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IN RE REZULIN PRODUCTS LIABILITY LITIGATION

March 15, 2004.

In Re: REZULIN PRODUCTS LIABILITY LITIGATION This Document Relates to: All Cases


The opinion of the court was delivered by: LEWIS KAPLAN, District Judge Page 2

MEMORANDUM OPINION (Corrected)

Among the antecedents of our modern jury trial was wager of law, or computation, a form of trial by ordeal. The accused found a number of people and then took a solemn oath that he or she was innocent. The "companions, or `compurgators' as they were called, then swore that the oath which he [or she] had taken was clean. In other words, the court call[ed] upon the accused to produce a specified number of people . . . who [we]re prepared to swear that in their opinion his [or her] oath [wa]s trustworthy. * * * They d[id] not swear to the facts of the case, but merely to their judgment that the accused is a credible person."*fn1

  A practice reminiscent of wager of law has become fashionable among some well-financed litigants — the engagement of "expert" witnesses whose intended role is more to argue the client's cause from the witness stand than to bring to the fact-finder specialized knowledge or expertise that would be helpful in resolving the issues of fact presented by the lawsuit. These "experts" thus are loosely analogous to compurgators, also known as oath helpers, in that they lend their credentials and reputations to the party who calls them without bringing much if any relevant knowledge to bear on the facts actually at issue. This case exemplifies the fashion to some extent, as the Plaintiffs' Executive Committee has engaged a number of "expert" witnesses to perform roles which, in greater or lesser degree, meet this description.

  Defendant Warner-Lambert Company and affiliates move in limine to exclude certain Page 3 proposed testimony of a number of plaintiffs' experts on issues other than silent liver injury, which is the subject of another motion. They object to proposed testimony of plaintiffs' "experts" regarding (1) what constitutes ethical behavior for a company, (2) the motive, intent, and state of mind of actors including Warner-Lambert, Glaxo-Wellcome, U.S. Food and Drug Administration ("PDA") employees, and the authors of scientific articles, (3) Warner-Lambert's alleged suppression of research, (4) foreign regulatory experience with respect to Rezulin [troglitazone] including a "history" of regulatory actions, (5) FDA procedures and regulations and Warner-Lambert's alleged failure to provide adequate information to the FDA about Rezulin, (6) Warner-Lambert's alleged failure adequately to protect patients who participated in the Rezulin clinical trials, (7) what other physicians understood about Rezulin, its benefits and risks, (8) decisions made by physicians who prescribed Rezulin, (9) a duty to warn patients (as well as alleged failure to warn patients);(10) Rezulin's efficacy and its risk-benefit ratio; and (11) one expert's reliance on certain spreadsheets created by a consultant for the defendants. Page 4

 I. Legal Framework: Daubert v. Merrell Dow Pharmaceuticals Inc. and Federal Rule of Evidence 702.

  A. General Background

  The standard governing a district court's determination whether to admit scientific or other expert testimony is familiar. Federal Rule of Evidence 702 provides:
"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."
  It incorporates principles established in Daubert v. Merrell Dow Pharmaceuticals, Inc., *fn2 in which the Supreme Court charged trial courts with a gatekeeping role to "ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable."*fn3

  In Daubert, the Supreme Court set forth the procedures a trial court is to follow in ruling on expert testimony. The trial court must determine "whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue."*fn4 The Court explained further that this requires "a preliminary assessment of whether the testimony is scientifically valid and of whether that reasoning or methodology properly can be Page 5 applied to the facts in issue" — in essence, whether it is reliable.*fn5 The proponent of expert testimony must demonstrate admissibility by a preponderance of proof.*fn6 The Daubert Court stressed that the inquiry concerning reliability is "a flexible one" and set forth a list of four nonexclusive factors to consider: (1) whether the expert's theory "can be (and has been) tested"; (2) whether the theory "has been subjected to peer review and publication;" (3) the "known or potential rate of error"; and (4) whether the theory has "`general acceptance.'"*fn7

  The Court elaborated upon Daubert in Kumho Tire Co. v. Carmichael *fn8 where it held that Daubert's general gatekeeping obligation "applies not only to testimony based on `scientific' knowledge, but also to testimony based on `technical' and `other specialized' knowledge."*fn9 Ultimately, the objective of Daubert is "to 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."*fn10

  In undertaking this inquiry, a district court must focus on the "principles and Page 6 methodology" employed by the expert, not on the conclusions reached.*fn11 Nevertheless, "nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence which is connected to existing data only by the ipse dixit of the expert. A court may conclude that there simply is too great an analytical gap between the data and the opinion proffered."*fn12

  In 2000, Rule 702 was amended in light of Daubert to require that "(1) the testimony [be] based upon sufficient facts or data, (2) the testimony [be] the product of reliable principles and methods, and (3) the witness [have] applied the principles and methods reliably to the facts of the case." The Advisory Committee Notes explain that the amendment was intended to affirm Daubert's designation of the trial court as gatekeeper and "provide[] some general standards that the trial court must use to assess the reliability and helpfulness of proffered expert testimony." *fn13 The standards set forth in Rule 702 were not intended to displace the nonexclusive list of factors set forth by the Supreme Court in Daubert, however.

