Anatomy of a Lawsuit II An inside look at the trial and $725

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					                                                                               Anatomy of a Lawsuit II

  Lawsuit II
     of a

An inside look at the trial and $7.25 million verdict in Mark Schiffer vs. Mark G.
Speaker, MD, Laser and Corneal Surgery Associates, PC, TLC Laser Eye Center, Regina
Zyszkowski and Drs. Farkas, Kassalow, Resnick and Associates, PC. Supreme Court
of the State of New York, County of New York. Index No. 101191-03.
B Y G I L L I A N M C D E R M O T T, E D I T O R - I N - C H I E F , A N D A D A M B . K R A F C Z E K , J D

                                                       n our July/August 2002 issue of Cataract & Refractive Surgery

                                                 I     Today, I authored “Anatomy of a Lawsuit”1 to provide an in-
                                                       side look at the trial and $4 million verdict in Stephen Post vs.
                                                       University Physicians, Inc., the lawsuit brought by the former
                                                 35-year-old United Airlines pilot claiming damages relating to his
                                                 LASIK surgery. The response to that article was overwhelmingly
                                                 positive. It included medical, healthcare, and business profession-
                                                 als incorporating portions of this article and lessons learned into
                                                 presentations that were given around the world as well as physi-
                                                 cians who actually required their entire staff to read the article.
                                                 The running theme in all of the positive feedback we received was
                                                 a sincere appreciation for our unbiased format and presentation
                                                 of the case in which we just presented the facts as they appeared
                                                 in the actual trial transcripts.
                                                    Although it is a challenge to summarize more than 2,000 pages
                                                 of trial transcripts during the course of the 12-day trial in Schiffer
                                                 vs. Speaker et al, we have attempted to do so by presenting concise
                                                 summaries of the trial testimony of each witness—complete with
                                                 citations to the actual trial record—in the order in which they
                                                 appeared during the trial. We hope that you find this article in-
                                                 structive and informative and that it sheds some light on our judi-
                                                 cial system and the legal process, which has rendered this most re-
                                                 cent landmark verdict. As always, we welcome your comments.
                                                                                                 —Adam B. Krafczek, JD

                                                                OCTOBER 2005 I CATARACT & REFRACTIVE SURGERY TODAY I 75
            Anatomy of a Lawsuit II

     PLAINTIFF MARK SCHIFFER’S LEGAL                                 that the Defendants were negligent in the medical care
     C L A I M S A N D A L L E G E D DA M AG E S                     and treatment rendered on behalf of Mr. Schiffer. His
        On October 6, 2000, Mark G. Speaker, MD, PhD, FACS,          Complaint filed with the Court alleges the Defendants
     Medical Director of the Manhattan TLC Laser Eye Cen-            were negligent “in failing to use reasonable care; in failing
     ter at that time, performed LASIK surgery on Mark               to heed Plaintiff’s condition, in departing from accepted
     Schiffer. Subsequently, the patient claimed to have suf-        standards in the procedures and treatment performed;
     fered impaired vision, which was particularly distorted in      in failing to follow appropriate practice; in failing to
     his left eye. Among Mr. Schiffer’s claims is that his kera-     properly examine Plaintiff; in failing to properly treat
     toconus was a condition that Dr. Speaker should have            Plaintiff’s eyes; in failing to determine that Plaintiff was
     identified or anticipated prior to surgery and therefore        not a candidate for LASIK eye surgery, in performing
     disqualified him as a candidate for LASIK. Mr. Schiffer         LASIK eye surgery on Plaintiff when said procedure was
     asserted that his impaired vision forced him to leave his       contraindicated; and were otherwise negligent in their
     position at Dresdner Kleinwort Wasserstein, an invest-          treatment of Plaintiff.”2
     ment banking firm on Wall Street.                                  The Complaint further alleges the Defendants failed
        On January 23, 2003, Mr. Schiffer filed suit against         to provide Mr. Schiffer “with information that reason-
     Mark G. Speaker, MD; Laser and Corneal Surgery Asso-            ably prudent medical practitioners should have provid-
     ciates, PC; TLC Laser Eye Center; Regina Zyszkowski; and        ed under the circumstances, and failed to make Plaintiff
     Drs. Farkas, Kassalow, Resnick and Associates, PC, in the       aware of the risks and benefits of, and the alternatives
     Supreme Court of the State of New York, County of               to, the procedures employed.”3
     New York, Index No. 101191-03. The Plaintiff claimed               The Defendants denied these allegations as set forth

          FAST FACTS*

         Case Caption                                                     Defendants’ Attorneys and Trial Counsel
         Mark Schiffer vs. Mark Speaker, MD, Laser and Corneal Surgery    Peter C. Kopff of Kopff, Nardelli & Dopf, LLP, attorney for
         Associates, PC, TLC Laser Eye Center, Regina Zyszkowski and      Defendants Mark G. Speaker, MD, and Laser and Corneal
         Drs. Farkas, Kassalow, Resnick & Associates, PC                  Surgery Associates, PC

         Index No.                                                        Ralph Catalano of Catalano, Gallardo, Petropoulous LLP, attorneys
         101191-03                                                        for Defendant TLC Laser Eye Center

         Judge                                                            Andrew Neubardt of Rende, Ryan & Downs LLP, attorneys for
         Alice Schlesinger                                                Defendants Regina Zyszkowski, and Drs. Farkas, Kassalow,
                                                                          Resnick and Associates, PC
         Court and County
         Supreme, New York County                                         Total Award
         Date of Verdict
         July 27, 2005                                                    Breakdown of Award
                                                                          Past Pain and Suffering:           $750,000
         Length of Trial                                                  Future Pain and Suffering:         $2,000,000 (10 years)
         12 days                                                          Past Lost Earnings:                $500,000
                                                                          Future Lost Earnings:              $4,000,000 (7 years)
         Plaintiff’s Attorneys and Trial Counsel
         Todd J. Krouner, Esq                                             Liability Percentages
         Law Office of Todd J. Krouner                                    100% Mark Speaker, MD
         93 North Greeley Avenue
         Chappaqua, NY 10514

                                                                                                    Anatomy of a Lawsuit II

       in Plaintiff’s Complaint. The outcome of this lawsuit,          this country called Surgical Eyes and an ectasia study
       tried in the Supreme Court of the State of New York,            group under the Yahoo! help group.6
       reportedly marks the largest award in a LASIK-related              According to Dr. Amoils, the standard of care for
       case to date, with the jury awarding the Plaintiff on July      LASIK surgery is the same worldwide. In June 2005, he
       27, 2005, the total amount of $7.25 million in damages.         was asked by Counsel for the Plaintiff to render an
                                                                       opinion on the quality of care received by Mr. Schiffer.
       THE TRIAL—WITNESSES IN ORDER OF                                 Dr. Amoils reviewed the records of the Farkas Group;
       T H E I R A P PE A R A N C E                                    TLC Laser Eye Center; Susan Margolis, MD; Richard
       Selig Percy Amoils, Plaintiff’s Expert                          Braunstein, MD; the Massachusetts Eye and Ear In-
       Testified July 12 to 15, 2005                                   firmary; and optometrist Michael Block. He also re-
       Direct Examination by Counsel for Plaintiff Mark Schiffer       viewed the sworn depositions that were taken prior to
         Dr. Amoils is an ophthalmic surgeon who practices in          the trial. He asserted that Mark Schiffer had received
       Sandton, Johannesburg, South Africa. He is also licensed        poor treatment, that Mark Speaker, MD, was negligent,
       to practice medicine in England and in New York State.4         and that all of the Defendants had departed from the
       He completed his fellowship in ophthalmology in the             standard of care. He stated that this departure had
       US between 1966 and 1969, and he is a fellow of the             caused Mr. Schiffer’s injuries.7
       AAO. He has written 35 peer-reviewed articles. In 2000,            Dr. Amoils said that Mr. Schiffer had forme fruste ker-
       he published an article on iatrogenic keratectasia after        atoconus preoperatively and that the danger of per-
       LASIK.5 He has come across tremendous complications             forming LASIK on patients with this ocular condition
       with LASIK surgery, and he has set up an organization in        was well known in October 2000. He said that the pre-

Jury Poll                                                       Special Damages Claimed by Plaintiff
6-0 liability, 5-1 past pain and suffering                      Lost earnings: $35,000,000

Time Jury Deliberated                                           Amount Plaintiff Asked of Jury
1 day                                                           $43,500,000

Composition of Jury                                             Settlement Demand
Three females, three males                                      Settlement Demand by Plaintiff: $2,300,000

Posttrial Motions                                               Offer of Settlement by Defendants
Defendant Mark Speaker has filed a Posttrial Motion for         0
Judgment for Defendant Mark Speaker or for a New Trial. This
Motion is returnable September 28, 2005, before Judge           Plaintiff’s Experts
Schlesinger.                                                    Selig Percy Amoils, MD, Ophthalmologist, South Africa
                                                                Alan Johnson, Compensation Expert
Appeal                                                          Todd Buchholz, Economist
Notice of Appeal will be filed by Defendant Mark Speaker and
Laser and Corneal Surgery Associates, PC, in the event          Defendant’s Expert
Defendant Mark Speaker’s Posttrial Motion is denied.            Edward Holland, MD, Ophthalmologist, Cincinnati, Ohio

                                                                * Information provided in the section entitled “Fast Facts” obtained from “VERDICT-
Insurance Carrier                                               SEARCH,” 128 Carleton Avenue, East Islip, NY 11730, as submitted by Defendant's
Medical Liability Mutual Insurance Company                      Counsel, Peter C. Kopff, Esquire, of Kopff, Nardelli & Dopf, LLP, attorney for Defendants
                                                                Mark G. Speaker, MD, and Laser and Corneal Surgery Associates, PC.

                                                                                    OCTOBER 2005 I CATARACT & REFRACTIVE SURGERY TODAY I 77
            Anatomy of a Lawsuit II
                                                                                                  Approval of the premarket approval appli-
                                                                                                  cation supplement for the Refractec
                                                                                                  ViewPoint® CK System is for the tempo-
                                                                                                  rary induction of myopia (-1.00 D
                                                                                                  to -2.00 D) to improve near vision in
                                                                                                  the non-dominant eye of presbyopic
     operative evaluation of LASIK candidates should include topography and a                     hyperopes or presbyopic emmetropes,
     slit-lamp examination but noted that a cornea with forme fruste kerato-                      via spherical hyperopic treatment of 1.00
     conus often appears to be normal. Dr. Amoils said that the FDA had                           D to 2.25 D, in patients 40 years of age
                                                                                                  or greater with a documented stability
     warned against signs of keratoconus8 [end of day 1].
                                                                                                  of refraction for the prior 12 months, as
        Dr. Amoils further testified that the treating optometrist’s (Regina                      demonstrated by a change of < 0.50 D
     Zyszkowski, OD) preoperative screening of Mr. Schiffer departed from the                     in spherical and cylindrical components
     standard of care when she failed to diagnose manifest, latent, forme fruste                  of the manifest refraction, and with
     keratoconus. He said the most useful test for diagnosing this condition is                   ≤ 0.75 D of cycloplegic refractive cylinder
     topography. He described the topographic map of Mr. Schiffer’s eyes from                     and with a successful preoperative trial
     the Farkas Group dated September 29, 2000, as abnormal.9                                     of monovision or history of monovision
                                                                                                  wear (i.e., dominant eye corrected for dis-
        When questioned by Counsel for the Plaintiff on Dr. Zyszkowski’s testimo-
                                                                                                  tance vision and non-dominant eye cor-
     ny that colors can be arbitrary and that she relies on K values, Dr. Amoils                  rected for near vision).

           TABLE 1. CLINICAL MEASUREMENTS OF THE PLAINTIFF’S EYES                                     ®
                                                                                                  CK is an elective procedure with the alter-
                           BEFORE AND AFTER LASIK*                                                natives including, but not limited
                                                                                                  to, reading glasses, bifocal eyeglasses, mul-
                                                                                                  tifocal contact lenses, monovision contact
                        Preoperative Topography (October 6, 2000; Humphrey†)                      lens wear, or other refractive surgeries.

