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In re Pfizer Inc. Securities Litigation

March 22, 2010

IN RE PFIZER INC. SECURITIES LITIGATION


The opinion of the court was delivered by: Laura Taylor Swain, United States District Judge

OPINION AND ORDER

The above-captioned putative class action litigation has been consolidated for pretrial purposes in the Southern District of New York pursuant to the June 21, 2005, order of the Judicial Panel on Multidistrict Litigation. The member actions share factual questions arising from allegations that Pfizer, Inc. ("Pfizer"), and other named defendants violated federal and state securities laws and committed fraud by misrepresenting and/or concealing the safety risks of Pfizer's COX-2 inhibitor drugs, Celebrex and Bextra.

Pending before this Court are Plaintiffs'*fn1 and Defendants'*fn2 motions to preclude from introduction into evidence in the above-captioned matter pursuant to Federal Rules of Evidence 702 and 104(a) the testimony of certain experts regardingthe cardiovascular risk*fn3 associated with Celebrex and/or Bextra. Plaintiffs move to preclude the testimony of Defendants' expert Lee-Jen Wei, Ph.D. ("Dr. Wei"). Defendants move to preclude the testimony of Plaintiffs' experts David Madigan, Ph.D. ("Dr. Madigan"), Curt D. Furberg, M.D., Ph.D. ("Dr. Furberg"), Richard A. Kronmal, Ph.D. ("Dr. Kronmal"), Lawrence Baruch, M.D. ("Dr. Baruch"), Joel S. Bennett, M.D. ("Dr. Bennett"), and Nicholas P. Jewell, Ph.D. ("Dr. Jewell"). For the reasons stated below, both motions are denied.

BACKGROUND

Plaintiffs allege that Defendants violated federal and state securities laws and committed common-law fraud by concealing the results of various medical studies concerning two Pfizer drugs, Celebrex and Bextra, and by making misstatements and omissions in their public filings and statements. The surviving allegations and issues in this litigation are summarized in the Court's July 1, 2008, Opinion and Order (docket entry no. 90) concerning Defendants' motion to dismiss the Complaint, familiarity with which is presumed.

At Defendants' request and pursuant to this Court's January 12, 2009, order, a hearing was set "to determine whether, on or before December 17, 2004, there was reliable scientific evidence that Celebrex or Bextra was associated with increased cardiovascular risk (the Daubert hearing)." Following the submission of expert reports and the deposition of the experts at issue, both parties filed motions (docket entry nos. 139 and 144) to preclude expert testimony, together with voluminous exhibits. These motions were fully briefed on September 25, 2009. In late October 2009, the Court held a five-day Daubert hearing which included thorough direct and cross-examination of certain experts, the use of demonstrative exhibits, and the submission of extensive written direct testimony. Following the conclusion of the Daubert hearing, the Court ordered both parties to file supplemental submissions. These post-hearing submissions and all responses thereto were filed on January 8, 2010. The Court has listened carefully to all of the hearing testimony and has reviewed thoroughly the parties' written submissions, documentary evidence, and demonstratives. Readers' familiarity with that record is presumed. For the reasons that follow, both parties' motions to preclude expert testimony are denied.

DISCUSSION

Federal Rule of Evidence 702 provides that, "[if] scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case." (West 2006). Preliminary questions of admissibility are determined by the court. Fed. R. Civ. P. 104(a). Where, as here, the admissibility of expert scientific or technical testimony is challenged, the proponent of the evidence must demonstrate admissibility to the satisfaction of the Court under Rule 104(a) by establishing scientific or technical reliability by a preponderance of the evidence. See Bourjaily v. United States, 483 U.S. 171, 175-76 (1987); Falise v. Am. Tobacco Co., 258 F. Supp. 2d 63, 66 (E.D.N.Y. 2000). The determination as to whether proffered scientific or technical evidence will "assist the trier of fact to understand the evidence or to determine a fact in issue" is in essence a question of the relevance, or "fit," of the proffered evidence. See Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 590 (1993). Evidence is relevant when it has "any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence." Fed. R. Evid. 401 (West 2006). The Court must determine whether the proffered testimony has a sufficiently "reliable foundation" to permit its consideration. Daubert, 509 U.S. at 597.

