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: Denise Elser, M.D.) 

 

Pending before the court is the Motion to Exclude Certain Opinions and 

Testimony of Denise Elser, M.D., [ECF No. 2053] 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 

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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

 

1 The plaintiffs identified the Wave 1 cases affected by this Motion in their Exhibit A [ECF No. 2053-

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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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 

remand, including those related to the admissibility of expert testimony pursuant to 

Daubert. Nevertheless, in some instances I face Daubert challenges where my 

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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 

firsthand.

III. Legal Standard 

By now, the parties should be intimately familiar with Rule 702 of the Federal 

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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). 

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. Elser is urogynecologist. She is the medical director of the Women’s Health 

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Institute of Illinois. 

a. Warnings 

 

The plaintiffs claim Dr. Elser is not qualified to offer expert testimony about 

product warnings, which includes expert testimony about the adequacy of the 

relevant Instructions for Use (“IFU”). According to the plaintiffs, Dr. Elser 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 urogynecologist 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. Elser does not possess the additional expertise to offer expert testimony 

about what an IFU should or should not include. Accordingly, Dr. Elser’s expert 

testimony about these matters is EXCLUDED.

2 

b. Design 

 

The plaintiffs claim Dr. Elser is not qualified to offer what they characterize 

as design opinions. But they do not explain or identify these opinions with sufficient 

 

2 In relation to the expert testimony about the adequacy of the IFU, Ethicon claims Dr. Elser 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. 

Elser 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. Elser 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. Elser does not possess.

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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. Elser 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. Elser 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. Safety and Efficacy 

 

The plaintiffs make a narrow challenge to the reliability of Dr. Elser’s expert 

testimony focused on the safety and efficacy rates derived from her medical practice, 

asking the court to exclude her precise safety and efficacy rates. During her 

deposition, Dr. Elser testified that her safety and efficacy rates may include nonEthicon products and that she could not recall the time period from which the 

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underlying data was taken or the number of patients accounted for by the data. Put 

simply, she seeks to offer precise statistics based on her own assurances that those 

statistics are reliable. But expert testimony about specific rates is unreliable without 

more than then expert’s assurances of reliability. But see Trevino v. Bos. Sci. Corp., 

No. 2:13-cv-1617, 2016 WL 2939521, at *33 (S.D. W. Va. May 19, 2016) (allowing 

expert testimony about broad concerns of safety and efficacy without providing exact 

statistics). Accordingly, this expert testimony is 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 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.

VI. Conclusion 

The court DENIES as moot in part, GRANTS in part, and RESERVES in part

the Motion to Exclude Certain Opinions of Denise Elser, M.D. [ECF No. 2053].

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 attached 

hereto.

ENTER: August 30, 2016 

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Exhibit A

Case 5:11-cv-06584-LHK Document 123 Filed 08/30/16 Page 13 of 15
EXHIBIT A – ELSER DAUBERT MOTION

THIS DOCUMENT RELATES TO 

PLAINTIFFS:

Jeanie Holmes

Case No. 2:12-cv-01206 

Laura Waynick 

Case No. 2:12-cv-01151 

Denise Burkhart

Case No. 2:12-cv-01023 

Pamela Free

Case No. 2:12-cv-00423 

Dorothy Baugher 

Case No. 2:12-cv-01053 

Lisa Thompson 

Case No. 2:12-cv-01199 

Rebecca Wheeler

Case No. 2:12-cv-01088 

Thelma 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 

Margaret Kirkpatrick 

Case No. 2:12-cv-00746 

Miranda Patterson 

Case No. 2:12-cv-00481 

Stacy Shultis

Case No. 2:12-cv-00654 

Myndal Johnson

Case 5:11-cv-06584-LHK Document 123 Filed 08/30/16 Page 14 of 15
2 

Case No. 2:12-cv-00498

Holly Jones 

Case No. 2:12-cv-00443 

Karen Bollinger 

Case No. 2:12-cv-01215 

Melissa Ridgley 

Case No. 2:12-cv-1311

Case 5:11-cv-06584-LHK Document 123 Filed 08/30/16 Page 15 of 15