Where a particular case is venued may have a significant impact on the admissibility of scientific expert opinions. Historically, Pennsylvania courts have adhered to the Frye standard when determining the admissibility of expert scientific testimony. The Frye standard was established by the U.S. Court of Appeals for the District of Columbia in Frye v. United States, 293 F. 1013 (D.C. Cir. 1923). The Frye test was adopted in Pennsylvania in 1977 and is embodied in Pennsylvania Rule of Evidence 702. The Frye test is also followed by state courts in Alaska, Arizona, California, Colorado, Florida, Illinois, Kansas, Maryland, Michigan, Nebraska, New York and Washington.

However, the federal courts and several state courts follow the standard established in Daubert v. Merrell Pharmaceuticals, Inc., 509 U.S. 579 (1993), now known as the Daubert standard. The Daubert standard is followed by all federal courts as well as state courts in Connecticut, Indiana, Kentucky, Louisiana, Massachusetts, Missouri, New Mexico, Oklahoma, South Dakota, Texas, West Virginia, Arkansas, Delaware, Georgia, Iowa, Minnesota, Montana, North Carolina, Oregon, Utah and Vermont.

Daubert

In 1993, the Supreme Court of the United States made a substantial and revolutionary change to the federal rules of evidence on the admissibility of expert testimony. In Daubert v. Merrell Dow Pharmaceuticals, 113 S.Ct. 2786 (1993), the Court overturned the seventy-year-old rule of admissibility for expert scientific testimony based on Frye v. United States, 293 F. 1013 (D.C. Cir. 1923). The Frye Court ruled that expert scientific testimony "was to be admitted only when it had received 'general acceptance' in the relevant scientific community." The Daubert Court ruled that Federal Rule of Evidence 702 did, in fact, supersede the Frye standard and set forth a new standard for the federal courts to follow on the admissibility of expert scientific testimony.

The Daubert Court ruled that the trial judge must ensure that all scientific evidence admitted is not only relevant, but reliable. In Daubert, the Supreme Court identified several factors which may be considered when the trial court undertakes its review of the reliability of proposed expert testimony:

(1) Whether a "theory or technique . . . can (and has been) tested" ;

(2) Whether it "has been subjected to peer review and publication" ;

(3) Whether, in respect to a particular technique, there is a high "known or potential rate or error" and whether there are "standards controlling the technique's operation" ; and

(4) Whether the theory or technique enjoys "general acceptance" within a "relevant scientific community

However, the Court acknowledged that these factors do not constitute a "definitive checklist or test." The Court emphasized that the admissibility inquiry must focus "solely" on the experts’ "principles and methodology," and not the conclusions that they generate.

The Court explained "cross-examination, presentation of contrary evidence, and careful examination of the burden of proof, rather than wholesale exclusion under an uncompromising general acceptance standard, is the appropriate means by which evidence based on valid principles may be challenged." Lastly, the Court acknowledged that the above standards would occasionally prevent juries from "learning of authentic insights and innovations," but the Court concluded "that is simply a consequence of the fact that the Rules are not designed to seek cosmic understanding but, rather, to resolve legal disputes."

Frye

The Pennsylvania Superior Court reexamined the circumstances under which proposed expert scientific testimony may be evaluated under the Frye standard in Trach v. Fellin, 2003 Pa Super. 53, 817 A.2d 1102 (2003). Trach was an otherwise healthy 47-year-old man who saw his dentist on July 11, 1995 for treatment of jaw pain. The dentist suspected an infection and prescribed the antibiotic Amoxil in 250-mg. capsules to be taken by mouth four times daily (1,000 mg. per day for five days).

Thrift Drug filled the prescription with an antidepressant, Doxepin, in 150-mg. capsules. Trach took twelve of the Doxepin capsules (1,800 mg.) on the first day.

The Physician’s Desk Reference provides that 300 mg. is the maximum recommended daily dose for Doxepin. Trach immediately experienced side effects and although his condition deteriorated, he continued to take the Doxepin capsules believing that they were Amoxil. When the error was finally discovered by his wife, Trach went to the hospital for testing. Most of Trach’s reactions to the Doxepin resolved within a month. In the subsequent lawsuit, Trach secured a $5 million verdict, but the trial court vacated the jury’s verdict and ordered a new trial on damages after deciding that it had erroneously permitted Trach’s scientific expert to testify about the effects of significant overdoses of Doxepin. Both Trach and Thrift Drug appealed to the Superior Court.

