Injectable Anesthesia – How Risky Is It?

By Dean C. Brick, MD

Digest, Spring 1998

It remains one of the most dreaded events in ophthalmic surgery. The eye is prepped for retrobulbar anesthesia. The injection is attempted, but the patient moves and the surgeon is unable to accurately gauge the position of the needle and perforates the globe. Surgery is canceled and attention turns to managing the ensuing complications. Despite prompt treatment and follow-up, the patient’s visual outcome is 20/400.

Fortunately, such events are uncommon, and improved techniques for administering local anesthesia to the eye have some practitioners questioning whether they should occur at all. Others suggest it may be time for a new standard of care so local ocular anesthesia is no longer the potentially riskiest part of routine cataract surgery.

But is injectable anesthesia so risky? While it’s true that regional injection is implicated in 87% of all anesthesia claims against OMIC insureds, this is to be expected given that it is the most common method of anesthesia used in ophthalmic surgery. A review of 598 closed and 218 open OMIC claims showed that over a 10-year period only 31 claims were filed because of complications from all types of ophthalmic anesthesia. Compare this to cataract surgery, which accounts for one-third of OMIC claims, or to retinal cases, which make up 17% of the total.

Reported complications following injectable anesthesia include needle perforation, orbital hemorrhage, central retinal artery occlusion, central retinal vein occlusion, optic atrophy and diplopia. Needle perforation of the globe is the most common complication, accounting for 19 of the 53 claims related to ophthalmic anesthesia in this review, 31 of which are OMIC and 22 non-OMIC. The clinical outcomes of these 19 needle perforation cases reveal that most were associated with a poor visual outcome; of course, it should be recognized that patients with a good visual outcome are less likely to file a claim in the first place. Seven of these cases occurred during the administration of peribulbar anesthesia and 12 during retrobulbar anesthesia. Patients who had a perforation from a peribulbar injection tended to do better than those whose perforation resulted from a retrobulbar injection.

In 12 cases, the perforation was recognized prior to surgery, the case was canceled and the patient was referred to a retinal specialist. These cases were analyzed separately to see if this had any affect on visual outcome, but there was no indication among this small group of patients that their outcomes were any better than those in whom the perforation was not recognized until postoperatively.

Three of the 19 needle perforation cases closed without payment; six settled for an average indemnity of $145,000; two non-OMIC cases resulted in plaintiff verdicts averaging $1.9 million; four closed with defense verdicts; and four remain open. Closer examination reveals final vision better than 20/100 in all three cases closed without payment and weak causation arguments or limited damages in the four defense verdicts. Pre-trial settlements and plaintiff verdicts were more likely when the patient suffered decreased vision or lost visual field as a result of the needle perforation.

Poor Outcomes Follow Retrobulbar Blocks

Other complications related to injection of local anesthesia in this review included six cases of retrobulbar hemorrhage, five cases of optic neuropathy, five cases of vascular occlusion, six deaths, two seizures and three miscellaneous complaints. Of the six patients suffering retrobulbar hemorrhages, all had retrobulbar blocks and five had poor visual outcomes (< 20/200). One patient was on Coumadin at the time of surgery; another was a hemophiliac who did not receive factor 8 before or after surgery and suffered a delayed hemorrhage after leaving the surgery center. In several cases, a lateral canthotomy was performed following the hemorrhage and in another the orbital hemorrhage was drained, but despite these measures, there was a poor visual outcome in all cases. Four of the six cases had closed at the time of this review, three without payment and the fourth settled for an undisclosed amount.

All five cases of optic neuropathy followed retrobulbar anesthesia and all had poor visual outcomes. Four of the cases closed with defense verdicts and one non-OMIC case closed with a plaintiff verdict of more than $500,000. Four of the five cases of diagnosed or presumed central retinal artery occlusion following retrobulbar injection had poor visual results. One of these closed with a plaintiff verdict for $225,000 and three closed without payment. Both seizure cases were canceled and closed without payment as the patients suffered no residual damage. The three miscellaneous complications following retrobulbar injection included a serious stroke, diplopia and persistent facial numbness. Two of the cases closed without payment; the other remains open.

