Sullivan et al v. Saint-Gobain Performance Plastics CorporationREPLY to Response to 218 MOTION to Exclude Plaintiffs' Expert TestimonyD. Vt.March 25, 2019UNITED STATES DISTRICT COURT DISTRICT OF VERMONT JAMES D. SULLIVAN et al., individually, and on behalf of a Class of persons similarly situated, Plaintiffs, v. SAINT-GOBAIN PERFORMANCE PLASTICS CORPORATION, Defendant. Case No. 5:16-cv-00125-GWC Hon. Geoffrey W. Crawford REPLY IN FURTHER SUPPORT OF SAINT-GOBAIN’S MOTION TO EXCLUDE PLAINTIFFS’ EXPERT TESTIMONY Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 1 of 63 TABLE OF CONTENTS Page i TABLE OF AUTHORITIES ........................................................................................................ iv PRELIMINARY STATEMENT ................................................................................................... 1 ARGUMENT ................................................................................................................................. 4 I. PLAINTIFFS’ EXPERTS’ CLASS CERTIFICATION OPINIONS ARE INADMISSIBLE UNDER DUKES ................................................................................... 4 A. Expert Evidence on Class Certification Must Reliably Show a Method for Common Proof on a Central Element as to All Class Members............................ 4 1. Plaintiffs Still Ignore the Controlling Holding of Dukes ........................... 4 2. Expert Opinion “on Behalf of the Class” Does Not Satisfy Dukes ........... 6 3. Expert Opinion on “Average” Class Members Does Not Satisfy Dukes.......................................................................................................... 7 4. An Issue Class Is Not an End-Run Around Individual Questions ............. 9 B. Plaintiffs’ Medical Monitoring Expert Testimony Is Inadmissible for Class Certification ......................................................................................................... 11 1. Dr. Ducatman’s Opinion Does Not Address the Putative Class Members or Their Admitted Individual Differences ............................... 11 2. Dr. Ducatman’s Exposure-Only Medical Monitoring Is Not Generally Accepted And Is Not A Shortcut Around Individual Issues ........................................................................................................ 12 C. Plaintiffs’ Fate and Transport Expert Testimony Is Inadmissible for Class Certification ......................................................................................................... 15 1. Dr. Hopke’s Arbitrary and Untested Opinion Cannot Support Class Certification ............................................................................................. 15 a. Dr. Hopke’s Emissions Scenarios Are Wholly Untethered to Actual Emissions Data ............................................................. 15 b. Dr. Hopke’s Sublimation Theory Is a Moving Target ................. 18 c. Dr. Hopke’s Sublimation Theory Is Unreliable ........................... 20 2. Mr. Yoder Does Not Offer Common Evidence of Presence or Amount of PFOA at Any Location in the Class Area ............................. 21 3. Dr. Siegel’s Opinion Is Inadmissible for Class Certification .................. 23 a. Dr. Siegel Does Not Purport to Show Presence, Amount, or Source of PFOA at Any Place in the Proposed Class Area ......... 23 b. Dr. Siegel’s Methods Were Made for Litigation ......................... 25 c. Dr. Siegel’s Alternative Source Analysis Is Unreliable............... 27 Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 2 of 63 TABLE OF CONTENTS (continued) Page ii D. Plaintiffs’ Damages Expert Testimony Is Inadmissible for Class Certification ......................................................................................................... 28 1. Mr. Unsworth’s Endorsement of Plaintiffs’ Diminution in Value Opinions Cannot Support Class Certification .......................................... 28 a. An Issue Class on “Liability” Would Violate The Constitution and Federal Law ...................................................... 28 b. Mr. Unsworth Cannot Vouch for Plaintiffs’ Lay Opinion ........... 29 2. Mr. Unsworth’s Added Cost Opinion Does Not Address the Damages of Putative Class Members ...................................................... 30 3. Mr. Unsworth’s Replacement Cost Opinion Does Not Address the Members of the Putative Class ................................................................ 34 II. PLAINTIFFS’ EXPERTS MERITS OPINIONS ARE INADMISSIBLE ...................... 35 A. Dr. Ducatman’s and Dr. Grandjean’s Causation Opinions Are Subjective, Untestable, and Not Generally Accepted ............................................................. 35 1. Expert “Judgment” Must Be Employed With Methodological Rigor ........................................................................................................ 35 2. Dr. Ducatman’s Medical Causation Opinion Is Not Based On A Reliable Methodology .............................................................................. 38 a. Dr. Ducatman Has No Discernible Methodology ........................ 38 b. Dr. Ducatman’s Methodological Errors Are Numerous and Pervasive ...................................................................................... 39 c. Dr. Ducatman’s Dose Threshold Is Arbitrary .............................. 42 3. Dr. Grandjean’s Medical Causation Opinions Are Unreliable ................ 43 a. Dr. Grandjean’s “Weight of the Evidence” Methodology Is Inapposite and Unreliable ............................................................ 43 b. Dr. Grandjean Commits Numerous Methodological Errors ........ 45 B. Plaintiffs’ Experts Regulatory Opinions Are Unhelpful And Inadmissible ........ 46 1. Dr. Hopke’s “Merits” Opinion Is Inadmissible ....................................... 46 2. Dr. Siegel’s “Merits” Opinion Is Inadmissible ........................................ 47 3. Mr. Mears’s Opinions Are Unhelpful and Unreliable ............................. 47 CONCLUSION ............................................................................................................................ 50 Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 3 of 63 iii TABLE OF AUTHORITIES CASES Adams v. Cooper Indus., Inc., 2007 WL 1805586 (E.D. Ky. 2007) ........................................................................................42 Alevromagiros v. Hechinger Co., 993 F.2d 417 (4th Cir. 1993) ...................................................................................................36 Allen v. Pennsylvania Eng’g Corp., 102 F.3d 194 (5th Cir. 1996) ...................................................................................................44 Am. Honda Motor Co. v. Allen, 600 F.3d 813 (7th Cir. 2010) .....................................................................................................1 Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d 256 (2d Cir. 2002).................................................................................................1, 36 Awad v. Merck & Co., 99 F. Supp. 2d 301 (S.D.N.Y. 1999), aff’d, 213 F.3d 627 (2d Cir. 2000) ...............................26 Blyden v. Mancusi, 186 F.3d 252 (2d Cir. 1999)...............................................................................................10, 29 Broussard v. Meineke Discount Muffler Shops, Inc., 155 F.3d 331 (4th Cir. 1998) .................................................................................................3, 8 Brown v. Nucor Corp., 785 F.3d 895 (4th Cir. 2015) .....................................................................................................5 Brown v. United States, 126 Fed. Cl. 571 (Ct. Cl. 2016)..................................................................................................5 Burst v. Shell Oil Co., 104 F. Supp. 3d 773 (E.D. La. 2015) ...........................................................................17, 25, 31 Bridge v. Phx. Bond & Indem. Co., 553 U.S. 639 (2008) ...................................................................................................................2 Cal. Dump Truck Owners Ass’n v. Nichols, 924 F. Supp. 2d 1126 (E.D. Cal. 2012), aff’d, 784 F.3d 500 (9th Cir. 2015) ..........................35 Carroll v. Litton Sys., Inc., 1990 WL 312969 (W.D.N.C. 1990), aff’d in part, rev’d in part on other grounds, 47 F.3d 1164 (4th Cir. 1995) ......................................................................................1 Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 4 of 63 iv Chen-Oster v. Goldman, Sachs & Co., 114 F. Supp. 3d 110 (S.D.N.Y. 2015)..................................................................................4, 24 City of Wichita, Kansas v. Trustees of APCO Oil Corp. Liquidating Tr., 306 F. Supp. 2d 1040 (D. Kan. 2003) ................................................................................18, 25 Claar v. Burlington N. R.R. Co., 29 F.3d 499 (9th Cir. 1994) ...............................................................................................27, 28 Clark v. Takata Corp., 192 F.3d 750 (7th Cir. 1999) ...................................................................................................22 Coleman v. Union Carbide Corp., 2013 WL 5461855 (S.D.W. Va. 2013) ....................................................................................40 Contini by Contini v. Hyundai Motor Co., 876 F. Supp. 540 (S.D.N.Y. 1995) ..........................................................................................49 Cooper v. Meritor, Inc., 2019 WL 545187 (N.D. Miss. 2019) .......................................................................................27 Covic v. Berk, 2014 WL 3510502 (W.D. Tenn. 2014) ..............................................................................48, 49 Crescenta Valley Water Dist. v. Exxon Mobil Corp., 2013 WL 12116333 (C.D. Cal. 2013)................................................................................17, 25 Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311 (9th Cir. 1995) ...................................................................................................26 Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993) ......................................................................................................... passim Denney v. Deutsche Bank AG, 443 F.3d 253 (2d Cir. 2006).................................................................................................9, 29 Densberger v. United Techs. Corp., 297 F.3d 66 (2d Cir. 2002).......................................................................................................47 DL v. D.C., 713 F.3d 120 (D.C. Cir. 2013) ...................................................................................................4 Donovan v. Philip Morris USA, Inc., 2012 WL 957633 (D. Mass. 2012) ............................................................................................4 Drake v. Allergan, Inc., 2014 WL 5392995 (D. Vt. 2014) .............................................................................................41 Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 5 of 63 v Dunn v. Sandoz Pharm. Corp., 275 F. Supp. 2d 672 (M.D.N.C. 2003) ....................................................................................41 Ebert v. General Mills, Inc., 823 F.3d 472 (8th Cir. 2016) ...................................................................................................10 Edison Wetlands Ass’n, Inc. v. Akzo Nobel Chems. Inc., 2009 WL 5206280 (D.N.J. 2009) ............................................................................................16 Frischhertz v. SmithKline Beecham Corp., 2012 WL 6697124 (E.D. La. 2012) .........................................................................................41 Gates v. Rohm & Haas Co., 265 F.R.D. 208 (E.D. Pa. 2010) ....................................................................................... passim Gates v. Rohm & Haas Co., 655 F.3d 255 (3d Cir. 2011)............................................................................................. passim Gen. Elec. Co. v. Joiner, 522 U.S. 136 (1997) ...........................................................................................................13, 28 Glastetter v. Novartis Pharms. Corp., 107 F. Supp. 2d 1015 (E.D. Mo. 2000), aff’d, 252 F.3d 986 (8th Cir. 2001) ....................19, 41 Haley v. Kolbe & Kolbe Millwork Co., 863 F.3d 600 (7th Cir. 2017) .....................................................................................................6 Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (D. Or. 1996) .............................................................................................41 Haller v. AstraZeneca Pharms. LP, 598 F. Supp. 2d 1271 (M.D. Fla. 2009) .............................................................................19, 41 Hiramoto v. Goddard Coll. Corp., 184 F. Supp. 3d 84 (D. Vt. 2016), aff’d, 684 F. App’x 48 (2d Cir. 2017) ...............................47 Huss v. Gayden, 571 F.3d 442 (5th Cir. 2009) ...................................................................................................27 Hygh v. Jacobs, 961 F.2d 359 (2d Cir. 1992).....................................................................................................48 In re Abilify Prods. Liab. Litig., 299 F. Supp. 3d 1291 (N.D. Fla. 2018)..............................................................................37, 38 In re Actos (Pioglitazone) Prod. Liab. Litig., 2014 WL 120973 (W.D. La. 2014) ..........................................................................................50 Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 6 of 63 vi In re Air Cargo Shipping Servs. Antitrust Litig., 2014 WL 7882100 (E.D.N.Y. 2014)..........................................................................................4 In re Asacol Antitrust Litig., 907 F.3d 42 (1st Cir. 2018) .............................................................................................. passim In re Baycol Prods. Liab. Litig., 596 F.3d 884 (8th Cir. 2010) .....................................................................................................1 In re Fluidmaster, Inc., Water Connector Components Prod. Liab. Litig., 2017 WL 1196990 (N.D. Ill. 2017) .....................................................................................9, 50 In re Foxamax Prod. Liab. Litig., 645 F. Supp. 2d 164 (S.D.N.Y. 2009)......................................................................................41 In re Heartland Payment Sys., Inc. Customer Data Sec. Breach Litig., 851 F. Supp. 2d 1040 (S.D. Tex. 2012) .....................................................................................5 In re LIBOR-Based Fin. Instruments Antitrust Litig., 299 F. Supp. 3d 430 (S.D.N.Y. 2018)..................................................................................4, 37 In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices & Prod. Liab. Litig., 892 F.3d 624 (4th Cir. 2018) ...................................................................................................41 In re Lipitor Mktg., Sales Practices & Prods. Liab. Litig., 185 F. Supp. 3d 786 (D.S.C. 2016) ..........................................................................................36 In re Mirena IUD Prods. Liab. Litig., 169 F. Supp. 3d 396 (S.D.N.Y. 2016)................................................................................20, 27 In re Mirena IUS Levonorgestrel-Related Prods. Lib. Litig. (No. II), 341 F. Supp. 3d 213 (S.D.N.Y. 2018)................................................................................38, 45 In re Nassau County Strip Search Cases, 461 F.3d 219 (2d Cir. 2006).....................................................................................................10 In re Pharmacy Benefit Mgrs. Antitrust Litig., 2017 WL 275398 (E.D. Pa. 2017) .....................................................................................12, 23 In re Rail Freight Fuel Surcharge Antitrust Litig., 725 F.3d 244 (D.C. Cir. 2013) ...................................................................................................9 In re Rezulin Prod. Liab. Litig., 369 F. Supp. 2d 398 (S.D.N.Y. 2005)......................................................................................16 In re Rhone-Poulenc Rorer, Inc., 51 F.3d 1293 (7th Cir. 1995) ...............................................................................................9, 10 Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 7 of 63 vii In re Scotts EZ Seed Litig., 304 F.R.D. 397 (S.D.N.Y. 2015) .............................................................................................22 In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., 858 F.3d 787 (3d Cir. 2017).....................................................................................................37 In re Zurn Pex Plumbing Prods. Liab. Litig., 644 F.3d 604 (8th Cir. 2011) .....................................................................................................6 Jensen v. Cablevision Sys. Corp., 2019 WL 955239 (E.D.N.Y. 2019)............................................................................................4 