Presenting a live 90‐minute webinar with interactive Q&A
O h h l l M l i S iOphthalmology Malpractice SuitsNavigating Eye Injury Proof Issues and Claims Involving LASIK, Cataracts, ROP, and Other Procedures
T d ’ f l f
1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific
TUESDAY, APRIL 23, 2013
Today’s faculty features:
Todd J. Krouner, Law Office of Todd J. Krouner, Chappaqua, N.Y.
C. Gregory Tiemeier, Partner, Tiemeier & Stich, Denver
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OPHTHALMOLOGY MALPRACTICE SUITS –NAVIGATING EYE INJURY ISSUES AND CLAIMSINVOLVING LASIK, CATARACTS, ROP ANDOOTHER PROCEDURES
Webinar PresentationTuesday, April 23, 2013
Todd J Krouner5
Todd J. Krouner(914) 238-5800
INTRODUCTION
LASIK SURGERY MALPRACTICE LASIK SURGERY MALPRACTICE CASES ARE ATTRACTIVE FOR PLAINTIFFS
A. GENERALLY, DOCTORS WIN 80% OF MEDICAL MALPRACTICE CASESMEDICAL MALPRACTICE CASES.
B GENERALLY MY SUCCESS WITH B. GENERALLY, MY SUCCESS WITH LASIK CASES EXCEEDS 80%.
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© Todd J. Krouner, April 15, 2013
C. WHY THE DIFFERENCE1. IT IS ELECTIVE
2. THERE IS NO UNDERLYING DISEASE
3. SURGEONS TURN CORNEAS INTO COMMODITIES, INVITING CONVEYOR BELT ANALOGIES THAT DESTROY BELT ANALOGIES THAT DESTROY JURIES’ PREDISPOSITION IN FAVOR OF DOCTORSOF DOCTORS.$250/EYE!
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© Todd J. Krouner, April 15, 2013
D. SIGHT IS THE MOST IMPORTANT OF OUR FIVE SENSES
80% of what we learn comes in through our 80% of what we learn comes in through our eyes.
Jurors can be made to appreciate how ppdiminished
vision adversely impacts all aspects of daily y p p ylife
activity - - even though plaintiffs may appear well
and are not physically deformed.8
© Todd J. Krouner, April 15, 2013
Defending the Ophthalmology Defending the Ophthalmology Defending the Ophthalmology Defending the Ophthalmology Malpractice LawsuitMalpractice Lawsuit
C Gregory TiemeierC. Gregory TiemeierTiemeier & Stich, P.C.1000 East 16th AveDenver, CO 80218Phone: (303) 531-0022Phone: (303) 531 0022Fax: (303) 531-0021Email: [email protected]
The Defense PerspectiveThe Defense PerspectiveThe Defense PerspectiveThe Defense Perspective
DIFFERENT TYPES OF DIFFERENT TYPES OF OPHTHALMIC MALPRACTICE
CASES
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Procedures/Treatments Resulting in Claims
Cataract Surgery 31.73%Other 18.26%
Corneal Treatment/Surgery
3.26%
Glaucoma Treatment/Surgery
4.87%
3.26%
Oculofacial 8.72%
Retina Treatment/Surgery
13 33%Refractive Surgery
13.33%
Medical Evaluation 10.46%
9.38%
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OMIC’s Top Ten Largest Payments to PlaintiffsOMIC’s Top Ten Largest Payments to PlaintiffsAmount Description Specialty Year
