Rhynehart v. Ethicon, Inc. et al

Filing 105

MEMORANDUM OPINION AND ORDER (Daubert Motion re: Peggy Pence, Ph.D.) The court DENIES in part, GRANTS in part, and RESERVES in part the Motion filed in MDL 2327 by Ethicon, Inc., Johnson & Johnson to Exclude Peggy Pence, Ph.D. in Wave 1 Cases, 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: Peggy Pence, Ph.D.)
Pending before the court is the Motion to Exclude Peggy Pence, Ph.D. [ECF
No. 2075] filed by the defendants Ethicon, Inc. and Johnson & Johnson (collectively
“Ethicon”). 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.
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

1 Ethicon

identified the Wave 1 cases affected by this Motion in its attached Exhibit A [ECF No. 20751], 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

Dr. Pence has a Ph.D. in toxicology and holds herself out as a specialist in
medical device product development, regulatory affairs, and labeling standards. She
intends to testify on behalf of the plaintiffs but Ethicon seeks exclusion of her

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opinions.
a. Warnings
Ethicon claims Dr. Pence is not qualified to offer expert testimony about the
adequacy of the relevant Instructions for Use (“IFU”). I disagree. Dr. Pence has over
forty years of experience in the research and development of medical devices, and she
has accumulated knowledge about the content of product labeling. Accordingly,
Ethicon’s motion is DENIED on this point.
Ethicon claims Dr. Pence’s expert testimony is not reliable because she never
spoke to any physicians about labeling and their knowledge. But an expert’s failure
to examine a particular source of information is not grounds for exclusion under

Daubert if the expert testimony is supported by other “sufficient facts or data.” Fed.
R. Evid. 702. Dr. Pence considered, for example, medical and scientific literature, the
relevant IFUs, and internal Ethicon documents. This collection of sources is sufficient
for the purposes of Daubert. Ethicon may attempt to expose any perceived
shortcomings through cross-examination. Accordingly, Ethicon’s Motion is DENIED
on this point.
Relatedly, Ethicon argues that Dr. Pence cannot offer expert testimony about
whether the relevant IFUs “are adequate for doctors to obtain informed consent
of their patients” because she is not qualified and because her expert testimony is
unreliable and irrelevant. Mem. Supp. Pence Mot. 14 [ECF No. 2078]. Because
application of the informed consent doctrine turns on the applicable state law, I
RESERVE ruling on this matter.

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b. Premarket Testing
Ethicon claims Dr. Pence is not qualified to offer expert testimony about
premarket testing of medical devices. Dr. Pence has over forty years of experience in
the research and development of medical devices. Over that time, she has
accumulated knowledge about the clinical testing of novel medical devices. So
Ethicon’s Motion is DENED on this point.
Ethicon claims Dr. Pence’s expert testimony is not reliable because she does
not apply the standards on which she relies to determine whether Ethicon met those
testing standards. In my view, the plaintiffs do not respond to this argument.
However, the plaintiffs respond that Dr. Pence’s expert testimony is reliable because
it is also based on her experience. As a result, the reliability inquiry must probe into
the relationship between the experience and the expert testimony. Cf. Fed. R. Evid.
702 advisory committee’s note to 2000 amendment (“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.”). In this context, I am without
sufficient information at this time to draw the fine line between reliable and
unreliable expert testimony on premarket testing. Accordingly, I RESERVE ruling
until further testimony may be offered and evaluated firsthand at trial.
c. Market Removal
Ethicon asks the court to exclude Dr. Pence’s opinion that Prosima should have
been removed from the market before it was actually removed from the market and,

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by failing to do so, Ethicon violated its commitment to patient safety. Most
problematic is Dr. Pence’s reliance on Ethicon’s “[c]redo of putting doctors and
patients first.” Pence Rep. 49 [ECF No. 2075-5]. Liability is not predicated on a
company’s compliance with its own credos or codes; liability is instead predicated on
the legal standards of the case. See, e.g., Restatement (Third) of Torts: Physical &

Emotional Harm § 13 cmt. f (Am. Law Inst. 2010). Accordingly, expert testimony of
this sort is not helpful to the jury and is thus unreliable and EXCLUDED.
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

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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.
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

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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
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.

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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

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

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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 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 Peggy Pence, Ph.D. [ECF No. 2075].
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

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF WEST VIRGINIA
AT CHARLESTON

Master File No. 2:12-MD-02327
MDL No. 2327

IN RE: ETHICON, INC., PELVIC
REPAIR SYSTEM PRODUCTS
LIABILITY LITIGATION
_________________________________
THIS DOCUMENT RELATES TO
ETHICON WAVE 1 CASES

Joseph R. Goodwin
UNITED STATES DISTRICT JUDGE

Exhibit A to Defendants’ Motion to Exclude Peggy Pence, Ph.D.
List of Applicable Cases1
Case Name

Case Number

Product(s)

