Hip fracture in 90-year-old female patient following fall in exam room
RYAN BUCSI, OMIC Senior Litigation Analyst
Allegation
Failure to monitor/assist an elderly patient resulting in a fall.
Disposition
Settled for $100,000. OMIC’s contribution was $50,000.
Following a dilated eye exam, a 90-year-old patient began to get up from the examination chair. In the process, she scuffed her shoe on the floor, which caused her to twist and fall to the ground. An ophthalmic technician was in the room and was able to catch the patient’s upper body protecting her head from injury. When the OMIC-insured ophthalmologist reentered the room the patient stated that she had “lost her balance or something” and complained of right hip pain. Minimal assistance was required to help her into a wheelchair and she was taken to her automobile, which was driven by her daughter. The patient did not want emergency medical attention so she was advised to use Tylenol for pain and to call her family doctor should discomfort persist. The following day the patient was taken via ambulance to the emergency room for right hip pain. An orthopedic surgeon diagnosed a nondisplaced subcapital right hip fracture and noted that the left hip had screws that were placed after a prior fracture. Moderate to advanced degenerative joint disease was also diagnosed in both hips. The fracture required surgery during which three cannulated screws were placed under fluoroscopic guidance. The patient was discharged from the hospital to a convalescent home, where she spent 45 days. She was then discharged to her home with progressive weight bearing allowed. At her last visit with the orthopedist, she described occasional right hip pain. Passive range of motion caused no discomfort.
Analysis
OMIC’s defense counsel retained an orthopedic expert who opined that the patient experienced a spontaneous or indirect traumatic subcapital hip fracture that caused her to fall. She had suffered a broken left hip approximately one year prior to this incident when she fell while boarding a bus. The bus driver caught her, but she still fractured her left hip. In our expert’s opinion, no matter how attentive the technician was, she would not have been able to prevent the fall and in fact did a good job of breaking the fall enough to prevent a serious cranial injury. The patient testified at her deposition that she was blind and could not see as a result of the dilated exam. She claimed that she called out to the ophthalmic technician for assistance, but the technician did not respond so she decided to get up on her own. The issue in this matter was whether the ophthalmic technician had a duty to escort the patient to the lobby and out of the building, and if so, whether she was negligent in performing this duty. Plaintiff counsel brought two claims in this case. The first was a medical negligence claim against the OMIC-insured ophthalmologist and the second was a general negligence claim against the OMIC-insured entity that employed the technician. Therefore, OMIC and the premises liability carrier jointly represented the entity. Unfortunately, the county in which this fall occurred was known to be a plaintiff-friendly venue. Although our defense counsel was confident about our chances for a defense verdict, he did advise that a plaintiff verdict could result in a $250,000 to $400,000 award. This case was therefore taken to mediation where a settlement of $100,000 was negotiated. OMIC and the premises liability carrier agreed to spilt the settlement 50/50. The settlement was negotiated on behalf of the entity since the ophthalmologist was not even in the room at the time of the fall. The OMIC insured was dismissed from the lawsuit and no report to the National Practitioner Data Bank or state medical board was required.
Risk management principles
During the claims investigation, it became clear that this particular patient had many risk factors for a fall. She was 90 years old and had fallen and broken her left hip the previous year. She also had just had her eyes dilated during an ophthalmic examination. The Hotline article provides a quick screening tool of questions that help determine who might need assistance. Knowing about this patient’s recent fall and hip fracture would have alerted the technician to stay with the patient and assist her in standing up and walking back to the lobby where relatives or other caregivers could take over assisting her back to the car.
Monovision misunderstanding leads to health department complaint
RYAN BUCSI, OMIC Senior Litigation Analyst
Allegation
Wrong powered lens placed during cataract surgery OS.
Disposition
Complaint dismissed by state department of health.
