"Our position in opening statement and throughout the trial was that there was absolutely nothing wrong technically with the surgery and nothing wrong with the postop care," said Tucson, Ariz., attorneys Bob Beal, JD, and Ted Schmidt, JD, who represent former United Airline Pilot Steve Post.

Beal told EyeWorld that he and his co-lead counsel, Schmidt, based their case on screening issues, questioning whether the patient's pupil size was appropriate for the Visx Star S2 (3.1 software) excimer laser's effective optical zone used in treatment. He also said meaningful informed consent was lacking before surgery.

UPI lawyer Jeff Campbell of Phoenix said Post's uncorrected visual acuity following the procedure was better than 20/20. Campbell also said the patient signed a consent form that specifically warns of risks such as glare, halo, and starbursts. But an expert witness for the plaintiff, Jeffery J. Machat, MD, of Toronto, testified that individuals whose occupation depends on function under dark conditions should be given special warning. He also said pupil size should be measured under dark, not just dim, lighting conditions.

But several weeks after the May 9 verdict, Machat allegedly contacted lawyers on both sides to say he may have been mistaken in his testimony regarding the Visx effective optical zone treatment sizes. Machat and other witnesses told EyeWorld they were instructed not to comment on the case. Campbell said Machat indicated "a grave injustice" had occurred following the jury verdict.
"We filed a motion for an evidentiary hearing to bring Dr. Machat back to tell us what he meant," Campbell said before the Aug. 12 hearing. "The implication was that he now realizes his testimony was inaccurate regarding the software used by Visx."
Campbell said Machat resigned from the board of TLC following the verdict and sent a letter to all TLC doctors that indicates surgeons can safely perform LASIK on pupils larger than 6.5 mm using the Visx system.
Campbell also said witnesses for the defense during trial indicated that the doctor who performed the surgery, University of Arizona chief of ophthalmology Robert Snyder, MD, is very conservative in not performing LASIK on any patient with pupil sizes larger than the treatment zone, even though many surgeons use an 8-mm pupil size as the cutoff point.
Beal said before the August evidentiary hearing that it was unfortunate Machat had received such tremendous peer pressure after the May LASIK verdict, particularly at the June meeting of the American Society of Cataract and Refractive Surgery in Philadelphia. "The weight of the literature seems to indicate that if scotopic pupil size is greater than effective optical zone, you are probably going to experience more glare than you ever had with the native eye before LASIK," he said. "The size of the effective optical zone is what is actually laid down by the laser, as opposed to what the manufacturer says the intended optical zone is. ... The degree of myopia makes all the world of difference in what kind of zone is laid down."
Beal referred to a March 2002 Review of Ophthalmology article by Jack T. Holladay, MD, professor, University of Texas, Houston, in which Holladay asserts that the effective optical zone for treatment for almost all commercial lasers is 10% smaller than intended for -5-D treatment, 23% smaller for a -10-D treatment, 37% smaller for a -15-D treatment, and 52% smaller for a -20-D treatment.
"If more uniformity comes from this trial and if patients have better informed consent, such that people are told to wait until better technology is available if in fact they do have large pupils, then this is better for the industry and better for the patients," Beal said.

The optical zone for treatment for the Visx excimer laser system with 3.1 software can be 6 mm or 6.5 mm, with the size left up to the surgeon based on patient examination, said Visx medical monitor Marc G. Odrich, MD, of New York. Visx officials make no recommendations regarding possible limitations of a patient's pupil size in low or no lighting, Odrich said. "This is a question for individual physicians to determine," he added.

He said the average indemnity payment to plaintiffs in OMIC LASIK cases is about $53,500, with the largest at $118,000. Of all OMIC cases with indemnity payments, he said, the average is about $126,000. Total indemnity on 10 paid OMIC LASIK cases is about $535,000.
Weber said another insurance company has statistics showing average payment in LASIK cases at $144,000, with the largest payment being $300,000. "It's important to keep in mind that ophthalmologists are sued for many of the procedures they perform and sometimes these cases result in very large verdicts or settlements."

He said the highest reward for an ophthalmic, non-LASIK case (as reported in Jury Verdict Reporter) in 2001 was $15 million. "Based on the facts of the Arizona case as I understand them, the verdict has no relation to the standard of care, causation, and damages evidence that was presented to the jury," Weber said. "Simply stated, I think the $4 million verdict represents a `runaway jury.' Unfortunately, I think there is very little for refractive surgeons to learn from this case other than some lawsuits arising from ophthalmic procedures result in very high damage awards. LASIK cases are no exception."

Contact Information
Beal: 520-790-5600, fax 520-790-1163
Campbell: 602-322-1600, fax 602-252-4431
Odrich: 718-432-2020, fax 718-432-8482
Weber: 800-562-6642, fax 415-771-7087