Monocular Patient Loses Vision After Vitrectomy
Ryan Bucsi, OMIC Senior Litigation Analyst
This is a recently closed claim study of the Ophthalmic Mutual Insurance Company.
Digest, V24 N1 2014
Allegation
Lack of informed consent of increased risk of bleeding during elective vitrectomy in a patient taking Plavix and aspirin.
Disposition
Case settled for $825,000.
Case Summary
A 77-year-old female patient was referred to an OMIC insured with a history of blindness OS following a stroke several years earlier, as well as diabetes and hypertension. She had previous cataract surgery OD with 20/40 visual acuity and complained of seeing “specks.” The insured diagnosed marked asteroid hyalosis and, although the retina was attached, he recommended a vitrectomy to reduce the floaters. The insured was aware of the patient’s history of stroke and lost vision OS and that she was taking Plavix and aspirin, but he did not have her discontinue these medications prior to surgery. Towards the conclusion of the vitrectomy, the patient developed a bleed that led to a retinal detachment. Unable to isolate the bleed, the insured closed the eye and scheduled a subsequent procedure one week later to remove the blood and reattach the retina using silicone oil. It was noted during this second procedure that there was extensive clotting from the previous procedure.
At this point, the insured consulted with the patient’s primary care physician, who decided to discontinue the Plavix. Two weeks later, a third procedure was performed to remove additional blood. The retina was detached for the removal of blood and reattached at the conclusion of the procedure, again using silicone oil. The insured then consulted with his partner as there was still some blood present in the eye and the retina continued to detach following each surgery. With the insured present, the partner performed a fourth surgery six weeks later in an attempt to remove all the remaining blood and reattach the retina. The surgery was successful in reattaching the retina, but all the blood could not be removed as the patient continued to bleed during the procedure. A final examination revealed a white optic nerve and indicated that blood underneath the retina for a prolonged period of time may have caused damage to the photoreceptors. The patient had nerve atrophy, atrophy of the eye itself, and NLP OD, rendering her completely blind.
Analysis
Our defense experts were split on whether it was within the standard of care to operate on this patient without first consulting her primary care physician about safely taking her off Plavix and aspirin prior to surgery. However, our experts unanimously agreed that a separate informed consent should have been given to the patient specifically detailing the risk of hemorrhage, retinal detachment, and potential loss of sight.
During his deposition, the insured testified that he had no discussions with the patient about an increased risk of bleeding, retinal detachment, and loss of vision because the vitrectomy was done in an avascular area and bleeding was not expected. Our experts disagreed and felt that bleeding was indeed a risk and since the patient had sight in only one eye, there should have been a more thorough review and discussion of all the risks associated with surgery. Indeed, the main weakness of the case was the apparent imbalance between the expected benefit of surgery to remove floaters and the potential risk of blindness in a functionally monocular patient.
Risk Management Principles
The patient history and physical exam were appropriately performed and documented; however, the insured did not take into account that the findings indicated an increased risk for bleeding and retinal detachment, which could lead to blindness in the patient’s remaining good eye. The patient was never informed of these possible complications and did not have the opportunity to make a well-informed decision about moving forward with a procedure that carried significant risks. Additionally, as pointed out by one of OMIC’s defense experts, since this was an elective procedure, a detailed, welldocumented discussion of the risks would have benefited the doctor when complications arose.
OMIC has a sample consent form to use with surgical patients who are taking anticoagulants. See it here.
Pseudotumor Cerebri in Young Female
Ryan Bucsi, OMIC Senior Litigation Analyst
Digest, Spring 2013
Allegation
Failure to diagnose and refer patient for treatment of pseudotumor cerebri.
Disposition
Settled for $850,000 split equally among two OMIC insureds and their insured entity.
