New Surgical Advances Come with Liability Risks
By Daniel A. Long, MD, and Monica L. Monica, MD, PhD
Argus, April, 1996
Using foldable lens implants, ophthalmologists can perform true small incision surgery with less induced astigmatism, less postoperative inflammation, and a speedier return of visual acuity. Corneal tunnel phacoemulsification with topical anesthesia further enhances the benefits of this implant. However, along with these clinical advancements arise risk management issues concerning patient selection, informed consent and surgical training.
Patient Selection and Education
A patient undergoing corneal tunnel phacoemulsification with topical anesthesia should be informed that this is a relatively new technique presently used by only a minority of ophthalmologists. Encourage the patient to weigh this information against the overall clinical benefits experienced by other patients who have undergone this technique. Document in the chart the entire informed consent discussion and note any educational materials the patient receives. This documentation will make it difficult for a patient to later claim that he or she was unaware this was a relatively new technique.
Most postoperative problems with silicone lenses can be avoided with proper patient selection. Overall clinical experience is good, but a few reports have found increased postoperative inflammation. Use these implants with caution in patients with advanced diabetes mellitus, exfoliation syndrome, uveitis, and possibly glaucoma since cell deposits on any implants may be worse if these conditions are present. If silicone implants are used, discuss the risks and advantages with the patient and note the discussion in the chart.
Avoid silicone lenses if a vitrectomy is likely after cataract surgery because visibility during the vitrectomy and gas-fluid exchange will be hampered by condensation of tiny vapor bubbles on the posterior surface of the silicone lens. Take this into consideration during the preop evaluation.
Training and Experience
New procedures can be broken down into component parts and learned in steps until the entire technique is completely mastered. Providing evidence of successfully mastering a step before moving on to the next one can help insulate an ophthalmologist from claims that he or she lacked the necessary training or experience to perform the new technique. Should a claim turn into a lawsuit, defense counsel will be able to elicit testimony from the ophthalmologist regarding his or her careful and methodical approach to training.
Corneal tunnel phacoemulsification with topical anesthesia is an excellent example. The authors have developed the following seven steps for a successful transition to this new procedure. Ophthalmologists should perform at least five cases for each step and more for any that are particularly difficult, such as step two.
- Change to a silicone lens.
- Change to a temporal location.
- Change to corneal incision.
- Eliminate traction sutures.
- Eliminate lid blocks.
- Change to subtenons injection.
- Begin topical anesthesia.
Whenever possible, observe and assist a more experienced surgeon who performs this technique. This helps weaken the plaintiff’s claim that the surgeon lacked proper training.
Finally, with any new technique, evaluate and adjust the postoperative regimen, if necessary. For instance, with topical anesthesia, pressure control is extremely important to prevent postoperative pain. Therefore, meticulously remove viscoelastic material and consider the use of intracameral acetylcholine, topical beta blockers and apraclonidine, and oral acetazolmide. Be particularly aggressive about pressure control in the glaucoma patient.
Ocular Regional Anesthesia: Who Should Inject?
By E. Randy Craven, MD
Argus, March 1997
Administering anesthesia blocks for ophthalmic surgery used to be the almost exclusive domain of the ophthalmologist; however, more and more anesthesia personnel are now performing blocks, in part because of economic and efficiency pressures. A 1994 survey of more than 557 anesthesiologists indicated that 23% were performing eye blocks.
Eye blocks present a number of possible complications, including globe perforations, optic nerve damage, arterial or venous occlusions, and intraocular hemorrhage. Additionally, anesthesia risks include brainstem anesthesia, respiratory arrest and seizures. Because of these risks, most ophthalmologists do not dispute the necessity of having anesthesia personnel present when blocks are given. The question that arises is: Should anesthesia personnel administer local ocular anesthesia or is it best handled by the ophthalmologist?
