Wheeler v. Johnson & Johnson et al

Filing 127

MEMORANDUM OPINION AND ORDER (Daubert Motion re: Jaime L. Sepulveda-Toro, M.D.) The court DENIES in part, GRANTS in part, and RESERVES in part the Motion by Certain Plaintiffs in Wave 1 Cases to Limit the Opinions and Testimony of Jaime L. Sepulveda-Toro, M.D., as more fully set forth herein. Signed by Judge Joseph R. Goodwin on 8/30/2016. (cc: attys; any unrepresented party) (REF: MDL 2327; Cases Listed on Exhibit) (bdr)

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: Jaime L. Sepulveda-Toro, M.D.)
Pending before the court is the Motion to Limit the Opinions and Testimony of
Jaime L. Sepulveda-Toro, M. D. [ECF No. 2014] 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

The plaintiffs identified the Wave 1 cases affected by this Motion in their attached Exhibit A [ECF
No. 2014-1], 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.
1

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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.
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
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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.
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
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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
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).
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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. Sepulveda-Toro is board-certified in obstetrics and gynecology. His practice
focuses on treating female urinary incontinence and other pelvic floor disorders.
a. Safety and Efficacy
The plaintiffs challenge the reliability of Dr. Sepulveda-Toro’s expert
testimony about the safety and efficacy of the SUI and POP products at issue. Dr.
Sepulveda-Toro’s expert testimony is unreliable, the plaintiffs claim, because he
agrees with an FDA classification that the plaintiffs believe is contradictory to his
testimony, because he stopped using the products after they were removed from the
market, and because he could not name the five-year studies on SUI products on
which he relied during his deposition. Upon review, each of these arguments is wholly
devoid of merit. I can easily reject the FDA classification argument because it is based
on the plaintiffs’ mischaracterization of Dr. Sepulveda-Toro’s deposition testimony.
The use argument is irrelevant because Dr. Sepulveda-Toro merely stopped using the
products because they were not on the market, not because they were not safe or
effective. The studies argument is meritless because the report includes citations to
long-term studies, so it does not matter whether Dr. Sepulveda-Toro could recall the
studies during his deposition. So the plaintiffs’ Motion is DENIED on this point.
b. Design
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The plaintiffs claim Dr. Sepulveda-Toro is not qualified to offer what they
characterize as design opinions. But they do not explain or identify these opinions
with sufficient specificity. This most recent wave of Daubert motions in this MDL is
plagued with some confusion about what constitutes a design opinion. So some
clarification is necessary before proceeding.
At first glance, it seems the plaintiffs want to prevent Dr. Sepulveda-Toro from
providing any opinions that even mention the word “design.” But the mere utterance
of a single word is not an incantation that transforms an opinion about one thing into
something else.
A close, contextual reading of the transvaginal mesh cases where this issue has
been raised before reveals the heart of the plaintiffs’ objections. In this motion—and
several others—the plaintiffs argue that the expert at issue lacks the particularized
skill, knowledge, experience, education, or training that is necessary to provide
opinions about the process of designing a product. Opinions of this sort include, for
example, opinions about pre-marketing product testing and product development.
But upon review, I find Dr. Sepulveda-Toro has not expressed any opinions about the
process of designing a product. So the plaintiffs’ Motion is DENIED as moot on this
very limited issue.
c. Warnings
The plaintiffs claim Dr. Sepulveda-Toro is not qualified to offer expert
testimony about product warnings, which includes expert testimony about the
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adequacy of the relevant Instructions for Use (“IFU”). According to the plaintiffs, Dr.
Sepulveda-Toro is not an expert in the development of warnings labels and thus is
not qualified to offer expert testimony about warnings. While an expert who is a
gynecologist may testify about the specific risks of implanting mesh and whether
those risks appeared on the relevant IFU, the same expert must possess additional
expertise to offer expert testimony about what information should or should not be
included in an IFU. Wise v. C. R. Bard, Inc., No. 2:12-cv-1378, 2015 WL 521202, at
*14 (S.D. W. Va. Feb. 7, 2015). Dr. Sepulveda-Toro does not possess the additional
expertise to offer expert testimony about what an IFU should or should not include.2
Accordingly, Dr. Sepulveda-Toro’s expert testimony about these matters is
EXCLUDED.
The plaintiffs also object to Dr. Sepulveda-Toro’s opinions on the adequacy of
Ethicon’s brochures, which he says “allow a patient to construct a base to be used in
the conversation about the procedure.” Sepulveda-Toro Report 18 [ECF No. 2014-2].
The court is doubtful of the relevance of such testimony given the usual application
of the learned intermediary doctrine to cases in these MDLs. As the relevance of this

