MEMORANDUM OPINION AND ORDER ( 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., 3 (2011). To handle motions to exclude or to limit expert testimony pursuant to , 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 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

rulings on several of the experts offered in this case. , No. 2:12-cv-05762, 2014 WL 4851989 (S.D. W. Va. Sept. 29, 2014); , 54 F. Supp. 3d 501 (S.D. W. Va. 2014); , 57 F. Supp. 3d 658 (S.D. W. Va. 2014). The parties have, for the most part, structured their 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 ’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. 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, , 460 F.3d 1217, 1231 (9th Cir. 2006), I refuse to credit arguments that simply react to the court’s rulings in and its progeny. Indeed, I feel bound by these earlier cases only to the extent that the expert testimony and objections presented to the court then are identical to those presented now. Otherwise, I assess the parties’ 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.” , 509 U.S. at 592–93. Any departure from , , or 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 . Nevertheless, in some instances I face 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 precise questions asked and answered. The alternative of live 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 , 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; , 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.

, 259 F.3d 194, 199 (4th Cir. 2001) (citing , 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. , 509 U.S. at 595; , 525 U.S. 137, 141, 150 (1999). Finally, and simply, relevance turns on whether the expert testimony relates to any issues in the case. , , 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. , 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 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

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 . 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. 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. 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, 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. , § 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 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 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. , 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. 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.” 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.

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. , 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. , , 948 F. Supp. 2d 589, 611 (S.D. W. Va. 2013); , , 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.”); , 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.” , 562 F. Supp. 2d 647, 652 (M.D. Pa. 2008). , 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. , 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 cross- examination 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 ~ Vide. AO ” GOODWIN ( UNITED STATES DISTRICT JUDGE 12

Exhibit A UNITEDSTATES DISTRICT COURT SOUTHERNDISTRICT OFWEST VIRGINIA AT CHARLESTON INRE:ETHICON,INC.,PELVIC Master File No.2:12-MD-02327 REPAIRSYSTEM PRODUCTS MDL No.2327 LIABILITYLITIGATION _________________________________ THIS DOCUMENT RELATES TO Joseph R.Goodwin ETHICONWAVE 1CASES UNITEDSTATES DISTRICT JUDGE ExhibitAtoDefendants’Motion toExcludePeggyPence, Ph.D. Listof ApplicableCases1 CaseName CaseNumber 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& 2:12cv00554 Prolift Gardner Cole,CareyBeth& David 2:12cv00483 Prolift Coleman,Angela & 2:12cv01267 TVT-O Timothy 1Plaintiffs’designationstatesthattheyrecognizetheFourthCircuit’saffirmanceofthisCourt’sexclusion ofevidenceofcompliancewiththe510(k)processand“reservetherighttodesignate”Dr.Pence“[i]ntheeventofa contraryruling.” Ex.L,Pls.GeneralExpertDesig.,p.2. EthiconunderstandsthistomeanthatDr.Penceisnot designatedatallifnoFDAevidenceisadmitted,eventhoughthisispotentiallyinconsistentwithDr.Pence’s currentdisclaimerofrelianceonFDAregulations. Inaddition,Ethiconnotesthatthis“reservationofrightto designate”insomeinstancesputsPlaintiffs’numberofexpertsovertheallottedfive. Collins, FranDenise 2:12cv00931 TVT-O Cone,MaryF. 2:12cv00261 TVT-O

Conti,Patricia 2:12cv00516 TVT Deleon,Amanda& 2:12cv00358 Prolift Raymond Destefano-Raston,Dina & 2:12cv01299 TVT-O Terry Drake, KarynE. & 2:12cv00747 TVT Douglas E. Forester,Karen &Joel 2:12cv00486 TVT-O Fox,Sherry&Roy,Jr. 2:12cv00878 TVT Free,Pamela 2:12cv00423 TVT Freeman,Shirley& 2:12cv00490 Prolift +M William 2:12cv00957 Funderburke, Betty Prolift &TVT Georgilakis, Teresa & 2:12cv00829 TVT-O Angelo Gomez,Rose&Jesus 2:12-cv-00344 Prolift &TVT-O Prolift &TVT- Gray-Wheeler,Pamela 2:12cv00455 Secur 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,BarbaraA. & Billy 2:12cv00806 Prolift W. Gynemesh PS & Johnson,Wilma 2:11cv00809 TVT Jones, Holly&Jason 2:12cv00443 TVT Kaiser, Barbara 2:12cv00887 Prolift Kirkpatrick,Margaret 2:12cv00746 TVT-O Gynemesh PS & Kriz,Paula&James 2:12cv00938 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 & 2:12cv00779 Prolift Timothy Nix,Cynthia 2:12cv01278 Prolift; TVT-O Olson, MaryJane& 2:12cv00470 Prolift; TVT-O Daniel 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 Prolift; TVT- Thaman,Susan 2:12cv00279 Secur Thomas, Kimberly 2:12cv00499 Prosima; TVT-O Thurston,Mary& 2:12cv00505 TVT Kenneth Warlick,Cathy 2:12cv00276 Prosima; Prolift Williams, Nancy 2:12cv00511 Prolift; TVT-O Wiltgen,Christine& 2:12cv01216 TVT MarkS. Wolfe,Sandra 2:12cv00335 Prolift; TVT-O *Dr. Pencewas also designated in anumberof cases involvingonlytheGynemesh PS, ProleneSoft,orTVT-Securproducts, butshedid notprovidean expertreportforthose products. CaseName CaseNumber Product(s) Beach,Harriet 2:12cv00476 Gynemesh PS Bridges, Robin 2:12cv00651 Gynemesh PS Evans, IdaDeanne 2:12cv01225 ProleneMesh 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 ProleneSoft *Defendants reserve therighttosupplement this listshould anyplaintiffdesignateDr. Penceas ageneral expertin MDL Wave1.