In almost every instance of death following local anesthesia injection, the patient was seriously ill at the time of the procedure: a post-cardiac transplant patient, a uremic patient on dialysis, an alcoholic patient with liver failure, and two patients with poorly controlled diabetes. Cardiopulmonary arrest was the stated cause of death in five of the six cases. One patient who had received large amounts of antihypertensives to treat elevated blood pressure during the procedure became very hypotensive following the procedure and arrested. The uremic patient who died at home later that night was found to have elevated serum potassium. Four of the six cases were settled and two closed without payment.

The anesthesiologist was the primary target in most of these cases; however, the ophthalmic surgeon was involved in some of the settlements as well.

Other Techniques Present Risks Too

These findings remind us that claims against ophthalmologists also arise from the use of general and topical anesthesia. Of five cases involving general anesthesia, two patients died following the anesthetic, one suffered an expulsive hemorrhage after gagging on the endotracheal tube, another suffered a transient ischemic attack, and the fifth developed adult respiratory distress syndrome. The last two patients fully recovered and their cases closed without indemnity while the expulsive hemorrhage case was settled with the anesthesiologist for $135,000. In the two cases involving topical anesthesia, the patients experienced suprachoroidal hemorrhages and had poor visual outcomes. A defense verdict was delivered in one case and the other settled for $150,000.

In summary, OMIC has experienced 31 cases related to ophthalmic anesthesia over the past 10 years. This represents only about 4% of all claims and is a small part of the 33% of claims related to cataract surgery, indicating that ophthalmic anesthesia needn’t be considered the riskiest part of cataract surgery. No standard of care exists with respect to choice of anesthetic technique and serious complications can occur with each method of anesthesia. The surgeon should choose the technique best suited to the needs of the patient and most appropriate for the procedure.

Risk Reduction Guidelines for Ophthalmic Anesthesia

1. Stay alert to symptoms (sudden loss of vision or severe pain) and signs of needle perforation (hypotony, decreased red reflex, vitreous hemorrhage, hyphema or increased intraocular pressure) when administering injections around the eye.
2. If a perforation is recognized, abort the procedure, advise the patient of the complication and obtain an immediate retinal consult. A patient whose complication is recognized and treated early may have a better final outcome.
3. Consider general, topical or blunt cannula local infiltration anesthesia in high-risk patients, i.e., high myopes, patients with prior scleral buckling or patients with a bleeding tendency, but remember these alternatives carry their own risks.
4. The ophthalmic surgeon may be held liable for damages even if an anesthesiologist or CRNA administers the anesthesia. Ascertain and document that the anesthesiologist or CRNA is adequately trained to give ocular injections and alert them to any risk factors that might increase the possibility of needle perforation such as increased axial length, previous scleral buckle or posterior staphyloma.
5. Consult with the patient’s primary care physician in cases where the severity of a pre-existing condition or illness could increase the patient’s anesthesia risks and document that you did so.
6. Needle perforation is a rare but potentially serious complication of local anesthesia injection and may be explained as such in the informed consent discussion or document.

Coumadin and Ocular Anesthesia

By Paul Weber, JD

Digest, Spring 1998

Recently, I took an incident report from an insured who stopped a patient’s Coumadin five days prior to surgery. Two days after surgery, the patient suffered a devastating stroke. The specific risks of discontinuing Coumadin were not discussed with this patient prior to surgery. It was the first time an incident of this kind was reported to OMIC, although the question of whether to stop Coumadin prior to cataract (or intraocular) surgery has come up a number of times. Quite often, an important risk management issue such as this one will raise both clinical and legal issues. When this occurs, we are fortunate to be able to collaborate on the clinical issues with ophthalmologists from OMIC’s Board and Committees.

In this case, Risk Management Committee Chairman Dean C. Brick, MD, a cornea specialist in Tucson, addressed the prevalent clinical issues. We realize this is a controversial topic and would appreciate hearing from our readers on this one.

Q  Should I discontinue a patient’s Coumadin prior to cataract (or intraocular) surgery?
A  This is a difficult situation since Coumadin puts both patient and surgeon at increased risk. If you continue the patient on Coumadin, you risk being sued if the patient develops bleeding problems. If you discontinue the Coumadin and the patient suffers a stroke, you may be sued for not advising the patient of the risks involved in stopping the medication. Two critical decisions must be made in these patients.

The first is whether the patient needs to be maintained on full doses of Coumadin prior to and during surgery. In many cases, patients are on Coumadin for prophylactic reasons and may safely discontinue it for a few days prior to surgery to allow the INR to decrease but not to a normal level. This option should be discussed with the primary care physician monitoring the patient’s anticoagulant and the discussion and decision reviewed with the patient and documented in the chart. If the decision to stop Coumadin is made, routine technique and anesthesia (including retrobulbar anesthesia) are appropriate.

