United States District Court, S.D. West Virginia, Charleston Division
IN RE C. R. BARD, INC., PELVIC REPAIR SYSTEM PRODUCTS LIABILITY LITIGATION
MEMORANDUM OPINION AND ORDER (DAUBERT MOTION RE:
ROBERT H. YOUNG, M.D.)
R. GOODWIN /UNITED STATES DISTRICT JUDGE.
DOCUMENT RELATES TO C. R. BARD WAVE 4 & WAVE 5 CASES
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.
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.
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
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.
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.
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.
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).
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.”).
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
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”).
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).
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.
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.
Opinions Regarding the Biocompatibility of
stated in his report, Dr. Young reached the following
Polypropylene is biocompatible and commonly used for surgical
mesh in the United States. Polypropylene mesh does not