Sabel v. Mead Johnson & Co.

MARK L. WOLF, DISTRICT JUDGE.

Plaintiffs have brought this action against defendant Mead Johnson & Co., a pharmaceutical manufacturer, alleging that on October 10, 1983 its antidepressant medication Desyrel caused Paul Sabel to develop a priapism, a prolonged, painful erection, which ultimately required surgery and left him impotent. They seek to recover on theories of negligence and breach of warranty concerning the warnings for Desyrel.

Plaintiffs seek to introduce three pieces of evidence at trial over defendant’s objections. These items are: 1) the tape and transcript of a March 21, 1983 meeting sponsored by defendant in Tucson, Arizona (the “Tucson tape”); 2) an April, 1984 letter written to defendant by Dr. Paul Leber, the director of the Food and Drug Administration’s (the "FDA") Division of Neuropharmacological Drug Products (the “Leber letter”); and 3) notes of two June, 1983 telephone conversations with Richard Yeager, an employee in defendant’s Regulatory Affairs department, made by Mr. Barash, an FDA employee (the “Barash notes”).

[EDITOR’S NOTE: This edited opinion only covers the Tucson Tape to convey the pedagogical point surrounding Federal Rule of Evidence 801(d)(2)]

For the reasons stated below, the court finds . . . that the Tucson tape, with the exception of statements made by full-time Mead Johnson employees, constitutes inadmissible hearsay. . . .

I. The Tucson Tape

The Tucson meeting was convened by Mead Johnson on March 21, 1983 to explore several aspects of the unexpected, but increasingly apparent association of Desyrel with priapism. The meeting was attended by five outside medical experts invited by Mead Johnson, as well as two employees of its Pharmaceutical Medical Services department. The meeting was chaired by Dr. Rubin Bressler, one of the outside experts, who had performed research sponsored by defendant in the past. One of the ten questions suggested for discussion at the meeting was “What should we tell the prescribing physician?” In general, topics discussed at the meeting included the potential pharmacological mechanisms by which Desyrel could cause priapism, possible avenues of research into the association of Desyrel with priapism, and what warnings to physicians should appropriately accompany Desyrel.

As a threshold matter, the court rejects defendant’s contention that the tape and transcript of the Tucson meeting are irrelevant. The thoughts of the invited experts on the content of appropriate warnings reflects on the adequacy of defendant’s warnings prior to plaintiff’s injury. In addition, these discussions are relevant to the related point of the information which Mead Johnson had concerning the adequacy of their warnings and, thus, to the reasonableness of their conduct during the relevant period. Defendant’s assertions that the outside consultants were not experts on labeling, and that they formed their opinions on the basis of incomplete information and analysis, affects the weight and not the relevance of the proffered evidence.

Plaintiffs seek to introduce the tape and transcript as an admission of Mead Johnson under F.R.Ev. 801(d)(2), which provides, in pertinent part, that an out-of-court statement is not hearsay if “the statement is offered against a party and is . . . (C) a statement by a person authorized by the party to make a statement concerning the subject, or (D) a statement by the party’s agent or servant concerning a matter within the scope of the agency or employment, made during the existence of the relationship.” Admissibility under these two provisions is governed not by the trustworthiness of the statement, but by the existence and scope of the principal-agent relationship as determined under the common law of agency. . . . Plaintiffs have not carried their burden of demonstrating the existence of an agency relationship between defendant and the outside invitees. Thus, invitees’ statements at the Tucson meeting are hearsay.

An agency relationship has three essential characteristics: 1) the power of the agent to alter the legal relationships between the principal and third parties and the principal and himself; 2) the existence of a fiduciary relationship toward the principal with respect to matters within the scope of the agency; and 3) the right of the principal to control the agent’s conduct with respect to matters within the scope of the agency. Restatement (Second) of Agency §§ 12-14 (1958). The courts have looked primarily at the issue of control in determining whether an agency relationship exists. See United States v. Paxson, . . . (admitting statement of corporate employee against corporate superior under Rule 801(d)(2)(D) where employee reported directly to superior); United States v. Young,. . .; United States v. Mandel,. . .(in criminal prosecution of governor, Rule 801(d)(2)(D) covered statements of governor’s legislative aides, but not of state senators); see also North American Van Lines, Inc. v. NLRB,. . .(right to control means and manner of performance the central inquiry in determining agency status for purposes of defining NLRB jurisdiction); Allbritton Communications Co. v. NLRB,. . .; Afonso v. City of Boston,. . .(liability to direction and control the essential element in existence of master-servant relationship). Payment for services is relevant only to the extent that it bears on the issue of control. Afonso. . . . Similarly, consent to control and to act in a fiduciary manner is important to a finding of an agency relationship. See Abatti v. C.I.R. . . . (admitting binders prepared by defendant’s accountant where accounting arrangements delegated to him); United States v. Summers,. . .(excluding taped statements of defendant’s former agent on grounds that he could not be agent of defendant and informant for FBI at same time); see also Johnson v. Bechtel Associates Professional Corp.,. . . (interpreting meaning of “agent” in context of indemnification statute), rev’d on other grounds sub nom. Washington Metro. Area Transit Auth. v. Johnson. . . .

In the present case, it does not appear that Mead Johnson controlled the manner or means of discussion and analysis employed by the participants at the Tucson meeting. To the contrary, the tape and transcript of the meeting indicate it was a free-wheeling exchange of ideas, loosely moderated by one of the outside consultants. [Footnote 1] It is not apparent who developed the agenda for the meeting. Although Mead Johnson financed the meeting and provided the factual information underlying the bulk of the discussion, there is no evidence in the transcript or otherwise that its employees sought to foreclose avenues of inquiry or to prevent the expression of potentially damaging ideas.