  One of the fundamental requirements of Rule 702 is that the proposed testimony "assist the trier of fact to understand the evidence or to determine a fact in issue." This helpfulness requirement is "akin to the relevance requirement of Rule 401, which is applicable to all proffered evidence[,] [but] . . . goes beyond mere relevance . . . because it also requires expert testimony to Page 7 have a valid connection to the pertinent inquiry."*fn14 The Daubert Court referred to this as "`fit,'" noting that "Rule 702's `helpfulness' standard requires a valid scientific connection to the pertinent inquiry as a precondition to admissibility."*fn15 Finally, Rule 702 requires also a finding that the proposed witness be qualified by virtue of specialized knowledge, skill, experience, training, or education.

  Recognizing that the application of the foregoing principles, "no matter how flexible, inevitably on occasion will prevent the jury from learning of authentic insights and innovations," the Supreme Court in Daubert nevertheless reasoned that this "is the balance that is struck by Rules of Evidence designed not for the exhaustive search for cosmic understanding but for the particularized resolution of legal disputes." *fn16

  B. Specific Considerations.

  Certain principles that are especially pertinent to the task at hand flow from the requirement that expert testimony be "scientific, technical, or other specialized knowledge." First, the requirement of "knowledge" guards against the admission of subjective or speculative opinions.*fn17 Page 8

  Second, in requiring that expert testimony be directed to "scientific, technical or specialized" knowledge, Rule 702 ensures that expert witnesses will not testify about "lay matters which a jury is capable of understanding and deciding without the expert's help."*fn18 In other words, experts should not be permitted to "supplant the role of counsel in making argument at trial, and the role of the jury in interpreting the evidence."*fn19 Examples of "expert" testimony that courts have excluded on this basis include factual narratives*fn20 and interpretations of conduct or views as to the motivation of parties.*fn21

  Likewise, in deciding whether the proposed testimony will be helpful to the fact-finder, courts in this Circuit analyze the testimony to determine whether it "`usurp[s] either the role of the trial judge in instructing the jury as to the applicable law or the role of the jury in applying that law to the facts before it.'"*fn22 Thus, although an expert may give an opinion to help the jury decide Page 9 an issue in the case, he or she may not tell the jury what result to reach*fn23 or communicate "a legal standard — explicit or implicit — to the jury."*fn24 This principle requires the exclusion of testimony that states a legal conclusion, although factual conclusions on an ultimate issue to be decided by the jury are permissible.*fn25

  Against this background, the Court now turns to its analysis of the challenged testimony.

 II. Testimony Regarding Ethics.

  The reports of two of plaintiffs' proposed experts indicate that they intend to testify, Page 10 at least in part, that Warner-Lambert, in their opinions, acted in an unethical manner, especially with respect to its presentation of, or reaction to, Rezulin clinical data and the conduct of Rezulin clinical trials. Two other experts gave such testimony in their depositions.*fn26 Defendants seek to preclude all such testimony by plaintiffs' experts. They argue that the opinions are (1) unreliable because Page 11 purely speculative; (2) unhelpful to the fact-finder because irrelevant in a case where liability is premised on legal, not ethical, standards, and (3) likely to prejudice and confuse fact-finders concerning the pertinent legal standards. Plaintiffs rejoin that the proffered testimony is reliable and establishes an industry standard that is relevant to the issues in the case.

  The opinions of plaintiffs' witnesses, however distinguished these individuals may be as physicians and scientists, concerning the ethical obligations of pharmaceutical companies and whether the defendants' conduct was ethical are inadmissible for the following reasons.

  A. Reliability Under Rule 702 and Daubert.

  Three of plaintiffs' four witnesses — Drs. Day, Bell and Kronmal — have admitted that their opinions concerning purported ethical standards are based on their personal, subjective views.*fn27 These opinions therefore do not meet the core requirement of Rule 702 that expert testimony rest on "knowledge," a term that "connotes more than subjective belief or unsupported Page 12 speculation."*fn28

  Such speculative testimony, contrary to plaintiffs' argument, cannot serve as the predicate for any purported industry ethical standard.*fn29 Even if expert testimony on the ordinary practices of a profession or trade were appropriate "to enable the jury to evaluate the conduct of the parties against the standards of ordinary practice in die industry,"*fn30 it still must comport with the reliability and helpfulness requirements of Rule 702. At their core, however, the witnesses' opinions regarding ethical standards for reporting or analyzing clinical trial data or conducting clinical trials articulate nothing save for the principle that research sponsors should be honest.*fn31 Even if charitably viewed as a "standard," the testimony nevertheless is "so vague as to be unhelpful to a fact-finder."*fn32 Page 13

  Plaintiffs press the notion that "there is no authority proscribing opinions which are personal, a label which can be attached to any expert's testimony."*fn33 The claim, at best, is frivolous word play. Its clear implication is that courts should permit "experts" to tender purely subjective views in the guise of expert opinions. This would border on the absurd.