                                                                                                  Approval of this application is based on
       Refraction                  OD -2.50 -0.50 X 075           20/20
                                                                                                  a clinical trial of 150 patients treated for
                                   OS -1.75 -1.50 X 125           20/20                           near vision in their non-dominant eye,
                                                                                                  with the other eye treated for distance
                                                                                                  vision in 38 of the patients. Of all eyes,
       Topographic                 OD 45.87D @ 180º OS 48.75D @ 78º                               148 near vision treatments were available
       Simulated                        46.26D @ 90º              46.50D @ 166º                   for analysis at 3 months, 146 eyes were
                                                                                                  available for analysis at 6 months, 94 eyes
       Keratometry                                                                                were available for analysis at 9 months,
                                                                                                  and 77 eyes were available for analysis
                                                                                                  at 12 months. Accountability was 99%
       Topographic                 OD 0.62D                   OS 2.25D
                                                                                                  at 3 months, 97% at 6 months, 97%
       Astigmatism                                                                                at 9 months, and 96% at 12 months.

                                                                                                  The data analysis was based on the
       Ultrasound Pachymetry       OD 590µm                   OS 595µm                            refractive data at all follow-up examina-
                                                                                                  tion timepoints (1 month,
                                                                                                  3, 6, 9, and 12 months). At 6 months,
                                                                                                  this analysis showed that 83% (67/81)
                        Postoperative Topography (June 5, 2001; Humphrey†)
                                                                                                  eyes were corrected to (J3) 20/40 and
                                                                                                  23% (19/81) were corrected to (J1+)
       Refraction                  OD -0.75 -0.25 X 088            20/20                          20/20 or better visual acuity without
                                                                                                  spectacles or contact lenses.
                                   OS +1.25 -2.00 X 090            20/30
                                                                                                  The study showed that all the adverse
                                                                                                  events occurred at low rates (< 1%).
       Topographic                 OD 44.62D @ 90º            OS 48.25D @ 46º
                                                                                                  Long-term risks of CK for improvement
       Simulated                         44.37D @ 180º             43.25D @ 136º
                                                                                                  of near vision have not been determined.
       Keratometry                                                                                The safety and effectiveness of re-treat-
                                                                                                  ment procedures with the Refractec
                                                                                                  ViewPoint CK System or other refractive
       Topographic                 OD 0.25D                    OS 5.00D                           surgical devices have not been estab-
       Astigmatism                                                                                lished.

               * All clinical measurements obtained from trial testimony and trial exhibits.
                                                          Carl Zeiss Meditec Inc. (Dublin, CA).

                                                                                                  L 325-134 Rev. A

            Anatomy of a Lawsuit II


                                    Postoperative Topography (June 7, 2001)
       Topographic                  OD 44.20D @ 136º                       OS 47.90D @ 78º
       Simulated Keratometry           43.90D @ 46º                           45.10D @ 168º

       Topographic                  OD 0.30D                               OS 2.90D

       Thinnest                     OD 511µm                                OS 472µm

                                                                                                          Bausch & Lomb (Rochester, NY).
                                                          †   All clinical measurements obtained from trial testimony and trial exhibits.

     stated that her remarks deviated from the standard of                patient’s left eye was 48.40D, a finding suggestive of
     care, based on the published literature and his own re-              forme fruste keratoconus. He said that there was an
     search. Specifically, he said that inferior corneal steepen-         approximate 6.00D difference in corneal power in the
     ing on the color scale of the preoperative topographic               inferior versus superior cornea, also significant for forme
     map of Mr. Schiffer’s left eye reflected bulging of the in-          fruste keratoconus. He added that Mr. Schiffer’s central
     ferior portion of the cornea. He faulted Dr. Zyszkowski              corneal power measured 45.10D OD and 48.40D OS, a
     for recommending LASIK for Mr. Schiffer and for not dis-             greater degree of asymmetry than the maximum 1.00D
     cussing the topography with Dr. Speaker, TLC, or                     stipulated by Drs. Rabinowitz and McDonnell. He
     Mr. Schiffer.10 Dr. Amoils testified that any retreatment of         asserted that Dr. Speaker should have canceled the orig-
     Mr. Schiffer’s left eye would certainly have resulted in             inal surgery, repeated the topography, and measured
     dandelion keratoconus or keratectasia, in which the                  the corneal thickness. The preoperative pachymetry of
     condition worsens with each enhancement.11                           the central cornea measured 595µm, and a measure-
        After remarking on a lack of notes on the case by                 ment with an Orbscan topographer (Bausch & Lomb,
     Dr. Speaker, Dr. Amoils said that there was no indica-               Rochester, NY) would have been appropriate.15
     tion that Dr. Speaker had reviewed the aforementioned                   Dr. Amoils testified that LASIK performed in an eye
     topographic maps or those taken on October 6, 2000,                  with inferior steepening and asymmetric central corneal
     prior to the LASIK procedure. Dr. Amoils testified that              power would result in iatrogenic keratectasia, as it did
     this behavior constituted gross negligence and a devia-              in Mr. Schiffer’s case. He said the complication had
     tion from the standard of care on the part of                        necessitated a corneal transplant in Mr. Schiffer’s left
     Dr. Speaker. He added that the topography subse-                     eye. He cited study findings that the cornea’s normal
     quently taken on October 6 by TLC was similar to the                 appearance on slit-lamp biomicroscopy does not rule
     results of the topography taken by the Farkas Group                  out keratoconus.16 He stated that LASIK was “absolutely
     on September 29 and confirmed the diagnosis of forme                 contraindicated” for Mr. Schiffer on the basis of his
     fruste keratoconus.12                                                topography.17
        Dr. Amoils referred to the pioneering work on corneal                If Mr. Schiffer’s preoperative examination had been
     topography by Yaron Rabinowitz, MD, and Peter                        entirely normal aside from the October 2000 topogra-
     McDonnell, MD.13 He explained that Drs. Rabinowitz                   phy, Dr. Amoils said the patient would still definitely
     and McDonnell quantitatively evaluated the risk factors              not have been a candidate for LASIK. He said his views
     for keratoconus and described three diagnostic meas-                 were backed by the literature and the medical commu-
     ures: (1) a central corneal power of greater than 47.00D;            nity.18 Dr. Amoils read into the record from an article by
     (2) a difference of 3.00D when comparing the inferior to             Douglas Koch, MD, a statement that surgeons should
     superior cornea; and (3) asymmetry in the corneal pow-               “be especially wary of performing LASIK in eyes with
     ers of both of an individual’s eyes.14                               abnormal topography and have a low threshold for
        Applying these factors to Mr. Schiffer’s preoperative             rejecting these patients for LASIK.”19,20
     topography taken on October 6, 2000 (Table 1),                          Referring to TLC’s informed consent (dated Septem-
     Dr. Amoils noted that the central corneal power of the               ber 1, 1999), which specified that LASIK candidates

should not have certain ocular dis-
eases, including keratoconus,
Dr. Amoils stated that Mr. Schiffer
had not been adequately informed
of his ocular problem and the risks
of the procedure.21
   According to Dr. Amoils, in the
summer of 2001, Mr. Schiffer com-
plained to Dr. Zyszkowski of a di-
minution of vision. She referred
him to TLC for an enhancement,
and he was seen by William
Tullo, OD, and Dr. Speaker on June
5, 2001. Dr. Tullo canceled the en-
hancement and ordered an
Orbscan measurement, which was
taken on June 7, 2001. Dr. Amoils
stated that the cancellation was
due to the patient’s development
of keratectasia and that the co-
managed team had recognized that
further LASIK surgery was contra-
indicated. Dr. Amoils said that
Orbscan measurements on June 7,
2001, showed signs of abnormality
in Mr. Schiffer’s right eye and re-
vealed a gross discrepancy in the
corneal power of his left eye that is
typical of keratectasia. Specifically,
the posterior float was 75µm. He
asserted that, based on its location,
this inferior bulge could not have
been produced by the laser. Cen-
tral thinning was also evident.
Dr. Amoils said that the Orbscan
measurement of Mr. Schiffer’s right
eye indicated an imminent pro-
gression to keratectasia.22
   For his 10 days at the trial,
Dr. Amoils was compensated be-
tween $23,00023 and $29,000.24 “I
have a huge practice,” he said. “It is
costing me money to come here”25
[end of day 2].
   Dr. Amoils testified that he had a
reasonable degree of medical cer-
tainty that Mr. Schiffer will need a
corneal graft in his right eye as
well.26 He said the difference be-
tween the inferior and superior ker-
atometry readings was approxi-
mately 6.00D on the September 29,
                                                                                  Anatomy of a Lawsuit II

2000, topography.27 Specifically, the inferior value was       notes that the enhancement should be cancelled and
51.90D, and the superior value was approximately               the left eye might have keratoconus. Dr. Amoils said
45.18D.28                                                      the notes indicated that Mr. Schiffer has keratectasia
   Dr. Amoils characterized Mr. Schiffer’s vision prior to     bilaterally but to a greater degree in his left eye. He
LASIK as good and said that patients usually do not            read similar findings on a topographic map dated May
regain their pre-LASIK vision. He said that Mr. Schiffer’s     2002 from Dr. Margolis’ record; a handwritten diagnosis
case was distinct from that of the general patient pop-        from Dr. Braunstein’s records dated June 4, 2004; and a
ulation who receive corneal grafts in that he has post-        chart dated January 14, 2005, from Dr. Braunstein’s
LASIK keratoconus. He testified that the use of Intacs         office.31
(Addition Technology, Inc., Des Plaines, IL) prior to the         Dr. Amoils stated that post-LASIK ectasia had been
transplant necessitated a larger corneal graft.29              the subject of peer-reviewed articles prior to 2003 and
   Drawing on his experience, Dr. Amoils said that kera-       that risk factors for the condition had been identified
tectasia after LASIK is usually bilateral but more severe      prior to that year. He disagreed with the possible de-
in one eye than its fellow. He said the condition is pro-      fense that TLC’s October 6, 2000, color topography
gressive.30 Mr. Schiffer’s TLC chart dated June 5, 2001,       showed a bowtie deformity, which might have been
from Plaintiff’s Exhibit No. 2 contained handwritten           caused by contact lens warpage or a displaced apex.32

                                        AN ACCOUNT OF THE 12-DAY TRIAL
 Summary of the trial proceedings day by day and of the identities of the trial witnesses in the order in
 which they appeared.

 Day 1: July 12, 2005                    Day 7: July 20, 2005                      Day 12: July 26, 2005
 JURY SELECTION                          Plaintiff’s Case (Witnesses Cont’d)       VERDICT ANNOUNCED
 PLAINTIFF’S CASE                        Regina Zyszkowski, OD*
 Selig Percy Amoils                      PLAINTIFF RESTS HIS CASE                  $750,000 awarded to Plaintiff
 (Plaintiff’s Expert)                                                              Mark Schiffer for conscious pain
                                         DEFENDANTS’ CASE                          and suffering from October 6,
 Day 2: July 13, 2005                    Defendant Mark Speaker, MD                2000, surgery to date.
 Plaintiff’s Case (Witnesses Cont’d)
 Selig Percy Amoils (Cont’d)             Day 8: July 21, 2005                      $2,000,000 awarded to Plaintiff
                                         Defendants’ Case (Witnesses Cont’d)       for future pain and suffering
 Day 3: July 14, 2005                    Edward John Holland, MD                   (10 years).
 Plaintiff’s Case (Witnesses Cont’d)     (Defendant’s Expert)
 Selig Percy Amoils (Cont’d)                                                       $500,000 awarded to Plaintiff for
                                         Day 9: July 22, 2005                      lost earnings from the October 6,
 Day 4: July 15, 2005                    Defendants’ Case (Witnesses Cont’d)       2000, surgery to date.
 Plaintiff’s Case (Witnesses Cont’d)     Mark Speaker, MD (Cont’d)
 Selig Percy Amoils (Cont’d)                                                       $4,000,00 awarded to Plaintiff for
 Plaintiff Mark Schiffer                 Day 10: July 25, 2005                     future lost earnings (7 years).
                                         Defendants’ Case (Witnesses Cont’d)
 Day 5: July 18, 2005                    William Tullo, OD                         *Indicates that the witness did not tes-
 Plaintiff’s Case (Witnesses Cont’d)     Ken B. Carnevale, MD*                     tify live on the date specified but that
 Plaintiff Mark Schiffer (Cont’d)        Regina Zyszkowski, OD                     designated portions of prior deposition
                                                                                   testimony were read to the jury.
 Day 6: July 19, 2005                    DEFENDANTS REST THEIR CASE
                                                                                   All information obtained from the Supreme Court of the
 Plaintiff’s Case (Witnesses Cont’d)                                               State of New York, Trial Transcripts in the matter of
 Alan Johnson (Compensation Expert)      Day 11: July 26, 2005                     Schiffer vs. Speaker, Laser and Corneal Surgery Associ-
                                                                                   ates, TLC Laser Eye Center, Zyszkowski, and Drs. Farkas,
 William Tullo, OD*                      CLOSING ARGUMENTS                         Kassalow, Resnick, and Associates, PC. Index No.
 Todd Buchholz (Economist)                                                         101191-03.
 Defendant Mark Speaker, MD*