A patient presented to an OMIC insured with complaints of poor vision related to cataracts. The patient refused to wear glasses or contact lenses and wanted to explore treatment options that would not require either. The insured discussed monovision with the patient, explaining that an operation would be required on both eyes and if successful, one eye would be used for distance vision and the other for near vision. It was explained that prior to the procedure, the patient would be required to wear a contact lens to determine if she was indeed a candidate for monovision and would be comfortable with the anticipated results. The insured determined that the patient was naturally nearsighted and that the contact lens would be placed in the right eye for distance vision. Following the contact lens trial, the patient reported that she had inserted the contacts on only three occasions, but that on these three occasions, her vision was “just fine” and therefore she believed that undergoing the monovision procedure was a “good solution.” The insured agreed that the patient was a good candidate for monovision, so cataract surgery for distance vision was performed on the right eye. Subsequently, cataract surgery was performed on the left eye for near vision. During the one month postoperative exam, the patient complained of blurred vision in the left eye when looking at items in the distance. The insured reminded the patient that her distance vision in the left eye was not supposed to be similar to her distance vision in the right eye as this was not the intended outcome of the monovision procedure. The insured did note a slight overcorrection in the left eye, for which he recommended a piggy back lens; however, the monovision procedure was successful. Following this examination, the patient did not return to the OMIC insured.
Analysis
Five months after his last contact with the patient, the insured received a letter from his state’s department of health alerting him that the patient had filed a complaint. The patient alleged that the wrong powered lens was placed in the left eye and that she had to undergo a subsequent procedure to correct this error.
The insured promptly contacted OMIC and the case was referred to local defense counsel, which drafted a response letter to the state department of health. In the letter, defense counsel contended that the appropriate lens was placed in the left eye since the patient had agreed to monovision. Defense counsel was able to use informed consent documents and the insured’s medical records to prove that the patient was well aware that her right eye would be corrected for distance vision and her left eye would be corrected for near vision. Furthermore, the letter stated that following the procedure there was a slight overcorrection in the left eye. The exact reason for this overcorrection was unknown to the insured; however, it was possible that the lens itself shifted during the healing process. Defense counsel pointed out that this is a well known complication of the monovision procedure and in no way reflected a deviation from the standard of care. In addition, defense counsel retained a local expert who signed an affidavit stating that the care provided by the OMIC insured was well within the accepted standard of care. The combination of defense counsel’s letter and the supportive expert opinion prompted the state department of health to dismiss the patient’s complaint.
Risk management principles
Complaints from state health departments or medical boards should be referred to the OMIC claims department. No matter how “informal” a request for a response to a patient’s complaint may seem, these matters are serious and require legal representation in order to assure that the proper process is followed. This increases the likelihood that the complaint will be dismissed and may help the insured avoid a related medical malpractice claim or lawsuit. This case also highlights the importance of the informed consent process when discussing a complex treatment plan with a patient. The insured in this case did such a good job documenting his informed consent discussion that it provided defense counsel with enough evidence to convince the medical board that the patient was well aware of the parameters of treatment as well as the risks.
FFK Diagnosed on Day of Planned Bilateral LASIK
Ryan Bucsi, OMIC Senior Litigation Analyst
Allegation
Failure to provide informed consent regarding risk of complications from PRK OS with forme fruste keratoconus.
Disposition
Case settled for $200,000.
Case summary
A 30-year-old female presented to an OMIC insured’s office for a LASIK evaluation. The initial consultation was handled by a technician, who discussed risks such as dry eyes, fluctuation in vision, light sensitivity, and glare with the patient. Upon examination, the insured noted SCVA of 20/800 OU and CCVA of 20/20 OD and 20/30 OS. The corneal examination revealed a pachymetry of 520 in each eye with a decreased tear film OU. The insured’s diagnosis was myopia and tear film insufficiency. The patient agreed to undergo bilateral simultaneous LASIK. Approximately two weeks later, when the patient presented for surgery, the insured diagnosed forme fruste keratoconus (FFK) OS based on the color topography. The patient signed consent forms for LASIK and PRK, and the insured performed LASIK OD and PRK OS. The postoperative course was unremarkable in the right eye; however, the patient complained of poor visual acuity, blurry vision, halos, light sensitivity, and headache in the left eye. Visual acuity fluctuated between SCVA 20/200-20/800 OS with CCVA 20/70 OS. The insured treated the patient’s complaints with Pred Forte and oral Prednisolone. After several months with no improvement, the patient requested and the insured provided a referral for a second opinion. The second opinion was central haze and inferior steepening on topography post PRK. Visual acuity was SCVA 20/200 pinholed to 20/30 OS. The patient was advised by the second ophthalmologist to continue Pred Forte and was fitted with a rigid gas permeable contact lens (RGPCL). The patient returned to the insured, who documented CCVA of 20/30 OS with the RGPCL; however, the patient could not tolerate the lens and a soft contact lens did not improve her vision. The insured noted SCVA of 20/400 OS. The patient self-referred to a third ophthalmologist, who diagnosed inferior steepening and mild corneal haze OS following PRK with FFK. CCVA was 20/80 OS. The third ophthalmologist recommended that the patient continue with the RGPCL. During the insured’s final exam, the SCVA was 20/20+1 OD and 20/400 OS, with CCVA of 20/60 OS. The insured’s diagnostic impressions were corneal haze and FFK OS.
