Kelley v. C.R. Bard, Inc.

Full title: Debra KELLEY, Plaintiff, v. C.R. BARD, INC., Defendant.

Court: United States District Court, N.D. Georgia, Gainesville Division

Date published: Dec 5, 2022

644 F. Supp. 3d 1316 (N.D. Ga. 2022)

Opinion

CIVIL ACTION FILE No. 2:20-CV-0045-SCJ

2022-12-05

Debra KELLEY, Plaintiff, v. C.R. BARD, INC., Defendant.

Edward A. Wallace, Pro Hac Vice, Molly Condon Wells, Pro Hac Vice, Timothy E. Jackson, Pro Hac Vice, Wallace Miller, Chicago, IL, James F. McDonough, III, Rozier Hardt McDonough PLLC, Atlanta, GA, for Plaintiff. Eric L. Alexander, Pro Hac Vice, Jamie L. Lanphear, Pro Hac Vice, Lindsay A. DeFrancesco, Reed Smith, Washington, DC, Lori Gail Cohen, Victoria Jean Langton, Greenberg Traurig, LLP, Atlanta, GA, Brandee Jarski Kowalzyk, Richard B. North, Jr., Nelson Mullins Riley & Scarborough, LLP, Atlanta, GA, Melissa Foster Bird, Nelson, Mullins, Riley & Scarborough, LLP, Huntington, WV, for Defendant.

STEVE C. JONES, UNITED STATES DISTRICT JUDGE

Edward A. Wallace, Pro Hac Vice, Molly Condon Wells, Pro Hac Vice, Timothy E. Jackson, Pro Hac Vice, Wallace Miller, Chicago, IL, James F. McDonough, III, Rozier Hardt McDonough PLLC, Atlanta, GA, for Plaintiff. Eric L. Alexander, Pro Hac Vice, Jamie L. Lanphear, Pro Hac Vice, Lindsay A. DeFrancesco, Reed Smith, Washington, DC, Lori Gail Cohen, Victoria Jean Langton, Greenberg Traurig, LLP, Atlanta, GA, Brandee Jarski Kowalzyk, Richard B. North, Jr., Nelson Mullins Riley & Scarborough, LLP, Atlanta, GA, Melissa Foster Bird, Nelson, Mullins, Riley & Scarborough, LLP, Huntington, WV, for Defendant. ORDER STEVE C. JONES, UNITED STATES DISTRICT JUDGE

This matter appears before the Court on three Daubert motions—Defendant's motions to exclude two of Plaintiff's experts, Dr. Rosenzweig, M.D., and Dr. Guelcher, Ph.D., (Doc. Nos. [106]; [107]) and Plaintiff's motion to partially exclude Defendant's expert, Dr. Culligan, M.D. (Doc. No. [110]).¹ For the following reasons, the Court GRANTS IN PART and DENIES IN PART each motion.

1 All citations are to the electronic docket unless otherwise noted, and all page numbers are those imprinted by the Court's docketing software.

I. BACKGROUND

Plaintiff suffers from a number of urogynecology health issues, namely stress urinary incontinence (SUI). Doc. Nos. [108-4], 2-3, 10; [116-3], 5-6. On October 26, 2010, Plaintiff had Defendant's Ajust Adjustable Single Incision Sling (the Ajust) implanted to address these problems. Doc. Nos. [108-4], 2-3, 10; [116-3], 5-6. Unfortunately, Plaintiff continued experienced further pain and complications, so she had the Ajust explanted on August 9, 2011. Doc. Nos. [117-4] (Moore Dep. Tr.), 104:11-19, 106:5-22; [108-4], 3-4. Plaintiff continues to suffer with SUI and other urogynecology problems that she claims were caused and amplified by the implant of Defendant's Ajust device. Doc. No. [116], 6-7.

