Ординатура / Офтальмология / Английские материалы / Risk Prevention in Ophthalmology_Kraushar_2008
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a retinal detachment. The same procedure should be followed for patients missing postoperative appointments or appointments for continuing therapy for cystoid macular edema, photodynamic therapy, and other diseases requiring subsequent treatment.
Diagnostic Problems
Medications and Tests
Documentation of informed refusal is indicated for patients who do not agree to bilateral pharmacologic mydriasis. Patients often use the excuse, “I have to go back to work when I leave the doctor’s office.” Bilateral intravenous fluorescein angiography may also be refused, and this also requires warning of risks with documentation.
Warnings about the potential difficulties that may be encountered should be given and documented in the medical record when a patient leaves the office in a state of partial or complete pharmacologic mydriasis. The documentation can be easily accomplished by means of a check-off box or an ink stamp. Reversing drops and/or disposable tinted glasses can be helpful. Although ophthalmologists are well aware of the risk that these patients may suffer an injury because of a “slip and fall,” there is a new, more far-reaching risk about which to be concerned. A Massachusetts court ruling in 2006 involved a patient on hypoglycemic medication who suffered an episode of low blood sugar while driving and hit and injured a motorcyclist who eventually sued the physician. There was no documentation in the record of the physician warning his patient, the auto driver, regarding this risk. The court ruled the physician has a “special duty” when “an individual does something that creates or increases the risk that a person will harm a third party.”7 It seems reasonable to assume that this “special duty” may some day be applied to an ophthalmologist who fails to warn and to document the warning to a patient leaving the office after pupillary dilation regarding the risk of injuring a third party in an auto accident.
Informed consent is appropriate and advised for intravenous fluorescein angiography, because significant problems can occur. It is of paramount importance that the tip of the needle be monitored by gentle palpation during injection of fluorescein to ensure that extravascular accumulation of dye is promptly diagnosed in time to stop the injection. There have been successful lawsuits against physicians because of skin sloughs from extravascular dye reactions that required plastic surgery. It is both appropriate and compassionate to include a warning about the postangiogram change in color of the skin and urine, which can be a shock to the uninformed patient or companion.
Test results should be promptly reported to and discussed with the patient, and the conversation should be documented. This is a good risk prevention measure, and it also improves the physician–patient relationship.
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Retinal Tear/Detachment
The most frequent error in the diagnosis of ocular diseases that leads to litigation is delay or failure to diagnose a retinal tear or detachment.2–4 These suits are usually against comprehensive ophthalmologists.6 Typical problems revealed by review of claims include failures to dilate the pupil for ophthalmoscopic examination of the ocular fundus, examine the peripheral retina including the ora serrata, to look for retinal pigment cells in the anterior vitreous, and to document the examination by making a drawing in the record. Attempting to convince a jury that a dilated ocular fundus examination was done merely by noting it in the chart in the absence of an actual drawing seriously risks jeopardizing the jury’s confidence and credibility in the ophthalmologist. A time-saving practice is to have a check list or ink stamp in the chart where the physician can indicate the pupil was dilated and what instruments were used for the examination, such as direct or indirect ophthalmoscope and slit lamp with contact or noncontact precorneal lenses.
It is important to remember that the physician’s performance is measured against the standard of an average physician. Provided the appropriate diagnostic steps have been taken, missing a retinal break may be excusable. There have been claims of failure to diagnose a retinal detachment in a patient complaining of a progressing peripheral visual field defect and an apparently normal ocular fundus examination. If a visual field examination had been obtained, it would have alerted the physician to a flat or partial retinal detachment.