Cl dClosed
$3,375,000 Failure to diagnose ROP Medical Retina 2007
$2,000,000 Failure to diagnose bilateral glioma in Pediatric 200910 mo old baby
$1,800,000 Failure to diagnose glaucoma in 8 yr old
Pediatric 2001
$1 000 000 F il l l i 2 C h i 1999$1,000,000 Failure to treat corneal ulcer in 2yr old
Comprehensive 1999
$1,500,000 Failure to diagnose ROP Pediatric 2012
$1,000,000 Misdiagnosis sarcoidosis/prednisoneoverdose
Oculofacial 2002
$1,000,000 Failure to diagnose ROP Pediatric 2009
$1,000,000 Failure to diagnose ROP Pediatric 2010
$1,000,000 Acute glaucoma post phakic implant Comprehensive 2011
$1,000,000 Failure to diagnose foreign body Oculofacial 2012
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Avg. Indemnity Payments Avg. Indemnity Payments Procedure/Treatment (OMIC data)Procedure/Treatment (OMIC data)Procedure/Treatment (OMIC data)Procedure/Treatment (OMIC data)
Number Total Millions Median
Cataract Surgery 201 $22 0 $60 000Cataract Surgery 201 $22.0 $60,000
Medical Evaluation 80 $17.8 $100,000
Oculoplastics 79 $12.4 $75,000
Refractive Surgery 86 $11.4 $55,000
Retina 63 $10.0 $100,000
$ $ROP 9 $8.3 $575,000
Glaucoma 39 $7.3 $135,000
Miscellaneous Other 79 $7.1 $30,000 $ $ ,
Corneal 19 $4.1 $75,000
Trauma related 24 $3.6 $110,000
Local Anesthesia 11 $2.6 $85,000
Strabismus 11 $1.4 $100,000 13
II. LASIK SURGERY NEGLIGENCE
A. TYPES OF CASES
CONTRAINDICATIONS - -
ECTASIA
Corneal ectasia is one of the most devastating complications ft LASIK P t LASIK t i i id d i after LASIK. Post-LASIK ectasia is considered in
patients who developed increasing myopia, with or without increasing astigmatism, loss of uncorrected visual acuity, often loss of best-corrected visual acuity, with keratometric steepening, with or without central with keratometric steepening, with or without central and paracentral corneal thinning, and topographic evidence of asymmetric inferior corneal steepening after LASIK procedure. Ectatic changes can occur as early as 1 week or can be delayed up to several years after LASIKLASIK.
© Todd J. Krouner, April 15, 2013
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ECTASIA IS PRESUMPTIVE EVIDENCE OF MEDICAL MALPRACTICE95% OF THE TIME POST-LASIK ECTASIA IS
CAUSED BY A SURGEON MISSING
WARNING SIGNS IN PRE-OPERATIVE
TOPOGRAPHIESTOPOGRAPHIES.See J. Bradley Randleman, MD, Buddy Russell, FCLSA,
Michael A. Ward, MMSc, FAAO, Keith P. Thompson, MD, R D l St lti MD PhD Ri k F t d P i f R. Doyle Stulting, MD, PhD, Risk Factors and Prognosis for Corneal Ectasia After LASIK, Ophthalmology, 2003; 110:267-275; Randleman JB, Woodward M, Lynn MJ, Stulting RD, Risk Assessment for Ectasia after Corneal g , f fRefractive Surgery, Ophthalmology 2008; 115: 37-50.