K.E. v. Glaxosmithkline LLC, 2017 WL 440242 (D. Conn. 2017) ....................................................................................40, 41 Kalamazoo River Study Grp. v. Rockwell Int’l Corp., 171 F.3d 1065 (6th Cir. 1999) ...................................................................................................1 Kumho Tire Co v. Carmichael, 526 U.S. 137 (1999) ...........................................................................................................25, 37 Langenbau v. Med-trans Corp., 167 F. Supp. 3d 983 (N.D. Iowa 2016) ........................................................................48, 49, 50 LifeWise Master Funding v. Telebank, 374 F.3d 917 (10th Cir. 2004) ...............................................................................................3, 8 Lujan v. Defs. of Wildlife, 504 U.S. 555 (1992) .....................................................................................................31, 32, 35 M.B. ex rel. Scott v. CSX Transp., Inc., 130 F. Supp. 3d 654 (N.D.N.Y. 2015) .....................................................................................16 M.D. ex rel. Stukenberg v. Perry, 675 F.3d 832 (5th Cir. 2012) .....................................................................................................5 Magistrini v. One Hour Martinizing Dry Cleaning, 180 F. Supp. 2d 584 (D.N.J. 2002), aff’d, 68 F. App’x 356 (3d Cir. 2003) .................... passim Mallozzi v. EcoSMART Techs., Inc., 2013 WL 2415677 (E.D.N.Y. 2013)........................................................................................41 Martin v. Behr Dayton Thermal Prods., LLC, 896 F.3d 405 (6th Cir. 2018) ...................................................................................................10 McClain v. Metabolife Int’l, Inc., 401 F.3d 1233 (11th Cir. 2005) ...................................................................................21, 43, 45 Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 8 of 63 viii McLaughlin v. Am. Tobacco Co., 522 F.3d 215 (2d Cir. 2008)............................................................................................. passim McMunn v. Babcock & Wilcox Power Generation Grp., Inc., 2013 WL 3487560 (W.D. Pa. 2013) ........................................................................................41 Michaels v. Avitech, Inc., 202 F.3d 746 (5th Cir. 2000) ...................................................................................................27 Mike’s Train House v. Lionel, L.L.C., 472 F.3d 398 (6th Cir. 2006) ...................................................................................................26 Milanowicz v. The Raymond Corp., 148 F. Supp. 2d 525 (D.N.J. 2001) ....................................................................................46, 47 Miller v. Pfizer, Inc., 356 F.3d 1326 (10th Cir. 2004) .........................................................................................19, 41 Myers v. Hertz Corp., 624 F.3d 537 (2d Cir. 2010).......................................................................................................5 Nordetek Envtl., Inc. v. RDP Techs., Inc., 862 F. Supp. 2d 406 (E.D. Pa. 2012) .........................................................................................1 Opperman v. Path, Inc., 2016 WL 3844326 (N.D. Cal. 2016) .........................................................................................9 Parker v. Town of Milton, 169 Vt. 74 (1998) .....................................................................................................................32 Parko v. Shell Oil Co., 739 F.3d 1083 (7th Cir. 2014) .................................................................................................10 Rhodes v. E.I. duPont de Nemours & Co., 253 F.R.D. 365 (S.D. W. Va. 2008), appeal dism’d, 636 F.3d 88 (4th Cir. 2011) ......................................................................................................................11, 12, 13, 44 Rink v. Cheminova Inc., 400 F.3d 1286 (11th Cir. 2005) .................................................................................................6 Rowe v. Bankers Life & Cas. Co., 2012 WL 1068754 (N.D. Ill. 2012) ...........................................................................................5 Rowe v. E.I. duPont de Nemours & Co., 2008 WL 5412912 (D.N.J. 2008) .................................................................................... passim Royal Park Invs. SA/NV v. Deutsche Bank Nat’l Trust Co., 2018 WL 1750595 (S.D.N.Y. 2018) ........................................................................................22 Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 9 of 63 ix Rutigliano v. Valley Bus. Forms, 929 F. Supp. 779 (D.N.J. 1996) ...............................................................................................36 Sheldon v. Ruggiero, 2018 VT 125 (Vt. Nov. 9, 2018) ..............................................................................................50 Singleton v. Fifth Generation, Inc., 2017 WL 5001444 (N.D.N.Y. 2017) .........................................................................................4 Tamraz v. Lincoln Elec. Co., 620 F.3d 665 (6th Cir. 2010) ...................................................................................................36 Tyson Foods, Inc. v. Bouaphakeo, 136 S.Ct. 1036 (2016) ....................................................................................................5, 32, 33 Valente v. Textron, Inc., 931 F. Supp. 2d 409 (E.D.N.Y. 2013), aff’d, 559 F. App’x 11 (2d Cir. 2014)........................25 Viterbo v. The Dow Chem. Co., 826 F.2d 420 (5th Cir. 1987) ...................................................................................................36 Wal-Mart Stores, Inc. v. Dukes, 564 U.S. 338 (2011) ......................................................................................................... passim Walsh v. Cluba, 198 Vt. 453 (2015) ...................................................................................................................31 Warth v. Seldin, 422 U.S. 490 (1975) .................................................................................................................35 Waskowski v. State Farm Mut. Auto. Ins. Co., 970 F. Supp. 2d 714 (E.D. Mich. 2013) .....................................................................................6 Weiner v. Snapple Beverage Corp., 2010 WL 3119452 (S.D.N.Y. 2010) ................................................................................ passim Zenith Elecs. Corp. v. WH-TV Broad. Corp., 395 F.3d 416 (7th Cir. 2005) ...................................................................................................36 Ziniti v. New England Central Railroad, Inc., 2019 VT 9 (2019).......................................................................................................................5 STATUTES, RULES, AND CONSTITUTIONAL PROVISIONS 1993 Vt. Legis. Serv. No. 92 (West)..............................................................................................48 ATSDR’s Final Criteria for Determining the Appropriateness of a Medical Monitoring Program Under CERCLA, 60 Fed. Reg. 38840, 33841 (Jul. 28, 1995) ..................................................................................................................................13, 14 Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 10 of 63 x Fed. R. Civ. P. 23 ................................................................................................................... passim Fed. R. Evid. 702 ................................................................................................................... passim Rules Enabling Act, 28 U.S.C. § 2072 .................................................................................. passim United States Constitution, amend. vii ............................................................................3, 9, 28, 32 United States Constitution, art. III, § 2 ......................................................................3, 9, 28, 31, 32 Vermont Groundwater Protection Act, 10 V.S.A. § 1410 .............................................................32 OTHER AUTHORITIES ABA Section of Antitrust Law, Econometrics: Legal, Practical, and Technical Issues 360 (2d ed. 2014) ..........................................................................................................31 Christine P. Bartholomew, Redefining Prey and Predator in Class Actions, 80 Brook. L. Rev. 743 (2015) .........................................................................................................5 Robert H. King, Jr., Four Lessons from Wal-Mart v. Dukes And Their Application to Montana Class Action Law, 73 Mont. L. Rev. 255 (2013)....................................................5 A. Benjamin Spencer, Class Actions, Heightened Commonality, and Declining Access to Justice, 93 B.U. L. Rev. 441 (2013) ..........................................................................5 Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 11 of 63 PRELIMINARY STATEMENT Plaintiffs fail to establish the admissibility of their expert testimony. Instead, they attempt to recharacterize as jury questions the expert issues that should be subject to the Court’s scrutiny. Thus they misapprehend the Court’s role with regard to the flaws in their expert testimony: to “undertake a rigorous examination of the facts on which the expert relies, the method by which the expert draws an opinion from those facts, and how the expert applies the facts and methods to the case at hand.” Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d 256, 267 (2d Cir. 2002). That inquiry does “not stop merely because plaintiffs attempt to characterize the situation as a ‘battle of the experts.’” Carroll v. Litton Sys., Inc., 1990 WL 312969, at *42 (W.D.N.C. 1990), aff’d in part, rev’d in part on other grounds, 47 F.3d 1164 (4th Cir. 1995).1 The “conventional devices” of “[v]igorous cross-examination” and “presentation of contrary evidence” are appropriate only for “shaky but admissible evidence,” “where the basis of scientific testimony meets the standards of Rule 702.” Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 596 (1993). Here, Plaintiffs’ expert testimony “is not merely shaky; it is unreliable.” Am. Honda Motor Co. v. Allen, 600 F.3d 813, 818 (7th Cir. 2010). It does not “fit” the claims of the putative class members. And it uses unreliable methods that are unreliably applied. It is inadmissible. Plaintiffs’ Expert Testimony Is Inadmissible for Class Certification Plaintiffs ignore and contradict the controlling standards for relevance of expert testimony on class certification. Their 97-page Daubert opposition fails even to mention the Supreme Court’s controlling holding in Dukes regarding the standard for commonality: that which can “resolve an issue that is central to the validity of each one of the claims in one stroke.” Wal-Mart 1 See also In re Baycol Prods. Liab. Litig., 596 F.3d 884, 892 (8th Cir. 2010); Kalamazoo River Study Grp. v. Rockwell Int’l Corp., 171 F.3d 1065, 1072 (6th Cir. 1999); Nordetek Envtl., Inc. v. RDP Techs., Inc., 862 F. Supp. 2d 406, 415 (E.D. Pa. 2012). Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 12 of 63 2 Stores, Inc. v. Dukes, 564 U.S. 338, 350 (2011) (emphasis added). Nor do they heed what Dukes instructs. Plaintiffs’ experts do not purport to address any element of the claims of each class member on a common basis. They do not even consider any data specific to the named Plaintiffs or the putative class members. Their expert testimony contains no analysis, for example, of Plaintiffs’ medical conditions, their properties, or the hydrogeological character of the materials beneath those properties. They do not do so because the individualized factors that affect each of those claims would defeat any attempt at common proof. Instead, Plaintiffs’ experts proffer broad, homogenous opinions that seek to obscure the inherently individualized issues this case presents. They do so through a variety of constructs. For example, Dr. Ducatman opines about a “medical monitoring program.” (Ducatman Class Rpt. at 9-11.) Dr. Siegel opines about PFOA transport in “broad locations.” (Siegel Reb. Rpt. at 2-5.) And Mr. Unsworth opines about the damages of “the class” or “the public.” (Unsworth Reb. Tr. at 173:9-19.) But expert testimony “on behalf of ‘the class’” cannot show commonality, for it is a “core principle that class actions are the aggregation of individual claims, and do not create a class entity.” In re Asacol Antitrust Litig., 907 F.3d 42, 56 (1st Cir. 2018) (emphasis added). The Second Circuit has categorically rejected proposals like these to adjudicate an award to a putative class and then allocate it later. McLaughlin v. Am. Tobacco Co., 522 F.3d 215, 232 (2d Cir. 2008), abrogated in part on other grounds by Bridge v. Phx. Bond & Indem. Co., 553 U.S. 639 (2008). Such methods of merely delaying individualized issues violate the Rules Enabling Act. Id. In the same manner, Plaintiffs’ experts opine about abstract facts, rather than those relating to the members of the putative class. These include, for example, Dr. Ducatman’s hypothetical patients (Ducatman Tr. at 37:8-17, 39:11-40:2, 45:8-12, 195:6-13), Dr. Hopke’s emissions “scenarios” (Hopke Class Rpt. at 4), Dr. Siegel’s “representative” locations (Siegel Tr. at 104:7- Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 13 of 63 3 105:10), and Mr. Unsworth’s “average” class members. (Unsworth Tr. at 167:24-168:2.) But this “shortcut” of “abstract ... ‘averages’” is “a caution signal ... that class-wide proof … [i]s impermissible.” Broussard v. Meineke Discount Muffler Shops, Inc., 155 F.3d 331, 343 (4th Cir. 1998); Gates v. Rohm & Haas Co., 655 F.3d 255, 266 (3d Cir. 2011); LifeWise Master Funding v. Telebank, 374 F.3d 917, 929 (10th Cir. 2004). Finally, Plaintiffs cannot repurpose their expert testimony to support a proposed issue class on “liability” and parcel off individual questions of “damages” into separate proceedings. (Dkt. 237 at 3-4.) Here, the elements of liability and damages are inextricably intertwined. To allow expert testimony in support of such an illusory “common” phase on liability would violate the Rules Enabling Act, Article III standing, and the Seventh Amendment’s Re-examination Clause. Plaintiffs’ Expert Testimony Is Inadmissible on the Merits Plaintiffs’ expert testimony on the merits is also inadmissible. Plaintiffs confirm that Dr. Ducatman and Dr. Grandjean lack any discernible methodology for general causation. Their so- called “weight of the evidence” approach is subjective and untestable. They cloak their opinions in their inscrutable “judgment,” a euphemism for their inadmissible ipse dixit. They also conflate regulatory standards with proof of medical causation, assume without demonstrating that “above- average” exposure is a reliable threshold for increased risk, and ground their causation opinions in little more than their say-so. This testimony is inadmissible. Likewise, the purported “regulatory” opinions of Dr. Hopke, Dr. Siegel, and Mr. Mears are not founded in either their personal knowledge or expertise. They are legal opinions that are unhelpful, irrelevant, and inadmissible. The Court should exclude Plaintiffs’ expert testimony. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 14 of 63 4 ARGUMENT I. PLAINTIFFS’ EXPERTS’ CLASS CERTIFICATION OPINIONS ARE INADMISSIBLE UNDER DUKES A. Expert Evidence on Class Certification Must Reliably Show a Method for Common Proof on a Central Element as to All Class Members 1. Plaintiffs Still Ignore the Controlling Holding of Dukes Plaintiffs do not dispute that Daubert’s principles of reliability and fit apply at class certification. Instead, they suggest that cases concerning the Court’s “‘rigorous analysis’ of class certification issues” under Rule 23 are irrelevant to its examination of the expert testimony proffered to support certification. (See Opp. at 6-9.)2 This misapprehends the significance of Plaintiffs’ “fit” problems: the relevance of expert evidence to show commonality is tied to the controlling standard for proof of commonality under Rule 23. See Gates, 655 F.3d at 266. Here, that controlling standard is supplied by the Supreme Court’s watershed decision in Dukes. Plaintiffs do not address the Dukes standard in their motion for class certification, their reply, or their Daubert opposition. At most, Plaintiffs have cited a handful of decisions that in turn cite Dukes, but they never address Dukes’s critical holding on commonality. (Dkt. 237 at 1.) Instead, Plaintiffs cite the district court’s opinion in Donovan v. Philip Morris USA, Inc., 2012 WL 957633 (D. Mass. 2012), to dispute the D.C. Circuit’s subsequent observation in DL v. D.C., 713 F.3d 120, 126 (D.C. Cir. 2013), “that Dukes ‘changed the landscape’ concerning commonality.” (Dkt. 237 at 20.) But Donovan is an outlier among the broad consensus of courts 2 Contrary to Plaintiffs’ suggestion, many district courts in the Second Circuit alone have excluded expert evidence proffered in support of class certification. See, e.g., Jensen v. Cablevision Sys. Corp., 2019 WL 955239, at *9 (E.D.N.Y. 2019); In re LIBOR-Based Fin. Instruments Antitrust Litig., 299 F. Supp. 3d 430, 470 (S.D.N.Y. 2018); Singleton v. Fifth Generation, Inc., 2017 WL 5001444, at *3 (N.D.N.Y. 2017); Chen-Oster v. Goldman, Sachs & Co., 114 F. Supp. 3d 110, 115 (S.D.N.Y. 2015); In re Air Cargo Shipping Servs. Antitrust Litig., 2014 WL 7882100, at *42 (E.D.N.Y. 2014); Weiner v. Snapple Beverage Corp., 2010 WL 3119452, at *8 (S.D.N.Y. 2010). Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 15 of 63 5 and commentators that Dukes “heightened the standards for establishing commonality.” M.D. ex rel. Stukenberg v. Perry, 675 F.3d 832, 839 (5th Cir. 2012).3 Dukes decisively rejected a series of older cases, many of which Plaintiffs rely on, that framed Rule 23(a)(2) commonality at a high level of generality. 564 U.S. at 350. Dukes held that commonality concerns not the ability to identify common questions, but rather “the capacity of a classwide proceeding to generate common answers apt to drive the resolution of the litigation.” Id. (citation omitted) (emphasis added). Plaintiffs’ claims must “depend upon a common contention … of such a nature that it is capable of classwide resolution—which means that determination of its truth or falsity will resolve an issue that is central to the validity of each one of the claims in one stroke.” Id. (emphasis added). Only where a central issue can “be resolved by way of generalized proof,” McLaughlin, 522 F.3d at 226, while accounting for any “defenses to individual claims,” Dukes, 564 U.S. at 367; Myers v. Hertz Corp., 624 F.3d 537, 551 (2d Cir. 2010), does it present a common question under Rule 23(a)(2). In contrast, if “members of a proposed class will need to present evidence that varies from member to member,” then the question is not common. Tyson Foods, Inc. v. Bouaphakeo, 136 S.Ct. 1036, 1045 (2016). Thus, to “fit” class certification, expert testimony must provide generalized proof that establishes a central element of “each one of the claims” of the members of the putative class. Dukes, 564 U.S. at 350. It must do so through reliable methods under Daubert, which considers 3 Brown v. Nucor Corp., 785 F.3d 895, 903 (4th Cir. 2015); Brown v. United States, 126 Fed. Cl. 571, 581-82 (Ct. Cl. 2016); In re Heartland Payment Sys., Inc. Customer Data Sec. Breach Litig., 851 F. Supp. 2d 1040, 1052 (S.D. Tex. 2012); Rowe v. Bankers Life & Cas. Co., 2012 WL 1068754, at *5 (N.D. Ill. 2012); Christine P. Bartholomew, Redefining Prey and Predator in Class Actions, 80 Brook. L. Rev. 743, 772 (2015); Robert H. King, Jr., Four Lessons from Wal-Mart v. Dukes And Their Application to Montana Class Action Law, 73 Mont. L. Rev. 255, 236 (2013); A. Benjamin Spencer, Class Actions, Heightened Commonality, and Declining Access to Justice, 93 B.U. L. Rev. 441 (2013). Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 16 of 63 6 whether the common proof “can be (and has been) tested,” has been subjected to evaluation by peer review and publication, has a known or potential rate of error, and is generally accepted. Daubert, 509 U.S. at 593-94.4 As Plaintiffs acknowledge, the law requires their experts to establish, on a “‘class-wide’” basis, elements of their claims “‘through generalized proof’” with methods “reliably applied to the class.” (See Opp. at 8 (quoting In re Ethylene Propylene Diene Monomer [EPDM] Antitrust Litig., 256 F.R.D. 82, 94, 101 (D. Conn. 2009)).) None of Plaintiffs’ class certification experts meets these standards. None proffers a method to establish the elements of any Plaintiff’s claim, much less the claim of every putative class member. Plaintiffs’ experts were charged with using a method to determine, on a common basis, the claims of the named Plaintiffs and those they seek to represent. Yet none of these experts reviewed or addressed data relating to any named Plaintiff or any other putative class member. An expert may not decline to “consider[] whether, and how, his proposed methodology could account for the specific circumstances of this case.” Weiner, 2010 WL 3119452, at *8. Where he does, testimony that matters within his opinion “can be proven on a class-wide basis is speculative and, therefore, unreliable.” Id. The same is true here. 2. Expert Opinion “on Behalf of the Class” Does Not Satisfy Dukes Instead of identifying a common method to establish the claims of putative class members, Plaintiffs’ experts proffer generalized opinions about “the class”: Dr. Ducatman does not address individual class members’ entitlement to monitoring. Instead, he opines about a “medical monitoring program” to be awarded as a lump sum, with any individual issues to “be addressed after … [its] implementation.” (Opp. at 11.) Dr. Siegel does not assess the presence, amount, and source of PFOA at locations in 4 Haley v. Kolbe & Kolbe Millwork Co., 863 F.3d 600 (7th Cir. 2017); In re Zurn Pex Plumbing Prods. Liab. Litig., 644 F.3d 604, 611-16 (8th Cir. 2011); Rink v. Cheminova Inc., 400 F.3d 1286, 1291-94 (11th Cir. 2005); LIBOR, 299 F. Supp. 3d at 470; Waskowski v. State Farm Mut. Auto. Ins. Co., 970 F. Supp. 2d 714, 721-23 (E.D. Mich. 2013). Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 17 of 63 7 the proposed class area. Instead, he opines that the class area “‘reasonably represents the area where groundwater has been contaminated with PFOA from the operations of the former ChemFab … facilities.’” (Id. at 21 (quoting Dkt. 107-44 at 3).) Mr. Unsworth does not calculate groundwater damages of members of the putative class. Instead, he claims only to determine the total damages of the putative class, whereupon “‘a simple formula can … allocate these damages’” to individual class members. (Id. at 39-40 (quoting Unsworth Mullin Reb. Rpt. at 11-12).) None of these approaches even purports to show what is required for commonality under Dukes. Each purports to establish something “on behalf of ‘the class,’” rather than “the aggregation of individual claims” of which a class action consists. Asacol, 907 F.3d at 56. That is contrary to Dukes. It is also barred by Second Circuit law. That is because proposals to “prove collective damages on a class-wide basis” and then allow individuals to “claim shares of this fund” violate the Rules Enabling Act. McLaughlin, 522 F.3d at 231 (citation omitted). “Roughly estimating the gross damages to the class as a whole and only subsequently allowing for the processing of individual claims would inevitably alter defendants’ substantive right to pay damages reflective of their actual liability.” Id. Plaintiffs point to superficial factual distinctions from these authorities: They observe that Asacol was a pharmaceutical antitrust case and McLaughlin a tobacco RICO action. But they never grapple with what these cases say about the constitutional and procedural limits of the class action device. (See Opp. at 40; Dkt. 237 at 1.) 3. Expert Opinion on “Average” Class Members Does Not Satisfy Dukes Plaintiffs also attempt to avoid the challenge of generalized proof applicable to each class member by offering expert opinions as to purportedly “average” or “representative” claims: Dr. Ducatman substitutes review data related to any individual Plaintiff with assumptions about hypothetical class members and “imaginary conversations” with “reasonable physicians.” (Ducatman Tr. at 133:23-134:11; see id. at 133:2-20; 166:7-16; 173:22-174:4.) Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 18 of 63 8 (Hopke Tr. at 113:10-115:9; Hopke Class Rpt. at 4.) Dr. Siegel’s opinion on the transmission of PFOA is not based on review of the actual soil conditions in the proposed class area. He employs two conceptual square-meter areas that he assumes are “representative” of “generically the kind of [soil and bedrock] conditions you find within those areas.” (Siegel Tr. at 33:7-18.) Mr. Unsworth does not consider data or evidence concerning any putative class members. In its place, he opines about the damages for “average” class members, which he says “[o]n average, … will be correct.” (Unsworth Tr. at 167:24-168:2.) These attempts to show commonality are illogical and circular. Named plaintiffs may pursue damages as class representatives only upon a finding that common questions predominate throughout that class. See Fed. R. Civ. P. 23. Plaintiffs may not sidestep that condition by assuming a set of “representative” circumstances at the outset. By doing so, the expert has already stacked the deck for a finding of commonality. Courts thus reject “[a]ttempts to meet the burden of proof using modeling and assumptions that do not reflect the individual characteristics of class members.” Broussard, 155 F.3d at 343. An average or a representative “methodology does not fit” the individual claims within a putative class. LifeWise, 374 F.3d at 929. The same goes for “community-wide estimations” about a proposed class, since “any one class member may have an exposure level well above or below the average.” Gates, 655 F.3d at 266. The “shortcut” of “abstract ... ‘averages’” does not substitute for proof of “individual damages.” Broussard, 155 F.3d at 343. Ultimately, an average is little more than “a convenient fiction made up of numbers that are higher and lower than the average.” Gates v. Rohm & Haas Co., 265 F.R.D. 208, 222 n.25 (E.D. Pa. 2010). Plaintiffs purport to distinguish these cases—Broussard, they say, involved franchise agreements, and Gates involved a slightly different application of average exposure rates. (Opp. at 27 n.14, 41.) But those trivial distinctions do not diminish the holdings of those and similar cases, whose legal principles controvert Plaintiffs’ argument and which they fail to dispute. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 19 of 63 9 Opperman v. Path, Inc., 2016 WL 3844326, at *14 (N.D. Cal. 2016); In re Fluidmaster, Inc., Water Connector Components Prod. Liab. Litig., 2017 WL 1196990, at *58 (N.D. Ill. 2017); In re Rail Freight Fuel Surcharge Antitrust Litig., 725 F.3d 244, 252-53 (D.C. Cir. 2013). 4. An Issue Class Is Not an End-Run Around Individual Questions As a further alternative to “allocation” proceedings, Plaintiffs say their expert testimony supports a Rule 23(c)(4) issue class. They say that the Court may certify an issue class to “prove Saint-Gobain’s liability for their common law property claims.” (Opp. at 31-32.) Then, after certification, they say individual class members “will prove their individual property damages” by separate proceedings. (Id. at 32.) That construct is inapplicable here, however, because “liability and damages … cannot be separated from one another.” Rowe v. E.I. duPont de Nemours & Co., 2008 WL 5412912, at *3 (D.N.J. 2008). Issue certification thus fails as a matter of law. A Rule 23(c)(4) issue class for liability followed by separate proceedings on damages is permitted only when those issues can be “carve[d] at the joints”—not when the individual-stage determination of proximate cause or injury “overlaps [with] the issue of the defendants’ negligence” that would be determined in class-stage proceedings. In re Rhone-Poulenc Rorer, Inc., 51 F.3d 1293, 1303 (7th Cir. 1995); (Dkt. 215 at 38 (collecting cases).) This is so for at least three reasons. First, the Rules Enabling Act prohibits a supposedly “common” phase of liability if it involves questions of causation and injury as to which the defendant has available individual defenses. See Dukes, 564 U.S. at 367; Asacol, 907 F.3d at 51-53. Second, such a proposal violates Article III because it would allow the adjudication of claims in a liability phase that may later be shown in individual proceedings to have no cognizable injury or causation—and thus no standing to be part of a certified class in the first place. See Denney v. Deutsche Bank AG, 443 F.3d 253, 264 (2d Cir. 2006). And third, such a proposal violates the Seventh Amendment’s Re-examination Clause, since it would invite a second jury in individual proceedings to find no injury or causation, Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 20 of 63 10 contrary to the first jury’s finding on liability. See Blyden v. Mancusi, 186 F.3d 252, 268-69 (2d Cir. 1999); Rhone-Poulenc, 51 F.3d at 1303. An issue class cannot be maintained here because the “liability” phase as to which Plaintiffs purport to offer common evidence contains embedded individual issues. Chief among these is the issue of injury, which is essential to liability. See Parko v. Shell Oil Co., 739 F.3d 1083, 1085-86 (7th Cir. 2014); Ebert v. General Mills, Inc., 823 F.3d 472, 479 (8th Cir. 2016). Based on the Complaint, this would include whether a given putative class member has experienced increased risk, added cost for groundwater, or diminution in value. Plaintiffs’ experts do not purport to offer common proof of which putative class members were injured—they do not address individual class members’ claims at all. As the First Circuit held, expert evidence that does not purport to do so cannot establish commonality. Asacol, 907 F.3d at 55-56. An issue class therefore fails. Contrary to Plaintiffs’ position, the Second Circuit does not follow the “broad view” of issue certification represented by the Sixth Circuit’s outlier opinion in Martin v. Behr Dayton Thermal Prods., LLC, 896 F.3d 405 (6th Cir. 2018). Although the Second Circuit evaluates predominance solely with respect to purported “common” issues selected for certification, In re Nassau County Strip Search Cases, 461 F.3d 219 (2d Cir. 2006), it permits certification only where it will “reduce the range of issues in dispute and promote judicial economy.” McLaughlin, 522 F.3d at 234 (quotation omitted). Here, liability is not a common question because it contains embedded individual questions of injury and causation, among others. An issue class would thus not “generate common answers apt to drive the resolution of the litigation.” Dukes, 564 U.S. at 350 (citation omitted). Instead, any purported common questions would be “artificial or merely preliminary to matters that necessarily must be adjudicated to resolve the heart of the matter.” Ebert, 823 F.3d at 479-80. The issue class is no cure for Plaintiffs’ experts’ lack of common proof. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 21 of 63 11 B. Plaintiffs’ Medical Monitoring Expert Testimony Is Inadmissible for Class Certification 1. Dr. Ducatman’s Opinion Does Not Address the Putative Class Members or Their Admitted Individual Differences Dr. Ducatman readily acknowledges the myriad “considerable individual differences” among the putative class members. (Ducatman Tr. at 55:25-61:6.) This is irreconcilable with the notion of class-wide proof of medical monitoring. Federal courts in other PFOA litigation seeking medical monitoring have reached the same conclusion. Rowe, 2008 WL 5412912, at *17, 20-21; Rhodes v. E.I. duPont de Nemours & Co., 253 F.R.D. 365, 374-76 (S.D. W. Va. 2008), appeal dism’d, 636 F.3d 88, 98-101 (4th Cir. 2011). Dr. Ducatman’s testimony merits no exception. Moreover, Dr. Ducatman ignores the individualized facts that permeate these claims. He concedes that he did not consider any of the Plaintiffs’ medical records, their discovery responses, their ages, their water consumption habits, or anything else about them. (Ducatman Tr. at 37:8- 17, 39:3-21, 45:8-12, 169:7-12, 173:4-8, 175:24-176:2, 179:5-8, 181:9-12, 189:9-13, 193:20-24, 195:6-13.) He relies instead on assumptions about a fictional group of homogenous Bennington residents that do not exist in reality. Thus, he fails to reconcile his class-wide opinion with “the litany of individualized issues that pervade Plaintiffs’ requests for medical monitoring.” Rowe, 2008 WL 5412912, at *21. Because he cannot connect the population at issue with their individual variabilities, his opinion does not fit the class members or class certification. And because he cannot “account for the specific circumstances of this case,” his opinion that matters within it “can be proven on a class-wide basis is … unreliable.” Weiner, 2010 WL 3119452, at *8. Dr. Ducatman and Plaintiffs dismiss the extensive evidence of the individualized nature of the putative class members as a “truism.” (Opp. at 12; Ducatman Class Rpt. at 11.) But the most important feature of truisms is their truth, which Dr. Ducatman fails to address in his opinion. The individualized nature of variables, such as “gender, age, drug/alcohol use, nutrition, body mass Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 22 of 63 12 index, physiology, behavior, medical history … , and general state of health,” in the context of PFOA exposure makes class-wide proof unattainable. Rowe, 2008 WL 5412912, at *17, 20-21; see also Rhodes, 253 F.R.D. at 374-76.5 Here, the putative class members are also highly individualized in areas relevant to their claims. For example, Dr. Ducatman acknowledged that Plaintiffs would vary in the amount of water they drink and the sources of their water. (Ducatman Tr. at 37:21-38:14.) He also acknowledged that this variation prevented extrapolation of the named Plaintiffs’ behaviors to the putative class. (Id. at 39:22-40-2.) Dr. Ducatman’s failure to say anything about the putative class members is an “insurmountable Daubert fit problem.” In re Pharmacy Benefit Mgrs. Antitrust Litig., 2017 WL 275398, at *20 (E.D. Pa. 2017). And his refusal to consider those facts that could have tested his theories renders his opinion unreliable. See Daubert, 509 U.S. at 593-94. Had he inquired, he would have learned none of the named Plaintiffs is even a candidate for the screening he proposes: (Guzelian Rpt. at 95.) Plaintiffs say his opinion is not based on hypothetical plaintiffs (Opp. at 11- 12), but they offer no alternative name for his subjects who are so unlike those in litigation. 