A common example of a claim for failure to diagnose a retinal tear or detachment is that of a patient complaining of floaters and flashes of light who on examination has a posterior vitreous detachment with no apparent retinal breaks. Several weeks later the patient sees a second ophthalmologist because of persistent symptoms, and a retinal detachment is found. Under most circumstances it will be difficult for a plaintiff’s expert to say “within a reasonable degree of medical certainty” that there was a missed retinal break on the visit to the first physician, because the symptoms of a retinal tear and vitreous detachment can be similar. Furthermore, posterior vitreous detachment may be progressive, and the tear may occur at a later time than that of the initial symptoms. A retinal break may be present for many weeks before a detachment develops. If the flap of a horseshoe break in attached or detached retina is shriveled or if the posterior edge of the break is rolled, it is strongly suggestive that the break is not fresh. One or more demarcation lines in an inferior retinal detachment is a sign of chronicity. Intraretinal cysts are also indicative of a longstanding detachment. In the absence of these findings, dating the occurrence of a retinal tear cannot be accurate purely on the basis of symptoms. If the examiner is confident there is neither a tear nor a detachment, the patient should be told to return immediately if the symptoms increase, and this warning should be documented.
The bottom line for risk prevention and for optimal patient care in this situation is as follows: if the examiner cannot feel completely confident in ruling out a tear or detachment in the eye of a symptomatic patient by means of the indirect ophthalmoscope with scleral depression, a contact or precorneal lens, and visual fields, the patient should be
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referred to a vitreoretinal specialist immediately. “A request for the opinion of another physician does not reflect badly on your competence. On the contrary, it shows your honesty in dealing with the situation and your concern for the patient’s welfare.”8
Endophthalmitis
Practically all endophthalmitis claims are brought against cataract surgeons for failure or delay in diagnosis. Occasionally the operating vitreoretinal surgeon is also sued for negligent treatment of the endophthalmitis. Despite the myriad claims in the summons and complaint, these lawsuits almost always involve the allegation of a postoperative evening or late night telephone call by the patient to the surgeon or covering physician claiming that the patient made specific complaints that were consistent with endophthalmitis and that the physician failed to see the patient in a timely manner, thus depriving the patient of the opportunity for a better result. Some cases involve inadequate or no coverage when the primary physician is not available.
In the final analysis it becomes a question of contradictory statements by the parties involved. The problem for the defense is almost always the failure of the on-call physician to document the conversation by the following morning. Very often no note is made in the record for several weeks or until the lawsuit is instituted at which time the on-call physician writes a lengthy document attempting to note every complaint of the patient and every patient response to the physician’s questions. Juries are understandably not likely to put much faith in a document written so long after the fact, because it is unreasonable for them to expect the physician’s recall can be so exquisitely accurate so long after the occurrence.
The best and most powerful defense to an allegation of not seeing the patient is putting contemporaneous, detailed documentation in the chart by the following morning. It will probably discourage the plaintiff’s expert from advising a lawsuit, and it will certainly impress a jury favorably. It is logical to assume the reason many ophthalmologists do not remember to document these conversations is because they occur after office hours. The patient’s chart is unavailable, and often the patient complaints may seem minor. The telephone call may be from another physician’s patient with whom the on-call doctor is unfamiliar. Fortunately, when there is no reliable proof as to what was or was not said by either party, the jury tends to believe the ophthalmologist. Regardless of the severity of the injury, it is often difficult for the patient to prevail in these claims.
Choroidal Melanoma
The frequency of claims for misdiagnosis of lesions resembling melanoma or failure to diagnose a malignant choroidal melanoma is significantly less than that of previous
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years because of modern diagnostic techniques. Suspicious lesions, such as nevi or subretinal hemorrhages, should be carefully documented and monitored. If there is any doubt as to the diagnosis, patients should be referred for vitreoretinal consultation. Photographs in the patient’s chart are helpful for comparison on subsequent examinations. A more detailed discussion on this topic is presented in Chapter 17.