Analysis
A dispute existed between the insured and the patient regarding the informed consent process. The insured informed our defense counsel that he fully discussed the risks of PRK with the patient due to the diagnosis of FFK on the day of surgery. The insured handwrote in the chart that he discussed this with the patient. The patient testified at her deposition that she did not recall the insured having any discussion with her about the risks, benefits, and alternatives to PRK with the diagnosis of FFK. Defense experts retained by OMIC felt that, even though the more conservative PRK procedure was performed on the left eye, the patient deserved more information regarding the specific higher risks she faced postoperatively due to the FFK. Defense counsel estimated a defense verdict chance of 50% with a plaintiff verdict as high as $500,000. With the insured’s consent, the case was settled for $200,000.
Risk management principles
It is important to review key studies like topography before the day of surgery. Even though the ophthalmologist correctly revised the surgical plan from bilateral simultaneous LASIK to LASIK OD and PRK OS, there was no urgency to perform either procedure the same day the FFK OS diagnosis was made. Due to the increased risk of complications following PRK on an eye with FFK, surgery could have been postponed to give the patient more time to reconsider whether to proceed with what are both elective procedures in light of this new information. Since the decision was made not to postpone surgery, the insured should have expanded his handwritten note to include a more thorough description of exactly which risks, benefits, and alternatives were discussed with the patient. Furthermore, a notation should have been made that the patient understood the new diagnosis along with the associated increased risks and still wished to proceed with surgery.
Fraudulent Enrollment of Patient in Clinical Trial
Ryan Bucsi, OMIC Senior Litigation Analyst
Allegation:
Manipulating screening data for study eligibility, failure to supervise technician, and abandonment.
Disposition:
Case settled for $250,000.
Case summary:
An OMIC insured was the principal site investigator (PSI) at an OMIC-insured research center during a clinical trial comparing the effectiveness of an anti-VEGF drug, focal laser photocoagulation, and steroids for the treatment of diabetic macular edema. Enrollment criteria included at least one eye showing definite retinal thickening involving the center of the macula due to diabetic macular edema on clinical exam and OCT central subfield ≥ 250 microns. A technician completed the OCT study; the PSI noted that it was off-center but assumed the subject could not keep her head still. Since the PSI’s exam showed macular edema, the PSI accepted the subject for the trial, obtained informed consent, and proceeded to administer an intravitreal injection of an anti-VEGF medication in the right eye and a sham injection in the left. The patient was instructed to use an antibiotic drop as prophylaxis against infection. Two days later, the patient returned to the PSI complaining of a pressure ache in the right eye and decreased vision. The PSI noted CF vision and diagnosed endophthalmitis, which was treated with a vitreous tap and intravitreal and subconjunctival antibiotic injections. The patient’s condition worsened the next day and surgical intervention was needed. As the patient did not have health insurance, the PSI called the study coordinating center (SCC) to see if it would pay for the treatment. When the PSI learned that no funds were available, the PSI referred the patient to a county facility for further treatment. A culture ultimately grew out a heavy growth of strep viridans. Despite a vitrectomy, the patient was left with LP vision in the right eye.
The insureds reported the adverse event to the SCC. A year later, the research center discovered and fired an employee for embezzlement. One year after that, the SCC conducted a review and noticed a significant number of off-center OCTs, all apparently manipulated or substituted by the fired employee. The research center did its own investigation and clarified to the SCC that it did not offer bonuses for enrolling subjects but suspected that the employee falsified the OCT scans in order to enroll as many subjects as possible as part of her embezzlement scheme. The SCC’s review also concluded, based upon a review of the OCTs and fundus photos, that many of the subjects did not have macular edema, thus calling into question the PSI’s clinical skills. The owner of the research center wrote to all affected subjects. The letter to the injured patient stated that the fired employee had intentionally altered the testing to increase eligibility for the study, that the right eye did not require an injection, and that, if the injection had not been performed, the eye would not have developed an infection. The patient sent a written claim to the research center expressing an intent to file suit.
