Parks et al v. Ethicon, Inc. et al, No. 3:2020cv00989 - Document 199 (S.D. Cal. 2022)

Court Description: ORDER Granting In Part And Denying In Part Reserved Daubert Issues [ECF Nos. 178 , 179 ]. Signed by Judge Linda Lopez on 6/2/2022.(ddf)

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Parks et al v. Ethicon, Inc. et al Doc. 199 Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2062 Page 1 of 19 1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 SOUTHERN DISTRICT OF CALIFORNIA 10 11 DONNA PARKS, Plaintiff, 12 13 v. 14 ETHICON, INC.; JOHNSON & JOHNSON, 15 Case No.: 20cv989-LL-RBB ORDER GRANTING IN PART AND DENYING IN PART RESERVED DAUBERT ISSUES [ECF Nos. 178, 179] Defendants. 16 17 18 Before the Court are Defendants’ fully briefed Motion to Exclude certain expert 19 opinions of Donald Ostergard, M.D., Dionysios K. Veronikis, M.D., and Scott Guelcher, 20 Ph.D. [ECF Nos. 178, 184, 186] and Plaintiff’s fully briefed Motion to Exclude certain 21 expert opinions of Peter Rosenblatt, M.D., Robert Rogers, M.D., Edward Stanford, M.D., 22 Douglas Grier, M.D., Shelby Thames, M.D., and Timothy Ulatowski [ECF Nos. 179, 183]. 23 For the reasons stated below, the Court GRANTS IN PART and DENIES IN PART the 24 Motions to Exclude. 25 I. BACKGROUND 26 Plaintiff filed this lawsuit in 2014 as part of a large multidistrict litigation (“MDL”) 27 action before the Honorable Joseph R. Goodwin in the Southern District of West Virginia 28 asserting medical products liability. ECF No. 1; In re Ethicon, Inc. Pelvic Repair System 1 20cv989-LL-RBB Dockets.Justia.com Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2063 Page 2 of 19 1 Products Liability Litigation, MDL No. 2327 (S.D. W. Va.). The action stems from the 2 surgical implantation of Defendants’ pelvic mesh product Gynemesh/Gynemesh PS in 3 January 2010. ECF No. 1 at 3–4; ECF No. 56-1. Plaintiff alleges the following causes of 4 action: (1) negligence, (2) strict liability – manufacturing defect, (3) strict liability – failure 5 to warn, (4) strict liability – defective product, (5) strict liability – design defect, 6 (6) common law fraud, (7) fraudulent concealment, (8) negligent misrepresentation, 7 (9) breach of express warranty, (10) breach of implied warranty, (11) violation of consumer 8 protection laws, (12) loss of consortium, (13) punitive damages, and (14) discovery rule 9 and tolling. ECF No. 1 at 4–5. On October 16, 2020, the Court granted Defendants’ motion 10 for summary judgment as to the following causes of action in their entirety: (1) strict 11 liability – manufacturing defect, (2) strict liability – defective product, (3) strict liability – 12 design defect, (4) loss of consortium, (5) breach of express warranty, and (6) breach of 13 implied warranty. ECF No. 109 at 11–12, 18–19. 14 The MDL court ruled on certain motions challenging expert opinions under Federal 15 Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), 16 but reserved some arguments for resolution by the trial court. ECF No. 120 at 2–3, 7. 17 On May 28, 2020, the MDL court transferred this matter back to this district for trial. 18 ECF No. 55 at 2. On January 5, 2022, this matter was transferred to the undersigned. 19 ECF No. 182. 20 II. LEGAL STANDARD 21 Federal Rule of Evidence 702 permits experts qualified by “knowledge, skill, 22 experience, training, or education” to testify “in the form of an opinion or otherwise” based 23 on “scientific, technical, or other specialized knowledge” if that knowledge will “help the 24 trier of fact to understand the evidence or to determine a fact in issue.” Fed. R. Evid. 702. 25 The expert’s testimony must be “based on sufficient facts or data,” “the product of reliable 26 principles and methods,” and the expert must have “reliably applied the principles and 27 methods to the facts of the case.” Id. 28 2 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2064 Page 3 of 19 1 Rule 702 “contemplates a broad conception of expert qualifications.” Hangarter v. 2 Provident Life & Accident Ins. Co., 373 F.3d 998, 1015 (9th Cir. 2004) (quoting Thomas 3 v. Newton Int’l Enterprises., 42 F.3d 1266, 1269 (9th Cir. 1994)). “Shaky but admissible 4 evidence is to be attacked by cross examination, contrary evidence, and attention to the 5 burden of proof, not exclusion.” Primiano v. Cook, 598 F.3d 558, 564 (9th Cir. 2010) 6 (citation omitted). The proponent of the expert bears the burden of establishing 7 admissibility by a preponderance of the evidence. Daubert v. Merrell Dow Pharms., Inc., 8 509 U.S. 579, 592 & n.10 (1993) [hereinafter Daubert I]. 9 “[T]he district judge must ensure that all admitted expert testimony is both relevant 10 and reliable.” Wendell v. GlaxoSmithKline LLC, 858 F.3d 1227, 1232 (9th Cir. 2017). “The 11 focus of the district court’s analysis ‘must be solely on principles and methodology, not on 12 the conclusions that they generate,’” and “the court’s ‘task . . . is to analyze not what the 13 experts say, but what basis they have for saying it.’” Id. (quoting Daubert I, 509 U.S. 14 at 595; Daubert v. Merrell Dow Pharms., Inc., 43 F.3d 1311, 1316 (9th Cir. 1995) 15 [hereinafter Daubert II]). Courts also consider “whether experts are testifying ‘about 16 matters growing naturally’ out of their own independent research, or if ‘they have 17 developed their opinions expressly for purposes of testifying.’” Id. (quoting Daubert II, 18 43 F.3d at 1317). 