Although there may not be one right answer to this question for all situations, it is useful to analyze the potential risks involved when using anesthesia personnel to administer local ocular anesthesia. According to the theory of vicarious liability, physician liability may exist if during surgery the physician “controls” the actions of his or her assistants, including nurses and even other physicians. Generally, the anesthesiologist and Certified Registered Nurse Anesthetist (CRNA) are considered specialists whose authority within that field is superior to that of the ophthalmologist; thus, the ophthalmologist would not control their actions and vicarious liability would not apply. The administration of local ocular anesthesia presents a truly unique situation, however, since an ophthalmologist’s training and experience in this regard may be superior to that of anesthesia personnel. Furthermore, the ophthalmologist is likely to have a better understanding of a particular patient’s eye, such as axial length and history of retinal buckle, and to be in a better position to determine the safest anesthesia technique for the patient in question. Under some circumstances, the ophthalmologist may actually order the type anesthesia he or she prefers. Finally, if an intraoperative complication does occur, such as globe perforation, the ophthalmologist is uniquely qualified to handle this complication.
Given these unique circumstances, it is prudent for the ophthalmologist to use a team approach when deciding to delegate blocks to anesthesia personnel. The ophthalmologist should first assess the anesthesia personnel’s knowledge of ocular anatomy, ability to recognize and prevent complications from anesthesia, and experience performing retrobulbar or peribulbar blocks. Medical malpractice claims adjusters who represent anesthesia personnel indicate that complications are most likely to involve anesthesia personnel who are less experienced giving ocular blocks. On the other hand, anesthesia personnel at eye clinics or surgery centers that routinely perform a large number of blocks per week probably have expertise superior or equal to that of the average ophthalmologist.
The ophthalmologist should be sure to convey to the anesthesia personnel any eye anatomy data specific to a patient undergoing a block. Finally, depending upon the relationship with the anesthesia personnel (e.g., an employed CRNA), the team approach could include special training by the ophthalmologist. In all cases, there should be ongoing dialogue between the ophthalmologist and anesthesia personnel and frequent reassessment of the methods used and results obtained. Should a claim arise in a case where anesthesia personnel administered an ocular block, a team approach would generally be viewed as part of the collaborative nature of medicine and in the best interests of the patient.
Take the Risk Out of Intraocular Surgery in Patients with Corneal Dystrophies
By Dean C. Brick, MD
Argus, April 1997
Corneal complications of cataract surgery are uncommon and rarely result in professional liability claims. In a recent review of 130 cataract related closed claims from OMIC’s files, only 9 (7%) could be related to corneal complications of cataract surgery. The causes of these claims included corneal edema, corneal burns after phacoemulsification, detached Descemet’s membrane, and corneal ulcers. Of these 9 claims, only 2 (1.5% of total cataract-related claims) resulted in indemnity payments to the plaintiff and, in both cases, the primary cause was not a corneal complication but a surgical complication necessitating a second procedure after which corneal edema developed.
Corneal dystrophies can make visualization during cataract surgery more difficult and result in a higher rate of other complications in these patients. However, despite the frequency of corneal dystrophies in the cataract population, corneal claims are relatively infrequent following cataract surgery. The reason for this dichotomy may be that while most professional liability claims arise because of unexpected outcomes, the findings of a corneal dystrophy are readily visible preoperatively. This allows the ophthalmologist to prepare the patient for possible complications and adverse outcomes and to obtain the proper informed consent, thereby preventing many potential liability suits.
Discuss and Document Preoperative Corneal Findings
While it is not always possible to predict which patients will develop corneal edema or other corneal complications following cataract surgery, the following guidelines may help prevent or mitigate litigation. First, document any corneal findings in the preoperative exam, especially evidence of edema, guttata or other dystrophic changes (such as increased corneal thickness, or pachymetry). Specular microscopy may help document the preoperative condition but is not necessarily a good predictor of endothelial function. If there is evidence of endothelial compromise, make a note in the chart that the increased risks of surgery were discussed with the patient. If you anticipate the possibility of reduced visualization during surgery, discuss this with the patient and document it in the chart.