                                                                        OCTOBER 2005 I CATARACT & REFRACTIVE SURGERY TODAY I 83
            Anatomy of a Lawsuit II

     Cross Examination by Counsel for Dr. Speaker                 mires did not pulsate during applanation tonometry,
        Dr. Amoils acknowledged that Dr. Speaker has some         nor did he experience an acute rupture of Descemet’s
     standing in the US ophthalmic community and that he          membrane, as some patients with keratoconus do.41
     is an experienced corneal surgeon. He expressed familiar-       Dr. Amoils agreed that deep stromal stress lines may
     ity with Dr. Speaker’s publications.33 Dr. Amoils has not    vanish if the examiner presses on the eye. He also
     been affiliated with a hospital in New York, has no          acknowledged that, in keratoconus, there is normally a
     teaching privileges at any of the state’s medical schools,   ring of iron deposits in the cornea and that these deposits
     and has not practiced medicine in the state. He has held     also accumulate at the epithelium’s base. Mr. Schiffer’s
     the license for 20 years but has not used it technically.    October 2000 examination did not show a Fleischer’s
     He disagreed with Dr. Rabinowitz’s statement in his arti-    ring, scarring of Bowman’s layer, or thinning of the
     cle13 that a comprehensive clinical examination remains      cornea. Dr. Amoils disagreed with the contention that
     the gold standard for the diagnosis of keratoconus and       the pachymetry measurement was normal but acknowl-
     asserted that the gold standard is topography.34             edged that the only reading was 590µm in the central
                                                                  cornea, an above-average finding. In addition, he con-
                                                                  curred that corneal steepening in keratoconus produces
                                                                  clinical signs such as Munson’s sign, which the Plaintiff
             “Dr. Amoils does not currently                       did not have in October 2000.42
           perform LASIK and last performed                          Dr. Amoils confirmed the existence of a global stan-
                 the procedure in 1994.”                          dard of care, both currently and in the year 2000. He said
                                                                  that LASIK had been accepted in some cities and coun-
                                                                  tries before others and that, during that period, there
                                                                  was no global standard of care. A 1998 case report43 of
        Dr. Amoils first heard about Mr. Schiffer in June 2005,   a German patient was included on his list [in evidence]
     only 5 weeks prior to when this case went to trial. He       of 10 important publications relevant to the case.
     spends 50% to 60% of his time performing surgery, gen-       Dr. Amoils maintained that its publication changed the
     erally 10 refractive cases, two retinal detachment sur-      standard of care for average US physicians,44 but he
     geries, three to four cataract procedures, and three to      agreed that the AAO helps define the standard of care
     four glaucoma operations per week. Dr. Amoils does           for the average ophthalmologist.45 He expressed unfa-
     not currently perform LASIK and last performed the           miliarity with an AAO-commissioned study of LASIK’s
     procedure in 1994. His 10 refractive procedures per          safety and efficacy that was published in 2003.46,47
     week are all PRK.35 He spends 40% to 50% of his time            Dr. Amoils acknowledged that he had submitted a
     consulting.36 He has never testified in the area of med-     paper to Dr. Speaker for publication and that it had
     ical malpractice in the US but has done so two or three      bothered him that it was rejected for publication. He
     times in South Africa.37                                     had expressed some unhappiness over its rejection in
        Dr. Amoils contended in 1999 that LASIK should            2000 by the AAO in a document he had written to
     never be performed in eyes with forme fruste kerato-         Mr. Krouner (Plaintiff’s Counsel).48
     conus or in any eye with asymmetric topography with
     inferior steepening.38 He confirmed his earlier testimony    Cross Examination by Counsel for TLC Laser Eye Center
     that the topography taken at Dr. Zyszkowski’s office            The October 2000 topography at TLC only reveals the
     showed corneal bulging. He said Mr. Schiffer had no          curvature of the front surface of the cornea. Dr. Amoils
     clinical signs of keratoconus. He agreed that, in 2000, a    concluded that this topography was abnormal based on
     physician could diagnose keratoconus or forme fruste         measurements taken 3mm out and 3mm down from
     keratoconus by looking at topography alone.39                the corneal center. He judged the difference between
        In Mr. Schiffer’s preoperative examination on Sep-        these measurements according to Dr. Rabinowitz’s work.
     tember 15, 2000, he had myopia of -2.50 to -2.75D OD         Dr. Amoils confirmed that the contours shown on
     and a BCVA of 20/20+1 OD. Mr. Schiffer had myopia of         topography can change within 6 months, 1 year, and
     -1.50 to -1.75D OS and a BCVA of between 20/25 and           several years49 [end of day 3].
     20/20-2 OS. Dr. Amoils disagreed with the idea that             Medical records reflected that Dr. Braunstein’s doc-
     visual acuity correctable to the 20/20 range is not sug-     tor/patient relationship with the Plaintiff began in Janu-
     gestive of keratoconus.40                                    ary 2003. Dr. Braunstein ordered a wavefront examina-
        According to Dr. Amoils, in October 2000, Mr. Schiffer    tion approximately 6 weeks before scheduling corneal
     did not exhibit Rizutti’s signs or a Charleaux sign. The     graft surgery.50 The examination (Tracey Technologies,

Houston, TX) taken on January 14,
2005, of Mr. Schiffer’s left eye includ-
ed a Snellen letter E for higher-order
aberrations 20/40.51 Dr. Amoils
agreed that the wavefront studies
ordered by Dr. Braunstein were con-
sidered reliable by the scientific
community in 2005. He concurred
that the use of the simulated Snellen
letter was also accepted in the oph-
thalmological community in January

Mark Schiffer, Plaintiff
Testified July 15, 2005
Direct Examination by Counsel for
Plaintiff Mark Schiffer
   Mr. Schiffer is 32 years old. He
graduated from Yale University in
1995 with a B.A. in economics.53 He
began matriculating at the Wharton
School at the University of Pennsyl-
vania in the fall of 1999 and gradu-
ated in the spring of 2001 with an
   The Plaintiff sought eye care in
September 2000 while attending
school in Philadelphia. He visited
Dr. Zyszkowski at the Farkas Group’s
office in Long Island, New York. He
was interested in LASIK, had a histo-
ry of contact lens intolerance, and
did not like wearing glasses. During
the first consultation, Dr. Zyszkowski
took his history. He expressed his in-
terest in LASIK and underwent a
LASIK screening. He discussed with
Dr. Zyszkowski an orbital fracture he
had sustained years ago, and she
expressed uncertainty as to how the
injury would affect his candidacy for
LASIK. The Plaintiff said the injury
had not affected his vision or his
globe. He had been diagnosed with
myopia and astigmatism and pre-
scribed glasses while a teenager. He
was examined, including at the slit
lamp. His refraction and topography
were measured. Dr. Zyszkowski said
that topography confirmed his
astigmatism, which could affect his
candidacy for LASIK. He testified
                                                                                 Anatomy of a Lawsuit II

that there was no discussion about keratoconus or ker-         including keratoconus, glaucoma, cataracts and retinal
atectasia. He received no indication that he had asym-         and optic nerve diseases.” Mr. Schiffer said he did not
metrical, inferior corneal steepening in his left eye.55       know in October 2000 that he had keratoconus. He said
                                                               Dr. Zyszkowski told him nothing regarding whether he
                                                               had the condition and neither did anyone at the Farkas
   “Mr. Schiffer was pleased with his vision                   Group, Dr. Speaker, or anyone from TLC. He had no rea-
                                                               son to suspect he had keratoconus and had never heard
     through the remainder of the year                         of the condition at that time. He had no reason to ex-
    2000, but he testified that it began to                    pect he was at increased risk of injury from LASIK.59
                                                                  He admitted signing and dating the informed consent
   deteriorate in 2001 through the spring.”                    and, as instructed, wrote on the form in his own hand-
                                                               writing that he understood that the procedure carried
                                                               risks and no guarantees, although he said he was not
   Dr. Zyszkowski said that a retinal spot in one of his       told that he was at particular risk.60
eyes would need to be investigated further to deter-              On October 6, 2000, the day of the Plaintiff’s surgery,
mine his LASIK candidacy. She referred him to a retina         a technician performed some tests on Mr. Schiffer be-
specialist, Ken Carnevale, MD. He was thereafter told          fore he met Dr. Speaker. One of the tests was topogra-
the retinal spot was not a contraindication to LASIK           phy. He did not recall being given a copy of this exami-
by Dr. Zyszkowski. Between leaving her office on Sep-          nation and did not discuss the results with anyone. No
tember 29 and his LASIK surgery on October 6, he did           one discussed the results of the topography performed
not see Dr. Zyszkowski but spoke to her on the phone.          by Dr. Zyszkowski on September 29, 2000, with him on
She told him that, based on her conversation with              the surgical day, either.61
TLC, the previous orbital fracture was not a contra-              He recalled lying on the operating table with
indication for LASIK. She also said that his astigmatism       Dr. Speaker behind him, from where he performed sur-
was not a contraindication.56                                  gery and described the procedure. Dr. Speaker took no
   She had originally wanted him to undergo LASIK with         history from him and performed no tests before the
Eric Donnenfeld, MD, at TLC’s Long Island office, due to       surgery. The Plaintiff met with no optometrist on the
its proximity to where the Plaintiff resided. She recom-       morning of surgery.62
mended he undergo the procedure in Manhattan with                 He underwent bilateral LASIK. Approximately 20 min-
Dr. Speaker instead, because he used a laser that she          utes elapsed between his entrance into and exit from
believed was better for astigmatism.57                         the OR. No complication occurred during the proce-
   Mr. Schiffer recalled no discussion of the risks of LASIK   dure. Dr. Speaker and he did not discuss his candidacy
between him and Dr. Zyszkowski, and he said she in no          for LASIK preoperatively. Neither did they speak about
way indicated that he was at increased risk versus the         his topography. After surgery, he received a pair of dark
general population. He arrived at the Manhattan office         sunglasses and an instruction sheet, and he left with his
on October 6, 2000. A patient consultant helped him            father.63
through the preoperative process. Mr. Schiffer made no            Mr. Schiffer met with Dr. Zyszkowski 1 day postopera-
direct payment to Dr. Zyszkowski or the Farkas Group.          tively and soon returned to the Wharton School of Busi-
During the September visit, she had told him that, if he       ness without incident with regard to his vision. Immedi-
had LASIK, the fee for the initial consultation would be       ately postoperatively, he was pleased with his surgical
taken from what he paid TLC. Mr. Schiffer understood           result; he felt his UCVA was what it had been preopera-
that she and her employer were responsible for his pre-        tively with contact lenses. He had a number of follow-up
and postoperative care.58                                      visits, one of which was not with Dr. Zyszkowski but with
   Mr. Schiffer did not recall receiving the informed          Dr. Susan Resnick, a partner at the practice. Mr. Schiffer
consent prior to surgery but did recall signing it on          was pleased with his vision through the remainder of the
that day at TLC. He said he did not discuss the con-           year 2000, but he testified that it began to deteriorate in
tents of the document with Dr. Zyszkowski. Section             2001 through the spring. At one of the follow-up visits,
three of the form listed LASIK indications and con-            Dr. Zyszkowski recommended an enhancement. The visu-
traindications as well as perioperative care. Mr. Schiffer     al deterioration consisted of regression to his preoperative
said he still did not know to what the term periopera-         visual acuity accompanied by some visual distortion he
tive care refers. He acknowledged that the form stated,        had not had previously.64
“Candidates must be free of certain eye diseases,                 Dr. Zyszkowski referred the Plaintiff back to TLC. He

