United States District Court, S.D. West Virginia, Charleston Division
December 16, 2016
IN RE ETHICON INC. PELVIC REPAIR SYSTEMS PRODUCT LIABILITY LITIGATION THIS DOCUMENT RELATES TO Cases Identified in Exhibit A attached hereto
ORDER ADOPTING MEMORANDUM OPINION AND ORDER (DAUBERT
RULING RE: GREGORY T. BALES, M.D.)
R. GOODWIN, UNITED STATES DISTRICT JUDGE
21, 2016, plaintiffs filed a Notice of Adoption of Prior
Daubert Motion of Gregory T. Bales, M.D. for Wave 2.
[ECF No. 2392]. The court ORDERS that the Memorandum Opinion
and Order (Daubert Motion re: Gregory T. Bales,
M.D.) [ECF No. 2665] entered on August 25, 2016 as to the
Ethicon Wave 1 cases is ADOPTED in the Wave 2 cases identified
in Exhibit A. The Memorandum Opinion and Order
(Daubert Motion re: Gregory T. Bales, M.D.) is
attached hereto as Exhibit B.
court DIRECTS the Clerk to file a copy of this Order Adopting
Memorandum Opinion and Order in 2:12-md-2327 and in the
Ethicon Wave 2 cases identified in the Exhibit attached
R. GOODWIN, UNITED STATES DISTRICT JUDGE
A - Gregory T. Bales, M.D.
THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF
WEST VIRGINIA CHARLESTON DIVISION
ETHICON INC. PELVIC REPAIR SYSTEMS PRODUCT LIABILITY
DOCUMENT RELATES TO:
Identified in the Motion
OPINION AND ORDER (DAUBERT MOTION RE: GREGORY T. BALES,
before the court is the Motion to Exclude the General Opinion
Testimony of Gregory T. Bales, M.D. [ECF No. 2054] filed by
the plaintiffs. The Motion is now ripe for consideration
because briefing is complete.
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
75, 000 cases currently pending, approximately 30, 000 of
which are in this MDL, which involves defendants Johnson
& Johnson and Ethicon, Inc. (collectively
“Ethicon”), among others.
MDL, the court's tasks include “resolv[ing]
pretrial issues in a timely and expeditious manner” and
“resolv[ing] important evidentiary disputes.”
Barbara J. Rothstein & Catherine R. Borden, Fed. Judicial
Ctr., Managing Multidistrict Litigation in
Products Liability Cases 3 (2011). To handle motions to
exclude or to limit expert testimony pursuant to Daubert
v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579
(1993), the court developed a specific procedure. In Pretrial
Order (“PTO”) No. 217, the court instructed the
parties to file only one Daubert motion per
challenged expert, to file each motion in the main MDL-as
opposed to the individual member cases-and to identify which
cases would be affected by the motion. PTO No. 217, at
plunging into the heart of the Motion, a few preliminary
matters need to be addressed.
compelled to comment on the parties' misuse of my
previous Daubert rulings on several of the experts
offered in this case. See generally Sanchez v. Bos. Sci.
Corp., No. 2:12-cv-05762, 2014 WL 4851989 (S.D. W.Va.
Sept. 29, 2014); Tyree v. Bos. Sci. Corp., 54
F.Supp.3d 501 (S.D. W.Va. 2014); Eghnayem v. Bos. Sci.
Corp., 57 F.Supp.3d 658 (S.D. W.Va. 2014). The parties
have, for the most part, structured their Daubert
arguments as a response to these prior rulings, rather than
an autonomous challenge to or defense of expert testimony
based on its reliability and relevance. In other words, the
parties have comparatively examined expert testimony and have
largely overlooked Daubert's core considerations
for assessing expert testimony. Although I recognize the
tendency of my prior evidentiary determinations to influence
subsequent motions practice, counsels' expectations that
I align with these previous rulings when faced with a
different record are misplaced, especially when an expert has
issued new reports and given additional deposition testimony.
of my role as gatekeeper for the admission of expert
testimony, as well as my duty to “respect[ ] the
individuality” of each MDL case, see In re
Phenylpropanolamine Prods. Liab. Litig., 460 F.3d 1217,
1231 (9th Cir. 2006), I refuse to credit Daubert
arguments that simply react to the court's rulings in
Sanchez and its progeny. Indeed, I feel bound by
these earlier cases only to the extent that the expert
testimony and Daubert objections presented to the
court then are identical to those presented now. Otherwise, I
assess the parties' Daubert arguments anew. That
is, in light of the particular expert testimony and
objections currently before me, I assess “whether the
reasoning or methodology underlying the testimony is
scientifically valid” and “whether that reasoning
or methodology properly can be applied to the facts in
issue.” Daubert, 509 U.S. at 592-93. Any
departure from Sanchez, Eghnayem, or
Tyree does not constitute a “reversal”
of these decisions and is instead the expected result of the
parties' submission of updated expert reports and new
objections to the expert testimony contained therein.