Second, use your judgment and experience to determine if corneal surgery will be required, and if so, whether it should be performed before, after, or in conjunction with cataract surgery. There are no absolute guidelines because so much depends upon the visual requirements of the patient and other factors unknown preoperatively. If necessary, obtain a second opinion from a cornea specialist or other cataract surgeon.
Use Trusted Surgical Techniques
Third, during surgery, use the techniques you feel will have the least risk of causing further endothelial compromise and document which techniques you used in the operative report; e.g., type of viscoelastic agent or incision used, type of emulsification technique, the use of irrigation or other intraocular drugs, etc. If complications arise during surgery, document your recognition of the complications and the steps taken to minimize their effects. In spite of these precautions, some individuals will unexpectedly develop corneal edema postoperatively. In some instances, this has been traced to preservatives and cleaning solutions retained in the cannulas; therefore, it is imperative that the OR staff notify the ophthalmologist if cleaning procedures are altered and that intraocular medications be used only when necessary.
Finally, if a corneal complication does develop during or after surgery, do not attempt to conceal it from the patient. Discuss it with the patient and obtain a timely consultation from a cornea specialist. Not only does early intervention improve the likelihood of a better outcome, but demonstrating concern for the patient’s welfare can diffuse the anger that leads to litigation.
Delay in Diagnosis Key to Endophthalmitis Claims
By Kirk H. Packo, MD
Argus, July 1997
Although endophthalmitis is an accepted rare complication of cataract surgery, it remains a common cause of malpractice claims. Of all claims related to retina-vitreous complications of cataract surgery, endophthalmitis heads the list over other problems, such as dropped lens nuclei and IOLs, expulsive hemorrhage, needle perforation, vascular occlusion, and cystoid macular edema. Endophthalmitis claims filed with OMIC over the past 10 years universally were associated with a poor visual outcome. While it is true that a poor visual result following an accepted complication does not automatically imply malpractice, it definitely invites a closer look from a plaintiff’s attorney.
The Endophthalmitis Vitrectomy Study (EVS), a randomized trial studying the treatment of postoperative bacterial endophthalmitis, showed that management of postcataract infection can result in a reasonable visual outcome. Indeed, 74% of patients managed in the EVS obtained a final visual acuity of 20/100 or better, with 53% achieving 20/40 or better. Still, 26% of patients ultimately ended up with poor final vision, and it is this group that presents the greatest potential liability for the ophthalmologist. (Archives of Ophthalmology, December 1995; 113: 1479-96.)
Initial Acuity Important Predictor
An important predictor of poor visual outcome for all treatment groups in the EVS was the initial presentation acuity. Eyes with worse initial acuity ultimately ended up with worse final vision regardless of the treatment method employed. One-quarter of the eyes managed in the EVS presented with light perception only vision, and this group as a whole ultimately did worse than the remaining 75% presenting with acuity of hand motion vision or better. It stands to reason that from a risk management standpoint alone, one would want to diagnose and treat patients before they have dropped to the light perception only level. The EVS was set up to compare the efficacy of vitrectomy with injection of intravitreal antibiotics vs. vitreous tap/biopsy alone with injection of intravitreal antibiotics. Vitrectomy was found to be superior to tap/biopsy only in the group presenting with light perception only vision. A less invasive vitreous tap/biopsy was equally effective as vitrectomy for the larger group presenting with hand motion or better initial acuity. The EVS thus demonstrated that a more aggressive vitrectomy procedure should be utilized in light perception only patients which, as previously noted, is the group with the largest potential liability.
Delay in Diagnosis Key
The time delay from onset of symptoms to referral to a retinal specialist also correlated with bad initial acuity. Of patients enrolled in the EVS, 26% presented without pain and another 14% presented without hypopyon, two usual “hallmarks” of endophthalmitis. Delaying the diagnosis, particularly in patients who have no pain or hypopyon, “hoping that the postop inflammation will go away” can have disastrous implications for the patient’s final vision. Most OMIC endophthalmitis claims that have settled with indemnity centered on delay in diagnosis as the key element.
