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 

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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. 2075-

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 

 

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: August 25, 2016

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Exhibit A 

Case 5:11-cv-06584-LHK Document 119 Filed 08/25/16 Page 13 of 17
1

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF WEST VIRGINIA

AT CHARLESTON

IN RE: ETHICON, INC., PELVIC

REPAIR SYSTEM PRODUCTS

LIABILITY LITIGATION

_________________________________

THIS DOCUMENT RELATES TO

ETHICON WAVE 1 CASES

Master File No. 2:12-MD-02327

MDL No. 2327

Joseph R. Goodwin

UNITED STATES DISTRICT JUDGE

Exhibit A to Defendants’ Motion to Exclude Peggy Pence, Ph.D.

List of Applicable Cases1

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.

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

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Collins, Fran Denise 2:12cv00931 TVT-O

Cone, Mary F. 2:12cv00261 TVT-O

Conti, Patricia 2:12cv00516 TVT

Deleon, Amanda &

Raymond 2:12cv00358 Prolift

Destefano-Raston, Dina &

Terry 2:12cv01299 TVT-O

Drake, Karyn E. &

Douglas E. 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

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

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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

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*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.

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

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