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Presenting a live 90‐minute webinar with interactive Q&AO hh lOphthalmologylMMalpracticeli SuitsS iNavigating Eye Injury Proof Issues and Claims Involving LASIK,Cataracts, ROP, and Other ProceduresTUESDAY, APRIL 23, 20131pm Eastern 12pm Central 11am Mountain 10am PacificT d ’ facultyToday’sfl features:fTodd J. Krouner, Law Office of Todd J. Krouner, Chappaqua, N.Y.C. Gregory Tiemeier, Partner, Tiemeier & Stich, DenverThe audio portion of the conference may be accessed via the telephone or by using your computer'sspeakers. Please refer to the instructions emailed to registrants for additional information. If youhave any questions, please contact Customer Service at 1-800-926-7926 ext. 10.
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OPHTHALMOLOGY MALPRACTICE SUITS –NAVIGATING EYE INJURY ISSUES AND CLAIMSINVOLVING LASIK, CATARACTS, ROP ANDOTHER PROCEDURESWebinar PresentationTuesday, April 23, 20135Todd JJ. Krouner(914) 238-5800tkrouner@krounerlaw.com
INTRODUCTION LASIK SURGERY MALPRACTICECASES ARE ATTRACTIVE FORPLAINTIFFSA. GENERALLY, DOCTORS WIN 80% OFMEDICAL MALPRACTICE CASES.CASESB GENERALLY,B.GENERALLY MY SUCCESS WITHLASIK CASES EXCEEDS 80%.6 Todd J. Krouner, April 15, 2013
C. WHY THE DIFFERENCE1.IT IS ELECTIVE2. THERE IS NO UNDERLYING DISEASE3. SURGEONS TURN CORNEAS INTOCOMMODITIES, INVITING CONVEYORBELT ANALOGIES THAT DESTROYJURIES’ PREDISPOSITION IN FAVOROF DOCTORS.DOCTORS 250/EYE!7 Todd J. Krouner, April 15, 2013
D.SIGHT IS THE MOST IMPORTANTOF OUR FIVE SENSES80% of what we learn comes in through oureyes.pphowJurors can be made to appreciatediminishedy impactspall aspectspof dailyyvision adverselylifeactivity - - even though plaintiffs mayappear welland are not physically deformed.8 Todd J. Krouner, April 15, 2013
Defending the OphthalmologyMalpractice LawsuitC. Gregory TiemeierCTiemeier & Stich, P.C.1000 East 16th AveDenver, CO 80218Phone: (303) 531531-00220022Fax: (303) 531-0021Email: gtiemeier@tslawpc.com
The Defense PerspectiveDIFFERENT TYPES OFOPHTHALMIC MALPRACTICECASES10
Procedures/Treatments Resulting in ClaimsCataract Surgery31.73%Other nt/Surgery4.87%Oculofacial 8.72%RetinaTreatment/Surgery13 33%13.33%Refractive Surgery9.38%Medical Evaluation10.46%11
OMIC’s Top Ten Largest Payments to PlaintiffsAmountDescriptionSpecialtyYearCldClosed 3,375,000Failure to diagnose ROPMedical Retina2007 2,000,000Failure to diagnose bilateral glioma in10 mo old babyPediatric2009 1,800,000Failure to diagnose glaucoma in 8 yroldPediatric2001 1 000 000 1,000,000FailureFilto treat corneall ulcerlini 2yr2oldCComprehensivehi1999 1,500,000Failure to diagnose ROPPediatric2012 1,000,000Misdiagnosis sarcoidosis/prednisoneoverdoseOculofacial2002 1,000,000Failure to diagnose ROPPediatric2009 1,000,000Failure to diagnose ROPPediatric2010 1,000,000Acute glaucoma post phakic implantComprehensive2011 1,000,000Failure to diagnose foreign bodyOculofacial201212
Avg. Indemnity PaymentsProcedure/Treatment (OMIC data)NumberTotal MillionsMedianCataract Surgery201 22.0 22 0 60,000 60 000Medical Evaluation80 17.8 100,000Oculoplastics79 12.4 75,000Refractive Surgery86 11.4 55,000Retina63 10.0 100,000ROP9 8.3 575,000Glaucoma39 7.3 135,000Miscellaneous Other79 7.1 , 30,000Corneal19 4.1 75,000Trauma related24 3.6 110,000Local Anesthesia11 2.6 85,000Strabismus11 1.4 100,00013
