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In re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation

United States District Court, S.D. West Virginia, Charleston Division

January 31, 2018





         Pending in In re C. R. Bard, Inc., No. 2:10-md-2187, MDL 2187, is the plaintiffs' Daubert Motion to Exclude Opinions and Testimony of Robert H. Young, M.D. [ECF No. 4554]. The Motion is now ripe for consideration because the briefing is complete. As set forth below, the plaintiffs' Motion is GRANTED in part and DENIED in part.

         I. Background

         These groups of cases reside in one of seven MDLs assigned to me by the Judicial Panel on Multidistrict Litigation (“MDL”) concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”). In the seven MDLs, there are more than 24, 000 cases currently pending, approximately 3, 000 of which are in the C. R. Bard, Inc. (“Bard”) MDL, MDL No. 2187.

         In an effort to manage the massive Bard MDL efficiently and effectively, the court decided to conduct pretrial discovery and motions practice on an individualized basis. To this end, I selected certain cases to become part of a “wave” of cases to be prepared for trial and, if necessary, remanded.

         Upon the creation of a wave, I enter a docket control order subjecting each active case in the wave to the same scheduling deadlines, rules regarding motion practice, and limitations on discovery. See, e.g., Pretrial Order (“PTO”) # 236, In re C. R. Bard, Inc., Pelvic Repair Sys. Prods. Liab. Litig., No. 2:10-md-02187, Jan. 27, 2017, Included among the discovery rules imposed by the court is the obligation of the parties to file Daubert motions seeking to limit or exclude the testimony of general experts in the main MDL, MDL 2187, and to identify which cases the motion would affect.

         Before plunging into the heart of the Motion, I am compelled to comment on the manner in which the parties filed several of their recent general Daubert motions. Rather than file a motion, the parties filed a “Notice” to adopt and incorporate the entirety of a motion filed in a previous wave - sometimes several years old. As such, the grounds upon which the parties challenge the proffered expert are sometimes inapplicable to the cases grouped in Wave 4 or Wave 5. With this in mind, the following analysis involves the parties' efforts to exclude or limit the general opinions and testimony of the experts so identified.

         II. Legal Standard

         Under Federal Rule of Evidence 702, expert testimony is admissible if it will “help the trier of fact to understand the evidence or to determine a fact in issue.” Fed.R.Evid. 702. Furthermore, the expert testimony must be (1) “based upon sufficient facts or data” and (2) “the product of reliable principles and methods” that (3) have been applied reliably “to the facts of the case.” Id. A two-part test governs the admissibility of expert testimony. The evidence is admitted if it “rests on a reliable foundation and is relevant.” Daubert v. Merrell Dow Pharm., 509 U.S. 579, 597 (1993). The proponent of expert testimony does not have the burden to “prove” anything. However, he or she must “come forward with evidence from which the court can determine that the proffered testimony is properly admissible.” Md. Cas. Co. v. Therm-O-Disc, Inc., 137 F.3d 780, 783 (4th Cir. 1998).

         The district court is the gatekeeper. It is an important role: “[E]xpert witnesses have the potential to be both powerful and quite misleading”; the court must “ensure that any and all scientific testimony . . . is not only relevant, but reliable.” Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 199 (4th Cir. 2001) (citing Daubert, 509 U.S. at 588, 595; Westberry v. Gislaved Gummi AB, 178 F.3d 257, 261 (4th Cir. 1999)). I “need not determine that the proffered expert testimony is irrefutable or certainly correct” - “[a]s with all other admissible evidence, expert testimony is subject to testing by ‘[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof.'” United States v. Moreland, 437 F.3d 424, 431 (4th Cir. 2006) (alteration in original) (quoting Daubert, 509 U.S. at 596); see also Md. Cas. Co., 137 F.3d at 783 (“All Daubert demands is that the trial judge make a ‘preliminary assessment' of whether the proffered testimony is both reliable . . . and helpful.”).

         Daubert mentions specific factors to guide the overall relevance and reliability determinations that apply to all expert evidence. They include (1) whether the particular scientific 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”; (4) the “existence and maintenance of standards controlling the technique's operation”; and (5) whether the technique has achieved “general acceptance” in the relevant scientific or expert community. United States v. Crisp, 324 F.3d 261, 266 (4th Cir. 2003) (quoting Daubert, 509 U.S. at 593-94).

         Despite these factors, “[t]he inquiry to be undertaken by the district court is ‘a flexible one' focusing on the ‘principles and methodology' employed by the expert, not on the conclusions reached.” Westberry, 178 F.3d at 261 (quoting Daubert, 509 U.S. at 594-95); see also Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150 (1999) (“We agree with the Solicitor General that ‘[t]he factors identified in Daubert may or may not be pertinent in assessing reliability, depending on the nature of the issue, the expert's particular expertise, and the subject of his testimony.'” (citation omitted)); see also Crisp, 324 F.3d at 266 (noting “that testing of reliability should be flexible and that Daubert's five factors neither necessarily nor exclusively apply to every expert”).

         With respect to relevancy, Daubert also explains:

Expert testimony which does not relate to any issue in the case is not relevant and, ergo, non-helpful. The consideration has been aptly described by Judge Becker as one of “fit.” “Fit” is not always obvious, and scientific validity for one purpose is not necessarily scientific validity for other, unrelated purposes. . . . Rule 702's “helpfulness” standard requires a valid scientific connection to the pertinent inquiry as a precondition to admissibility.

Daubert, 509 U.S. at 591-92 (citations and internal quotation marks omitted).

         III. Analysis

         In this case, Bard offers Dr. Young to testify as a general expert witness on gynecological surgical pathology issues related to the mesh products that are the subject of this pending litigation. See Notice of Adoption of Prior Daubert Mot. of Robert H. Young, M.D., for Waves 4 & 5, Ex. 1 (“Young Report”), at 4 [ECF No. 4554-1]. Among other things, Dr. Young specializes in the area of diagnostic surgical pathology, with a subspecialty interest in gynecological and urological pathology, and is an active professor of pathology at Harvard Medical School. Id. at 3. In addition to more than 350 peer-reviewed contributions, Dr. Young has co-authored five books. Id. His clinical experience includes prior service as the head of the gynecological and urological pathology units at Massachusetts General Hospital, and he continues to review approximately 6000 pathology cases a year. Id.

         The plaintiffs argue that Dr. Young is not qualified to opine generally on four matters: (A) biocompatibility of polypropylene; (B) the adequacy of Bard's testing to determine biocompatibility; (C) pore size; and (D) vaginal mesh contraction and shrinkage. In addition, the plaintiffs challenge the reliability of each of these opinions on the ground that they are unreliable ipse dixit opinions. I will address each argument in turn.

         A. Opinions Regarding the Biocompatibility of Polypropylene

         As stated in his report, Dr. Young reached the following conclusions:

Polypropylene is biocompatible and commonly used for surgical mesh in the United States. Polypropylene mesh does not ...

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