Plaintiff accordingly filed this products liability suit against Defendant with an MDL court in November 2013, asserting causes of action for design defect and failure to warn.² Doc. No. [1]. The MDL court transferred Plaintiff's case to this Court on January 22, 2020. Doc. No. [33]. The parties completed discovery on June 10, 2022. Doc. No. [104]. In addition to moving for summary judgment,³ Defendant moved to exclude the expert testimony of two of Plaintiff's experts, Dr. Bruce Rosenzweig, M.D., and Dr. Scott Guelcher, Ph.D. (Doc. Nos. [106]; [107]). Further, Plaintiff moved to partially exclude Defendant's expert, Dr. Patrick Culligan, M.D. (Doc. No. [110]). Each party opposes the motions to exclude their respective experts. Doc. Nos. [114]; [115]; [117]. These issues have been fully briefed and are now ripe for the Court's review.

2 Plaintiff also claimed causes of action for negligent manufacturing, manufacturing defect, breach of express warranty, and breach of implied warranty, but these have since been dismissed by joint stipulation. Doc. No. [105].

3 The Court will resolve Defendant's motion for summary judgment (Doc. No. [108]) in a separate order.

II. LEGAL STANDARD

Federal Rule of Evidence 702 governs the admissibility of expert testimony in federal cases. See United States v. Gillis, 938 F.3d 1181, 1193 (11th Cir. 2019). Trial courts serve an important gatekeeping role in determining the admissibility of expert testimony. See Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) ("[T]he trial judge must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable."); see also Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999) ("The objective . . . is to ensure the reliability and relevancy of expert testimony."). Specifically, the Supreme Court has "tasked [trial courts] with screening out 'speculative, unreliable expert testimony.' " Kilpatrick v. Breg, Inc., 613 F.3d 1329, 1335 (11th Cir. 2010) (citing Daubert, 509 U.S. at 597, 113 S.Ct. 2786); see also Adams v. Lab'y Corp. of Am., 760 F.3d 1322, 1327 (11th Cir. 2014).

To be admissible, expert testimony must meet three requirements:

First, "the expert must be qualified to testify competently regarding the matter he or she intends to address"; second, "the expert's methodology . . . must be reliable as determined by a Daubert inquiry"; and third, "the expert's testimony must assist the trier of fact through the application of expertise to understand the evidence or determine a fact in issue."

Id. at 1328 (quoting Kilpatrick, 613 F.3d at 1335). "[T]he party seeking to introduce the expert at trial bears the burden of establishing his qualifications, reliability, and helpfulness." Knepfle v. J-Tech Corp., 48 F.4th 1282, 1294 (11th Cir. 2022).

To determine if an expert is qualified, the Court must look to the expert's "scientific training, education, or field experience." Id. To assess the reliability of an expert, the Court asks, "whether the reasoning or methodology underlying the testimony is scientifically valid and whether that reasoning or methodology properly can be applied to the facts in issue." Arevalo v. Mentor Worldwide LLC, No. 21-11768, 2022 WL 16753646, at *3 (11th Cir. Nov. 8, 2022) (quoting United States v. Frazier, 387 F.3d 1244, 1261-62 (11th Cir. 2004)). This reliability analysis considers a number of factors, including "(1) whether the expert's theory can be and has been tested; (2) whether the theory has been subjected to peer review and publication; (3) the known or potential rate of error of the particular scientific technique; and (4) whether the technique is generally accepted in the scientific community." Knepfle, 48 F.4th at 1294 (quoting Frazier, 387 F.3d at 1260-61). Finally, an expert's testimony is helpful to the trier of fact when it involves issues "beyond the understanding of the average lay person." Id. (quoting Frazier, 387 F.3d at 1262). The Court must also determine if there is "too great an analytical gap between" the facts of the case and the expert's opinion for the testimony to be helpful. Id. (quoting Frazier, 387 F.3d at 1262); see also Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997) ("[N]othing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert.").

The Eleventh Circuit has made clear, however, that the Court's gatekeeping role "is not intended to supplant the adversary system or the role of the jury" and that "vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence." Adams, 760 F.3d at 1334 (quotations and citations omitted); see also 29 Charles Alan Wright & Arthur R. Miller, Federal Practice and Procedure § 6268.2 (2d ed. 2022) ("[T]rial judges are gatekeepers, not armed guards.").

