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: Steven MacLean, Ph.D., P.E.) 

 

Pending before the court is the Motion to Exclude, or in the Alternative, to 

Limit the Opinions and Testimony of Steven MacLean, Ph.D., P.E. [ECF No. 2205]

filed by the plaintiffs. The Motion is ripe for consideration.

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 

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 1 of 16
2

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 The plaintiffs identified the Wave 1 cases affected by this Motion in their attached Exhibit A [ECF 

No. 2205-1], 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.

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 2 of 16
3

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 

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 3 of 16
4

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.

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 4 of 16
5

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 

 

Steven MacLean, Ph.D., P.E., is a polymer scientist and engineer whom 

Ethicon offers as an expert witness. The plaintiffs challenge Dr. MacLean’s testimony 

on a number of fronts. 

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 5 of 16
6

First, the plaintiffs seek exclusion of Dr. MacLean’s biocompatibility and 

regulatory opinions. In response, Ethicon states that Dr. MacLean “has not disclosed 

and will not offer opinions regarding biocompatibility or regulatory issues in this 

litigation.” Resp. 5 [ECF No. 2287]. Accordingly, the plaintiffs’ Motion on these issues 

is DENIED as moot.

Second, the plaintiffs challenge Dr. MacLean’s reliance on Ethicon’s seven-year 

dog study to opine that Prolene is not subject to degradation. Specifically, Dr. 

MacLean relies on the study’s finding that Prolene does not lose molecular weight in 

vivo. The plaintiffs argue that this finding is unreliable because the study compared 

the molecular weight of the samples being studied to an inappropriate control (i.e., 

comparing Prolene 5/0 sutures to Prolene 4/0 sutures). Ethicon defends the study’s 

findings and suggests plaintiffs’ argument reflects a misunderstanding of the concept 

of molecular weight. During his deposition, Dr. MacLean explained that the 

molecular weight of the two versions of Prolene is the same because they are 

composed of the same base polymer, which he claims is the relevant comparison for 

molecular weight purposes. The court does not find that the plaintiffs’ concerns with 

the dog study’s findings render Dr. MacLean’s testimony unreliable. The plaintiffs’ 

Motion on this point is DENIED. 

Third, the plaintiffs seek to exclude Dr. MacLean’s testimony that Dr. Jordi’s 

conclusions about the melting point of mesh are incorrect. To reach his conclusion, 

Dr. MacLean used several sets of data, including those of Dr. Jordi, from different 

studies to calculate molecular weight. The plaintiffs contend Dr. MacLean’s 

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 6 of 16
7

calculations involved unreliable extrapolations, and they take issue with both the 

combination of findings from different studies and the reliability of the studies 

themselves. The use of inputs from different studies does not necessarily render an 

expert’s conclusions unreliable. However, the court is without sufficient information 

in this instance to explore the scientific validity of Dr. MacLean’s assumptions and 

methods used in this instance. Accordingly, I RESERVE ruling on Dr. MacLean’s 

calculations related to Dr. Jordi’s testimony until the testimony can be evaluated 

firsthand at trial. 

Fourth, the plaintiffs contend that Dr. MacLean is not qualified to offer 

pathology opinions because he is not a pathologist. However, as Ethicon points out, 

the opinions the plaintiffs characterize as pathology opinions are those related to 

staining, microtoming, and microscopy, which are processes used across medical and 

scientific fields, including polymer science. As an experienced polymer scientist and 

engineer, Dr. MacLean is qualified to opine on the chemical and physical interactions 

between fluid stains and polymer materials such as Prolene. Insofar as the plaintiffs 

challenge Dr. MacLean’s qualifications, their Motion is DENIED. 

Finally, the plaintiffs challenge the reliability of Dr. MacLean’s experiment in 

which he used chemicals and ultra-violet radiation to intentionally degrade Prolene 

samples, sent the samples to a lab for Hematoxylin and Eosin (H&E) staining, and 

concluded the samples did not stain. Dr. MacLean uses these experiments to refute 

Dr. Iakovlev’s opinions that H&E will stain the outer layer of degraded Prolene. The 

plaintiffs raise several arguments as to why Dr. MacLean’s testing is unreliable. 

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 7 of 16
8

Upon careful consideration of the plaintiffs’ concerns, Ethicon’s responses, and Dr. 

MacLean’s expert report, I do not find that the challenges raised credibly undermine 

the reliability of Dr. MacLean’s testing. Accordingly, the plaintiffs’ Motion on this 

matter is DENIED.

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 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 

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 8 of 16
9

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 

device in question was being designed. 

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 9 of 16
10

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 

using experts to usurp the jury’s fact-finding function by allowing testimony of this 

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 10 of 16
11

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 

Evidence.

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 11 of 16
12

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 excluded, the parties ask the court to prevent experts from offering 

other expert testimony that the moving 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, RESERVES in part, and GRANTS in part the 

Motion to Exclude, or in the Alternative, to Limit the Opinions and Testimony of 

Steven MacLean, Ph.D., P.E. [ECF No. 2205].

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: September 2, 2016

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 12 of 16
EXHIBIT A 

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 13 of 16
1 

THIS DOCUMENT RELATES TO PLAINTIFFS:

Ida Evans 

2:12-cv-01225 

Rose Gomez

2:12‐cv‐00344 

Jeanie Holmes

2:12-cv-01206 

Mary Jane Olson 

2:12-cv-00470 

Christine Wiltgen

2:12-cv-01216 

Kathleen Wolfe 

2:12-cv-00337 

Monica Freitas

2:12-cv-01146 

Denise Sacchetti

2:12-cv-01148 

Sheri Scholl 

2:12-cv-00738 

Cindy Smith

2:12-cv-01149 

Laura Waynick 

2:12-cv-01151 

Denise Burkhart

2:12-cv-01023 

Jo'Ann Lehman 

2:12-cv-00517 

Patricia Conti 

2:12-cv-00516 

EXHIBIT - McClean

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 14 of 16
2 

Patricia Ruiz

2:12-cv-01021 

Pamela Free

2:12-cv-00423 

Melissa Ridgley

2:12-cv-01311 

Marty Babcock

2:12-cv-001052 

Dorothy Baugher 

2:12-cv-01053 

Patti Ann Phelps

2:12-cv-01151 

Lisa Thompson 

2:12-cv-01199 

Rebecca Wheeler

2:12-cv-01088 

Thema Wright 

2:12-cv-01090 

Rocio Herrera-Nevarez

2:12-cv-01294 

Debra A. and Donald Schnering

2:12-cv-01071 

Rebekah Bartlett (Pratt)

2:12‐cv‐01273 

Amanda Deleon 

2:12‐cv‐00358 

Karyn Drake 

2:12‐cv‐00747 

Paula Kriz

2:12‐cv‐00938 

_____ 1171

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 15 of 16
3 

Stacy Shultis

2:12‐cv‐00654 

Kimberly Thomas (Wyatt) 

2:12‐cv‐00499 

Tyler, Patricia

2:12‐cv‐00469 

Myndal Johnson 

2:12-cv-00498 

Beverly Kivel

2:12-cv-00591 

Karen Bollinger 

2:12-cv-01215 

Virginia Dixon 

2:12-cv-01081 

Shirley Walker

2:12-cv-00873 

Dawna Hankins

2:12‐cv‐00369 

Wilma Johnson 

2:11‐cv‐00809 

Margaret Kirkpatrick

2:12‐cv‐00746 

Harriet Beach

2:12-CV-00476 

Holly Jones 

2:12-cv-00443 

_______

Dennis W. 

Case 5:11-cv-06584-LHK Document 126 Filed 09/02/16 Page 16 of 16