I have attempted to resolve all possible disputes before
transfer or remand, including those related to the
admissibility of expert testimony pursuant to
Daubert. Nevertheless, in some instances I face
Daubert challenges where my interest in accuracy
counsels reserving ruling until the reliability of the expert
testimony may be evaluated at trial. At trial, the expert
testimony will be tested by precise questions asked and
answered. The alternative of live Daubert hearings
is impossible before transfer or remand because of the
numerosity of such motions in these seven related MDLs. As
these MDLs have grown and the expert testimony has
multiplied, I have become convinced that the critical
gatekeeping function permitting or denying expert testimony
on decisive issues in these cases is best made with a live
expert on the witness stand subject to vigorous examination.
course of examining a multitude of these very similar cases
involving the same fields of expertise, I have faced
irreconcilably divergent expert testimony offered by
witnesses with impeccable credentials, suggesting, to me, an
unreasonable risk of unreliability. The danger-and to my
jaded eye, the near certainty-of the admission of “junk
science” looms large in this mass litigation.
parties regularly present out-of-context statements,
after-the-fact rationalizations of expert testimony, and
incomplete deposition transcripts. This, combined with the
above-described practice of recycling expert testimony,
objections, and the court's prior rulings, creates the
perfect storm of obfuscation. Where further clarity is
necessary, I believe it can only be achieved through live
witness testimony- not briefing-I will therefore reserve
ruling until expert testimony can be evaluated firsthand.
the parties should be intimately familiar with Rule 702 of
the Federal Rules of Evidence and Daubert, so the
court will not linger for long on these standards.
testimony is admissible if the expert is qualified and if his
or her expert testimony is reliable and relevant. Fed.R.Evid.
702; see also Daubert, 509 U.S. at 597. An expert
may be qualified to offer expert testimony based on his or
her “knowledge, skill, experience, training, or
education.” Fed.R.Evid. 702. Reliability may turn on
the consideration of several factors:
(1) whether a theory or technique can be or has been tested;
(2) whether it has been subjected to peer review and
publication; (3) whether a technique has a high known or
potential rate of error and whether there are standards
controlling its operation; and (4) whether the theory or
technique enjoys general acceptance within a relevant
Cooper v. Smith & Nephew, Inc., 259 F.3d 194,
199 (4th Cir. 2001) (citing Daubert, 509 U.S. at
592-94). But these factors are neither necessary to nor
determinative of reliability in all cases; the inquiry is
flexible and puts “principles and methodology”
above conclusions and outcomes. Daubert, 509 U.S. at
595; see also Kumho Tire Co. v. Carmichael, 525 U.S.
137, 141, 150 (1999). Finally, and simply, relevance turns on
whether the expert testimony relates to any issues in the
case. See, e.g., Daubert, 509 U.S. at
591-92 (discussing relevance and helpfulness).
bottom, the court has broad discretion to determine whether
expert testimony should be admitted or excluded.
Cooper, 259 F.3d at 200.
Bales is a board-certified urologist who has performed over
1, 000 pelvic floor surgeries, placed over 1, 000 midurethral
slings, and treated mesh complications.
plaintiffs seek exclusion of Dr. Bales's testimony about
whether or not clinical data and evidence indicate that mesh
degrades, is cytotoxic, is biocompatible, or causes an
inflammatory response. They argue Dr. Bales is unqualified to
offer this testimony because he lacks training in chemical
engineering, structural engineering, or biomechanics. The
lack of engineering expertise does not render Dr. Bales
unqualified to offer these opinions, particularly because he
intends to opine only on the clinical aspects of these
characteristics. Dr. Bales has performed thousands of pelvic
mesh procedures and treated patients experiencing
complications. Resp. 9. This extensive clinical experience,
combined with his review of peer-reviewed literature,
qualifies Dr. Bale to opine on mesh's reaction to and
effect on the human body. The plaintiffs' Motion on this
matter is DENIED.
plaintiffs challenge the reliability of Dr. Bales's
complication rate opinions relating to native tissue
procedures based on their allegation that Dr. Bales failed to
cite to certain studies that calculated much lower
complication rates. The plaintiffs point out that one study
Dr. Bales relies on-the Weber Study-was later updated in 2011
to account for altered definitions of “prolapse”
and “success, ” but Dr. Bales did not rely on the
updated study. Finally, the plaintiffs state that Dr.
Bales's complication rate opinions should be excluded
because they are “not supported by overwhelming current
scientific literature.” Mem. Supp. Mot. re: Dr. Bales 7
[ECF No. 2057].