2. Dr. Ducatman’s Exposure-Only Medical Monitoring Is Not Generally Accepted And Is Not A Shortcut Around Individual Issues Plaintiffs contend that Dr. Ducatman’s total disregard of the considerable individual differences among the proposed class can be excused. They claim it is “generally accepted” for 5 Plaintiffs attempt to limit these decisions to their holdings on the propriety of class certification, but ignore the necessary effect of the recognition that “each individual’s risk of disease will vary depending on his/her actual PFOA exposure … [and] background risk of disease absent PFOA exposure.” Rowe, 2008 WL 5412912, at *17, *20-21; accord Rhodes, 253 F.R.D. at 374-76. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 23 of 63 13 medical monitoring to be based solely on an individual’s above-background exposure to a purported toxic agent. (Opp. at 11-12.) Plaintiffs thus attempt to reduce medical monitoring class certification to a single variable. This is completely untenable. Plaintiffs point to two pages from Dr. Ducatman’s report (id. at 13-14), but apart from that ipse dixit, they do not cite any scientific literature to show that this exposure-only method for establishing eligibility for medical monitoring is generally accepted. See Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). Plaintiffs’ argument is contradicted by compelling precedent: No federal appellate court has ever approved the certification of a medical monitoring class action. (See Dkt. 215 at 8 (collecting cases).) Likewise, the two prior federal decisions involving exposure to PFOA have rejected class certification due to the inherently individualized issues associated with medical monitoring. Rowe, 2008 WL 5412912, at *17, *20-21; Rhodes, 253 F.R.D. at 374- 76. (See Guzelian Rpt. at 29-46.) Plaintiffs point to Agency for Toxic Substances and Diseases Registry (ATSDR) criteria, ostensibly to show that exposure-only monitoring is “generally accepted.” (Opp. at 14.) But Dr. Ducatman did not rely on ATSDR criteria to form his opinion. And those regulatory criteria are not “exposure only.” Rather, ATSDR considers such “factors as the underlying risk of the selected outcome, the risk attributable to the exposure, and the presence of sensitive subpopulations.” ATSDR’s Final Criteria for Determining the Appropriateness of a Medical Monitoring Program Under CERCLA, 60 Fed. Reg. 38840, 33841 (Jul. 28, 1995) (emphasis added). Moreover, Plaintiffs’ reliance on ATSDR criteria is selective and misplaced. When it comes to PFOA, the ATSDR does not recommend “health screening … because of PFAS exposure” since “PFAS blood concentrations cannot be linked to any specific health Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 24 of 63 14 effect(s).” (See Ducatman Tr. Ex. 10 at 27-28 (emphasis added).) Those criteria are triggered by “a scientific basis for a reasonable association.” Id. (emphasis added). They are inapposite to the questions of causation and medical utility that apply in this tort case. (See Mem. at 72-74, 77.) Dr. Ducatman attempts an end-run around these other considerations because he admits they cannot be shown on a common basis. Contrary to Plaintiffs’ assertions, Dr. Ducatman acknowledges that neither exposure nor risk are common within the proposed class. (Ducatman Tr. at 56:5-61:12.) He further concedes that there would be “considerable individual differences” among putative class members according to “age,” “gender,” “physiology,” “diet and nutrition,” “drug and alcohol history,” “Body Mass Index,” “general state of health,” medical history, “sources of water,” and “route of exposure,”6 among others. (Id. at 56:17-59:17.) Because he ignored these individual differences in forming his opinion, it does not “fit” class-wide monitoring. This exclusive focus on exposure for determining medical monitoring ignores the risks of such intervention. Medical monitoring is not an unalloyed good. Dr. Ducatman acknowledges that medical screening carries the risk of harm. (Ducatman Tr. at 145:14-147:6.) He agrees, for example, that a false negative or false positive result may have medical, psychosocial, and financial consequences. (Id. at 137:20-139:5, 141:10-142:1.) He also concedes medical monitoring should be performed only after weighing its potential benefits and harms. (Id. at 123:18-22.) Despite these concessions, he does not discuss the risks of diagnostic testing. Nor is it evident that he designed his medical monitoring proposal to minimize the risk of false testing results and overdiagnosis. (See Mem. at 23.) His reports are silent as to test specificity and sensitivity. And they contain no information on the prevalence of the health endpoints to be screened. (Id. at 156:9- 6 (Mandel Rpt. at 26.) Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 25 of 63 15 16.) Yet specificity, sensitivity, and prevalence are concepts crucial to determining the utility of medical diagnosis. (See Mem. at 23.) His exposure-only approach short-cuts this entire analysis. As a final gesture to the individuation of the putative class, Plaintiffs propose “to accommodate any such individualized issues … after implementation of [Dr. Ducatman’s] proposed medical monitoring program.” (Opp. at 46; see also id. at 15-16.) This concession undermines their argument that individual differences are irrelevant. Nor is the postponement of individual issues authorized under Second Circuit law. “Roughly estimating the gross damages to the class as a whole and only subsequently allowing for the processing of individual claims would inevitably alter defendants’ substantive right to pay damages reflective of their actual liability,” McLaughlin, 522 F.3d at 231 (citation omitted). This would be contrary to the Rules Enabling Act. Id. Plaintiffs’ concession to address individual issues at a later time is no excuse for Dr. Ducatman’s failure to consider them in the first instance. C. Plaintiffs’ Fate and Transport Expert Testimony Is Inadmissible for Class Certification Dr. Hopke, Mr. Yoder, and Dr. Siegel use unreliable methods and arbitrary assumptions that do not fit class certification or this case in general. Their opinions are inadmissible. 1. Dr. Hopke’s Arbitrary and Untested Opinion Cannot Support Class Certification a. Dr. Hopke’s Emissions Scenarios Are Wholly Untethered to Actual Emissions Data (Hopke Class Rpt. at 4.) But he does so without considering either of the two sets of emissions data for the Chemfab facilities: (1) Saint-Gobain’s “Process Material Balance Report Glass Cloth Coating”; and (2) an industry-wide material balance report titled “Dispersion Processor Material Balance Project, Final Report.” His opinion is not Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 26 of 63 16 based on “what is known,” Daubert, 509 U.S. at 590, and “ignore[s] the ‘real world.’” Edison Wetlands Ass’n, Inc. v. Akzo Nobel Chems. Inc., 2009 WL 5206280, at *6 (D.N.J. 2009) (citation omitted). Disconnected from actual emissions data, his opinion does not “fit” class certification. See In re Rezulin Prod. Liab. Litig., 369 F. Supp. 2d 398, 425 (S.D.N.Y. 2005); accord M.B. ex rel. Scott v. CSX Transp., Inc., 130 F. Supp. 3d 654, 667-68 (N.D.N.Y. 2015). He has not “considered whether, and how, his proposed methodology could account for the specific circumstances of this case.” Weiner, 2010 WL 3119452, at *8. Thus, his opinion that these matters “can be proven on a class-wide basis is speculative and, therefore, unreliable.” Id. Plaintiffs desperately attempt to show that Dr. Hopke’s emissions “scenarios” considered this emissions data. They claim that “it is clear” Dr. Hopke reviewed Saint-Gobain’s material balance report on emissions data because he “commented on it” and gave “his view of Barr’s interpretation of this data.” (See Opp. at 48-49 & n.22.) But noting the existence of the data and commenting on another’s review of it is not an analysis of the data. There is no indication in Dr. Hopke’s class certification opinion that he used the actual emissions data to form his opinion. In fact, because he did not rely on that data, he had no recollection of having even reviewed it in connection with forming his opinion: Q: Did you review [the Saint Gobain-specific material balance] when coming to your opinions in this case? A: Not until after the report was submitted. I’ve seen this more recently. (Hopke Tr. at 104:6-17 (emphasis added).) Q: You’re confident you didn’t review this until after your report, right? A: Yeah, I think I included it as a reference but I think I got that as a derivative from the Barr report, without actually looking at this report, per se, and that’s how … it’s in this report. (Id. at 105:24-106:4 (emphasis added).) Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 27 of 63 17 He was even presented with the section of his report that Plaintiffs cite as quoting from the Saint-Gobain material balance. But he made clear again that its data did not factor into his opinion: Q: You see where it says, “however, the report makes it clear that ‘a determination’ regarding destruction is inconclusive for several reasons.” A: Mm-hmm. Q: Isn’t that sentence contained within [the Saint Gobain-specific material balance] that you didn’t review at the time you wrote this paper, this report? A: Yes. Q: How did you come to quote a document you hadn’t reviewed? A: I’m not sure. Again, this was last summer and obviously had it from something. Maybe I had a copy last summer but I don’t remember having seen it so, again, I know I got another copy recently … so I’d have to go back and look and see whether I actually had it before or not. (Id. at 106:11-107:1.) In addition, Plaintiffs do not dispute that Dr. Hopke did not review the industry-wide material balance. (See Hopke Tr. at 108:14-17.) Instead, they complain that “Saint-Gobain did not produce this report to Plaintiffs in discovery, and it was first shown to Dr. Hopke in his deposition” on his rebuttal report. (Opp. at 49 n.22) Yet, the industry-wide material balance was publicly available on the EPA’s website, as disclosed at Dr. Hopke’s first deposition. (Hopke Tr. 108:10-13.) Dr. Hopke still did not address it in either his rebuttal report or second deposition. Without any validating connection to available emissions data, Dr. Hopke’s three emissions “scenarios” are arbitrary. Plaintiffs’ experts admit as much. (Yoder Tr. at 76:12-24, 102:12-103:8.) Because he did not review actual emissions data, Dr. Hopke admitted that he could not determine “with any scientific certainty” where in between his 1,000 and 10,000 pound per year estimates the actual emissions amount would fall. (Hopke Tr. at 137:10-24; see also Mem. at 41-44.) Modeling opinions cannot be made in a “vacuum without any attempt to validate [their calculations] against reality” and still be inadmissible. Burst v. Shell Oil Co., 104 F. Supp. 3d 773, 781 (E.D. La. 2015); see also Crescenta Valley Water Dist. v. Exxon Mobil Corp., 2013 WL Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 28 of 63 18 12116333, at *1, 5 (C.D. Cal. 2013); City of Wichita, Kansas v. Trustees of APCO Oil Corp. Liquidating Tr., 306 F. Supp. 2d 1040, 1108-09 (D. Kan. 2003). Plaintiffs deflect. They say Dr. Hopke simply “us[ed] the same chemical usage numbers relief upon by Barr, but with different assumptions on PFOA concentrations and destruction percentages[.]” (Opp. at 53.) But these very assumptions are contrary to, among other things, peer-reviewed literature, and are precisely what make his methodology arbitrary and unreliable: For PFOA concentrations, Dr. Hopke used a concentration of 5,000 ppm. He based this value on DuPont’s Material Data Safety Sheets for some of the dispersions used in the process, which listed the concentration as “< 0.5%” (i.e., less than 5,000 ppm). Nowhere do Plaintiffs justify his use of the highest value of a “less than” range. Barr, for example, used 2,000 ppm for the same concentration.7 For destruction percentages, Dr. Hopke assumed that 100% of the PFOA used in the process converts to APFO and is emitted into the air. He says this happens by either vaporizing (according to his opening report) or subliming (according to his rebuttal report). But his 100%-emissions assumption is contrary to the actual emissions data—which he did not consider. The actual data show that most of the PFOA is destroyed before it can be emitted. It is also contrary to peer-reviewed literature, which he cites for one proposition but rejects for another (without explanation). b. Dr. Hopke’s Sublimation Theory Is a Moving Target Dr. Hopke’s rebuttal report proposes a new theory to defend his upper-bound emissions scenario. He now states that 100% of APFO sublimes to PFOA before it can be destroyed by the heat of the stacks. (Hopke Reb. Tr. at 35:8-12; 37:3-15.) Plaintiffs admit that Dr. Hopke does not mention sublimation in his opening report. (See Opp. at 50.) Instead, they argue that this theory was simply providing “more detail … than he did in his original expert report.” (Id. at 49.) 7 Plaintiffs also note that AMEC Foster Wheeler recently “used 3,000 ppm in its most recent calculations.” (Opp. at 53 n.26.) But Dr. Hopke did not rely on this document in forming his opinion. And it should not be considered in assessing the reliability of his methodology. (See Dkt. 245.) In any event, 3,000 ppm is still 40% less than what Dr. Hopke uses. Therefore, AMEC Foster Wheeler’s use of 3,000 ppm does not rescue his unreliable input. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 29 of 63 19 (Hopke Class Rpt. at 3.) He now opines that PFOA sublimed (i.e., turned from a solid into a gas). (Hopke Reb. Rpt. at 2.) As he admits, sublimation and vaporization are distinct chemical terms that should not be used interchangeably: Q: Is vaporization the same thing as sublimation? A: No. Q: Do you use those terms interchangeably? A: I shouldn’t. I hope I have not done so. (Hopke Reb. Tr. at 27:7-11 (emphasis added).) Plaintiffs say Dr. Hopke’s rebuttal only “explain[s] his opinion in more detail” (Opp. at 50), but he testified he did not find support for sublimation until just before his first deposition: Q: And that theory that you just described [sublimation] is not stated in any of your reports, correct? A: No, because this paper I found much more recently. … Q: The idea that you read about after you submitted your reports is not expressed in your reports, correct? A: Sure. Q: When was it that you first read this paper that you seem to remember that gave you this idea? A: About a week ago. I did another follow-up search on this. (Hopke Tr. at 231:23-232:13 (emphasis added).)8 The “underpinnings” of Dr. Hopke’s opinion changed from vaporization to sublimation “in direct response” to litigation scrutiny. Haller v. AstraZeneca Pharms. LP, 598 F. Supp. 2d 1271, 1296 (M.D. Fla. 2009). His opinion is a “veritable moving target,” and properly excluded as such. Id.; see also Miller v. Pfizer, Inc., 356 F.3d 1326, 1330 (10th Cir. 2004); Glastetter v. Novartis Pharms. Corp., 107 F. Supp. 2d 1015, 1032 (E.D. Mo. 2000), aff’d, 252 F.3d 986 (8th Cir. 2001). 8 Plaintiffs suggest that the sublimation theory is present in Dr. Hopke’s opening report because he cited a paper, Barton (2008), which mentioned sublimation over 20 times. (See Opp. at 50.) (See Hopke Class Rpt. 3-4.) Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 30 of 63 20 c. Dr. Hopke’s Sublimation Theory Is Unreliable Dr. Hopke’s sublimation theory is also unreliable. It is refuted by basic chemistry and is based on misapplication of the scientific literature—specifically Zhu (2007) and Barton (2009). (See Mem. at 40.) Plaintiffs’ attempts to justify that flawed reliance are untenable. First, Plaintiffs say that, even though “Zhu’s experiment tested ammonium chloride,” not APFO, Zhu “stated that his mechanism was applicable to ammonium salts in general, which would include APFO.” (Opp. at 50.) But Plaintiffs cite nothing in Zhu (2007) to support that interpretation. Nor could Dr. Hopke: Q: Can you identify anywhere in Zhu that says the mechanism that you adopted is highly likely to apply to APFO? A: No. (Hopke Reb. Tr. at 152:11-14 (emphasis added).) Second, Plaintiffs argue that Barton (2009) “also believes the Zhu mechanism is applicable to APFO.” (Opp. at 51.) Once again, Dr. Hopke testified to the contrary, stating only that Barton (2009) “hypothesized that [Zhu (2007)] may apply” to APFO: Q: So it’s a hypothesis, according to Barton, that the sublimation mechanism proposed by Zhu for ammonium chloride could apply to APFO; is that fair? A: Yes. (Hopke Reb. Tr. at 41-42, 158:6-9 (emphasis added).) In fact, Barton (2009) casts doubt on the sublimation mechanism altogether. Rather, the authors note that the process in Zhu (2007) was “speculate[d].” (Hopke Reb. Tr. at 153:12-16.) Third, Plaintiffs argue that “it is of no moment” that Dr. Hopke’s sublimation hypothesis is untested because, they say, “the mechanism is not critical.” (Opp. at 51 n.23.) To the contrary, his emissions estimate depends critically upon his opinion that 100% of the APFO in the process sublimes before decomposing. (See Hopke Reb. Rpt. at 2.) His reliance on “an untested hypothesis ... falls into the category of unreliable speculation that is inadmissible under Daubert.” In re Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 31 of 63 21 Mirena IUD Prods. Liab. Litig., 169 F. Supp. 3d 396, 450-51 (S.D.N.Y. 2016) (internal quotations and citation omitted). Authors of scientific articles “limit the application of their studies consistent with the principles of good science.” McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1247 (11th Cir. 2005). Dr. Hopke’s untested extension of the Zhu (2007) hypothesis to APFO is unreliable.9 2. Mr. Yoder Does Not Offer Common Evidence of Presence or Amount of PFOA at Any Location in the Class Area Plaintiffs do not dispute that Mr. Yoder’s methodology provides no information about the presence, amount, or source of PFOA at any individual class member’s property, nor that this deficiency presents an “insurmountable Daubert fit problem” in relation to class certification. (Mem. at 25 (quoting Pharmacy Benefit Managers, 2017 WL 275398, at *20).) Instead, Plaintiffs try to cure this defect with his untimely and inappropriate second declaration, arguing that “[a]lthough Mr. Yoder’s model has not yet been used for this purpose, it can be.” (Pls.’ Opp. at 28.) Initially, Mr. Yoder’s second declaration, which contains a brand new purported method of common proof proffered in the middle of Daubert briefing and without an opportunity to conduct discovery, is the subject of a pending motion to strike. (See Dkt. 145.) But even apart from the impropriety of the untimely disclosure of this opinion, it fails on its own terms. Mr. Yoder has already served two reports in this case. He also submitted a sworn declaration that his class certification report contains “a complete statement of the opinions [he] express[ed] on the issue of class certification” (Dkt. 107-46, Yoder Decl., ¶ 3; see also Yoder Class 9 In addition to these errors, Dr. Hopke even uses a version of the sublimation mechanism of ammonium chloride that the authors of Zhu explicitly reject in the same paper. He admits that he relied on Zhu’s “Scheme 1” as a mechanism for sublimation of APFO, when Zhu “actually rejects Scheme 1 and proposes Scheme 2.” (Hopke Reb. Tr. at 51:11-20.) Also, Dr. Hopke’s cite to an incorrect equation for the vapor pressure of APFO is not, as Plaintiffs claim, a mere “typographical error.” (See Opp. at 51 n.24, 52.) It is an entirely incorrect formula for a different chemical altogether (PFOA, not APFO). (See Hopke Reb. Tr. at 103:7-23, 108:4-15; 111:4-20). Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 32 of 63 22 Rpt.), as well as a rebuttal report. (See Yoder Reb. Rpt.) Nowhere in those reports or at deposition does Mr. Yoder ever reveal a method of common proof of PFOA at any property. A proposal for a model of common proof must, as Plaintiffs’ cases and others hold, detail how the model will be applied to the facts in litigation. See Weiner, 2010 WL 3119452, at *8; see also Royal Park Invs. SA/NV v. Deutsche Bank Nat’l Trust Co., 2018 WL 1750595 at *8 (S.D.N.Y. 2018); In re Scotts EZ Seed Litig., 304 F.R.D. 397, 413-14 (S.D.N.Y. 2015). But here, Mr. Yoder specifically admits that his model “wasn’t designed to tell us how much PFOA was deposited on property owned by a particular individual at a particular time.” (Yoder Tr. at 162:8-22 (emphasis added).) He did not even “attempt to determine when over time PFOA may or may not have actually [been] deposited [onto] any given ... property in Bennington.” (Id. at 163:5-10.) Plaintiffs cannot repurpose Mr. Yoder’s opinion to an end for which it was not designed. Nor can Mr. Yoder’s model compute the source of PFOA at any location in the proposed class area. Plaintiffs admit his “role was modeling the emissions from [the Chemfab facilities].” (Opp. at 55.) Mr. Yoder admitted that he began “with the conclusion that all the PFOA depositions came from Chemfab” and did “not look at any individual property in Bennington as a receptor and then work backwards to determine the source of any PFOA depositions at that property.” (Yoder Tr. 171:16-172:8.) Having “assume[d] as truth the very issue [he] needs to prove,” Clark v. Takata Corp., 192 F.3d 750, 757 (7th Cir. 1999), he necessarily lacks a common method to determine whether PFOA at any location is in fact attributable to the Chemfab facilities, as opposed to the other potential sources he acknowledged. (See Yoder Tr. at 172:10-18.) In addition, Plaintiffs now admit that Mr. Yoder’s AERMOD model is based on averages, as opposed to individualized analysis. (Mem. at 25; Opp. at 27, n.14.) As explained, supra Section I.A.3, class “certification is inappropriate” based upon such “an averaging technique.” Gates, 265 Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 33 of 63 23 F.R.D. at 222 n.25;10 see also Pharmacy Benefit Managers, 2017 WL 275398, at *20-21. Such “community-wide estimations” about exposure in a proposed class area are not probative of any individual’s exposure, which may be “well above or below the average.” Gates, 655 F.3d at 266. Plaintiffs cannot cure defects in Mr. Yoder’s methodology by arguing that he modeled “more than one scenario” and utilized this method because he did not have data regarding the actual emission of PFOA. (Opp. at 26.) Plaintiffs’ reference to his use of “more than one scenario” refers only to Dr. Hopke’s unreliable emissions rates scenarios, which Mr. Yoder admitted were “arbitrary.” (Yoder Tr. 102:12-103:8.) To the extent actual emissions data were unavailable to Mr. Yoder, it is because Dr. Hopke chose not to consider them. See supra Section I.C.1.a. Mr. Yoder did not attempt to compute actual air deposition, which he admits is “likely going to be different” throughout the proposed class area. (Yoder Tr. at 160:16-162:22.) His model is unreliable, does not offer common proof, and cannot support class certification.11 3. Dr. Siegel’s Opinion Is Inadmissible for Class Certification a. Dr. Siegel Does Not Purport to Show Presence, Amount, or Source of PFOA at Any Place in the Proposed Class Area While Plaintiffs attempt to repurpose Mr. Yoder’s opinion as a means of common proof, they readily admit that Dr. Siegel’s analysis cannot determine the presence, amount, or source of PFOA for any particular location in the class area. (Opp. at 25.) Though they say “that was not 10 Plaintiffs fail to successfully distinguish Gates. (Opp. at 27 n.14.) They argue that, unlike here, the averages discussed in Gates were used for human exposure calculations. (Id.) But the principle articulated in Gates is also applicable to this case—“an average is an average is an average” and a technique utilizing averages is inappropriate to class certification. 265 F.R.D. at 222 n.25. 11 As Plaintiffs acknowledge (see Opp. at 26-27), the issue is not whether AERMOD, a computerized model used by the EPA, is a reliable method. Rather, as Mr. Yoder testified, the reliability of the AERMOD program is only as good as its inputs (Yoder Tr. 69:17-22), and Mr. Yoder’s use of Dr. Hopke’s arbitrary emissions scenarios as inputs necessarily renders his results unreliable. Plaintiffs do not address or dispute any of the case law supporting this legal principle. (See Mem. at 45 (collecting cases).) Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 34 of 63 24 the purpose of his modeling” (id.), it renders his opinion inadmissible for class certification. If he cannot opine on any issue relevant to the claims of each member of the putative class, he offers nothing of value to class certification. Dukes, 564 U.S. at 350. Class certification evidence that “does not purport to address” commonality is inadmissible. Chen-Oster, 114 F. Supp. 3d at 115. Instead, Plaintiffs offer that Dr. Siegel can opine as to PFOA transport in the proposed class area based on his “back-of-the-envelope” calculations about two one-square-meter areas. (Opp. at 28; Siegel Tr. at 100:22-24.) But these two square-meters are “conceptual.” (Siegel Tr. at 57:11-14.) They do not exist anywhere within the class area. (Id. at 105:4-8.) Plaintiffs contend that these two one-square-meter areas are “representative” of the proposed class area. (Opp. at 28.) This is legally and factually flawed. The data for these two areas are not derived from sampling actual soil in the proposed class area, but rather from evaluating the characteristics of two samples from Europe. (See id. at 76:22-24, 79:11-80:25.) Nor is it possible to find a “representative” sample within the class area, given the substantial variability Dr. Siegel concedes exists in types of soils, bedrock, and surficial materials between the soil and bedrock that affect the transport of PFOA. (See Siegel Tr. at 40:12-42:9, 47:8-48:16, 93:12-94:2.) Not only is he unable to capture all of these individual differences in just two “conceptual” one-square-meter areas, but even if he could, it would not tell the Court anything meaningful about PFOA transport at any location. See supra Section I.A.3. The same is true of Dr. Siegel’s purported calculations of PFOA dissipation from the proposed class area, for which Plaintiffs concede he “has to rely upon representative conditions.” (Opp. at 30.) A generalized calculation obscures the time variation for PFOA to be flushed from these particular locations, including due to the differing manner in which wells react to recharge across the class area. (Siegel Reb. Rpt. at 2-13.) These opinions do not fit class certification. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 35 of 63 25 Nor are they reliable. Dr. Siegel’s purported “representative” areas also fail to account for the wide variation within the proposed class area that affects the transport of PFOA. He offers a “back-of-the-envelope” calculation but does not attempt to validate it against real world data at any location in the class area. (Siegel Tr. at 58:15-24, 76:22-24; 100:22-24.) Without this validation, Dr. Siegel cannot establish “whether [his] methodology, even one based on established scientific foundations, is reliable for the facts of the particular case.” Valente v. Textron, Inc., 931 F. Supp. 2d 409, 421 (E.D.N.Y. 2013), aff'd, 559 F. App’x 11 (2d Cir. 2014). Models, like Dr. Siegel’s, must be “tested by calibration”— “comparing the results of th[e] simulations to the field data and then adjusting [the model].” City of Wichita, 306 F. Supp. 2d at 1108-09. Failure to calibrate “may not be scientifically sound” and therefore “excluded under Daubert.” Crescenta Valley, 2013 WL 12116333, at *5; see also Burst, 104 F. Supp. 3d at 781. It is inadmissible. b. Dr. Siegel’s Methods Were Made for Litigation Dr. Siegel fails to apply the same standards for courtroom opinions as in his academic work. Plaintiffs cannot dismiss evidence of this double standard as “innuendo.” (Opp. at 20.) He admits that academics, like himself, “strive to attain” “certainty … before they publish a paper, maybe >90%,” while he holds his litigation consulting work to a much lower standard. (Siegel Tr. Ex. Q at 522.) He says the type of model that he used here, a “solute transport model,” does “not accurately predict hydrologic and geochemical phenomena well.” (Id.) He says the “reliability of … simple solute transport models … to predict fate and transport outside their calibration sites has not been demonstrated.” (Id. Ex. R at S113.) He places these models closer to “Dead Wrong” than to certainty on his scale of “hydrologic certainty.” (Id. Ex. Q at 522.) It is foundational Daubert law that an expert must “employ[] in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” Kumho Tire Co v. Carmichael, 526 U.S. 137, 152 (1999). In deciding whether to exclude expert opinion, Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 36 of 63 26 courts often consider “[w]hether the expert is being as careful as he would be in his regular work outside his paid litigation consulting.” Fed. R. Evid. 702, Advisory Committee’s Note (citation and internal quotations omitted). It is also foundational that expert testimony “created for the purpose of litigation” is inherently suspect. Mike’s Train House v. Lionel, L.L.C., 472 F.3d 398, 408 (6th Cir. 2006); see also Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1316-17 (9th Cir. 1995) (“Daubert II”); Awad v. Merck & Co., 99 F. Supp. 2d 301, 304 (S.D.N.Y. 1999), aff’d, 213 F.3d 627 (2d Cir. 2000). Because a “scientist’s normal workplace is the lab or the field, not the courtroom or the lawyer’s office,” testimony based on methods used for the first time in litigation is unreliable. See Daubert II, 43 F.3d at 1317. Dr. Siegel’s admission that he follows a lower standard in the courtroom warrants exclusion of his opinion. Notably, in this specific case Dr. Siegel used methods for purposes not recognized by the published literature. See Daubert, 509 U.S. at 593-94. Plaintiffs do not dispute that he used a first-of-its-kind application of an approach from an article by Rao (1985) to estimate the transport of PFOA through soil. Dr. Siegel does not know of one instance—in peer-reviewed literature or elsewhere—in which the Rao model, has been applied to PFOA. (Siegel Tr. at 52:3-18.) Rao was not intended “to be a predictive tool, but rather a simple method for ranking a number of pesticides in terms of their relative potential to intrude into groundwater.” (Siegel Tr. Ex. G at 7 (emphasis added).) Although Dr. Siegel knows Dr. Rao, he never even asked him whether it would be scientifically appropriate to use the Rao model for PFOA. (Id. at 68:12-20.) Plaintiffs rely on a National Academy of Sciences report that they say “highlighted the validity of the Rao methodology.” (Opp. at 57.) But they do not contend that the report, for which neither Plaintiffs nor Dr. Siegel provide a specific citation, says anything about applying the Rao method to PFOA. The report does not say which types of chemicals, beyond the pesticides for Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 37 of 63 27 which Dr. Rao explicitly designed the model, the method can be applied to. While Plaintiffs also claim that Rao’s “calculations can be used for any chemical based on the properties of the chemical” (id. at 57), Dr. Siegel has not demonstrated why PFOA is a chemical that fits that bill. To the contrary, Dr. Siegel himself admits that the “absorption capacity of PFOA is far less than pesticides.” (Siegel Tr. at 51:25-52:2; see also Siegel Class Rpt. at 6-1.) Plaintiffs offer no explanation for Dr. Siegel’s use of the Rao method where key assumptions that underlying it do not apply. (See Mem. at 49-50.) This extension of the Rao article to a context not permitted by the author’s explicit limitations is unreliable. See Huss v. Gayden, 571 F.3d 442, 459 (5th Cir. 2009); Mirena IUD, 169 F. Supp. 3d at 431. Dr. Rao stated that “heterogeneities with depth” of the water table “would invalidate” one of the core assumptions underlying his method. (Siegel Tr. at 71:10-15.) Yet Dr. Siegel concedes that the water table depth is heterogeneous throughout the Bennington area. (Id. at 71:20-25.) Further, Dr. Rao assumed that the organic partition coefficient, which measures the way a chemical sticks to soil, can be estimated. (Siegel Tr., Ex. G, at 7.) But Dr. Siegel recognizes that this variable is “uncertain” in the class area. (Id. at 79:1-6.) Plaintiffs’ lack of response on these points is telling. c. Dr. Siegel’s Alternative Source Analysis Is Unreliable It is well-settled that a causation opinion that fails to adequately account for obvious “alternative explanations renders [an expert’s] analysis essentially worthless.” Cooper v. Meritor, Inc., 2019 WL 545187, at *19 (N.D. Miss. 2019) (citation omitted); accord Michaels v. Avitech, Inc., 202 F.3d 746, 753 (5th Cir. 2000); Claar v. Burlington N. R.R. Co., 29 F.3d 499, 504 (9th Cir. 1994); see also Fed. R. Evid. 702, Advisory Committee Notes to 2000 Amendments. Dr. Siegel fails to do so here. The only potential source he considered was the Bennington Landfill. Plaintiffs defend Dr. Siegel’s opinion on the Landfill by pointing to his “[s]everal pages” on the topic (Opp. 58-59), without addressing the logical flaws in his analysis. (See Mem. at 52-53.) Dr. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 38 of 63 28 Siegel does not consider any of the other potential sources identified by Barr Engineering (Opp. at 58), but rather dismisses them on his own say-so. See Joiner, 522 U.S. at 146. Nor does Dr. Siegel consider a host of residential or business sources of PFOA, even though products containing PFOA have been used pervasively for decades in an array of consumer and industrial applications. (TAC, Dkt. 113, ¶ 17.) Instead, he engages in post-hoc rationalization, asserting that these sources could not have produced the “plume” that exists. (See Siegel Reb. Rpt. at 2-16; Siegel Tr. at 154:19-25.) But “[c]oming to a firm conclusion first and then doing research to support it is the antithesis of [the scientific] method.” Claar, 29 F.3d at 502-03. And by framing his analysis in all-or-nothing terms about causation of the whole plume, Dr. Siegel’s dismissive explanation fails to account for the potential contributory role of any of these alternate sources. D. Plaintiffs’ Damages Expert Testimony Is Inadmissible for Class Certification 1. Mr. Unsworth’s Endorsement of Plaintiffs’ Diminution in Value Opinions Cannot Support Class Certification Plaintiffs now say that they “do not intend to prove their common law damages as a class,” but rather to prove class-wide “liability for their common law property claims,” with individual proceedings on damages. (Opp. at 31-32.) They offer Mr. Unsworth to rebut certain assertions by Saint-Gobain’s experts and to opine that individual Plaintiffs’ lay opinions on property value diminution would be “reasonable” and Plaintiffs “have the legal right and the information before them to make” such estimates. (Unsworth Reb. Tr. 236:11-237:7, 245:6-23.) These opinions are inadmissible because (a) individual questions of diminution in property value cannot be carved off into a separate proceeding; and (b) Mr. Unsworth cannot vouch for Plaintiffs’ lay opinion. a. An Issue Class on “Liability” Would Violate The Constitution and Federal Law Mr. Unsworth’s proposal for individual proceedings on diminution in value damages does not fit class certification because it violates the Rules Enabling Act, Article III, and the Seventh Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 39 of 63 29 Amendment. See supra Point I.A.4. Mr. Unsworth acknowledged the numerous individual issues that pervade claims for diminution in value, which he admitted would make class-wide proof of diminished value “difficult.” (See Mem. at 28-34.) But those individual issues also concern key elements of liability, such as injury and proximate cause: for example, whether any loss in value in fact occurred, and, if it did, whether it is attributable to PFOA from the Chemfab facilities. (Unsworth Reb. Tr. at 194:17-196:5; Jackson Rpt. at 12-14.) Because those issues are inextricably intertwined with any determination of liability, then liability cannot be adjudicated based on common evidence. Rowe, 2008 WL 5412912 at *5-6. To do so would abridge Saint-Gobain’s right to present individual defenses, see Dukes, 564 U.S. at 367, certify a class including members without standing, Denney, 443 F.3d at 264, and invite a second jury to re-examine findings of the first. Blyden, 186 F.3d at 268-69. Mr. Unsworth’s opinion does not “fit” class certification. b. Mr. Unsworth Cannot Vouch for Plaintiffs’ Lay Opinion Mr. Unsworth’s opinion that it is not “unreasonable for [Plaintiffs] to express their own opinion as to diminution” on an individual basis is a poorly masked and unfounded legal opinion, and inadmissible as such. (Opp. at 96-97.) Although Plaintiffs insist that he is not “vouching for the Plaintiffs’ opinions” (id. at 97), that is exactly what he is doing, and without any factual basis. He has not reviewed Plaintiffs’ diminution in value opinions, their bases, or anything else about the individual class members. (Unsworth Reb. Tr. 244:9:23.) He says, mistakenly, that their opinions are reasonable because they could have relied on internet valuations, though none of them in fact did so. (Unsworth Reb. Tr. 242:23-243:24.) His opinion stands on nothing more than his misguided invocation of a Vermont statute about opinions on property value, which was furnished to him by Plaintiffs’ counsel. (Unsworth Reb. Tr. at 219:22-220:2.) Plaintiffs’ lay opinion on diminution in value is not grounded in their personal knowledge and is itself not admissible. (See Dkt. 216 at 7-8.) There is thus no basis for Mr. Unsworth’s purported expert opinion endorsing it. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 40 of 63 30 2. Mr. Unsworth’s Added Cost Opinion Does Not Address the Damages of Putative Class Members Mr. Unsworth’s “added cost” model cannot support class certification, much less reliably, because it purports to determine the aggregate damages of the putative class based on average values, rather than the damages of individual members. His reports and deposition testimony highlight the critical differences among putative members of the proposed Property Class— including well depth, water consumption, electricity costs, equipment maintenance, available financing, equipment selection, alternate remediation through POET systems and deeper wells,12 and many others. (Mem. at 29; Unsworth Merits Rpt. at 12; Unsworth Tr. 160:11-161:19.) Even the purported “common set of inputs” that Mr. Unsworth describes yield significant individual differences on each of these issues. (See Unsworth Reb. Tr. at 56:4-14.) Mr. Unsworth has not tested his average model—he admits he did not “look at” or even request any “individual plaintiff data” that would bear on these differences for the named Plaintiffs, to say nothing of the absent putative class members. (Unsworth Tr. at 172:17-23.) That he has not “considered whether, and how, his proposed methodology could account for the specific circumstances of this case,” means that his opinion that damages “can be proven on a class-wide basis is speculative and, therefore, unreliable.” Weiner, 2010 WL 3119452, at *8. Instead of addressing these individual differences (see Mullin Rpt. at 3-5), Mr. Unsworth purports to calculate damages for an “average” putative class member, opining that “[o]n average, it will be correct.” (Unsworth Tr. at 167:21-168:2.) This does not fit class certification and cannot 12 Here, Plaintiffs contradict Mr. Unsworth, who opines in his new declaration that “[t]hose residences that are able to construct deeper wells, yielding potable groundwater without the need for a POET, would not be included in my calculations of damage. In effect, in the long-run they will be in the same position as residences that never had contaminated well water.” (Dkt. 237-15. at ¶ 2.) Ignoring this adjustment, Plaintiffs maintain that those with “re-engineered well [have] suffered losses based on the ‘unreasonable harm’ to the groundwater.” (Opp. at 40.) Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 41 of 63 31 support it reliably. At minimum, Mr. Unsworth could have tested his model or determined its rate of error by checking its results against the actual data for the putative class members. See Daubert, 509 U.S. at 594; Burst, 104 F. Supp. 3d at 781. He did not attempt to do so. Proof as to a purported “average” class member is not a method of generalized proof as to each member of the putative class. See supra Section I.A. Nor is it, as Plaintiffs say, a “common and well-accepted methodology.” (Dkt. 237 at 61.) Quite the opposite, it is well-recognized that the use of averages can be “a critical flaw in the work of a plaintiffs’ economics expert.” ABA Section of Antitrust Law, Econometrics: Legal, Practical, and Technical Issues 360 (2d ed. 2014). This is so because “there is a risk that the averages may hide substantial differences ... which may be critical for determining whether there is individual impact.” Id.; see also Reference Manual on Scientific Evidence (“RMSE”) 266 (3d ed. 2011). That is precisely the problem here, where Mr. Unsworth’s “average” is only “a convenient fiction made up of numbers that are higher and lower than the average.” Gates, 265 F.R.D. at 222 n.25. (Mullin Rpt. at 28.) Not only is this “average” incapable of determining any individual class member’s damages, it also cannot determine whether they have an injury-in-fact, an essential ingredient both to Article III standing and to liability. Lujan v. Defs. of Wildlife, 504 U.S. 555, 560 (1992); Walsh v. Cluba, 198 Vt. 453, 466 (2015). Even Mr. Unsworth’s simplistic consideration of just two variables—town of residence and use of a water softener—reveals individuals who have no legal injury as a result of the switch to municipal water under his damages theory. (Unsworth Merits Rpt. at 13-14.) Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 42 of 63 32 (Mullin Reb. Rpt. at 7-9.) Thus, proffering his model for a purported “liability phase” proceeding would lead to the very same problems under the Rules Enabling Act, Article III standing, and the Seventh Amendment that are outlined above. See supra Section I.D.1.a. Attempting to circumvent these individual issues, Plaintiffs read the Vermont Groundwater Protection Act’s allowance of cause of action for “[a]ny person” for “unreasonable harm” to groundwater as conferring an undifferentiated public right. 10 V.S.A. § 1410(c). This is factually and legally flawed. Mr. Unsworth acknowledged substantial individual variation in the proposed class members’ use of the groundwater and the harms he claims they may have experienced (Unsworth Tr. at 74:17-75:1; Unsworth Reb. Tr. at 75:2-76:3), rendering a class-wide application of the Groundwater Protection Act’s nine-factor test for “unreasonable harm” to groundwater infeasible. And Plaintiffs’ overbroad reading of the Act to allow anyone to sue for anyone else’s harm is irreconcilable with both Vermont and federal law, which require a “particularized” injury that “affect[s] the plaintiff in a personal and individual way.” Lujan, 504 U.S. at 560 & n.1; accord Parker v. Town of Milton, 169 Vt. 74, 78 (1998). Mr. Unsworth’s testimony cannot support a generalized theory of harm that both his testimony and the law foreclose. Finally, Plaintiffs defend Mr. Unsworth’s class certification opinion by observing that the Supreme Court has “rejected any blanket prohibition” against the use of “[a] representative or statistical sample.” (Opp. at 40-41 (quoting Tyson Foods, 136 S. Ct. at 1046).) But the absence of a general prohibition is a far cry from a specific endorsement, and as in Asacol, “plaintiffs’ reliance on Tyson Foods falls short of the mark.” 907 F.3d at 54. In Tyson Foods, a wage and hour class action, the defendant lacked the records about employees necessary to make an individual determination of injury. 136 S. Ct at 1047. Nevertheless, the plaintiffs’ expert built a model based on real data from actual class members. To determine injury, the model evaluated a Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 43 of 63 33 data set derived from nearly 750 recorded observations of actual proposed class members to develop an estimate of the amount of uncompensated time employees spent changing in and out of protective clothing. Id. at 1043. Then, it applied that estimate of uncompensated time to the specific facts relating to each class member to yield a damages opinion. Id. at 1043-44. Because “each class member could have relied on that sample to establish liability” as to their claim, and the defendant lacked any individualized data to furnish defenses to that evidence, the Supreme Court held it could support commonality under Rule 23(a)(2). Id. at 1046-47. Mr. Unsworth’s “model” bears no resemblance to the wage and hour class action in Tyson Foods. Here, the record furnishes abundant individual data with respect to the purported injuries of each class member, but Mr. Unsworth simply ignores it. (See Mullin Rpt. at 26-33.) Instead of looking at data for actual class members as in Tyson Foods, he bases his opinions for an “average” class member on internet research for purported average values regarding equipment cost and lifespan, use of water softeners, well maintenance, and others. (Unsworth Merits Rpt. at 13.) Having estimated this average amount of damages, he does not apply it to the members of the putative class—instead, he defers any such individualized considerations to an indefinite “allocation” phase in the future. (Unsworth Mullin Reb. Rpt. at 11-12.) Because there is well- documented proof of the putative class members’ various well maintenance and utility costs, they would not be entitled to rely on his unfounded average to prove their claims. Cf. Tyson Foods, 136 S. Ct at 1047. The Tyson model’s use of a single, representative value for the amount of time to don and doff protective wear is not analogous to Mr. Unsworth’s elision of individual differentiation in numerous variables. See id. Mr. Unsworth’s model, untethered to the data for the putative class members, cannot establish any element of any class member’s claims, much less all of them. See Dukes, 564 U.S. at 350. It is inadmissible for class certification. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 44 of 63 34 3. Mr. Unsworth’s Replacement Cost Opinion Does Not Address the Members of the Putative Class Finally, Mr. Unsworth’s “replacement cost” model cannot support class certification because it purports to calculate damages to “the public” or the Town of Bennington rather than the putative class. (Unsworth Reb. Tr. 173:9-19.) Plaintiffs say Mr. Unsworth’s proposed measures would “offset the loss of a source of clean groundwater experienced by all residents in the Property Class area” (Opp. at 42), and “compensate members of the Bennington Community.” (Id. at 45.) But the putative class in this case does not consist of “all residents” or “the Bennington Community”—it consists of those within the geographically defined class area who were on private wells with PFOA. (Dkt. 113 at 19.) Nor does it include the Town of Bennington, the entity that has proposed and would benefit from the infrastructure projects in Mr. Unsworth’s opinion, which he concedes are not related to PFOA. (Unsworth Tr. at 243:15-244:8.) A model that purports to award “damages” with no relation to the alleged harm is per se unreliable. See McLaughlin, 522 F.3d at 231. Mr. Unsworth’s proposal that an award under this model be held in an “environmental trust account” cannot cure the fact that it would ultimately provide relief to those who are not class members and require action by non-parties to the litigation. (Opp. at 44.) His opinion cannot be admitted in support of what would constitute such a patent violation of the Rules Enabling Act. McLaughlin, 522 F.3d at 231-32. That he has not developed “any other alternatives that [] can go directly to those class members”—apart from his added cost model—does not permit his proposal for such an award in violation of the requirements of Rule 23. (Unsworth Tr. at 238:19-22, 239:23-240:11.) Mr. Unsworth’s replacement cost opinion is also per se irrelevant. It proposes relief that Plaintiffs are unable to pursue. Plaintiffs do not represent the Town of Bennington, which is not a class member. They have no standing to “rest [their] claim[s] to relief on the legal rights or Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 45 of 63 35 interests of third parties.” Warth v. Seldin, 422 U.S. 490, 499 (1975). Plaintiffs’ reliance on the Groundwater Protection Act and offhanded dismissal of possible “spillover benefit” to non- members of the putative class do not cure this issue. (Opp. at 45.) To be constitutionally cognizable, a claim must not only be premised on an injury-in-fact, but also be amenable to redress by “a favorable decision” of the court. Lujan, 504 U.S. at 561. But Mr. Unsworth’s replacement cost opinion would instead provide redress to a non-party outside the proposed class. “One of the basic principles of law is that a person who is not a party to an action”—like the Town of Bennington—“is not bound by the judgment in that action.” Cal. Dump Truck Owners Ass’n v. Nichols, 924 F. Supp. 2d 1126, 1147 (E.D. Cal. 2012), aff’d, 784 F.3d 500 (9th Cir. 2015) (internal quotation and citation omitted). An award of Mr. Unsworth’s proposed replacement cost damages to the Town would not redress Plaintiffs’ alleged injuries because, among other things, the Town would not “be obliged to honor an incidental legal determination the suit produced.” Lujan, 504 U.S. at 569. Plaintiffs are silent as to how the Court can award relief to a non-party, let alone one under no obligation to accept and implement that relief. Mr. Unsworth’s replacement cost opinion does not fit any issue in this litigation and is inadmissible. II. PLAINTIFFS’ EXPERTS MERITS OPINIONS ARE INADMISSIBLE A. Dr. Ducatman’s and Dr. Grandjean’s Causation Opinions Are Subjective, Untestable, and Not Generally Accepted 1. Expert “Judgment” Must Be Employed With Methodological Rigor Plaintiffs do not dispute that the mere recitation of epidemiological studies by Drs. Ducatman and Grandjean does not establish that PFOA causes any health outcomes. As they concede, “epidemiology, in and of itself, cannot prove causation.” (Opp. at 62.) Something more “is needed to bridge the gap between association and causation.” RMSE at 218. This something more, Plaintiffs argue, is provided by their experts’ “judgment.” (Opp. at 62.) But judgment “does Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 46 of 63 36 not substitute for scientific method” and is not exempted from Daubert’s requirements. Magistrini v. One Hour Martinizing Dry Cleaning, 180 F. Supp. 2d 584, 608 (D.N.J. 2002), aff’d, 68 F. App’x 356 (3d Cir. 2003). Just like other expert opinion, it must be employed with scientific