© Todd J. Krouner, April 15, 2013
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2. FLAP COMPLICATIONS
3. DATA ENTRY ERRORSO
4. MAINTENANCE ERRORS
5. PRODUCT ERRORSALCON LADAR 6000ALCON LADAR 6000BAUSCH & LOMB ZYOPTIX 317
BUT SEE Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
© Todd J. Krouner, April 15, 2013
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REFRACTIVE SURGERY MALPRACTICEREFRACTIVE SURGERY MALPRACTICE 1. Schiffer v. Speaker – Ectasia - $7.25 M Verdict 2. J.C. - Ectasia where prior doctor said patient was not a good candidate 3. R.P. - Failure to calibrate laser resulting in severe central islands 4. R.G. - PRK on central frank keratoconus (see case study by Dr. Randleman) 5. Martinez v. Neatrour - Ectasia 6. S.D. - DEA cocaine use (ectasia) 7. A. P. - Ectasia/alteration of records/loss of insurance coverage 8. Devadas v. Niksarli - Ectasia/alteration of records/$5.6 M verdict 9. R.D. - Ectasia 10. J.R. - Defective medical device recall of Alcon Ladar vision 6000 central
islands11 D K D f ti di l d i ll f Al L d i i 6000 t l 11. D.K. - Defective medical device recall of Alcon Ladar vision 6000 central islands
12. S.P. - Defective medical device recall of Alcon Ladar vision 6000 central islands
13. M.S. -Hyperopic ectasia after 11 refractive proceduresyp p p 14. L.S. - Hyperopic ectasia following four surgeries 15. J.D. - Steroid induced glaucoma following LASIK 16. E.K. - Ectasia - $950,000 for housewife with no loss of earned income 17. D.D. – Ectasia - $1M$
© Todd J. Krouner, April 12, 2013
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B STATUTES OF LIMITATIONSB. STATUTES OF LIMITATIONS
1. NEW YORK – CONTINUOUS TREATMENTTREATMENT
2. NEW JERSEY – DISCOVERY2. NEW JERSEY DISCOVERY
3. FLORIDA – STATUTE OF REPOSE
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ECTASIA IS A TIME BOMB WITH A LONG FUSEWITH A LONG FUSELITERATURE REPORTS 6-YEAR DELAYIN DETONATIONIN DETONATION
ONE DOCTOR REPORTED A 13-YEARONE DOCTOR REPORTED A 13 YEARDELAY IN ONSET
WHERE DOES THAT LEAVE PATIENTS INTERMS OF A CLAIM?
IS THE CLAIM BARRED BEFORE AN INJURY EVEN
MANIFESTS ITSELF?© Todd J. Krouner, April 15, 2013
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C STANDARD OF CAREC. STANDARD OF CARE WHITE PAPER WHITE PAPER
See Perry S Binder MS MD; Richard L Lindstrom MD; R Doyle Stulting See Perry S. Binder, MS, MD; Richard L. Lindstrom, MD; R. Doyle Stulting, MD, 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 LASIK
© Todd J. Krouner, April 15, 2013
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A. INTRAOPERATIVE PACHYMETRY
B. MICROKERATOME
2. BUT SEE, T.J. HOOPER
© Todd J. Krouner, April 12, 2013
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D CASE EVALUATIOND. CASE EVALUATION LIABILITY LIABILITY
EXPERT REVIEW – PRE-SUITGOOD LUCK FINDING AN EXPERTGOOD LUCK FINDING AN EXPERT
CASE STRENGTH 1-10CASE STRENGTH 1-10A. ECTASIA - - 9.5B WRONG NUMBERS 12B. WRONG NUMBERS - - 12C. DRY EYE - - 1D INFORMED CONSENT 2D. INFORMED CONSENT - - 2
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2. DAMAGES
(a) ECONOMIC LOSS(b) PAIN AND SUFFERING,
INCLUDING LOSS OF LIFE’S ENJOYMENTENJOYMENT
(c) MEDICAL EXPENSESCORNEAL TRANSPLANTS
© Todd J. Krouner, April 15, 2013
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E. MEDICAL RECORDS
WITHHELD WITHHELD
BLACK AND WHITE INSTEAD OF COLOR
ALTERED (LOSS OF INSURANCE
COVERAGE)
FORGED/FABRICATED
DESTROYED DESTROYED
ELECTRONIC
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F. VISUAL FUNCTION FORMULA
1.VF = VA + VQFUNCTION = ACUITY PLUS
QUALITYQUALITY
© Todd J. Krouner, April 15, 2013
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2. ELEMENTS OF VISUAL QUALITY
LIGHT SENSITIVITYDIFFICULTY NIGHT DRIVINGDOUBLE VISIONFLUCTUATION IN VISIONGLAREHALOSSTARBURSTSTARBURSTDRYNESSPAINFOREIGN BODYFOREIGN BODYSEE GEORGE WARING, M.D., et al., “Laser in situ Keratomileusis for Spherical Hyperopia and Hyperopic Astigmatism Using the NIDEK EC-5000 Excimer Laser,” JOURNAL OF REFRACTIVE SURGERY, 2008; 24 123 136
© Todd J. Krouner, April 15, 2013
24:123-136. 26
3. POOR VISUAL QUALITY CAN ELIMINATE GOOD VISUAL ACUITY
A. CONTRAST B. DEBILITATING SENSITIVITY GLARE
© Todd J. KK
rouner, April 15, 20133
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The Defense PerspectiveThe Defense PerspectiveThe Defense PerspectiveThe Defense Perspective
EVALUATING THE NEW CASE
DEFEND OR SETTLE?