Case summary
A 23-year-old female presented to the emergency room with blurred vision and was advised to see the OMIC-insured ophthalmologist the following day for examination. She did not keep the appointment, but five days later called the insured’s office to complain of decreased vision and was advised to come in. On initial examination, the patient’s visual acuity was 20/125 OD and 20/50 OS. The pupils were reactive with trace evidence of an afferent papillary defect. A visual field test was not performed. The OMIC insured’s diagnosis was significant bilateral papilledema likely secondary to pseudotumor. Based on the patient’s size (4’11” and 150 pounds), the insured prescribed 1000 mg of Diamox to be taken daily. He also referred the patient to a neurologist for a lumbar puncture. Upon the advice of the neurologist, the patient did not start the Diamox until after the lumbar puncture. The ophthalmologist advised the patient that the pressure was 36 (normal <25) and instructed her to start the Diamox. Approximately three weeks later, the patient returned to the OMIC insured and his partner, another OMIC-insured ophthalmologist, for an examination. Visual acuity was count fingers OU. A positive finding of afferent papillary defect OD was again noted. A constricted visual field based on a confrontational field test revealed a significantly limited visual field OU. The patient was diagnosed with pseudotumor cerebri and Diamox was increased to 1500 mg daily. The OMIC insureds documented that if no improvement was seen in the next week, the patient would be referred to a neuro-ophthalmologist. The patient did not return to the OMIC insureds after this visit. She self-referred to another ophthalmologist, who referred her on to a neuro-ophthalmologist. The neuro-ophthalmologist suspected that the patient had asymptomatic but uncontrolled bilateral disc edema for much longer than six weeks and that for unclear reasons it went into an accelerated phase resulting in significant loss of vision. The patient underwent two bilateral optic nerve sheath fenestrations, but final visual acuity was hand motion at 1.5 feet OD and 6/200 OS.
Analysis
Plaintiff’s experts opined that both OMIC insureds failed to appropriately diagnose and manage the patient’s pseudotumor cerebri and violated the standard of care by failing to refer the patient to a neuro-ophthalmologist for evaluation of pseudotumor cerebri. Several experts were retained by OMIC to review this case and some common opinions emerged. First, all of the defense experts were concerned that a visual field test was not done during the patient’s initial examination by the insureds. They felt a visual field test was warranted in order to determine the degree of central vision loss. The patient could not see the left part of the visual acuity chart so the experts felt that the extent of the patient’s disease was quite evident during the initial examination. Most of the defense experts opined that upon initial presentation, the patient’s condition was an ophthalmic emergency and “cried out for an immediate referral” to a neuro-ophthalmologist. The two OMIC insureds themselves were not entirely confident in the care they provided to the patient and expressed concern that any neuro-ophthalmologist called to testify would be critical of their care and treatment. As a result of the opinions of our retained experts and the OMIC insureds, the case was settled at mediation on behalf of the two OMIC insureds and their insured corporation for $850,000.
Risk management principles
The insureds made the correct diagnosis in this case but, sadly, delayed aggressive treatment of the pseudotumor cerebri as they did not appreciate that it was an emergency situation. Not only did this patient have a high-risk condition, but her behavior in delaying follow-up treatment for five days after her ER visit made her a high-risk patient. Patients who risk serious vision loss and do not take their condition seriously should be referred early for subspecialist care. Early referral ensures that patients likely to delay care or not follow treatment recommendations receive the most advanced care from the start.
Improper Disposal of Medical Records
Natalie Kelly, NAS Insurance Services/Lloyds Associate Vice President of Claims
Allegation
Violation of Health Care Privacy and Security Rules.
Disposition
Settled without fines or penalties. Legal and patient notification costs totaled $85,000.
Case summary
Employees of a physician disposed of medical records inappropriately by placing them into office recycling bins. Although the contents of the recycling bins were supposed to be shredded, these instructions were not communicated to the building’s janitorial services. As a result, the files were transferred to the building’s recycling area without being shredded. Although only approximately 500 patients were involved in the breach, the physician could not be sure which files had been placed in the recycling bins and which had not. Therefore, all of the physician’s 7,500 current and past patients had to be notified of the breach. The physician was also required to notify the Department of Health and Human Services (HHS), which responded by opening an investigation and requiring the physician to implement a program to comply with Privacy and Security Rules. Once its investigation had been completed, HHS dismissed the matter without assessing fines or penalties against the physician.
