Schnering et al v. Ethicon, Inc.

Filing 123

MEMORANDUM OPINION AND ORDER (Daubert Motion re: Timothy Ulatowski) The court GRANTS in part, DENIES in part, and RESERVES in part the DAUBERT MOTION filed in MDL 2327 by Certain Plaintiffs in Wave 1 Cases to Exclude the Opinions of FDA Expert Timothy Ulatowski, 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) (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: Timothy Ulatowski)
Pending before the court is the Motion to Exclude the Opinions of FDA Expert
Timothy Ulatowski [ECF No. 2060] 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
testimony. Although I recognize the tendency of my prior evidentiary determinations

The plaintiffs identified the Wave 1 cases affected by this Motion in their attached Exhibit A [ECF
No. 2060-1], 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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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
testimony may be evaluated at trial. At trial, the expert testimony will be tested by

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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
standards.

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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

Mr. Ulatowski holds a master’s degree in physiology and a bachelor’s degree in
microbiology. Mr. Ulatowski owns a consulting company that specializes in medical
device regulations, policies, and procedures administered by the Food and Drug

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Administration (“FDA”). Mr. Ulatowski was once an employee of the FDA.
Because I have either excluded or reserved ruling on the admissibility of Mr.
Ulatowski’s testimony on the grounds explained below in the Recurring Issues
section, I find it unnecessary to address alternate challenges to his reliability or
qualifications.
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 case, 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 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, 5-9 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
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.
V.

Conclusion

The plaintiffs’ Motion regarding Mr. Ulatowski falls entirely within the
reoccurring issues presented to this court. Accordingly, the court GRANTS in part,
DENIES in part, and RESERVES in part the Motion to Exclude the Opinions of FDA
Expert Timothy Ulatowski [ECF No. 2060].
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

EXHIBIT A – ULATOWSKI DAUBERT MOTION
THIS DOCUMENT RELATES TO
PLAINTIFFS:
Daphne Barker
Case No. 2:12-cv-00899
Sharon Carpenter
Case No. 2:12-cv-00554
Mary Cone
Case No. 2:12-cv-00261
Joy Essman
Case No. 2:12-cv-00277
Ida Evans
Case No. 2:12-cv-01225
Shirley Freeman
Case No. 2:12-cv-00490
Rose Gomez
Case No. 2:12-cv-00344
Louise Grabowski
Case No. 2:12-cv-00683
Barbara A. Hill
Case No. 2:12-cv-00806
Jeanie Holmes
Case No. 2:12-cv-01206
Diane Kropf
Case No. 2:12-cv-01202
Danni Laffoon
Case No. 2:12-cv-00485
Alfreda Lee
Case No. 2:12-cv-01013
Dee McBrayer
Case No. 2:12-cv-00779

______________
Charlene Miracle Romona Greer
Case No. 2:12-cv-00510
Mary Jane Olson
Case No. 2:12-cv-00470
Jennifer Reyes
Case No. 2:12-cv-00939
Brenda Riddell
Case No. 2:12-cv-00547
Carrie Smith
Case No. 2:12-cv-00258
Virginia White
Case No. 2:12-cv-00958
Judy Williams
Case No. 2:12-cv-00657
Christine Wiltgen
Case No. 2:12-cv-01216
Kathleen Wolfe
Case No. 2:12-cv-00337
Donna Zoltowski
Case No. 2:12-cv-00811
Sherry Fox
Case No. 2:12-cv-00878
Lois Durham
Case No. 2:12-cv-00760
Monica Freitas
Case No. 2:12-cv-01146
Beth Harter
Case No. 2:12-cv-00737
Mary Holzerland
Case No. 2:12-cv-00875
Lois Hay
Case No. 2:12-cv-00876
2

