Wroble et al v. Johnson & Johnson Inc. et al

Filing 143

MEMORANDUM OPINION AND ORDER (Daubert Motion re: Gregory T. Bales, M.D.) The court DENIES in part, GRANTS in part, and RESERVES in part the Motion filed in MDL 2327 by Certain Plaintiffs in Wave 1 Cases to Exclude the General Opinion Testimony of Gregory T. Bales, M.D., as more fully set forth herein. Signed by Judge Joseph R. Goodwin on 8/25/2016. (cc: attys; any unrepresented party) (REF: MDL 2327; Cases Listed on Exhibit) (ts)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
IN RE:

ETHICON INC.
PELVIC REPAIR SYSTEMS
PRODUCT LIABILITY LITIGATION
MDL No. 2327
______________________________________________________________________________
THIS DOCUMENT RELATES TO:
Cases Identified in the Motion
MEMORANDUM OPINION AND ORDER
(Daubert Motion re: Gregory T. Bales, M.D.)
Pending 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.
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 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.
In this 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 4.1
II.

Preliminary Matters

Before plunging into the heart of the Motion, a few preliminary matters need
to be addressed.
I am 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

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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 herein.

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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.
Mindful 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.
Finally, 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

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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.
In the 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.
The 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.
III.

Legal Standard

By now, 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

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standards.
Expert 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
scientific community.

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).
At bottom, the court has broad discretion to determine whether expert
testimony should be admitted or excluded. Cooper, 259 F.3d at 200.
IV.

Discussion

Dr. 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.

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a. Properties
The 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.
b. Complications
The 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

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No. 2057].
Dr. 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.
The 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

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literature, they may cross-examine him on those points. The plaintiffs’ Motion is
DENIED regarding Dr. Bales’s dyspareunia opinions.
The 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 DENIED.
c. Selective Review
The 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.

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V.

Recurring Issues

Many of the Daubert motions filed in this MDL raise the same or similar
objections.
One 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.
I have 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

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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.
A 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 designed.
Nevertheless, 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

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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.
Similarly, 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.
Additional—and 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 discussing here.

First, 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

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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).
Second, 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.

Third, 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 crossexamination or impeachment as appropriate and as provided by the Federal Rules of
Evidence.

Fourth, 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

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may constitute hearsay. Cf. Daubert, 509 U.S. at 595. Hearsay objections are more
appropriately raised at trial.

Finally, 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 context.
VI.

Conclusion

The 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].
The 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.

ENTER:

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August 25, 2016

EXHIBIT A - BALES

CASE STYLE

CASE NUMBER

Joy Essman v. Ethicon, Inc., et al.

Case No. 2:12-cv-00277

Christine Wiltgen v. Ethicon, Inc., et al.

Case No. 2:12-cv-01216

Shirley Walker v. Ethicon, Inc., et al.

Case No. 2:12-cv-00873

Julie Wroble v. Ethicon, Inc., et al.

Case No. 2:12-cv-00883

Nancy Jo Williams v. Ethicon, Inc., et al.

Case No. 2:12-cv-00511