Michael C. Tigani, MD – OMIC Nominee to Academy’s Leadership Development Program (LDP) XVII Class of 2015

OMIC Risk Management and Underwriting Committee Member Michael C. Tigani, MD was accepted for the LDP XVII, Class of 2015. Dr. Tigani was nominated by OMIC to join a select group of twenty participants chosen from among a large group nominated by state, subspecialty and specialized interest societies.  The purpose of the Leadership Development Program (LDP) is to provide both orientation and skill development to future leaders of state, subspecialty and specialized interest societies.

Nominees to the LDP must agree to develop a project that will benefit the nominating group. As a member of the OMIC Risk Management Committee, Dr. Tigani chose a project that would educate OMIC members regarding the malpractice reporting guidelines of the National Practitioner Data Bank and state Board of Medicine. With assistance from OMIC staff and Virginia defense counsel, Dr. Tigani developed an educational format (case studies) that he used at the workshop, Oh No! Who Needs to Know?, presented at the 2015 Virginia Society of Eye Physicians and Surgeons (VSEPS) Annual Meeting. The subject matter and format of the presentation were well received. About 60 ophthalmologists attended the workshop. Attendees who subsequently responded to a VSEPS survey found the flow chart and handout material to be very useful.

Dr. Tigani is pleased to share the slides and handout material from the VSEPS workshop as well as a PIAA article related to the interplay between state board actions and medical professional liability (MPL).

VSEPS  handout

VSEPS PowerPoint

PIAA Interplay between State Board Actions and MPL

OMIC Forms 43rd Educational Alliance with the Michigan Society of Eye Physicians and Surgeons (MiSEPS)

This cooperative venture will significantly reduce malpractice premiums for MiSEPS members by offering a 10% discount (averaging more than $1,300) to members for attending a qualifying cosponsored risk management event. CME credit available for some courses.

For more information on OMIC’s CV program contact Deena Mader at OMIC at 800-562-6642, ext. 628. www.omic.com

For Michigan state society membership, please contact Theresa Wiley, Associate Director for the Society at 313 823 1000 or email at twiley@miseps.org.

Visit the MiSEPS website for more info: www.MiSEPS.org.

Several New and Revised Consent Forms Published by OMIC

Several new and revised informed consent documents and risk management recommendations documents were recently uploaded.

CATARACT SURGERY

• New: Same Day Sequential Bilateral Surgery Addendum
• New: Femtosecond Laser Cataract Surgery Addendum

RETINA

• New: Intravitreal Anti-VEGF Injections for Adults: Risk Management Recommendations
• Revised: Avastin^TM (bevacizumab) Consent
• Revised: Eylea^TM (aflibercept) Consent
• Revised: Lucentis^TM (ranibizumab) Consent
• Revised: Ozurdex^TM (dexamethasone) Consent

RETINOPATHY OF PREMATURITY

• New: Intravitreal Anti-VEGF Injections for ROP: Risk Management Recommendations
• Revised: Intravitreal Anti-VEGF Injections for ROP Consent

See all new consent forms here.

See all new risk management recommendation guides here.

OMIC Encourages Prompt Reporting of Endophthalmitis in Patients given Brilliant Blue G (BBG)

An alert was released this week by the American Academy of Ophthalmology (AAO) and the Food and Drug Administration (FDA) regarding the use of Brilliant Blue G for eye surgery. (See below) OMIC encourages policyholders who report cases to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program to also call OMIC’s Risk Management Hotline to report the incident and for advice on mitigating risks associated with the event.   Hotline: OMIC’s ophthalmic risk management hotline receives thousands of calls each year from policyholders and their employees in every region of the country. Policyholders and their staffs should know that any time they encounter a difficult situation, they can call an OMIC Risk Manager for help. OMIC’s risk management hotline is confidential from other OMIC Departments and Risk Management staff does not discuss any issues raised through the hotline with anyone else..Records are kept within a secure document imaging system and access to files are limited to Risk Management/Legal staff only.

Policyholders should encourage staff members to use this policyholder benefit whenever needed.

Call (800) 562-6642 then press 4.

UPDATE: FDA Clarifies Its Recall of Brilliant Blue G for Eye Surgery
 

The U.S. Food and Drug Administration issued additional clarifications this week regarding a March 19 recall of Brilliant Blue G (BBG). The FDA recommends that ophthalmologists immediately quarantine and return only any remaining Brilliant Blue G product that was received from Franck’s Compounding Lab in Ocala, Fla.

