Anatomy of a Lawsuit

Doctors and lawyers everywhere are scratching their heads. How did a jury return a $4 million verdict in favor of a pilot who had undergone a successful LASIK procedure? If you attended the recent ASCRS conference in Philadelphia, Pennsylvania, you probably heard all of the questions and rumors surrounding this landmark case, which resulted in the largest LASIK verdict in US history. People asked what claims were alleged by Stephan Post, who testified, and how a jury arrived at the damages verdict. Physicians also wondered whether they were at risk and how they could protect themselves. There was standing room only at the lecture given by Richard Abbott, MD, at ASCRS last month entitled, “Update: Malpractice Litigation and Refractive Surgery Complications: How Do You Reduce the Legal Risks?” (See page 65.)

As this trial shows, there is good reason for the tremendous interest in this topic. Cataract & Refractive Surgery Today contacted the lawyers and key witnesses involved in the Post case, but nearly everyone we reached declined to comment. Because no one is talking, we went to the Pima County Superior Court of Arizona, in Tucson, Arizona, where the case was filed, to bring you the inside story. We reviewed trial transcripts, court filings, and trial exhibits in order to present the following summary of the facts, the filings, the 10-day trial, and the bizarre turn of events after the trial that resulted in the defense counsel's post-trial motion for an evidentiary hearing to further question Plaintiff's expert, Jeffery Machat, MD, and motion for a new trial.

THE FACTS
Stephan Post is a 35-year-old pilot for United Airlines who elected to undergo the LASIK procedure on both eyes. His preoperative measurements were -4 + 50 X 87 OD and -4 + 25 X 94 OS, and his BCVA was 20/20 OU. On May 17, 2000, Robert Snyder, MD, of University Physicians, Inc. (UPI), in Tucson, Arizona, performed LASIK surgery on Mr. Post's eyes. By all accounts, the procedure improved his vision to 20/20 or better in each eye without spectacle correction. Mr. Post subsequently complained of nighttime vision problems, including starbursts, halos, and ghosting.

POST'S LEGAL CLAIMS AND ALLEGED DAMAGES
On April 19, 2001, nearly a year after his LASIK procedure, Stephan Post filed an 11-page Complaint against UPI. The Complaint alleges that after Rand Siekert, OD, of UPI performed a preoperative examination, he “informed Stephan that he was an ‘excellent candidate' for the LASIK procedure,” and that, based on Dr. Siekert's recommendation, “Stephan elected to have the surgery performed.” The Complaint further alleges that he “was not informed that his pupil size greatly increased the risk of a poor outcome.”¹ The Complaint also alleges that, “during the week following the procedure, Stephan followed the postoperative instructions carefully. He experienced dry eyes (which Stephan was told was a risk factor of the procedure), [as well as] starbursts, halos, and ghosting, (which Stephan was not told was a risk or complication of the surgery).”²

Mr. Post acknowledged in his Complaint that his vision improved after LASIK, but he claimed that he continued to see starbursts, halos, and ghosting, which allegedly had not resolved and continued at the date of the filing of this lawsuit.³ As a result of his vision problems, Mr. Post claimed he was unable to work as a pilot since the LASIK procedure performed on May 17, 2000, and that his nighttime vision problems precluded him from obtaining both Federal Aviation Administration certification and employment as a pilot for the rest of his life.⁴

The Complaint alleges that UPI was negligent in: (1) its “failure to properly measure Stephan's pupils and failure to do subsequent measurements to ensure his pupils were the appropriate size for LASIK to be performed”; (2) “not measuring Stephan's pupil under proper lighting and/or failure to conduct the appropriate number of measurements to ensure Stephan's pupils were of an appropriate size to have LASIK surgery performed”; (3) “failing to properly train employees to take accurate measurements and/or measure Stephan's pupils under the appropriate lighting”; and (4) failing “to properly explain the risks associated with the LASIK procedure and the possibility and/or probability of an unsuccessful outcome.”⁵

Mr. Post claimed that, as a result of UPI's negligence, he suffered severe and permanent medical complications and personal injuries, including the loss of his employment as a pilot, lost wages, pain, suffering, emotional distress and suffering, loss of enjoyment of life, and a diminished quality of life. He also claimed that he will continue to sustain these damages for the remainder of his life.⁶
Defendant, UPI, filed an Answer to the Complaint denying any negligence or liability, and affirmatively alleging that at all times the Defendants, through their employees, met or exceeded the applicable standard of care.⁷ UPI further alleged that Mr. Post was “advised of the risks of surgery and consented to the surgery before it was performed.”⁸

The 10-day jury trial commenced on April 23, 2002. The following is a summary of highlights from the trial testimony of the key medical witnesses.