  B. Relevance Under Rule 702 and Daubert.

  Even assuming that the ethics testimony were based on a reliable foundation, it would not assist the fact-finder in determining any factual dispute in this case. The principal issues here are whether the defendants breached their legal duties to the plaintiffs in the manufacturing, labeling and marketing of Rezulin and, if so, whether any such breaches were proximate causes of injury. While the defendants may be liable in the court of public opinion, or before a divine authority for any ethical lapses, expert opinion as to the ethical character of their actions simply is not relevant to these lawsuits.

  Ethics testimony similar to that proposed here was excluded as irrelevant in Diet Page 14 Drugs, a pharmaceutical products liability proceeding analogous in some ways to this MDL.*fn34 There, the court excluded the opinions of a "clinical medical ethics" expert because the testimony was "at best, only marginally relevant to [the manufacturer's] conduct in the manufacturing and marketing of diet drugs," and the "pertinent issues in this litigation are the obligations of a pharmaceutical company in testing, surveying and labeling medications."*fn35 Those same obligations, not what is ethical, are the central issues in this case, and the proffered ethics testimony is "at best, only marginally relevant."*fn36 Page 15

  C. Federal Rule of Evidence 403.

  Even assuming that the proposed ethics testimony were reliable and marginally relevant under Rule 702, it would be likely unfairly to prejudice and confuse the trier by introducing the "experts'" opinions and rhetoric concerning ethics as alternative and improper grounds for decision on bases other than the pertinent legal standards.*fn37 Accordingly, plaintiffs are precluded from offering any testimony, including that cited in the margin, concerning ethical standards and the application of ethical standards to the alleged conduct of the defendants and others.

 III. Motive, Intent, and State of Mind Testimony

  Several of plaintiffs' proposed experts have rendered reports articulating, and/or testified in depositions to, opinions concerning the motive, intent and state of mind of Warner-Lambert and others.*fn38 Defendants object that the testimony (1) is unreliable speculation because the Page 16 witnesses lack relevant qualifications, and (2) would invade the province of the jury.*fn39 Plaintiffs rejoin that the witnesses are qualified, and the opinions are helpful under Rule 702 and proper under Rule 704. The Court concludes that the testimony is inadmissible.

  First, the opinions of these witnesses on the intent, motives or states of mind of corporations, regulatory agencies and others have no basis in any relevant body of knowledge or Page 17 expertise.*fn40 The Taylor court aptly described similar testimony as "musings as to defendants' motivations [that] would not be admissible if given by any witness — lay or expert."*fn41 Furthermore, plaintiffs' experts propose improperly to assume the role of advocates for the plaintiffs' case by arguing as to the intent or motives underlying the conduct of Warner-Lambert or others, a transgression that has resulted in the exclusion of "expert" testimony as to the "real motive" behind Page 18 certain business transactions.*fn42

  The testimony is improper also because it describes "lay matters which a jury is capable of understanding and deciding without the expert's help."*fn43 Dr. Bell's proposed testimony illustrates the point. At times he merely repeated facts or opinions stated by other potential witnesses or in documents produced in discovery, as with his reiteration of Dr. Misbin's view as to what the FDA might have done with different information. Elsewhere, he drew simple inferences from documents produced in discovery, as when he said he "knows for sure" that Glaxo took Rezulin off the market for safety reasons because "the chairman of the company allegedly wrote this in a letter.*fn44 Similar repetitions of facts and speculative inferences about intent appear throughout the challenged testimony.*fn45

  Inferences about the intent or motive of parties or others lie outside the bounds of expert testimony. As the Diet Drugs court stated in excluding testimony that the pharmaceutical defendant's conduct with respect to labeling was motivated by its desire to increase profits, "[t]he Page 19 question of intent is a classic jury question and not one for the experts."*fn46

  Dr. Gale's opinion that Warner-Lambert's conduct with respect to clinical trial data potentially constituted "negligence" or "something more serious"*fn47 is excluded for the additional reason that it impermissibly embraces a legal conclusion.*fn48 Such testimony "usurp[s] . . . the role of the trial judge in instructing the jury as to the applicable law [and] the role of the jury in applying that law to the facts before it."*fn49

  Accordingly, plaintiffs are precluded from offering expert opinion evidence, including that cited in the margin, of the alleged motive, intent ...


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