Sabel v. Mead Johnson & Co.
737 F. Supp. 135 (1990)
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Rule of Law:
Statements by outside consultants are not admissible as party-opponent admissions under F.R.Ev. 801(d)(2) if the consultants are not agents under the principal's control. However, a letter from a government agency containing factually-based opinions and conclusions is admissible as a public record under F.R.Ev. 803(8)(C) if it is trustworthy and results from an investigation made pursuant to legal authority.
Facts:
- Mead Johnson & Co. manufactured an antidepressant medication called Desyrel.
- The company became aware of an association between Desyrel and priapism, a prolonged, painful erection.
- On March 21, 1983, Mead Johnson sponsored a meeting in Tucson, Arizona with five outside medical experts and two of its employees to discuss the link between Desyrel and priapism, including potential warnings for physicians.
- In June 1983, Richard Yeager, a Mead Johnson employee, had two telephone conversations with Mr. Barash, an FDA employee, regarding proposed labeling changes for Desyrel.
- On October 10, 1983, Paul Sabel ingested Desyrel and subsequently developed priapism.
- Sabel's condition required surgery, which resulted in his permanent impotence.
- In April 1984, Dr. Paul Leber, director of the FDA’s Division of Neuro-pharmacological Drug Products, sent a letter to Mead Johnson recommending a boxed warning be added to Desyrel's label to emphasize the risk of priapism.
Procedural Posture:
- Paul Sabel and his co-plaintiffs sued Mead Johnson & Co. in the U.S. District Court for the District of Massachusetts.
- The complaint alleged claims of negligence and breach of warranty concerning the warnings provided for the drug Desyrel.
- During pre-trial proceedings, Plaintiffs filed a motion to introduce three pieces of evidence.
- Defendant Mead Johnson & Co. filed objections to the admissibility of all three items.
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Issue:
Under the Federal Rules of Evidence, do out-of-court statements from outside consultants at a company-sponsored meeting, a letter from an FDA official, and an FDA employee's notes of a phone call fall within exceptions to the hearsay rule, such as party admissions or public records, to be admissible in a product liability case?
Opinions:
Majority - Wolf, District Judge
No, for the consultants' statements and the employee notes, but Yes, for the FDA letter. The admissibility of each piece of evidence depends on whether it meets the specific requirements of a hearsay exception. The court held: 1. Tucson Tape (Inadmissible): The statements made by the outside medical experts are inadmissible hearsay. They do not qualify as admissions of a party-opponent under F.R.Ev. 801(d)(2)(C) or (D) because the experts were not agents of Mead Johnson. The court found no evidence that Mead Johnson controlled the experts, that the experts were authorized to speak for the company, or that a fiduciary relationship existed. The court characterized the meeting as a 'free-wheeling exchange of ideas' or 'brainstorming session.' Furthermore, even if offered for a non-hearsay purpose (such as to prove notice), the tape is excluded under F.R.Ev. 403 because its probative value is substantially outweighed by the danger of unfair prejudice and confusing the jury, given the off-the-cuff nature of the statements. 2. Leber Letter (Admissible): The letter from FDA Director Dr. Leber is admissible under the public records exception to the hearsay rule, F.R.Ev. 803(8)(C). Citing the Supreme Court's decision in Beech Aircraft Corp. v. Rainey, the court found that the rule encompasses factually-based conclusions and opinions. The letter qualifies as 'factual findings resulting from an investigation made pursuant to authority granted by law,' as the FDA was acting within its statutory duty to regulate drug safety. The court also found the letter to be trustworthy, considering the expertise of the agency, the lack of bias, and the reliability of the sources on which the opinion was based. 3. Barash Notes (Inadmissible): The handwritten notes of an FDA employee, Mr. Barash, memorializing phone calls with a Mead Johnson employee are inadmissible hearsay. They do not fall under any subsection of F.R.Ev. 803(8). The notes are not a record of agency 'activities' (A), they do not document 'matters observed pursuant to duty' (B), and they are not 'factual findings resulting from an investigation' (C). The court described them as informal memoranda lacking the 'built-in indicia of reliability' that underpins the public records exception.
Analysis:
This decision provides a clear framework for analyzing the admissibility of different types of third-party statements in product liability litigation. It reinforces the narrow definition of 'agent' for the purposes of party-opponent admissions under F.R.Ev. 801(d)(2), establishing that merely sponsoring a discussion with outside experts does not make their statements attributable to the company. More significantly, the opinion offers a robust application of the Beech Aircraft precedent, extending the public records exception in F.R.Ev. 803(8)(C) to include opinion letters from regulatory agencies like the FDA. This broad interpretation increases the potential for government documents to be used as powerful evidence concerning the adequacy of warnings or product safety, impacting litigation strategies for companies in highly regulated industries.
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