Q  What surgical technique or anesthesia should I use in patients whose anticoagulant cannot be discontinued or decreased such as those with artificial heart valves?
A  This leads to the second critical decision: Should you change your technique of surgery or anesthesia? If a patient’s INR remains significantly elevated prior to surgery, the patient faces the risk of retrobulbar hemorrhage following retrobulbar or peribulbar anesthesia as well as the possibility of a more severe suprachoroidal hemorrhage. It might seem that topical anesthesia would be the technique of choice in these cases; however, OMIC has had two cases of suprachoroidal hemorrhage associated with topical anesthesia in which the patients complained of pain during surgery. It was alleged that the patient’s pain and discomfort resulted in elevated blood pressure and hemorrhage. Even though there are still risks of complications, topical anesthesia is probably the technique of choice for such patients provided the physician and anesthetist are experienced with its application.

If not, the surgeon should refer the patient to a surgeon who is experienced with this technique or modify his or her technique to fit the circumstances.

Q  If after weighing the options, it is decided that injectable anesthesia is the technique to use on a patient, how can I minimize the risk of complications?
A  Use a Greenbaum cannula or blunted needle to administer the anesthetic. A prolonged massage following the injection will prevent the formation of a large hemorrhage, which would compromise circulation to the globe or optic nerve. Closely observe the patient for signs of hemorrhage prior to, during and after surgery. Provide instructions before the patient leaves the hospital on how to recognize the signs of hemorrhage and how to contact you if any of these symptoms occur. Always be prepared to respond to emergencies. There are health risks to the patient and concomitant liability risks to the surgeon with any decision in situations like this. Discuss all the options and risks with the patient and document the reasons for the final decision in the chart.

Anesthesia and Sedation Risks and Precautions

By Carol Poindexter, JD, and Kimberly Wittchow, JD

Ms. Poindexter is a partner with the international law firm of Shook, Hardy and Bacon LLP specializing in health law.

Ms. Wittchow is OMIC’s staff attorney.

Digest, Summer/Fall 2004

Use the Download option in the toolbar above view the chart  titled “Monitoring and Recovery Equipment for Office-Based Anesthesia” mentioned in this article.

Advances in science, technology, and training, combined with reimbursement pressures by third party payors, have had the effect of moving the vast majority of ophthalmic procedures from hospitals to freestanding ambulatory surgery centers (ASCs) and office-based facilities. While this change has generally benefited ophthalmologists and their patients, there are concerns about compromised patient safety and increased physician liability when sedation and anesthesia are administered outside the hospital setting. The first section of this article outlines several risk avoidance practices that can help ophthalmologists, especially those operating in office-based settings, maximize patient safety and minimize sedation and anesthesia-related liability risks.

In some cases, sedation or anesthesia may be administered by an anesthesiologist or other qualified anesthesia provider, such as a certified registered nurse anesthetist (CRNA). Federal and state guidelines often require that in hospital and ASC settings, the treating surgeon supervise the CRNA. The second section of this article addresses the surgeon’s supervisory role and how it affects liability risk.

While hospitals and ASCs are typically closely regulated by accrediting agencies, the office-based surgical setting is currently only regulated in a handful of states. If surgeons do not follow reasonable and published guidelines for office-based surgery and sedation, there is an increased risk that procedures may be performed in settings lacking the appropriately educated and trained clinical staff and/or sufficient equipment and emergency protocols to handle adverse reactions to sedation or anesthesia or other emergencies that may arise. Administering sedation and anesthesia without adequate experience or equipment can have devastating consequences.

Precautions for In-Office Procedures The decision to perform a procedure in an office-based setting should only be made after careful evaluation. The surgeon is responsible for conducting or reviewing an appropriate physical exam and formulating and prescribing a written patient-specific plan for sedation or anesthesia care that addresses fasting requirements and treatment locale. Because it is impossible to accurately predict how each patient will respond to sedation or anesthesia of any type, and given the fact that the physician and office staff may be called upon to rescue the patient if an adverse reaction occurs, all staff should be thoroughly trained in emergency treatment protocols. The surgeon and other clinical support staff should be certified in Basic Life Support (BLS); Advanced Cardiac Life Support (ACLS) or Pediatric Advanced Life Support (PALS) certification is ideal.