19 “These factors are illustrative, and they are not all applicable in each case.” Id. (citing 20 Daubert II, 43 F.3d at 1317). “The inquiry is flexible, . . . and Rule 702 should be applied 21 with a liberal thrust favoring admission.” Id. (citations and internal quotation marks 22 omitted). “Daubert’s list of specific factors neither necessarily nor exclusively applies to 23 all experts or in every case. Rather the law grants a district court the same broad latitude 24 when it decides how to determine reliability as [the court] enjoys in respect to its ultimate 25 reliability determination.” Kumho Tire Co. v. Carmichael, 526 U.S. 137, 141–42 (1999). 26 /// 27 /// 28 /// 3 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2065 Page 4 of 19 1 2 3 4 5 III. DISCUSSION Defendants and Plaintiff seek resolution of their challenges to certain expert opinions that were reserved by the MDL court for the trial court to decide. A. Plaintiff’s Experts 1. Donald Ostergard, M.D. 6 Defendants seek to exclude the following opinions of Donald Ostergard, M.D.: 7 (1) testimony on FDA regulatory requirements and whether Defendants’ warning labels 8 satisfied those requirements, and (2) testimony on the adequacy of the warning 9 accompanying Defendants’ Gynemesh PS mesh product’s Instructions for Use (“IFU”). 10 ECF No. 178 at 6–8. Plaintiff does not oppose and states that “[c]onsistent with prior 11 rulings by the MDL Court and the vast majority of transferee courts addressing this specific 12 issue, Plaintiff agrees to withdraw any of Dr. Ostergard’s opinions as to whether the 13 Gynemesh PS IFU warnings were adequate (either legally or for regulatory purposes) but 14 asserts that Dr. Ostergard, as an experienced urogynecologist, can testify about the specific 15 risks of implanting the Gynemesh PS and opine about risks that are obvious to pelvic mesh 16 surgeons and may testify as to knowledge common within the medical community.” 17 ECF No. 184 at 2. In its reply, Defendants “agree[] that this is the appropriate standard to 18 apply to each side’s experts.” ECF No. 186 at 2. Because Plaintiff does not oppose, the 19 Court GRANTS Defendants’ Motion to Exclude certain testimony of Dr. Ostergard. 20 21 2. Dionysios Veronikis, M.D. Defendants seek to exclude the following opinions of Dionysios Veronikis, M.D.: 22 (1) testimony about safer alternative designs and (2) testimony about the adequacy of the 23 warnings in the IFU for the Gynemesh PS. ECF No. 178 at 8, 11–12. 24 a. Adequacy of Warnings in the IFU 25 Plaintiff “agrees to withdraw any of Dr. Veronikis’s opinions as to whether the 26 Gynemesh IFU warnings were adequate (either legally or for regulatory purposes) but 27 asserts that Dr. Veronikis, as an experienced urogynecologist, can testify about the specific 28 risks of implanting Gynemesh PS and opine about risks that are obvious to pelvic mesh 4 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2066 Page 5 of 19 1 surgeons and may testify as to knowledge common within the medical community.” 2 ECF No. 184 at 8. Because Plaintiff does not oppose Defendants’ Motion to Exclude 3 Dr. Veronikis’s testimony about the adequacy of the warnings in the IFU for the Gynemesh 4 PS, the Court GRANTS this portion of Defendants’ Motion. 5 b. Safer Alternative Designs 6 In his expert report, Dr. Veronikis opines that “[d]espite having safer, equally as 7 effective, alternative materials Ethicon used the polypropylene mesh that is known to 8 contract and degrade in the human body.” ECF No. 60-1 at 53. He includes a footnote after 9 the word “materials” that includes quotations from several internal Ethicon emails 10 discussing products called “PVDF” and “Pronova” “as a more stable filament” than 11 polypropylene. ECF No. 60-1 at 53 n.22, 67–68. The full footnote is as follows: 12 HMESH_ETH_02860031 (7/06/07 internal e-mail from Ethicon Research Fellow regarding prior “dog” study) – "I recall the long-term dog study did show some ‘fibrillation’ of PROLENE suture where none was observed for PRONOVA suture. My polymer colleagues tell me that PP has the potential to do this because of its molecular structure."); ETH.MESH.00857704 (2/12/09 internal e-mail regarding development of potential new mesh product constructed of PVDF “Pronova”) – “I think we have multiple advantages over +M like:…If we use PRONOVA a more elastic fiber which show less degradation than PP. Better, longer function of Implant.”); HMESH_ETH_00228962 (2/17/10 internal e-mail chain discussing polypropylene literature) – "[W]e know from literature that polyester and even polypropylene tend to alter over time in the body…. [H]ow has the general surgery group responded to this [degradation literature]?...[W]e proposed for several new product developments...to use PVDF or PRONOVA as a more stable filament, however Senior Management decided to go ahead with PP as a standard." (HMESH_ETH_00228961)). 