Early Reporting and Investigation of Potential Claims Averts a Lawsuit
By Ryan Bucsi, OMIC Senior Claims Associate
Digest, Spring 2005
ALLEGATION: Negligent upper and lower blepharoplasties, resulting in pain during surgery, lid ptosis, loss of eyebrow hair, and scarring.
DISPOSITION: No lawsuit was filed and the case was closed without an indemnity payment.
Case Summary
An elderly female patient presented to the OMIC insured with a chief complaint of ptosis affecting her vision. The patient did not wear glasses and visual acuities were 20/30 OD and 20/20 OS, uncorrected. Upon physical examination, the insured diagnosed right and left upper lid dermatochalasis, acquired myogenic ptosis, and brow ptosis with superior visual field impairment OU. Surgical options were discussed and two months later, the insured performed therapeutic right and left upper lid blepharoplasties and external levator resection ptosis repairs with direct brow lifts. There were no noted operative complications. During several postoperative visits with the insured, the patient’s complaints included lid redness, lid asymmetry, lashes in the visual field, skin bags nasally with soreness, skin above the lids pushing the eyelids down, and pain when rubbing the eyelids. She also complained for the first time of experiencing pain during surgery. She continued to express her displeasure with the results of the surgery on subse- quent visits, complaining of baggy skin by the bridge of her nose, loss of eyebrows, and occasional irritation to her eyelids. Her visual acuities were unchanged at 20/30 OD and 20/20-2 OS.
The insured informed the patient that the strongest local anesthesia had been used during her surgery and that in-patient surgery with general anesthesia might offer better pain management, but she would have to wait a minimum of three months before undergoing any repeat procedure. The insured also informed the patient that her lids were still healing and that the final benefits of surgery might not be seen for four months after surgery. Subsequently, the patient phoned the insured and informed him of additional proce- dures she had scheduled in another state. This was the insured’s last contact with the patient, nearly five months after her initial surgery. Eventually, the patient requested that the insured pay her $100,000 for her dissatisfaction with her outcome. The insured promptly referred the matter to OMIC.
Analysis
OMIC’s Claims Department has access to several ophthalmology consultants who are able to provide a detailed standard of care review within a relatively short time frame. With the insured’s permission, the patient was contacted by OMIC and informed that her case could be reviewed by a board certified oph- thalmologist to determine if there were issues related to the care provided by the insured physician. She accepted the offer. The reviewer felt that the surgery was definitely indicated based upon the physical findings outlined in the chart, that the technical aspects of the surgery were properly performed, and that the postoperative care was appropriate. Fur- thermore, the reviewer indicated that several of the patient’s complaints were outside the scope and purpose of the surgery, in particular, the complaint of fullness and heaviness in the glabellar region with a crowding of the skin in the nasal quadrants of the upper eyelid. Since the only purpose of the surgery was for visual improvement, correction in this area should not have been anticipated by the patient. OMIC openly discussed these points with the patient, including the fact that the reviewer found the insured’s care to be completely within acceptable standards. The patient decided not to pursue a lawsuit and the case was closed after the statute of limitations expired.
Risk Management Principles
OMIC cannot always avert a claim or lawsuit. Ultimately, it is up to the patient and his or her attorney, if one is involved, to decide whether or not to pursue a complaint. However, if an insured is proactive and reports a potential claim when a patient has voiced significant dissatisfaction, the Claims Department may be able to intervene and conduct an early investigation of the claim. If the reviewing ophthalmologist’s opinion on the standard of care is supportive, patients can sometimes be dissuaded from pursuing lawsuits. Conversely, if the consultant cannot support the insured on the standard of care, a settlement might be reached prior to the patient obtaining an attorney and filing a lawsuit.
Fire in the Operating Room
By Ryan Bucsi, OMIC Senior Litigation Analyst
Digest, Summer 2006
ALLEGATION Facial burns from a fire in the operating room.
DISPOSITION Plaintiff verdict and subsequent post- trial settlement of $430,000.
Case Summary
An OMIC insured scheduled a repair for a patient with extreme ptosis on the right side under local anesthesia. The patient’s nose and chin were fully draped, and the anesthesiologist was administering oxygen via a mask. The ophthalmologist performed the initial incision and then proceeded to use cautery to achieve hemostasis, sparking a fire. The OMIC insured placed pressure on both eyes, removed the surgical drapes, and splashed water on the patient’s face while the nurses and anesthesiologist put out the fire. The surgical wound was sutured by the OMIC insured without performing the ptosis repair. The patient was transferred to the burn unit with first and second degree burns over her lips, the medial aspect of the cheeks, chin, paranasal region, right ear, right lateral neck, and posterior neck. The patient did not lose consciousness during the fire and remained in stable condition. The discharge note stated a diagnosis of 1% total body surface area partial- thickness burns to multiple areas of the face, adjustment disorder with mixed emotional response, and acute post-traumatic stress disorder.
