IN THE UNITED STATES DISTRICT COURT 

FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA 

 

CHARLESTON DIVISION

IN RE: ETHICON, INC.

PELVIC REPAIR SYSTEMS

PRODUCT LIABILITY LITIGATION MDL No. 2327

______________________________________________________________________________

THIS DOCUMENT RELATES TO:

Cases Identified in the Exhibit 

Attached Hereto

MEMORANDUM OPINION AND ORDER 

(Daubert Motion re: Timothy Ulatowski) 

 

Pending before the court is the Motion to Exclude the Opinions of FDA Expert 

Timothy Ulatowski [ECF No. 2060] filed by the plaintiffs. The Motion is now ripe for 

consideration because briefing is complete.

I. Background 

This case resides in one of seven MDLs assigned to me by the Judicial Panel 

on Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat 

pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”). In the seven 

MDLs, there are more than 75,000 cases currently pending, approximately 30,000 of 

which are in this MDL, which involves defendants Johnson & Johnson and Ethicon,

Inc. (collectively “Ethicon”), among others.

In this MDL, the court’s tasks include “resolv[ing] pretrial issues in a timely 

and expeditious manner” and “resolv[ing] important evidentiary disputes.” Barbara 

J. Rothstein & Catherine R. Borden, Fed. Judicial Ctr., Managing Multidistrict 

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 1 of 18
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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. 2060-1], which the court has attached to this Memorandum Opinion and Order. At the time of 

transfer or remand, the parties will be required to designate relevant pleadings from MDL 2327, 

including the motion, supporting memorandum, response, reply, and exhibits referenced herein.

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 2 of 18
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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 

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 3 of 18
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precise questions asked and answered. The alternative of live Daubert hearings is 

impossible before transfer or remand because of the numerosity of such motions in 

these seven related MDLs. As these MDLs have grown and the expert testimony has 

multiplied, I have become convinced that the critical gatekeeping function permitting 

or denying expert testimony on decisive issues in these cases is best made with a live 

expert on the witness stand subject to vigorous examination. 

In the course of examining a multitude of these very similar cases involving 

the same fields of expertise, I have faced irreconcilably divergent expert testimony

offered by witnesses with impeccable credentials, suggesting, to me, an unreasonable 

risk of unreliability. The danger—and to my jaded eye, the near certainty—of the 

admission of “junk science” looms large in this mass litigation. 

The parties regularly present out-of-context statements, after-the-fact 

rationalizations of expert testimony, and incomplete deposition transcripts. This, 

combined with the above-described practice of recycling expert testimony, objections, 

and the court’s prior rulings, creates the perfect storm of obfuscation. Where further 

clarity is necessary, I believe it can only be achieved through live witness testimony—

not briefing—I will therefore reserve ruling until expert testimony can be evaluated 

firsthand. 

III. Legal Standard 

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

Rules of Evidence and Daubert, so the court will not linger for long on these 

standards.

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Expert testimony is admissible if the expert is qualified and if his or her expert 

testimony is reliable and relevant. Fed. R. Evid. 702; see also Daubert, 509 U.S. at 

597. An expert may be qualified to offer expert testimony based on his or her 

“knowledge, skill, experience, training, or education.” Fed. R. Evid. 702. Reliability 

may turn on the consideration of several factors:

(1) whether a theory or technique can be or has been tested; 

(2) whether it has been subjected to peer review and 

publication; (3) whether a technique has a high known or 

potential rate of error and whether there are standards 

controlling its operation; and (4) whether the theory or 

technique enjoys general acceptance within a relevant 

scientific community.

Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 199 (4th Cir. 2001) (citing Daubert, 

509 U.S. at 592–94). But these factors are neither necessary to nor determinative of 

reliability in all cases; the inquiry is flexible and puts “principles and methodology” 

above conclusions and outcomes. Daubert, 509 U.S. at 595; see also Kumho Tire Co. 

v. Carmichael, 525 U.S. 137, 141, 150 (1999). Finally, and simply, relevance turns on 

whether the expert testimony relates to any issues in the case. See, e.g., Daubert, 509 

U.S. at 591–92 (discussing relevance and helpfulness). 

At bottom, the court has broad discretion to determine whether expert 

testimony should be admitted or excluded. Cooper, 259 F.3d at 200.

IV. Discussion 

Mr. Ulatowski holds a master’s degree in physiology and a bachelor’s degree in 

microbiology. Mr. Ulatowski owns a consulting company that specializes in medical 

device regulations, policies, and procedures administered by the Food and Drug 

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 5 of 18
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Administration (“FDA”). Mr. Ulatowski was once an employee of the FDA.

Because I have either excluded or reserved ruling on the admissibility of Mr.