13 14 15 16 17 18 19 20 21 22 23 Id. 24 Dr. Veronikis is a urogynecologist with board certifications in Female Pelvic 25 Medicine and Reconstructive Surgery as well Obstetrics and Gynecology. ECF No. 60-1 26 at 10. He has been the Chief of Gynecology and Director of Vaginal Reconstructive 27 Surgery and Urogynecology at St. John’s Mercy Medical Center in St. Louis, Missouri 28 from 1997 to at least the time of his expert report in 2016. Id. at 11, 25. Since 1994, 5 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2067 Page 6 of 19 1 Dr. Veronikis’s surgical practice has focused exclusively on vaginal reconstructive surgery 2 and urogynecology with over 600 cases annually. Id. at 12. He has performed nearly 10,000 3 vaginal reconstructive surgeries for incontinence and pelvic organ prolapse and implanted 4 thousands of mesh products. Id. 5 Defendants contend that Dr. Veronikis’s opinion regarding safer alternative designs 6 should be excluded because it is unreliable, irrelevant, and not helpful to the jury. ECF 7 No. 178 at 11. Defendants argue that Dr. Veronikis’s opinion is unreliable because he does 8 not base this opinion on his experience with the alternative material, but instead on 9 “nothing more than internal company documents he saw during his preparation for this 10 case.” Id. at 9. Defendants argue that this opinion is also irrelevant and not helpful to the 11 jury because Dr. Veronikis fails to demonstrate that Pronova was available or feasible. Id. 12 at 9–10. Defendants state that Pronova “is a suture indicated for use in general soft tissue 13 approximation or ligation, including cardiovascular, ophthalmic and neurological surgery 14 and was cleared by the FDA only for those uses” and argue that its lack of FDA approval 15 for other uses renders it not feasible as an alternative design. Id. at 10. 16 Plaintiff argues that Dr. Veronikis’s opinion regarding Pronova as a safer alternative 17 design than Gynemesh PS is reliable because it is based primarily on his own experience 18 as well as four internal Ethicon documents. ECF No. 184 at 5. Plaintiff states that Dr. 19 Veronikis has extensive knowledge of the properties of a safer mesh based on his extensive 20 experience in using mesh implants to treat pelvic organ prolapse and treating women 21 suffering from complications of mesh implants, including the removal of hundreds of 22 transvaginal mesh products. Id. at 6. Plaintiff also states that Dr. Veronikis cites journal 23 articles that discuss which properties of mesh make a safer mesh. Id. Plaintiff further 24 contends that Dr. Veronikis need not have used the alternative design material himself to 25 have the requisite experience to support a safer alternative design opinion. Id. at 5. 26 The Court finds Plaintiff has met her burden to show Dr. Veronikis’s alternative 27 design opinions are admissible. A transferee court in the Central District of California faced 28 similar arguments regarding Dr. Veronikis and denied the motion to exclude his alternative 6 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2068 Page 7 of 19 1 design opinions, finding that it is appropriate for Dr. Veronikis to use Defendants’ internal 2 documents to show that other, safer designs were feasible and that Defendants’ arguments 3 are a basis for cross-examination rather than exclusion. ECF No. 183-2 at 4, 6; Acosta v. 4 Ethicon, Inc., No. 20cv5992-DSF-GJS, at 3, 5 (C.D. Cal. Dec. 13, 2021) (order regarding 5 Daubert motions). This Court agrees with the Central District of California court. In his 6 expert report, Dr. Veronikis opines—with references to Defendants’ internal documents, 7 other studies, or his own observations—that certain properties of polypropylene mesh can 8 create problems and that Defendants at one point proposed “to use PVDF or PRONOVA 9 as a more stable filament.” ECF No. 60-1 at 40–42, 52–55. Dr. Veronikis’s experience and 10 his reference to Defendants’ internal documents are sufficient to show his opinions on 11 alternative designs are reliable. He does not need to have personal experience with the 12 alternative design. See Ramirez v. ITW Food Equip. Grp., LLC, 686 F. App'x 435, 440 13 (9th Cir. 2017) (“Given that a plaintiff need not show an alternative, safer design is already 14 used in similar products, it follows that her expert is not required to have experience with 15 that safer design in such products.”). Dr. Veronikis’s opinions are also relevant because the 16 material he references discuss using Pronova as the material to make up a mesh rather than 17 Pronova sutures as an alternative procedure. ECF No. 60-1 at 62–63 (n.4), 67–68 (n.22). 