Schering Corporation v. Pfizer Inc. And Ucb Pharma, Inc.

189 F.3d 218
CourtCourt of Appeals for the Second Circuit
DecidedSeptember 29, 1999
Docket1998
StatusPublished
Cited by168 cases

This text of 189 F.3d 218 (Schering Corporation v. Pfizer Inc. And Ucb Pharma, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Second Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Schering Corporation v. Pfizer Inc. And Ucb Pharma, Inc., 189 F.3d 218 (2d Cir. 1999).

Opinion

SOTOMAYOR, Circuit Judge:

This appeal invites us to revisit an increasingly important issue in the law of evidence, and one that has confused many courts. Today we clarify the circumstances under which scientifically conducted surveys may be admitted into evidence over a hearsay objection. The case comes to us on appeal from an order of the United States District Court for the Southern District of New York (McKenna, J.) denying a motion for a preliminary injunction made by plaintiff-appellant Schering Corporation (“Schering”) against defendants-appellees Pfizer Inc. (“Pfizer”) and UCB Pharma, Inc. (“UCB”). The primary evidence Schering offered in support of its motion were the results of five surveys in which physicians were asked to relate their memories, and sometimes their impressions, of communications that defendants’ sales representatives had made in the course of their promotional campaigns. Schering offered these surveys to support the more general proposition that defendants’ representatives were engaging in widespread false promotional activity in violation of both the Lanham Trade-Mark Act, 15 U.S.C. § 1051 et seq. (1994) (the “Lanham Act”), and a settlement agreement between the parties. The district court excluded all five surveys on hearsay grounds and then ruled that there was insufficient evidence to support a preliminary injunction.

We hold that two of the surveys in this case, which polled physicians’ impressions of the communications at issue, should have been admitted under the present state of mind exception to the hearsay rule, see FedR.Evid. 803(3), for the limited purpose of establishing a pattern of implied falsehood. We also find that in determining whether to admit the five surveys to establish literal falsehoods under the residual hearsay rule, see Fed.R.Evid. 807, the district court relied on an erroneous per se rulé against memory surveys offered to prove the facts remembered. The court thereby abused its discretion, and we remand to the court to determine the surveys’ trustworthiness on the basis of their methodological strengths and their relative susceptibilities to the risks of faulty memory and perception. Finally, we hold that the district court should have admitted one of the surveys, which Pfizer itself commissioned, as well as Pfizer’s internal analysis of this survey as party admissions. See Fed.R.Evid. 801(d)(2).

Because the survey evidence was integral to Schering’s case, we vacate the district court’s denial of a preliminary injunction and remand for reconsideration.

BACKGROUND

Schering is a pharmaceutical corporation that produces Claritin, a leading prescription antihistamine. A factor that strongly contributes to success in the antihistamine market is whether a drug can deliver effective relief from hay fever and other allergy symptoms without causing drowsiness. The first generation of antihistamines, introduced in the 1940s, caused drowsiness in a high percentage of users, and modern over-the-counter antihistamines have this same effect. Claritin, by contrast, is a new, second-generation prescription antihistamine, launched in 1993, which causes no more sedation than placebos in clinical tests. This feature has been important to Claritin’s market success.

UCB is a European pharmaceutical company that has developed a competing second-generation prescription antihistamine called “Zyrtec.” Because of UCB’s limited *222 presence in the United States, UCB licensed Pfizer, a Delaware corporation, to co-proraote the product domestically. Regulations promulgated by the United States Food and Drug Administration (“FDA”) required Pfizer to perform several controlled clinical tests on Zyrtec before the drug could be registered for domestic use, however, and these tests revealed that Zyrtec causes approximately twice as much sedation as a placebo. The FDA therefore required Pfizer to caution both physicians and consumers, through proper labeling and warning instructions, that Zyrtec has these sedating qualities. The FDA also warned Pfizer that it would be misleading to advertise Zyrtec by focusing on the rate at which customers discontinued using the drug because of somnolence (ie., 1%) rather than the drug’s somnolence level itself (ie., 11-14%).

In early 1996, Pfizer and UCB began selling Zyrtec in the United States. To promote the product, Pfizer used a method that is common in the pharmaceutical industry: it employed a team of approximately 1200 sales representatives to visit physicians across the nation and emphasize the product’s qualities in one-on-one informational meetings called “detailings.” In these meetings, Pfizer representatives were to promote Zyrtec, persuade doctors to prescribe it more often and respond to any questions or concerns that doctors might have about the drug. No records were kept of these meetings.

Suspicious that Zyrtec representatives might be misrepresenting the product’s somnolence levels in the detailings, Scher-ing hired IMS America, a commercial vendor of market surveys, to conduct a survey of physicians to determine whether any such misrepresentations were being made. The survey results led Schering to believe that they were. In February 1996, Scher-ing thus filed suit against Pfizer for violating Section 43(a)(2) of the Lanham Act, 15 U.S.C. § 1125(a)(2) (1994), by false advertising. See Schering Corp. v. Pfizer, Inc., No. 96 Civ. 1462(LMM) (S.D.N.Y. Feb. 29, 1996). On April 4, 1996, this dispute ended in a settlement agreement (the “Settlement Agreement”), under which Pfizer and UCB agreed not to permit their sales representatives to state either ‘expressly’ that Zyrtec was ‘lowsedating’ or ‘expressly or by implication’ that Zyrtec was ‘nonsedat-ing’ or ‘essentially nonsedating.’ These restrictions applied to all forms of advertising, including “verbal statements made to doctors.”

In order to monitor Pfizer’s and UCB’s compliance with the Settlement Agreement, Schering hired DTW in early 1998 to perform another survey of physicians concerning statements being made in the detailings. This survey polled 78 physicians who had been detailed between March 30 and June 5, 1998, and who were allegedly representative of a panel of over 6000 physicians nationwide who prescribe high volumes of antihistamines. 1 The doctors were asked the following question on the same day as the detailings:

What did the sales representatives tell you about [Zyrtec]? Please be as specific and complete as you can in describing the message or information that was conveyed to you about [Zyrtec].

The survey results suggested that approximately 30% of the Zyrtec agents were representing that the drug was either low sedating or nonsedating.

Schering subsequently commissioned a second survey from DTW, which was customized to be representative of a panel of over 6000 physicians nationwide who prescribe antihistamines in any amount.

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189 F.3d 218, Counsel Stack Legal Research, https://law.counselstack.com/opinion/schering-corporation-v-pfizer-inc-and-ucb-pharma-inc-ca2-1999.