Ulatowski’s testimony on the grounds explained below in the Recurring Issues 

section, I find it unnecessary to address alternate challenges to his reliability or 

qualifications. 

V. Recurring Issues 

Many of the Daubert motions filed in this MDL raise the same or similar

objections.

One particular issue has been a staple in this litigation, so I find it best to 

discuss it in connection with every expert. A number of the Daubert motions seek to 

exclude FDA testimony and other regulatory or industry standards testimony. To the 

extent this Motion raises these issues it is GRANTED in part and RESERVED in 

part as described below. 

I have repeatedly excluded evidence regarding the FDA’s section 510(k) 

clearance process in these MDLs, and will continue to do so in these case, a position 

that has been affirmed by the Fourth Circuit. In re C. R. Bard, Inc., 81 F.3d 913, 

921–23 (4th Cir. 2016) (upholding the determination that the probative value of 

evidence related to section 510(k) was substantially outweighed by its possible 

prejudicial impact under Rule 403). Because the section 510(k) clearance process does 

not speak directly to safety and efficacy, it is of negligible probative value. See In re 

C. R. Bard, 81 F.3d at 920 (“[T]he clear weight of persuasive and controlling authority 

favors a finding that the 510(k) procedure is of little or no evidentiary value.”). 

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 6 of 18
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Delving into complex and lengthy testimony about regulatory compliance could 

inflate the perceived importance of compliance and lead jurors “to erroneously 

conclude that regulatory compliance proved safety.” Id. at 922. Accordingly, expert 

testimony related to the section 510(k) process, including subsequent enforcement 

actions and discussion of the information Ethicon did or did not submit in its section 

510(k) application, is EXCLUDED. For the same reasons, opinions about Ethicon’s 

compliance with or violation of the FDA’s labeling and adverse event reporting 

regulations are EXCLUDED. In addition to representing inappropriate legal 

conclusions, such testimony is not helpful to the jury in determining the facts at issue 

in these cases and runs the risk of misleading the jury and confusing the issues. 

Insofar as this Motion challenges the FDA-related testimony discussed here, the 

Motion is GRANTED.

A number of experts also seek to opine on Ethicon’s compliance with design 

control and risk management standards. Some of this testimony involves the FDA’s 

quality systems regulations, and some—likely in an attempt to sidestep my 

anticipated prohibition on FDA testimony—involve foreign regulations and 

international standards. I find all of this proposed testimony of dubious relevance. 

Although these standards relate to how a manufacturer should structure and 

document risk assessment, the standards do not appear to mandate any particular 

design feature or prescribe the actual balance that must be struck in weighing a 

product’s risk and utility. Nor is it clear that the European and other international 

standards discussed had any bearing on the U.S. medical device industry when the

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 7 of 18
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device in question was being designed. 

Nevertheless, because the nuances of products liability law vary by state, I will 

refrain from issuing a blanket exclusion on design process and control standards 

testimony, whether rooted in the FDA or otherwise. Each standard must be assessed 

for its applicability to the safety questions at issue in this litigation, consistent with 

state law. I am without sufficient information to make these findings at this time. 

Accordingly, I RESERVE ruling on such matters until a hearing, where the trial 

judge will have additional context to carefully evaluate the relevance and potential 

prejudicial impact of specific testimony. 

Similarly, I doubt the relevance of testimony on the adequacy of Ethicon’s 

clinical testing and research, physician outreach, or particular product development 

procedures and assessments otherwise not encompassed by the above discussion. 

Again, such matters seem to say very little about the state of the product itself (i.e., 

whether or not it was defective) when it went on the market. But because the scope 

of relevant testimony may vary according to differences in state products liability law, 

I RESERVE ruling on such matters until they may be evaluated in proper context at 

a hearing before the trial court before or at trial. 

Additional—and more broad—matters also warrant mention. While some of 

these concerns may not apply to this particular expert, these concerns are raised so 

frequently that they are worth discussing here. 

First, many of the motions seek to exclude state-of-mind and legal-conclusion 

expert testimony. Throughout these MDLs, the court has prohibited the parties from 

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 8 of 18
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using experts to usurp the jury’s fact-finding function by allowing testimony of this 

type, and I do the same here. E.g., In re C. R. Bard, Inc., 948 F. Supp. 2d 589, 611 

(S.D. W. Va. 2013); see also, e.g., United States v. McIver, 470 F.3d 550, 562 (4th Cir. 

2006) (“[O]pinion testimony that states a legal standard or draws a legal conclusion 

by applying law to the facts is generally inadmissible.”); In re Rezulin Prods. Liab. 

Litig., 309 F. Supp. 2d 531, 546 (S.D.N.Y. 2004) (“Inferences about the intent and 

motive of parties or others lie outside the bounds of expert testimony.”). Additionally,

an expert may not offer expert testimony using “legal terms of art,” such as 

“defective,” “unreasonably dangerous,” or “proximate cause.” See Perez v. Townsend 

Eng’g Co., 562 F. Supp. 2d 647, 652 (M.D. Pa. 2008).