Rule 702 specifically requires examination of the qualifications of the proffered expert to testify to pertinent scientific knowledge, whether the facts or data upon which the expert relies are sufficient, whether the methodology employed is valid and whether its application by the expert in formulating the testimony is proper. Id. at 592-93.

In Daubert, the Supreme Court held that the trial judge's "gatekeeping responsibility" requires the court to "ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable." Id. at 589. The Daubert Court identified a number of factors that, while not constituting a "definitive checklist or test," could be considered by a district court in evaluating the reliability of a proffered expert: "whether a theory or technique had been and could be tested, whether it had been subjected to peer review, what its error rate was, and whether scientific standards existed to govern the theory or technique's application or operation." Nimely v. City of New York, 414 F. 3d 381, 396 (2d Cir. 2005) (citing Daubert, 509 U.S. at 593-94). The trial judge should "make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field." Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999). "[T]he law grants a district court the same broad latitude when it decides how to determine reliability as it enjoys in respect to its ultimate reliability determination." Id. at 142; see also id. at 141 ("[A]s the Court stated in Daubert, the test of reliability is 'flexible,' and Daubert's list of specific factors neither necessarily nor exclusively applies to all experts or in every case."). Questions of credibility generally do not render an expert's testimony inadmissible. See Daubert, 509 U.S. at 596; Hemmings v. Tidyman's, Inc., 285 F.3d 1174, 1188 (9th Cir. 2002). Nor should district courts prejudge the weight of conflicting evidence or substitute the judgment of the court for that of the jury. See In re Joint E. & S. Dist. Asbestos Litig., 52 F.3d 1124, 1133 (2d Cir. 1995).

Here, Defendants challenge the admissibility of testimony by six individuals trained in medicine and/or statistics proffered by Plaintiffs as evidence of increased cardiovascular risk associated with Celebrex and Bextra prior to December 17, 2004. The Court, having reviewed carefully the record, is persuaded that Plaintiffs have carried their burden of demonstrating that each of their challenged witnesses is possessed of the requisite qualifications to testify as to his respective opinion regarding the interpretation of clinical trials and/or analysis and interpretation of data.

Defendants contend, among other things, that Plaintiffs' proffered evidence that there was reliable scientific evidence prior to December 17, 2004, that Celebrex and Bextra were associated with increased cardiovascular risk is inadmissible because Plaintiffs' experts have defined cardiovascular risk too broadly and/or inconsistently, and have not presented evidence of statistically significant indicia of thromboembolic risk. As noted above (see footnote 3), this argument is inconsistent with Defendants' own articulation of the subject matter of the hearing. It bears noting that this Daubert process was initiated at an early juncture in the case, prior to significant discovery and prior to the preparation of the opinions proffered here, at Defendants' request. Defendants cannot now be heard to complain that Plaintiffs failed to tailor their opinions to a view of the issues that Defendants chose not to share until after the opinions had been formulated. Nor is the use of the term "cardiovascular" or attention to non-thromboembolic cardiovascular issues inconsistent with claims in the complaint or, indeed, with a number of statements by Defendants that are quoted in the complaint and challenged as misleading. (See, e.g., Compl. ¶¶ 41, 74-75, 84-87, 90-94, 111, 118-19, 127-29, 144, 169.) The ultimate issues for the fact finder in this litigation do not involve medical causation of injuries but, rather, include whether Pfizer should have disclosed certain information it had earlier than it did, and whether the undisclosed information rendered misleading Defendants' public representations as to the existence of cause for concern about the safety of the two drugs.

Furthermore, Plaintiffs have demonstrated, by competent, credible testimony, that the non-thromboembolic "endpoints" utilized in their analyses of pre-December 2004 Pfizer study data are derived from scientific principles of sufficient validity and/or from Pfizer's own analytical methods. The record is sufficient to demonstrate the relevance of evidence of the associations identified in Plaintiffs' evidentiary proffers and thus to render Defendants' thromboembolic association arguments ones that go to the weight, rather than to the admissibility, of Plaintiffs' evidence.

The Court has considered carefully the record and all of Defendants' other arguments concerning the admissibility of the challenged testimony and finds that Plaintiffs have met their Rule 702 burden with respect to each of the challenged proffers. The Court's principal ...


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