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The Pennsylvania Superior Court has ruled that testimony that a wrongly dispensed drug caused permanent visual and cognitive damage to a healthy 47-year-old man did not satisfy the Frye test, because the expert’s opinion that the drug overdose caused the plaintiff’s damages was not generally accepted in the relevant scientific community. The ruling in Trach v. Fellin affirmed a Lehigh County common pleas judge’s decision reversing a $5 million verdict and granting a new trial solely on the issue of damages. “Before scientific evidence can be admitted it must satisfy certain standards of reliability,” Senior Judge Phyllis Beck wrote for the two-judge majority. “This insures that the fact finder arrives at a factual conclusion based on evidence that is generally accepted by the scientific community.” Also on the panel were Senior Judges Kate Ford Elliott and John G. Brosky. While all three judges agreed the Frye rule prevented certain aspects of a pathologist’s testimony from being considered, Ford Elliott wrote a concurrence in which she expressed strong dissatisfaction with the necessary outcome of the case. “It is unfortunate that in cases such as this, when science enters the courtroom, common sense must leave,” Ford Elliott said. The judge said that despite the strictures of Frye, a layman would conclude there was “an obvious causal link” between Trach’s symptoms and his overdose of Doxepin, an antidepressant. Allan Trach in July 1995 was prescribed the antibiotic Amoxil by his dentist for jaw pain. A pharmacist’s assistant on duty at Thrift Drug mistakenly filled the prescription with Doxepin. Thrift Drug told Trach to come back to pick up the rest of his prescription in a few days, as it was short the full number of pills. The prescription directed Trach to take two pills every four hours, or 1,800 milligrams daily; the maximum allowable daily dosage of Doxepin is 300 mg. Within three days, Trach had experienced shakiness, dizziness and confusion and a crescent-shaped blind spot in his right eye. When Trach returned to Thrift Drug to pick up the balance of his pills one week later, his wife noticed the 11 new pills were different from the original 29. After calling the pharmacy, she discovered Trach had earlier been given the wrong drug. In March 1996, Trach was diagnosed with chronic open-angle glaucoma. He continued to experience the blind spot in his right eye as a result of optic nerve damage from the glaucoma. His vision problems, which limit his ability to read and pursue his hobbies of hunting and photography, are permanent. Trach sued Thrift Drug/Eckerd and testified that although most of his symptoms disappeared within a month, he continued to experience vision and cognitive difficulties. Before trial, Thrift Drug moved to suppress the testimony of Trach’s only causation witness, pathologist and toxicologist John Shane. Thrift Drug argued Shane’s proffered testimony didn’t meet the requirements for scientific expert evidence set forth in Frye v. U.S. The trial court denied Thrift Drug’s motion. Shane testified that Doxepin could cause side effects that are consistent with the symptoms experienced by Trach, but he linked these symptoms to “closed-angle glaucoma,” a condition distinct from the “open-angle glaucoma” with which Trach was diagnosed. Thrift Drug presented an ophthalmologist who pointed out this discrepancy and said there was nothing in medical literature to support the proposition that Doxepin can cause open-angle glaucoma. Thrift Drug’s neurologist added there was nothing in the relevant medical literature to support the idea that Doxepin caused Trach’s continuing cognitive difficulties. The trial court granted a directed verdict in favor of Trach on the issue of negligence, which went unchallenged on appeal. The issue of damages went to the jury, which returned a $5 million verdict for Trach. Thrift Drug filed a post-trial motion requesting a JNOV or in the alternative, a new trial. ANALYSIS There was “no question” that Shane’s testimony was admissible to the extent it causally connected the Doxepin overdose to Trach’s immediate symptoms, Beck said. However, Shane’s testimony regarding the long-term symptoms of that overdose, “was not demonstrated to be ‘generally accepted’ in the relevant scientific community, nor was his opinion that open-angle glaucoma and closed-angle glaucoma are interchangeable terms for the same general condition of intraocular pressure,” Beck wrote. The Frye test allows for two possible analyses of testimony, Beck said: whether the causal relationship is generally accepted by the scientific community, or whether the expert’s methodology is generally accepted. Since it was “unlikely the scientific community would have engaged in any systematic research studies on the effects of the overdose,” the court turned to whether Shane’s methodology would be generally accepted. “Shane could point to no medical literature to support his opinion on causation of these conditions, and the [Physicians' Desk Reference] did not state that Doxepin causes a permanent change in brain chemistry or that it leads to permanent cognitive or vision problems,” Beck said. “The trial court properly noted that the fact that glaucoma is identified as a contraindication [for Doxepin] suggests a possible biological relationship. However, it is impossible to infer from the PDR that the scientific community generally accepts the proposition that an overdose of Doxepin can cause glaucoma.” And although there was evidence that Trach’s visual problems occurred for the first time shortly after he took the Doxepin, the temporal connection was not sufficient to show legal causation, Beck said. “Shane’s testimony regarding causation of the alleged long-term effects of the Doxepin did not pass muster under Frye, and therefore, the trial judge did not err in his determination that he should not have admitted that testimony.” Beck said the trial court also did not err in refusing to grant a JNOV to the defense and ordering a new trial solely on the issue of damages. A JNOV is an “extreme remedy” that can only be properly granted in a clear case, where no two reasonable minds could fail to agree that the verdict was improper, Beck said. This was not one of these cases, Beck said. ‘DEEPLY TROUBLED’ CONCURRENCE Ford Elliott’s concurrence was glum in tone. “Regrettably, I must join the majority opinion, although I am deeply troubled by the problem this case so clearly illustrates when a trial court applies the Frye test to scientific expert testimony under circumstances such as those existing here.” Ford Elliott conceded the evidentiary standard of Frye was not met, “despite what to the average layman would be an obvious causal link between a massive overdose of a potent drug and the development of previously non-existing, permanent symptoms the same as or similar to the transient symptoms the drug is known to cause in recommended doses.” John P. Karoly Jr. of Karoly Law Offices in Allentown, Pa., represented Trach. He said Tuesday that the court’s result was “extremely disappointing. But the comments by the court — especially in the concurrence — are encouraging. At least Kate Ford Elliott [is cognizant of] an extreme injustice.” Karoly said he plans to petition for reargument before an en banc Superior Court. Thrift Drug/Eckerd was represented in the appeal by Alan K. Cotler, Joan A. Yue and Andrew P. Hoppes. All three were with Klett Rooney at the start of the case but moved to Reed Smith in May, taking the case with them. William C. Foster of Kelly McLaughlin in Plymouth Meeting, Pa., was trial counsel for Thrift Drug and represented the pharmacy in post-trial motions along with Cotler, Yue and Hoppes. Reached Tuesday, Yue said she was pleased with the decision on Shane’s testimony, which she said was “consistent with Blum and previous Superior Court decisions on Frye.” Yue said, however, that she was very disappointed in the Superior Court’s decision to affirm the denial of a JNOV in the case. “We believe we should have been entitled to a JNOV, particularly since plaintiffs have been put out of court on summary judgment in a number of cases in which the expert fails to meet Frye on causation,” she said. Yue said Thrift Drug has not yet decided whether to pursue the issue on appeal.

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