II. LASIK SURGERY NEGLIGENCEA. TYPES OF CASES CONTRAINDICATIONS - ECTASIACorneal ectasia is one of the most devastating complicationsafterft LASIKLASIK. PPost-LASIKt LASIK ectasiat i isi consideredid d inipatients who developed increasing myopia, with orwithout increasing astigmatism, loss of uncorrectedvisual acuity, often loss of best-corrected visual acuity,with keratometric steepening, with or without centraland paracentral corneal thinning, and topographicevidence of asymmetric inferior corneal steepening afterLASIK procedure. Ectatic changes can occur as early as1 week or can be delayed up to several years afterLASIK.LASIK Todd J. Krouner, April 15, 201314
ECTASIA IS PRESUMPTIVE EVIDENCEOF MEDICAL MALPRACTICE95% OF THE TIME POST-LASIK ECTASIA ISCAUSED BY A SURGEON MISSINGWARNING SIGNS IN PRE-OPERATIVETOPOGRAPHIES.TOPOGRAPHIESSee J. Bradley Randleman, MD, Buddy Russell, FCLSA,Michael A. Ward, MMSc, FAAO, Keith P. Thompson, MD,R DR.Doylel Stulting,St ltiMD PhD,MD,PhD RiskRi k FFactorstanddPPrognosisi fforCorneal Ectasia After LASIK, Ophthalmology, 2003;110:267-275; Randleman JB, Woodward M, Lynn MJ,g RD,, Risk Assessment ffor Ectasia afterfCornealStultingRefractive Surgery, Ophthalmology 2008; 115: 37-50. Todd J. Krouner, April 15, 201315
2. FLAP COMPLICATIONS3. DATA ENTRY ERRORSO4. MAINTENANCE ERRORS5. PRODUCT ERRORSALCON LADAR 6000BAUSCH & LOMB ZYOPTIX 317BUT SEE Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).16 Todd J. Krouner, April 15, 2013
REFRACTIVE SURGERY MALPRACTICE 1. Schiffer v. Speaker – Ectasia - 7.25 M Verdict2. J.C. - Ectasia where prior doctor said patient was not a good candidate3. R.P. - Failure to calibrate laser resulting in severe central islands4. R.G. - PRK on central frank keratoconus (see case study by Dr. Randleman)5. Martinez v. Neatrour - Ectasia6. S.D. - DEA cocaine use (ectasia)7. A. P. - Ectasia/alteration of records/loss of insurance coverage8. Devadas v. Niksarli - Ectasia/alteration of records/ 5.6 M verdict9. R.D. - Ectasia10. J.R. - Defective medical device recall of Alcon Ladar vision 6000 centralislands11 D.K.11.D K - DefectiveD f ti medicaldi l deviced i recallll off AlconAlL d visionLadari i 6000 centralt lislands12. S.P. - Defective medical device recall of Alcon Ladar vision 6000 centralislands13. M.S. -Hyperopicyp p ectasia after 11 refractive pprocedures14. L.S. - Hyperopic ectasia following four surgeries15. J.D. - Steroid induced glaucoma following LASIK16. E.K. - Ectasia - 950,000 for housewife with no loss of earned income17. D.D. – Ectasia - 1M 17 Todd J. Krouner, April 12, 2013
B STATUTES OF LIMITATIONSB.1. NEW YORK – CONTINUOUSTREATMENT2. NEW JERSEY – DISCOVERY3. FLORIDA – STATUTE OF REPOSE18 Todd J. Krouner, April 15, 2013
ECTASIA IS A TIME BOMBWITH A LONG FUSELITERATURE REPORTS 6-YEAR DELAYIN DETONATIONONE DOCTOR REPORTED A 1313-YEARYEARDELAY IN ONSETWHERE DOES THAT LEAVE PATIENTS INTERMS OF A CLAIM?IS THE CLAIM BARRED BEFORE AN INJURYEVENMANIFESTS ITSELF? Todd J. Krouner, April 15, 201319
C STANDARD OF CAREC. WHITE PAPERSee Perry SS. BinderBinder, MSMS, MD; Richard L.L Lindstrom,Lindstrom MD; R.R Doyle Stulting,StultingMD, PhD; Eric Donnenfeld, MD; Helen Wu, MD; Peter McDonnell, MD;Yaron Rabinowitz, MD; Keratoconus and Corneal Ectasia After LASIK,Journal of Refractive Surgery, 2005, 21:749-752.NO STANDARDS?WILD WILD WEST OF LASIK20 Todd J. Krouner, April 15, 2013
A. INTRAOPERATIVE PACHYMETRYB. MICROKERATOME2. BUT SEE, T.J. HOOPER21 Todd J. Krouner, April 12, 2013
D CASE EVALUATIOND. LIABILITYEXPERT REVIEW – PRE-SUITGOOD LUCK FINDING AN EXPERTCASE STRENGTH 1-10A. ECTASIA - - 9.5B WRONG NUMBERS - - 12B.C. DRY EYE - - 1D INFORMED CONSENT - - 2D. Todd J. Krouner, April 12, 201322
2. DAMAGES(a) ECONOMIC LOSS(b) PAIN AND SUFFERING,INCLUDING LOSS OF LIFE’SENJOYMENT(c) MEDICAL EXPENSESCORNEAL TRANSPLANTS23 Todd J. Krouner, April 15, 2013
