## Facts

- Plaintiffs brought a products-liability action alleging that Mead Johnson’s antidepressant Desyrel caused priapism requiring surgery and resulting in impotence.
- Plaintiffs pursued negligence and breach of warranty theories centered on the adequacy of warnings about priapism risk.
- Before trial, the court resolved admissibility disputes concerning three proposed exhibits offered primarily to show Mead Johnson’s knowledge, notice, and conduct regarding priapism and warnings.
- Mead Johnson sponsored a March 21, 1983 meeting in Tucson to address the reported association between Desyrel and priapism; attendees included outside medical experts and Mead Johnson personnel, and the meeting was recorded (the “Tucson tape”).
- In April 1984, an FDA division director sent Mead Johnson a letter reflecting the agency’s assessment of Desyrel and related labeling issues (the “Leber letter”).
- An FDA employee made notes of two June 1983 telephone conversations with a Mead Johnson regulatory affairs employee about Desyrel and priapism (the “Barash notes”).

## Issues

1. Whether the Tucson tape’s recorded statements were admissible as party-opponent admissions under Federal Rule of Evidence 801(d)(2) or for a non-hearsay purpose, and whether exclusion was warranted under Rule 403.
2. Whether the Leber letter was admissible as a public record containing factual findings from a legally authorized investigation under Rule 803(8)(C).
3. Whether the Barash notes were admissible under Rule 803(8) or any other hearsay exception despite containing layered hearsay.

## Decision

- The court excluded most of the Tucson tape as hearsay; only statements made by full-time Mead Johnson employees qualified as potential party admissions.
- The court admitted the Leber letter under Rule 803(8)(C) as an FDA investigative findings record with sufficient indicia of trustworthiness.
- The court excluded the Barash notes as inadmissible hearsay not covered by Rule 803(8) or other exceptions, emphasizing their informal nature and double-hearsay problems.

## Legal Principles

- Statements by non-employee outside experts are not admissible as party admissions under Rule 801(d)(2)(C) or (D) absent an adequate showing of authorization to speak or an agency relationship within the scope of the statement.
- Evidence offered for a limited non-hearsay purpose (such as notice or state of mind) may still be excluded under Rule 403 when the danger of unfair prejudice, confusion, or misuse substantially outweighs probative value.
- An FDA letter may be admitted under Rule 803(8) when it reflects factual findings resulting from an investigation conducted pursuant to legal authority and the circumstances support trustworthiness.
- Informal agency notes summarizing conversations generally do not constitute “factual findings” of an investigation for Rule 803(8) purposes and may be excluded where they present hearsay-within-hearsay and reliability concerns.

## Conclusion

In this pretrial evidentiary ruling, the court permitted plaintiffs to use an FDA findings letter as substantive evidence under the public-records exception, but largely excluded a manufacturer-sponsored meeting recording and an FDA employee’s conversation notes as hearsay, limiting admissible admissions to statements by the manufacturer’s own employees and applying strict reliability and prejudice controls.


Sabel v. Mead Johnson & Co., 737 F. Supp. 135 (D. Mass. 1990)