                                                                       OCTOBER 2005 I CATARACT & REFRACTIVE SURGERY TODAY I 87
            Anatomy of a Lawsuit II

     visited TLC on June 5, 2001, and was examined by                    He visited Dr. Margolis in Manhattan in April 2002.
     Dr. Tullo, the clinical director. He recalled Dr. Tullo’s per-   He accounted for the elapsed time between his last visit
     forming a slit-lamp examination and topography.                  with Dr. Zyszkowski and his first with Dr. Margolis by
     Mr. Schiffer stated that no one performed a slit-lamp            saying that he did not require a corneal transplant at
     examination on the day of his original surgery and said          that time and that he knew he would not be able to
     he was unaware of any preoperative pachymetry readings           tolerate a hard contact lens. He decided to cope with
     on that day or in June 2001. Dr. Tullo informed him on           his deteriorating vision.68
     June 5 that he might have keratoconus, a contraindica-              During his visit to Dr. Margolis, he discussed with her
     tion for the LASIK enhancement, which was canceled.              his history. She diagnosed keratoconus in both of his
     Dr. Tullo discussed keratoconus with him immediately             eyes, but to a greater degree in his left. At TLC, Dr. Tullo
     after the examination and described the condition. He            had also said he thought Mr. Schiffer had keratoconus
     said he wanted the Plaintiff to undergo another test to          bilaterally, more so in his left eye. The Plaintiff had visit-
     confirm the diagnosis, specifically Orbscan topography.          ed Dr. Margolis based on the recommendation of one
     Mr. Schiffer testified he had never heard of this technolo-      of his mother’s friends, whose sister has keratoconus.
     gy or been tested with it before June 5, 2001.65                 When he asked if Dr. Speaker had made an error operat-
                                                                      ing on his eyes, she disclosed a personal relationship
                                                                      with him. The Plaintiff decided to visit another doctor.69
           “Mr. Schiffer [said he] left his job at                       Mr. Schiffer left his job at Wasserstein in July 2002 and
            Wasserstein in July 2002 ... because                      began working for his father’s software company, Safe
                                                                      Banking. He said he departed because his visual difficul-
           his visual difficulties were negatively                    ties were negatively affecting his career; he claimed he
                    affecting his career.”                            had been passed over for important projects and was
                                                                      working himself to exhaustion. Mr. Schiffer’s initial re-
                                                                      sponsibilities at Safe Banking were sales and marketing
        Dr. Zyszkowski, Dr. Tullo, Mr. Schiffer, and Dr. Speaker      of the software products, office management, book-
     met at the offices of TLC in New York. They discussed his        keeping, and accounting.70 The Plaintiff said that his
     possible keratoconus and need for an Orbscan. He was             injury was the only reason he was not currently an in-
     told that, if the diagnosis of keratoconus were confirmed,       vestment banker. He admitted that he had said nothing
     he would not be able to have an enhancement. He asked            about his vision’s affecting his ability to perform his job
     Dr. Speaker if he should not have undergone the original         to anyone when he left Wasserstein.71
     procedure. He testified that Dr. Speaker responded yes, in          Dr. Margolis had referred the Plaintiff to Dr. Block,
     hindsight, but that the preoperative charts gave no indi-        who fitted him with piggyback contact lenses in 2002.
     cation that the problem would occur. He added that               According to Mr. Schiffer, the lenses were unsuccessful,
     LASIK sometimes triggers the manifestation of kerato-            and he had great difficulty putting them in his eyes and
     conus. Mr. Schiffer was told the prognosis of kerato-            would often leave them out. When able to insert the
     conus, that the condition is not correctable, that it            lenses, he found them very uncomfortable, and they
     requires the use of hard contact lenses, and that it can         reddened and irritated his eyes. He further testified that
     progress to the point of requiring a corneal transplant.66       the lenses had little effect on his visual distortion and
        During his June 5 visit to TLC, an appointment was            he had trouble removing them. He used the lenses from
     made for the Plaintiff to go to Cornell Medical Center           the middle of 2002 to early 2004.72
     for the Orbscan topography a few days later. The results            Mr. Schiffer’s treatment by Drs. Braunstein and Block
     of the Orbscan were communicated to Dr. Zyszkowski.              overlapped. Dr. Braunstein practices at Columbia-
     He visited her in Long Island shortly after seeing her in        Presbyterian Hospital in New York. He said the only pos-
     New York. The results of the June 7, 2001, Orbscan con-          sibility aside from the contact lenses was a corneal trans-
     firmed the diagnosis of keratoconus (Table 2). He never          plant, which he was reluctant to perform. He described a
     spoke again to Dr. Speaker or Dr. Tullo. Mr. Schiffer and        new Intacs procedure that he did not perform and
     Dr. Zyszkowski discussed how to proceed with managing            referred the Plaintiff to Dimitri Azar, MD, at the Massa-
     his left eye, which had keratoconus. She told him he             chusetts Eye and Ear Infirmary, who implanted the seg-
     would require a hard contact lens, and he understood             ments. The Plaintiff hoped the surgery would reduce his
     he was no longer a LASIK candidate. He had no further            discomfort with his vision. The procedure lasted approxi-
     contact with Dr. Zyszkowski, because he was unhappy              mately 1 hour and required him to miss a couple of days
     with his care.67                                                 of work. According to Mr. Schiffer, he experienced no

                                                                    ns     trumen
improvement, which he discussed
with Dr. Braunstein, who prescribed             Glau coma I
eye drops to lower his IOP in an
                                                                             ti          o s
                                                                                 vate Fsuercep
                                                           r Caoicnajnulingcof delica tis
effort to improve the results. He tes-

                                                 Fechtnretraum t h d n
tified that the drops did not help.
The last resort was a transplant,73
which was scheduled for February                      fo a
28, 2005, but was canceled, because                                                                                                 0
the Plaintiff had the flu.74
   The Intacs were removed in mid-
February by Dr. Braunstein. This                                                                                                           val
                                                                                                                           soft co           g
procedure caused the Plaintiff to                                                                           force ps allow ithout crushin
                                                                                           g tip s of this ate traction w handling and
miss a couple of days of work. The                                                graspin ening to cre                  rms for
                                                                          shaped           op                  g platfo
transplant was rescheduled for                              lic ate ring into the ring               h as tyin
                                                    The de               te               forceps
March 17, at which time he received                             penetra           n, this
                                                    tissue to it. In additio                        rsey
                                                             ing                             New Je
eye-banked corneal tissue.75 He                      or tear cate sutures. r, M.D., Newark,
                                                                li           htne
                                                     ty ing dey Robert D. Fec
missed 1 week of work. Currently, he                 Design
                                                           ed b

experiences no discomfort in his left
eye. Since the transplant, he has expe-
rienced a lack of contrast sensitivity,
                                                                      Luntz-Dodick Punch
however. The stitches from the sur-                                        for trabecu            lectomies
gery have not been removed, and, per-
haps as a result, his vision is still blurry.
His last visit with Dr. Braunstein was a                                  K2-9505
couple of weeks prior to the trial.76
The Plaintiff remains under                                                  The Luntz-Dod
                                                                                              ick Punch feat
                                                                            for easy inserti                   ures a bullet
Dr. Braunstein’s care. The physician told                                                    on. Its angled                  shaped tip
                                                                            to engage the                      cutting edge is
him that he could expect a maximal                                                        scleral lip at th                     designed
                                                                           of tissue. The                   e base and cut
                                                                                            tip may be pr                  0.5mm bites
cure 1 year postoperatively and that                                       directions and                   eset to cut in
                                                                                                                           one of four
                                                                                           will not rotate
the stitches could stay in for that time.                                  easily disassem                   while cutting tis
                                                                                                                               sue. It is
                                                                                           bled for clean
Mr. Schiffer said that his eye will never                                                                  ing after each
be normal again and that it will always
be at risk of a ruptured globe due to
disease and of rejecting the tissue.77
   The Plaintiff characterized his pre-
LASIK vision as normally blurry but
correctable with contact lenses or
spectacles. He described his current
vision as severely distorted. He said                                                idutSrpueecnuthleulobe
                                                                    Screhraottlits Litho p ess r o     g
                                                                        t c dw
he tries to avoid driving and stated                                                                                                          5
that he cannot read signs. He said                                   to
he does not recognize people at                                                                                                    up and
                                                                                                                          fts them
the distance normal people do and                                                                                t also li retraction and
                                                                                                         lids bu
                                                                                                 cts the            oth the          tient.
that his trouble seeing facial expres-                                                   ly retra al pressure. B ed for each pa
                                                                                  not on     extern            requir
                                                                       n speculum     te any             ly as
sions negatively affects his interac-                          al actio be to elimina           separate
                                                      This du           lo              trolled
tions with people. He asked his wife                            om the g lid can be con
                                                      away fr          ach
that morning to verify if he had                               ing of e
                                                       the lift
missed any spots while shaving.78
   Mr. Schiffer plans to attend Rand                                                                          4 Stewart Court
                                                                                                              Denville, NJ 07834 • USA
Institute’s doctoral program in pub-
lic policy in September 200579 [end             ☎ 973- 989-1600 • 800-225-1195 • Fax 973- 989-8175 • •
of day 4].
            Anatomy of a Lawsuit II

     Cross Examination by Counsel for                             that both night vision and refractive problems were
     Dr. Speaker                                                  possible. He was informed that over- or undercorrec-
        In 1993, Mr. Schiffer sustained an injury that ripped     tions were possible and that imbalanced vision could be
     through his sinus cavity, fractured his left orbit, and      problematic. The form stated he might require specta-
     required surgery with a titanium plate. His brain was her-   cles or contact lenses after surgery. The Plaintiff was also
     niated and contused. A nerve in the left side of his fore-   informed that further surgery carried additional risks
     head was severed, resulting in a permanent loss of sensa-    and that its outcome was not guaranteed. The form
     tion and a partial loss of movement. He said the event       noted that a severe potential complication was corneal
     did not permanently affect his earning potential. He         perforation and that irregular astigmatism was possible.
     admitted suing the Dix Hill Diner—where the injury took      The Plaintiff was further informed of the possibility of
     place—and others in 1995 and claiming $10 million in         unanticipated or rare complications, and the informed
     damages relating to his lifetime employment. The claim       consent stated that the procedure’s long-term effects
     was based on his inability to achieve Phi Beta Kappa sta-    might not be known or expected when he underwent
     tus as a college sophomore by maintaining a 4.0 GPA and      surgery. He also admitted the informed consent stated
     his inability to participate in a Master’s program at Yale   that a corneal transplant might be necessary and that
     simultaneously with his Bachelor’s program.80                complete or partial vision loss was possible. He volun-
                                                                  tarily signed the informed consent.82
                                                                     Mr. Schiffer testified that he has a New York State dri-
          “[Mr. Schiffer] admitted the informed                   ver’s license on which no visual limitations are stated. He
         consent stated that a corneal transplant                 said he feels safe driving to work each day, a distance of
                                                                  about 30 miles. He arrives between 9:00 and 9:30 AM and
        might be necessary and that complete or                   departs between 6:00 and 7:00 PM. He also testified that
            partial vision loss was possible. He                  he drove a vehicle to court on Friday and that Dr. Amoils
        voluntarily signed the informed consent.”                 rode with him as a passenger83 [end of day 5].