Denise Sacchetti
Case No. 2:12-cv-01148
Sheri Scholl
Case No. 2:12-cv-00738
Margaret Stubblefield
Case No. 2:12-cv-00842
Laura Waynick
Case No. 2:12-cv-01151
Teri Key Shively
Case No. 2:12-cv-00379
___________
Tina Morrow
____________________
Case No. 2:12-cv-00378 WAVE 2
Dina Sanders Bennett
Case No. 2:12-cv-00497
Joan Adams
Case No. 2:12-cv-01203
Denise Burkhart
Case No. 2:12-cv-01023
Jo’Ann Lehman
Case No. 2:12-cv-00517
_____
Elizabeth Blynn Wilson WOLFE
Case No. 2:12-cv-01286
Patricia Conti
Case No. 2:12-cv-00516
Patricia Ruiz
Case No. 2:12-cv-01021
Barbara Vignos-Ware
Case No. 2:12-cv-00761
Cynthia Nix
Case No. 2:12-cv-01278
Fran Collins
Case No. 2:12-cv-00931
3

Shirley Walker
Case No. 2:12-cv-00873
Carol Jean Dimock
Case No. 2:12-cv-00401
Karen Forester
Case No. 2:12-cv-00486
Cherise Springer
Case No. 2:12-cv-00997
Joyce Justus
Case No. 2:12-cv-00956
Melissa Clayton
Case No. 2:12-cv-00489
Bonnie Blake
Case No. 2:12-cv-00995
Melissa Ridgley
Case No. 2:12-cv-01311
Pamela Gray Wheeler
Case No. 2:12-cv-00455
Dorothy Baugher
Case No. 2:12-cv-01053
Wendy Hagans
Case No. 2:12-cv-00783
Donna Massey
Case No. 2:12-cv-00880
Angela Morrison
Case No. 2:12-cv-00800
Maria Eugenia Quijano
Case No. 2:12-cv-00799
Lisa Thompson
Case No. 2:12-cv-01199
Rebecca Wheeler
Case No. 2:12-cv-01088
4

Thema Wright
Case No. 2:12-cv-01090
Rocio Herrera-Nevarez
Case No. 2:12-cv-01294
Debra A. and Donald Schnering
Case No. 2:12-cv-01071
Donna Shepherd
Case No. 2:12-cv-00967
Rebekah Bartlett (Pratt)
Case No. 2:12-cv-01273
Robin Bridges
Case No. 2:12-cv-00651
Myra Byrd
Case No. 2:12-cv-00748
Angela Coleman
Case No. 2:12-cv-01267
Amanda Deleon
Case No. 2:12-cv-00358
Karyn Drake
Case No. 2:12-cv-00747
Paula Fisk
Case No. 2:12-cv-00848
Teresa Georgilakis
Case No. 2:12-cv-00829
Dawna Hankins
Case No. 2:12-cv-00369
Wilma Johnson
____________
Case No. 2:12-cv-00809 2:11-cv-0809
Margaret Kirkpatrick
Case No. 2:12-cv-00746
Noemi Padilla
Case No. 2:12-cv-00567
5

Stacy Shultis
Case No. 2:12-cv-00654
Isabel Swint
Case No. 2:12-cv-00786
Susan Thaman (Reeves)
Case No. 2:12-cv-00279
Kimberly Thomas (Wyatt)
Case No. 2:12-cv-00499
Patricia Tyler
Case No. 2:12-cv-00469
Cathy Warlick
Case No. 2:12-cv-00276
Myndal Johnson
Case No. 2:12-cv-00498
Beverly Kivel
Case No. 2:12-cv-00591
Harriet Beach
Case No. 2:12-cv-00476
Holly Jones
Case No. 2:12-cv-00443
Donna Amsden
Case No. 2:12-cv-00960
Karen Bollinger
Case No. 2:12-cv-01215
Virginia Dixon
Case No. 2:12-cv-01081
Susan Guinn
Case No. 2:12-cv-01121
Heather Long
Case No. 2:12-cv-01275
Penny Rhynehart
Case No. 2:12-cv-01119
6

Mary and Kenneth Thurston
Case No. 2:12-cv-00505
Nancy Jo Williams
Case No. 2:12-cv-00511
Cheryl Lankston
Case No. 2:12-cv-00755
Maria Stone
Case No. 2:12-cv-00652
Donna Loustaunau
Case No. 2:12-cv-00666
Barbara Kaiser
Case No. 2:12-cv-00887
Pameal Free
Case No. 2:12-cv-00423
Julie Wroble
Case No. 2:12-cv-00883
Ana Ruebel
Case No. 2:12-cv-00663
Jackie Frye
Case No. 2:12-cv-01004
Sandra Wolfe
Case No. 2:12-cv-00335

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