Analysis
The insured’s responsibility to safeguard patients’ protected health information was not met. Failure to adequately supervise the destruction of the records created a scenario that could have resulted in a significant fine under HIPAA Privacy or other regulations. Although no fine or penalty was imposed, there were significant legal and patient notification costs related to compliance with privacy laws, and the insured’s staff were forced to deal with unwanted distractions that took time away from their normal duties.
Risk management principles
Protecting patients’ health information should be given a high priority to avoid violations of HIPAA, HITECH, and other health information regulations. Avoid outsourcing or delegating the destruction of files or records to others unless you or your staff members are present to supervise the shredding of files or the destruction of data storage devices. OMIC’s professional liability policy includes coverage for this type of event. Under the Broad Regulatory Protection and eMD Cyber Liability benefits, there is a $50,000 limit to pay for legal and patient notification costs related to alleged HIPAA Privacy and other regulatory and data breach violations. See Policy Issues for more information. Learn about the 14 Additional Benefits in your OMIC policy that will protect you from these (and related) types of exposures.
Abandonment or Noncompliance?
Ryan Bucsi, OMIC Senior Litigation Analyst
Allegation
Failure to follow up with patient after a negligent injection of Kenalog.
Disposition
Defense verdict.
Case summary
A 56-year-old male patient with type II diabetes began to complain of decreased vision OD one month following uncomplicated cataract surgery OD. He was referred to an OMIC-insured retinal specialist, who diagnosed diabetic macular edema and proliferative diabetic retinopathy OD. The insured recommended an intravitreal injection of preservative-free triamcinolone acetate (Kenalog), which was performed without complication. The following day, the patient returned to the retinal specialist with hand motion vision, pain, pressure, and photophobia. The insured diagnosed pseudoendophthalmitis and prescribed antibiotics. Three days later, the patient returned to the insured with hand motion vision. The insured diagnosed pseudo versus infectious endophthalmitis and the patient elected to continue with antibiotics and steroid drops versus injection. Ten days later, the patient’s visual acuity improved to 20/100 OD; however, two weeks later, the patient called to report pain and redness OD. The insured asked the patient to come into a satellite office, but the patient declined due to the increased driving distance. The patient was advised of the risk of not being seen and an appointment was scheduled for two days later. On the following day, the patient telephoned the retinal specialist to report pain and increased blurring. The patient was advised to come into the satellite office, but once again refused citing the increased distance. When the patient finally did return to the office, visual acuity was hand motion OD and intraocular pressure was 66. The insured tapped the right eye on two occasions, which only temporarily decreased the pressure. When the patient declined a third tap, the insured referred the patient for a trabeculectomy, but this was delayed as the patient was admitted to the hospital for dehydration. Following this hospitalization, a trabeculectomy was performed which eventually resolved the increased pressure. A second retinal consultation by a non-OMIC insured was performed, which revealed hand motion vision, no detachment, vitreous opacity, and controlled pressure OD. A pars plana vitrectomy and lens removal were eventually performed which resolved the endophthalmitis, but the vision remained at hand motion.
Analysis
Plaintiff alleged that the Kenalog injection caused glaucoma and endophthalmitis resulting in hand motion vision OD. He also alleged that he was not aware of the off-label use of Kenalog and that the insured “abandoned” him. Plaintiff’s expert testified that the insured had a duty to travel to see the patient. The defense argued that the insured met the standard of care for informed consent by advising the patient of the risks and alternatives and that the patient signed a consent form for the Kenalog injection. The defense refuted the abandonment allegation and argued contributory negligence by the patient when he declined to drive to a satellite office, even though it was no more than 27 additional miles from where he was regularly seen. The defense expert testified at trial that the patient’s noncompliance played a definite role in his outcome. The defense also noted that post-injection, steroid-induced glaucoma and endophthalmitis are known side effects of intravitreal Kenalog injections. Although the discussion about the off-label use of Kenalog was not documented in the patient’s chart, during deposition the office technician explained that the insured “always” explained to patients when drugs were used off-label. The plaintiff demanded $750,000 to settle, but the insured and OMIC agreed that the case was defensible. After a three-day trial and 90 minutes of deliberation, the jury returned with a defense verdict.
