Post on 20-Jun-2020
Ophthalmology Malpractice Suits: Pursuing or Defending Claims Navigating Eye Injury Proof Issues in Med Mal Cases Involving LASIK, Cataracts, ROP, and Other Procedures
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THURSDAY, MAY 8, 2014
Presenting a live 90-minute webinar with interactive Q&A
C. Gregory Tiemeier, Partner, Tiemeier & Stich, Denver
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Prosecuting and Defending the Ophthalmology Malpractice Lawsuit
C. Gregory Tiemeier Tiemeier & Stich, P.C. 1000 East 16th Ave Denver, CO 80218 Phone: (303) 531-0022 Fax: (303) 531-0021 Email: gtiemeier@tslawpc.com
LASIK cases can be more successful for plaintiffs than other cases.
1. LASIK and PRK are elective surgery
2. Myopia (nearsighted) Hyperopia (farsighted) are treatable with non-surgical methods with a long, successful track record
3. Some people are offended by the heavy
advertising and “commoditization” of LASIK surgery
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SIGHT IS PERHAPS THE MOST CRITICAL OF SENSES
Jurors can easily appreciate how diminished vision adversely affects daily life
Vision loss is entirely subjective, like headache,
pain Easy to understand that outwardly normal
appearance means nothing.
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The Defense Perspective
DIFFERENT TYPES OF OPHTHALMIC MALPRACTICE
CASES
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Cataract Surgery 31.73%
Retina Treatment/Surgery
13.33%
Medical Evaluation 10.46%
Refractive Surgery 9.38%
Oculofacial 8.72%
Glaucoma Treatment/Surgery
4.87%
Corneal Treatment/Surgery
3.26%
Other 18.26%
Procedures/Treatments Resulting in Claims
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OMIC’s Top Ten Largest Payments to Plaintiffs Amount Description Specialty Year
Closed
$3,375,000 Failure to diagnose ROP Medical Retina 2007
$2,000,000 Failure to diagnose bilateral glioma in 10 mo old baby
Pediatric 2009
$1,800,000 Failure to diagnose glaucoma in 8 yr old
Pediatric 2001
$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/prednisone overdose
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
Avg. Indemnity Payments Procedure/Treatment (OMIC data)
Number Total Millions Median
Cataract 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 10
Severity by Specialty Average Settlements per year as of December 31, 2013
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Refractive 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 islands 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 procedures 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
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The Plaintiff ’s Perspective: LASIK Surgery Negligence
1. ECTASIA 2. FLAP COMPLICATIONS 3. DATA ENTRY ERRORS
4. MAINTENANCE ERRORS 5. PRODUCT ERRORS ALCON LADAR 6000 BAUSCH & LOMB ZYOPTIX 317 BUT SEE Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
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The Plaintiff ’s Perspective: LASIK Surgery Negligence
1. ECTASIA Ectasia is the uncontrolled bulging of the cornea of
the eye. Can occur as a result of 1) the thinning of the cornea from the LASIK procedure, or 2) natural progression of keratoconus. It a devastating problem, can require corneal transplant, and make useful vision unattainable.
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Ectasia Onset Timing
LITERATURE REPORTS 6-YEAR DELAY IN ONSET, ONE DOCTOR REPORTED A 13-YEAR DELAY IN ONSET
IS THE CLAIM BARRED BEFORE AN INJURY EVEN MANIFESTS ITSELF?
IS THE DELAY THE RESULT OF
KERATOCONUS?
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The Plaintiff ’s Perspective – LASIK Surgery Negligence
1. LIABILITY CASE STRENGTH: A. WRONG NUMBERS - strongest B. ECTASIA C. FLAP COMPLICATIONS D. INFORMED CONSENT E. DRY EYE - weakest
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The Plaintiff ’s Perspective – Cataract Surgery Negligence Was the Correct IOL power used? How measured? ◦ IOL Master ◦ A-Scan – Immersion or topical?
Capsular tear is “common” Back-up lens available in OR? Post-op monitoring?
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The Plaintiff ’s Perspective – Glaucoma Negligence How frequently were IOP’s checked? Monitoring of Optic Nerve Health ◦ Perimetry, visual fields, OCT
Surgery offered? ◦ Medications ineffective
Medications used? ◦ Different meds affect different aspects
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Plaintiff ’s Case Evaluation 2. DAMAGES A. ECONOMIC LOSS Loss of income, employability B. NON-ECONOMIC LOSS Loss of enjoyment of life, pain, suffering,
driving, ADL’s C. MEDICAL EXPENSES Corneal transplants, dry eye treatment,
reoperations
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Obtaining Medical Records
WITHHELD, ALTERED, AMENDED
BLACK AND WHITE TOPOGRAPHIES
INSTEAD OF COLOR
FORGED/FABRICATED DESTROYED
ELECTRONIC RECORDS
TOPOGRAPHIES, WAVESCAN, OCT
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ELEMENTS OF VISUAL QUALITY LIGHT SENSITIVITY DIFFICULTY NIGHT DRIVING DOUBLE VISION FLUCTUATION IN VISION GLARE HALOS STARBURST DRYNESS PAIN FOREIGN BODY SEE 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.
