the primary factor in its decision-making process. This presented a very compelling case to appeal.

Standard of Review for Appealing a Case

Typically, under a “no evidence” review, the court of appeals (or supreme court) must adhere to what the jury found unless there is no more than a scintilla of proof to establish a particular issue, “scintilla” being shorthand for that virtually indefinable quantum of proof that makes the reviewing court comfortable enough to say, “there is sufficient evidence to support the jury’s verdict.”

In the OMIC insured’s case, the defense argued primarily that there was no legally sufficient evidence – no more than a scintilla – to establish that the insured had an ongoing physician-patient relationship with Twin B. If no physician-patient relationship existed, there could be no duty, and therefore no malpractice, regardless of how badly the patient may have suffered.

Specifically, the insured argued, and the state court of appeals accepted, that the various pieces of evidence – the “Dear Parent” letter, the missed appointments, the participation in the twin’s health plan, the alleged referral from the first pediatrician – did not constitute legally sufficient evidence that the insured had an ongoing physician-patient relationship with Twin B. The plaintiffs argued the opposite interpretation of that same evidence.

Rendered in February 2004, the opinion of the majority of the state court of appeals explained: “We believe, however, that none of these facts, either individually or combined, are evidence of the actual continuation of the physician- patient relationship.” The appellate court was concerned about expanding the duty of continued care and stated: “If we were to expand the duty of continued care to all patients who are seen at hospitals by consulting physicians beyond the hospital setting based solely upon the fact that they were seen by the physician in the hospital, there would be no end to the physician- patient relationship.”

Supreme Court’s Final Review

The case was by no means over after the appellate court’s opinion. Over the following eighteen months, the plaintiffs petitioned for an en banc rehearing, in which the full eight members of the court of appeals would review the case, but their petition was denied. They appealed the rehearing denial to the state supreme court, arguing that the court of appeals did not apply the appropriate standard of review in a “no evidence or legal sufficiency” case. The state supreme court denied a rehearing. OMIC was delighted with this decision in the ophthalmologist’s favor and felt that the $730,000 it cost to defend this insured’s care was money well spent.

This case illustrates both the complexity of providing medical care to premature infants and the intricacies of the legal process. The appellate court’s decision was based on the particular facts of this case and may not apply generally to ophthalmology consultants. Additionally, this case was state specific and may or may not be used as precedent for other states. The detailed risk management recommendations for hospital- and outpatient-based ROP care that OMIC developed in response to this case, however, have proved generally useful to pediatric ophthalmologists and retina specialists. This sample protocol better protects physicians and premature infants by standardizing the nonclinical aspects of care and assigning responsibility for all steps in the treatment process. This document, “ROP: Creating a Safety Net,” can be found in the Risk Management Recommendations section of www.omic.com.

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.

When Lawyers Come Beckoning with the Color-Coded Maps

By Dean C. Brick, MD, Argus, October, 1994

As use of corneal topography increases, a risk management question arises: will ophthalmologists have to invest huge sums of money to protect themselves from the lawyer carrying the beautiful color-coded maps, who will try to persuade a jury that the results of treatment or surgery would have been different if this new technology had been used?

Background

For years ophthalmologists used standard keratometry to measure corneal curvature. Ophthalmologists who performed corneal transplantation realized the deficiencies of standard keratometry in evaluating patients after penetrating keratoplasty and became adept at interpreting Placido disc images or photokeratoscopic images. Recently, however, qualitative measurements of the cornea obtained by these instruments have been surpassed by quantitative corneal measurements with computer videokeratoscopes (CVK).

Most of the CVK systems currently available are based on Placido disc imaging recorded by a video camera and analyzed by computer software. Newer systems that measure the surface elevation of the cornea rather than analyze the Placido image are being developed, but the advantages of these newer systems have yet to be determined.

Quantitative corneal mapping has increased ophthalmologists’ knowledge of corneal shape and how to change it, primarily when performing refractive procedures. It has opened up new ways to diagnose corneal diseases, treat corneal problems, and fit contact lenses. In the future, corneal mapping may prove useful for predicting visual acuity before and after refractive surgery and for determining the refractive procedure most beneficial for a particular patient.

The Corneal Specialist

Corneal specialists appreciate topography for diagnosing pellucid marginal degeneration, keratoglobus, keratoconus, irregular astigmatism and other corneal diseases. Many of these conditions can be diagnosed by more conventional means; however, the CVK enables the physician to accurately follow the progression of the disease, assists in fitting contact lenses when these conditions are present, and aids in surgical planning and postop evaluation and management. The CVK also helps the corneal surgeon evaluate postoperative penetrating keratoplasty patients, including diagnosing the astigmatism axis and type, suture removal and adjustment, and secondary procedures to decrease astigmatism.

In many instances, CVK has not yet been proven to be superior to other clinical methods, but its increasingly widespread availability and published effectiveness is boosting its popularity. From a risk management standpoint, it seems prudent for ophthalmologists to use CVK in the diagnosis and management of corneal disease in which it has been shown to be effective, especially when it is available in the community.

The Refractive Surgeon

CVK is frequently used by refractive surgeons. Although corneal topography has not yet proven itself to be superior in planning primary radial keratotomy procedures, it is indispensable in other ways. It is effective in preoperative screening for diagnosing keratoconus and for recognizing asymmetric astigmatism. It also has been helpful in diagnosing “forme fruste” keratoconus. Although it is not known whether these patients respond differently to refractive surgery, the ophthalmologist should present this information during the informed consent discussion so patients with “forme fruste” keratoconus are not unpleasantly surprised if a complication arises.

CVK also has been shown to be effective when following patients in whom rigid or gas permeable contact lenses have been discontinued prior to refractive surgery. CVK has shown that the time required for the cornea to stabilize after contact lens removal is quite possibly much longer than commonly thought. Following the refractive surgery patient out of contacts until the topography stabilizes helps prevent postoperative surprises. It also allows for preoperative recognition of nonorthogonal astigmatism and helps with surgical planning.

Postoperatively, CVK assists in evaluating RK, AK and PRK patients. After RK and/or AK surgery, shallow or short incisions may show up as areas of less flattening. Using topography to find this condition allows for more accurate planning of secondary procedures. After PRK, topography has been useful in detecting central islands, recognizing and following regression, identifying eccentric ablations, and diagnosing irregular postop astigmatism.

From a review of the literature, it does not appear that topography has become “standard” when performing refractive procedures. However, this standard may change as more comprehensive studies are completed and the price of instrumentation drops, making it more available.

The General Ophthalmologist and the Cataract Surgeon

The general ophthalmologist and the cataract surgeon use CVK less frequently. It may be used to assist in contact lens fitting, but it has not proven superior to other methods. Similarly, it may help evaluate the corneal astigmatism of preoperative cataract patients, allowing the surgeon to plan wound construction and location. However, traditional methods of evaluating astigmatism in cataract patients also have proven effective over time. In the future, topography may help improve IOL power calculations; however, for risk management purposes, use of the CVK does not appear to have an impact on the general ophthalmologist or cataract surgeon at this time.

Conclusion

The role of computerized videokeratography in the practice of ophthalmology is evolving with almost every published article. Corneal specialists who perform refractive surgery should stay abreast of the published studies regarding the use of corneal topography and its effectiveness in diagnosing and treating diseases. Keeping current is important primarily to help ophthalmologists determine what is in the best interest of their patients, but it also may afford protection if confronted by the lawyer with the color-coded maps.