Tyree v. Bos. Scientific Corp.

• Decision Date: 17 October 2014
• Docket Number: Civil Action No. 2:12–cv–08633.
• Citation: 54 F.Supp.3d 501
• Court: U.S. District Court — Southern District of West Virginia
• Parties: Jacquelyn TYREE, et al., Plaintiffs, v. BOSTON SCIENTIFIC CORPORATION, Defendant.

54 F.Supp.3d 501

Jacquelyn TYREE, et al., Plaintiffs

v.BOSTON SCIENTIFIC CORPORATION, Defendant.

Civil Action No. 2:12–cv–08633.

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

Signed Oct. 17, 2014.

As Amended Oct. 29, 2014.

Fidelma L. Fitzpatrick, Jonathan D. Orent, Providence, RI, Fred Thompson, III, Mount Pleasant, SC, Harry F. Bell, Jr., Charleston, WV, 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) Defendant's Motion to Exclude Plaintiffs' Experts' Opinion that Polypropylene Mid–Urethral Slings Are Defective [Docket 227]; (2) Defendant's Motion to Exclude the Opinions and Testimony of Michael Thomas Margolis, M.D. [Docket 237](3) Defendant's Motion to Exclude the Opinions and Testimony of Richard W. Trepeta, M.D. [Docket 235]; (4) Defendant's Motion to Exclude the Opinions and Testimony of Jimmy W. Mays, Ph.D. and Samuel P. Gido, Ph.D. [Docket 221]; (5) Defendant's Motion to Exclude the Opinions and Testimony of Peggy Pence, Ph.D., RAC, FRAPS [Docket 219]; (6) Defendant's Motion to Exclude the Opinions and Testimony of Thomas H. Barker, Ph.D. [Docket 223]; (7) Defendant's Motion to Exclude the Opinions and Testimony of Donald R. Ostergard, M.D. [Docket 217]; (8) Defendant's Motion to Exclude the Opinions and Testimony of Vladimir Iakovlev, M.D. [Docket 225]; (9) Defendant's Motion to Exclude the Opinions and Testimony of Jerry Blaivas, M.D. [Docket 239]; (10) Defendant's Motion to Exclude the Opinions and Testimony of Alison Vredenburgh, Ph.D., CPE [Docket 241]; (11) Defendant's Motion to Exclude the Opinions and Testimony of Bruce Allen Rosenzweig, M.D. [Docket 251]; (12) Defendant's Motion to Exclude the Opinions of Christopher Walker, M.D. [Docket 247]; and (13) Defendant's Motion to Strike Rebuttal Report of Dr. Abbas Shobeiri [Docket 400].

The following motions have been brought by the plaintiffs: (1) Plaintiffs' Motion to Exclude the Testimony of Stephen H. Spiegelberg, Ph.D. [Docket 215]; (2) Plaintiff's Motion to Exclude the Testimony of Stephen F. Badylak, D.V.M., Ph.D., M.D. [Docket 213]; (3) Plaintiffs' Motion to Exclude the Testimony of Gary L. Winn, Ph.D. [Docket 229]; (4) Plaintiffs' Motion to Exclude or Limit Testimony of Christine Brauer, Ph.D. [Docket 231]; (5) Plaintiffs' Motion to Limit the Testimony of Patrick Culligan, M.D. [Docket 233]; and (6) Plaintiffs' Motion to Limit the Testimony of Lonny Green, M.D. [Docket 354].

For the reasons explained below, the defendant's motion with respect to Plaintiffs' Experts' Opinion that Polypropylene Mid–Urethral Slings Are Defective [Docket 227] is DENIED. The defendant's motion with respect to Dr. Margolis [Docket 237] is GRANTED IN PART and DENIED IN PART and RESERVED IN PART. The defendant's motion with respect to Dr. Trepeta [Docket 235] is GRANTED IN PART and DENIED IN PART. The defendant's motion with respect to Drs. Mays and Gido [Docket 221] is GRANTED IN PART and DENIED IN PART. The defendant's motion with respect to Dr. Pence [219] is GRANTED IN PART and DENIED IN PART. The defendant's motion with respect to Dr. Barker [Docket 223] is GRANTED. The defendant's motion with respect to Dr. Ostergard [Docket 217] is GRANTED IN PART and DENIED IN PART. The defendant's motion with respect to Dr. Iakovlev [Docket 225] is GRANTED. The defendant's motion with respect to Dr. Blaivas [Docket 239] is GRANTED IN PART and DENIED IN PART. The defendant's motion with respect to Dr. Vredenburgh [Docket 241] is GRANTED. The defendant's motion with respect to Dr. Rosenzweig [Docket 251] is DENIED. The defendant's motion with respect to Dr. Walker [Docket 247] is DENIED. The defendant's motion to strike the rebuttal report of Dr. Shobeiri [Docket 400] is GRANTED.

The plaintiffs' motion with respect to Dr. Spiegelberg [Docket 215] is RESERVED IN PART and GRANTED IN PART. The plaintiffs' motion with respect to Dr. Badylak [Docket 213] is RESERVED IN PART and GRANTED IN PART. The plaintiffs' motion with respect to Dr. Winn [Docket 229] is GRANTED. The plaintiffs' motion with respect to Dr. Brauer [Docket 231] is GRANTED. The plaintiffs' motion with respect to Dr. Culligan [Docket 233] is GRANTED. The plaintiffs' motion with respect to Dr. Green [Docket 354] is GRANTED IN PART and DENIED IN PART.

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 and stress urinary incontinence. 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 consolidated plaintiffs were surgically implanted with the Obtryx Transobturator Mid–Urethral Sling System (“the Obtryx”), a mesh product manufactured by BSC. (See Pretrial Order # 78 [Docket 9], at 1–2).¹ All of the plaintiffs received their surgeries in West Virginia. They claim that as a result of implantation of the Obtryx, 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 4 (quoting the master complaint)). The plaintiffs allege negligence; strict liability for design defect; strict liability for manufacturing defect; strict liability for failure to warn; breach of express warranty; breach of implied warranty; and punitive damages. (Id. at 2). The spouse of one plaintiff (Ms. Tyree) has also alleged loss of consortium. (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 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, Daub...