18 The Court is also not persuaded by Defendants’ arguments regarding feasibility and 19 FDA approval. In this situation, disputes over feasibility go to weight, rather than 20 admissibility of the opinions. See Ramirez v. ITW Food Equip. Grp., LLC, 686 F. App'x 21 435, 438 (9th Cir. 2017) (“[T]he feasibility of alternative safety devices is irrelevant under 22 the consumer-expectations test and, under the risk-benefit test, the defendant bears the 23 burden to prove the lack of feasible safety devices.” (citing Chavez v. Glock, Inc., 207 Cal. 24 App. 4th 1283, 1303 (2012))); Eisenbise v. Crown Equip. Corp., 260 F. Supp. 3d 1250, 25 1260 n.3 (S.D. Cal. 2017) (denying the defendant’s motion to exclude an expert’s 26 alternative design opinions that defendant claimed would not prevent the problem in all 27 circumstances because “it is not Plaintiffs' burden to present feasible alternative designs at 28 7 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2069 Page 8 of 19 1 all; rather, it is [defendant’s]” (citing Ramirez, 686 F. App’x at 438)).1 Defendants’ reliance 2 on Trejo v. Johnson & Johnson, 13 Cal. App. 5th 110 (2017), for the proposition that an 3 alternative design must be FDA approved is also misplaced. In Trejo, the court found that 4 federal law preempted the plaintiff’s design defect claim for a drug because unilaterally 5 altering the chemical composition of an FDA-approved drug is prohibited by federal law. 6 Trejo, 13 Cal. App. 5th at 154–55. Whether a federal law preempts Plaintiff’s design defect 7 claim is not at issue here. Accordingly, the Court DENIES Defendants’ Motion to Exclude 8 Dr. Veronikis’s opinions regarding safer alternative designs. 9 3. Scott Guelcher, Ph.D. 10 Defendants seek to exclude the following opinions of Scott Guelcher, Ph.D.: 11 (1) potential alternative designs and (2) the effects of Prolene mesh degradation in a 12 patient’s body. ECF No. 178 at 12–13. Dr. Guelcher has a Ph.D. in chemical engineering 13 and was a post-doctoral research associate in biomedical engineering. ECF No. 57-1 at 10; 14 ECF No. 57-8 at 9. 15 a. Alternative Designs 16 In his expert report, Dr. Guelcher opines about alternative designs as follows: 2 17 Using autologous fascia lata, allograft, sutures (including polypropylene sutures), or polyvinylidene fluoride (PVDF) mesh does not present with the same chronic complications associated with the material properties of Ethicon’s PP mesh. All of these alternative materials, including using a less 18 19 20 21 22 23 24 25 26 27 28 1 In a strict liability action based on defective design, a product can be found to be defective using a consumer-expectation test or a risk-benefit test. Merrill v. Navegar, Inc., 26 Cal. 4th 465, 479, 28 P.3d 116, 125 (2001) (citing Barker v. Lull Eng'g Co., 20 Cal. 3d 413, 418, 573 P.2d 443, 446 (1978)). In a product liability action based on negligent design, “‘most of the evidentiary matters’ relevant to applying the risk/benefit test in strict liability cases ‘are similar to issues typically presented in a negligent design case.’” Id. (quoting Barker, 20 Cal. 3d at 431). 2 Defendants cited to an expert report by Dr. Guelcher that does not contain an opinion on alternative designs. ECF No. 178 at 13 (citing ECF No. 57-1 at 17–20). The Court located the correct report. See ECF No. 57-8 at 9. 8 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2070 Page 9 of 19 1 dense version of its PP mesh, were available when Ethicon’s SUI and POP meshes were first commercialized. 2 3 ECF No. 57-8 at 11, 33. 4 Defendants contend that Dr. Guelcher’s alternative design opinions are irrelevant 5 because they present alternative treatment options rather than alternative designs to 6 Ethicon’s mesh device. ECF No. 178 at 13. To support their argument, Defendants cite to 7 decisions by the MDL court and other transferee courts to exclude testimony about 8 alternative procedures as not relevant. Id. at 13–16. Plaintiff opposes, arguing that the cited cases are inapposite because none of them 9 10 involved a claim of negligent design defect under California law. ECF No. 184 at 9–10. 11 The Court finds some of Dr. Guelcher’s opinions as to alternative designs are 12 irrelevant. The Court is persuaded by the MDL court’s finding that “alternative 13 procedures/surgeries do not inform the issue of whether an alternative design for a product 14 exists.” In re Ethicon, Inc. Pelvic Repair Sys. Prod. Liab. Litig., No. MDL 2327, 2017 WL 15 1264620, at *3 (S.D.W. Va. Mar. 29, 2017). Dr. Guelcher’s report appears to describe 16 sutures, autologous fascia lata (or “autografts”), and allografts as alternative procedures or 17 treatments to Ethicon’s synthetic mesh product, instead of as materials to create a safer 18 design for it. See ECF No. 57-8 at 33–35; see also Enborg v. Ethicon, Inc., 19 No. 220CV02477AWIBAK, 2022 WL 800879, at *5 (E.D. Cal. Mar. 16, 2022) (excluding 20 Dr. Guelcher’s opinions as to autologous fascia lata, allografts, and sutures because they 21 are alternative procedures that are not relevant to the question of alternative design).3 22 23 3 24 25 26 27 28 The Court is not persuaded by Plaintiff’s argument that the cases cited by Defendants distinguishing between alternative procedures and alternative designs are inapposite because they did not consider negligent design defect claims under California law. A recent opinion issued after briefing on the instant motions was completed considered California design defect law and found that an alternative procedure does not offer insight on whether a safer alternative design exists. See Enborg, 2022 WL 800879, at *5 (considering the inquiries for design defect under California law, including negligent design, and finding 9 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2071 Page 10 of 19 1 Additionally, Plaintiff does not argue that autologous fascia lata, allografts, and sutures are 2 not alternative procedures or treatments. However, PVDF mesh and “a less dense version 3 of [Ethicon’s] PP mesh” appear to be alternative materials, and therefore relevant to the 4 issue of a safer alternative design. See ECF No. 57-8 at 36; Enborg, 2022 WL 800879, at 5 *4–5 (finding PVDF was recognized as a “mesh alternative”). Accordingly, the Court 6 GRANTS IN PART and DENIES IN PART Defendants’ Motion to Exclude 7 Dr. Guelcher’s alternative design opinions by excluding his opinions as to autologous 8 fascia lata, allografts, and sutures. 