Post-Retrobulbar Retinal Artery Occlusion and Informed Consent for Clinical Investigation of Intraocular Lenses
Digest, Winter 1996
Allegation
Failure to obtain informed consent. Negligent administration of retrobulbar anesthesia, resulting in an incomplete central retinal artery occlusion.
Disposition
Jury verdict for the defendant ophthalmologist.
Case Summary
The patient was a 71-year-old woman who saw the insured with complaints of decreased vision and difficulty night driving. The patient denied any history of heart disease or diabetes. Uncorrected VA was 20/400 OD pinholing to 20/50 and 20/200 OS pinholing to 20/40. The insured diagnosed cataracts OU and discussed the risks, complications, and expectations of surgery. The patient was given a clinical investigation consent form to sign for implantation of a CILCO Intraocular Lens from Alcon Surgical, Inc. The consent form explained that the clinical investigation was under a Congressional mandate to study the safety and efficacy of intraocular lenses.
The patient underwent an ECCE with posterior IOL. No complications were reported during surgery. On the first post-op day, the patient reported she had slept well with no pain but could barely see out of her right eye. On examination, there was a trace of corneal edema superiorly. The central portion of her cornea was clear with 2+ cells and flare in the AC. The implant was well positioned, and the pupil reacted to light but not actively. A fundus exam revealed macular edema but only minimally. The patient was immediately referred to a retinal surgeon, who performed a fluorescein which showed poor but definite arteriole perfusion OD relative to OS. No emboli were seen, and there was no evidence of vasculitis. This was all consistent with an incomplete central retinal artery occlusion.
The patient was started on Coumadin. An ECHO showed a dilated left ventricle with a mild reduction in systolic contractility but no intracavitary thrombus. A bilateral carotid sonogram showed no narrowing. A 24-hour circadian monitor showed unifocal premature ventricular contractions but no apparent cardiac dysrhythmia as a source for arterial emboli. No evidence of arteriosclerotic retinal artery occlusion or emboli was found. The patient’s vision stabilized at count fingers OD and 20/60 OS with pinhole to 20/40.
Analysis
The ophthalmology experts who reviewed this case indicated that retinal artery occlusion is an unfortunate but known complication of a retrobulbar injection and that it can and does occur in the absence of negligence. Each of the experts reviewed the recorded technique used for the injection and was firmly able to defend the insured’s actions as well within the standard of care. The plaintiff’s attorney, on the other hand, was able to find an expert who stated that this result should not have happened in skilled hands. This expert also opined, without any degree of specificity, that this degree of vision loss would not have occurred if the insured had provided more prompt and appropriate follow-up care.
All of these issues were adequately dispelled by the defense experts, but there was one remaining issue that undermined the defendant’s case: the patient claimed she had not been informed that the lens being used in the surgery was under investigation, and had she known this, she never would have undergone the surgery. She also claimed the insured never mentioned this type of vision loss as a complication and had assured her that this was a “simple procedure” and “not to worry about it.” Unfortunately, the insured had documented nothing in his office records regarding his informed consent discussion with the patient. Additionally, the required consent form that the patient signed before surgery under the protocol of the investigational study was nowhere to be found in the medical record. The lens manufacturer claimed it had never received a copy of the consent form and thus sidestepped involvement. Without this documentation, it was questionable whether the case could be defended. Serious thought was being given to settling the case when the lens manufacturer finally secured a copy of the required consent form, signed by the patient and filed with the state Investigational Research Board. The case was defensible again.
At trial, defense counsel was able to successfully argue the informed consent issues, which allowed the jury to focus on the remaining medical issues. A defense verdict was granted by the jury after a brief two-hour deliberation.
Risk Management Principles and Commentary
This case illustrates the difference in the legal effect between generic informed consent and a protocol-required informed consent for research purposes. Lack of documentation of the basic informed consent process often can be overcome at trial if the surgeon testifies as to his or her usual and customary discussions with patients about complications and alternatives prior to surgery. It becomes a credibility issue but may not be a fatal flaw in every circumstance.