Second, and on a related note, many of the motions seek to prohibit an expert 

from parroting facts found in corporate documents and the like. I caution the parties 

against introducing corporate evidence through expert witnesses. Although an expert 

may testify about his review of internal corporate documents solely for the purpose 

of explaining the basis for his or her expert opinions—assuming the expert opinions 

are otherwise admissible—he or she may not offer testimony that is solely a conduit 

for corporate information. 

Third, many of the motions also ask the court to require an expert to offer 

testimony consistent with that expert’s deposition or report or the like. The court will 

not force an expert to testify one way or another. To the extent an expert offers 

inconsistent testimony, the matter is more appropriately handled via crossexamination or impeachment as appropriate and as provided by the Federal Rules of 

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 9 of 18
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Evidence.

Fourth, in these Daubert motions, the parties have addressed tertiary 

evidentiary matters like whether certain statements should be excluded as hearsay. 

The court will not exclude an expert simply because a statement he or she discussed 

may constitute hearsay. Cf. Daubert, 5-9 U.S. at 595. Hearsay objections are more 

appropriately raised at trial. 

Finally, in some of the Daubert motions, without identifying the specific expert 

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

other expert testimony that the moving party claims the expert is not qualified to 

offer. I will not make speculative or advisory rulings. I decline to exclude testimony 

where the party seeking exclusion does not provide specific content or context.

V. Conclusion 

The plaintiffs’ Motion regarding Mr. Ulatowski falls entirely within the 

reoccurring issues presented to this court. Accordingly, the court GRANTS in part, 

DENIES in part, and RESERVES in part the Motion to Exclude the Opinions of FDA 

Expert Timothy Ulatowski [ECF No. 2060].

The court DIRECTS the Clerk to file a copy of this Memorandum Opinion and 

Order in 2:12-md-2327 and in the Ethicon Wave 1 cases identified in the Exhibit 

attached hereto. 

ENTER: August 25, 2016

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 10 of 18
Exhibit A 

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 11 of 18
EXHIBIT A – ULATOWSKI DAUBERT MOTION

THIS DOCUMENT RELATES TO 

PLAINTIFFS:

Daphne Barker 

Case No. 2:12-cv-00899 

Sharon Carpenter

Case No. 2:12-cv-00554 

Mary Cone 

Case No. 2:12-cv-00261 

Joy Essman 

Case No. 2:12-cv-00277 

Ida Evans 

Case No. 2:12-cv-01225 

Shirley Freeman

Case No. 2:12-cv-00490 

Rose Gomez

Case No. 2:12-cv-00344 

Louise Grabowski 

Case No. 2:12-cv-00683 

Barbara A. Hill 

Case No. 2:12-cv-00806 

Jeanie Holmes

Case No. 2:12-cv-01206 

Diane Kropf 

Case No. 2:12-cv-01202 

Danni Laffoon 

Case No. 2:12-cv-00485 

Alfreda Lee

Case No. 2:12-cv-01013 

Dee McBrayer

Case No. 2:12-cv-00779 

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 12 of 18
2 

Charlene Miracle

Case No. 2:12-cv-00510 

Mary Jane Olson 

Case No. 2:12-cv-00470 

Jennifer Reyes

Case No. 2:12-cv-00939 

Brenda Riddell 

Case No. 2:12-cv-00547 

Carrie Smith

Case No. 2:12-cv-00258 

Virginia White

Case No. 2:12-cv-00958 

Judy Williams

Case No. 2:12-cv-00657 

Christine Wiltgen

Case No. 2:12-cv-01216 

Kathleen Wolfe

Case No. 2:12-cv-00337 

Donna Zoltowski 

Case No. 2:12-cv-00811 

Sherry Fox

Case No. 2:12-cv-00878 

Lois Durham

Case No. 2:12-cv-00760 

Monica Freitas 

Case No. 2:12-cv-01146 

Beth Harter

Case No. 2:12-cv-00737 

Mary Holzerland

Case No. 2:12-cv-00875 

Lois Hay 

Case No. 2:12-cv-00876

______________ Romona Greer

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 13 of 18
3 

Denise Sacchetti

Case No. 2:12-cv-01148 

Sheri Scholl

Case No. 2:12-cv-00738 

Margaret Stubblefield 

Case No. 2:12-cv-00842 

Laura Waynick 

Case No. 2:12-cv-01151 

Teri Key Shively

Case No. 2:12-cv-00379 

Tina Morrow 

Case No. 2:12-cv-00378 

Dina Sanders Bennett

Case No. 2:12-cv-00497 

Joan Adams 

Case No. 2:12-cv-01203 

Denise Burkhart

Case No. 2:12-cv-01023 

Jo’Ann Lehman 

Case No. 2:12-cv-00517 

Elizabeth Blynn Wilson

Case No. 2:12-cv-01286 

Patricia Conti

Case No. 2:12-cv-00516 

Patricia Ruiz

Case No. 2:12-cv-01021 

Barbara Vignos-Ware

Case No. 2:12-cv-00761 

Cynthia Nix

Case No. 2:12-cv-01278 

Fran Collins 

Case No. 2:12-cv-00931

___________

____________________ WAVE 2

_____ WOLFE

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 14 of 18
4 

Shirley Walker

Case No. 2:12-cv-00873 

Carol Jean Dimock 

Case No. 2:12-cv-00401 

Karen Forester

Case No. 2:12-cv-00486 

Cherise Springer

Case No. 2:12-cv-00997 

Joyce Justus

Case No. 2:12-cv-00956 

Melissa Clayton

Case No. 2:12-cv-00489 

Bonnie Blake 

Case No. 2:12-cv-00995 

Melissa Ridgley

Case No. 2:12-cv-01311 

Pamela Gray Wheeler

Case No. 2:12-cv-00455 

Dorothy Baugher 

Case No. 2:12-cv-01053 

Wendy Hagans 

Case No. 2:12-cv-00783 

Donna Massey

Case No. 2:12-cv-00880 

Angela Morrison 

Case No. 2:12-cv-00800 

Maria Eugenia Quijano 

Case No. 2:12-cv-00799 

Lisa Thompson 

Case No. 2:12-cv-01199 

Rebecca Wheeler

Case No. 2:12-cv-01088

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 15 of 18
5 

Thema Wright

Case No. 2:12-cv-01090 

Rocio Herrera-Nevarez

Case No. 2:12-cv-01294 

Debra A. and Donald Schnering 

Case No. 2:12-cv-01071 

Donna Shepherd

Case No. 2:12-cv-00967 

Rebekah Bartlett (Pratt)

Case No. 2:12-cv-01273 

Robin Bridges 

Case No. 2:12-cv-00651 

Myra Byrd

Case No. 2:12-cv-00748 

Angela Coleman 

Case No. 2:12-cv-01267 

Amanda Deleon 

Case No. 2:12-cv-00358 

Karyn Drake 

Case No. 2:12-cv-00747 

Paula Fisk 

Case No. 2:12-cv-00848 

Teresa Georgilakis 

Case No. 2:12-cv-00829 

Dawna Hankins 

Case No. 2:12-cv-00369 

Wilma Johnson 

Case No. 2:12-cv-00809 

Margaret Kirkpatrick 

Case No. 2:12-cv-00746 

Noemi Padilla

Case No. 2:12-cv-00567

____________ 2:11-cv-0809

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 16 of 18
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Stacy Shultis

Case No. 2:12-cv-00654 

Isabel Swint 

Case No. 2:12-cv-00786 

Susan Thaman (Reeves)

Case No. 2:12-cv-00279 

Kimberly Thomas (Wyatt)

Case No. 2:12-cv-00499 

Patricia Tyler

Case No. 2:12-cv-00469 

Cathy Warlick

Case No. 2:12-cv-00276 

Myndal Johnson 

Case No. 2:12-cv-00498 

Beverly Kivel

Case No. 2:12-cv-00591 

Harriet Beach

Case No. 2:12-cv-00476 

Holly Jones 

Case No. 2:12-cv-00443 

Donna Amsden 

Case No. 2:12-cv-00960 

Karen Bollinger 

Case No. 2:12-cv-01215 

Virginia Dixon 

Case No. 2:12-cv-01081 

Susan Guinn

Case No. 2:12-cv-01121 

Heather Long

Case No. 2:12-cv-01275 

Penny Rhynehart

Case No. 2:12-cv-01119

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 17 of 18
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Mary and Kenneth Thurston

Case No. 2:12-cv-00505 

Nancy Jo Williams

Case No. 2:12-cv-00511 

Cheryl Lankston 

Case No. 2:12-cv-00755 

Maria Stone 

Case No. 2:12-cv-00652 

Donna Loustaunau 

Case No. 2:12-cv-00666 

Barbara Kaiser 

Case No. 2:12-cv-00887 

Pameal Free

Case No. 2:12-cv-00423 

Julie Wroble 

Case No. 2:12-cv-00883 

Ana Ruebel

Case No. 2:12-cv-00663 

Jackie Frye

Case No. 2:12-cv-01004 

Sandra Wolfe 

Case No. 2:12-cv-00335 

Case 5:11-cv-06584-LHK Document 117 Filed 08/25/16 Page 18 of 18