THE PLAINTIFF'S CASE
Robert Beauchene, MD, Plaintiff's Expert:
Testified April 24, 2002
Direct Examination by Counsel for Mr. Post
Dr. Beauchene is a pilot with 20 years experience, and is familiar with the lighting conditions of a Boeing 737 cockpit, which is similar to the type of aircraft Mr. Post was flying as of May 2000. He first examined Mr. Post on September 15, 2000, 4 months post-LASIK, for about 30 minutes. During the visit, Mr. Post complained of halos, starbursts, and glare, and he advised Dr. Beauchene that he was seeking a second opinion relating to his complaints after his LASIK surgery, because he felt they affected his ability to work as a pilot.

According to Dr. Beauchene, “examination of the pupils reveals the pupils measured 6.0 to 7.0 mm with lights on in a fully lit examination room.”⁹ His clinic notes show that, when the lights were off and the windowless room was completely black, the pupils measured approximately 7.0 to 8.0 mm with a pupil card. He said he used a darkened room to measure Mr. Post's pupils to see how large they would get, because it has been known for some time that “a lot of people that have nighttime glare problems have larger-than-average pupils.”¹⁰ He added that, “Given his [Mr. Post's] flying job, he needed to be able to see in absolutely virtually totally dark surroundings. And that is why I was trying to mimic that in my office as best I could.”¹¹ He expressed the opinion that “it was probable that, from the LASIK, he [Mr. Post] had a relatively small treatment area that caused his complaints of halo and nighttime glare” and, “because the effective optical zone is smaller than his nighttime or scotopic pupil size, that the difference in focal point causes his nighttime glare and halo complaints.”¹²

Cross Examination by Counsel for UPI
Dr. Beauchene stated that he has never performed a LASIK procedure and has never used a VISX S2 laser (Santa Clara, CA), which was used to perform Mr. Post's surgery. Mr. Post did not tell him during his examination that he had been seen the day before by Stephen Phillips, OD, who measured his eyes with a pupillometer in dim or dark conditions at 6.0 mm in both eyes. Dr. Beauchene agreed that there are other optical aberrations following LASIK surgery that could account for Mr. Post's vision problems.

Jeffery Machat, MD, Plaintiff's Expert:
Testified April 30, 2002
Direct Examination by Counsel for Mr. Post
Dr. Machat examined Mr. Post in Toronto, Canada, for several hours on two separate dates, October 29, 2001, and April 12, 2002. Dr. Machat stated that the different pupil measurements by different doctors in the case (Table 1) showed that UPI's preoperative pupil measurement by ophthalmic assistant Jennifer Evans of 5 mm on May 15, 2000, was “consistent with Dr. Sadun's¹³ and our reading in bright light, but it's inconsistent with all the other readings.” Dr. Machat stated that, in dim lighting, “there is no question he [Mr. Post] is at least 6 mm. More likely 6.25 [mm].”¹⁴

He said he did not use the Zywave aberrometer (Bausch & Lomb, San Dimas, CA), because he found that his results were better with a Tscherning aberrometer and the Tracey Visual Function Analyzer (“Tracey”) (Tracey Technologies, Bellaire, TX). According to Dr. Machat, by using the latter, he can objectively show where the effective optical zone is, as well as where the light rays are hitting on the cornea and the retina, and, with a “very high probability,” can establish the cause of a person's nighttime glare problem.¹⁵ When examining Mr. Post, Dr. Machat used the Tscherning aberrometer. On his second visit, he measured Mr. Post's vision on a regular eye chart using new Tracey software at 20/20 and 20/15, which proved that the Plaintiff's “quantitative vision was superb in bright light,” and that “he had a little bit of coma.” With a 3-mm pupil, Mr. Post's spherical aberration measured 0.019 µm, which Dr. Machat confirmed was 10 times smaller than average. As soon as the radius of the rays was set between 2.5 and 2.75 (meaning a 5-mm to 5.75-mm pupil), Mr. Post's spherical aberrations started to increase. Dr. Machat interpreted these results to mean that everything within the first 5.5 mm was “extremely well focused,” but that, outside that zone, Mr. Post started to have “less well-focused rays,” leading to the symptoms of halo and glare that Mr. Post described.¹⁶ At a scan diameter of 6.5 mm and in a darkened room, the spherical aberrations increased to 0.625 µm, meaning 250% greater than normal.