However, failure to document consent when required by a research or investigational protocol is a fatal flaw that can totally undermine an otherwise defensible case. The “testimony of customary practice” defense does not apply in such cases. If it can be shown that a patient participating in a research project did not sign a research consent form, the investigator surgeon will be in violation of the research protocol itself and any testimony he or she may offer will not correct the violation. Under research conditions, if any specification of the protocol is breached, particularly in the areas of medical qualifications or exclusions for a particular research patient, the defense of the underlying case will be seriously jeopardized. Physicians who participate in a clinical investigation of any size or description must be particularly careful with documentation throughout the process because less leniency will be afforded by the legal system.
Negligent Administration of Retrobulbar Anesthesia
Mary Kasher, MSN, JD, OMIC Claims Manager
Digest, Spring 1998
Allegation
Lack of informed consent and negligent administration of retrobulbar anesthesia.
Disposition
Lawsuit dismissed by plaintiff.
Case Summary
A 61-year-old woman with macular degeneration and corrected vision of 20/400 in the right eye had been under the care of the insured ophthalmologist for several years when she presented with complaints that her left eye was losing vision and had dropped to a corrected acuity of 20/80. The insured diagnosed a +3 nuclear sclerotic cataract OS and discussed the pros and cons of cataract surgery with the patient, who decided to put off surgery as long as possible since she relied on her left eye for vision. Shortly before this visit, the patient had been given a new prescription for glasses and instructed to return in six months.
A month later, the patient returned stating she had noticed no improvement with the new glasses and wished to have cataract surgery. She was scheduled for outpatient cataract extraction three days later. In the operating room, retrobulbar anesthesia was administered with no apparent complication. Prior to prepping, however, it was noted that the lids were firm and swollen. The insured performed a lateral canthotomy to relieve the pressure and elected to postpone surgery because of an apparent retrobulbar hemorrhage. The patient remained under observation until the eye stabilized and she could be discharged for follow-up the next day.
At the insured’s office the next morning, the patient’s vision in the left eye was count fingers only. The pupil was mid-dilated and somewhat fixed; the retina revealed signs of hemorrhage and swelling in the macular region. The insured referred the patient to a retina specialist who saw her later that day. Fluorescein angiography showed spotty hemorrhages on the surface of the retina consistent with circulatory compromise. Examination of the macula revealed significant retinal thickening and nerve fiber layer opacification in the presence of a central cherry red spot. The retina specialist’s impression was vascular occlusion on the left with secondary macular ischemia and infarction. The patient did not regain vision in the left eye.
Analysis
At deposition, the plaintiff claimed that the insured failed to warn her of the risks associated with anesthesia injection and that had she been advised of these risks, she would have requested an alternate procedure to “sticking a needle into my eye.” Fortunately, the insured presented chart documentation and consent forms that proved otherwise, and the plaintiff ultimately lost the informed consent argument. Still, the plaintiff’s attorney was able to hold up the needle used in the procedure and with the plaintiff’s own statements demonstrate the visual aversion it creates in a lay person.
The defense produced a strong, charismatic expert who relied upon the insured’s well-documented records and clearly stated diagnosis to refute the plaintiff’s claims. The expert was able to present clinical facts in support of the insured’s decision to use injectable anesthesia and to pinpoint which factors were and were not responsible for the patient’s injury. It was primarily because of this testimony that shortly after OMIC’s expert witness was deposed the plaintiff dismissed the case.
Risk Management Principles
Probably the most difficult aspect of puncture cases is explaining to a lay jury that a needle puncture is a known complication of administering anesthesia when the needle itself looks so ominous and the outcome can be so devastating. It is extremely important that the defense expert be engaging, honest and believable, able to employ scientific facts to support the use of this technique and explain to the jury how it is possible to cause significant damage in the absence of negligence.
As with any malpractice litigation success story, however, the most critical factor is documentation. In this case, the plaintiff attorney was foiled at every juncture with a clearly set forth argument by the defense that was readily supported by the medical record.