To address patient safety con- cerns, the physician must have an adequate number of competent, professional staff members available to monitor the patient during the sedation. The person responsible for monitoring the patient during the procedure cannot be the same one performing it. This person should be familiar with the medications used; know how to recognize airway obstruction and correct it; know how to monitor the required para- meters, recognize abnormalities in them, and intervene; and be able to manage ventilation with a self- inflating bag valve mask. Additionally, all staff members who will be involved in patient care duties must meet all licensure and certification requirements; have sufficient experience to perform their duties; and be supervised by the operating surgeon or other licensed physician throughout the peri, intra, and postoperative/anesthesia periods.

Upon completion of the surgical procedure, the ophthalmologist who administered or medically directed the sedation should evaluate the patient prior to transferring the care to a qualified licensed nurse. The nurse assuming care of the patient should be qualified to identify surgical and sedation or anesthetic complications that might occur during the postoperative period. The patient should be sent home only after discharge criteria are met and in the company of a competent adult. (For more information on office-based sedation, see Hotline article.)

Supervision of CRNAs at Hospitals and ASCs In ASC and hospital settings, ophthalmologists are often required to supervise nurse anesthetists and sign various anesthesia-related orders, evaluations, and reports. This has raised questions about the ophthalmologist’s exposure to claims based on the actions of the CRNA.

Under federal law, it is a condition of participation in the Medicare and Medicaid programs for ASCs that a non-physician anesthetist be under the supervision of the operating physician. The requirement for hospitals varies slightly in that a CRNA must be under the supervision of the operating practitioner or an anesthesiologist who is immediately available if needed.

States may request that their ASCs and hospitals be exempted from this supervision requirement. According to the American Association of Nurse Anesthetists’ web site, however, the only states that had opted out of the federal supervision requirement as of November 2004 were Alaska, Idaho, Iowa, Kansas, Minnesota, Montana, Nebraska, New Hampshire, New Mexico, North Dakota, Oregon, and Washington. If your state is not on this list, there is likely a state law that either mirrors or expands upon the federal provision. See your state government, state medical society, or nurse anesthetists’ association web sites for more information.

Proving Supervision Has Occurred

The Centers for Medicare & Medicaid Services (CMS) do not define or specify how to prove supervision. Nevertheless, having the supervising physician sign certain anesthesia orders, evaluations, or records may be the simplest way for the ASC or hospital to confirm that supervision has occurred.

It is OMIC’s understanding that the role of the treating physician, in relation to the provision of anesthesia services, is to (1) determine whether a patient requires the surgery or diagnostic procedure, (2) request that anesthesia be administered, and (3) determine that the patient is an appropriate candidate for the procedure and anesthesia. Therefore, it is not uncommon for the treating physician to be asked to sign perioperative orders for anesthesia, sedation, and anxiolytic drugs and to co-sign the pre-anesthesia evaluation conducted by the nurse anesthetist in addition to signing the record of the operation prepared by the circulating nurse as well as the dictated operative report. It is less common, however, for the surgeon to sign the anesthesia record. If asked to do so, the ophthalmic surgeon may wish to clarify with the ASC or hospital the reason for this requirement, since proof of the surgeon’s presence and/or supervision during the procedure should be ample from the aforementioned signed orders, co-signed pre-op evaluation, and/or operative records.

Liability for the Actions of CRNAs

Depending on state law, you may be held vicariously liable under the doctrine of “respondeat superior” for the actions of nurse anesthetists who are your employees. Also termed the “master-servant rule,” this doctrine holds that an employer is liable for the employee’s wrongful (or negligent) acts committed within the scope of employment.

If you supervise nurse anesthetists who are not your employees, however, you are not necessarily liable for their actions. Courts generally focus on the amount of control the treating physician exercises over the anesthesia provider to determine whether the physician should be liable for the anesthetist’s actions (whether the anesthetist is a CRNA or an anesthesiologist). The fact that you sign certain anesthesia orders, evaluations, or records might be used by a plaintiff’s attorney to attempt to prove control, but without further evidence, it would doubtfully be sufficient.