In one of the most contested issues of this case, Dr. Machat testified regarding the “true effective optical zone” of the VISX S2. He claimed that his knowledge came from Carol Harner, head of VISX research: “I told her that it was my understanding that on the VISX S2, you put in a 6.5-mm zone, that your true effective optical zone is less than 6.5 for a moderate myope, and in the range of 5.5 and not 6.5 [mm] which is what other defense witnesses were saying. She said, yes, you are correct.”¹⁷ Dr. Machat expressed the opinion that, “based on both topography and specifically on wavefront testing that his [Mr. Post's] effective optical zone is 5.5 mm, even though his treatment zone was 6.5 [mm].”¹⁸

Dr. Machat agreed with Jack Holladay, MD's,¹⁹ conclusion that Mr. Post's problem relates to the effective optical zone size of 5.5 mm and a pupil size in the dark of 7.0 mm, as shown in the Holladay Diagnostic Summary. The 1.5-mm disparity, he said, allows light to pass through the untreated cornea, causing glare, halos, and night vision problems common in patients with pupils that are 7.0 mm or larger. Dr. Machat stated that Mr. Post's wavefront demonstrated that, the larger his pupil size gets, the more night glare he has, and that the Tracey proves this conclusion. He added that the Wavelight he performed on Mr. Post also showed “abnormal spherical aberration, which increased dramatically between 5.5 and 6.0 mm into the abnormal range, and then increased quite rapidly or exponentially [from] there on.”²⁰

Dr. Machat stated, “There is no question in my mind that the cause of his [Mr. Post's] night glare problems are the spherical aberration that was induced by having an inadequate optical zone for the size of his pupils in dim or dark light.”²¹ He added that, in his opinion, “the weight of literature worldwide shows that pupil size in dim or dark conditions is definitely related to the incidence of of night glare and is a risk factor.”²²

Dr. Machat also reported that he examined Mr. Post for surface distortions that might have caused problems with nighttime glare (eg, malpositioning or wrinkling of the flap and dry eyes), but found the Plaintiff's flap to look “absolutely perfect.”²³ He deemed the surgery “technically superb,” aside from the optical zone's being too small for his pupil size in dim light and the cornea's being more oblate than prolate in shape.²⁴ While he approved of Dr. Snyder's surgical planning and preparation, his creation of the flap, and the postoperative care provided to Mr. Post by UPI, Dr. Machat stated “that UPI employees did act unreasonably in its preoperative care of Stephan Post, and that's why he has the injuries that he does.”²⁵ He agreed that UPI's technique for measuring pupil size was “well above what a lot of ophthalmologists were doing,” but he asserted that the Colvard pupillometer (OASIS Medical, Inc., Glendora, CA), when employed, must be used properly.²⁶ Referring to the similarity of Ms. Evans' pupil-size measurements with those taken by him in bright conditions, and noting that, according to Mr. Post's testimony, UPI did not tell him to look in the distance while measuring his pupils, Dr. Machat concluded that both lighting and accommodation were not taken into account.²⁷ He emphasized for “all patients,” and particularly for “pilots, radiologists, [and] truckers,” the importance of measuring pupils in a room that is “as dark as possible. You want to know the scotopic pupil size, not the mesotopic.”²⁸ [sic]

Comparing his own informed consent (11 pp) and process to UPI's (3 pp), Dr. Machat stated his belief that Mr. Post “did not have adequate informed consent based upon his risk factors and his profession in order to determine whether or not he would proceed [with LASIK].”²⁹
In Dr. Machat's opinion, the wavefront technology he is developing is the “absolute best clinical option for him to restore his [Mr. Post's] night vision and give him back his career.”³⁰ While he acknowledged that surgical revision could be done today, Dr. Machat said that he does not feel he has enough data to know exactly how Mr. Post will react.

During his April 12, 2002, examination of Mr. Post, he performed measurements of his pupils with the Procyon (Keeler Instruments Inc., Broomall, PA), which measured 7.23 mm in the left and 6.98 mm in the right under scotopic conditions.