== Footnote 1 ==
Although Dr. Bressler had apparently conducted research sponsored by Mead Johnson previous to the meeting, no evidence has been presented that he was an employee of Mead Johnson or that Mead Johnson controlled or influenced his research beyond the mere fact of sponsorship.
== End Footnote ==

In addition to Mead Johnson’s apparent lack of control, there is no evidence that the consultants were empowered to speak or act on Mead Johnson’s behalf. See Ellis v. Kneifl,. . .(statements of clerk of state court not admissible in suit against state court judge because clerk not authorized to act on judge’s behalf). Mead Johnson never expressed an intent to be bound by the recommendations of the outside experts, nor did it even authorize or request them to prepare a written report on their findings and recommendations. The diversity of opinions expressed at the meeting, and the lack of resolution of differences among the experts, supports defendant’s characterization of the meeting as a “brainstorming session,” intended to generate ideas for defendant’s further consideration, but not meant to establish its official position in any way.

F.R.Ev. 801(d)(2)(D) expanded the traditional admissions exception to the hearsay rule to include statements made by agents on matters within the scope of their agency, on the theory that an agent authorized to act on a principal’s behalf is impliedly authorized to speak on the same matters. J. Weinstein & M. Berger, supra, at para. 801(d)(2)(D)⁰¹. Here, however, plaintiffs have not shown that the consultants possessed the power to act on defendant’s behalf in any respect, much less that they enjoyed the specific “speaking authority” contemplated by F.R.Ev. 801(d)(2)(C). Where defendant did not control the participants in the discussion, where the participants lacked the power to legally bind defendant through their statements and actions, and where the participants did not enter into a fiduciary relationship with defendant, the factors which support attribution of an agent’s statements to her principal are completely missing. Mead Johnson could not control the actions or statements of the participants in the Tucson meeting; nor would it have had reason to do so, given the unforeseeability that the statements of those individuals would be attributed to it in a court of law.

The cases cited by plaintiffs in support of admission are distinguishable. In Reid Brothers Logging Co. v. Ketchikan Pulp Co.,. . ., the court held that a report prepared by an employee of defendant’s corporate parent on defendant’s business operations was admissible under F.R.Ev. 801(d)(2)(C) as an admission of defendant. The author of the report was given full access to defendant’s records and was aided by defendant’s employees, and defendant circulated the report to its directors, officers and managers. Under such circumstances, the court concluded, the employee was authorized by defendant to make statements regarding its business operations and the defendant adopted these statements by adopting his report. Here, by contrast, Mead Johnson controlled the information given to the outside consultants, did not request or receive a final report from them, and did not adopt as its own the ideas expressed during the meeting. Moreover, the statements made by the experts were off-the-cuff, rather than opinions carefully formulated after thorough investigation and analysis. Collins v. Wayne Corp.,. . ., is distinguishable from the present case on essentially the same grounds. Id. at 780-82 (report of expert hired by defendant to investigate and analyze bus accident admissible under F.R.Ev. 801(d)(2)(C) because expert was a “speaking agent” of defendant).

Although the Tucson tape is not rendered non-hearsay by F.R.Ev. 801(d)(2), it could possibly be admitted for non-hearsay purposes. For example, the tape could demonstrate that Mead Johnson knew as of March, 1983 that several scientific experts thought its existing warnings were inadequate. A second, but related, purpose would be to show the context within which defendant took its subsequent remedial actions, such as the formation of a Desyrel task force and the preparation of a May, 1983 letter to doctors addressing, among other things, the risk of priapism. Overwhelming these relevant and probative purposes, however, are the dangers of unfair prejudice and confusion which introduction of the tape would entail.

First, as defendant points out, the outside participants in the Tucson meeting had not engaged in extensive analysis or thought on the problem of priapism in general or the adequacy of defendant’s warnings in particular. The consultants first learned much of the data underlying their expressed views on the day of the conference. They also frequently took positions merely for the sake of provoking discussion. The tape indicates that several seemingly damaging statements about the company were made in jest. Much irrelevant discussion occurred concerning other drugs, other companies, other side effects, and other medical problems.

In addition, the qualifications of the speakers, and thus the weight to be given their opinions, cannot be accurately assessed. Their expertise on the issue of warnings cannot be determined from the evidentiary record, nor can such basic facts as whether they are treating physicians or solely clinical researchers. Indeed, most statements on the tape cannot be accurately attributed to a particular speaker. Under these circumstances, there is a significant danger that the jury would give the expressed opinions far greater weight than they deserve.

The court also has serious doubts whether, because of the close relationship between the possible non-hearsay and hearsay purposes of the tape (i.e. — defendant’s knowledge of the experts’ opinions on the adequacy of the warnings versus the adequacy of the warnings themselves), it could fashion an appropriate and effective limiting instruction.

The plaintiffs have offered considerable other evidence on the inadequacy of the warning for Desyrel in the relevant period, as well as on the non-hearsay purposes for which the tape of the Tucson meeting is offered. In these circumstances, the probative value of the tape for non-hearsay purposes is substantially outweighed by the risk of confusion and unfair prejudice. Thus, F.R.Ev. 403 precludes admission of the tape for the previously described non-hearsay purposes. Cf. City of New York v. Pullman Inc.,. . . (excluding interim government report under Rule 403 where “as a so-called government report which in fact was incomplete and based largely on hearsay, the report would have been presented to the jury in ‘an aura of special reliability and trustworthiness’ which would not have been commensurate with its actual reliability”). . . .