9 b. Mesh Degradation 10 Dr. Guelcher opines in his expert report that the Prolene mesh—made almost entire 11 of polypropylene—used in Ethicon devices to treat stress urinary incontinence and pelvic 12 organ prolapse degrades over time as a result of oxidation caused by reaction with 13 chemicals in the body. ECF No. 57-8 at 11–12. 14 Defendants argue that Dr. Guelcher’s opinions on mesh degradation are irrelevant 15 because the case-specific expert did not opine that Plaintiff’s mesh degraded or that 16 degradation caused any of her injuries. ECF No. 178 at 17. Defendants also contend that 17 Dr. Guelcher’s opinions are unreliable because he relies on a research paper previously 18 found to be unreliable by the MDL court, and other articles he relies on are inapposite. 19 Id. at 17–18. 20 Plaintiff opposes, arguing that other courts have found Dr. Guelcher’s opinions on 21 mesh degradation to be reliable and relevant, and Defendants’ criticisms go to the weight 22 of the opinion, not admissibility. ECF No. 184 at 10–11. 23 The Court finds that Dr. Guelcher’s opinions on mesh degradation are relevant. 24 Defendants point the Court to the report of Plaintiff’s case-specific expert Dr. Daniel S. 25 Elliott, arguing that Dr. Elliott did not opine that mesh degradation occurred in this case. 26 27 28 that alternative procedures that make no use of the device at issue are not relevant to the question of safer alternative design). 10 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2072 Page 11 of 19 1 ECF No. 186 at 5. However, the expert report cited is obviously incomplete because the 2 pages do not logically follow each other. ECF No. 36-1 at 2–5. Therefore, the Court cannot 3 ascertain if Dr. Elliott did not find mesh degradation to be an issue in Plaintiff’s case. 4 Furthermore, the Court finds mesh degradation to be relevant to the issue of 5 Ethicon’s alleged negligence. The California Supreme Court explained that “the test of 6 negligent design ‘involves a balancing of the likelihood of harm to be expected from a 7 machine with a given design and the gravity of harm if it happens against the burden of the 8 precaution which would be effective to avoid the harm.’” Merrill v. Navegar, Inc., 26 Cal. 9 4th 465, 479 (2001) (citation omitted). The issue of mesh degradation and what was known 10 about it is relevant to this inquiry. 11 The Court also finds that Dr. Guelcher’s opinions on mesh degradation are 12 sufficiently reliable to be admissible. In 2015 the MDL court found a test in one of the 13 studies that Dr. Guelcher relied on to be unreliable because the testing “failed to follow a 14 written protocol or utilize a sufficiently large sample size.” Mathison v. Bos. Sci. Corp., 15 No. 2:13-CV-05851, 2015 WL 2124991, at *22 (S.D.W. Va. May 6, 2015). The test was 16 performed by Russell Dunn, Ph.D., and was included in a peer-reviewed paper referred to 17 as the “Talley study” published by Dr. Guelcher and others in 2017 in the Journal of 18 Biomaterials Science. Id.; see also ECF No. 178 at 17; ECF No. 57-8 at 78. In 19 Dr. Guelcher’s deposition, he stated that they “did not repeat the experiment, but [they] did 20 more work on the analysis to basically present the paper in a form that could be published.” 21 ECF No. 57-8 at 78. It appears to the Court that in 2015 the MDL court did not have the 22 2017 published paper before it. Although the test at issue was not redone, there was 23 additional analysis, and the paper was subsequently peer-reviewed and published. 24 Moreover, the Talley study was only one of the many articles that Dr. Guelcher 25 relied on. Defendants argue that none of the articles specifically states that Prolene oxidizes 26 and degrades in the body. However, Dr. Guelcher cites to articles involving oxidative 27 degradation of polypropylene in the body, which lends support to his opinion because 28 Prolene is “more than 97% polypropylene.” See ECF No. 57-8 at 12, 18, 20. The Court 11 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2073 Page 12 of 19 1 finds that Defendants’ criticisms of Dr. Guelcher’s opinion go to weight rather than 2 admissibility. See Clausen v. M/V NEW CARISSA, 339 F.3d 1049, 1060 (9th Cir. 2003), as 3 amended on denial of reh'g (Sept. 25, 2003) (“The fact that a cause-effect relationship . . . 