Cross Examination by Counsel for UPI
Dr. Machat continued to disagree with Jennifer Evans' pupil measurements of 5 mm. He restated his belief that using the VISX S2 laser with 3.1 software on a patient with moderate myopia creates an effective optical zone of 5.5 mm, and with .5 mm on either side. He knows that Drs. Snyder and Mackman disagree with him on this issue. He claimed that there was no possibility that he is mistaken regarding his conversation with Carol Harner. At the time Mr. Post had his surgery performed, the VISX S2 laser had two options for setting the ablation zone, 6.0 and 6.5 mm, and Dr. Snyder used the 6.5-mm setting, which was the largest FDA-approved LASIK at the time.

He disagreed with Stephen Slade, MD's testimony that contact lens intolerance prior to LASIK usually goes away after LASIK. In fact, he claimed, his personal experience has been “just the opposite.”³¹ Dr. Machat's criticism of the UPI informed consent process is that the consent was based on what he believes were Jennifer Evans' erroneous pupil measurements of 5 mm.

DEFENSE CASE
Jennifer Evans, Defense Witness:
Testified May 2, 2002
Direct Examination by Counsel for UPI
Jennifer Evans, Defense witness who testified on May 2, 2002,³² is the UPI refractive surgery counselor who performed the first preoperative examination of Mr. Post on May 15, 2000. At the trial, she testified to performing an Orbscan and then measuring his pupils with the Colvard pupillometer. When using the pupillometer, she said she “would turn the lights off, shut the door, and close the blinds to make the room very dim.”³³ She specifically recalled shutting the blinds when she measured Mr. Post's pupils, testifying “there is no doubt in my mind, because that's my standard practice. I do it with all my patients.”³⁴ She described the lighting in the room where she measured Mr. Post's pupils on May 15, 2000, as “very dim.” Using the Colvard pupillometer, she measured Mr. Post's right pupil at 5.0 mm and left pupil at 5.0 mm, and said she was “absolutely” confident these measurements were accurate.³⁵

Cross Examination by Counsel for Mr. Post
On cross examination, Ms. Evans testified that she measured between 300 and 400 pupils between December of 1999 (when Larry Warden of UPI trained her on the use of the Colvard pupillometer) and May of 2000. She was never trained to take a pupil measurement in complete darkness, nor was she trained to cover the other eye during this test. She “wasn't trained to do anything with the other eye.”³⁶ She took Mr. Post's Orbscan measurements in a bright room with open blinds and with his back away from the open blinds. The Orbscan reading was 3.4 mm. She was not trained to differentiate between any patient based on occupation or anything else.

Redirect Examination by Counsel for UPI
When measuring a patient's eye with the pupillometer, Ms. Evans has the patient keep the fellow eye open, because she wants the patient to be looking straight ahead across the room. She wants them to “accommodate” in the distance, because, if they covered the opposite eye she was not testing, they would be looking inside the pupillometer, which might cause their pupils to constrict, because they would then be looking at a closer object.³⁷ She also testified the windows at UPI are “tinted.” When the blinds are closed, they overlap each other, so there is no light coming between the blinds.³⁸

Larence Warden, Jr, Defense Witness:
Testified May 2, 2002
Direct Examination by Counsel for UPI
Mr. Warden, who testified on May 2, 2002,³⁹ was employed at UPI as a LASIK surgical coordinator. He spoke with Mr. Post on the phone prior to his coming in to UPI and answered some of Mr. Post's questions and advised him of the risks associated with LASIK, including halos and starbursts. On the day of Mr. Post's surgery, Mr. Warden was the laser operator. On Mr. Post's chart, he had written the word “pilot” and highlighted it in yellow. He also entered both of Mr. Post's pupil measurements as 5 mm on his surgery checklist, which he obtained from the measurements that Jennifer Evans wrote in her chart. He also wrote on the surgery checklist “check pupils with pupillometer day of surgery one more time.” Mr. Warden testified he personally remeasured Mr. Post's pupils on May 17, 2000, the day of his surgery, and witnessed Dr. Snyder do the same, in “dim” conditions. He recalls using the pupillometer, but does not recall what the measurements were. He did not document them anywhere because the only time he would document them would be if they were really “out of whack.”⁴⁰ Although Dr. Snyder did not tell him what Mr. Post's remeasurements were, he recalls Dr. Snyder giving him the “thumbs up” which means “he has the exact reading that I have, or close to it, which meant all systems are go.”⁴¹ Mr. Warden disagrees with Mr. Post's testimony that neither he nor Dr. Snyder measured Mr. Post's pupils with the pupillometer on May 17, 2000.

