Schnering et al v. Ethicon, Inc.

Filing 130

MEMORANDUM OPINION AND ORDER (Daubert Motion re: Kimberly Kenton, 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 Expert Testimony of Kimberly Kenton, M.D., M.S., as more fully set forth herein. Signed by Judge Joseph R. Goodwin on 8/31/2016. (cc: attys; any unrepresented party) (REF: MDL 2327; Cases Listed on Exhibit) (mek)

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 Exhibit
Attached Hereto
MEMORANDUM OPINION AND ORDER
(Daubert Motion re: Kimberly Kenton, M.D.)
Pending before the court is the Motion to Exclude the Expert Testimony of
Kimberly Kenton, M.D. [ECF No. 2087] 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. 2087-1], 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.

2

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—and I will therefore reserve ruling until the 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. Kimberly Kenton is board-certified in obstetrics, gynecology, and female
pelvic medicine and reconstructive surgery. She is currently a professor at the

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Feinberg School of Medicine at Northwestern University in Chicago, Illinois. Her
experiences include clinical and surgical care of women with SUI and POP.
a. Alternatives
To start, the plaintiffs claim Dr. Kenton is not qualified to offer expert
testimony on whether there are clinical differences between mechanical-cut and
laser-cut mesh products. According to the plaintiffs, Dr. Kenton cannot offer expert
testimony on this issue because she is not a chemical engineer, structural engineer,
or biomechanical engineer. However, I find that a urogynecologist who has extensive
experience working with mechanical-cut and laser-cut mesh products—like Dr.
Kenton—is qualified to offer expert testimony of this sort. The plaintiffs’ motion is
DENIED on this point.
Next, the plaintiffs turn to the reliability of Dr. Kenton’s expert testimony
about mechanical-cut and laser-cut mesh. Ethicon argues that Dr. Kenton’s clinical
experience provides a reliable foundation for this expert testimony. Experience is
especially essential, Ethicon emphasizes, because there is little literature comparing
mechanical-cut and laser-cut mesh products.
In the abstract, experience—on its own or accompanied by little else—is a
reliable basis for expert testimony. See Kumho, 526 U.S. at 156. But the reliability
inquiry must probe into the relationship between the experience and the expert
testimony:
If the witness is relying solely or primarily on experience, then the
witness must explain how that experience leads to the conclusion
reached, why that experience is a sufficient basis for the opinion, and
how that experience is reliably applied to the facts.
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Fed. R. Evid. 702 advisory committee’s note to 2000 amendment. Here, the court does
not have enough information to judge the reliability or relevance of Dr. Kenton’s
particular experience.
In this specific context, I am without sufficient information at this time to draw
the fine line between reliable and unreliable expert testimony on whether
mechanical-cut mesh is safer than laser-cut mesh based primarily on an expert’s
clinical experiences. Accordingly, I RESERVE ruling until further testimony may be
offered and evaluated firsthand at trial.
b. Mesh Properties
The plaintiffs also challenge Dr. Kenton’s qualifications to opine on the
chemical, structural, or biochemical makeup of the TVT device because she lacks
training in “chemical or structural engineering and/or in biomechanics.” Mem. 6 [ECF
No. 2088]. Dr. Kenton is a board-certified urogynecologist specializing in female
pelvic medicine and reconstructive surgery who has performed well over 1,000 mesh
surgeries. She also has a Masters in Clinical Research Design and Statistical
Analysis and has participated in and designed studies comparing the effectiveness of
various mesh sling devices. This extensive clinical and research experience, combined
with Dr. Kenton’s review of clinical literature, qualifies Dr. Kenton to opine on mesh’s
reaction to and effect on the human body, and relatedly, the safety and efficacy of
mesh products. The plaintiffs’ Motion on this matter is DENIED.
c. Complications
Next, the plaintiffs argue that Dr. Kenton should be excluded from offering her
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opinion that post-operative chronic pain is a rare complication with the TVT device
because it is based on an unsound methodology. The plaintiffs argue that Dr. Kenton’s
opinion is mostly based on her personal experience and that she discounts certain
“Level 1” scholarship discussing episodic chronic pain.
The plaintiffs do not address at all the numerous citations Dr. Kenton includes
in her report to support her opinions on this point. The plaintiffs simply challenge
Dr. Kenton’s opinions on the basis that she failed to consider other existing
scholarship regarding “episodes” of chronic pain. Yet Dr. Kenton cited to this very
same scholarship for other opinions in her report. An expert’s methodology may be
unreliable if he or she does not explain why certain contrary scientific literature was
rejected or not considered. See, e.g., Bethune v. Bos. Sci. Corp., No. 2:13-cv-6199, 2016
WL 2983697, at *4 (S.D. W. Va. May 20, 2016) (noting an expert’s methodology “may
be flawed if he does not provide an adequate explanation for why he disagrees with
[contrary] studies”). I do not have enough information to determine the reliability of
Dr. Kenton’s opinions regarding the rarity of post-operative chronic pain because Dr.
Kenton does not explain why she relies on certain studies for some purposes but not
for her chronic pain opinions. Accordingly, I RESERVE ruling on the plaintiffs’
Motion on this point.
d. Blaivas Article
The plaintiffs also seek to exclude any testimony that Dr. Kenton may offer at
trial regarding a specific article written by Dr. Blaivas. Dr. Kenton did not cite or
otherwise offer an opinion on the article until the plaintiffs’ counsel asked her about

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it in her deposition. The fact that Dr. Kenton did not cite to the article in her report
suggests that Dr. Kenton does not intend to offer an opinion on the article at trial or
that the opinion would be excluded on Rule 26 grounds. Either way, the plaintiffs
have wholly manufactured this situation, and their Motion on this point is DENIED
as moot.
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.”).

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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.
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

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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
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

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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).
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 or her 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

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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
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 excluded, the parties ask the court to prevent experts from offering
testimony 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 Expert Testimony of Kimberly Kenton, M.D. [ECF No. 2087].
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 31, 2016

EXHIBIT A - Kenton

CASE STYLE

CASE NUMBER

Christine Wiltgen v. Ethicon Inc., et al.

Case No. 2:12-cv-01216

Laura Waynick v. Ethicon Inc., et al.

Case No. 2:12-cv-01151

Denise Burkhart v. Ethicon Inc., et al.

Case No. 2:12-cv-01023

Debra A. and Donald Schnering v. Ethicon Inc., et al.

Case No. 2:12-cv-01071

Karen Bollinger v. Ethicon Inc., et al.

Case No. 2:12-cv-01215