Waynick et al v. Johnson & Johnson et al

Filing 99

MEMORANDUM OPINION AND ORDER (Daubert Motion re: Timothy Ulatowski) The court GRANTS in part, DENIES in part, and RESERVES in part the DAUBERT MOTION filed in MDL 2327 by Certain Plaintiffs in Wave 1 Cases to Exclude the Opinions of FDA Expert Timothy Ulatowski, as more fully set forth herein. Signed by Judge Joseph R. Goodwin on 8/25/2016. (cc: attys; any unrepresented party) (REF: MDL 2327; Cases Listed on Exhibit) (bdr)

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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 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 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. 1 2 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 3 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. 4 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 5 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.”). 6 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 7 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 8 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 9 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: 10 August 25, 2016 Exhibit A 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 ______________ Charlene Miracle Romona Greer 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 2 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 WAVE 2 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 WOLFE 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 3 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 4 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 2:11-cv-0809 Margaret Kirkpatrick Case No. 2:12-cv-00746 Noemi Padilla Case No. 2:12-cv-00567 5 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 6 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 7

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