III. ANALYSIS

The parties present the Court with three motions to exclude expert testimony. Doc. Nos. [106]; [107]; [110]. The Court addresses each in turn, ultimately concluding that each motion should be GRANTED IN PART and DENIED IN PART.

A. Dr. Rosenzweig

Plaintiff offers Dr. Bruce Rosenzweig as a general and specific causation expert for her design defect claim and to offer his expert opinion on the adequacy of Defendant's disclosures for her failure to warn claim. Rosenzweig offered his expert conclusions in 2014 for the MDL cases, submitting a report on Defendant's Align device specifically and the risks of polypropylene mesh more generally. Doc. No. [106-3] ("2014 General Report"). Once the MDL court transferred the case back to this Court, Rosenzweig then considered Plaintiff's specific circumstances and submitted a case specific report in 2019, which adopted his 2014 General Report and rendered opinions specific to Plaintiff. Doc. No. [106-4]. Rosenzweig then updated his case-specific report in 2021, and this 2021 report is now the operative report. Doc. No. [106-2] ("2021 Case Specific Report"). On October 14, 2021, the Court allowed Rosenzweig to further supplement his report with additional materials he has since considered. Doc. Nos. [98]; [97-2].

In both the 2014 General Report and 2021 Case Specific Report, Rosenzweig's conclusions primarily relate to the use of polypropylene mesh in slings implanted in women to resolve urogynecology problems. Specifically, Rosenzweig's conclusion is that polypropylene mesh is never a suitable material to permanently implant in a human body because it can degrade, cause chronic foreign body reactions and fibrotic bridging, shrink, be deformed, roll, curl, fold, and lead to cording and roping of the mesh. Doc. Nos. [106-3], 4; [106-2], 4. With regard to Plaintiff, Rosenzweig determines that her polypropylene mesh implant caused her pain and persistent health problems. Doc. No. [106-2], 5. Rosenzweig also concludes that Defendant's Instructions for Use (IFU)—which are distributed to doctors to warn them of the risks of a medical device or procedure in order to obtain informed consent from the patient—inadequately warned of the risks of polypropylene mesh. Doc. Nos. [106-3], 4; [106-2], 27.

Defendant challenges the admissibility of Rosenzweig's testimony on numerous grounds. Specifically Defendant argues that Rosenzweig's expert testimony should not be admitted because: (1) his deposition testimony goes beyond the scope of his reports, (2) he is not qualified to render the design defect conclusions he reaches, (3) his methodology in making his design defect opinions was unreliable, (4) his opinions in the 2014 General Report are unfit and unhelpful in Plaintiff's case, (5) his 2021 Specific Case Report lacks factual foundation, (6) his opinions on Plaintiff's post-explant pain are unfit because they are not factually supported, and (7) his opinions on the Ajust IFU are unreliable.⁴

4 Defendant also makes broad objections to Rosenzweig's opinions on Defendant's knowledge and state of mind, his narrative reviews of corporate documents, and assertions of legal opinions. Doc. No. [106-1], 13 n.2. Without a more specific argument on this objection, the Court will not exclude further testimony at this time.

In sum, the Court concludes that Rosenzweig's expert testimony is admissible under Daubert subject to the follow exceptions: first, that his post-explant conclusions are against the weight of the undisputed evidence, and thus are not reliable or helpful in this case and, second, his IFU opinions are unreliable because he supports them only with conclusions about the Align device's IFU—not the Ajust IFU. Thus, the Court GRANTS IN PART and DENIES IN PART Defendant's motion to exclude.⁵

5 Both parties have submitted a notice of supplemental authority in support of their positions on the admissibility of Rosenzweig's expert report and opinions. Doc. Nos. [122] (Defendant's submission of Arevalo, 2022 WL 16753646, at *3); [123] (Plaintiff's submission of Pizzitola v. Ethicon, Inc., No. 4:20-CV-02256, 2022 WL 6225661, at *1 (S.D. Tex. Oct. 7, 2022)). Both involve Daubert motions to exclude Rosenzweig's testimony in cases involving synthetic mesh devices. The Court has reviewed both submissions, but because each case presents distinct issues, their persuasiveness is limited.