Prior quarantine recommendations had not been specific to that compounding laboratory.

Academy members are asked to report any cases of post-procedural fungal or bacterial endophthalmitis that occurred in the last six months that are associated with eye surgery in which BBG was used. Reports should be made to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Online at www.fda.gov/MedWatch/report.htm; or

Call 800.332.1088 to request a reporting form and return to the address on the pre-addressed form, or submit by fax to 800.332.0178.

AAO/FDA Alert:

The Academy is assisting the U.S. Food and Drug Administration, the U.S. Centers for Disease Control and Prevention and state and local health agencies with an ongoing public health investigation. The FDA has received reports of fungal endophthalmitis in patients who were given Brilliant Blue G (BBG) during eye surgeries. Clinicians in several states have reported adverse events. The BBG was supplied by Franck’s Compounding Lab in Ocala, Fla. The pharmacy issued a recall of all lots of BBG on March 9.

Brilliant Blue G is not an approved drug in the United States. The FDA recommends that all Brilliant Blue G be immediately quarantined and returned. This includes all lots of BBG received from Franck’s Pharmacy. To assist with this investigation, Academy members are asked to report any cases of post-procedural fungal or bacterial endophthalmitis that occurred in the last six months that are associated with eye surgery in which BBG was used. Reports should be made to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Online at www.fda.gov/MedWatch/report.htm; or
• Call 800.332.1088 to request a reporting form and return to the address on the pre-addressed form, or submit by fax to 800.332.0178.

For more information, contact the Academy’s Governmental Affairs Office at 202.737.6662.

Retina Claims Pay Fewer But Costlier Indemnities

By Arthur W. Allen, MD, and Paul Weber, JD

Dr. Allen is Chairman of OMIC’s Board of Directors and Claims Committee. He is a retina specialist in San Francisco, CA. Mr. Weber is OMIC’s Risk Manager.

Digest, Fall 1999

Almost half of all claims brought against OMIC insureds involve either retina or cataract procedures. From 1987 through mid-1999, OMIC counted 120 closed claims related to the retina (not including ROP claims), or 16% of 742 closed cases, compared to cataract’s 224 claims, or 30% of the total. Of the 120 retina claims, 94 (78%) were brought against retina subspecialists and 26 (22%) were brought against general ophthalmologists and others. Most often, retina claims arose from complications of lasers (33 claims), vitrectomies (31), and scleral buckles (24), or failure to diagnose and/or timely treat a retinal detachment or macular degeneration (25).

As with most OMIC claims, retina claims are usually resolved without a payment to the plaintiff. In fact, retina claims settle slightly less often with a payment to the plaintiff than the average OMIC claim: 20% for retina versus 24% for all OMIC claims. Yet the average retina indemnity payment of $142,000 is 20% higher than the $114,000 average for all OMIC claims. One would expect a high indemnity payment to correlate to the severity of the patient’s visual loss. However, in six of OMIC’s twelve large loss payments (over $100,000), the plaintiff had reasonable vision after the alleged negligence of the insured, but the facts and circumstances surrounding the alleged error by the insured (rather than the visual loss) made the case too risky to bring to trial. Often, in claims against vitreoretinal subspecialists, the “errors” seemed to arise from lapses in pre and postoperative care, while many of the general ophthalmologists appeared to be performing a procedure or surgery beyond their perceived skill and expertise.

In four of the five large loss retina claims against general ophthalmologists, the injury occurred because the ophthalmologist failed to properly treat a retinal condition, apparently due to the alleged limited knowledge of treatment principles for such conditions.

Pushing the Skills Envelope

Case #12 (see Table) is illustrative of this problem. A primary care physician referred the plaintiff to the insured after she hit her head and left eye during a fall at home. She did not see the insured until two months after the injury, at which time she complained of blurred vision and foreign body sensation OS for two months duration. Examination revealed visual acuity of 20/30 OD and CF, 2 feet OS. External and SLE examinations were normal and the IOP was 20/19. However, fundoscopic examination revealed a vitreous hemorrhage in the left eye. The insured treated the patient conservatively by patching the left eye to allow the blood to reabsorb.