Analysis
Once the fire was recognized, all members of the surgical team did all they could to care for the patient. Unfortunately, the patient not only suffered physical injuries requiring plastic surgery, she was unable to work as a result of post-traumatic stress disorder, severe depression, anxiety, and trauma. The loss of income and necessary psychiatric care greatly increased the economic damages she claimed in her lawsuit and made her allegation that the fire should have been prevented all the more compelling. When plaintiff and defense experts reviewed the care, they both criticized the poor communication between the ophthalmologist and anesthesiologist. The OMIC insured testified that he had a standing order with the facility for no oxygen during ptosis repairs; despite extensive searching, no such document could be found. The ophthalmologist acknowledged that he did not remind the anesthesiologist beforehand not to administer oxygen during the procedure or notify him that he was about to use the cautery. Instead, he assumed that the anesthesiologist would automatically turn off the oxygen and switch the patient to air. The plaintiff’s anesthesiology expert testified that the surgeon must either warn of impending cautery use or the anesthesiologist must ask whether any is planned. Other factors con- tributed to the risk of a surgical fire. Hospital staff testified that the surgeon used a pencil cautery, which does not allow for voltage control. Another expert pointed out that regard- less of the type of cautery, by fully draping the patient’s head, the surgeon allowed oxygen to accumulate below the drapes and ignite once the cautery was used.
Given the lack of support and substantial economic damages, OMIC and the surgeon’s attorney urged the insured to make a settlement offer in response to the plaintiff’s global demand of both defendants of $299,999. Despite this advice, the ophthalmologist was unwilling to offer more than $29,000, which would keep him below his state’s threshold for reporting an indemnity payment. Accordingly, the case was taken to trial, where the jury found in favor of the plaintiff against both defendants, with the ophthalmologist 80% and the anesthesologist 20% responsible for the outcome. Although the jury awarded a total of $474,994, state law allowed the plaintiff to recover both interest and the cost of the lawsuit, including expert fees. These added costs significantly raised the award, making the OMIC insured alone responsible for $439,325. OMIC was able to settle the case after the trial for $430,000.
Risk Management Principles
As this case demonstrates, surgical fires are difficult to defend. While OMIC has not had many such cases, we have had to settle all five of them, with payments ranging from $10,000 to $430,000. Just because a complication of surgery is extremely rare does not mean that proper precautions should not be taken to decrease the risk. Please see the Risk Management Hotline article in this issue for information on how to prevent surgical fires.
Conflicting Consent Forms Force a Settlement in Case of Hypopigmentation
By Ryan Bucsi, OMIC Senior Litigation Analyst
ALLEGATION
Facial laser resurfacing performed too soon after Accutane use, lack of informed consent, and alteration of consent forms.
DIspOsITION
The case settled for $800,000.
Case Summary n oMiC policyholder recommended full facial laser resurfacing on a 45- year-old female patient for treatment of sun damage and facial rhytids. the patient had stopped using accutane nine months earlier and was counseled during a preopera- tive visit about the risk of redness and scar- ring. since the patient managed the building where the ophthalmologist’s office was lo- cated, some discussions regarding the pro- cedure took place informally in passing. the patient signed a consent form in the insured’s office prior to the procedure; she also signed a consent form at the surgery center on the day of the procedure.
Postoperatively, the patient demonstrated early reepithelialization; however, she was anxious about what she felt was prolonged healing. the patient self-referred to a plastic surgeon, who diagnosed a deep partial-thick- ness burn over her entire face where the laser surfacing was performed and instructed her to scrub her face and then apply Bacitracin. During a follow-up exam, the ophthalmologist suspected a toxic reaction to the Bacitracin since the patient’s skin was sloughing off. he debrided the skin, encouraged the patient to follow his instructions only, and informed her that she was now at a higher risk for scarring, delayed healing, and retraction. Poor epitheli- alization continued. Despite the ophthalmolo- gist’s warning, the patient continued to con- sult with dermatologists and plastic surgeons, one of whom opined that the patient’s use
of accutane nine months prior to facial laser resurfacing had resulted in fewer sebaceous glands and contributed to slower wound healing. at this point, the patient stopped treatment with the oMiC insured and filed a lawsuit, during which she produced evidence of severe, irreversible hypopigmentation.