Similarly, the fact that you are required to supervise nurse anesthetists’ provision of services during a procedure does not, by itself, create an employer-employee relationship, nor does it prevent you from maintaining independent contractor relationships with them (or no formal relationships at all, such as in a hospital setting). The substance of the relationship, not the label, governs the nurse anesthetist’s status as an employee or independent contractor. In order to determine whether a CRNA would be considered an employee, there are several factors to consider:

Do you have a right to direct and control how the nurse anesthetist does the task for which he or she was hired? An employee is generally subject to the employer’s instructions about when, where, and how to work.

Does he or she bill separately for his or her own services? Independent contractors are more likely than employees to have non- reimbursed expenses and to bill separately for their own services.

Is there a written contract describing the relationship of the parties? Do you provide the nurse anesthetist with benefits, such as insurance, a pension plan, vacation pay, or sick pay? Is his or her compensation subject to withholdings for income taxes, unemployment, or workers’ compensation? Whether under contract or not, an employee often will receive benefits and his or her compensation is subject to withholdings.

An ophthalmologist’s supervision of one portion of the nurse anesthetist’s provision of services is not determinative of the nurse anesthetist’s employment status. Rather, it is only one of many factors used to determine the nature of the relationship.

OMIC’s policy covers its insureds for liability arising from the supervision of nurse anesthetists (subject to all policy conditions and exclusions). It is your decision whether to seek less responsibility for CRNA supervision at ASCs or hospitals.

Message from the Chairman: Retrobulbar and Periorbital Ocular Blocks

One of the many benefits of the close relationship between OMIC and the Academy is the ability to coordinate our efforts to address legal, regulatory, and quality of care issues of common concern. Recently, OMIC and the Academy joined forces to stop legislation that would have adversely affected ophthalmic practice in two states.

In March, OMIC responded to a request from Academy EVP/CEO, David Parke, MD, to help the Washington Academy of Eye Physicians and Surgeons (WAEPS) respond to a proposed state Medical Quality Assurance Commission (MQAC) regulation that would characterize retrobulbar and periorbital ocular blocks as anesthesia “where significant cardiovascular or respiratory complications may result.” Such a characterization would require every ophthalmology office that administers anesthetic blocks to undergo an accreditation or certification process similar to that of the Accreditation Association for Ambulatory Healthcare. Clearly, the process would not only be burdensome, but also extraordinarily expensive and unnecessary as ophthalmologists have been administering these anesthetic blocks in their office practices for decades with no significant risk to patients.

As is often the case, this rule was “hidden” in a larger regulation pertaining to office-based surgery. When it appeared likely the regulation would pass, WAEPS contacted the Academy for assistance, and Dr. Parke asked OMIC for claims data related to the use of local blocks in office-based surgery. His response to MQAC stated:

“…complications of retrobulbar injection in the outpatient office setting are extraordinarily rare. A survey by the largest medical malpractice carrier in ophthalmology (Ophthalmic Mutual Insurance Company) found only one case in a 21-year review of its claims data bank of a cardiovascular event from a retrobulbar injection performed outside of the operating room. This is in a period of time when literally millions of such injections were performed. This indicates that the risk is very small.”

Having compelling evidence-based data is of extraordinary benefit when dealing with regulatory agencies. With the support of the Academy, the Washington Medical Association, and other concerned organizations, WAEPS was successful in having the rule taken off the hearing calendar and reevaluated with more input from ophthalmology.

OMIC also worked closely with Academy Secretary for State Affairs, Dan Briceland, MD, to help the West Virginia Academy of Ophthalmology (WVAO) fight an optometry bill that would have allowed optometrists to perform glaucoma surgery. OMIC has extensive experience in this area. Over 300 optometrists are directly insured by OMIC, and approximately 35% of its 4,100 insured ophthalmologists employ or contract with an optometrist. In a letter drafted for WVAO to present to West Virginia legislators, OMIC pointed out the risk to patients:

“OMIC engages in an ongoing process of assessing the risk of optometrists performing ‘surgery.’ Based on an objective risk assessment, OMIC is not willing to extend liability coverage to any optometrist who performs laser surgery or any therapeutic ophthalmic laser procedure.”

The letter noted that only one state (Oklahoma) allows optometrists to perform surgical or therapeutic laser procedures.

“OMIC’s decision to not extend this coverage to optometrists is based on the lack of data available on this liability risk, as well as the company’s assessment that there is also an absence of data to properly underwrite, determine a premium rate, and have the expertise to administer claims arising from surgical or therapeutic laser procedures performed by optometrists.”