Miscellaneous
Claims of negligent diagnosis for prevalent vitreoretinal diseases, such as diabetic retinopathy, age-related macular degeneration, and retinal vascular disease, are uncommon.1
Medical Treatment
Topical Medications
Lawsuits involving treatment with topical medications are uncommon. The usual precautions, especially intraocular pressure monitoring and observation for cataract, should be taken and documented for prolonged treatment with corticosteroids. It is good practice not to prescribe antibiotics unless absolutely indicated. The appropriate tests should be ordered and the results documented for patients during extended therapy of any chronic problem if there is a risk of harmful local or systemic effects from the medication.
Periocular/Retrobulbar Medications
The usual precautions should be observed when delivering any anesthetic or therapeutic medication by injection anywhere around the exterior of the eyeball. This is discussed in Chapters 10 and 13.
Intraocular Medications
The recent off-label use of intravitreal corticosteroids for macular edema and antivasoproliferative or other drugs for choroidal neovascularization has raised new questions about medical ethics.9 Because the safety and efficacy of some of these medications have not been tested by well-designed clinical trials, an appropriate informed consent is indispensable with respect to ethics and risk prevention.
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Possible deleterious side effects, which may occur over a longer time, have also not been determined. This topic is covered in Chapter 13.
Laser Treatment for Diabetic Retinopathy
Background diabetic retinopathy, or proliferative diabetic retinopathy, is the most common retinal problem treated with laser. Lawsuits by patients undergoing focal, grid, or panretinal laser have been brought for every possible reason, including failure to treat, delay in treatment, initially treating the incorrect eye, and negligent treatment. Suits have been initiated for continued vision loss following treatment, failure to improve vision, and alleged decreased vision due to negligent treatment.2 All of these allegations are indicative of the need for an effective informed consent discussion.
Inadequate panretinal photocoagulation over an appropriate time interval allowing proliferative diabetic retinopathy to progress is not uncommon. Such delay may allow development of tractional retinal detachment and other complications requiring vitrectomy and unnecessary loss of vision that might have been obviated with adequate and timely treatment. Cases of a patient seeking the opinion of a second ophthalmologist following protracted neglect by the initial ophthalmologist have prompted attorneys to attempt to sue the second ophthalmologist because of the extensive advanced disease.
Laser and Medical Treatment of Age-Related Macular
Degeneration
Litigation has been brought by patients with age-related macular degeneration for many of the same reasons as for diabetic retinopathy. The poor visual prognosis for most cases of exudative age-related macular degeneration, problems unique to photodynamic therapy, and anti–vascular endothelial growth factor treatment with the frequent need for repeated treatment make an effective informed consent discussion essential for patient education. Many of the newer anti–vascular endothelial growth factor or off-label medications have shown a short-term relative benefit but no proven long-term success. What may seem a relative triumph in preservation or restoration of vision to the ophthalmologist may not represent useful vision to the patient and lead to dissatisfaction.
Laser Treatment of Arterial and Venous Retinal Vascular Diseases
Litigation for laser treatment for retinal vascular disease is uncommon. This may be related to the relatively better visual prognosis of this group of diseases.
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Laser/Cryotherapy Treatment of Retinal Tears
Failure or delay of treatment, negligent treatment, and improper choice between cryotherapy or laser has been alleged. It is important to discuss the choice of the therapeutic modality and the reason for not using others in the informed consent discussion.
Treatment of Central Retinal Artery Occlusion
There have been lawsuits for delay or failure to treat as well as negligent treatment of central retinal artery occlusion (CRAO) despite the fact that there is significant controversy regarding the timing of intervention and the efficacy of the therapy. Accurate assessment of pretreatment visual acuity is not always dependable, because some patients are so shocked by the sudden, severe loss of vision they may assume the eye is blind and do not look for residual vision. Some patients with a patent cilioretinal artery may eventually discover an island of vision and falsely assume it is the result of treatment. For risk prevention purposes as well as for optimal patient care, it is advisable to go through the steps of treatment for most patients who have been symptomatic for less than 24 hours. There have been lawsuits alleging failure to diagnose cranial arteritis in elderly patients with CRAO.