Analysis
OMIC’s retained expert opined that the claimant did not meet the criteria for either the study or off-label use of the drug. He also felt that the failure of the PSI to obtain a second OCT when the first was clearly off-center was below the standard of care. While the claimant alleged abandonment because the PSI did not provide all care needed for the endophthalmitis, the expert supported the PSI’s management of the complication itself (see Hotline for a discussion of what care must be provided by an investigator). The claimant ultimately accepted a settlement on behalf of the research center for $250,000.
Risk management principles
Ensuring that research subjects meet enrollment criteria protects the research subject, the investigator, and the data. The trial developers in this case built safety into the protocol for enrollment through redundancy: findings of edema were required on both clinical exam and OCT, so either a competent exam or an accurate OCT would have excluded this subject from the trial. A more cautious approach when faced with a questionable test result, such as repeating the OCT scan, may have helped the PSI determine that the patient was not qualified for the study. Improved employee oversight may also have helped the insureds ferret out the fraudulent actions of the employee and uncover the falsification of the OCT scans.
Surgeon Responsible for Unreported Adverse Event
Ryan Bucsi, OMIC Senior Litigation Analyst
Allegation
Negligent retinal detachment surgery resulting in permanent retinal detachment.
Disposition
Case settled for $190,000.
Case summary
A 49-year-old female patient presented to an OMIC insured on an emergency basis with complaints of a dark semicircle and haziness for five weeks, which she described as a curtain over her left eye. Visual acuity was 20/80-1 with a diagnosis of rhegmatogenous retinal detachment requiring surgery. The patient was referred to another OMIC insured for the surgery. The first contact that the OMIC-insured retinal surgeon and his surgical assistant (another OMIC-insured ophthalmologist) had with this patient was on the day of surgery. This was the assistant’s first day scrubbing in to a case. The surgeon informed the patient that his assistant would participate and assist in the surgery. The patient did not object. The surgeon and his assistant performed a repair of the retinal detachment in the left eye with 23-gauge pars plana vitrectomy, endolaser, cryopexy, and fluid-15% C3F8 gas exchange. The circulating nurse and surgical technician (both insured by the hospital) assisting the surgeon had done so for many years. The assistant introduced the surgical instrumentation into the eye. The principal stages of the procedure were virtually completed, including the trimming of the vitreous and vitreous base and release of traction to the retina breaks, when there was a sudden tugging of the cord connected to the light pipe while it was still positioned inside the eye. This caused the instrument to be dislodged from the assistant’s hand. The full length of the probe ended up inside the eye. An iatrogenic linear retinal break superior to the optic nerve was noted. In a subsequent surgery, the surgeon performed a 28-gauge pars plana vitrectomy, membrane peel, retinectomy, silicone oil endotamponade, and sub-tenon triamcinolone acetonide injection in the left eye. Laser treatment around the retinal break was also performed. Despite the surgeries, at the time of the surgeon’s last examination, the patient’s retina remained detached and her visual field remained limited secondary to loss of blood flow to a large area of the retina encroaching upon the center. Final visual acuity in the left eye was 20/200.
Analysis
There was definite liability in this case but who would be held responsible? After receiving a notice of intent, the surgeon and his assistant claimed that it was the surgical technician who accidentally tugged on the cord, but there was no indication in the record that she precipitated the adverse event. The surgeon claimed that following the surgery he had discussed the event with another nurse at the hospital, but this was not documented and the nurse had no recollection of the conversation. OMIC defense counsel concluded that the two physicians would bear the brunt of liability in this case. Counsel noted that liability would have been clearer if, right after surgery, the event had been documented in the operative report and an incident report had been filed with the hospital. The surgeon claimed he did not want to upset the tech, who he felt would have taken it very hard. Counsel feared that a jury would take a negative view of the physicians’ failure to document the tugging on the cord by the surgical technician until after they received an intent to sue. Both the plaintiff attorney and the hospital attorney could make the argument that blaming the technician was simply a way for the doctors to avoid responsibility. If a jury believed this was true, it could anger the jury and result in a higher than expected verdict. For this reason, the case was settled.
Risk management principles
The physicians could have avoided liability for this injury by documenting the event in the operative note and filing an incident report with the hospital following the procedure. Not doing so prevented the hospital and staff from learning from this adverse event and aroused suspicion when the surgeon later placed blame on the technician. The fact that there was no documentation of the surgeon’s version of events until after a notice of intent was received made this case impossible to defend. Incident reports are generally part of a confidential peer review process; to protect their confidentiality, do not refer to them in the medical record or photocopy them.
