Case Summary

P1186 Although compliance with statute or administrative rules generally is not a defense to tort liability, instructing the jury that action or inaction by the FDA, though not dispositive, could be considered to show whether a product was safe or not safe was not error; the Kelly rule, which requires testimony based on application of a new scientific technique to meet criteria relating to scientific reliability controls admission of evidence based on new scientific methodology, but not evidence of the degree of professionalism with which the methodology was applied; admission of evidence as a party admission requires proof the declarant had implied authority to make such admissions, and this cannot be determined solely from declarant's title; admission of evidence as former testimony requires proof that the declarant is presently unavailable and that parties to the action in which it was given had a motive to cross-examine similar to that of the party against whom the testimony is now offered; judicial notice of court records cannot be taken to prove the truth of facts found and recited in those records.

O'NEILL v NOVARTIS (FDA Standards) 147 CA4 1388 [See: Ramirez v Plough 6 C4 539, T/AT 2/94; People v Kelly 17 C3 24; O'Mary v Mitsubishi 59 563, T/AT 1/98; Gatton v Green 64 688, T/AT 7/98]