Amsden, Donna

2:12cv00960

Prolift

Banks Smith, Marie

2:12cv01318

TVT

Boggs, Sharon & Michael

2:12cv00368

TVT-O & Prolift

Bollinger, Karen

2:12cv01215

TVT

Burkhart, Denise

2:12cv01023

TVT

Byrd, Myra & Richard

2:12cv00748

TVT-O

Carpenter, Sharon &
Gardner

2:12cv00554

Prolift

Cole, Carey Beth & David

2:12cv00483

Prolift

Coleman, Angela &
Timothy

2:12cv01267

TVT-O

1

Plaintiffs’ designation states that they recognize the Fourth Circuit’s affirmance of this Court’s exclusion
of evidence of compliance with the 510(k) process and “reserve the right to designate” Dr. Pence “[i]n the event of a
contrary ruling.” Ex. L, Pls. General Expert Desig., p. 2. Ethicon understands this to mean that Dr. Pence is not
designated at all if no FDA evidence is admitted, even though this is potentially inconsistent with Dr. Pence’s
current disclaimer of reliance on FDA regulations. In addition, Ethicon notes that this “reservation of right to
designate” in some instances puts Plaintiffs’ number of experts over the allotted five.

1

Collins, Fran Denise

2:12cv00931

TVT-O

Cone, Mary F.

2:12cv00261

TVT-O

Conti, Patricia

2:12cv00516

TVT

2:12cv00358

Prolift

2:12cv01299

TVT-O

2:12cv00747

TVT

Forester, Karen & Joel

2:12cv00486

TVT-O

Fox, Sherry & Roy, Jr.

2:12cv00878

TVT

Free, Pamela

2:12cv00423

TVT

Freeman, Shirley &
William

2:12cv00490

Prolift +M

Deleon, Amanda &
Raymond
Destefano-Raston, Dina &
Terry
Drake, Karyn E. &
Douglas E.

Funderburke, Betty

2:12cv00957

Prolift & TVT

Georgilakis, Teresa &
Angelo

2:12cv00829

TVT-O

Gomez, Rose & Jesus

2:12-cv-00344

Prolift & TVT-O

Gray-Wheeler, Pamela

2:12cv00455

Prolift & TVTSecur

Guinn, Susan

2:12cv01121

TVT-O

Hankins, Dawna

2:12cv00369

TVT-O

Hankins, Donna & Roger

2:12cv01011

TVT

Hendrix, Mary & Thomas

2:12cv00595

TVT

Herrera-Nevarez, Rocio

2:12cv01294

TVT-O

Hill, Barbara A. & Billy
W.

2:12cv00806

Prolift

Johnson, Wilma

2:11cv00809

Gynemesh PS &
TVT

Jones, Holly & Jason

2:12cv00443

TVT

Kaiser, Barbara

2:12cv00887

Prolift

2

Kirkpatrick, Margaret

2:12cv00746

TVT-O

Kriz, Paula & James

2:12cv00938

Gynemesh PS &
TVT-O

Lehman, JoAnn

2:12cv00517

TVT-O

Long, Heather

2:12cv01275

TVT

Loustaunau, Donna

2:12cv00666

Prolift

Lozano, Deborah & Felipe

2:12cv00347

Prolift & TVT-O

McBrayer, Dee &
Timothy

2:12cv00779

Prolift

Nix, Cynthia

2:12cv01278

Prolift; TVT-O

Olson, Mary Jane &
Daniel

2:12cv00470

Prolift; TVT-O

Padilla, Noemi

2:12cv00567

Prolift +M

Patterson, Miranda

2:12cv00481

TVT-O

Pratt Bartlett, Rebecca

2:12cv01273

TVT

Reyes, Jennifer & Jerry

2:12cv00939

TVT

Rhynehart, Penny

2:12cv01119

Prolift & TVT-O

Ruebel, Ana

2:12cv00663

Prolift; TVT-O

Shultis, Stacy

2:12cv00654

TVT-O

Sikes, Jennifer

2:12cv00501

TVT-O

Smith, Carrie

2:12cv00258

TVT-O

Springer, Cherise & Marty

2:12cv0997

TVT-O

Swint, Isabel

2:12cv00786

TVT-O

Teasley, Krystal

2:12cv00500

TVT-O

Thaman, Susan

2:12cv00279

Prolift; TVTSecur

Thomas, Kimberly

2:12cv00499

Prosima; TVT-O

3

Thurston, Mary &
Kenneth

2:12cv00505

TVT

Warlick, Cathy

2:12cv00276

Prosima; Prolift

Williams, Nancy

2:12cv00511

Prolift; TVT-O

Wiltgen, Christine &
Mark S.

2:12cv01216

TVT

Wolfe, Sandra

2:12cv00335

Prolift; TVT-O

*Dr. Pence was also designated in a number of cases involving only the Gynemesh PS,
Prolene Soft, or TVT-Secur products, but she did not provide an expert report for those
products.
Case Name

Case Number

Product(s)

Beach, Harriet

2:12cv00476

Gynemesh PS

Bridges, Robin

2:12cv00651

Gynemesh PS

Evans, Ida Deanne

2:12cv01225

Prolene Mesh

Fisk, Paula

2:12cv00848

Gynemesh PS

Grabowski, Louise

2:12cv00683

Gynemesh PS

Hooper, Nancy & Daniel

2:12cv00493

Gynemesh PS

Lee, Alfreda & James

2:12cv01013

TVT-Secur

Ruiz, Patricia

2:12cv004701021

TVT-Secur

Tyler, Patricia

2:12cv00469

Prolene Soft

* Defendants reserve the right to supplement this list should any plaintiff designate Dr.
Pence as a general expert in MDL Wave 1.

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