Risk management principles
To prove abandonment, the plaintiff must show that there was an established physician-patient relationship and that care was withdrawn without adequate warning. OMIC is not aware of any legal duty during this relationship for a physician to go to a patient’s home, nursing home, or, as in this case, another office. Patients have a legal right to refuse care. On the other hand, physicians have a legal duty to explain the consequences of refused care, which the insured did. OMIC recommends that physicians inform patients of off-label use, especially if the treatment consists primarily of an off-label medication, as in this case (see sample consent form at http://www.omic.com/informed-consent-for-off-label-use-of-a-drug-or-device/).
Injection of Anecortave Acetate into Globe during ARMD Risk Reduction Trial
Ryan Bucsi, OMIC Senior Litigation Analyst
Digest, Fall 2012
Allegation
Negligent administration of Anecortave Acetate into globe.
Disposition
Drug manufacturer indemnified OMIC insured and settled claim for $500,000.
Case Summary
A 75-year-old female was diagnosed with wet macular degeneration and treated with photodynamic therapy and intravitreal Kenalog. Subsequently, she developed a massive subretinal hemorrhage secondary to age-related macular edema in the right eye. The left eye also had high-risk macular drusen. A non-OMIC-insured ophthalmologist recommended that the patient participate in an age-related macular degeneration risk reduction trial, as he felt there was no other treatment currently available that would be of benefit to the left eye. An OMIC insured performed eight injections of Anecortave Acetate under the trial protocol.
During the last procedure, the insured applied Xylocaine on a Q-tip to the conjunctival surface superotemporally, approximately 8 mm back from the limbus. Xylocaine was then injected about 8mm posterior to the limbus superotemporally. While waiting for the anesthesia to take effect, he pushed the medication through the cannula to the appropriate mark on the syringe. One additional drop of topical anesthetic was applied and the lid speculum was inserted. The insured marked the spot using calipers on the slightly elevated conjunctiva that was 8 mm posterior to the limbus superotemporally. The insured then used grasping forceps to pinch the slightly elevated conjunctiva and make a small snip in the conjunctiva and tenons capsule. A fair amount of scarring was encountered as he tried to dissect down to the sclera surface. The insured was able to insert a cannula but upon withdrawing the tip he noticed a clear strand of material. The insured suspected it was vitreous and realized at this point that the medication had been injected into the globe. A non-OMIC insured retinologist subsequently performed a vitrectomy to remove the Anecortave with silicone oil tamponade and silicone removal OS along with epiretinal membrane peeling. The macula was stable; however, the prognosis for visual recovery was uncertain. The patient’s visual acuity remained at 20/200 OS despite cataract surgery.
Analysis
The OMIC insured was adamant that he did not deviate from the standard of care during the final trial injection. It was the insured’s opinion that the previous injections were responsible for the scarring. The insured reported to his attorney that he had discovered reports of several other patients who experienced similar complications. As discovery progressed, the drug manufacturer abandoned the treatment as it became apparent that it was not beneficial to patients. Prior to the drug trial, the OMIC-insured had obtained a specific indemnification agreement covering this type of incident. OMIC’s defense attorney approached the manufacturer’s attorney about this agreement; however, the attorney for the manufacturer maintained that there was no indemnification since the proposed claim was for alleged negligence by the OMIC insured. Defense counsel reminded this attorney that the agreement specifically spelled out that the manufacturer would indemnify the OMIC-insured in that context. The attorney for the manufacturer continued to disagree but allowed that the manufacturer, for professional relationship reasons, would indemnify the OMIC insured. The manufacturer recommended that defense counsel submit a formal demand for indemnification. The demand was accepted and the insured was dismissed from the claim. The drug manufacturer settled for $500,000.
Risk Management Principles
The insured and the entity he was working for at the time of this incident were extremely thorough in drafting their agreement with the drug manufacturer prior to participating in the trial. By entering into a legally enforceable indemnification agreement with the drug manufacturer, the insured was able to avoid a large settlement. Ophthalmologists should indeed negotiate such agreements before they become involved in surgical and drug studies. Furthermore, the insured applied good technique throughout the trial and thoroughly documented his approach and technique during each injection. This documentation made it very difficult for the drug manufacturer to allege that the insured’s technique was improper.
