Opinion ID: 1360544
Heading Depth: 3
Heading Rank: 2

Heading: FDA Transcripts Admissible as Public Records.

Text: Next, Surgidev argues that the transcripts of the Panel hearings are hearsay and that the trial court abused its discretion by admitting them into evidence as public records. The public records exception to the hearsay rule, SCRA 1986, 11-803(H)(3) (Repl. Pamp.1994), provides for the admission of [r]ecords, reports, statements or data compilations, in any form, of public offices or agencies, setting forth ... factual findings resulting from an investigation made pursuant to authority granted by law, unless the sources of information or other circumstances indicate lack of trustworthiness. Id. Surgidev contends that the transcripts are not factual findings under SCRA 11-803(H)(3) because they contain opinions of the Panel members. The U.S. Supreme Court addressed this issue under the federal equivalent to SCRA 11-803(H)(3) in Beech Aircraft Corp. v. Rainey, 488 U.S. 153, 109 S.Ct. 439, 102 L.Ed.2d 445 (1988). In Beech Aircraft the Court considered the admissibility of an investigatory report on the cause of an airline crash. Id. at 157-59, 109 S.Ct. at 443-45. The Court held that portions of investigatory reports otherwise admissible under Rule 803(8)(C) are not inadmissible merely because they state a conclusion or opinion. As long as the conclusion is based on a factual investigation and satisfies the Rule's trustworthiness requirement, it should be admissible along with other portions of the report. Id. at 170, 109 S.Ct. at 450; see also Clark v. Clabaugh, 20 F.3d 1290, 1294 (3d Cir.1994), ([T]he [official report], which was authored by officers charged with a legal duty and authorized to conduct the investigation, is presumed admissible under Rule 803(8)(C), including its opinions, conclusions and recommendations, unless the defendants demonstrate its untrustworthiness.); Anaya v. New Mexico State Personnel Bd., 107 N.M. 622, 627, 762 P.2d 909, 914 (Ct.App.) (noting that findings included conclusions and opinions of the factfinder), cert. denied, 107 N.M. 673, 763 P.2d 689 (1988). The Beech Aircraft Court noted: Rather than requiring that we draw some inevitably arbitrary line between the various shades of fact/opinion that invariably will be present in investigatory reports, we believe the Rule instructs usas its plain language statesto admit reports ... setting forth ... factual findings. The Rule's limitations and safeguards lie elsewhere: First, the requirement that reports contain factual findings bars the admission of statements not based on factual investigation. Second, the trustworthiness provision requires the court to make a determination as to whether the report, or any portion thereof, is sufficiently trustworthy to be admitted. Beech Aircraft, 488 U.S. at 169, 109 S.Ct. at 449-50. The Court pointed out four factors that help determine trustworthiness in a report: (1) the timeliness of the investigation; (2) the investigator's skill or experience; (3) whether a hearing was held; and (4) possible bias when reports are prepared with a view to possible litigation. Id. at 167 n. 11, 109 S.Ct. at 449 n. 11. In addition, the court in Kehm v. Procter & Gamble Manufacturing Co., 724 F.2d 613, 618 (8th Cir.1983), noted that the burden of proving untrustworthiness is on the party opposing admission of the report. The Kehm court pointed out: The public records and reports exception rests on the assumption that a public official will perform his duty properly and the unlikelihood that he will remember details independently of the record. The rule assumes admissibility in the first instance but with ample provision for escape if sufficient negative factors are present. The burden is on the party opposing admission to prove the report's untrustworthiness. Id. (citations omitted) (allowing admission of Center for Disease Control evaluation of toxic shock syndrome based on doctor and patient questionnaires); cf. Baker v. Firestone Tire & Rubber Co., 793 F.2d 1196 (11th Cir.1986) (finding subjective, politically-motivated congressional committee report inadmissible). In the present case the Panel was under a duty to hold hearings and make findings concerning the safety and efficacy of the Style 10 lens. Thus the Panel transcripts are presumed trustworthy. Surgidev, however, has not made any showing under the factors described in Beech Aircraft that would overcome this presumption. The Panel hearings were timely, occurring as early as 1982, before large-scale use of the Style 10 lens. The Panel was composed of expert ophthalmologists who were very familiar with the technology and surgical methods involved. Indeed, Surgidev went to great lengths to tout the Panel's expertise. Surgidev also acknowledged that its representatives were present at the hearings regarding the Style 10 and therefore could have alerted the Panel to any inaccuracies. Finally, Surgidev offers no evidence of any bias by the Panel indicating untrustworthiness. In fact, Surgidev provided all of the evidence the Panel relied on and argued strenuously that the Panel's ultimate recommendation that the FDA give the Style 10 premarket approval was scientifically sound. Surgidev's only claim for excluding the hearing transcripts is that they contain opinions. However, as discussed above, the mere fact that the transcripts contain opinions of the Panel does not render them inadmissible. Of course, Surgidev could have attempted to identify and exclude specific portions of the hearing transcripts that may have been less trustworthy or irrelevant. Beech Aircraft, 488 U.S. at 169, 109 S.Ct. at 449-50. Instead, Surgidev opted to introduce the full set of transcripts from all the Panel hearings once the trial court held that they fell within the public records exception to the prohibition against hearsay. Accordingly, we find that the trial court did not abuse its discretion by admitting the Panel hearing transcripts into evidence as public records.