rigor. Expert “judgment” cannot be used as a rhetorical shortcut to avoid having to show the methods underlying an expert’s opinion. “[I]t is critical that an expert’s analysis be reliable at every step.” Amorgianos, 303 F.3d at 267 (emphasis added). But basing an opinion on one’s “judgment” renders the opinion “nothing more than” a euphemism for one’s own “unacceptable ipse dixit testimony.” In re Lipitor Mktg., Sales Practices & Prods. Liab. Litig., 185 F. Supp. 3d 786, 806 (D.S.C. 2016) (citing Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)); see also Alevromagiros v. Hechinger Co., 993 F.2d 417, 421 (4th Cir. 1993); Viterbo v. The Dow Chem. Co., 826 F.2d 420, 424 (5th Cir. 1987). “A witness who invokes ‘my expertise’ rather than analytic strategies widely used by specialists is not an expert as Rule 702 defines that term.” Zenith Elecs. Corp. v. WH-TV Broad. Corp., 395 F.3d 416, 419 (7th Cir. 2005); see also Tamraz v. Lincoln Elec. Co., 620 F.3d 665, 670 (6th Cir. 2010); Rutigliano v. Valley Bus. Forms, 929 F. Supp. 779, 786 (D.N.J. 1996). “[W]ithout a reliable method, result-oriented ‘judgment’ cannot be distinguished from scientifically or methodologically-based judgment.” Magistrini, 180 F. Supp. 2d at 608. Thus, even an expert’s “judgment” must be auditable. The same goes for Plaintiffs’ invocation of “weight of the evidence,” which they use as a euphemism for “judgment,” and which cannot stand in for rigorous application of a reliable methodology for inferring causation. Dr. Ducatman had no response when asked to describe his method (Ducatman Tr. at 86:1-20) (Guzelian Reb. Rpt. at 12). Thus he cannot invoke it to defend the opinions he offered previously. Nor does “weight-of-the-evidence” have a universally accepted definition. It Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 47 of 63 37 is most often employed as a regulatory standard that is inapplicable to the questions of medical or tort causation here. (See Mem. at 73-75.) (Guzelian Reb. Rpt. at 90 (quoting James et al. (2014)).) Because it has no meaning apart from what an expert gives it, the expert must set out his particular method of analysis and show that it is reliable. In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., 858 F.3d 787, 796 (3d Cir. 2017); Magistrini, 180 F. Supp. 2d at 602. Plaintiffs cite Magistrini as accepting “weight-of-the-evidence,” but here, just as in Magistrini, “the question … is not the reasonableness, in general, of undertaking a ‘weight-of-the- evidence’ analysis.” Id. at 603. Rather, Magistrini excluded the expert evidence because of application: whether the expert’s “particular method of analyzing the data,” is a reasonable means of “draw[ing] a conclusion regarding the particular matter to which the expert testimony was directly relevant.” Kumho Tire, 526 U.S. at 154. “To ensure that the ... weight of the evidence criteria is truly a methodology, rather than a mere conclusion-oriented selection process ... there must be a scientific method of weighting that is used and explained.” Zoloft, 858 F.3d at 796 (citations omitted). As a case cited by Plaintiffs explains, weight-of-the-evidence cannot be reliable unless “the expert considers all available evidence carefully and explains how the relative weight of the various pieces led to his conclusion.” In re Abilify Prods. Liab. Litig., 299 F. Supp. 3d 1291, 1311 (N.D. Fla. 2018). That is, “an expert must explain 1) how conclusions are drawn for each ... criterion and 2) how the criteria are weighed relative to one another.” Zoloft, 858 F.3d at 796. This “crucial” requirement prevents an expert from “mere[ly] listing … studies” and then “jumping to a conclusion.” Magistrini, 180 F. Supp. 2d at 602. Thus, without regard to the name assigned to an expert’s methodology, a reliable causation opinion based on epidemiological data must Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 48 of 63 38 (1) identify an association between an exposure and a disease, (2) consider a range of plausible explanations for the association, (3) rank the rival explanations according to their plausibility, (4) seek additional evidence to separate the more plausible from the less plausible explanations, (5) consider all of the relevant available evidence, and (6) integrate the evidence using professional judgment to come to a conclusion about the best explanation. Abilify, 299 F. Supp. 3d at 1311 (quotation omitted). Courts have also asked whether the expert’s “particular combination of evidence considered and weighed here has not been subjected to peer review”; how the list of cited studies was composed; and whether the expert evaluated each study’s statistical methods and internal validity, including consideration of chance, bias, and confounding. Magistrini, 180 F. Supp. 2d at 602-04. Drs. Ducatman and Grandjean do none of this. 2. Dr. Ducatman’s Medical Causation Opinion Is Not Based On A Reliable Methodology Dr. Ducatman’s causation opinion fails to employ a reliable methodology, and his attempt to repackage it as doing so is unavailing. Plaintiffs contort themselves to argue that he follows a weight-of-the-evidence methodology and that the only reason it was not initially apparent was because the right question was never posed. But even if Dr. Ducatman had invoked that method,13 assigning a name to his approach is irrelevant if it cannot be reliably applied. His causation opinion lacks any indicia of the scientific rigor required by Daubert and should be excluded. a. Dr. Ducatman Has No Discernible Methodology Dr. Ducatman’s approach amounts to an “unscientific ‘black box’ approach,” which “prevents the finder of fact, or other experts seeking to validate or check his work, from conducting a meaningful and informed review.” In re Mirena IUS Levonorgestrel-Related Prods. Lib. Litig. (No. II), 341 F. Supp. 3d 213, 249 (S.D.N.Y. 2018). None of his reports describes (1) what criteria 13 That Dr. Ducatman used a weight-of-the-evidence methodology is neither an accurate fact nor a conceded one. (Opp. at 67.) When asked to describe his method, he provided no response except to call the question “very broad.” (Ducatman Tr. at 86:1-20.) Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 49 of 63 39 he uses to include, exclude, and weigh evidence; (2) how he draws inferences as to those criteria; (3) how the criteria are weighed relative to one another; or (4) how he integrates evidence to form an opinion. Nor does he point to guidelines of any agency whose methodology he claims to follow. Lacking any objective indications that Dr. Ducatman followed a reliable methodology, Plaintiffs offer only conclusory defenses. They claim, for example, that Dr. Ducatman “has adequately explained how he chose and evaluated the studies he reviewed.” (Opp. at 67.) They do not point to or cite any portion of his report or deposition that would support that bald contention. They claim his review is “comprehensive” and based on “best in class” literature (id. at 68, 70), but do not explain what those standards mean or how Dr. Ducatman satisfies them. Nor does Dr. Ducatman describe his review as comprehensive. Rather, he says that he “ran out of gas” and he does not discuss any study in more than a sentence or two. (Ducatman Tr. at 82:17-83:13, 83:22-23.) Far from being indicative of a reliable methodology, Dr. Ducatman “sheds little light on which studies … he thought ‘had limitations,’” offering “no discussion of possible biases or confounding factors found in the studies.” Magistrini, 180 F. Supp. 2d at 604-05. b. Dr. Ducatman’s Methodological Errors Are Numerous and Pervasive Dr. Ducatman’s reports and testimony are silent as to what objective standards governed his selection, exclusion, and evaluation of the scientific literature. Instead of explaining the methodological defects that pervade his opinions (Mem. at 62-70.), Plaintiffs simply declare that these shortcomings do not exist—pointing to no portion of the record that would back up their argument. (Opp. at 69-70.) None of these flaws constitutes a minor flaw that, as Plaintiffs assert, would have no bearing on admissibility. (Opp. at 71-83.) Rather, the flaws reflect the systemic failure to employ a rigorous methodology. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 50 of 63 40 First, Dr. Ducatman’s so-called literature review lacks rigor. This observation is not, as Plaintiffs contend, a critique of any specific study he cites. (See id. at 74.) Presenting “a full picture” of the epidemiological evidence is necessary to demonstrate that an opinion is reliable. K.E. v. Glaxosmithkline LLC, 2017 WL 440242, at *10-11 (D. Conn. 2017). Absent a basis from which to evaluate whether his literature review was “thorough and comprehensive” (Ducatman Reb. Rpt. at 9; see also Opp. at 74 (citation omitted)), Dr. Ducatman’s opinion offers only “the illusion of clarity” and is not reliable. K.E., 2017 WL 440242, at *10-11. Second, Dr. Ducatman’s failure to address the results and limitations of the studies he cites exacerbates the flaws in his literature review. “In assessing causation,” it is incumbent upon researchers to “look for alternative explanations for the [reported] association,” which may include chance, bias or confounding. RMSE at 598. Thus, a reliable methodology, at minimum, considers confidence intervals, p-values, and other factors from study results that bear on that determination. Coleman v. Union Carbide Corp., 2013 WL 5461855, at *38 (S.D.W. Va. 2013). Unlike the cases cited by Plaintiffs, the issue is not a dispute regarding the limitations of a specific study. (Opp. at 76 (citing cases).) Rather, the problem is that his opinion does not address how, if at all, the results and limitations of any of his studies affected his opinion. He cannot outsource consideration of these issues to the study authors and assume that the study and its findings are valid simply because they appear in a peer-review journal. (See id. at 75.) Nor does his Merits Report provide a more “comprehensive” review than his Class Report. (Id.) The former consists solely of a generic overview of the materials he reviewed, with fewer than nine pages devoted to study findings, none of which discusses the studies in any detail. (Ducatman Merits Rpt. at 4-13.) Third, Dr. Ducatman failed to address the difficulties in extrapolating from findings in experimental animals to humans. Notably, each of the cases cited by Plaintiffs recognized the Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 51 of 63 41 inherent challenges of using animal studies and caution against such uncritical extrapolation. Accord K.E., 2017 WL440242, at *11-12; Drake v. Allergan, Inc., 2014 WL 5392995, at *8 (D. Vt. 2014); In re Foxamax Prod. Liab. Litig., 645 F. Supp. 2d 164, 186-87 (S.D.N.Y. 2009). “[I]n the absence of a scientific explanation of why such extrapolation is warranted,” it is “generally not considered reliable.” Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387, 1410 (D. Or. 1996). Dr. Ducatman offers no such explanation, though he admits that species, and even strains within a species, can vary in their “metabolic rates, anatomy, cellular or biochemistry and in the absorption, distribution, metabolism and elimination of chemicals.” (Ducatman Tr. 32:25-33:17.) Fourth, Dr. Ducatman formed his causation opinion without any consideration of the Bradford-Hill criteria, which Plaintiffs do not dispute comprise the gold standard framework for inferring causation. See In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices & Prod. Liab. Litig., 892 F.3d 624, 638 (4th Cir. 2018); McMunn v. Babcock & Wilcox Power Generation Grp., Inc., 2013 WL 3487560, at *14 & n.18 (W.D. Pa. 2013).14 The issue here is not the application or relevance of any specific factor; rather, it is Dr. Ducatman’s failure to engage in a “searching analysis … of why a factor or factors may be absent despite a causal relationship.” RMSE at 600. He ignores the Bradford-Hill criteria in forming his opinions in his class certification and merits reports and did not even mention them until rebuttal, only after being asked about them at his deposition. (Ducatman Reb. Rpt. at 15.) That he purported to change the “underpinnings” of his causation opinion “in direct response” to litigation scrutiny shows it to be a “veritable moving target.” Haller, 598 F. Supp. 2d at 1296-97; Miller, 356 F.3d at 1330; Glastetter, 107 F. Supp. 2d 14 See also e.g., Mallozzi v. EcoSMART Techs., Inc., 2013 WL 2415677, at *5 (E.D.N.Y. 2013); Frischhertz v. SmithKline Beecham Corp., 2012 WL 6697124, at *3 (E.D. La. 2012); In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164, 187 (S.D.N.Y. 2009); Dunn v. Sandoz Pharm. Corp., 275 F. Supp. 2d 672, 678-80 (M.D.N.C. 2003); Magistrini, 180 F. Supp. 2d at 592-93. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 52 of 63 42 at 1032. Dr. Ducatman’s perfunctory attempt to retrofit the Bradford-Hill criteria into an opinion he already formed still fails to even refer to most of the factors—including a consideration of alternative explanations. (Ducatman Reb. Rpt. at 9, 15); RMSE at 600. c. Dr. Ducatman’s Dose Threshold Is Arbitrary Dr. Ducatman’s purported “above-background” dose threshold of 2.1 µg/L is unreliable. That threshold is not itself a “background” level of PFOA, but rather a national measure of the average amount of PFOA in Americans’ blood. “[E]quating ‘unusual’ or ‘abnormal’ with ‘above- average’ is not a scientifically valid methodology because it does not take into account the normal distribution of data within a given population.” Adams v. Cooper Indus., Inc., 2007 WL 1805586, at *4 (E.D. Ky. 2007) (citation omitted).15 The reliability of Dr. Ducatman’s dose threshold is further belied by the use of a one-time average of nationwide exposure, which is not specifically tied to evidence of actual background exposures in the Bennington area.16 His dose threshold of 2.1 μg/L was the approximate nationwide average in 2011-12, but ten years earlier it was 5.21 μg/L in 1999-2000. (Ducatman Tr. at 102:22-103:21; Ducatman Tr. Ex. 10.) Thus, in addition to the total lack of support for the claim that 2.1 μg/L causes an increased risk for any endpoint he seeks to monitor, he offers no basis for tying his dose threshold to the average exposure in 2011-12. (Opp. at 81.) “[S]cientific knowledge of the harmful level of exposure to a chemical plus knowledge that plaintiff was 15 Plaintiffs’ attempt to distinguish Adams falls short. Not only do they not address the legal principle in Adams, but their attempt to distinguish the flawed statistical analysis in Adams from their own undermines the admissibility of Dr. Ducatman’s opinion. Plaintiffs argue that Dr. Ducatman’s medical monitoring opinions involve a “compari[son of] the mean of an exposed population to the mean for a control population to test for the differences across the groups.” (Opp. at 83.) Yet “averages or community-wide estimations of exposure” create Daubert fit problems. (See Mem. at 18-19.) Further, Plaintiffs’ argument is inconsistent with their argument that “Dr. Ducatman has not relied on any such averages or estimations.” (Opp. at 17.) 16 Plaintiffs do not disclose that the Gates court’s endorsement of an “average” exposure was premised on regional data, not nationwide data. See 265 F.R.D. at 211 n.2. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 53 of 63 43 exposed to such quantities are minimal facts necessary to sustain the plaintiff’s burden.” McClain, 401 F.3d at 1241 (quoting Allen v. Pennsylvania Eng’g Corp., 102 F.3d 194, 199 (5th Cir. 1996)) (emphasis added).17 Instead, under this threshold based on a national average, half of the United States population would be candidates for monitoring. That line is drawn by litigation, not science. Plaintiffs primarily rely on Gates, 265 F.R.D. 208, to contend that Dr. Ducatman appropriately employed an average blood level as the measure of increased risk. But Gates in no way endorses average serum levels as a reliable cut-point for this purpose. Rather, the Gates court—which denied class certification and was affirmed by the Third Circuit—only found that an average could satisfy an element of Pennsylvania’s medical monitoring claim: whether an individual has been “expos[ed to] greater than normal background levels.” Id. at 220-25. Gates further noted that plaintiffs would need to establish that such exposure “caused each individual plaintiff to have a significantly increased risk of contracting serious latent disease[].” Id. at 226 (internal quotation omitted) (alteration in original). The court cautioned against using a cut-point that did not follow from “an appropriate methodology for calculating a ‘danger point’ for purposes of a medical monitoring claim.”18 Id. Dr. Ducatman has no such methodology here. 3. Dr. Grandjean’s Medical Causation Opinions Are Unreliable a. Dr. Grandjean’s “Weight of the Evidence” Methodology Is Inapposite and Unreliable Dr. Grandjean’s weight of the evidence methodology is inapposite because it is used for regulatory matters, which follow a lesser standard for proof of causal relationships than tort 17 Plaintiffs attempt to distinguish McClain on the ground that the expert there “offered no testimony about the dose of Metabolife required to injure the plaintiffs or anyone else.” (Opp. at 82.) There is no functional difference, however, between the McClain expert’s failure to select a dose threshold and Dr. Ducatman’s selection of a threshold without any reliable basis. 