4 has not been conclusively established does not render [the expert's] testimony 5 inadmissible.” (citation omitted)); Gomez v. Am. Med. Sys. Inc., No. CV-20-00393-PHX- 6 ROS, 2021 WL 1163087, at *13 (D. Ariz. Mar. 26, 2021) (“Offering a hypothesis as an 7 opinion goes to weight, not admissibility, so long as there is support in objective 8 evidence.”); Wood v. Am. Med. Sys. Inc., No. 120CV00441DDDKLM, 2021 WL 1178547, 9 at *5 (D. Colo. Mar. 26, 2021) (finding similar criticisms of the articles relied on by 10 Dr. Guelcher to be “legitimate bases for cross examination, but they don't fundamentally 11 undermine the reliability of Dr. Guelcher or Dr. Mays's testimony”). Accordingly, the 12 Court DENIES Defendants’ Motion to Exclude Dr. Guelcher’s opinions about mesh 13 degradation. 14 B. 15 Defendants’ Experts 1. Edward Stanford, M.D. 16 Plaintiff seeks to exclude the opinion of Edward Stanford, M.D., regarding the 17 adequacy of Defendants’ warnings regarding the Prolene Soft mesh. 4 ECF No. 179 at 34. 18 Plaintiff noted that when this same issue was brought before another transferee court, 19 Defendants “concede[d] that Dr. Stanford is not a regulatory expert and will not opine on 20 the adequacy of product warnings even if such opinions were relevant to the remaining 21 claims.” Id. at 4 (quoting McBroom v. Ethicon, Inc., No. CV-20-02127-PHX-DGC, 2021 22 WL 2709292, at *15 (D. Ariz. July 1, 2021)). Defendants state that they stand by their prior 23 concession. ECF No. 183 at 3. Because Defendants assert that Dr. Stanford will not offer 24 25 4 26 27 28 Plaintiff had previously sought to exclude the following additional opinions of Dr. Stanford: (1) other physicians knew about the risks of these transvaginal mesh devices, (2) his personal experience with Ethicon’s Prolene mesh products, and (3) mesh degradation. ECF No. 179 at 3–5. However, Plaintiff states that she withdraws her arguments regarding these opinions given other transferee courts’ decisions allowing these opinions. Id. at 4–5. 12 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2074 Page 13 of 19 1 this opinion, the Court DENIES AS MOOT Plaintiff’s Motion to Exclude Dr. Stanford’s 2 opinion regarding the adequacy of Defendants’ warnings regarding the Prolene Soft mesh. 3 2. Robert Rogers, M.D. 4 Plaintiff seeks to exclude the opinion of Robert Rogers, M.D., that Ethicon behaved 5 admirably, was a “good company,” and that the development of Ethicon mesh products 6 was done “with the patient’s best interests at the top of each agenda.” ECF No. 179 7 at 5–6. Dr. Rogers is board certified in Obstetrics and Gynecology since 1986 and in 8 Female Pelvic Medicine and Reconstructive Surgery since 2013. ECF No. 183-3, TVT and 9 TVT-O Expert Report of Robert M. Rogers, Jr. M.D. (Ex. C), at 3. He practices 10 gynecologic surgery and urogynecology. Id. Dr. Rogers has performed over 700 surgeries 11 since 2008 “for reconstruction of various vaginal support defects, with several hundred of 12 these cases involved with placement of Gynemesh PS and the Prolift products from 13 Ethicon,” including over 200 midurethral slings with most of those involving TVT, 14 TVT-O, and TVT-Secur products from Ethicon. 5 Id. at 6. 15 In his expert report, Dr. Rogers stated that “[f]rom the late 1990s to 2007, I was 16 asked by the research and clinical scientists at Ethicon to consult with them on the design 17 and performance of the Prolift, TVT-O, TVT-Secur products, as well as one or two other 18 developing products.” 6 Id. He opined, “I found that at Ethicon all my contacts, discussions 19 and work with the research scientists, biomedical engineers and clinicians were 20 consistently respectful, appreciated, and honest.” Id. at 8. He further opined, “All the 21 product development in which I was involved was thoroughly evaluated and reevaluated 22 step by step, in accordance to the Ethicon standards, the industry standards, and of course, 23 the FDA and federal government standards.” Id. Dr. Rogers summarized a trip he 24 25 5 26 27 28 The TVT and its variations are pelvic mesh products designed to treat stress urinary incontinence in women. ECF No. 56-1 ¶¶ 17–18. 6 Prolift is a pelvic mesh product for the treatment of medical conditions in the female pelvis, primarily pelvic organ prolapse and stress urinary incontinence. ECF No. 56-1 ¶¶ 14–15, 18. 13 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2075 Page 14 of 19 1 participated in during the fall of 2003 to France and Belgium to observe and question Prolift 2 inventors and the urologist who developed the TVT-O. Id. He opined, “Upon returning to 3 Ethicon in New Jersey, the development of the Prolift products and TVT products 4 continued in earnest with the patients’ best interests always at the top of each agenda.” 5 Id. at 9. 6 Plaintiff contends that Dr. Rogers’s opinions that Ethicon behaved admirably, was a 7 “good company,” and that the development of Ethicon mesh products was done “with the 8 patient’s best interests at the top of each agenda” should be excluded as inadmissible 9 character evidence and because they are irrelevant and any probative value is substantially 10 outweighed by its prejudicial value. ECF No. 179 at 6. 11 Defendants argue that Dr. Rogers did not opine that Ethicon was “a good company” 12 and that he instead offered admissible opinion based on his “specialized knowledge 13 regarding product development, clinical studies, and professional education, and his 14 experiences working with Ethicon in these areas.” ECF No. 183 at 4. 