                                                                  Alan Johnson, Plaintiff’s Compensation Expert
        He admitted being notified in writing by TLC that the     Testified July 19, 2005
     only way in which to avoid all surgical risks was not to     Direct Examination by Counsel for Plaintiff Mark Schiffer
     have the procedure. He also admitted that he initialed          A compensation consultant, Mr. Johnson and his
     this area of the informed consent. He read the form’s        company serve major corporations. They advise com-
     general descriptions of LASIK and PRK. Prior to under-       panies on salary structures, incentive plans, property
     going LASIK, he was aware of the alternatives to the         sharing, and equity.84 He was asked to perform a career
     procedure, including glasses, contact lenses, and PRK.       income analysis for the Plaintiff.85 He calculated the
     He knew there were contraindications to LASIK. He            present value of Mr. Schiffer’s projected income on
     declined monovision. He acknowledged that approxi-           Wall Street at $17.6 million, going back to 2002.86 He
     mately three pages of the informed consent were devot-       based this calculation on two possible career paths—a
     ed to complications and that he initialed the form. He       typical one, the completion of which was 70% likely,
     was notified in writing of the refractive, flap-related,     and an accelerated one, which had a 30% probability.87
     corneal healing-related, and other complications. The        In the case of the latter, the estimated figure was $20.7
     informed consent described the possibilities of foreign      million versus $16.2 for the former, an average career
     body sensation, pain, and discomfort postoperatively.        path for a managing director.88 The present value of the
     The form also listed the complications of light sensitivi-   Plaintiff’s total expected earnings at Rand (eg, in acade-
     ty, blurred vision, ocular dryness, tearing, and fluctua-    mia) was $4.3 million.89 Mr. Johnson estimated that the
     tions in vision. Persistent pain, although uncommon,         Plaintiff had lost income from 2002 to the time of the
     was also included and noted to indicate a possible           trial in the amount of $500,000.90 He further projected
     problem with the epithelium. Mr. Schiffer was further        that the future lost income would total $12.8 million.91
     informed about the possible displacement of the cor-            Mr. Johnson said that, if Mr. Schiffer made a full re-
     neal flap and potential infection, and he was instructed     covery within 1 year of the transplant and were able to
     to contact the physician if the latter occurred.81           return to investment banking, he would have a hard
        In addition, the informed consent indicated that          time resuming a career in the field because his skills
     steroid treatment and further surgery might be needed.       are out of date and the field is competitive. He would
     It stated that his vision might not be fully restored and    need to start at ground level.92

William Tullo, OD
Sworn testimony read into the trial
record by Counsel for Plaintiff Mark
Schiffer on July 19, 2005, from a
transcript of his deposition on Octo-
ber 21, 2003
   When the Plaintiff arrived at
TLC’s Manhattan office for an en-
hancement on June 5, 2001, per-
fect distance vision was targeted
for both of the Plaintiff’s eyes.93 At
the time of that visit, Dr. Tullo was
TLC’s Clinical Director. He said
that, in October 2000, Dr. Speaker
was the most experienced LASIK
surgeon affiliated with TLC’s Man-
hattan office.94 Dr. Tullo noted in
writing that the enhancement was
canceled and the patient referred
for Orbscan topography due to
possible ectasia, worse in the left
eye than the right.95
   Referring to Mr. Schiffer’s chart,
Dr. Tullo said that the Plaintiff un-
derwent a LASIK screening at
Dr. Resnick’s practice in September
2000 as well as additional screen-
ing examinations at TLC by tech-
nicians and possibly Dr. Speaker
on the operative day (October 6,
2000). In his chart were also a pa-
tient history form completed by
the Plaintiff on October 6, 2000,
and a topographic map from TLC
performed on that date with the
Humphrey Atlas topographer
(Carl Zeiss Meditec Inc., Dublin,
CA) (Table 1). A preoperative
topographic examination of all
surgical patients is routine, he said,
as a means of disqualifying anyone
who has a contraindication for the
procedure. One of these is ectasia,
and another is keratoconus.96
   Dr. Tullo said that TLC’s topog-
raphy of the Plaintiff’s eyes on
October 6, 2000, showed astigma-
tism, to a greater degree in his left
eye than his right. It also demon-
strated some ocular dryness and
mild irregularity bilaterally. He said
                                                                                   Anatomy of a Lawsuit II

some inferior corneal steepening was present in the             Group had referred Mr. Schiffer.104 Dr. Speaker per-
Plaintiff’s left eye, with a curvature of approximately         formed bilateral LASIK on Mr. Schiffer’s eyes on October
50.00D. Although the topographic map taken at TLC on            6, 2000, the date when they first met. The surgeon’s role
June 5, 2001, was not worse than the earlier one taken          was to review the patient’s preoperative data and to
there in October 2000, Dr. Tullo still thought an under-        perform the operation. Dr. Speaker reviewed the form
lying condition might contraindicate further surgery.97         filled out by Mr. Schiffer, the preoperative examination
He said the topographic map dated June 1, 2001, from            form submitted by the Farkas Group, and the informa-
Dr. Resnick’s practice differed from that taken at TLC in       tion obtained that day at TLC prior to the surgery. He
October 2000, because they were taken with two differ-          evaluated the Plaintiff preoperatively as well at the slit
ent machines and thus cannot be compared.98                     lamp. Other preoperative testing by TLC on that date
                                                                included a refraction, pachymetry measurements, sco-
Todd Buchholz, Plaintiff’s Economist                            topic pupillometry, and topography.105
Testified July 19, 2005
Direct Examination by Counsel for Plaintiff Mark Schiffer
  Mr. Buchholz is an economist who is self-employed by              “Dr. Speaker normally did not record
Victoria Capital.99 He was asked at the end of 2004 to
calculate the earnings lost by Mr. Schiffer due to his                his slit-lamp examination unless he
medical condition. His analysis was based on two possi-
ble scenarios, a typical and an accelerated career on                     found something abnormal.”
Wall Street for investment banking. On a typical career
track, the Plaintiff’s estimated peak earnings were
$740,000 per year.100 Mr. Buchholz testified that, by              The screening criteria were no different for patients
2032, this amount would have risen to $32,068,661. If           referred to TLC than for those he saw for the first time in
Mr. Schiffer had followed an accelerated career path,           his office. He said contraindications included kerato-
Mr. Buchholz estimated he would have earned                     conus, clinically significant dry eye, glaucoma, active her-
$43,686,950 in his lifetime. Based on probabilities,            pes simplex virus, corneal scars, excess corneal neovascu-
Mr. Buchholz estimated Mr. Schiffer’s lifetime earnings         larization, acute or chronic ocular inflammation, abnor-
would have been $35,458,000.101 He calculated lost              mal corneal thinning, retinal detachment or edema, reti-
earnings due to the shift to working in academics               nal complications from diabetes mellitus, hypertension,
instead of on Wall Street to be $26,753,332.102                 and acute blepharoconjunctivitis. Dr. Speaker stated that,
                                                                based on the aforementioned materials, Mr. Schiffer had
Mark Speaker, MD                                                no contraindications to LASIK.106 Dr. Speaker said that, in
Called to testify as a witness by the Plaintiff. Sworn testi-   the year 2000, keratoconus would have been a contra-
mony read into the trial record by Counsel for Plaintiff        indication for LASIK, because the surgery could further
Mark Schiffer on July 19, 2005, from the deposition tran-       destabilize the cornea.107 He did not suspect kerato-
script of Dr. Speaker taken on November 10, 2003                conus at that time, and he ruled out the condition by
  Dr. Speaker was board certified in ophthalmology in           examining the patient and reviewing the data. He found
October 1987. He ran the cornea section of the AAO              no evidence at the slit lamp of abnormal corneal thin-
Program Committee. He was employed at the time of               ning, Vogt’s striae, a Fleischer ring, or a disruption of
his deposition by Laser and Corneal Associates, which           Bowman’s membrane. Dr. Speaker also looked at the
has the same physical location as TLC but a different           topography, pachymetry, refractive, and keratometry
address. Dr. Speaker specializes in diseases and surgery        readings (Table 1).108
of the cornea, including LASIK. In 2000, he performed              Dr. Speaker normally did not record his slit-lamp ex-
LASIK annually on approximately 1,000 patients, 2,000           amination unless he found something abnormal. He did
eyes. He estimated that about 40% of his professional           not know when the Farkas Group sent its topography
time was spent on LASIK procedures. The rest of his             from September 2000 to TLC. He did not recall seeing
time was spent seeing patients and performing corneal           that measurement prior to performing LASIK.109
transplants.103                                                    Dr. Speaker testified that every patient’s topography is
  Dr. Speaker said he referred patients to the Farkas           measured on the day of surgery at TLC. The Plaintiff’s
Group for contact lens fittings. He stated that the             measurement was taken at 10:03 AM on October 6, 2000.
Farkas Group referred patients to TLC and to Laser and          He reviewed this map before performing surgery. He said
Corneal Associates for consultation and that the Farkas         that the topography of Mr. Schiffer’s right eye was normal

                                                                        OCTOBER 2005 I CATARACT & REFRACTIVE SURGERY TODAY I 93
            Anatomy of a Lawsuit II

     with some spots of possible drying, whereas the left eye        eye. Dr. Speaker asserted that, if he had wanted to rule
     showed some asymmetry. He stated that the asymmetry             out corneal thinning in Mr. Schiffer’s eyes, the only
     could have been due to corneal warpage from a contact           pachymetry measurement he would have taken was at
     lens, keratoconus, a dry ocular surface, improper fixation      the cornea’s center. He said a normal reading is approxi-
     by the patient, or irregularity of the corneal surface. To      mately 525µm. The Plaintiff’s measurement was 595µm,
     rule out keratoconus, Dr. Speaker would consider the            which Dr. Speaker characterized as “unusually thick” and
     patient’s history of wearing contact lenses, his pachymetry     said was thicker than for 95% of patients. This reading
     readings, the refraction, the slit-lamp examination, and        meant he was a good candidate.113
     the overall corneal power. He did not recall the specifics         The data Dr. Speaker entered regarding the spherical
     of the Plaintiff’s history of contact lens wear or what ques-   correction for the Plaintiff’s left eye were based on data
     tions he asked about Mr. Schiffer’s lens wear.110               provided by Dr. Resnick or Zyszkowski and the refrac-
                                                                     tion at TLC. Dr. Speaker customarily examines patients
          “If he had wanted to rule out corneal                      at the slit lamp before they leave after surgery, so he
                                                                     would have done so with Mr. Schiffer, although he did
            thinning in Mr. Schiffer’s eyes, the                     not specifically remember it.114 He next saw the Plaintiff
              only pachymetry measurement                            on June 5, 2001, when he was referred by the Farkas
           [Dr. Speaker] would have taken was                        Group for a retreatment. Dr. Speaker stated that ap-
                                                                     proximately 5% of the patients he saw in 2000 required
                  at the cornea’s center.”                           an enhancement.115
                                                                        He did not know if Mr. Schiffer presented with forme
        Dr. Speaker stated that there was no indication that         fruste keratoconus on October 6, 2000. Dr. Speaker tes-
     the patient had fixated improperly for the October 2000         tified that, if a physician suspects a patient has kerato-
     topography. He explained that a contact lens can cause          conus, he should not perform surgery. He said that, on
     a thickening of the epithelium that produces corneal            the color topography taken on October 6, 2000, the
     asymmetry and that he had examined Mr. Schiffer at the          measurements were not suggestive of keratoconus in
     slit lamp to rule out this potential cause of asymmetry.        and of themselves. Dr. Speaker said that keratometry
     He made no notation about epithelial thickening, but            readings greater than 50.00D raise the possibility of ker-
     this omission does not mean that there was no apparent          atoconus but added that this number is an arbitrary
     thickening. Dr. Speaker said it is difficult to determine at    cut-off he uses.116
     the slit lamp if one quadrant of the corneal epithelium is         An informed consent was part of the patient’s
     thicker than another. He said there is no other test to         chart. Dr. Speaker did not recall what he and the
     rule out the presence of such a condition.111                   Plaintiff discussed preoperatively. Dr. Speaker said fur-
        In October 2000, Dr. Speaker routinely examined              ther informed consent would be merited if he
     LASIK candidates at the slit lamp prior to surgery. He          thought a patient were a poor or high-risk candidate
     did so for all patients, although he did not specifically       or had medical conditions predisposing him to an
     recall Mr. Schiffer’s examination. Regarding Mr. Schiffer’s     unusual result. He said Mr. Schiffer fit none of these
     color topography from October 6, 2000, the possibility          descriptions.117
     of keratoconus was indicated by greater steepening in-             Eight months postoperatively, looking at a copy of
     feriorly than superiorly. The color scale on the diagram        the procedural planning form from June 2001 for
     showed the number of diopters of steepening at a par-           Mr. Schiffer, Dr. Speaker thought the handwriting was
     ticular location on the cornea. The simulated keratome-         Dr. Tullo’s. Dr. Speaker said that Dr. Tullo’s reference to
     try values were 48.75D at 76º and 46.50D at 166º. He            an Orbscan secondary to possible ectasia meant that
     said the color topography showed more steepening in             either he or they wanted to evaluate the patient’s cor-
     the lower versus upper part of the map, as shown by             nea further. He said that the enhancement would not
     the areas of red. The presence of nine red areas below          have been canceled without Dr. Tullo’s discussing it with
     compared with one above indicated that the patient              him, so the decision for an Orbscan was theirs.117
     had a warped cornea, keratoconus, poor fixation, or a              Dr. Speaker did not know to which institution
     dry cornea.112                                                  Mr. Schiffer was referred for the Orbscan topography.
        Based on the Plaintiff’s chart, Dr. Speaker did not see      He was not aware of communication between Dr. Tullo,
     any pachymetry measurement from the Farkas Group.               TLC, and the Farkas Group on or after June 5, 2001.118
     He said that pachymetry readings were taken at TLC on              The Plaintiff’s enhancement was canceled, because
     October 6, 2000, and were in the Plaintiff’s chart for each     Drs. Speaker and Tullo felt the examination contraindi-