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Defend or Settle Defend or Settle –– Cataract?Cataract?Defend or Settle Defend or Settle Cataract?Cataract?
Wrong IOL Powerg Wrong IOL (or Wrong Patient) Ruptured Capsule –Vitrectomy Ruptured Capsule Vitrectomy Lens displacement, rotation
P O i C li i Post-Operative Complications◦ Cystic Macular Edema◦ Vitreous/Retinal Detachment◦ Wound Leak Endophthalmitis
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Evaluating Damages Evaluating Damages -- CataractCataractEvaluating Damages Evaluating Damages CataractCataract
Wrong IOL Powerg Possible Problems:◦ Contact vs. Immersion A-scanContact vs. Immersion A scan◦ IOL Master ◦ Correct calculation mistake in picking lensCorrect calculation, mistake in picking lens◦ Capsule shrinkage – change in location◦ Improper calculation◦ Improper calculation◦ Using a Posterior lens for Anterior (or Sulcus)
placement.placement.
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Evaluating Damages Evaluating Damages -- CataractCataractEvaluating Damages Evaluating Damages CataractCataract
Wrong IOL/Wrong Patientg g Possible Problems◦ Surgery Center staff mis-orders patient, or Surgery Center staff mis orders patient, or
lens stock◦ Patient ID mixupp◦ Pick the wrong IOL power◦ Bringing in the Surgery Center staff?Bringing in the Surgery Center staff? Captain of Ship Supervision and Control?
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Evaluating Damages Evaluating Damages -- CataractCataractEvaluating Damages Evaluating Damages CataractCataract
Ruptured Capsule –Vitrectomyp p y Possible Problems:◦ High rate of capsular ruptureHigh rate of capsular rupture◦ Poor Capsulorhexis ◦ Excessive Emulsification powerExcessive Emulsification power◦ Failure to recognize – strand displaces IOL◦ Vitreous strand to the wound (infection)◦ Vitreous strand to the wound (infection)
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Evaluating Damages Evaluating Damages -- CataractCataractEvaluating Damages Evaluating Damages CataractCataract
Lens Displacement – Rotationp Possible Problems◦ Zonular damageZonular damage◦ Capsular damage◦ Poor sulcus fixationPoor sulcus fixation◦ Wrong IOL for Anterior Chamber
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Evaluating Damages Evaluating Damages -- CataractCataractEvaluating Damages Evaluating Damages CataractCataract
Post-Operative Complicationsp p Possible Problems:◦ Cystic Macular EdemaCystic Macular Edema◦ Vitreous/Retinal Detachment◦ Wound Leak EndophthalmitisWound Leak Endophthalmitis
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Defend or Settle Defend or Settle -- LASIK?LASIK?Defend or Settle Defend or Settle LASIK?LASIK?
Irregular Astigmatismg g Ectasia Night vision problems (pupil size) Night vision problems (pupil size) Under/Overcorrection
D E C L I l Dry Eye, Contact Lens Intolerance Wrong axis of astigmatism
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Evaluating DamagesEvaluating DamagesEvaluating DamagesEvaluating Damages
Irregular Astigmatismg g Possible Problems:◦ Problems with microkeratome? Femtosecond?Problems with microkeratome? Femtosecond?◦ Excimer laser calibrated before surgery?◦ Post-op stria?Post op stria?◦ Refloat done properly?◦ Epithelial ingrowth?◦ Epithelial ingrowth?◦ DLK?◦ CTK?◦ CTK?