15 Two transferee courts have ruled on arguments similar to Plaintiff’s regarding 16 Dr. Rogers’s opinions. A district court in South Dakota excluded Dr. Rogers’s opinions 17 “about Ethicon’s work environment being ‘consistently respectful, appreciated, and 18 honest,’ or that Ethicon behaved admirably or as a ‘good’ company.” Foster v. Ethicon, 19 Inc., No. 4:20-CV-04076-RAL, 2021 WL 4476642, at *4 (D.S.D. Sept. 30, 2021). A 20 district court in the Central District of California also excluded some of Dr. Rogers’s 21 opinions regarding “his general experience with Ethicon, its general dedication to patient 22 safety, and his general interactions with Ethicon staff.” ECF No. 183-2 at 2–3; Acosta v. 23 Ethicon, Inc., No. 20cv5992-DSF-GJS, at 1–2 (C.D. Cal. Dec. 13, 2021) (order regarding 24 Daubert motions). The California court found that “[t]o the degree that Rogers is not 25 discussing specific interactions regarding the specific product at issue in this case,” it is 26 inadmissible character evidence pursuant to Federal Rule of Evidence 404(a). Id. at 3. 27 However, the court ruled that Dr. Rogers was “free to testify regarding the Ethicon product 28 14 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2076 Page 15 of 19 1 development process, its application to the relevant product in this case, and as to his 2 opinion whether this process was up to industry standards.” Id. 3 The Court finds that to the extent that Dr. Rogers has opinions about the general 4 character of Ethicon, they are inadmissible character evidence and irrelevant. However, his 5 opinions regarding Ethicon’s product development process as it relates to this case is 6 relevant to the issue of Plaintiff’s product liability and negligence claims. Accordingly, the 7 Court GRANTS Plaintiff’s Motion to Exclude Dr. Rogers’s opinions that development of 8 the Ethicon mesh products was done “in earnest” and “with the patient’s best interests 9 always at the top of each agenda” (i.e., opinions regarding the general affect, character, or 10 demeanor of the Ethicon staff and its subjective commitment to patient safety). Plaintiff 11 does not appear to seek to exclude other opinions of Dr. Rogers, but the Court will clarify 12 that Dr. Rogers may testify regarding the Ethicon product development process, its 13 application to the relevant product in this case, and whether this process was up to industry 14 standards. 15 3. Timothy Ulatowski 16 Plaintiff seeks to exclude the following opinions of regulatory consultant Timothy 17 Ulatowski: (1) the 510(k) review process is robust and a basis for the determination of the 18 safety and effectiveness of medical devices; (2) Prolene, the primary material used in 19 Prolene Soft Mesh, is safe and effective from a regulatory perspective; and (3) a change in 20 material or Prolene weave specifications for the Prolene Soft Mesh would require the 21 submission of a new 510(k) to the FDA and clearance by the FDA before the modified 22 device could be marketed. ECF No. 179 at 7–10. However, Defendants state that Mr. 23 Ulatowski is not a currently designated expert. ECF No. 183 at 2 n.1. They aver that if the 24 Court allows FDA evidence, then Defendants may then seek to substitute Mr. Ulatowski 25 in place of one of their five designated experts. Id. Defendants contend that the issue of 26 whether FDA evidence may be allowed is more appropriate for a motion in limine and not 27 a Daubert challenge. Id. Accordingly, because Mr. Ulatowski is not currently a designated 28 expert, the Court DENIES AS MOOT Plaintiff’s Motion to Exclude Mr. Ulatowski’s 15 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2077 Page 16 of 19 1 opinions related to regulatory issues, but without prejudice should Mr. Ulatowski be 2 substituted in as an expert. 3 4. Recurring Reserved Issues for General Causation Experts 4 Plaintiff seeks to exclude the following general types of recurring opinions from 5 Defendants’ general causation experts: (1) opinions on Ethicon’s compliance with design 6 control and risk management standards; and (2) opinions regarding the adequacy of 7 Ethicon’s clinical testing and research, physician outreach, or particular product 8 development procedures and assessments. ECF No. 179 at 10. Plaintiff argues that they 9 both “implicate the [FDA’s section] 510(k) regulatory process which has repeatedly been 10 excluded by the MDL court and transferee courts.” Id. Plaintiff adds that it seeks exclusion 11 of these reserved issues under Federal Rule of Evidence 403, so their admissibility is 12 “probably more appropriately addressed as a motion in limine.” Id. at 11. 13 Defendants oppose on several grounds: (1) Plaintiff fails to identify where any of 14 their experts provide these opinions; (2) Plaintiff fails to cite to any specific challenge to 15 these opinions in her MDL briefing; and (3) evidence of Defendants’ compliance with 16 industry standards and clinical testing is directly relevant to Plaintiff’s claims of product 17 liability and negligence and to Defendants’ defense. ECF No. 183 at 7. 