Inform Cataract Patients of Anesthesia Risks
By Monica L. Monica, MD, PhD, and Daniel A. Long, MD
Argus, May, 1994
When informing patients about the risks and benefits of cataract surgery, the ophthalmologist should also discuss the type of anesthesia that will be used and its potential problems. Risks and complications may occur with either local or general anesthesia. This article will address the concerns of patients and ophthalmologists with regard to local anesthesia, including seventh nerve akinesia.
The federal mandate of 1986 requiring that all Medicare-reimbursed cataract surgery be done in an outpatient setting prompted ophthalmologists to seek anesthesia that would allow a safe and rapid recovery after surgery. Less invasive techniques such as the use of topical rather than injected anesthetic agents became desirable in short-stay facilities where early ambulation is required.
Currently, most cataract surgery is performed under local anesthesia and involves one or more of the following: retrobulbar anesthesia, peribulbar block or topical anesthesia.
Retrobulbar Anesthesia
Retrobulbar anesthesia has been routinely used for cataract surgery for many years. It affords a complete loss of orbital sensation, an eye that remains immobile throughout the operative procedure, and postoperative pain control lasting up to several hours. When securing preoperative consent, the ophthalmologist must communicate to the patient the risks of retrobulbar injections, including orbital hemorrhage, perforation of the globe and damage to the optic nerve. Rather than surprise a patient on the day of surgery, tell the patient in advance that surgery may have to be canceled and rescheduled if a complication such as a retrobulbar hemorrhage occurs.
As part of the informed consent process, ophthalmologists warn patients of possible loss of vision or blindness following cataract surgery. This warning is particularly significant should an anesthetic agent be inadvertently injected into the optic nerve sheath, or if the circulation to the optic nerve and retina is compromised from an injection that injures the ophthalmic artery.
Peribulbar Block
A peribulbar block, an alternative to retrobulbar anesthesia, offers the advantages of less pain from injection and no loss of vision in the immediate postoperative period. But it requires a longer waiting period for the anesthetic agent to take effect and a possible ecchymosis of the skin of the eyelid. Penetration of the globe has been known to occur with the use of small-bore sharp disposable needles.
Topical Anesthesia
Recently, ophthalmologists have been returning to a technique that was popularized during the early 1900s the use of topical anesthetic agents, employed particularly when the surgical incision is being made through clear cornea. Agents of choice are proparacaine or tetracaine. Tetracaine penetrates deeper into the cornea and is less toxic on the corneal epithelium. Both agents allow a rapid recovery and avoid the risks associated with injecting anesthetics around or behind the globe. The disadvantages of topical anesthetic agents include a less profound anesthesia (such as when agents like Miochol are used for myosis after the IOL is placed), an eye that may move at an inappropriate time, and possible sensitivity to the medication.
The authors have used topical anesthesia for clear cornea cataract surgery in more than 300 cases and have followed the patients for up to one year. In addition to avoiding the risks associated with injections, patients need little, if any, medication for preoperative sedation. They are alert before, during and after the procedure, and are immediately ambulatory and able to leave the surgery area. Good communication is essential when topical anesthesia is used for cataract surgery. The ophthalmologist must give the patient thorough preoperative instructions, including:
They will be fully awake throughout the procedure and will be expected to communicate with the surgeon about any anxiety or discomfort they feel.
They may be required to move their eyes as directed by the surgeon or to keep it still and focused on a light throughout the surgery.
If necessary, the surgeon may give them a sedative during the procedure and the type of anesthesia used may change if the need arises.
Seventh Nerve Akinesia
Regional blocks of the seventh nerve often are used prior to cataract surgery. Patients should be forewarned of complications that may occur, most of which are not severe. If a Van Lint block is used, the authors believe that it should be done prior to the retrobulbar block to avoid the possibility of penetrating the globe in case the retrobulbar injection proptoses the eye. With Atkinson akinesia, care must be taken because hemorrhage from the superficial temporal blood vessels may occur when the injection is made along the zygomatic arch.
