ABSTRACT
The objective of this chapter is to describe the primary challenges associated with identifying, accumulating, and presenting evidence in support of presumptive claim(s). The claims made, however, are sometimes at odds with the views and standards held by the US regulatory agencies and may thus be judged not to be “truthful and not misleading,” the standard to which claims are held. The end result is often a challenge to the regulatory agency decision, whether through a meeting with the agency, through an administrative procedure (including, but not limited to a hearing before an administrative law judge), or in a federal court. The issue then becomes one of demonstrating that the claim is adequately supported by sufcient evidence according to the standard cited above-a question that often comes down to reasonableness. What then qualies as admissible evidence and how should it be presented? Gone are the days of the testimony of amboyant expert witnesses, whose credentials, personalities, and powerful presentations sway juries, which often resulted in the other side producing equally impressive experts for the traditional in-court “battle of the experts.” The court case referred to as “Daubert” [1] put an end to these dramas, mandating that the court use a gatekeeper method to assess the degree of relevance, rigor, and validity of what would be admissible. However, in a classic example of the conict between theory and practice, the gatekeepers (i.e., the judges) often lack the scientic background required to make the often ne distinctions between “good” and “bad” science. Thus, neither side in our adversarial system has provided much insight into what is required to win a case-good rhetoric or good science? This chapter favors the burden of proof over the burden of persuasion-it is a study of what has worked and what has not worked in terms of admissibility and viability in claims support in and out of the courtroom.