Cross Examination by Counsel for Mr. Post
Mr. Warden was never instructed to measure pupils with the Colvard pupillometer in a “dark” room. The standard was “dim” and he was never trained to simulate any other type of lighting conditions based on occupation.

Rand Siekert, OD, Defense Witness:
Testified May 7, 2002
Direct Examination by Counsel for UPI
Rand Siekert, OD, who testified on May 7, 2002,⁴² was employed by UPI as staff optometrist and faculty member. He met Mr. Post on May 15, 2000 for a preoperative surgical exam. At that time, he reviewed Mr. Post's Orbscan (Orbscan diagnostic system, Bausch & Lomb Surgical) measurements (3.4 mm left eye, 3.5 mm right eye, under mesopic conditions) and correlated these to Jennifer Evans' measurements of 5 mm in both eyes. Adding 1.7 mm or 1.8 mm to each Orbscan measurement, he claimed that they were in a “reasonable” range.⁴³ He performed different tests to confirm Jennifer Evans' tests. He performed a “cover test” to assess the six eye muscles around each eye, then performed a retinoscopy to double-check pupil size. Then, he checked the prescription using a phoropter, performed a manifest refraction, and a slit lamp examination (again confirming pupil size, which he agreed were 5 mm in each eye). All of his confirming tests verified Jennifer Evans' measurements of 5 mm in each eye. Based on the information he received from Mr. Post, he informed Mr. Post that he was an “excellent candidate” for LASIK, but he also informed him of the various risks of the surgery.⁴⁴ He was concerned because Mr. Post was a pilot, and when Mr. Post asked about the size of his pupils, Mr. Warden told him they would recheck them on the day of the surgery with a pupillometer one more time. When the exam was over, he told Mr. Post he was going to “highlight” that note on his chart to make sure Dr. Snyder saw it. He also followed up with Dr. Snyder and told him he needed to recheck Mr. Post's pupils the day of surgery.

Cross Examination by Counsel for Mr. Post
Dr. Siekert informed Mr. Post that pupils play a role in glare, halos and night vision problems, but he did not advise Mr. Post he was at any increased risk based on his pupil size.

Paul Karpecki, OD, Defense Expert:
Testified May 2, 2002
Direct Examination by Counsel for UPI
Dr. Karpecki defined “standard of care” to be “what any prudent physician would do in that situation. And that's based on what the majority are doing. It's based on current research for new technology coming out. It's based on legal cases. It's based on all the stuff that, put together, what the prudent physician would do in a similar situation. I believe that's standard of care.”⁴⁵

Dr. Karpecki testified that Dr. Siekert's and Jennifer Evans' pre-LASIK examination of Mr. Post at UPI exceeded the standard of care, and as support, he cited their use of the Colvard pupillometer instead of the pupil card. Dr. Karpecki testified that it is inappropriate to measure pupils in a completely dark room, because it will cause the eyes to converge and thereby make any measurement inaccurate. It is necessary, he said, to leave just enough light to permit scotopic adaptation and allow the examiner to take measurements. He stated that the standard of care is to take the measurements in dim light.

Dr. Karpecki understood that, after Jennifer Evans obtained Mr. Post's history and measured his pupils, Mr. Post went to see Dr. Siekert, the optometrist at UPI, for a preoperative assessment on May 15, 2000. Dr. Siekert verified Ms. Evans' measurements via objective observation, retinoscopy, a slit lamp examination, and an Orbscan reading. Dr. Karpecki determined that Dr. Siekert (having performed four checks) had been reasonable in concluding that Mr. Post had a pupil size consistent with 5 mm in both eyes. He also stated that Dr. Siekert appropriately informed Mr. Post of the risks and benefits of the procedure when he met with him on May 15, 2000, and he described the conversation Dr. Siekert had with Mr. Post as appropriate and within the standard of care as part of the informed consent process. He disagreed with Dr. Machat's testimony that the pupil measurements taken on May 15, 2000, were wrong, and with Dr. Machat's opinion that UPI's informed consent does not meet the standard of care. Although Dr. Karpecki acknowledged that Mr. Post did not sign the consent form until the day of surgery, May 17, 2000, he asserted that Dr. Siekert's role in the informed consent process met the standard of care.