The O’Brien method blocks the facial nerve over the condyle of the mandible but, due to anatomic variations, sometimes does not accomplish complete akinesia. The Spaeth modification of the O’Brien technique is often more successful since it catches the nerve at the edge of the mandible before it divides into its branches.
Finally, the Nadbeth technique blocks the facial nerve after its emergence from the stylomastoid foramen. It is successful and easy to perform but occasionally leaves patients with a bitter taste in their mouths, something that should be mentioned prior to surgery. A few patients have reported dysphoria as well as swallowing and respiratory difficulties following Nadbeth blocks. Thin patients are more prone to complications. A long needle with a deep injection and the use of hyaluronidase should be avoided when injecting at the stylomastoid foramen.
Just as anesthesiologists are expected to communicate the risks of standby or general anesthesia to patients prior to cataract surgery, the operating surgeon is responsible for discussing and reviewing aspects of local anesthesia before surgery. An informed patient is more cooperative and suffers less anxiety before, during and after surgery.
Medicolegal Hazards of Local Anesthesia
By Jerome W. Bettman Sr., MD
Argus, April, 1996
Ophthalmologists usually associate retrobulbar injections with adverse claims arising from administration of local anesthesia. While more claims arise after retrobulbar injections than after other types of local anesthesia, these cases can be successfully defended.
Retrobulbar Injections
The hazards associated with retrobulbar injections are well known to ophthalmologists: penetration of the globe, optic atrophy, orbital hemorrhage, external ocular muscle palsies and, rarely, problems associated with injecting the fluid into the optic nerve sheath, which may result in respiratory arrest or a cavernous sinus syndrome.
Retrobulbar cases often are successfully defended in court because the defense experts can demonstrate for the jurors that the surgeon cannot see the needle tip, but can only attempt to judge its position based on the angle the luer is held and the depth of the injection. Jurors can be instructed that the orbits, the position of the globe, and the length of the eyeball vary from person to person, and that it is difficult to know the location of the needle tip at all times.
It also can be demonstrated that ophthalmologists cannot depend completely on their sense of touch because the sclera may be softer than usual and the tissues around the eye may deviate from what a surgeon normally expects. Given these factors, jurors can understand that complications arising from retrobulbar injections, although not common, can occur in anyone’s practice, no matter how skillful the surgeon. There are fewer complications with peribulbar injections, but the hazard of puncturing the globe does exist. Defending these cases is similar to retrobulbar cases.
Subconjunctival and Subtenons Injections
The liability and defense issues are more problematic when penetration of the globe occurs after subconjunctival and subtenons injections. The seriousness of this complication and whether a claim arises depends upon the dose and what material is mistakenly injected into the eye — some anesthesias are retinotoxic and some are tolerated by the eye. Defending these cases is more difficult than retrobulbar cases. The plaintiff will allege that the surgeon should have moved the needle point to be sure it was not engaged in the sclera unless the needle point could be seen at all times, because if it were visible, the penetration could not have happened. Jurors will have much less difficulty finding negligence for something the ophthalmologist should have been able to see.
Topical Drops
Instilling topical anesthetic drops can precipitate a malpractice claim in two types of situations. First, if an untoward reaction occurs after instillation, the plaintiff may assert that the wrong drops were used or the medication was not properly manufactured. A claim that the wrong drops were used is more likely to be based on an incident in the operating room. This mistake can usually be avoided by having only one bottle of drops on the tray at any one time. If there is an untoward incident, secure the drops and other related devices in a safe place so they can be analyzed and tested if necessary.
Second, when topical anesthetics are prescribed for home use, the patient may inadvertently traumatize the anesthetized eye, or if a corneal ulcer is present, topical anesthesia may impede its healing. When prescribing drops for home use, document that the patient understands how to instill the drops, knows the signs and symptoms of complications, and knows to contact the office immediately if problems occur.
Given the potential for complications, the ophthalmologist should warn the patient that vision loss is a possibility in all ocular operations.