cated further treatment. Dr. Tullo
performed a refraction, measured
topography, and conducted a slit-
lamp examination. Dr. Speaker
was sure he had also examined
Mr. Schiffer on June 5, 2001,
although he had made no notes to
that effect, because he could not
imagine canceling the enhance-
ment without doing so. He said he
had never canceled a patient on
Dr. Tullo’s say so. He made no
notes on the examination because
he had had nothing to add.119
   Dr. Speaker stated that the plan-
ning form for the patient’s right
eye was incomplete as regards the
keratometry. Dr. Tullo’s findings
from his slit-lamp examination
were not noted. Dr. Speaker said he
knew Dr. Tullo had performed the
examination because the enhance-
ment would not otherwise have
been canceled. Dr. Speaker noted
that the increased astigmatism was
another sign that further surgery
was inappropriate. The increase, as
evident on the refraction, was con-
sistent with ectasia, he said. He did
not see any pachymetry readings
noted in June 2001 and did not
recall their being ordered.120
   Dr. Speaker said that corneal
thinning would have been evident
to him and Dr. Tullo at the slit
lamp in June 2001 but that none
was evident in October 2000. He
did not know what had caused
the thinning but concurred that,
if Mr. Schiffer had keratoconus in
October 2000 and underwent
LASIK, ectasia might have been
apparent in June 2001. He said a
gene for keratoconus or eye rub-
bing could have predisposed the
Plaintiff to ectasia. Dr. Speaker did
not know who ordered the topog-
raphy taken in June 2001 but was
certain he had reviewed it on that
day, although he did not recall
doing so. He said the topography
of the patient’s left eye represent-
            Anatomy of a Lawsuit II

     ed an improvement over the one taken in October                 College of Medicine after 6 years. He completed his
     2000 in that less asymmetry and steepness were pres-            internship in 1983 at Columbia Presbyterian in general
     ent. Additionally, the simulated keratometry numbers            surgery, and his 3-year (1983 to 1986) ophthalmology
     had decreased, and the color topography was less sus-           residency was at the New York Eye and Ear Infirmary.126
     picious for keratoconus than the earlier one.                   He has served as an investigator in FDA-sponsored clini-
     Dr. Speaker suspected keratoconus in June 2001, based           cal trials of numerous lasers.127 Dr. Speaker specializes in
     on the slit-lamp examination. He said that the Plaintiff        corneal and refractive surgery and cares for patients
     was not a keratoconus suspect in October 2000121                with corneal disease. He has performed corneal trans-
     (Table 1) [end of day 6].                                       plants and probably has 1,000 keratoconic patients in
                                                                     his practice.128
     Regina Zyszkowski, OD
     Called to testify as a witness by the Plaintiff. Sworn testi-
     mony read into the trial record by Counsel for Plaintiff
     Mark Schiffer on July 20, 2005, from her deposition tran-                “[Dr. Speaker] testified it was
     script taken on November 21, 2003                                    inaccurate to say inferior steepening
       Dr. Zyszkowski was employed by Drs. Farkas,                         on corneal topography is a bulge.”
     Kassalow, and Resnick in 2003. She recalled first meeting
     the Plaintiff on September 29, 2000, and that he visited
     her because he was interested in having LASIK. She
     specifically chose to refer him to Dr. Speaker, because            He disagreed with Dr. Amoils’ testimony regarding his
     she thought he had access to the laser best suited in           interpretation of the topographic maps taken of the
     2000 for treating astigmatism.122 She thought the               Plaintiff. Dr. Speaker stipulated that curvature maps
     Plaintiff was a candidate for LASIK, except for the reti-       only measure localized curvature but cannot determine
     nal findings and the need to find out more regarding his        elevation. He said that they cannot identify a bulge in
     orbital fracture.123                                            the cornea and that elevation topography could in the
       Dr. Zyszkowski was trained at the time to recognize           year 2000 by means of Orbscan topography. He testified
     keratoconus, and she testified that Mr. Schiffer did not        it was inaccurate to say inferior steepening on corneal
     present with the condition in September 2000 and was            topography is a bulge.129
     not a keratoconus suspect. Her opinion was based on                In his experience, Dr. Speaker said, approximately one-
     the biomicroscopy she performed. Her findings from              third of the general population who have corneal to-
     September 29, 2000, were recorded in the patient’s              pography exhibit inferior steepening and as many as
     chart.124                                                       15% of patients meet the criteria for forme fruste kera-
       At the conclusion of the visit, Dr. Zyszkowski said she       toconus in the general population. Dr. Speaker stated
     would have proceeded with scheduling a date for the             that forme fruste keratoconus is a controversial diagno-
     LASIK procedure, which may have been done that day              sis but, as defined by Dr. Amoils, involves a normal
     or later. He would have received a copy of the informed         cornea with inferior steepening on topography. Accord-
     consent to read at his convenience and her card so that         ing to Dr. Speaker, saying that inferior steepening is a
     he could contact her with any questions.125                     bulge and evidence of forme fruste keratoconus is a
                                                                     contradiction, because, as noted by Dr. Amoils, there is
     Plaintiff Rests Its Case at the Conclusion of                   no bulge in this form of keratoconus. In clinical kerato-
     Testimony by Regina Zyszkowski, OD, on July 20,                 conus, bulging may be present for advanced disease but
     2005                                                            cannot be diagnosed with curvature topography130
     Defense Presents Its Case Commencing With the                   [end of day 7].
     Direct Testimony of Mark Speaker, MD, on July 20,                  Dr. Speaker first saw Mr. Schiffer on October 6, 2000.
     2005                                                            He signed the patient’s chart to indicate that he had
                                                                     reviewed all of its data as well as the surgical plan and
     Mark Speaker, MD, Defendant                                     that everything in the chart was in accord with his
     Testified July 20 and 22, 2005                                  plan for the patient and his observations.131 Moreover,
     Direct Examination by Counsel for Dr. Speaker                   Dr. Speaker examined the patient at the slit lamp and
       Dr. Speaker’s business address is in New York. He             with a pachymeter, the latter of which produced meas-
     holds a B.S. in physics from Brown University, and he           urements of 590µm OD and 595µm OS (Table 1).
     completed an MD/PhD program at Albert Einstein                  Dr. Speaker said the average pachymetry for the general

            Anatomy of a Lawsuit II

     population is 525µm. He found the Plaintiff to be a low          retinoscopy, and a dilated fundus examination. Some of
     myope with a normal BCVA, pachymetry measure-                    the information from the Farkas Group was duplicated
     ments higher than normal, and a normal slit-lamp ex-             at TLC on October 6 such as the refraction and slit-
     amination. The patient’s retinoscopy and fundus exami-           lamp examination. This testing was repeated because
     nation with Dr. Zyszkowski were normal. Dr. Speaker              Dr. Speaker’s policy is not to perform surgery on any
     spoke with the Plaintiff prior to surgery, and the latter        patient with only one set of data. He did not recall ever
     reviewed the informed consent. Dr. Speaker testified             seeing the topography from the Farkas Group dated
     that he reviewed the data with Mr. Schiffer and asked if         September 29, so he could not say he had relied on it.138
     he had any questions and if he understood the in-
     formed consent. Any specific abnormalities or concerns           Cross Examination by Counsel for Plaintiff Mark Schiffer
     he has about a patient’s prognosis he notes on a com-               Asked to compare the topographies of the patient’s
     ment sheet.132                                                   left eye from September 29 and October 6, Dr. Speaker
        Dr. Speaker created LASIK flaps in the Plaintiff’s eyes       said they were qualitatively similar. Both reflected inferi-
     that were 130µm thick. The treatment removed 48.7µm              or corneal steepening. He said the one from TLC taken
     of tissue. The residual stromal bed in each eye was thick-       on October 6 showed irregular astigmatism but the one
     er than 400µm.133                                                from Dr. Resnick’s group did not.139
        Dr. Speaker testified that the Plaintiff was not at risk of
     ectasia due to his level of myopia in either eye. The pa-
     tient’s topography did not make LASIK inappropriate in               “In October 2000, Dr. Speaker ... did
     October 2000. He said asymmetric topography with infe-               not consider Orbscan topography to
     rior steepening was a common presentation, and he esti-
     mated operating on at least 750 eyes like that with no               be reliable for the diagnosis of forme
     complications.134 As a result, he did not have a duty to                      fruste keratoconus.”
     inform the Plaintiff that he was not a suitable candidate
     for LASIK, because his examination was normal and there
     was no evidence of keratoconus from his clinical exami-             In October 2000, Dr. Speaker did not believe the
     nation. As a corneal specialist, Dr. Speaker said, he would      Plaintiff needed an Orbscan.140 At that time, he did not
     have been able to identify the condition and, in such a          consider Orbscan topography to be reliable for the
     case, would have said LASIK was contraindicated.135              diagnosis of forme fruste keratoconus. His purpose in
        He said that the dominance of the patient’s right eye         ordering Orbscan topography for the patient on June 5,
     was significant, because individuals principally view            2001, was not to determine if the patient had kerato-
     things with their dominant eye. Mr. Schiffer’s right eye         conus, among other things. At that time, he did not
     was dominant, and the nondominant eye was the one                know whether the technology was reliable. He con-
     that developed ectasia.136                                       firmed his disagreement with Dr. Amoils’ testimony that
                                                                      the topography from October 6, 2000, at TLC demon-
     Cross Examination by Counsel for TLC Laser Eye Center            strated forme fruste keratoconus in the Plaintiff’s left
       Dr. Speaker said that technicians are not responsible          eye. He confirmed that he had testified that some peo-
     for interpreting diagnostic testing. He is, and he did not       ple used software to calculate the inferior/superior val-
     have anyone else interpret the Plaintiff’s corneal topog-        ues as Dr. Amoils did and that some used it to screen
     raphy in October 2000.137                                        for keratoconus in October 2000.141
                                                                         Dr. Speaker did not agree that, in 1999, forme fruste
     Cross Examination by Counsel for Drs. Zyszkowski, Farkas,        keratoconus could be identified on preoperative topog-
     Kassalow, and Resnick                                            raphy.142 He was familiar with the contraindication list-
        Dr. Speaker performed Mr. Schiffer’s LASIK evaluation         ed by the laser manufacturer in October 2000 or before
     and decided whether or not to proceed with LASIK on              that LASIK was contraindicated in patients with signs of
     October 6, 2000. He testified that “The final decision is        keratoconus, but he said the Plaintiff did not present
     always mine.” In performing his evaluation, he relied on         with signs of this condition at that time.143
     data collected at TLC on that day (October 6, 2000)                 According to the Plaintiff’s chart, Dr. Speaker first met
     and the clinical examination he performed. He also               Mr. Schiffer on October 6, 2000. Dr. Speaker did not
     relied on information collected by the Farkas Group,             specifically remember whether he inquired about a his-
     specifically the results of the comprehensive examina-           tory of contact lens wear at that visit. He confirmed that
     tion, which included a refraction, slit-lamp examination,        he had made no notes at that time but reiterated that