After a hard-fought battle, the WVAO was able to defeat the bill and stop the expansion of optometry into glaucoma surgery.

Richard L. Abbott, MD OMIC Chairman of the Board

Ocular Anesthesia Claims: Causes and Outcomes

Anne M. Menke, RN, PhD, and James J. Salz, MD

Anne Menke is OMIC’s Risk Manager. Dr. Salz is a member of OMIC’s Claims and Risk Management Committees.

Digest, Winter 2006

To view the charts mentioned in this article use the Download button on the toolbar above.

Ocular anesthesia presents challenges for both the ophthalmologist and anesthesiologist. Each must address patient anxiety about eye surgery, including concerns about eye pain or movement during surgery, and possible vision loss. When determining the appropriate anesthesia to use, physicians must take into consideration possible multiple medical comorbidities in elderly patients and the particular anesthesia risks for pediatric patients, especially those who may be premature or have congenital syndromes. Following application of the anesthetic agents, they may need to manage intraocular pressure or respond to cardiovascular events precipitated by oculocardiac reflexes.

OMIC recently conducted a review of claims related to anesthesia and sedation in order to identify issues that can be addressed through proactive risk management. The results of this study are summarized in this article and in an online course. The study was a retrospective analysis of 18 years of OMIC claims experience (1987-2005). While OMIC’s database includes incidents reported by physicians on a precautionary basis, only actual malpractice claims – defined as written demands for money and lawsuits – were included. Cases were located by searching for anesthesia- and sedation-related words in allegations and through codes assigned to these procedures, such as retrobulbar or peribulbar injections. Therapeutic injections were excluded. At times, information was available only from case summaries, not from medical records. As these results show, very few of the thousands of patients who undergo ophthalmic procedures sue their provider for professional negligence in the administration of anesthesia or sedation.

Out of 2,474 OMIC claims during this 18-year period, only 78, or 3%, were related to anesthesia and sedation. Of the 65 closed anesthesia/sedation claims, 43, or 66%, were closed without any indemnity payment to the plaintiff. Claims resolved without any payment to the plaintiff (former patient) for several reasons: (1) the claim was not pursued by the plaintiff,often after OMIC denied it for lack of merit; (2) the physician was dis- missed from the lawsuit through legal action; this was most common when he or she did not administer the anesthesia; or (3) a jury, medical review panel, or arbitrator sup- ported the physician’s care.

In 22 of the 65 closed cases, the plaintiff was awarded money as a result of settlements or plaintiff ver- dicts at trial or arbitration. While the frequency of anesthesia claims is low, both the percentage of claims result- ing in payments and the severity of the indemnity awards were higher than OMIC’s overall claims averages (see Table 1). Defense costs for these 65 closed claims, however, were some- what lower than OMIC’s overall aver- age ($34,574 vs. $39,324) and median ($21,688 vs. $26,223) cost per case.

Types of Anesthesia Resulting in Claims

Complications of orbital injection anesthesia accounted for the over- whelming majority of anesthesia/ sedation-related claims against OMIC insureds (69 claims), while general and topical anesthesia accounted for only 5 and 4 claims, respectively. Sedation was an issue in 5 of the 69 orbital claims. Retrobulbar anesthesia was administered in 49 cases: 32 times by ophthalmologists, including one ophthalmology resident, 14 times by anesthesiologists, and 3 times by Certified Registered Nurse Anesthetists. Of the 16 peribulbar blocks, 9 were given by eye surgeons and 6 by anesthesiologists. The only O’Brien block was injected by an ophthalmologist; the type of orbital anesthesia was not specified in 3 claims. Of note, there were no claims resulting from sub-Tenon’s blocks.

Complications of Ocular Anesthesia

The complications resulting from retro- and peribulbar blocks in the OMIC cases correlate closely with those reported in the medical literature 1,2 (see Table 2). Perforation was the most likely complication, followed by cardiovascular events and hemorrhage. Sedation-related problems were the primary issue in two settled claims. In one case, the plaintiff alleged that her pain and anxiety were inadequately controlled, resulting in a $450,000 indemnity payment on behalf of the ophthalmologist. In the second, the ophthalmologist ordered a nurse to administer sublingual Procardia and oral Valium to an elderly patient, who suffered a series of strokes after she was discharged with a blood pressure significantly lower than upon admission. Neither the ophthalmologist nor the nurse was aware of the “black box” warning associating sublingual Procardia with severe hypotension and stroke. The ophthalmologist and ambulatory surgery center each contributed $375,000 toward the settlement.