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3. POOR CONTRAST SENSITIVITY CAN AFFECT GOOD VISUAL ACUITY
A. CONTRAST SENSITIVITY B. DEBILITATING GLARE
© Todd J. Krouner, April 15, 2013 22
The Defense Perspective
EVALUATING THE NEW CASE
DEFEND OR SETTLE?
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Defend or Settle – Cataract?
Wrong IOL Power Wrong IOL (or Wrong Patient) Ruptured Capsule – Vitrectomy Lens displacement, rotation Post-Operative Complications ◦ Cystic Macular Edema ◦ Vitreous/Retinal Detachment ◦ Wound Leak Endophthalmitis
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Evaluating Damages - Cataract
Wrong IOL Power Possible Problems: ◦ Contact vs. Immersion A-scan ◦ IOL Master ◦ Correct calculation, mistake in picking lens ◦ Capsule shrinkage – change in location ◦ Improper calculation ◦ Using a Posterior lens for Anterior (or Sulcus)
placement.
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Evaluating Damages - Cataract
Wrong IOL/Wrong Patient Possible Problems ◦ Surgery Center staff mis-orders patient, or
lens stock ◦ Patient ID mixup ◦ Pick the wrong IOL power ◦ Bringing in the Surgery Center staff? Captain of Ship Supervision and Control?
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Evaluating Damages - Cataract
Ruptured Capsule – Vitrectomy Possible Problems: ◦ High rate of capsular rupture ◦ Poor Capsulorhexis ◦ Excessive Emulsification power ◦ Failure to recognize – strand displaces IOL ◦ Vitreous strand to the wound (infection)
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Evaluating Damages - Cataract
Lens Displacement – Rotation Possible Problems ◦ Zonular damage ◦ Capsular damage ◦ Poor sulcus fixation ◦ Wrong IOL for Anterior Chamber
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Evaluating Damages - Cataract
Post-Operative Complications Possible Problems: ◦ Cystic Macular Edema ◦ Vitreous/Retinal Detachment ◦ Wound Leak Endophthalmitis
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Defend or Settle - LASIK?
Irregular Astigmatism Ectasia Night vision problems (pupil size) Under/Overcorrection Dry Eye, Contact Lens Intolerance Wrong axis of astigmatism
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Evaluating Damages
Irregular Astigmatism Possible Problems: ◦ Problems with microkeratome? Femtosecond? ◦ Excimer laser calibrated before surgery? ◦ Post-op stria? ◦ Refloat done properly? ◦ Epithelial ingrowth? ◦ DLK? ◦ CTK?
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Evaluating Damages
Ectasia Possible Problems: ◦ Misinterpretation of corneal topography,
Orbscan ◦ Did not review topography, Orbscan ◦ Did not verify corneal stability pre-op ◦ Predisposition to Ectasia/Keratoconus Keratoconus in contralateral eye
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Evaluating Damages
Night Vision Problems Possible Problems: ◦ Pre-op evaluation of pupil size (Schallhorn,
Pop, Hawe and Manche, Trattler) ◦ Profession or Job requirements (Post v. U. of
Arizona) ◦ High Degree of Correction ◦ INFORMED CONSENT
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Evaluating Damages
Under/Overcorrection Possible Problems: ◦ No determination of corneal stability pre-op ◦ Laser calibration ◦ Incorrect data entry ◦ Laser malfunction (3rd party practice) ◦ Human variability (e.g. my result)
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Evaluating Damages
Dry Eye Possible Problems: ◦ History of CL wear? ◦ Schirmer’s test? (controversial) ◦ CL trial ◦ Tear film bioassay
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Evaluating Damages: Non-Economic Loss Emotional, psych – caused by surgery ro pre-
existing? Loss of enjoyment (“Didn’t get to see my
daughter walk down the aisle”) Personality changes, irritability Perception, sensory impairment Hazards: ◦ driving ◦ stairs, uneven surfaces ◦ contrast sensitivity loss
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INFORMED CONSENT CLAIMS
Waive or keep? Consent forms are thorough, unless only
using ASC forms Manufacturer’s DVD (Multifocal IOL’s) Use video consents? How do consent form warnings compare
to advertising claims?
