In re Rezulin Products Liability Litigation
| Decision Date | 15 March 2004 |
| Docket Number | No. 00 Civ.2843(LAK).,00 Civ.2843(LAK). |
| Citation | 309 F.Supp.2d 531 |
| Parties | In re REZULIN PRODUCTS LIABILITY LITIGATION (MDL No. 1348). |
| Court | U.S. District Court — Southern District of New York |
Mark P. Robinson, Jr., Kevin F. Calcagnie, Robinson, Calcagnie & Robinson, Newport Beach, CA, Irving H. Greines, Cynthia E. Tobisman, Greines, Martin, Stein & Richland, LLP, Beverly Hills, CA, Ramon Rossi Lopez, Lopez Hodes Restaino Milman & Skikos, Chris Tisi, Aschraft & Gerel, for Plaintiffs.
David Klingsberg, Steven Glickstein, Maris Veidemanis, Wendy S. Dowse, Kaye Scholer LLP, New York City, for Defendants.
Among the antecedents of our modern jury trial was wager of law, or compurgation, 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 1
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 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 ("FDA") 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.
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.,2 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."3
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."4 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 applied to the facts in issue" — in essence, whether it is reliable.5 The proponent of expert testimony must demonstrate admissibility by a preponderance of proof.6 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.'"7
The Court elaborated upon Daubert in Kumho Tire Co. v. Carmichael,8 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."9 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."10
In undertaking this inquiry, a district court must focus on the "principles and methodology" employed by the expert, not on the conclusions reached.11 Nevertheless, 12
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."13 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 have a valid connection to the pertinent inquiry."14 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."15 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."16
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.17 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."18 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."19 Examples of "expert" testimony that courts have excluded on this basis include factual narratives20 and interpretations of conduct or views as to the motivation of parties.21
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.'"22 Thus, although an expert may give an opinion to help the jury decide an issue in the case, he...
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