Eghnayem v. Bos. Scientific Corp.

• Decision Date: 27 October 2014
• Docket Number: Civil Action No. 2:13–cv–07965.
• Citation: 57 F.Supp.3d 658
• Court: U.S. District Court — Southern District of West Virginia
• Parties: Amal EGHNAYEM, et al., Plaintiffs, v. BOSTON SCIENTIFIC CORPORATION, Defendant.

57 F.Supp.3d 658

Amal EGHNAYEM, et al., Plaintiffs

v.BOSTON SCIENTIFIC CORPORATION, Defendant.

Civil Action No. 2:13–cv–07965.

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

Signed Oct. 27, 2014.

Bryan F. Aylstock, D. Renee Baggett, Douglass Alan Kreis, Aylstock Witkin Kreis & Overholtz, Pensacola, FL, Joseph A. Osborne, Babbitt Johnson Osborne & Le Clainche, West Palm Beach, FL, W. Michael Moreland, Clark Love & Hutson, Houston, TX, Henry G. Garrard, III, Blasingame Burch Garrard & Ashley, Athens, GA, Roy D. Wasson, Wasson & Associates, Miami, FL, for Plaintiffs.

Eric M. Anielak, Jon A. Strongman, Matthew D. Keenan, Robert T. Adams, Shook Hardy & Bacon, Kansas City, MO, Lindsey M. Saad, Flaherty Sensabaugh & Bonasso, Morgantown, WV, Michael Bonasso, Flaherty Sensabaugh & Bonasso, Charleston, WV, for Defendant.

MEMORANDUM OPINION AND ORDER

(Daubert Motions )

JOSEPH R. GOODWIN, District Judge.

The following motions have been brought by the defendant, Boston Scientific Corporation (“BSC”): (1) Motion to Exclude the Testimony of Richard W. Trepeta, M.D. [Docket 86]; (2) Motion to Exclude the Testimony of Dr. Michael Thomas Margolis [Docket 88]; (3) Motion to Exclude the Testimony of Thomas H. Barker, Ph.D. [Docket 90]; (4) Motion to Exclude the Testimony of Jimmy W. Mays, Ph.D. and Samuel P. Gido, Ph.D. [Docket 92]; (5) Motion to Exclude the Opinions and Testimony of Emery Salom, M.D., FACOG [Docket 94]; (6) Motion to Exclude the Testimony of Dr. Peggy Pence, Ph.D. [Docket 96]; (7) Motion to Exclude the Testimony of Dr. Mark Slack [Docket 98]; (8) Motion for Leave to File Supplemental Brief to Its Motion to Exclude Testimony of Dr. Mark Slack [Docket 147]; (9) Motion to Exclude the Testimony of Dr. Raybon [Docket 100]; (10) Motion to Exclude the Testimony of Linda Kiley, M.D. [Docket 102]; (11) Motion to Exclude the Testimony of Vladimir Iakovlev, M.D. [Docket 104]; (12) Motion to Exclude the Testimony of Konstantin Walmsley, M.D. [Docket 109]; and (13) Motion to Exclude the Opinions and Testimony of Jorge Pando, M.D. [Docket 155].

The following motions have been brought by the plaintiffs: (1) Motion to Exclude the Testimony of Stephen H. Spiegelberg, Ph.D. [Docket 111]; (2) Motion to Exclude the Testimony of Stephen Badylak, M.D. [Docket 113]; (3) Motion to Exclude the Testimony of Matthew F. Davies, M.D. [Docket 115]; (4) Motion to Exclude the Testimony of Christine L. Brauer, Ph.D. [Docket 117]; (5) Motion to Exclude the Testimony of Gary L. Winn, Ph.D. [Docket 119].

For the reasons explained below, the defendant's motion with respect to Dr. Trepeta [Docket 86] is GRANTED IN PART and DENIED IN PART. The defendant's motion with respect to Dr. Margolis [Docket 88] is GRANTED IN PART and DENIED IN PART. The defendant's motion with respect to Dr. Barker [Docket 90] is GRANTED. The defendant's motion with respect to Drs. Mays and Gido [Docket 92] is GRANTED IN PART and DENIED IN PART. The defendant's motion with respect to Dr. Salom [Docket 94] is DENIED. The defendant's motion with respect to Dr. Pence [Docket 96] is GRANTED IN PART and DENIED IN PART. The defendant's motions with regard to Dr. Slack [Dockets 98 and 147] are GRANTED and DENIED. respectively. The defendant's motion with respect to Dr. Raybon [Docket 100] is GRANTED IN PART and DENIED IN PART. The defendant's motion with respect to Dr. Kiley [Docket 102] is GRANTED IN PART and DENIED IN PART. The defendant's motion with regard to Dr. Iakovlev [Docket 104] is GRANTED IN PART and DENIED IN PART. The defendant's motion with regard to Dr. Walmsley [Docket 109] is DENIED IN PART and DENIED AS MOOT. The defendant's motion with respect to Dr. Pando [Docket 155] is GRANTED.

The plaintiffs' motion with regard to Dr. Spiegelberg [Docket 111] is GRANTED IN PART and RESERVED IN PART. The plaintiffs' motion with respect to Dr. Badylak [Docket 113] is GRANTED IN PART and RESERVED IN PART. The plaintiff's motion with regard to Dr. Davies [Docket 115] is DENIED. The plaintiffs' motion with regard to Dr. Brauer [Docket 117] is GRANTED. The plaintiffs' motion with regard to Dr. Winn [Docket 119] is GRANTED.

I. Background

This consolidated case resides in one of seven MDLs assigned to me by the Judicial Panel on Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”). In the seven MDLs, there are over 60,000 cases currently pending, over 13,000 of which are in the Boston Scientific Corporation MDL, MDL 2326. In this particular case, the four plaintiffs were surgically implanted with the Pinnacle Pelvic Floor Repair Kit (“the Pinnacle”), a mesh product manufactured by BSC to treat POP. (See Pretrial Order # 91 [Docket 10], at 1–2).¹ All of the plaintiffs received their surgeries in Florida. The plaintiffs claim that as a result of implantation of the Pinnacle, they have experienced “erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia (pain during sexual intercourse), blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, and chronic pelvic pain.” (Id. at 3 (quoting the master complaint)). The plaintiffs allege negligence, design defect, manufacturing defect, failure to warn, breach of express warranty, breach of implied warranty, and punitive damages. (Id. at 1–2). 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 and testimony pursuant to Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993).

II. Legal Standard

Under Federal Rule of Evidence 702, 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 U.S. Supreme Court 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, 113 S.Ct. 2786. The proponent of expert testimony does not have the burden to “prove” anything to the court. Md. Cas. Co. v. Therm–O–Disc, Inc., 137 F.3d 780, 783 (4th Cir.1998). He or she must, however, “come forward with evidence from which the court can determine that the proffered testimony is properly admissible.” Id.

The district court is the gatekeeper.² 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 Westberry v. Gislaved Gummi AB, 178 F.3d 257, 261 (4th Cir.1999) and Daubert, 509 U.S. at 588, 595, 113 S.Ct. 2786 ). 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, 113 S.Ct. 2786 ); 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, 113 S.Ct. 2786 ).

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, 113 S.Ct. 2786 ); see also Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150, 119 S.Ct. 1167, 143 L.Ed.2d 238 (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 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, 113 S.Ct. 2786 (internal citations and quotation marks omitted).

Finally, in several of the instant Daubert motions, a specific scientific methodology...