While CRAO has been reported secondary to pressure on the eyeball from improper facial support for patients undergoing spine surgery in the prone position, it can also occur in patients during lengthy prone positioning for surgery even with proper facial support. In these instances, if proptosis of the globe is noted in the recovery room the ophthalmologist has an opportunity for risk prevention by decompressing the orbit.10 Hypertensive patients often with diabetes mellitus or papilledema have developed CRAO and optic atrophy because the blood pressure was excessively lowered for prolonged periods during general anesthesia.
Treatment of Rhegmatogenous Retinal Detachment
Allegations of delay in treatment of rhegmatogenous retinal detachment (RRD) can be problematic for the defense. Although there are pilot studies suggesting similar visual results in detachments repaired after 1 day and after 7–10 days of macular involvement, there are no data from randomized, controlled studies for compassionate reasons. The evidence-based data for this situation are not extensive. Furthermore, good fellow eye vision and the element of denial are but some of the confounding problems in patient awareness of the symptoms of retinal detachment and dating the actual onset of macular involvement. It appears advisable not to delay treatment any longer than is necessary not only for humanitarian reasons but also because it can be
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difficult to convince jurors, many of whom believe that most retinal detachments are emergencies that a longer delay did not affect deleteriously.
Pneumatic retinopexy, scleral buckle, and pars plana vitrectomy are used to repair rhegmatogenous retinal detachments. Lawsuits have been brought for improper choice of technique. Patients have also sued for alleged improper choice of thermal reaction among diathermy, cryotherapy, and indirect laser. It is advisable to involve the patient in the choice of technique and the reasons for the surgeon’s choice.
The negligent use of intraocular gas with vitrectomy has resulted in devastating loss of vision in some patients. This is usually caused by excessive postoperative intraocular pressure, which may occur if an expansile percentage of gas is prepared by mistake or if an excessive volume of gas is injected. Failure to evaluate the intraocular pressure at the conclusion of a fluid–gas exchange or following an intraocular air or gas injection may also allow dangerous elevation of the intraocular pressure.
It is the surgeon’s responsibility to educate the patient receiving intraocular gas regarding head positioning, prohibition of air travel, and nitrous oxide use during anesthesia for emergency surgery. These warnings must be documented, preferably with a patient signature. Such documentation would have been a strong defense in a claim initiated by a patient who had a pneumatic retinopexy and lost light perception from obstruction of the central retinal artery during elective spine surgery with nitrous oxide anesthesia only 3 days later. The patient never told the vitreoretinal surgeon about the planned spine surgery. He never told the spine surgeon and the anesthesiologist about the gas, and they never asked. Contemporaneous documentation is often the difference between winning and losing these lawsuits.
Patients requiring one or more pars plana vitrectomies for proliferative vitreoretinopathy can elicit great sympathy from a jury as they recall their multiple procedures, weeks of face-down positioning, pain, and suffering. These experiences in combination with a poor visual result and the unfortunate cosmetic appearance of a hypotonous eye can bring a large monetary award in the event of a plaintiff verdict for a claim of negligent surgery. For these reasons an effective informed consent is a sine qua non. A caring, sympathetic vitreoretinal surgeon can assuage the anxiety and resentment of most of these patients.
Pars Plana Vitrectomy for Problems Other than Rhegmatogenous Retinal Detachment
Patients with more serious problems affecting vision, such as diabetic traction retinal detachment, choroidal neovascular membranes, acute retinal necrosis, and central retinal vein obstruction, typically have had poor vision for a significant period of time and thus may be relatively resigned to the state of monocular vision. If these patients participate in an effective informed consent discussion, litigation should be less likely in the event of minimal visual improvement or failed surgery. Patients experiencing poor monocular vision for only a brief period of time, as in endophthalmitis or
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rhegmatogenous retinal detachment, are understandably concerned and usually less prepared to cope with the concept of permanent monocular vision loss. These patients require all the caring the surgeon and staff have to offer. The necessarily abbreviated preoperative interval for development of the physician–patient relationship further compounds the problem.