Cross Examination by Counsel for Mr. Post
Dr. Karpecki agreed that, if a patient's pupils were larger than 6.0 mm, the examiner should tell the patient that he/she was at an increased risk for nighttime halos and glare, and that not doing so would fall below the standard of care. He then affirmed that UPI's informed consent document meets the standard of care for someone with pupils sized 6.0 mm or larger. He admitted that he had not done any work with the VISX laser. Dr. Karpecki was shown his copy of Dr. Snyder's deposition testimony, in which Dr. Snyder testified that he knew he remeasured Mr. Post' pupils on the day of his surgery, but does not remember the measurement, and that he did not record it anywhere on the chart. Dr. Karpecki admitted that he wrote next to this testimony, “Unfortunately, not written equals not done.”⁴⁶ He explained that he intended his remark to reflect how Dr. Snyder's notes would be interpreted.

Peter McDonnell, MD, Defense Expert:
Testified May 3, 2002
Direct Examination by Counsel for UPI
Dr. McDonnell disagreed with Dr. Machat that the VISX S2 laser only flattens the central 5.5-mm zone of the cornea. In 1995, the FDA approved the original VISX laser to treat 6.0 mm, and prior to Mr. Post's procedure, VISX and the FDA expanded the treatment zone to 6.5 mm, and then added a further blend zone. He asserted that Mr. Post's nighttime vision problems are not related to his pupil size, based on the applicable FDA studies and the postoperative examinations of Mr. Post. When Dr. Sadun gave Mr. Post a drop of pilocarpine to constrict the pupil size, the only symptom that improved was the starburst problem; the ghosting and halos remained. Dr. McDonnell concluded that, if these conditions were related to his pupil size, he would have expected the constricted pupil size to alleviate all symptoms. He added that the FDA did not place any limitations on pupil size when using the VISX S2 laser.

Dr. McDonnell stated there is a 1 to 2% risk of experiencing glare or halos at night when using a 6.0-mm zone, but he said there is no effective way to predict which patients will experience those symptoms. Some patients with pupil sizes of only 3.0 to 4.0 mm experienced these problems, while some patients with pupil sizes of 8.0 to 9.0 mm did not. Pupil size is not a fixed measurement for any individual, and varies due to a variety of factors, such as medications, caffeine intake, truthfulness, etc. LASIK surgery can also change the pupil size, he commented. Mr. Post's condition is due to “imperfect healing causing some irregularity in this flap,” Dr. McDonnell asserted.⁴⁷ He claimed that there were no scientific studies to support Dr. Machat's opinions as to causation, and that Dr. Machat was only drawing inferences.

Cross Examination by Counsel for Mr. Post
On cross, Dr. McDonnell disagreed with Dr. Sadun's opinion that the cause of Mr. Post's problems are that his pupils are larger than the optical zone of the cornea as created by LASIK. Furthermore, he said the testimony in this case is the opposite of what is normally encountered in patients with post-LASIK night vision problems: Normally, they are at their worst right after the surgery and improve over time, compared to Mr. Post, who claims to have worsened over time.

Gary Mackman, MD, Defense Expert:
Testified May 3, 2002
Direct Examination by Counsel for UPI
Dr. Mackman testified that the treatment zone for the VISX S2 can be set to either 6.0 or 6.5 mm. There is no such thing as an “effective optical zone.” The ablation zone of the VISX S2 is the entire 6.0 or 6.5 mm. The printout from Mr. Post's procedure confirms he received a 6.5 mm treatment. Dr. Mackman disagreed with Dr. Machat's testimony that the VISX S2 laser only flattens the central 5.5-mm zone of the cornea; the “knee” is at the end of the 6.5-mm zone, he said, and the “smoothing” occurs on the 0.2 mm on either side of the treatment zone. He confirmed his testimony by reading the product literature and making a phone call to VISX.

Dr. Mackman asserted that Dr. Snyder's care exceeded the appropriate standard of care of a reasonable ophthalmologist. He stated that Dr. Snyder and his staff provided a tremendous amount of preoperative counseling to the patient, and Mr. Post acknowledged receipt of the literature, which provided sufficient notice of the possibility of glare, etc. He disagreed with Dr. Machat that the informed consent document, signed by Mr. Post, was inadequate, because it does provide notice of glare, halo effects, light sensitivity, double vision, and shadow images. Dr. McDonnell testified that “the ASCRS Society … actually has a model consent form on their Web site, and they actually mention less about the glare and halos than is mentioned here.”⁴⁸ He also claimed that the standard of care did not require Dr. Snyder to inform Mr. Post of an increased risk of nighttime problems if his pupils measured 6.0 mm or higher, because the ablation zone is 6.5 mm.

