“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.”
How later courts described this case
- “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.”
Written by the judges who cited it.
The opinion
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8 UNITED STATES DISTRICT COURT
9 SOUTHERN DISTRICT OF CALIFORNIA
10
11 DONNA PARKS, Case No.: 20cv989-LL-RBB
12 Plaintiff,
ORDER GRANTING IN PART AND
13 v. DENYING IN PART RESERVED
DAUBERT ISSUES
14 ETHICON, INC.;
JOHNSON & JOHNSON,
15 [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 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
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 / / /
1 III. DISCUSSION
2 Defendants and Plaintiff seek resolution of their challenges to certain expert
3 opinions that were reserved by the MDL court for the trial court to decide.
4 A. Plaintiff’s Experts
5 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 2. Dionysios Veronikis, M.D.
21 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
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
13
show some ‘fibrillation’ of PROLENE suture where none was observed for
14 PRONOVA suture. My polymer colleagues tell me that PP has the potential
to do this because of its molecular structure."); ETH.MESH.00857704
15
(2/12/09 internal e-mail regarding development of potential new mesh product
16 constructed of PVDF “Pronova”) – “I think we have multiple advantages over
+M like:…If we use PRONOVA a more elastic fiber which show less
17
degradation than PP. Better, longer function of Implant.”);
18 HMESH_ETH_00228962 (2/17/10 internal e-mail chain discussing
polypropylene literature) – "[W]e know from literature that polyester and even
19
polypropylene tend to alter over time in the body…. [H]ow has the general
20 surgery group responded to this [degradation literature]?...[W]e proposed for
several new product developments...to use PVDF or PRONOVA as a more
21
stable filament, however Senior Management decided to go ahead with PP as
22 a standard." (HMESH_ETH_00228961)).
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,
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
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
1 all; rather, it is [defendant’s]” (citing Ramirez, 686 F. App’x at 438)). 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
18
same chronic complications associated with the material properties of
19 Ethicon’s PP mesh. All of these alternative materials, including using a less
20
21
22 1 In a strict liability action based on defective design, a product can be found to be defective
23 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,
24
418, 573 P.2d 443, 446 (1978)). In a product liability action based on negligent design,
25 “‘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
26
Barker, 20 Cal. 3d at 431).
27 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
28
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.
9 Plaintiff opposes, arguing that the cited cases are inapposite because none of them
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 The Court is not persuaded by Plaintiff’s argument that the cases cited by Defendants
24
distinguishing between alternative procedures and alternative designs are inapposite
25 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
26
design defect law and found that an alternative procedure does not offer insight on whether
27 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
28
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
that alternative procedures that make no use of the device at issue are not relevant to the
28
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
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. Defendants’ Experts
15 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 Plaintiff had previously sought to exclude the following additional opinions of Dr.
26
Stanford: (1) other physicians knew about the risks of these transvaginal mesh devices, (2)
27 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
28
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 The TVT and its variations are pelvic mesh products designed to treat stress urinary
26
incontinence in women. ECF No. 56-1 ¶¶ 17–18.
27 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 ¶¶
28
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
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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
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 Plaintiff also cites to Mr. Ulatowski’s expert report, but Defendants stated that Mr.
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1 Nevertheless, because the nuances of products liability law vary by
state, I will refrain from issuing a blanket exclusion on design process and
2
control standards testimony, whether rooted in the FDA or otherwise. Each
3 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
4
to make these findings at this time.
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 For the reasons stated above, the Court GRANTS IN PART AND DENIES IN
17 PART the parties’ Motions to Exclude certain expert opinions as follows:
18 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.
1 3. The Court DENIES Defendants’ Motion to Exclude Dionysios Veronikis’s
2 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 5. The Court DENIES Defendants’ Motion to Exclude Scott Guelcher’s
7 opinions about mesh degradation.
8 6. The Court DENIES AS MOOT Plaintiff’s Motion to Exclude Edward
9 Stanford’s opinions regarding the adequacy of Defendants’ warnings regarding the Prolene
10 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 / / /
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 IT IS SO ORDERED.
5 ||Dated: June 2, 2022 NO
6 DE |
7 Honorable Linda Lopez
United States District Judge
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