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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