Chapter 13 Evidentiary Issues Unique to Product Liability Litigation in Federal Court

• Jurisdiction: New York

CHAPTER THIRTEEN EVIDENTIARY ISSUES UNIQUE TO PRODUCT LIABILITY LITIGATION IN FEDERAL COURT William G. Gandy, Esq.
Jason R. Waters, Esq.*

I. INTRODUCTION

Few considerations affect the conduct and outcome of product liability litigation as profoundly as evidentiary matters. The trial court’s decision to admit or preclude expert testimony can make the difference between summary judgment for the defense and a substantial verdict for the plaintiff. Evidence of a product’s compliance with a trade association standard could sway the jury’s opinion regarding a product’s safety. A government agency’s findings about a product or a product-related accident may also influence the outcome of litigation. And subsequent remedial measures, such as design changes and product recalls, implicate important public policy considerations. This chapter will address these evidentiary issues as they relate to product liability cases in New York’s federal courts

II. FEDERAL RULES CONCERNING THE ADMISSIBILITY OF EXPERT TESTIMONY

Product liability cases frequently require juries to consider complicated evidence of scientific and technical matters, such as engineering, toxicology, and epidemiology. Parties rely extensively on expert witnesses to present such evidence to the jury. As a result, the court’s evidentiary decisions about expert testimony are particularly important to the outcome of any product liability case. Not surprisingly, evidentiary standards for admitting expert testimony have a long and complicated history in federal courts

A. Frye v. United States and “General Acceptance”

The “general acceptance” test, as stated in Frye v. United States ²⁴⁰⁹ was the “dominant standard for determining admissibility of novel scientific evidence at trial” for several decades ²⁴¹⁰ In 1923, the U.S. Court of Appeals for the District of Columbia Circuit addressed the admissibility of a blood-pressure deception test. This device purported to measure changes in blood pressure as a gauge of a subject’s veracity. ²⁴¹¹ During a murder trial, the defendant asked the court to admit his blood-pressure test results into evidence, along with the testimony of the scientist who administered the test. He also requested an opportunity to repeat the blood-pressure test at trial before the jury. The trial court excluded the evidence, and the defendant was convicted. ²⁴¹²

On appeal, the circuit court affirmed the decision to preclude this evidence. The court concluded that the blood-pressure deception test was not sufficiently reliable to be admitted into evidence:

• Just when a scientific principle or discovery crosses the line between experimental and demonstrable stages is difficult to define. Somewhere in this twilight zone the evidential force of the principle must be recognized, and 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.²⁴¹³

Initially, the “general acceptance” standard was followed with little debate. ²⁴¹⁴ In the decades following the Frye ruling, however, the “general acceptance” approach became the subject of increasing criticism with several courts limiting or modifying its application and a minority even rejecting Frye. ²⁴¹⁵ Furthermore, Frye’s application in product liability litigation raised questions because toxic tort and pharmaceutical cases frequently depend on scientific theories of causation that are novel and untested. ²⁴¹⁶

The adoption of the Federal Rules of Evidence in 1975 raised even more questions about Frye’s “general acceptance” standard. Although the Rules included instructions about the admissibility of expert testimony, they did not address whether Frye remained viable authority. ²⁴¹⁷ Rules 702 and 703 did not state specifically whether they incorporated “general acceptance” as a requirement for admissibility. ²⁴¹⁸ The advisory committee’s note was equally silent about whether trial courts could reject Frye. ²⁴¹⁹ Therefore, while some courts continued to apply Frye, others construed Rules 702 and 703 as rejecting “general acceptance” as the test for admitting expert testimony. ²⁴²⁰

B. Daubert v. Merrell Dow Pharmaceuticals, Inc.

To resolve the confusion about whether the Rules overturned Frye’s “general acceptance” standard, the U.S. Supreme Court granted certiorari in Daubert v. Merrell Dow Pharmaceuticals, Inc., in 1993 ²⁴²¹ Daubert involved claims that Bendectin, a prescription anti-nausea drug marketed by Merrell Dow, caused two infant plaintiffs to have serious birth defects after their mothers used the drug during their respective pregnancies. The plaintiffs claimed that Merrell Dow concealed, in its own laboratory, the discovery that animals exhibited adverse reactions to Bendectin. The plaintiffs’ suit also asserted that Merrell Dow failed to provide warnings consistent with those findings. ²⁴²²