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DISCOVERY CONSIDERATIONS
Defense Goals of Discovery, based on what can or cannot be done to rehabilitate eye after injury. ◦ Keep in mind that injury is subjective, like a
headache or pain. ◦ So need to look for consequential behavior or
actions
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DISCOVERY CONSIDERATIONS
Plaintiff Goals of Discovery, based on decision to offer, perform surgery: ◦ alternative treatments available ◦ permanence of injury ◦ inducements to surgery (profitability, financing,
advertising)
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Discovery Considerations
Plaintiff Goals of Discovery, for glaucoma: ◦ opportunities to monitor, followup ◦ medical treatments vs. surgical treatments ◦ knowledge of (non)compliance ◦ monitoring of Optic Nerve (perimetry, OCT)
vs. IOP
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Plaintiff ’s Discovery Goals - Cataract Pre-surgical testing: ◦ what was patient’s vision? ◦ glare testing done? How?
Activities interfered with? How long was it followed? ◦ variable rate of progression ◦ but – more difficult if wait longer
Options offered? ◦ multifocal, accomodating, monovision?
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Plaintiff ’s Discovery Goals - LASIK
ADVERTISING? Website claims? Experience with procedure? Payment plan? If monovision, eye dominance testing? Timing of “Enhancement” surgery PRK or ICL offered, discussed? ◦ Low or high myope, astigmatism
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Glaucoma Discovery Goals - Damages Different from cataract, LASIK – cannot
be corrected or treated once vision is lost (optic nerve)
Loss of peripheral vision Premature vision loss in future Impact on employment, driving, ADL’s
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Cataract Discovery Goals - Damages Wrong IOL Power Treatment Options: ◦ Remove, replace IOL ◦ “Piggyback” IOL ◦ LASIK or PRK ◦ Contact Lens or Glasses
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Cataract Discovery Goals - Damages Wrong IOL/Wrong Patient Treatment options: ◦ Remove, replace IOL ◦ “Piggyback” IOL ◦ LASIK or PRK ◦ Contact Lens or Glasses ◦ DON’T SEND TO COLLECTIONS
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Cataract Discovery Goals - Damages Ruptured Capsule – Vitrectomy Treatment Options: ◦ Refer to a Retinal Specialist ◦ Antibiotic coverage ◦ IOL re-positioning
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Cataract Discovery Goals - Damages Lens Displacement –Rotation Treatment Options: ◦ 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 Goals - Damages
Irregular astigmatism? Treatment Options: ◦ RGP Contact Lenses ◦ Wavefront-guided excimer laser ◦ Topo-Link excimer laser (not yet FDA-
approved) ◦ Wait (epithelial remodeling)
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LASIK Discovery Goals - Damages
Ectasia? Treatment Options: ◦ RGP Contact Lens ◦ Intacs ◦ Corneal Transplant ◦ Collagen Cross-Linking (Riboflavin-UV) (not
FDA-approved, but available)
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LASIK Discovery Goals - Damages
Night Vision Problems (pupil size) Treatment Options ◦ Pilocarpine ◦ Artificial pupil or Reading Device ◦ Strong defense available ◦ Glasses or CL’s
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LASIK Discovery Goals - Damages
Under/Overcorrection Treatment Options ◦ Re-operation (“enhancement”) ◦ Mitigation of damages? Consent form discuss need for re-operation
◦ Contact Lenses, Glasses
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LASIK Discovery Goals - Damages
Dry Eye – Contact Lens Intolerance Treatment Options ◦ Hybrid lenses (Saturn) ◦ Toric Lenses (soft, but correct astigmatism) ◦ Punctal plugs ◦ Artificial tears ◦ Homologous tears (from plasma)
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SURVEILLANCE
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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PROFITABILITY OF LASIK, PREMIUM IOL LASIK cost
“UPSELLING” Of cataracts surgery
CO-MANAGED Care – who gets what?
Surgical Schedule – about 15-20 minutes each
◦ “LUCY AT THE CHOCOLATE FACTORY”
◦ Conveyor Belt
◦ Mc Donald’s Of LASIK (for LASIK-only centers
Patients may see surgeon only at surgery
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TRIAL CONSIDERATIONS
Voir Dire: ◦ Jurors will likely have some experience,
personal, friend or relative ◦ MUST find out satisfaction, results ◦ Squeamish about operating, touching eye?
Needles in the eye? ◦ Understand what 20/20 means?
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TRIAL CONSIDERATIONS
Demonstrative Exhibits ◦ Driver’s License (and application) ◦ Snellen Eye Chart ◦ Model of the eye ◦ Trial lens frames (publish to jury) ◦ Diagrams, Photos to simulate glare, halos,
double vision
Online availability of images, videos of surgery (VisionSimulations.com)
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