Dr. Mackman remarked that, at the time of this procedure, the standard of care to measure a pupil was a pupil card, and that UPI exceeded that standard by using a Colvard pupillometer. Under either method, he said, there is a need to have some light in the room to measure properly. He claimed that the patient also needs to be looking into the distance, which will not happen in total darkness.

Cross Examination by Counsel for Mr. Post
Dr. Mackman agreed that it would have been negligent if Jennifer Evans had not instructed Mr. Post to look into the distance when she measured his pupils or if she had measured his pupils while the blinds were open. He also agreed that Dr. Snyder would be negligent if he did not remeasure Mr. Post's pupil size on the date of the procedure. Regarding the standard of care to be used, he cited a recent study of LASIK surgeons, in which over 80% stated that they would perform LASIK if the pupil size exceeded the ablation size by 1.0 to 1.5 mm. He was aware that Dr. Machat had testified that Carol Harner, head of VISX research, allegedly told him that the “effective optical zone” is 5.5 mm. Dr. Mackman testified that Greg Halstead of VISX advised him the entire 6.5 mm is the treatment area and the smoothing occurs outside of that area.

Dr. Stephen Slade, Defense Expert:
Testified May 7, 2002
Direct Examination by Counsel for UPI
Dr. Slade examined Mr. Post on March 28, 2002. His technician first measured Mr. Post's pupils in a darkened room (an east-facing room with a window covered by metal blinds) with a Colvard pupillometer, which he described as the current “gold standard.”⁴⁹ He then measured the pupils himself.

Dr. Slade used a candelameter when measuring Mr. Post's pupils, and reported a measurement of 1.4 candelas when the examination room's lights were out, the blinds closed, and the hallway lights on (no door), which is the typical conditions in which he would measure pupils. With the hallway lights extinguished, the reading was 0.4 candelas, which he described as very dark. At 0.4 candelas, Dr. Slade measured both pupils with both eyes open, with one eye open and the other covered, and with one eye open and the other closed; he found the largest pupil size to be 5.75 mm and 6.0 mm OD and 6.0 mm OS.⁵⁰

He described Mr. Post as having “great vision” and picking out 20/10 letters on the Snellen chart. “The surgery looked perfect to me,” he testified. “It was well healed. Clean. It's hard to even see it. It looked great.”⁵¹ Dr. Slade performed a cycloplegic refraction, Zywave twice, topography testing, Orbscan topography, and Tracey readings. The Shack-Hartmann readings showed spherical aberrations that one would expect after ablative surgery.

Dr. Slade recommended two types of treatment for Mr. Post. First, he recommended the use of rigid gas-permeable contact lenses, which he believed would take care of Mr. Post's nighttime visual disturbances. If Mr. Post had dry eyes, Dr. Slade said that treatments for dry eyes, such as tear drops or punctal occlusion, should be considered. He thought he could “fit” Mr. Post with a reasonable degree of medical probability.⁵² The second treatment option would be doing a “wavefront-guided ablation with some guidance with topography.”⁵³ Mr. Post's pupil size was not significant for this procedure, Dr. Slade stated, because it involves treating the areas of the cornea that have induced spherical aberration; he said it was not a matter of “treating towards a pupil size. It's the wavefront devices. They are in the Orbscan. They are looking at the cornea, the changes. And so that's what you're treating.”⁵⁴

Cross Examination by Counsel for Mr. Post
Dr. Slade said he believed he could put Mr. Post back in the pilot's seat in the next 6 to 18 months.
Redirect Examination by Counsel for UPI
Dr. Slade asserted that Dr. Machat made four different “leaps of assumptions”: (1) “he used the Tracey in a way that had not been used before”; (2) “he used a device that, again, is a minority opinion and has never been proven with a cut”; (3) he had used Mydriacyl on Mr. Post, which “puts the lens in a totally unnatural state”; and (4) that Mr. Post's Tracey numbers relate to his symptoms. ⁵⁵

Dr. Robert Snyder (UPI Physician Who Performed LASIK on Mr. Post):
Testified May 8, 2002
Direct Examination by Counsel for UPI
Dr. Snyder, an employee of UPI, testified on May 8, 2002.⁵⁶ He performed LASIK surgery on Mr. Post on May 17, 2000, at UPI and described the risks and benefits of the surgery with him: He could lose some of his best-corrected vision, something unexpected could happen, there were risks associated with the flaps, he could lose some of his contrast sensitivity, and that glare and halos could be a problem, as well. He determined that Mr. Post had read the patient education manual and booklet that was given to him. Dr. Snyder said that Mr. Post had clearly understood that he could lose his vision as a result of the surgery. He disagreed with Mr. Post's testimony that he did not discuss the risks and benefits of LASIK with him.

