Ophthalmology Malpractice Suits: Pursuing or Defending Claims

Transcription

1 Presenting a live 90-minute webinar with interactive Q&A Ophthalmology Malpractice Suits: Pursuing or Defending Claims Navigating Eye Injury Proof Issues in Med Mal Cases Involving LASIK, Cataracts, ROP, and Other Procedures THURSDAY, MAY 8, pm Eastern 12pm Central 11am Mountain 10am Pacific Today s faculty features: C. Gregory Tiemeier, Partner, Tiemeier & Stich, Denver The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions ed to registrants for additional information. If you have any questions, please contact Customer Service at ext. 10.

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4 Prosecuting and Defending the Ophthalmology Malpractice Lawsuit C. Gregory Tiemeier Tiemeier & Stich, P.C East 16th Ave Denver, CO Phone: (303) Fax: (303)

5 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 5

6 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. 6

7 The Defense Perspective DIFFERENT TYPES OF OPHTHALMIC MALPRACTICE CASES 7

8 Procedures/Treatments Resulting in Claims Other 18.26% Cataract Surgery 31.73% Corneal Treatment/Surgery 3.26% Glaucoma Treatment/Surgery 4.87% Oculofacial 8.72% Refractive Surgery 9.38% Retina Treatment/Surgery 13.33% Medical Evaluation 10.46% 8

9 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 $1,800,000 Failure to diagnose glaucoma in 8 yr old $1,000,000 Failure to treat corneal ulcer in 2yr old Pediatric 2009 Pediatric 2001 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

10 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

11 Severity by Specialty Average Settlements per year as of December 31,

12 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 12

13 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). 13

14 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. 14

15 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? 15

16 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 16

17 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? 17

18 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 18

19 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 19

20 Obtaining Medical Records WITHHELD, ALTERED, AMENDED BLACK AND WHITE TOPOGRAPHIES INSTEAD OF COLOR FORGED/FABRICATED DESTROYED ELECTRONIC RECORDS TOPOGRAPHIES, WAVESCAN, OCT 20

21 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:

22 A. CONTRAST SENSITIVITY B. DEBILITATING GLARE 3. POOR CONTRAST SENSITIVITY CAN AFFECT GOOD VISUAL ACUITY Todd J. Krouner, April 15,

23 The Defense Perspective EVALUATING THE NEW CASE DEFEND OR SETTLE? 23

24 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 24

25 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. 25

26 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? 26

27 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) 27

28 Evaluating Damages - Cataract Lens Displacement Rotation Possible Problems Zonular damage Capsular damage Poor sulcus fixation Wrong IOL for Anterior Chamber 28

29 Evaluating Damages - Cataract Post-Operative Complications Possible Problems: Cystic Macular Edema Vitreous/Retinal Detachment Wound Leak Endophthalmitis 29

30 Defend or Settle - LASIK? Irregular Astigmatism Ectasia Night vision problems (pupil size) Under/Overcorrection Dry Eye, Contact Lens Intolerance Wrong axis of astigmatism 30

31 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? 31

32 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 32

33 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 33

34 Evaluating Damages Under/Overcorrection Possible Problems: No determination of corneal stability pre-op Laser calibration Incorrect data entry Laser malfunction (3 rd party practice) Human variability (e.g. my result) 34

35 Evaluating Damages Dry Eye Possible Problems: History of CL wear? Schirmer s test? (controversial) CL trial Tear film bioassay 35

36 Evaluating Damages: Non-Economic Loss Emotional, psych caused by surgery ro preexisting? 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 36 36

37 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? 37 37

38 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 38

39 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) 39

40 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 40

41 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? 41

42 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 42

43 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 43

44 Cataract Discovery Goals - Damages Wrong IOL Power Treatment Options: Remove, replace IOL Piggyback IOL LASIK or PRK Contact Lens or Glasses 44

45 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 45

46 Cataract Discovery Goals - Damages Ruptured Capsule Vitrectomy Treatment Options: Refer to a Retinal Specialist Antibiotic coverage IOL re-positioning 46

47 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 47

48 LASIK Discovery Goals - Damages Irregular astigmatism? Treatment Options: RGP Contact Lenses Wavefront-guided excimer laser Topo-Link excimer laser (not yet FDAapproved) Wait (epithelial remodeling) 48

49 LASIK Discovery Goals - Damages Ectasia? Treatment Options: RGP Contact Lens Intacs Corneal Transplant Collagen Cross-Linking (Riboflavin-UV) (not FDA-approved, but available) 49

50 LASIK Discovery Goals - Damages Night Vision Problems (pupil size) Treatment Options Pilocarpine Artificial pupil or Reading Device Strong defense available Glasses or CL s 50

51 LASIK Discovery Goals - Damages Under/Overcorrection Treatment Options Re-operation ( enhancement ) Mitigation of damages? Consent form discuss need for re-operation Contact Lenses, Glasses 51

52 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) 52

53 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... 53

54 PROFITABILITY OF LASIK, PREMIUM IOL LASIK cost UPSELLING Of cataracts surgery CO-MANAGED Care who gets what? Surgical Schedule about 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 54 54

55 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? 55

56 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) 56