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Evaluating DamagesEvaluating DamagesEvaluating DamagesEvaluating Damages
Ectasia Possible Problems:◦ Misinterpretation of corneal topography, Misinterpretation of corneal topography,
Orbscan◦ Did not review topography, Orbscanp g p y,◦ Did not verify corneal stability pre-op◦ Predisposition to Ectasia/KeratoconusPredisposition to Ectasia/Keratoconus Keratoconus in contralateral eye
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Evaluating DamagesEvaluating DamagesEvaluating DamagesEvaluating Damages
Night Vision Problemsg Possible Problems:◦ Pre-op evaluation of pupil size (Schallhorn, Pre op evaluation of pupil size (Schallhorn,
Pop, Hawe and Manche, Trattler)◦ Profession or Job requirements (Post v. U. of J q (
Arizona)◦ High Degree of Correctiong g◦ INFORMED CONSENT
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Evaluating DamagesEvaluating DamagesEvaluating DamagesEvaluating Damages
Under/Overcorrection Possible Problems:◦ No determination of corneal stability pre-opNo determination of corneal stability pre op◦ Laser calibration◦ Incorrect data entryIncorrect data entry◦ Laser malfunction (3rd party practice)◦ Human variability (e g my result)◦ Human variability (e.g. my result)
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Evaluating DamagesEvaluating DamagesEvaluating DamagesEvaluating Damages
Dry Eyey y Possible Problems:◦ History of CL wear?History of CL wear?◦ Schirmer’s test? (controversial)◦ CL trialCL trial◦ Tear film bioassay
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III. TRIAL OF THE LASIK CASE
A. JURY SELECTIONA. JURY SELECTION
1. JURY EXPERIENCE WITH LASIK1. JURY EXPERIENCE WITH LASIK
2. ELECTIVE SURGERY2. ELECTIVE SURGERY
© Todd J. Krouner, April 15, 2013
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B. THE LASIK CONVEYOR BELTBELT1 LASIK CO$T1. LASIK CO$T
2. LASIK SHOOTERS
3 CO MANAGED CARE FOLLOW THE MONEY3. CO-MANAGED CARE. FOLLOW THE MONEY
4. SURGICAL SCHEDULE –
15 MIN/PATIENT
5. “LUCY AT THE CHOCOLATE FACTORY”
MCDONALD'S OF LASIK
6. DOCTORS DON’T KNOW THEIR PATIENTS
© Todd J. Krouner, April 15, 2013
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C. SHOW AND TELL1. VISION SIMULATIONS2. LASIK SURGERY3. CORNEAL TRANSPLANT SURGERY4. ANTICIPATE SURVEILLANCE
© Todd J. Krouner, April 15, 2013
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D. INFORMED CONSENT1. WAIVE THE CLAIM
2. PRECLUDE PLAINTIFF FROM BEING CROSS-EXAMINED BY LAUNDRY LIST OF SURGICAL RISKSRISKS
© Todd J. Krouner, April 15, 2013
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E. PAIN AND SUFFERING
1 PHYSICAL1. PHYSICAL2. EMOTIONAL – DEPRESSION3 LOSS OF LIFE’S ENJOYMENT3. LOSS OF LIFE S ENJOYMENT4. PERSONALITY AFFECT5 AESTHETIC LOSS5. AESTHETIC LOSS6. HAZARDS
(a) MEDICAL CORNEAL (a) MEDICAL – CORNEAL TRANSPLANT(b) ENVIRONMENTAL(b) ENVIRONMENTAL
© Todd J. Krouner, April 15, 2013
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DISCOVERY CONSIDERATIONSDISCOVERY CONSIDERATIONSDISCOVERY CONSIDERATIONSDISCOVERY CONSIDERATIONS
Goals of Discovery, based on what can or ycannot be done to rehabilitate eye after injury.j y
Keep in mind that injury is completely Keep in mind that injury is completely subjective, like a headache or pain.◦ So need to look for consequential behavior or ◦ So need to look for consequential behavior or
actions
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Cataract Discovery Goals Cataract Discovery Goals --DamagesDamages Wrong IOL Powerg Treatment Options:◦ Remove, replace IOLRemove, replace IOL◦ “Piggyback” IOL◦ LASIK or PRK LASIK or PRK ◦ Contact Lens or Glasses