Patients with relatively good preoperative visual acuity, as often seen with epiretinal membranes, macular holes, retained lens fragments after cataract surgery, and subluxated intraocular lenses, can be expected to have higher expectations for good vision and greater disappointment if it is not achieved. Because these procedures are relatively more elective, informed consent is of paramount importance. Documentation of the significant risk of postoperative cataract formation in phakic patients is essential.
Treatment of Intraocular Tumors
Treatment of intraocular tumors is discussed in Chapter 17.
Treatment of Retinopathy of Prematurity
Retinopathy of prematurity has perhaps the highest risk of litigation of any vitreoretinal disease. A large number of these young patients will have little or no vision despite optimal treatment, and treatment failures are not uncommon. Furthermore, in many states the statute of limitations can run for 15 to 20+ years, and thus many physicians are at risk of litigation in their retirement. Because awards for malpractice claims have escalated dramatically over the years, it can be expected that the award for a claim closed 15 to 20 years after the treatment will exceed the upper limit of the physician’s insurance coverage by a significant margin. A classic example of this is an ophthalmologist who was the only retina surgeon to practice in his area in the late 1950s. He volunteered to see the premature infants at no charge, as at that time health insurance for newborns was uncommon. Three years before he retired he was sued by a patient who was about to reach the age of 21 at which time the statute of limitations was to expire. The lawsuit alleged negligence when the baby was born in 1961 at which time the typical insurance coverage was $10,000. The claim, 20 years later, was for 2 million dollars. The lawsuit was eventually dropped but not before the retina surgeon lost 35 pounds and practically all of his hair. When these considerations are combined with the facts that management of this disease is time consuming and few if any of these patients have insurance, it seems unjust that the treating physicians are not accorded some form of immunity from litigation. This is especially true when the alleged complication for which the ophthalmologist is being sued occurred some years after he or she last examined the patient. Litigation in the management of this condition is discussed in Chapter 19.
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Conclusion
The poor visual prognosis for most vitreoretinal diseases carries a significant risk for reduced vision even with successful management. Vitreoretinal diseases are thus high risk diagnoses for both the patient and the treating physician. Effective risk management for the treatment of these patients begins with educating the patient through the process of informed consent, which should include the possibility of complications and of visual acuity that may be less than expected by the patient. A thorough explanation makes it more likely that the patient will be satisfied with or accept the final result. Complete contemporaneous documentation of warnings, prognoses, reciprocal patient responsibilities, and possible complications is powerful evidence in the event of litigation. If a competent, caring, sympathetic physician takes these steps, the risk of litigation will be effectively minimized.
References
1.Kraushar MF. Medical malpractice experiences of vitreoretinal specialists. Retina 2003;23:523–529.
2.Sorrel AL. Failure to diagnose is the No.1 allegation in liability lawsuits. AMA News 2006;49:8–9.
3.Kraushar MF, Turner M. Medical malpractice litigation in ophthalmology: the New Jersey experience. Ophthalmic Surg 1986;17:671–674.
4.Bettman JW. Ophthalmology: The Art, the Law and a Little Bit of Science. New York: Aesculapius; 1977:75.
5.Kraushar MF, Robb JH. Ophthalmic malpractice lawsuits with large monetary awards. Arch Ophthalmol 1996;114:333–337.
6.Kraushar MF. Medical malpractice litigation in the management of vitreoretinal diseases. Arch Ophthalmol 1987;105:187–190.
7.Arsenault v. McConarty, 21 Mass. L. Rptr, 2006;500.
8.Alton WG. Malpractice: A trial lawyer’s advice for physicians. Boston: Little, Brown; 1977:56.
9.Holekamp NM. The ethics of Avastin. Retina Times 2006;16:32.
10. Leibovitch I, Casson R, Laforest C, Dinesh S. Ischemic orbital compartment syndrome as a complication of spinal surgery in the prone position. Ophthalmology 2006;113:105–108.