Analysis
the plaintiff alleged that the ophthalmologist should have waited longer post-accutane use to perform the facial laser resurfacing. if this had been the only allegation, it is quite possible that the insured’s care could have been suc- cessfully defended at trial. unfortunately, the primary issue in this case shifted to informed consent upon the plaintiff attorney’s discovery of two separate consent forms on which differ- ent risks had been circled from the same list of complications and different additional risks had been handwritten in by the ophthalmologist. the insured’s explanation of how this occurred seemed plausible: he took his office chart copy of the form with the patient’s name, procedure, signature, and date to the surgery center and used it during the discussion he had again with the patient that day. following the procedure, the surgery center approached him and asked him to fill out the center’s copy of the consent form, which he did without consulting the copy that was in his records. the plaintiff attorney alleged that the insured wrote in the risk of severe hypopigmentation after the patient’s difficulties began in postoperative recovery and then falsely entered the date. these allega- tions of fraudulent alteration would have been difficult to defend and could have exposed the insured to a verdict exceeding his policy limits. for these reasons, the insured requested that oMiC settle the case on his behalf.
Risk Management Principles
Whether treating employees, business acquain- tances, or friends, physicians should follow nor- mal office protocols for conducting preopera- tive assessments, obtaining informed consent, and monitoring the patient postoperatively. Document all discussions with a patient, even if they occur outside the office setting or by telephone. it is not sufficient to simply docu- ment that a consent discussion took place.
the specific risks and complications discussed with the patient should be noted, dated, and signed. Particular attention should be paid to documenting complications for which the patient is at increased risk (e.g., your prior use of accutane puts you at higher risk for delayed healing). ideally, the patient should sign a pro- cedure-specific consent form in the physician’s office and be given a copy to review at home. rather than fill out two forms, physicians should provide the hospital or surgery center with a copy of their signed office consent form as proof that the legal duty of obtaining informed consent has been fulfilled.
Cosmetic Treatment by Technician Results in Fine and Suspended License for Medical Director
By Ryan Bucsi, OMIC Senior Litigation Analyst
Digest, Spring 2009
ALLEGATION: Negligent supervision of unlicensed staff performing laser skin resurfacing.
DISPOSITION: Lawsuits were settled on behalf of the OMIC insured for a collective $48,750. Insured was fined $35,000 and his license suspended for aiding and abetting the unlicensed practice of medicine.
Case Summary
In two separate cases occurring one week apart, patients received Intense Pulse Light (IPL) treatment from a technician in a medical spa. Following treatment, each patient complained of being burned. The spa returned the money in both cases and even compensated one patient for her missed time from work. Nonetheless, they sued the OMIC-insured ophthalmologist in his role as medical director of the spa even though he had not been present at either procedure.
Analysis
The ophthalmology expert who reviewed this case testified that one of the patients had experienced normal skin darkening that was likely to improve. The other patient was a smoker with prior skin damage from the sun and no new injury. While the expert concluded that the patients were not harmed, he shared the plaintiffs’ concerns about the delegation process. First, he noted that neither the insured nor another physician documented a pre-treatment exam or the reasons for recommending IPL. Next, the expert could not find an order for the technician to perform the treatment, a protocol defining treatment parameters, or an indication from any physician of subsequent examinations. As the medical records contained only documentation by the technician, the expert concluded that the technician made treatment decisions and performed the IPL sessions without supervision. Delegation of such authority for medical decision-making, he opined, was below the standard of care. The insured initially disagreed with the review and reported that regardless of the laws and regulations, it was quite common for physicians he knew to designate a “range of therapy” for IPL treatments. Based upon the technician’s training and skills, she had been granted the discretion to adjust the IPL power up or down within that range in order to achieve the desired result. The insured also did not feel that his presence was required for these treatments as they were routinely performed by technicians in his area. He acknowledged, however, that his medical board had already determined that such delegation was illegal. Moreover, the expert reported that he was always physically present on site in his own practice when IPL procedures were being performed by his technicians. The insured was certain that written consent for at least one of the procedures had been obtained; however, the consent document could not be located and there were no documented risk/benefit discussions.