Many patients enrolled in the EVS had the use of various routes of preop and intraop antibiotics such as topical, subconjunctival, and within the infusion fluid. While the EVS was unfortunately not set up to determine risk factors for endophthalmitis, it is clear that the use of pre- and intraoperative antibiotics does not totally prevent the occurrence of postop infection. Individual surgeons still must establish their own standard of care for the use of prophylactic antibiotics. The EVS has clearly demonstrated, however, that the use of intravenous antibiotics as utilized in the study is unnecessary in the management of post cataract endophthalmitis.
Endophthalmitis is a potentially devastating complication of intraocular surgery. The mere occurrence of endophthalmitis alone, despite its acceptance as a recognized complication of cataract surgery, still may invite an attempted malpractice claim. The key to success in avoiding liability in these cases is to try to obtain the best final visual outcome possible. The EVS has given ophthalmologists several key risk management principles in this regard.
Retina Claims Pay Fewer But Costlier Indemnities
By Arthur W. Allen, MD, and Paul Weber, JD
Dr. Allen is Chairman of OMIC’s Board of Directors and Claims Committee. He is a retina specialist in San Francisco, CA. Mr. Weber is OMIC’s Risk Manager.
Digest, Fall 1999
Almost half of all claims brought against OMIC insureds involve either retina or cataract procedures. From 1987 through mid-1999, OMIC counted 120 closed claims related to the retina (not including ROP claims), or 16% of 742 closed cases, compared to cataract’s 224 claims, or 30% of the total. Of the 120 retina claims, 94 (78%) were brought against retina subspecialists and 26 (22%) were brought against general ophthalmologists and others. Most often, retina claims arose from complications of lasers (33 claims), vitrectomies (31), and scleral buckles (24), or failure to diagnose and/or timely treat a retinal detachment or macular degeneration (25).
As with most OMIC claims, retina claims are usually resolved without a payment to the plaintiff. In fact, retina claims settle slightly less often with a payment to the plaintiff than the average OMIC claim: 20% for retina versus 24% for all OMIC claims. Yet the average retina indemnity payment of $142,000 is 20% higher than the $114,000 average for all OMIC claims. One would expect a high indemnity payment to correlate to the severity of the patient’s visual loss. However, in six of OMIC’s twelve large loss payments (over $100,000), the plaintiff had reasonable vision after the alleged negligence of the insured, but the facts and circumstances surrounding the alleged error by the insured (rather than the visual loss) made the case too risky to bring to trial. Often, in claims against vitreoretinal subspecialists, the “errors” seemed to arise from lapses in pre and postoperative care, while many of the general ophthalmologists appeared to be performing a procedure or surgery beyond their perceived skill and expertise.
In four of the five large loss retina claims against general ophthalmologists, the injury occurred because the ophthalmologist failed to properly treat a retinal condition, apparently due to the alleged limited knowledge of treatment principles for such conditions.
Pushing the Skills Envelope
Case #12 (see Table) is illustrative of this problem. A primary care physician referred the plaintiff to the insured after she hit her head and left eye during a fall at home. She did not see the insured until two months after the injury, at which time she complained of blurred vision and foreign body sensation OS for two months duration. Examination revealed visual acuity of 20/30 OD and CF, 2 feet OS. External and SLE examinations were normal and the IOP was 20/19. However, fundoscopic examination revealed a vitreous hemorrhage in the left eye. The insured treated the patient conservatively by patching the left eye to allow the blood to reabsorb.
The patient returned two weeks later for follow-up. The hemorrhage had cleared slightly and her vision had improved to 20/400. The insured performed a pars plana vitrectomy the following week. Postoperative vision was 20/60 and the patient appeared to do well; one week postop, however, it was noted that she had a retinal detachment with HM vision. The insured attempted to repair the retinal detachment by performing a scleral buckle procedure. Vision improved to 20/100, but the retina re-detached and another scleral buckle was performed, again unsuccessfully. The patient was then referred to a retinal specialist. Three more unsuccessful repairs were attempted. The patient was left with a retinal detachment and vision of bare light perception in the eye. There was no further recommendation for treatment.