Bales's opinions are supported by peer-reviewed
scientific literature, and Dr. Bales testified that he
considered the updated 2011 Weber Study and explained why he
did not rely on it. To the extent that the plaintiffs believe
that Dr. Bales did not adequately consider conflicting
studies, the plaintiffs are free to cross-examine Dr. Bales
on those points. The standards elucidated in Daubert
do not require Dr. Bales to offer opinions that are
“supported by overwhelming current scientific
literature.” Mem. Supp. Mot. re: Dr. Bales 7. Dr.
Bales's opinions are passably reliable under
Daubert. The plaintiffs' Motion is DENIED
regarding Dr. Bales's native tissue procedure
complication rate opinions.
plaintiffs next argue that Dr. Bales should be precluded from
opining that dyspareunia is not a significant risk of POP
surgeries using mesh because such opinions are not supported
by the scientific literature. Dr. Bales, however, does not
offer this opinion in his report. Instead, Dr. Bales states
that “[d]yspareunia is a longstanding, well-known
complication that is well established in the surgical
literature regarding the surgical repair of POP.” Bales
Report 8 [ECF No. 2054-2]. Dr. Bales concludes by saying that
“[o]verall, the studies comparing Prolift to native
tissues repairs do not show any statistically significant
differences in rates of de novo dyspareunia, pelvic pain or
sexual dysfunction.” Id. Thus, Dr. Bales makes
no opinion regarding “significant risk.” Instead,
Dr. Bales discusses “significant differences in rates,
” and he backs up his opinions with citations to
scientific literature. To the extent that the plaintiffs
believe that Dr. Bales failed to consider contrary scientific
literature, they may cross-examine him on those points. The
plaintiffs' Motion is DENIED regarding Dr. Bales's
plaintiffs next challenge Dr. Bales's opinions regarding
the clinical significance of mesh contracture. The plaintiffs
argue that Dr. Bales opines that mesh contraction does not
“lead to complications of clinical consequence”
and “shrinkage is of no clinical importance.”
Mem. Supp. Mot. re: Dr. Bales 9-10. Dr. Bales, however,
actually opines that “[t]here is no medical literature
conclusively establishing that mesh contracts with vaginal
use to clinically significant degrees.” Bales Report 8.
Dr. Bales cites to published studies regarding his opinion,
and he relies on his own clinical experience in arriving at
his opinions. Further, Dr. Bales explained why he chose not
to rely on certain contrary studies. To the extent that the
plaintiffs believe that Dr. Bales failed to consider contrary
scientific studies, they may cross-examine Dr. Bales on those
points. The plaintiffs' Motion regarding Dr. Bales's
opinions on complications associated with mesh contracture is
plaintiffs ask the court to exclude as unreliable Dr.
Bales's opinions insofar as any opinions are based on his
allegedly selective review of medical literature. The
plaintiffs do not, however, indicate which opinions are
founded on his allegedly selective review of medical
literature. I will not parse through an expert's report
to determine whether a party's broad claim of
unreliability has any merit; it is the party's obligation
to support its motion. Accordingly, the plaintiffs'
Motion is DENIED on this point.
the Daubert motions filed in this MDL raise the same
or similar objections.
particular issue has been a staple in this litigation, so I
find it best to discuss it in connection with every expert. A
number of the Daubert motions seek to exclude FDA
testimony and other regulatory or industry standards
testimony. To the extent this Motion raises these issues it
is GRANTED in part and RESERVED in part as described below.
repeatedly excluded evidence regarding the FDA's section
510(k) clearance process in these MDLs, and will continue to
do so in these cases, a position that has been affirmed by
the Fourth Circuit. In re C. R. Bard, Inc., 81 F.3d
913, 921-23 (4th Cir. 2016) (upholding the determination that
the probative value of evidence related to section 510(k) was
substantially outweighed by its possible prejudicial impact
under Rule 403). Because the section 510(k) clearance process
does not speak directly to safety and efficacy, it is of
negligible probative value. See In re C. R. Bard, 81
F.3d at 920 (“[T]he clear weight of persuasive and
controlling authority favors a finding that the 510(k)
procedure is of little or no evidentiary value.”).
Delving into complex and lengthy testimony about regulatory
compliance could inflate the perceived importance of
compliance and lead jurors “to erroneously conclude
that regulatory compliance proved safety.” Id.
at 922. Accordingly, expert testimony related to the section
510(k) process, including subsequent enforcement actions and
discussion of the information Ethicon did or did not submit
in its section 510(k) application, is EXCLUDED. For the same
reasons, opinions about Ethicon's compliance with or
violation of the FDA's labeling and adverse event
reporting regulations are EXCLUDED. In addition to
representing inappropriate legal conclusions, such testimony
is not helpful to the jury in determining the facts at issue
in these cases and runs the risk of misleading the jury and
confusing the issues. Insofar as this Motion challenges the
FDA-related testimony discussed here, the Motion is GRANTED.
number of experts also seek to opine on Ethicon's
compliance with design control and risk management standards.