Risk Management Principles
Experts base their review of malpractice claims upon the standard of care—reasonable prudence—not the “standard of the community.” Attorneys remind physicians, moreover, that ignorance or violation of laws and regulations may make a case indefensible, even if the care was properly rendered and there were no injuries. The physician remains liable for damages sustained by patients cared for by his staff and under his supervision, even if he has properly delegated, trained, and supervised the staff. If the cause of the injury cannot be attributed to the staff or equipment, the indemnity payment is made on behalf of the physician, not the practice, as happened here. In compliance with federal and state law, the payments made on behalf of the OMIC insured were reported to the National Practitioner Data Bank and the state board and were available to health care facilities performing credentialing reviews. The state board levied a $35,000 fine and suspended the insured’s medical license. This fine was not covered by the OMIC insurance policy since the insured’s role was limited to being the medical director of a non-OMIC insured spa.
As this case indicates, a cosmetic procedure with seemingly minor clinical risks may end up causing severe consequences for the physician. Protect yourself if you are delegating medical procedures. Know your state laws. Ensure that you are competent to perform a procedure yourself prior to training non-physician personnel to perform it. Keep files with evidence of adequate training, competency evaluations, and protocol development and review. For each patient, evaluate the necessity of a procedure, and write an order for staff to perform the procedure, including treatment parameters. Document the informed consent discussion and ask the patient to sign a procedure-specific consent form. See the Hotline article in this Digest for information on what can be delegated.
Reducing Your Risk of Hypodermic Perforations
By Jerome W. Bettman Sr., MD, and Byron H. Demorest, MD
Argus, December, 1991
Cases of hypodermic perforation of the eye during lid or orbital injections have been recorded in the literature more frequently than one might imagine, indicating how easily such incidents can occur. The sharp disposable needles currently used for injections around the eye may penetrate the sclera unless special care is taken. When such complications do occur, it is imperative to provide appropriate follow-up treatment promptly.
A review of two case histories illustrates this complication. A 68-year-old insulin dependent diabetic man with eight diopters of myopia was being prepared for a cataract extraction. After an uneventful akinesia, retrobulbar injection of Xylocaine was given using a 27-gauge disposable 1-1/4 inch needle. The patient complained of pain and decreased vision. The eye was extremely soft and the surgeon could not see a red reflex. Ultrasound disclosed a hemorrhagic choroidal detachment and later, a retinal detachment. After the blood cleared, a scar in the posterior fundus was seen, apparently the result of perforation by the retrobulbar needle.
In the second case, a prophylactic subconjunctival injection of 40 mg. of gentamicin was given following an uncomplicated cataract extraction with an implant. The patient complained of severe pain and inability to see. The cornea was hazy and the pressure elevated. Several days later, marked retinal ischemia and a cherry red spot were seen in the macula. Vision was light perception. Weeks later, the optic nerve was pale. Vision was NLP.
Penetration of the eye with a retrobulbar needle can happen even to a very skilled and competent surgeon. One can only evaluate where the needle tip is by the angle that the syringe is held, the amount of needle in the orbit and a sense of resistance. Orbital relationships, the length of the globe, and the resistance of the tissue all vary. A myopic eye is longer than a hyperopic eye. An inflamed eye is soft. The globe may be enophthalmic or exophthalmic.
A globe perforation is a complication that may be successfully defended if care is taken to follow up on the side effects, including intraocular hemorrhage, optic nerve atrophy, and arterial or venous occlusions. Unfortunately, death from presumed injection into the optic nerve sheath has also been reported. These problems may occur with the use of either sharp disposable or so-called “dull” retrobulbar needles. Excellent surgeons often use one or the other and neither is considered substandard.
Medicolegal hazards are also associated with penetration during subconjunctival or subtenons injections. Fortunately, this is easier to avoid. During the past several decades, articles have publicized the fact that a subtenon or subconjunctival needle should be moved extensively before any fluid is injected. Such movement provides the assurance that the needle is not engaged in the sclera.
If penetration of the globe should occur, the eye must be treated as it is following any traumatic injury. The patient should be examined with ultrasound when indicated, intraocular infection should be avoided by proper use of antibiotics, and vitreous hemorrhage must be managed even with vitrectomy if needed to prevent retinal detachment or loss of the globe. Timely referral to the appropriate specialist is advised and the patient must be informed of the nature and severity of the complication.
In conclusion, penetration of the globe with a hypodermic needle is relatively common. Liability from perforation following retrobulbar injections can usually be successfully defended if reasonable care, proper documentation and informed consent have been followed. Fortunately, perforation from subconjunctival or subtenons injections is easier to avoid if proper precautions are taken.