E. MEDICAL RECORDS WITHHELD BLACK AND WHITE INSTEAD OF COLOR ALTERED (LOSS OF INSURANCECOVERAGE) FORGED/FABRICATED DESTROYED ELECTRONIC24 Todd J. Krouner, April 15, 2013
F.VISUAL FUNCTIONFORMULA1.VF VA VQFUNCTION ACUITY PLUSQUALITY25 Todd J. Krouner, April 15, 2013
2. ELEMENTS OF VISUAL QUALITY LIGHTSENSITIVITY DIFFICULTY NIGHT DRIVING DOUBLE VISION FLUCTUATION IN VISION GLARE HALOS STARBURST DRYNESS PAIN FOREIGN BODYSEE GEORGE WARING, M.D., et al., “Laser in situ Keratomileusis forSpherical Hyperopia and Hyperopic Astigmatism Using the NIDEK EC5000 Excimer Laser,” JOURNAL OF REFRACTIVE SURGERY, 2008;24 123 13624:123-136. Todd J. Krouner, April 15, 201326
3.POOR VISUAL QUALITY CANELIMINATE GOOD VISUALACUITYA. CONTRASTSENSITIVITYB. DEBILITATINGGLARE Todd J. Krouner, April 15, 2013327
G. VISION SIMULATIONS1.VISIONSIMULATIONS. COM28 Todd J. Krouner, April 15, 2013
The Defense PerspectiveEVALUATING THE NEW CASEDEFEND OR SETTLE?29
Defend or Settle – Cataract?Wrongg IOL Power Wrong IOL (or Wrong Patient) Ruptured Capsule – Vitrectomy Lens displacement, rotation Post-OperativePOi CComplicationsli i Cystic Macular Edema Vitreous/Retinal Detachment Wound Leak Endophthalmitis30
Evaluating Damages - CataractWrongg IOL Power Possible Problems: Contact vs. Immersion AA-scanscanIOL MasterCorrect calculationcalculation, mistake in picking lensCapsule shrinkage – change in locationImproper calculationUsing a Posterior lens for Anterior (or Sulcus)placement.31
Evaluating Damages - CataractWrongg IOL/Wrongg Patient Possible Problems Surgery Center staff mismis-ordersorders patient, orlens stock Patient ID mixupp Pick the wrong IOL power Bringing in the Surgery Center staff? Captain of Ship Supervision and Control?32
Evaluating Damages - CataractRupturedpCapsulep– Vitrectomyy Possible Problems: High rate of capsular rupturePoor CapsulorhexisExcessive Emulsification powerFailure to recognize – strand displaces IOLVitreous strand to the wound (infection)33
Evaluating Damages - CataractLens Displacementp– Rotation Possible Problems Zonular damageCapsular damagePoor sulcus fixationWrong IOL for Anterior Chamber34
Evaluating Damages - CataractPost-OperativepComplicationsp Possible Problems: Cystic Macular Edema Vitreous/Retinal Detachment Wound Leak Endophthalmitis35
Defend or Settle - LASIK?IrregulargAstigmatismg Ectasia Night vision problems (pupil size) Under/Overcorrection DryD Eye,E ContactCLensLIntoleranceI l Wrong axis of astigmatism 36
Evaluating DamagesIrregulargAstigmatismg Possible Problems: Problems with microkeratome? Femtosecond?Excimer laser calibrated before surgery?Post-opPostop stria?Refloat done properly?Epithelial ingrowth?DLK?CTK?37
Evaluating DamagesEctasia Possible Problems: Misinterpretation of corneal topography,Orbscanp g p y, Orbscan Did not review topography, Did not verify corneal stability pre-op Predisposition to Ectasia/Keratoconus Keratoconus in contralateral eye38
Evaluating DamagesNightg Vision Problems Possible Problems: Pre-opPre op evaluation of pupil size (Schallhorn,Pop, Hawe and Manche, Trattler)q((Post v. U. of Profession or JJob requirementsArizona)g Degreegof Correction High INFORMED CONSENT39
Evaluating DamagesUnder/Overcorrection Possible Problems: No determination of corneal stability prepre-opopLaser calibrationIncorrect data entryLaser malfunction (3rd party practice)Human variability (e(e.g.g my result)40
Evaluating DamagesDryy Eyey Possible Problems: History of CL wear?Schirmer’s test? (controversial)CL trialTear film bioassay41
III. TRIAL OF THE LASIK CASEA. JURY SELECTION1. JURY EXPERIENCE WITH LASIK2. ELECTIVE SURGERY42 Todd J. Krouner, April 15, 2013