Some of this testimony involves the FDA's quality systems
regulations, and some-likely in an attempt to sidestep my
anticipated prohibition on FDA testimony-involve foreign
regulations and international standards. I find all of this
proposed testimony of dubious relevance. Although these
standards relate to how a manufacturer should structure and
document risk assessment, the standards do not appear to
mandate any particular design feature or prescribe the actual
balance that must be struck in weighing a product's risk
and utility. Nor is it clear that the European and other
international standards discussed had any bearing on the U.S.
medical device industry when the device in question was being
because the nuances of products liability law vary by state,
I will refrain from issuing a blanket exclusion on design
process and control standards testimony, whether rooted in
the FDA or otherwise. Each standard must be assessed for its
applicability to the safety questions at issue in this
litigation, consistent with state law. I am without
sufficient information to make these findings at this time.
Accordingly, I RESERVE ruling on such matters until a
hearing, where the trial judge will have additional context
to carefully evaluate the relevance and potential prejudicial
impact of specific testimony.
I doubt the relevance of testimony on the adequacy of
Ethicon's clinical testing and research, physician
outreach, or particular product development procedures and
assessments otherwise not encompassed by the above
discussion. Again, such matters seem to say very little about
the state of the product itself (i.e., whether or not it was
defective) when it went on the market. But because the scope
of relevant testimony may vary according to differences in
state products liability law, I RESERVE ruling on such
matters until they may be evaluated in proper context at a
hearing before the trial court before or at trial.
more broad-matters also warrant mention. While some of these
concerns may not apply to this particular expert, these
concerns are raised so frequently that they are worth
many of the motions seek to exclude state-of-mind and
legal-conclusion expert testimony. Throughout these MDLs, the
court has prohibited the parties from using experts to usurp
the jury's fact-finding function by allowing testimony of
this type, and I do the same here. E.g., In re
C. R. Bard, Inc., 948 F.Supp.2d 589, 611 (S.D. W.Va.
2013); see also, e.g., United States v.
McIver, 470 F.3d 550, 562 (4th Cir. 2006)
(“[O]pinion testimony that states a legal standard or
draws a legal conclusion by applying law to the facts is
generally inadmissible.”); 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.”).
Additionally, an expert may not offer expert testimony 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).
and on a related note, many of the motions seek to prohibit
an expert from parroting facts found in corporate documents
and the like. I caution the parties against introducing
corporate evidence through expert witnesses. Although an
expert may testify about his review of internal corporate
documents solely for the purpose of explaining the basis for
his or her expert opinions-assuming the expert opinions are
otherwise admissible-he or she may not offer testimony that
is solely a conduit for corporate information.
many of the motions also ask the court to require an expert
to offer testimony consistent with that expert's
deposition or report or the like. The court will not force an
expert to testify one way or another. To the extent an expert
offers inconsistent testimony, the matter is more
appropriately handled via cross-examination or impeachment as
appropriate and as provided by the Federal Rules of Evidence.
in these Daubert motions, the parties have addressed
tertiary evidentiary matters like whether certain statements
should be excluded as hearsay. The court will not exclude an
expert simply because a statement he or she discussed may
constitute hearsay. Cf. Daubert, 509 U.S. at 595.
Hearsay objections are more appropriately raised at trial.
in some of the Daubert motions, without identifying
the specific expert testimony to be exclude, the parties ask
the court to prevent experts from offering other expert
testimony that the moving party claims the expert is not
qualified to offer. I will not make speculative or advisory
rulings. I decline to exclude testimony where the party
seeking exclusion does not provide specific content or
court DENIES in part, GRANTS in part, and RESERVES in part
the Motion to Exclude the General Opinion Testimony of Dr.
Gregory T. Bales, M.D. [ECF No. 2054].
court DIRECTS the Clerk to file a copy of this Memorandum
Opinion and Order in 2:12-md-2327 and in the Ethicon Wave 1
cases identified in the Exhibit attached hereto.
August 25, 2016
 On Exhibit A, I have marked through
cases that are closed, on the inactive docket or assigned to
another District Judge and any cases that could not be
identified because of an error in the style or case
 The plaintiffs identified the Wave 1
cases affected by this Motion in their attached Exhibit A
[ECF No. 2054-1], which the court has attached to this
Memorandum Opinion and Order. At the time of transfer or
remand, the parties will be required to designate relevant
pleadings from MDL 2327, including the motion, supporting
memorandum, response, reply, and exhibits referenced