Merrell Dow challenged the plaintiffs’ evidence of causation and moved for summary judgment. In support of its motion, Merrell Dow submitted the affidavit of an epidemiologist who asserted that there were no published epidemiological studies demonstrating a statistically significant association between Bendectin and birth defects. In response, the plaintiffs submitted affidavits from eight experts to show that several studies established this link. Among those studies were analyses of test-tube and live-animal data. The plaintiffs’ experts also presented pharmacological studies to show similarities between the chemical structure of Bendectin and other substances known to cause birth defects. Additionally, the plaintiffs’ experts re-analyzed previously published epidemiological reports. ²⁴²³

Concluding that the plaintiffs failed to demonstrate that their expert evidence was “sufficiently established to have general acceptance to the field to which it belongs,” the U.S. District Court for the Southern District of California ruled that the plaintiffs’ expert testimony was inadmissible to establish causation. The district court found that the plaintiffs’ evidence was not based on the “vast body of epidemiological data concerning Bendectin.” The court faulted the plaintiffs’ experts because they relied on recalculations of previously published data, which found no causal link between the drug and birth defects. The court also noted that the studies the plaintiffs’ experts relied on had not been published or subjected to peer review. ²⁴²⁴ The Ninth Circuit affirmed because “expert opinion based on a methodology that diverges significantly from the procedures accepted by recognized authorities in the field cannot be shown to be generally accepted as a reliable technique.” ²⁴²⁵

On appeal, the Supreme Court acknowledged that Frye’s “general acceptance” standard had been the subject of increasing attack, particularly after adoption of the Federal Rules of Evidence. But the Court also observed that a majority of circuits, including the Ninth Circuit, continued to apply the “general acceptance” test. Based on its review of Frye and the Federal Rules of Evidence, the Court concluded that the Rules “occupy the field.” ²⁴²⁶ Rule 702 specifically addressed the admissibility of expert opinion and testimony, and the Court observed nothing in the Rule’s text establishing “general acceptance” as “an absolute prerequisite” to admissibility. The Court also noted that the drafting history of Rule 702 does not mention Frye. Therefore, the Court concluded that the Rules did not assimilate Frye because “Frye made ‘general acceptance’ the exclusive test for admitting expert scientific testimony [and] [t]hat austere standard, absent from, and incompatible with, the Federal Rules of Evidence, should not be applied in federal trials.” ²⁴²⁷

Upon concluding that the Rules did not adopt Frye’s “general acceptance” standard, the Court continued to evaluate the standards of admissibility for expert testimony. The Court advised trial judges that their duties to screen expert evidence remained unchanged, and the Court charged the district courts to ensure that “any and all scientific testimony or evidence admitted is not only relevant, but reliable.” ²⁴²⁸ The “primary locus” of the trial judge’s responsibility for screening expert evidence for admissibility is embedded in Rule 702, “which clearly contemplates some degree of regulation” of an expert’s testimony. ²⁴²⁹

The content of a proposed expert’s testimony must be “scientific knowledge,” with “scientific” implying a foundation in the methods and procedures of science and “knowledge” meaning more than a subjective belief or unsupported speculation. The Court rejected Frye to the extent it had been interpreted to require the subject of scientific testimony to be known to a certainty because there are no certainties in science. ²⁴³⁰ Instead, the Court held that an expert’s assertion must be derived by the scientific method. In other words, proposed testimony must be supported by appropriate validation, meaning “ ‘good grounds,’ based on what is known.” ²⁴³¹

The Court also identified several non-exhaustive and non-definitive factors to assist the trial judge in performing the screening, or “gatekeeping,” function. These factors include evaluating: (1) whether the particular theory or technique can be and has been tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) the known or potential rate of error of a particularly scientific technique, including the maintenance of standards controlling the technique’s operation; and (4) whether the principle has achieved general acceptance by the relevant scientific community. ²⁴³²

Although Rules 702 and 703 did not adopt Frye, the Court acknowledged that the degree of

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