Trevino v. Bos. Scientific Corp.

MARIA TREVINO, Plaintiff, v. BOSTON SCIENTIFIC CORPORATION, Defendant.

CIVIL ACTION NO. 2:13-cv-01617

UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA CHARLESTON DIVISION

April 28, 2016

MEMORANDUM OPINION AND ORDER

(Daubert Motions)

Pending before the court are the following motions brought by the defendant: (1) Motion to Exclude the Opinions and Testimony of Niall Galloway, M.D. [ECF No. 32]; (2) Motion to Exclude the Testimony of Michael Thomas Margolis, M.D. [ECF No. 30]; (3) Motion to Exclude the Opinions and Testimony of Thomas H. Barker, Ph.D. [ECF No. 33]; (4) Motion to Limit the Opinions and Testimony of Bobby L. Shull, M.D. [ECF No. 39]; (5) Motion to Exclude the Opinions and Testimony of Jimmy W. Mays, Ph.D. [ECF No. 40]; (6) Motion to Exclude the Opinions and Testimony of Peggy Pence, Ph.D. [ECF No. 43]; (7) Motion to Exclude the Opinions and Testimony of Russell Dunn, Ph.D. [ECF No. 44]; (8) Motion to Exclude the Opinions and Testimony of Scott Guelcher, Ph.D. [ECF No. 45]; (9) Motion to Limit the Opinions and Testimony of Dionysios Veronikis, M.D. [ECF No. 36]; (10) Motion to Exclude the Opinions and Testimony of Richard Trepeta, M.D. [ECF No. 47]; (11) Motion to Exclude the Opinions and Testimony of David Goldfarb, M.D. [ECF No. 41]; and (12) Motion to Strike and Exclude the Opinions and Testimony of Vladimir Iakovlev, M.D. [ECF No. 55].

Also pending before the court are the following motions brought by the plaintiff: (1) Motion to Exclude the Opinions and Testimony of Gary L. Winn, Ph.D. [ECF No. 34]; (2) Motion to Exclude Certain Opinions and Testimony of Dr. Patrick Culligan [ECF No. 38]; (3) Motion to Exclude or Limit the Testimony Christine Brauer, Ph.D. [ECF No. 37]; (4) Motion to Exclude the Opinions and Testimony of Roger Goldberg, M.D. [ECF No. 35]; (5) Motion to Exclude the Testimony and Opinions of Dr. Stephen Spiegelberg, Ph.D. [ECF No. 53]; (6) Motion to Exclude the Opinions and Testimony of Stephen F. Badylak, D.V.M., Ph.D., M.D. [ECF No. 54]; and (7) Motion to Exclude the Opinions and Testimony of Dr. Michael Douso [ECF No. 29].

I. Background

This case resides 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 75,000 cases currently pending, approximately 19,000 of which are in the Boston Scientific Corporation ("BSC") MDL, MDL No. 2326. In this particular case, the plaintiff, Maria Trevino, was surgically implanted with the Uphold Vaginal Support System ("Uphold"), a mesh product manufactured by BSC to treat POP, and the Prefyx PPS System, a mesh device manufactured by BSCto treat SUI. Ms. Trevino received her surgery at St. Luke's Patient's Medical Center in Pasadena, Texas, on December 28, 2009. Short Form Compl. 4 [ECF No. 1]. She now claims that, as a result of the implantation of these devices, she has experienced various complications and injuries. The plaintiff advances the following claims against BSC: negligence; strict liability for design defect, manufacturing defect, failure to warn; breach of express and implied warranties; discovery rule, tolling, and fraudulent concealment; and punitive damages. Id. The parties have retained experts to render opinions regarding the elements of these causes of action, and the instant motions involve the parties' efforts to exclude or limit the experts' opinions pursuant to Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993).

II. Legal Standard

Under Rule 702 of the Federal Rules of Evidence, expert testimony is admissible if the expert is "qualified . . . by knowledge, skill, experience, training, or education" and if his testimony is (1) helpful to the trier of fact in understanding the evidence or determining a fact in issue; (2) "based upon sufficient facts or data;" and (3) "the product of reliable principles and methods" that (4) have been reliably applied "to the facts of the case." Fed. R. Evid. 702. The Supreme Court has established a two-part test to govern the admissibility of expert testimony under Rule 702: the evidence is admitted if it "rests on a reliable foundation and is relevant." Daubert, 509 U.S. at 597. The proponent of expert testimony does not have the burden to "prove" anything to the court. Md. Cas. Co. v. Therm-O-Disk, Inc., 137 F.3d 780, 783 (4th Cir. 1998). He or she must, however, "come forward with evidence from which the court candetermine that the proffered testimony is properly admissible." Id.

The district court is the gatekeeper. "[E]xpert witnesses have the potential to be both powerful and quite misleading," so 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 Westberry v. Gislaved Gummi AB, 178 F.3d 257, 261 (4th Cir. 1999); Daubert, 509 U.S. at 588, 595). In carrying out this role, 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 'vigorous 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) (quoting Daubert, 509 U.S. at 596); see also Md. Cas. Co., 137 F.3d at 783 (noting that "[a]ll 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 court in making the overall reliability determinations that apply to expert evidence. These factors 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) ("[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)); 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 relevance, the second part of the analysis, Daubert further 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 quotation marks omitted).

Ultimately, the district court has broad discretion in determining whether to admit or exclude expert testimony, and the "the trial judge must have considerable leeway in deciding in a particular case how to go about determining whether particular expert testimony is reliable." Cooper, 259 F.3d at 200 (quoting Kumho Tire, 526 U.S. at 152).

III. Preliminary Matters

I begin by addressing a few preliminary matters that affect many of the Daubert motions. First, both parties consistently challenge experts' opinions as improper state-of-mind or legal-conclusion testimony. As I have maintained throughout these MDLs, I will not permit the use of experts to usurp the jury's fact-finding function by allowing an expert to testify as to a party's knowledge, state of mind, or whether a party acted reasonably. See, e.g., In re C. R. Bard, Inc., 948 F. Supp. 2d 589, 611 (S.D. W. Va. 2013) (excluding expert opinions on the defendant's knowledge, state of mind, alleged bad acts, failures to act, and corporate conduct and ethics). The reasonableness of conduct and a party's then-existing state of mind "are the sort of questions that lay jurors have been answering without expert assistance from time immemorial," and therefore, these matters are not appropriate for expert testimony. Kidder v. Peabody & Co. v. IAG Int'l Acceptance Grp., N.V., 14 F. Supp. 2d 391, 404 (S.D.N.Y. 1998); see also In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 546 (S.D.N.Y. 2004) ("Inferences about the intent and motive of parties or others lie outside the bounds of expert testimony.").¹ Likewise, "opinion testimony that states a legal standard or draws a legal conclusion by applying law to the facts is generally inadmissible." United States v. McIver, 470 F.3d 550, 562 (4th Cir. 2006). An expert may not state his opinion using "legal terms of art," such as "defective,""unreasonably dangerous," or "proximate cause." See Perez v. Townsend Eng'g Co., 562 F. Supp. 2d 647, 652 (M.D. Pa. 2008).

I have diligently applied these rules to previous expert testimony, and I continue to apply them in this case. This does not mean that each objection to state-of-mind or legal-conclusion testimony raised in these motions is valid. But I will not parse the numerous reports and thousand-page depositions for each expert to determine the validity of these same objections. Instead, the...