Wise et al v. C. R. Bard, Inc.

Filing 251

MEMORANDUM OPINION AND ORDER (Dr. Reitman Daubert Motion) reserving ruling for trial re: 145 MOTION by Debra Wise, Ronald Wise to Exclude Opinions and Testimony of Maureen Reitman, SC.D. Signed by Judge Joseph R. Goodwin on 2/11/2015. (cc: counsel of record; any unrepresented party) (ts)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
DEBRA WISE, et al.,
Plaintiffs,
v.

CIVIL ACTION NO. 2:12-cv-01378

C. R. BARD, INC.,
Defendant.
MEMORANDUM OPINION AND ORDER
(Dr. Reitman Daubert Motion)
Pending before the court is the plaintiffs’ Motion to Exclude Opinions and Testimony of
Maureen Reitman, Sc.D. [Docket 145]. For the reasons set forth below, I RESERVE my ruling
on this motion for trial.
I.

Background
This 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 more
than 70,000 cases currently pending, approximately 10,000 of which are in the Bard MDL, MDL
2187. In this particular case, the plaintiff, Debra Wise, was surgically implanted with the Avaulta
Plus Anterior Support System and the Avaulta Plus Posterior Support System (collectively
“Avaulta”), mesh products manufactured by Bard to treat POP. (See Short Form Compl. [Docket
1], at 2). 1 The plaintiff received her surgery in West Virginia. (Id. at 4). The plaintiff claims that

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The present case is part of Wave 1 of the Bard MDL, MDL 2187. (Pretrial Order # 118 (Docket Control Order for
Selection and Discovery of 200 Cases) [Docket 15]). Because the parties agree that the Southern District of West
Virginia is the proper venue, I set this case for trial in the Southern District. (See Am. Joint Submission, MDL 2187
[Docket 1004], at 8; see also Order [Docket 63]).

as a result of implantation of the Avaulta products, she has experienced multiple complications,
including vaginal spasms, damage to her ureter, vagina, and rectum, kidney reflux, urinary tract
infections, chronic constipation, dyspareunia (pain during sexual intercourse), lower pelvic pain,
incontinence, and kidney stones. (See Pl. Fact Sheet [Docket 102-9], at 7). The plaintiff alleges
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. (Short Form Compl. [Docket 1], at 4). 2 Additionally, the plaintiff’s husband, Ronald
Wise, alleges loss of consortium. (Id.). The parties have retained experts to render opinions
regarding the elements of these causes of action, and the instant motion involves the plaintiffs’
effort to exclude or limit an expert’s opinions and testimony pursuant to Daubert v. Merrell Dow
Pharm., Inc., 509 U.S. 579 (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. 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,

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By Memorandum Opinion and Order entered on February 5, 2015, I granted Bard’s Motion for Summary
Judgment with respect to the plaintiffs’ claims of strict liability for manufacturing defect and breach of warranty.
(See Mem. Op. & Order (Def.’s Mot. for Summ. J.) [Docket 224]).

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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. 3 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). 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).

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With more than 70,000 cases related to surgical mesh products currently pending before me, this gatekeeper role
takes on extraordinary significance. Each of my evidentiary determinations carries substantial weight with the
remaining surgical mesh cases. Regardless, while I am cognizant of the subsequent implications of my rulings in
these cases, I am limited to the record and the arguments of counsel.

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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 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 (internal citations and quotation marks omitted). I now turn to the
instant motion.
III.

Discussion
The plaintiffs seek to exclude the opinions and testimony of Maureen Reitman, Sc.D. Dr.

Reitman is Corporate Vice President and Director of the Polymer Science and Materials
Chemistry Practice at Exponent, Inc. She opines that polypropylene does not degrade and bases
this opinion on scanning electronic microscopy (“SEM”), Fourier Transform Infrared
Spectroscopy (“FTIR”), and Thermal Gravimetric Analysis (“TGA”) testing performed on
polypropylene samples at Exponent and on an “anti-oxidant” analysis of polypropylene pellets

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conducted by an outside laboratory. In particular, she contends that the cracked or rough surface
one may observe on polypropylene explants is not evidence of degradation caused by
oxidation—rather, it is a biologic crust or layer the forms on the polypropylene that can be
removed with special cleaning.
In its response, Bard frequently cites to a deposition of Dr. Reitman taken after the
plaintiffs’ motion was filed. Bard additionally discusses new tests conducted by Dr. Reitman and
a new testing protocol that she produced. In their reply, the plaintiffs argue that any new
information should be stricken from the record.
Given the current state of the pleadings before me, I find it necessary to defer ruling on
this motion until trial. The deposition testimony and motion practice with Dr. Reitman have been
inconsistent, and the court believes that it is in the best interest of justice to decide the issue of
reliability after hearing a foundation of reliable principles and methods at trial.
IV.

Conclusion
For the reasons set forth above, I RESERVE my ruling on the plaintiffs’ Motion to

Exclude Opinions and Testimony of Maureen Reitman, Sc.D. [Docket 145] for trial. The court
DIRECTS the Clerk to send a copy of this Order to counsel of record and any unrepresented
party.
ENTER:

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February 11, 2015