B. THE LASIK CONVEYORBELT11.LASIK CO T2.LASIK SHOOTERS33.CO MANAGED CARECO-MANAGEDCARE. FOLLOW THE MONEY4.SURGICAL SCHEDULE –15 MIN/PATIENT5.“LUCY AT THE CHOCOLATEFACTORY”MCDONALD'S OF LASIK6.DOCTORS DON’T KNOW THEIR PATIENTS43 Todd J. Krouner, April 15, 2013
C. SHOW AND TELL1.2.3.4.VISION SIMULATIONSLASIK SURGERYCORNEAL TRANSPLANT SURGERYANTICIPATE SURVEILLANCE44 Todd J. Krouner, April 15, 2013
D. INFORMED CONSENT1.WAIVE THE CLAIM2.PRECLUDE PLAINTIFF FROMBEING CROSS-EXAMINED BYLAUNDRY LIST OF SURGICALRISKS45 Todd J. Krouner, April 15, 2013
E. PAIN AND SUFFERING11.2.33.4.55.6.PHYSICALEMOTIONAL – DEPRESSIONLOSS OF LIFE’SLIFE S ENJOYMENTPERSONALITY AFFECTAESTHETIC LOSSHAZARDS(a) MEDICAL – CORNEALTRANSPLANT(b) ENVIRONMENTAL Todd J. Krouner, April 15, 201346
DISCOVERY CONSIDERATIONS Goals of Discovery,y based on what can orcannot be done to rehabilitate eye afterinjury.j y Keep in mind that injury is completelysubjective, like a headache or pain. So need to look for consequential behavior oractions47
Cataract Discovery Goals DamagesWrongg IOL Power Treatment Options: Remove, replace IOL“Piggyback” IOLLASIK or PRKContact Lens or Glasses48
Cataract Discovery Goals DamagesWrongg IOL/Wrongg Patient Treatment options: Remove, replace IOL“Piggyback” IOLLASIK or PRKContact Lens or GlassesDON’TDONT SEND TO COLLECTIONS49
Cataract Discovery Goals DamagesRupturedpCapsulep– Vitrectomyy Treatment Options: Refer to a Retinal Specialist Antibiotic coveragere-positioningpositioning IOL re50
Cataract Discovery Goals DamagesLens Displacementp–Rotation Treatment Options: Remove/replace IOL with different type ofIOL Rotate lens with hook Move lens fixation to sulcus, anterior chamber51
LASIK Discovery Goals - DamagesIrregulargastigmatism?g Treatment Options: RGP Contact Lenses Wavefront-guided excimer laserTopo-LinkLink excimer laser (not yet FDAFDA Topoapproved) Wait (epithelial remodeling)52
LASIK Discovery Goals - DamagesEctasia? Treatment Options: RGP Contact LensIntacsCorneal TransplantCollagen Cross-Linking (Riboflavin-UV) (notFDA-approved,FDAapproved, but available)53
LASIK Discovery Goals - DamagesNightg Vision Problems (pupil(p p size)) Treatment Options PilocarpineArtificial pupil or Reading DeviceStrong defense availableGlasses or CL’s54
LASIK Discovery Goals - DamagesUnder/Overcorrection Treatment Options ReRe-operationoperation (“enhancement”)( enhancement ) Mitigation of damages? Consent form discuss need for rere-operationoperation Contact Lenses, Glasses55
LASIK Discovery Goals - DamagesDryy Eyey – Contact Lens Intolerance Treatment Options Hybrid lenses (Saturn)Toric Lenses (soft, but correct astigmatism)Punctal plugsArtificial tearsHomologous tears (from plasma)56
SURVEILLANCE BE CAREFUL! Easy to offend jurors with surreptitiousfilming Hard to tell if someone is having troubleseeing BUT – sometimes can – Basketball Tell Investigator to observe, NOT film unless. .57
TRIAL CONSIDERATIONS Voir Dire: Jurors will likely have some experience,personal, friend or relative MUST find out satisfaction, results Squeamish about operating, touching eye? Understand what 20/20 means?58
TRIAL CONSIDERATIONS Demonstrative Exhibits Driver’s License (and application)y ChartSnellen EyeModel of the eye(publish to jjury)y)Trial lens frames (p59
II. LASIK SURGERY NEGLIGENCE A. TYPES OF CASES CONTRAINDICATIONS - - ECTASIA Corneal ectasia is one of the most devastating complications aft LASIK P tfter LASIK. Post-LASIK ectitasia i id d i is considered in patients who developed increasing myopia, with or without increasing astigmatism, loss of uncorrected