The patient returned two weeks later for follow-up. The hemorrhage had cleared slightly and her vision had improved to 20/400. The insured performed a pars plana vitrectomy the following week. Postoperative vision was 20/60 and the patient appeared to do well; one week postop, however, it was noted that she had a retinal detachment with HM vision. The insured attempted to repair the retinal detachment by performing a scleral buckle procedure. Vision improved to 20/100, but the retina re-detached and another scleral buckle was performed, again unsuccessfully. The patient was then referred to a retinal specialist. Three more unsuccessful repairs were attempted. The patient was left with a retinal detachment and vision of bare light perception in the eye. There was no further recommendation for treatment.

Three physician experts retained on behalf of the insured were of the opinion that the insured was not qualified to perform a retinal detachment repair despite some limited training in this procedure. These experts also were of the opinion that most general ophthalmologists would not have attempted to perform the vitrectomy and would have referred the patient to a vitreoretinal specialist right away. One expert opined that the insured did not have the necessary equipment (endolaser and air fluid exchange equipment) to properly perform a retinal detachment repair. Lacking expert support for the insured, the case was settled prior to trial.

Dropping the Ball Postop

In four of the large loss cases against vitreoretinal subspecialists (see Table), the allegations involved errors in diagnosing a post-vitrectomy or scleral buckle complication. Often, it was lack of documentation of communication with the patient that played a key role in determining the outcome of the case.

In case #3, a patient had retinal surgery on Thursday, including a fluid gas exchange (FGE), for repair of a large retinal tear. On Friday, the insured released the patient from the hospital with the retina totally reattached and pressures within normal limits. On Saturday, the patient called the insured, who received the call on his car phone, and said her eye felt “different.” When asked if she was experiencing stomach upset, nausea, vomiting or eye pain, the patient said no. The insured reminded her he would be out of town that weekend, but his partner would be covering for him if she had any problems. He did not document the call. On Sunday, the patient called again and was referred to the ophthalmologist’s partner (also an OMIC insured) who took the call at home. The patient complained of seeing “black” and feeling pressure. Since the patient was now three days postop and was on Neptazane and Prednisone, the partner was not too concerned that she was feeling some pressure. He told her to come to the office the next day but did not document this conversation.

On Monday, when the patient presented at the office, IOP was 60, visual acuity was no light perception, and the lens and iris diaphragm had shifted forward, flattening the anterior chamber. She eventually lost the eye and needed an enucleation. The patient filed a lawsuit against both ophthalmologists, alleging that she had complained of “pain” during her telephone conversations with them and that their failure to promptly treat the condition resulted in the loss of her eye.

Defense experts were supportive of the clinical care given to the patient with the possible exception of not seeing her on Sunday. However, the plaintiff made a very credible and sympathetic witness, and there was no documentation to support either physician’s version of what was said during their telephone conversations with her. It was decided to settle on behalf of both insureds, rather than go to trial and risk a jury’s perception that they did not respond to the patient’s plea for help in a timely manner.

Going to Trial

Only three retina-related lawsuits have gone to jury trial and OMIC won two of them. The third case resulted in OMIC’s largest retina-related indemnity payment to date, a $675,500 jury verdict. Even though the visual outcome after vitrectomy surgery for a rhegmatogenous retinal detachment with a large retinal tear was good (20/60), the jury was angry at the ophthalmologist for allegedly delaying treatment by asking for payment from the patient prior to the procedure (see Table case #1).

During a medical malpractice trial, the professional ethics and credibility of the physician are under intense scrutiny by the jurors. Not only does the physician need to possess irreproachable ethics, but any perceived lack of credibility can doom the defense. Although the defense was able to argue that the ophthalmologist in this case followed the standard of care in performing the two RD surgeries, plaintiff’s counsel successfully attacked the defendant’s credibility and judgment on two issues: the alleged demand for prepayment and the reason for the delay in surgery. This case might have been successfully defended on clinical issues alone; however, the associated nonmedical issues were extremely damaging to the defense and most likely contributed to the high jury award.

In the other two jury trials, lack of informed consent was the driving issue. An analysis of how informed consent played a factor in one of these cases can be found in the Closed Claim Study on page 6. Ophthalmologists and their staff who are interested in procedure specific forms should visit the forms and documents section of OMIC’s web site at http://www.omic.com/resources/risk_man/forms.cfm for retina surgery and laser procedure forms.