Dr. Snyder recalled remeasuring Mr. Post's pupils prior to surgery on May 17, 2000, in what he described as a “relatively dark environment.” He did not recall what the measurement was and had not documented the measurements he obtained. He explained he did not “redocument it, because it was just a confirmatory result.”⁵⁷ He recalled Jennifer Evans and Larence Warden telling him the pupils were normal. Mr. Post signed the informed consent document, and Dr. Snyder also signed at the bottom certifying he informed Mr. Post of the consequences, risks, complications, and alternate methods of treatment.

Dr. Snyder used a VISX Star 2 laser with 3.1 software, which he testified has an effective treatment zone of 6.5 mm. Dr. Snyder disagreed with Dr. Machat's testimony that this system would have created an effective optical zone of 5.5 mm. He verified that the effective treatment zone was 6.5 mm in a conversation with Greag Halstead, a product manager from VISX for the Star 2 laser. During one of Mr. Post's follow-up examinations of September 8, 2000, Dr. Snyder measured his pupils at 5.0 mm in the right and 6.0 mm in the left in a “dark” room with a pupillometer. During his visit on October 8, 2000, they were 5.5 mm in the left and 6.0 mm in the right. Dr. Snyder stated that he would not have given Mr. Post a different informed consent document if his pupils had measured between 6.0 mm and 6.5 mm prior to surgery, because he does not think Mr. Post would have been at any increased risk, and, if he had thought Mr. Post would be at a higher risk, Dr. Snyder would not have performed the surgery.

Cross Examination by Counsel for Mr. Post
Dr. Snyder asserted that it would be acceptable for Jennifer Evans to take pupil measurements in UPI's examination room, provided the blinds were closed. Dr. Snyder agreed that, if a patient's pupils are larger than what he believes is the effective optical zone, the patient, at minimum, should be told that he/she has an increased risk of problems if he/she has surgery. Dr. Snyder said his personal preference is to tell the patient that he will not do the surgery and to recommend that the patient be put on a large-pupil waiting list. He does not want to perform surgery on someone whose pupil exceeds what he considers to be the treatment zone on the machine he is using. He agreed a connection is possible between large pupils and night vision problems and said that this is why pupils are measured in accordance with the pupillometer manual's instructions.

Although Dr. Snyder acknowledged a lack of firsthand knowledge of the lighting conditions in a cockpit, he disputed Dr. Beauchene's testimony that the equivalent of flying at night is driving down a road without the headlights on.

Dr. Snyder asserted that he would never have performed LASIK on Mr. Post if the preoperative measurements of his pupils had been the same as those taken by Dr. Sadun (7.5 mm), Dr. Beauchene (7.0 to 8.0 mm), Dr. Holladay (7.0 mm), or Dr. Boxer Wachler (6.9 mm in dim light) (Table 1, below).

THE VERDICT
On May 9, 2002, after only 3 hours of deliberations, the jury reached a verdict. They found in favor of the Plaintiff and against Defendant UPI, awarding damages in the amount of $4 million, and found relative degrees of fault to be Plaintiff 15%, Defendant 85%. The actual damages awarded against the Defendant is $3.4 million. For a closer look at this verdict and what it means, as well as the events that occurred after trial, see the related sidebar in this issue entitled “Why $4 Million?” on page 56 and the article entitled “Defense Claims Dr. Machat ‘Dropped a Bombshell' in Post vs. UPI” on page 60.

As of the date this article went to print, neither party had filed an appeal.

Adam B. Krafczek, Jr, Esq, is cofounder and Vice President of Bryn Mawr Communications LLC, the publisher of Cataract & Refractive Surgery Today, located in Bryn Mawr, Pennsylvania. He is also a civil trial attorney with the Law Offices of Adam B. Krafczek, and "Of Counsel" with the Law Offices of Elliott Reihner Siedzikowski & Egan P.C. He may be reached at adam@bmctoday.com