In all 4 closed general anesthesia claims, the ophthalmologists were dismissed from the lawsuits despite complications that included adult respiratory distress syndrome, intraoperative choking with a post- operative CVA, and death due to aspiration. The authors do not have information on the outcome for the anesthesia providers in these claims. Failure to control pain and/or movement was the allegation in 2 open topical anesthesia claims, while inadequate pain relief allegedly led to hypertension and hemorrhage in 2 closed topical anesthesia claims. In the closed cases, a cataract surgery claim closed without payment, while a combined cataract/trabeculectomy case settled for $150,000. Both plain- tiff and defense experts criticized the use of topical anesthesia for trabeculectomy and felt surgery was not indicated in the first place, as the patient did not have glaucoma.

Standard of Care Was Met But Other Issues Arose

Eye surgeons who meet the standard of care expect to successfully defend their treatment. Nonetheless, in 6 of the 22 paid indemnity cases, the plaintiff prevailed even though OMIC’s Claims Committee, claims associates, and defense experts were fully supportive of the care provided. Three of these cases were settled at the request of the insured physician due to the ophthalmologist’s health issues, nervousness, or desire to compensate the patient for lost wages. In another, an unwitting dictation mistake concerning the timing of a perforation following a retrobulbar unduly complicated the defense. In 2 instances, the plaintiff attorneys made side deals with the anesthesia providers just before trial in order to pressure the ophthalmologists to settle, even though the anesthesiologists were felt to be responsible for the plaintiffs’ injuries. The anesthesiologist was dismissed in one of these cases and the anesthesiology group made a nominal payment, leaving the ophthalmologist as the sole defendant. After similar maneuvers in the other case, a new theory of negligence was introduced against the ophthalmologist. When the medicine is complicated, the venue is plaintiff-oriented, the outcome is poor, and the ophthalmologist is the only defendant left, a settlement within policy limits can be a prudent move to protect the insured’s personal assets.

Concerns About Care

During the informed consent discussion, ophthalmologists warn patients about the complications associated with anesthesia and the patient’s particular surgery. If a complication occurs but is promptly recognized and appropriately managed, the outcome is considered to be a maloccurrence rather than malpractice or negligence. A single concern about an aspect of care can usually be explained to a jury. Multiple concerns about care still do not constitute negligence, but they can greatly strengthen a plaintiff’s case and persuade a jury to give the plaintiff, rather than the physician, the benefit of the doubt. Three of OMIC’s 22 cases that closed with indemnity payments fall into this category. In the first case, lack of indications for surgery, failure to communicate to the anesthesiologist the difficulties of a wide and long eye, and criticisms about the lack of documentation of a staphyloma led to a settlement. In the second case, a settlement was reached because there was no documented consent, the cause of the injury to the optic nerve could not be ascertained, and the postoperative management was subpar. Question- able indications for a second surgery coupled with scanty documentation and a difficult venue led to a settlement in the third claim.

Negligence

Physician negligence was felt to be the cause of the plaintiff’s injury in 13 of the 22 cases that resulted in an indemnity payment. Table 3 indicates the point in the care process at which the skill, judgment, or expertise of the insured was not that of a reasonably prudent ophthalmologist, which is generally the standard experts use when evaluating a case.

Lawsuits may be mitigated by applying risk management principles at every step of care, from determining the proper procedure to making appropriate care decisions after maloccurrences, and documenting that care clearly and completely. Careful informed consent discussions about anesthesia choices, clear communication with other providers, and an empathetic response to patient concerns and questions can also significantly reduce the likelihood of claims. Please see the document “Ophthalmic Anesthesia Liability” at www.omic.com.

Finally, while the actual choice of anesthesia or its administration was less frequently a concern, physicians should consider substituting sub-Tenon’s for orbital injection anesthesia when appropriate, given its significantly lower risk profile. OMIC’s online “Ophthalmic Anesthesia Liability” course, nearing completion, will feature a video demonstrating this technique.

1. Stead SW and Bell SB, Focal Points: Ocular Anesthesia, The Foundation of the American Academy of Ophthalmology, March 2001: Vol. XIX, No. 3.

2. Anesthesia Alternatives for Ocular Surgery, American Academy of Ophthalmology, 2001.