his signature on the operative                                                                          from Katena
form indicates he performed a
preoperative slit-lamp examina-
tion. Dr. Speaker also confirmed           Corneal Dissectors
that he had not noted his review           K2-3660 angled, straight blade
of the patient’s color topography          K2-3661 angled, curved blade
taken at TLC on the morning of             12mm long x 3mm wide
surgery. He did not recall how long        semi-sharp spatulated tip                   K2-3660                  K2-3661
he spent with the patient preoper-         For intrastromal dissection.
atively, who scheduled the surgery,
or for what time it was scheduled.
He neither recollected whether he
had performed a slit-lamp exami-
nation on June 5, 2001, the day on         Rosenwasser Shovel
which the enhancement was to               K3-4260                                                  K3-4260
have occurred, nor had he made             8mm long x 4mm wide
any notes of performing the exam-          with retaining rim on 2 sides
ination. He said that he had no            For insertion of the
specific memory of performing              donor lamella.
the slit-lamp examination on
October 6, 2000, or of reviewing
the color topography that day. He
expressed familiarity with the             DLEK Manipulators
phrase if it’s not in the notes, it did-   K3-5000 Z-hook
n’t happen144 [end of day 9].              0.15mm diameter with blunt tip
                                           K3-5002 Reversed Sinskey
Edward John Holland, MD,
                                           0.2mm diameter with blunt tip
Defendant’s Expert                                                                      K3-5000                 K3-5002
Testified July 21, 2005                    For manipulation of the
Direct Examination by Counsel for          donor lamella.
Dr. Speaker
   Dr. Holland is from Union, Ken-
tucky. He is an ophthalmologist            Rosenwasser Scissors
who specializes in the cornea and          K4-2041                                                    K4-2041
corneal disease. He has an active          Long blades with medium curve
surgical practice that included
LASIK in the year 2000. The Court
                                           Long blades with strong curve
recognized him as an expert in
ophthalmology, specifically cor-           For excision of the                          K4-2042
neal and refractive surgery.               internal lamella.
Dr. Holland reviewed materials
provided by Counsel for
Dr. Speaker, including the records
from TLC, Dr. Zyszkowsi’s group,           Barron Disposable Artificial
Columbia Visual (where                     Anterior Chamber
Mr. Schiffer’s transplant was per-
formed), and his current ophthal-          K20-2125 sterile, disposable
mologist as well as depositions and        To safely retain and inflate the donor
trial testimony in the case. Asked if      cornea in preparation for dissection.
Mr. Schiffer had forme fruste kera-
toconus based on the topography
from October 2000, Dr. Holland
                                                    4 Stewart Court, Denville, NJ 0783 4 • USA 973-989-160 0 • 80 0-225-1195
                                                    F A X 973-989-817 5 • w w • email
            Anatomy of a Lawsuit II

     said he could not diagnose forme fruste or early kerato-       rior elevation map, not available in 2000, there was no
     conus from topography alone. He stated that a diagnosis        evidence of ectasia in the Plaintiff’s right eye. Based on
     of early keratoconus involved clinical findings and an         the medical records, the surgical outcome, and his expe-
     extensive examination, of which topography is one              rience treating patients who have had a corneal trans-
     part.145                                                       plant, Dr. Holland saw no indication that Mr. Schiffer
        From his review of the records and clinical findings        would ever require a transplant in that eye.149
     preoperatively, Dr. Holland saw no evidence of kerato-            Dr. Holland has patients who have undergone surgery
     conus and thought Mr. Schiffer was a suitable candidate        such as a corneal transplant and determines, based on
     for LASIK in October 2000. He stated that none of the          visual function, if they can return to certain occupa-
     Defendants had deviated from the standard of care in           tions, such as driving, flying a plane, or operating ma-
     screening the patient or performing LASIK surgery. His         chinery. He stated that the Plaintiff had a visual acuity
     opinion was based on the examinations and descrip-             of 20/50 and 20/70 without correction. His degree of
     tions of the doctors. He thought Mr. Schiffer’s eye was        myopia was low and correctable to 20/25 OD with
     normal except for myopia and astigmatism. Dr. Holland          glasses. The BCVA of the patient’s left eye was 20/40.
     said Mr. Schiffer showed no pathological findings for          Based on his review of the Plaintiff’s visual acuity, chart,
     keratoconus; specifically, no breaks in Bowman’s layer         examination, and topography, Dr. Holland testified that
     were visible on biomicroscopy. He stated that inferior         Mr. Schiffer would have no limitations on the vast ma-
     steepening was common and not a contraindication for           jority of occupations. He could not obtain a commer-
     LASIK in October 2000.146                                      cial truck license but could read, work on the computer,
        Dr. Holland estimated that, in 2000, approximately          and drive a car.150
     4 million patients in the US had undergone laser surgery.         Asked about Dr. Amoils’ testimony, Dr. Holland said
     By the middle or end of that year, he thought seven            there are three criteria for the analysis of topography but
     cases were in the medical literature worldwide about           that they were not the standard of care in 2000.151 Re-
     post-LASIK ectasia. Dr. Holland said the most common           garding informed consent, he said that Dr. Speaker had
     risk factor in the majority of those cases was a residual      no reason to discuss with the Plaintiff inferior corneal
     stromal bed of less than 250µm. Making the cornea too          steepening as a risk to surgical outcomes. Dr. Holland
     thin was the one risk factor of which surgeons were            based his opinion on the normal topography and the
     aware for this rare complication. In Mr. Schiffer’s case,      informed consent, which listed many complications. He
     the residual stromal bed was greater than 400µm.147            stated that, in 2000, there was no accepted standard of
        Dr. Braunstein diagnosed the Plaintiff with post-LASIK      care for pachymetry and that many ophthalmologists
     ectasia, which Dr. Holland said is not synonymous with         did not use it. He added that the Orbscan technology
     keratoconus. He said Dr. Braunstein had not diagnosed          was evolving and that few of the machines were avail-
     the patient with keratoconus. Dr. Holland added that           able. Dr. Holland stated that a corneal transplant of
     the Plaintiff had not had keratoconus and did not have         8.5mm [the size of Mr. Schiffer’s graft] is typical.152
     forme fruste keratoconus, based on his record. He noted           Dr. Holland said the standard of care is how the ma-
     that, after 2003, multiple enhancements were described         jority of physicians manage patients. Disagreeing with
     as a risk factor for ectasia but that the Plaintiff had only   Dr. Amoils’ testimony, he asserted that single case re-
     undergone one procedure in each eye. Dr. Holland com-          ports, especially from outside the US, do not change
     mented that high myopia is a risk factor, but Mr. Schiffer     the standard of care for the average US physician.
     was a low myope. Dr. Holland was not aware of any              Rather, he said that the standard of care typically
     other risk factors known today for post-LASIK ectasia.148      changes over time owing to controlled, comparative,
        Based on his review of Mr. Schiffer’s Orbscan topogra-      prospective studies for review in the literature by re-
     phy from June 7, 2001, and other data, Dr. Holland said        spected clinicians.153
     the Plaintiff did not have post-LASIK ectasia in his right        He acknowledged that Drs. Rabinowitz and
     eye. He said that curvature maps do not allow a diagno-        McDonnell’s first criterion was a central cornea power
     sis of corneal bulging, whereas the Orbscan topographer        greater than 47.00D but said that it “was not accepted
     reveals elevation of the front and back of the cornea. He      as a standard of care to diagnose forme fruste or early
     said that some investigators hold that a posterior eleva-      keratoconus” in the year 2000. Dr. Holland said that
     tion of the cornea greater than 40 to 50µm is indicative       many patients have K readings of 47.00 to 49.00D and
     of ectasia and that Dr. Amoils had written as much.            are considered normal.154 Dr. Holland acknowledged
     Dr. Holland said the Plaintiff’s posterior elevation of        that Drs. Rabinowitz and McDonnell’s second criterion
     30µm was within normal limits. According to the poste-         was a difference of 3.00D or more in corneal power

                                                                                Anatomy of a Lawsuit II

between 0.4mm above and 3mm below. He did not                 November 8, 2003, of a partial Fleischer ring but said he
agree that this criterion constituted the standard of care    was not surprised. He said the finding did not support
in 2000, however. He said many patients have an abnor-        that the Plaintiff had keratoconus after laser surgery.160
mal inferior/superior ratio but have a normal examina-
tion and normal LASIK. He has operated on such indi-
viduals, and they have done well.155                                 “Dr. Holland saw no evidence of
   Dr. Holland also said that Drs. Rabinowitz and
McDonnell’s third criterion of asymmetry between the              keratoconus and thought Mr. Schiffer
central corneal power of an individual’s eyes was not part        was a suitable candidate for LASIK in
of the standard of care for pre-LASIK evaluation in 2000.
                                                                  October 2000. He stated that none of
He stated that differences between eyes are common,
including as regards corneal curvature and the degree of           the Defendants had deviated from
myopia. He asserted that Dr. Rabinowitz later dropped             the standard of care in screening the
this criterion. Dr. Holland asserted that the doctors in
this case met the standard of care for the preoperative           patient or performing LASIK surgery.”
evaluation and treatment of the Plaintiff in 2000.156
Moreover, he stated that taking multiple pachymetry
readings was not the standard of care in 2000.157                Dr. Holland asserted that Orbscan topography was
                                                              not common in 2000, but he acknowledged that the
Cross Examination by Counsel for Drs. Zyszkowski, Farkas,     technology was available prior to 2003.161 Dr. Holland
Kassalow, and Resnick                                         expressed familiarity with Dr. Koch’s article19 and con-
  Dr. Holland disagreed with Dr. Amoils’ contention           sidered portions of the piece to be authoritative. He
that, in 2000, topography was the gold standard for           knows Dr. Koch and said he is well regarded and recog-
diagnosing keratoconus. The reason, he said, is that a        nized as authoritative in the field. He recalled Dr. Koch’s
corneal thinning disorder cannot be diagnosed based           recommendation to be wary of performing LASIK if the
on a curvature map but, rather, requires clinical findings    eye’s topography is abnormal. Dr. Holland did not be-
such as visual acuity, because most keratoconic patients      lieve that the Plaintiff’s topography from October 6 was
cannot achieve a BCVA of 20/20. Additional findings in-       abnormal for his left eye.162
clude an irregular reflex off the eye or off the retina in       Dr. Holland believed that pachymetry was the stan-
the form of an oil droplet sign when the pupil is dilated.    dard of care in October 2000, but he did not agree that,
Other findings at the slit lamp are corneal thinning,         at that time, it should have been performed centrally
cracks in Bowman’s layer, striae, and a Fleischer ring.       and at 3, 5, and 7mm paracentrally.163 Neither did he
He concurred that, when comparing the topography              agree that corneal topography is the gold standard for
performed by the Farkas Group in September 2000 and           diagnosing keratoconus164 [end of day 8].
an Orbscan topography, the latter more accurately de-
scribes the shape and dimensions of the cornea.158            William Tullo, OD
                                                              Testified July 25, 2005
Cross Examination by Counsel for Plaintiff Mark Schiffer      Direct Examination by Counsel for TLC Laser Eye Center
   When asked about a note by Dr. Braunstein dated               Dr. Tullo is familiar with the Ladarvision 4000 excimer
January 14, 2005, Dr. Holland said the doctor had diag-       laser (Alcon Laboratories, Inc., Fort Worth, TX) and knew
nosed keratectasia bilaterally but to a greater degree in     it was used for the LASIK procedures on Mr. Schiffer in
the Plaintiff’s left eye. He disagreed with both              October 2000, according to his chart.165
Dr. Braunstein’s and Dr. Margolis’ diagnosis of keratecta-
sia in the Plaintiff’s right eye.159                          Ken B. Carnevale, MD
   Referring to the topography taken in October 2000 at       Sworn testimony read into the trial record by Counsel for
TLC, Dr. Holland said asymmetric astigmatism with infe-       TLC Laser Eye Center on July 25, 2005, from a transcript of
rior steepening was present in the Plaintiff’s left eye. He   his deposition on June 24, 2004
said the topography was normal. Dr. Holland confirmed           Dr. Carnevale was a retina specialist employed by
that he does not think the patient had keratoconus            Ophthalmic Consultants of Long Island, where he be-
after laser surgery, based on pathological findings such      gan working in July 2000. Mr. Schiffer was referred to
as the absence of reports of breaks in Bowman’s layer.        him for evaluation. Dr. Carnevale did not recall treating
He stated that he was unaware of a finding at TLC on          him. He examined the patient on September 30, 2000.