18 The Court finds that Plaintiff’s arguments are deficient. Plaintiff fails to provide 19 enough specificity to identify the challenged opinions because she does not cite to the 20 specific opinions, but rather to the MDL court orders reserving ruling on these two types 21 of general recurring opinions for Dr. Thames, Dr. Rosenblatt, Dr. Grier, and Dr. Rogers.7 22 ECF No. 179 at 10. And although it is true that the MDL court excluded evidence regarding 23 the FDA’s section 510(k) clearance process and was inclined to doubt the relevance of the 24 two general types of opinions challenged by Plaintiff, Judge Goodwin also stated the 25 following: 26 27 7 28 Plaintiff also cites to Mr. Ulatowski’s expert report, but Defendants stated that Mr. Ulatowski is not currently a designated expert. See supra Section III.B.3. 16 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2078 Page 17 of 19 1 Nevertheless, because the nuances of products liability law vary by state, I will refrain from issuing a blanket exclusion on design process and control standards testimony, whether rooted in the FDA or otherwise. Each standard must be assessed for its applicability to the safety questions at issue in this litigation, consistent with state law. I am without sufficient information to make these findings at this time. 2 3 4 5 6 ECF No. 76-1 at 9–10. Judge Goodwin also reserved ruling on the relevancy of opinions 7 on Ethicon’s clinical testing and research, physician outreach, or particular product 8 development procedures and assessments for the same reason. Id. at 10. However, Plaintiff 9 provides no arguments as to how these opinions are not relevant under California law. 10 Accordingly, the Court DENIES Plaintiff’s Motion to Exclude these two general types of 11 expert opinions, without prejudice to being raised as motions in limine. 12 IV. CONCLUSION 13 The Court adopts the MDL court’s previous rulings as to experts from prior waves 14 of cases except to the degree that those rulings are contradicted by orders from this Court. 15 See ECF No. 120 at 7–17. 16 17 18 For the reasons stated above, the Court GRANTS IN PART AND DENIES IN PART the parties’ Motions to Exclude certain expert opinions as follows: 1. The Court GRANTS Defendants’ Motion to Exclude the following opinions 19 of Donald Ostergard: (1) FDA regulatory requirements and whether Defendants’ warning 20 labels satisfied those requirements, and (2) the adequacy of the warning accompanying 21 Defendants’ Gynemesh PS mesh product’s Instructions for Use. Dr. Ostergard may testify 22 about (1) the specific risks of implanting the Gynemesh PS, (2) risks that are obvious to 23 pelvic mesh surgeons, and (3) knowledge common within the medical community. 24 2. The Court GRANTS Defendants’ Motion to Exclude Dionysios Veronikis’s 25 opinions about the adequacy of the warnings in the IFU for the Gynemesh PS. 26 Dr. Veronikis may testify about (1) the specific risks of implanting the Gynemesh PS, 27 (2) risks that are obvious to pelvic mesh surgeons, and (3) knowledge common within the 28 medical community. 17 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2079 Page 18 of 19 1 2 3. The Court DENIES Defendants’ Motion to Exclude Dionysios Veronikis’s opinions about safer alternative designs. 3 4. The Court GRANTS IN PART and DENIES IN PART Defendants’ Motion 4 to Exclude Scott Guelcher’s alternative design opinions by excluding his opinions as to 5 autologous fascia lata, allografts, and sutures. 6 7 5. opinions about mesh degradation. 8 9 10 The Court DENIES Defendants’ Motion to Exclude Scott Guelcher’s 6. The Court DENIES AS MOOT Plaintiff’s Motion to Exclude Edward Stanford’s opinions regarding the adequacy of Defendants’ warnings regarding the Prolene Soft mesh. 11 7. The Court GRANTS Plaintiff’s Motion to Exclude Robert Rogers’s opinions 12 that development of the Ethicon mesh products was done “in earnest” and “with the 13 patient’s best interests always at the top of each agenda” (i.e., opinions regarding the 14 general affect, character, or demeanor of the Ethicon staff and its subjective commitment 15 to patient safety). 16 8. The Court DENIES AS MOOT Plaintiff’s Motion to Exclude Timothy 17 Ulatowski’s opinions related to regulatory issues, but without prejudice should Mr. 18 Ulatowski be substituted in as an expert. 19 9. The Court DENIES Plaintiff’s Motion to Exclude the following general types 20 of recurring opinions from Defendants’ general causation experts: (1) opinions on 21 Ethicon’s compliance with design control and risk management standards; and (2) opinions 22 regarding the adequacy of Ethicon’s clinical testing and research, physician outreach, or 23 particular product development procedures and assessments, without prejudice to being 24 raised as motions in limine. 25 /// 26 /// 27 /// 28 /// 18 20cv989-LL-RBB Case 3:20-cv-00989-LL-RBB Document 199 Filed 06/02/22 PageID.2080 Page 19 of 19 1 Additionally, the Court ORDERS the parties to contact the chambers of the 2 magistrate judge on or before June 9, 2022 to schedule a settlement conference in a further 3 effort to resolve their differences prior to trial. 4 5 IT IS SO ORDERED. Dated: June 2, 2022 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 19 20cv989-LL-RBB

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