18 Neither Plaintiffs nor their experts can point to any major medical organization’s endorsement of any cut-point for recommending medical monitoring for PFOA exposure, much less Dr. Ducatman’s use of average background levels. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 54 of 63 44 requires. (See Mem. at 73-75.) Although Plaintiffs concede that “[t]his is a case … not [about] the carrying out of a regulatory risk assessment for purposes of public health” (Opp. at 86), Dr. Grandjean bases his opinion on “weight-of-evidence procedures applied by regulatory agencies and international organizations.” (Grandjean Rpt. at 4-5; see also id. at 18-19, 63-64, 70; Grandjean Tr. at 85:2-19.) Because of the “protection function” and “generalized goals” that regulatory risk assessments serve, they have “limited utility” in tort law. Rhodes, 253 F.R.D. at 377-78. This is because they employ a “threshold of proof [that] is reasonably lower than that appropriate in tort law” and do not “traditionally make [the] more particularized inquiries into cause and effect” that tort law requires. Allen, 102 F.3d at 198. While Plaintiffs say Dr. Grandjean “was not offering his causal opinion for purposes other than to establish increased risk amongst members of the putative Exposure Class” (Opp. at 86), they cannot explain how that distinguishes one approach from the other. Neither can Dr. Grandjean. (See Grandjean Tr. at 71:17-22.) Like Dr. Ducatman, Dr. Grandjean’s “weight of the evidence” analysis is subjective and untestable. His failure to meaningfully define and describe a specific method he followed for weighting, weighing, and integrating evidence renders his causation opinion unreliable. While claiming Saint-Gobain’s illustrations of his methodological failures are unrepresentative, Plaintiffs do not identify any testimony or report citations to rebut these errors. (Opp. at 87.) They refer to Dr. Grandjean’s “approximate 35-page weight of the evidence analysis” and “section devoted to ‘Methodological Aspects’” (id.), but do not cite what part of that section sets out his methodology. This is because it is not there. Nowhere does Dr. Grandjean systematically weigh and integrate the characteristics of the studies he cites. (See Grandjean Tr. at 87:17-23.) He applies subjective, qualitative weight to evidence but offers no explanation for how this approach should fit the quantitative attributes— Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 55 of 63 45 like statistical significance, power, and relative risk—that he purports to weigh. (See id. at 89:8- 13.) He does not “rigorously explain how [he has] weighted the criteria,” and thus offers nothing more than an “unscientific ‘black box’ approach.” Mirena IUS, 341 F. Supp. 3d at 247, 249. b. Dr. Grandjean Commits Numerous Methodological Errors Dr. Grandjean’s opinion also suffers from other methodological flaws. (See Mem. at 77- 85.) Like Dr. Ducatman, Dr. Grandjean’s opinion fails to justify the use of 2.1 μg/L blood level threshold. See supra Section II.A.2.c. Plaintiffs argue that Dr. Ducatman—not Dr. Grandjean— “select[ed]” 2.1 μg/L as the dose threshold (Opp. at 88), making no effort to defend Dr. Grandjean’s endorsement and integration of that standard into his opinion. This failure to lay a “reliable groundwork for determining the dose-response relationship” “signals a methodology” problem, McClain, 401 F.3d at 1241, and Dr. Grandjean’s opinion therefore fails. Similarly, Dr. Grandjean’s opinion does not reflect a systematic, critical evaluation and discussion of the scientific literature. While Plaintiffs contend that he “‘cited the most relevant studies’” and avoided “‘studies of less validity or less strength,’” they do not identify the criteria by which he searched for and then determined which studies were most relevant, less valid, or less strong. (Opp. at 87 (quoting Grandjean Rpt. at 27)). Then, drawing on the adage of quantity over quality, they note that Dr. Grandjean cited “almost 300 published studies” (Opp. at 87), omitting that “the annual number of publications on the PFASs now exceeds 400.” (Grandjean Rpt. at 16.) In addition, as with Dr. Ducatman, Plaintiffs fail to redeem Dr. Grandjean’s lack of a reliable framework for inferring causation. Plaintiffs contend that he did consider the Bradford- Hill factors to infer causation, thereby shifting the blame to Saint-Gobain’s purported failure to ask the right questions about the absence of any reference to those criteria in his 115-page report or deposition. (Opp. at 88.) In so doing, they do not argue the details of how the Bradford-Hill factors featured in his analysis, but refer generally to a forty-page span in his report. (Id.) In fact, Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 56 of 63 46 this cited span of his report contains no discussion of how he infers causation from the statistical associations (or lack thereof) reported in the various studies he happened to cite. (Grandjean Rpt. at 24-62.) The three pages under the heading of “Weight of the evidence and Sir Austin’s ‘criteria’” do not so much affirmatively lay out his framework for inferring causation as they trade in ad hominem attacks on Saint-Gobain’s experts. (Id. at 24-26.) The absence of a methodology for inferring causation is compounded by Dr. Grandjean’s mistaken understanding that the standard governing this case is merely whether “PFOA is associated with the particular outcomes.” (Grandjean Tr. at 101:18-102:11.) His causation opinion is unreliable and inadmissible. B. Plaintiffs’ Experts Regulatory Opinions Are Unhelpful And Inadmissible 1. Dr. Hopke’s “Merits” Opinion Is Inadmissible (See Hopke Merits Rpt. at 6.) Plaintiffs attempt to defend this inadmissible legal opinion as “in the nature of state of the art and state of the knowledge opinions that are commonly admitted through expert testimony.” (Opp. at 90.) Yet Plaintiffs fail to explain how his speculation on what Chemfab “knew or should have known” is anything other than legal conclusion unrelated to any technical opinion he might have otherwise offered. What Chemfab “knew or should have known” is a question for the factfinder, not a technical expert. See Milanowicz v. The Raymond Corp., 148 F. Supp. 2d 525, 535 (D.N.J. 2001). Likewise, Dr. Hopke’s opinion about whether it would be reasonable for a company working with perfluorinated compounds to consider potential PFOA emissions is unreliable guesswork with no technical basis, offered by a career-long academic who has never been employed by a company working with perfluorinated compounds. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 57 of 63 47 Plaintiffs also attempt to connect Dr. Hopke’s legal opinions on Saint Gobain’s alleged regulatory violations to “increased air emissions in general and increased emissions of PFOA specifically.” (Opp. at 92-93.) (Hopke Merits Rpt. at 4.) Nowhere does he offer a technical opinion regarding those alleged emissions. Instead, Plaintiffs use him as a mouthpiece for a legal argument he has no right to offer. See Hiramoto v. Goddard Coll. Corp., 184 F. Supp. 3d 84, 97 (D. Vt. 2016), aff’d, 684 F. App’x 48 (2d Cir. 2017); Densberger v. United Techs. Corp., 297 F.3d 66, 74 (2d Cir. 2002). 2. Dr. Siegel’s “Merits” Opinion Is Inadmissible Plaintiffs claim, without explanation, that Dr. Siegel has the “appropriate experience” to opine on the state of mind of Chemfab/Saint-Gobain. (Opp. at 90-91.) Initially, Dr. Siegel never worked for Chemfab or Saint-Gobain (Mem. at 86; Siegel Tr. at 174:10-14), or for DuPont, whose internal documents he characterizes. (Mem. at 88; Siegel Tr. at 174:15-16, 189:13-193:18). He does not even have a basis to believe that these documents were ever sent to Chemfab. (Mem. at 88; Siegel Tr. at 196:1-197:5.) But even if Dr. Siegel did have “appropriate experience,” he does not employ any methodology for determining what a company knew or should have known about whether its air emissions of PFOA would result in alleged groundwater contamination. See Milanowicz, 148 F. Supp. 2d at 535. Instead, he submits an admittedly speculative opinion regarding Chemfab/Saint-Gobain’s knowledge. (Siegel Tr. 205:5-9.) It is inadmissible. 3. Mr. Mears’s Opinions Are Unhelpful and Unreliable Plaintiffs’ opposition confirms that Mr. Mears’s opinion seeks to impose liability based on purported regulatory violations unrelated to their claims. Plaintiffs expressly proffer their regulatory experts’ opinions “to prove that Defendant’s entire history of operations in Vermont Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 58 of 63 48 reflected its failure to use due care.” (Opp. at 93 (emphasis added).) Lacking any evidence that the purported violations caused or contributed to PFOA emissions, Plaintiffs instead argue that expert testimony regarding such violations should be admitted to show Saint-Gobain’s supposed “disregard” for its neighbors and “willingness” to violate Vermont law. (Id.)19 Plaintiffs cite no authority in support of these arguments, which other courts have squarely rejected. See Covic v. Berk, 2014 WL 3510502 (W.D. Tenn. 2014); Langenbau v. Med-trans Corp., 167 F. Supp. 3d 983 (N.D. Iowa 2016). And Plaintiffs’ cursory attempt to distinguish these cases is without merit. (Opp. at 92 n. 47.) In Covic, the plaintiff’s expert opined that a trucking company’s history of unrelated safety violations “‘calls into question [the company’s] overall driver management controls and the company’s commitment to ensuring their driver workforce operated safely and that they were fully qualified to drive.’” 2014 WL 3510502, at *5. Rephrased in Plaintiffs’ terms here, the Covic expert opined that the trucking company’s “history of operations” showed its “disregard” for highway safety and “willingness” to employ unqualified drivers. (Cf. Opp. at 93.) Covic rejected this argument and excluded the expert’s opinions as an improper attempt to impugn the company’s character. See 2014 WL 3510502, at *5. Likewise, the Langenbau court rejected the plaintiffs’ attempt to “‘bootstrap’” expert opinions regarding unrelated safety violations “into a broader criticism of [the defendant’s] ‘practices’ and ‘attitude.’” 167 F. Supp. 3d at 1002 (citations omitted). Similar to Plaintiffs here, the Langenbau plaintiffs argued that unrelated violations were relevant to show that the defendant 19 Plaintiffs do not address the fact that Mr. Mears’s opinion that Chemfab’s emission testing should have included PFOA is based on a 1993 amendment to Vermont law after the testing in question was already completed to the regulators’ satisfaction. See 1993 Vt. Legis. Serv. No. 92, at 1 (West). Mr. Mears’s opinion is inadmissible because it offers “a legal conclusion” and is “‘phrased in terms of inadequately explored legal criteria.’” Hygh v. Jacobs, 961 F.2d 359, 363- 64 (2d Cir. 1992) (citation omitted). Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 59 of 63 49 “disregarded the standard of care.” Id. The court correctly excluded the expert’s testimony, as calling for “a liability verdict improperly based on an emotional response to essentially unrelated misconduct that was irrelevant to the crash.” Id. at 1003. The same result is warranted here. Moreover, the law precludes experts from interpreting regulations and opining about violations even where related to the plaintiff’s claims. See, e.g., Contini by Contini v. Hyundai Motor Co., 876 F. Supp. 540, 545 (S.D.N.Y. 1995); Langenbau, 167 F. Supp. 3d at 1004. Plaintiffs’ response attempts to distinguish these authorities by arguing that the present case is “not a regulatory enforcement proceeding.” (Opp. at 93.) Neither were Contini or Langenbau. In Contini, the plaintiffs asserted state law tort claims against the defendant auto manufacturer. 876 F. Supp. at 541. In support of those claims, the plaintiffs proffered expert testimony that the defendant’s seat belt design violated federal safety standards. See id. Unlike here, the safety standards at issue in Contini related directly to the alleged mechanism of injury, namely, the seatbelt’s “pelvic restraint” performance. Id. Thus, the court held that “experts will be permitted to give limited background information about [the federal safety standard].” Id. at 545. However, Contini did not—as Plaintiffs contend—permit the experts “to testify regarding whether regulatory standard satisfied.” (Opp. at 94.) To the contrary, Contini held the experts could not opine “about whether the seat belt complied with or violated the standard.” 876 F. Supp. at 545. Likewise, the Langenbau plaintiffs asserted “negligence claims” and proffered regulatory experts’ opinions in support. 167 F. Supp. 3d at 987. Plaintiffs say Langenbau is distinguishable because the experts there offered opinions regarding unrelated “maintenance violations.” (Opp. at 92 n.47.) As discussed above, Mr. Mears’s regulatory opinions are equally unrelated to Plaintiffs’ claims in this case. Moreover, Plaintiffs overlook the Langenbau court’s separate holding that excluded expert opinion testimony regarding non-maintenance-related regulatory violations. See Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 60 of 63 50 167 F. Supp. 3d at 1004-05. The Langenbau court excluded this testimony not because the asserted violations were unrelated, but because “‘[t]he law is clear that experts may not opine as to whether or not a party violated a given regulation.’” Id. at 1004 (citation omitted). Plaintiffs cite no support for their position that a tort plaintiff’s expert may opine that a defendant’s conduct violated a regulation. The decision in In re Actos (Pioglitazone) Prod. Liab. Litig. is inapposite because the plaintiffs there did not allege, and their expert did not opine, that “there was a violation of FDA regulations.” 2014 WL 120973, *12 (W.D. La. 2014). In contrast, Mr. Mears opines that “CHEMFAB/SAINT-GOBAIN VIOLATED VERMONT AIR POLLUTION CONTROL PERMITS AND REGULATIONS.” (Mears Reb. Rpt. at 4.) Plaintiffs also cite various authorities for the proposition that “violation of a safety statute is admissible evidence of negligence.”20 (Opp. at 92.) However, none of these cases addresses the admissibility of expert testimony, and none supports Plaintiffs’ position that their regulatory experts may opine that “violations” occurred. Instead, these cases address the doctrine of “prima facie negligence,” which has no bearing on the present motion. Moreover, under the prima facie negligence doctrine, “the statute or regulation must have been intended to protect the class of persons to which the plaintiff belongs against the particular hazard and harm that resulted.” Sheldon v. Ruggiero, 2018 VT 125, ¶ 24 (Vt. Nov. 9, 2018) (emphasis added). Here, there is no meaningful connection between the purported regulatory violations and Plaintiffs’ alleged harm. CONCLUSION For the foregoing reasons and those set forth in Saint-Gobain’s opening brief, the Court should exclude Plaintiffs’ expert testimony. 20 (Opp. at 94 (citing Ziniti v. New England Central Railroad, Inc., 2019 VT 9, ¶ 33 (2019); Bacon v. Lascelles, 165 Vt. 214, 222 (1996); Ball v. Melsur Corp., 161 Vt. 35 (1993); Duncan v. Wescott, 142 Vt. 471, 474 (1983); Landry v. Hubert, 101 Vt. 111 (1928)).) Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 61 of 63 51 Dated: March 25, 2019 Respectfully submitted, /s/ R. Bradford Fawley R. Bradford Fawley DOWNS RACHLIN MARTIN PLLC 28 Vernon Street, Suite 501 Brattleboro, VT 05301-3668 Telephone: (802) 258-3070 Facsimile: (802) 258-4875 bfawley@drm.com Sheila L. Birnbaum (pro hac vice) Mark S. Cheffo (pro hac vice) Douglas Fleming (pro hac vice) Bert L. Wolff (pro hac vice) Lincoln Davis Wilson (pro hac vice) DECHERT LLP Three Bryant Park 1095 Sixth Avenue New York, NY 10036 Tel: (212) 698-3500 Fax: (212) 698-3599 sheila.birnbaum@dechert.com mark.cheffo@dechert.com douglas.fleming@dechert.com bert.wolff@dechert.com lincoln.wilson@dechert.com Attorneys for Saint-Gobain Performance Plastics Corp. Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 62 of 63 52 CERTIFICATE OF SERVICE I hereby certify that, on March 25, 2019, I served the foregoing REPLY IN FURTHER SUPPORT OF SAINT-GOBAIN’S MOTION TO EXCLUDE PLAINTIFFS’ EXPERT TESTIMONY on the following counsel by electronic case filing: Gary A. Davis James S. Whitlock DAVIS & WHITLOCK, P.C. 21 Battery Park Ave., Suite 206 Asheville, NC 28801 Telephone: (828) 622-0044 Facsimile: (828) 398-0435 jwhitlock@enviroattorney.com gadavis@enviroattorney.com Emily J. Joselson, Esq. James W. Swift, Esq. LANGROCK SPERRY & WOOL, L.L.P. P.O. Drawer 351 Middlebury, VT 05753 Telephone: (802) 388-6356 Facsimile: (802) 388-6149 ejoselson@langrock.com jswift@langrock.com David F. Silver, Esq. BARR STERNBERG MOSS SILVER & MUNSON, P.C. 507 Main Street Bennington, VT 05201 Telephone: (802) 442-6341 Facsimile: (802) 442-1151 dsilver@barrsternberg.com DATED: March 25, 2019 /s/ R. Bradford Fawley R. Bradford Fawley Case 5:16-cv-00125-gwc Document 261 Filed 03/25/19 Page 63 of 63