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Cataract Discovery Goals Cataract Discovery Goals --DamagesDamages Wrong IOL/Wrong Patientg g Treatment options:◦ Remove, replace IOLRemove, replace IOL◦ “Piggyback” IOL◦ LASIK or PRK LASIK or PRK ◦ Contact Lens or Glasses ◦ DON’T SEND TO COLLECTIONS◦ DON T SEND TO COLLECTIONS
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Cataract Discovery Goals Cataract Discovery Goals --DamagesDamages Ruptured Capsule –Vitrectomyp p y Treatment Options:◦ Refer to a Retinal Specialist Refer to a Retinal Specialist ◦ Antibiotic coverage◦ IOL re-positioningIOL re positioning
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Cataract Discovery Goals Cataract Discovery Goals --DamagesDamages Lens Displacement –Rotationp Treatment Options:◦ Remove/replace IOL with different type of Remove/replace IOL with different type of
IOL◦ Rotate lens with hook◦ Move lens fixation to sulcus, anterior chamber
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LASIK Discovery LASIK Discovery Goals Goals -- DamagesDamagesLASIK Discovery LASIK Discovery Goals Goals DamagesDamages
Irregular astigmatism?g g Treatment Options:◦ RGP Contact LensesRGP Contact Lenses◦ Wavefront-guided excimer laser◦ Topo-Link excimer laser (not yet FDA-Topo Link excimer laser (not yet FDA
approved)◦ Wait (epithelial remodeling)Wait (epithelial remodeling)
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LASIK Discovery Goals LASIK Discovery Goals -- DamagesDamagesLASIK Discovery Goals LASIK Discovery Goals DamagesDamages
Ectasia? Treatment Options:◦ RGP Contact LensRGP Contact Lens◦ Intacs◦ Corneal TransplantCorneal Transplant◦ Collagen Cross-Linking (Riboflavin-UV) (not
FDA-approved, but available)FDA approved, but available)
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LASIK Discovery Goals LASIK Discovery Goals -- DamagesDamagesLASIK Discovery Goals LASIK Discovery Goals DamagesDamages
Night Vision Problems (pupil size)g (p p ) Treatment Options◦ PilocarpinePilocarpine◦ Artificial pupil or Reading Device◦ Strong defense availableStrong defense available◦ Glasses or CL’s
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LASIK Discovery Goals LASIK Discovery Goals -- DamagesDamagesLASIK Discovery Goals LASIK Discovery Goals DamagesDamages
Under/Overcorrection Treatment Options◦ Re-operation (“enhancement”)Re operation ( enhancement )◦ Mitigation of damages? Consent form discuss need for re-operationConsent form discuss need for re operation
◦ Contact Lenses, Glasses
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LASIK Discovery Goals LASIK Discovery Goals -- DamagesDamagesLASIK Discovery Goals LASIK Discovery Goals DamagesDamages
Dry Eye – Contact Lens Intolerancey y Treatment Options◦ Hybrid lenses (Saturn)Hybrid lenses (Saturn)◦ Toric Lenses (soft, but correct astigmatism)◦ Punctal plugsPunctal plugs◦ Artificial tears◦ Homologous tears (from plasma)◦ Homologous tears (from plasma)
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SURVEILLANCESURVEILLANCESURVEILLANCESURVEILLANCE
BE CAREFUL!◦ Easy to offend jurors with surreptitious
filming◦ Hard to tell if someone is having trouble
seeing◦ BUT – sometimes can – Basketball◦ Tell Investigator to observe, NOT film unless. .
.
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TRIAL CONSIDERATIONSTRIAL CONSIDERATIONSTRIAL CONSIDERATIONSTRIAL 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?
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