The Superior Court reinstated the jury’s verdict and vacated the order granting a new trial on damages. The case turned on whether Trach’s scientific expert, Dr. Shane, could reliably testify about causation by Doxepin overdose. At trial, Thrift Drug’s expert conceded that Doxepin can cause narrow or closed-angle glaucoma in susceptible individuals. The Court addressed the question of whether Dr. Shane’s testimony was permissible under Frye, noting: "For obvious reasons, however, no one has conducted studies to determine the effects of a massive overdose of Doxepin such as the dose Trach took."

Dr. Shane testified that the symptoms Trach suffered immediately after taking the Doxepin overdose, and continuing thereafter, all resulted directly from the Doxepin. Dr. Shane was the only causation witness for Trach. Thrift Drug contended that Dr. Shane’s testimony did not meet the Frye standard. The Superior Court restated the following language from Frye as dispositive of this issue: "While courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs." The Superior Court noted that "the essence of admissibility is general acceptance...we are merely stating the law in Pennsylvania when we state that Frye applies only to novel science."

The opinion also stated that Pennsylvania courts in McKenzie v. Westinghouse Elec. Corp.,and Blum v. Merrell Dow Pharmaceuticals, Inc., have cited Frye as requiring "two bases" for analysis of whether expert testimony is admissible:

the expert’s methodology, and

the expert’s conclusion on causation.

An analysis of both centers on whether the expert’s methodology and the expert’s conclusion are either novel (and thus inadmissible) or generally accepted by the scientific community. The previous opinions, Blum specifically, held that if either the methodology or the conclusion was novel, the testimony was inadmissible. The Superior Court cited the dissents in the affirmance of Blum and Daubert to support its rejection of the "two bases" analysis. "[I]t appears as if the two bases analysis arose from confusing principles with conclusions." The Superior Court’s decision stressed that under Pennsylvania law, only the methodology need be generally accepted.

The Superior Court confronted the issue that the trial court had not faced: it distinguished the uncertainty of Dr. Shane’s testimony. The trial court had conceded that Dr. Shane could not testify to a reasonable degree of medical certainty that Trach sustained the injuries that he alleged from the Doxepin overdose because no studies on the effect of such an overdose were available. Thus, "Dr. Shane’s opinions on these issues were based on his own reasoning from general toxicological principles." The Court also noted: "There is no evidence that any other members of the medical community share his conclusions or concur in his reasoning process."

The Superior Court was not concerned with Dr. Shane’s use of "extrapolation," i.e., the projection of what a massive overdose of Doxepin might have done based on what smaller doses have done. Dr. Shane’s use of extrapolation in this case, in the opinion of the Superior Court, led to a "logical inference that a substance known to cause adverse side effects in its recommended dose is likely to cause a heightened level of the same or similar adverse effects when taken in a massive overdose."

Defendants should be concerned about the Superior Court’s ruling. This decision permits an expert to present any opinion to a jury as long as the court finds that the methodology from which the opinion was generated is "generally accepted." The Superior Court’s discussion of the patent fallibility of Dr. Shane’s testimony – inherent in the use of extrapolation as opposed to hard data – and the defendant’s duty to expose it with "vigorous cross-examination" is practically useless. The Superior Court seems to have forgotten that by the time cross-examination begins, the expert’s opinion (flawed, questionable or otherwise) is already before the jury. The only redeeming characteristic of the opinion is its recognition that its rationale is applicable only in specific, limited circumstances.

Pennsylvania Cases

Courts in Pennsylvania have precluded experts from testifying in a number of areas including:

Blum v. Merrell Dow Pharmaceuticals, Inc., 564 Pa. 3, 764 A.2d 1 (2000) (precluding expert testimony that an infant's clubbed feet resulted from ingestion of the drug Benedectin by mother during fetal gestation);

Thomas v. West Bend Co., 760 A.2d 1174 (Pa. Super. 2000) (precluding expert testimony that plaintiff's low voltage shock from popcorn popper caused plaintiff's cardiomyopathy);

Checchio v. Frankford Hospital-Torresdale Div., 717 A.2d 1058 (Pa. Super 1998) (precluding expert testimony that infant's oxygen deprivation within 12 hours after birth caused autism);

Grady v. Frito-Lay, Inc., 576 Pa. 546, 839 A.2d 1038 (2003) (precluding expert testimony that corn chips ingested by plaintiff contained hidden-hazardous physical-strength and physical-shape properties);

Riccio v. S&T Contractors, 2001 WL 1334202 (Pa.Com.Pl. 2001) (precluding expert testimony on the causation of fibromyalgia).

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