Three physician experts retained on behalf of the insured were of the opinion that the insured was not qualified to perform a retinal detachment repair despite some limited training in this procedure. These experts also were of the opinion that most general ophthalmologists would not have attempted to perform the vitrectomy and would have referred the patient to a vitreoretinal specialist right away. One expert opined that the insured did not have the necessary equipment (endolaser and air fluid exchange equipment) to properly perform a retinal detachment repair. Lacking expert support for the insured, the case was settled prior to trial.
Dropping the Ball Postop
In four of the large loss cases against vitreoretinal subspecialists (see Table), the allegations involved errors in diagnosing a post-vitrectomy or scleral buckle complication. Often, it was lack of documentation of communication with the patient that played a key role in determining the outcome of the case.
In case #3, a patient had retinal surgery on Thursday, including a fluid gas exchange (FGE), for repair of a large retinal tear. On Friday, the insured released the patient from the hospital with the retina totally reattached and pressures within normal limits. On Saturday, the patient called the insured, who received the call on his car phone, and said her eye felt “different.” When asked if she was experiencing stomach upset, nausea, vomiting or eye pain, the patient said no. The insured reminded her he would be out of town that weekend, but his partner would be covering for him if she had any problems. He did not document the call. On Sunday, the patient called again and was referred to the ophthalmologist’s partner (also an OMIC insured) who took the call at home. The patient complained of seeing “black” and feeling pressure. Since the patient was now three days postop and was on Neptazane and Prednisone, the partner was not too concerned that she was feeling some pressure. He told her to come to the office the next day but did not document this conversation.
On Monday, when the patient presented at the office, IOP was 60, visual acuity was no light perception, and the lens and iris diaphragm had shifted forward, flattening the anterior chamber. She eventually lost the eye and needed an enucleation. The patient filed a lawsuit against both ophthalmologists, alleging that she had complained of “pain” during her telephone conversations with them and that their failure to promptly treat the condition resulted in the loss of her eye.
Defense experts were supportive of the clinical care given to the patient with the possible exception of not seeing her on Sunday. However, the plaintiff made a very credible and sympathetic witness, and there was no documentation to support either physician’s version of what was said during their telephone conversations with her. It was decided to settle on behalf of both insureds, rather than go to trial and risk a jury’s perception that they did not respond to the patient’s plea for help in a timely manner.
Going to Trial
Only three retina-related lawsuits have gone to jury trial and OMIC won two of them. The third case resulted in OMIC’s largest retina-related indemnity payment to date, a $675,500 jury verdict. Even though the visual outcome after vitrectomy surgery for a rhegmatogenous retinal detachment with a large retinal tear was good (20/60), the jury was angry at the ophthalmologist for allegedly delaying treatment by asking for payment from the patient prior to the procedure (see Table case #1).
During a medical malpractice trial, the professional ethics and credibility of the physician are under intense scrutiny by the jurors. Not only does the physician need to possess irreproachable ethics, but any perceived lack of credibility can doom the defense. Although the defense was able to argue that the ophthalmologist in this case followed the standard of care in performing the two RD surgeries, plaintiff’s counsel successfully attacked the defendant’s credibility and judgment on two issues: the alleged demand for prepayment and the reason for the delay in surgery. This case might have been successfully defended on clinical issues alone; however, the associated nonmedical issues were extremely damaging to the defense and most likely contributed to the high jury award.
In the other two jury trials, lack of informed consent was the driving issue. An analysis of how informed consent played a factor in one of these cases can be found in the Closed Claim Study on page 6. Ophthalmologists and their staff who are interested in procedure specific forms should visit the forms and documents section of OMIC’s web site at http://www.omic.com/resources/risk_man/forms.cfm for retina surgery and laser procedure forms.