In relation to the expert testimony about the adequacy of the IFU, Ethicon claims Dr. SepulvedaToro is qualified to testify about whether certain risks were commonly known in the medical
community. In my view, this is not the subject of the plaintiffs’ motion. The plaintiffs’ motion focuses
on whether Dr. Sepulveda-Toro is qualified to offer expert testimony about what should be included in
or what may be excluded from an IFU. So I offer no opinion on whether Dr. Sepulveda-Toro may testify
about whether certain risks were common knowledge. However, an expert cannot testify about
whether any risks should have been included in an IFU unless he or she possess additional expertise—
expertise Dr. Sepulveda-Toro does not possess.
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testimony will best be determined on a case-by-case basis applying the applicable
state law, I RESERVE ruling on this point.
d. Value of Explanted Materials
The plaintiffs challenge Dr. Sepulveda-Toro’s qualifications to opine that
explanted mesh undergoes forces beyond those it would experience in an SUI or POP
procedure. They argue that Dr. Sepulveda-Toro is unqualified to make this statement
because he is not a pathologist. But Dr. Sepulveda-Toro has extensive experience
studying the relevant part of the body, both through surgery and through the
dissection of hundreds of cadaver specimens. He has also written a manual on
dissection and how to make the best of specimens. Accordingly, I find Dr. SepulvedaToro sufficiently qualified to make the statements at issue here and DENY the
Motion on this point.
The plaintiffs also challenge Dr. Sepulveda-Toro’s qualifications to critique the
plaintiffs’ pathologists’ testimony because he is not a pathologist himself. Without
more specificity as to which opinions are being challenged, the court must DENY the
Motion on this point.
e. Medical Literature Support
The plaintiffs object to Dr. Sepulveda-Toro’s characterizations of the medical
literature that allegedly supports his opinions on cytotoxicity, degradation, and
inflammatory response. The court is without sufficient information at the time to
judge the reliability of Dr. Sepulveda-Toro’s methodology in considering the relevant
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literature, and therefore RESERVES ruling until the evidence may be evaluated
firsthand at trial.
f. Gold Standard
The plaintiffs seek to exclude Dr. Sepulveda-Toro’s use of the phrase “gold
standard” in describing the TVT. Ethicon represents that Dr. Sepulveda-Toro will not
use the phrase at trial, so the Motion on this point is DENIED as moot.
g. Defectiveness
The plaintiffs also object to the reliability of Dr. Sepulveda-Toro’s opinion that
“[t]he long term data on TVT and TVT[-]O are also inconsistent with a theory that
mechanical cut tape is defective.” They claim that this statement is inconsistent with
Dr. Sepulveda-Toro’s other testimony describing the availability of certain types of
studies and critique the literature he relied on. The court finds these objections
insufficient to credibly call into question the reliability of Dr. Sepulveda-Toro’s
statement. The Motion is DENIED on this point.
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
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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
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
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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
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
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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
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
13

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
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 expert
testimony to be excluded, the parties ask the court to prevent experts from offering
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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 Limit the Opinions and Testimony of Jaime L. Sepulveda-Toro, M. D. [ECF
No. 2014].
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 Exhibit 1
attached to the Motion to Limit the Opinions and Testimony of Jaime L. SepulvedaToro, M. D. [ECF No. 2014].

ENTER:

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August 30, 2016

EXHIBIT A

EXHIBIT A – SEPULVEDA-TORO DAUBERT MOTION

THIS DOCUMENT RELATES TO PLAINTIFFS:
Mary Cone
Case No. 2:12-cv-00261
Dina Destefano-Raston
Case No. 2:12-cv-01299
Nancy Hooper
Case No. 2:12-cv-00493
Alfreda Lee
Case No. 2:12-cv-01013
Romona Greer (deceased)
Case No. 2:12-cv-00510
Jennifer Reyes
Case No. 2:12-cv-00939
Carrie Smith
Case No. 2:12-cv-00258
Beth Harter
Case No. 2:12-cv-00737
Sheri Scholl
Case No. 2:12-cv-00738
Margaret Stubblefield
Case No. 2:12-cv-00842
Roberta Warmack
Case No. 2:12-cv-01150
Jackie Frye
Case No. 2:12-cv-01004
Dina Sanders Bennett
Case No. 2:12-cv-00497
Joan Adams
Case No. 2:12-cv-01203
1

Barbara Vignos-Ware
Case No. 2:12-cv-00761
Fran Collins
Case No. 2:12-cv-00931
Pamela Gray Wheeler
Case No. 2:12-cv-00455
Deborah Lynn Joplin
Case No. 2:12-cv-00787
Donna Shepherd
Case No. 2:12-cv-00967
Paula Fisk
Case No. 2:12-cv-00848
Teresa Georgilakis
Case No. 2:12-cv-00829
Jennifer Sikes
Case No. 2:12-cv-00501
Isabel Swint
Case No. 2:12-cv-00786
Krystal Teasley
Case No. 2:12-cv-00500
Susan Thaman (Reeves)
Case No. 2:12-cv-00279
Kimberly Thomas (Wyatt)
Case No. 2:12-cv-00499
Louise Grabowski
Case No. 2:12-cv-00683
Cathy Warlick
Case No. 2:12-cv-00276

2