                                                                     OCTOBER 2005 I CATARACT & REFRACTIVE SURGERY TODAY I 101
            Anatomy of a Lawsuit II

     Dr. Carnevale received a document from Dr. Zyszkowski         tive visit. Dr. Zyszkowski saw the patient for the first
     that listed her funduscopic findings and requested his        time postoperatively for his 1-week visit on October 13.
     evaluation of the patient’s retinas. She had referred him     His only medication was artificial tears. His UCVA meas-
     because of some abnormal findings in the peripheral           ured 20/20 OD and 20/4+2 OS. His next visit was to
     portions of both of his retinas. Dr. Carnevale was asked      have been on November 3. It was canceled and resched-
     to evaluate the patient to determine his candidacy for        uled for December 20, but this appointment was also
     LASIK, as stated by Dr. Zyszkowski.166                        canceled. Mr. Schiffer visited the office on January 26,
        Dr. Carnevale took the patient’s history, conducted a      2001, and his UCVA measured 20/25 OD and 20/25 OS.
     review of systems, evaluated his visual acuity, measured      She explained that the visual result for his left eye had
     his IOP, and examined the front part of his eyes, his         improved and said that, due to healing, the visual result
     pupils, his extraocular movements, and the inside of his      may not be immediately stable after surgery.172
     eyes. Dr. Carnevale found that the patient had areas of          She asked Mr. Schiffer to visit again for a 6-month
     peripheral degeneration bilaterally and lattice degenera-     visit, but he did not come to the office again until May
     tion in his right eye. He also found congenital hypertro-     16, 2001, approximately 7 months after surgery. At that
     phy of the retinal pigment epithelium of Mr. Schiffer’s       time, he complained that the vision in his left eye was
     left eye. The physician also noted the patient’s myopia.      off. She said his UCVA measured 20/30 OU, but his
     Dr. Carnevale concentrated his evaluation on the reti-        vision could still be corrected to 20/20. She stated that
     nas. At the slit lamp, he found that the patient had nor-     his left eye had some astigmatism and myopia, possibly
     mal eyelids, eyelashes, conjunctivas, scleras, corneas (all   due to striae, so she wanted it evaluated further. To
     five layers), and anterior chamber depths. He also noted      that end, she scheduled an enhancement, rather than
     the clarity of his crystalline lenses. He did not perform     another type of appointment, to make sure that the
     topography.167                                                surgeon and Dr. Tullo would evaluate the patient. She
        Rather than assess the patient’s candidacy for LASIK,      stated that referring to the visit as an enhancement was
     Dr. Carnevale evaluated his peripheral retinal lesions in     standard protocol.173 During the May visit, she also
     order to determine if he were at any risk of a retinal tear   dilated his eyes and examined his retinas and corneas.
     or detachment if he underwent LASIK. He did not iden-         Dr. Zyszkowski did not remember when she next saw
     tify any retinal contraindications to LASIK. His precurso-    Mr. Schiffer, but the record showed it was June 1.174
     ry evaluation of the patient’s corneas did not reveal ker-       On June 5, she recorded speaking with Drs. Speaker
     atoconus, so Dr. Carnevale did not give an opinion on         and Tullo. She stated that they indicated a 70% chance of
     whether or not the patient had the condition.168 When         an enhancement to the patient’s right eye but that they
     Dr. Carnevale wrote that the patient had no contraindi-       said they required more information. No enhancement
     cations, this assertion was limited to the retinal            was scheduled, but they would perform Orbscan topog-
     findings.169                                                  raphy. She did not have access to that device. On July 11,
                                                                   she measured the patient’s visual acuity. Some fluctua-
     Regina Zyszkowski, OD, Defendant                              tion in his prescription was evident between visits. His
     Testified July 25, 2005                                       visual acuity measured 20/20 OD and 20/30 OS.175
     Direct Examination by Counsel for Zyszkowski, Farkas,
     Kassalow, and Resnick                                         Defense Rests Its Case
        Dr. Zyszkowski first met the Plaintiff on September        Close of Trial Testimony
     29, 2000. She recalled his visit to her office, because she   Court Considers Pending Motions and Dismisses
     had not before encountered a patient with a previous          Dr. Zyszkowski and the Farkas Group as Defendants Prior
     facial fracture who was interested in laser treatment.        to Sending Case to Jury
     When she asked if she could obtain his earlier medical           Upon the conclusion of all testimony and before send-
     records or call a doctor of his for more information, he      ing the case to the jury, the trial judge made the finding
     said he could not find that out.170                           based on trial evidence that Dr. Speaker was ultimately
        The patient’s examination that day included autore-        the one to determine whether or not the Plaintiff should
     fraction and visual acuity testing. His UCVA measured         have had surgery, and the Court dismissed the claims
     20/300 OD and 20/150 OS. She said she would not have          against Dr. Zyszkowski and the Farkas group. The Court
     anticipated these acuities, because he had driven with-       recognized that, as an optometrist, Dr. Zyszkowski had
     out correction and the minimum acuity for driving is          limited responsibilities.176
     20/40. With correction, he saw 20/20 OU.171                      Stressing that the trial testimony showed that
        Dr. Resnick saw Mr. Schiffer for his 1-day postopera-      Dr. Speaker alone determined Mr. Schiffer’s candidacy for

                                                                                  Anatomy of a Lawsuit II

LASIK, the Court said that no evidence demonstrated             Peter C. Kopff, Esq—Counsel for Dr. Speaker
that TLC or any of its other employees controlled                 Counsel for Dr. Speaker stated that, if corneal steep-
Dr. Speaker’s actions or decisions regarding Mr. Schiffer       ening evident on topography of the Plaintiff’s left eye
on October 6 or earlier.177 Nevertheless, the Court ruled       caused ectasia, then one-third of the 4 million patients
that TLC would remain a defendant in the case, but not          who had undergone laser eye surgery by 2000 would
on the basis of vicarious liability.178                         have developed post-LASIK ectasia instead of the seven
                                                                individuals reported in the literature at that time.
Closing Arguments                                               Moreover, Attorney Kopff asked, “If their theory were
July 26, 2005                                                   correct that corneal steepening in the left eye is an
Ralph Catalano, Esq—Counsel for TLC Laser Eye Center            obvious sign of a problem you shouldn’t do LASIK,
   At issue, Counsel for TLC stated, were (1) whether TLC       how can they claim he got it in his right eye? He didn’t
held Dr. Speaker out as its employee and (2) whether            have any … steepening there.” Counsel further noted
Mr. Schiffer relied on that relationship when deciding          that Mr. Schiffer regularly drives 30 miles per day in rush
whether or not to undergo LASIK by that surgeon.179             hour and that he had driven himself and his expert wit-
Attorney Catalano stated that Dr. Speaker’s relationship        ness to court 1 week earlier.187
with TLC did not influence the Plaintiff’s choice of a            Attorney Kopff questioned how the Plaintiff could
LASIK surgeon.180 Counsel stated that the Plaintiff want-       not remember his salaries for various positions, the
ed the jury to disregard all but the topography,181             amount of interest he holds in his father’s company, or
although the topographic map only shows inferior steep-         the fact that he had sued another party for $10 million.
ening and is not of itself a contraindication for surgery.182   Counsel asserted that the Plaintiff had demonstrated
                                                                that his focus was not on investment banking.188
                                                                Attorney Kopff also stated that Dr. Amoils “has no aca-
                                                                demic standing in medicine.”189
       “Counsel for Mr. Schiffer asserted                         Counsel said, “There was no indication in 2000
       that Dr. Speaker ‘sold out patient                       accepted by any consensus that Mark Schiffer was not a
       care in pursuit of patient profit.’”                     proper candidate for LASIK.”190 Attorney Kopff stated,
                                                                “You can’t be held to a higher standard than what’s
                                                                known and accepted.”191

  Counsel asserted that the Plaintiff was not candid            Todd J. Krouner, Esq—Counsel for Plaintiff Mark Schiffer
about his orbital fracture and ensuing visual difficulties,        Counsel for Mr. Schiffer asserted that Dr. Speaker “sold
including blurred vision in his left eye.183 Attorney           out patient care in pursuit of patient profit” and that
Catalano stated Mr. Schiffer lacked any clinical signs of       “TLC is the McDonald’s of LASIK surgery.”192 Attorney
keratoconus.184                                                 Krouner also said that, due to their rush and high volume
  Counsel argued that Dr. Amoils “had an ax to grind            of patients, the Defendants had “ignored the clear and
against LASIK, and he had an ax to grind against                obvious warning signs on Mark Schiffer’s preoperative
Dr. Speaker.” Attorney Catalano added that, by “trashing        topography.”193 Referring to Dr. Speaker, Counsel said that
LASIK,” Dr. Amoils was attempting to increase the vol-          “even an outstanding professional can make a mistake”
ume of PRK surgery performed and thus the number of             and added that he is “held to the standard of care of that
his epithelial brushes sold. “Dr. Amoils never wrote            superior knowledge that he possesses.” Counsel stated
about a single thing he wasn’t selling,” Attorney               that Dr. Speaker had admitted to no recollection of per-
Catalano asserted.185                                           forming a slit-lamp examination on the Plaintiff. Fur-
  If Mr. Schiffer had left his job at Wasserstein due to        thermore, Attorney Krouner asserted that Dr. Speaker
ocular problems, this reason should have been on                never saw the topography and had proceeded with sur-
record with the firm, Counsel stated. Moreover,                 gery without properly screening the patient.194 Counsel
Attorney Catalano said that, thanks to the Americans            said, “Whatever the excuse, corneal warpage, dry eye,
with Disabilities Act, the Plaintiff could have requested       poor fixation, all the Defendants had to do was say, wait,
assistance. Counsel asserted that the Plaintiff’s vision        let’s do this again.”195
will not prevent him from doing or being what he                   Attorney Krouner said that Mr. Schiffer paid TLC for
wants. Attorney Catalano also said, “There is no truer          his LASIK procedures, that all of the preoperative forms
statement about medicine than there are risks and               were from TLC, and that the surgery occurred at TLC’s
there are no guarantees.”186                                    office. Counsel stated that the Plaintiff would reasonably

                                                                       OCTOBER 2005 I CATARACT & REFRACTIVE SURGERY TODAY I 103
               Anatomy of a Lawsuit II

     conclude that Dr. Speaker was an employee of TLC.196                                               Adam B. Krafczek, JD, is Cofounder and Vice
     Attorney Krouner said that complaining of a disability on                                       President of Bryn Mawr Communications LLC,
     Wall Street would be “professional suicide.” In addition,                                       the publisher of Cataract & Refractive Surgery
     Counsel said that, if they had wished to question the size                                      Today. He is also a civil trial attorney with the
     of the Plaintiff’s economic loss, the Defendants could                                          Law Offices of Adam B. Krafczek and is “Of
     have served subpoenas to employees of the companies                                             Counsel” with the Law Offices of Elliott Reihner
     for which he had worked or other relevant individuals.197                                       Siedzikowski & Egan PC. Mr. Krafczek may be reached at
     Attorney Krouner also asserted that Dr. Holland had only                              
     testified in order to assist “a member of the powerful and                                         Gillian McDermott is Editor-in-Chief of
     influential corneal society fraternity.”198 ■                                                   Cataract & Refractive Surgery Today and of
                                                                                                     Glaucoma Today. Ms. McDermott may be
       The authors would like to give special recognition to                                         reached at
     Carmen Quinones, Executive Assistant to Peter Kopff, Esq,
     and to Attorney Kopff for their assistance in providing
     access to the trial record in support of this article.

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