1. Deposition Testimony

Defendant first objects to parts of Rosenzweig's deposition testimony because it exceeded the scope of his written report. Doc. No. [106], 14-16. The Federal Rules require Rosenzweig to file a written report with, among other items, "a complete statement of all opinions the witness will express and the basis and reasons for them." Fed. R. Civ. Pro. 26(a)(2)(B)(i). The purpose of this disclosure is "to provide opposing parties reasonable opportunity to prepare for effective cross examination and perhaps arrange for expert testimony from other witnesses." In re Stand "N Seal Prod. Liab. Litig., 623 F. Supp. 2d 1355, 1361 (N.D. Ga. 2009) (quoting Reese v. Herbert, 527 F.3d 1253, 1265 (11th Cir. 2008)); see also 8A Charles Alan Wright & Arthur R. Miller, Federal Practice and Procedure § 2031.1 (3d ed. 2022) ("The Advisory Committee Notes explain that the report 'is intended to set forth the substance of the direct examination.' " (citing 146 F.R.D. at 634)).

The Court disagrees that Rosenzweig's deposition testimony exceeds his report. Defendant objects to statements in Rosenzweig's deposition that were responsive to questions asked by Defendant's own counsel. Moreover, Rosenzweig's testimony is not so "significantly" or "radically" different from his submitted reports to exclude it.⁶ Zimmer v. Prison Health Servs., Inc., No. 4:04-CV-029-SPM, 2004 WL 5644163, at *2 (N.D. Fla. Aug. 2, 2004).

6 All four instances that Defendant cites as being outside the scope of Rosenzweig's report in some way pertain to the structure of the Ajust as a "tubular mesh" and its adverse effects. Doc. No. [117-5] (Rosenzweig Dep. Tr.), Tr. 86:7-19; 70:2-71:15; 144:7-145:11; 38:4-18. To the extent that Defendant's objection here is really objecting to the sufficiency of Rosenzweig's report's descriptions and conclusions on the Ajust features, the Court addresses the admissibility of Rosenzweig's testimony and report separately in the opinion.

Defendant takes issue with four statements made by Rosenzweig in his deposition. The first is Rosenzweig responding to a question asking if the Ajust's adjustable single incision feature was a "bad idea." Doc. No. [117-5] (Rosenzweig Dep. Tr.), Tr. 86:7-19. Rosenzweig so testifies that "tubular mesh" as found in the Ajust is "problematic" because it doubles the amount of mesh, increases its density, and decreases its pore size. Doc. Nos. [106-1], 15; [117-5] (Rosenzweig Dep. Tr.), Tr. 86:7-19.

The second statement is description of a design feature of the Ajust, namely that the ends of the mesh are "tubular." Doc. Nos. [106-1], 15; [117-5] (Rosenzweig Dep. Tr.), Tr. 70:2-71:15. This statement, again, was answering defense counsel's questions about the apparent lack of evidence to support Rosenzweig's opinions that Plaintiff's mesh was roped or frayed. Doc. No. [117-5] (Rosenzweig Dep. Tr.), Tr. 70:2-71:15.

The third statement further expounds on the Ajust's characteristics, namely its tubular mesh and locking mechanism. Rosenzweig concludes these characteristics increased the risk of a foreign body reaction, pain, and degradation. Doc. Nos. [106-1], 15; [117-5] (Rosenzweig Dep. Tr.), Tr. 144:7-145:11. This testimony specifically responded to questions about the increased risks of complications or reoperation with the Ajust device compared to other slings on the market. Doc. No. [117-5] (Rosenzweig Dep. Tr.), Tr. 144:7-145:11.

The final statement Defendant objects to is Rosenzweig discussing the possibility of the mesh "flaking" when removed given the tubular nature and adjustable locks. Doc. Nos. [106-1], 15; [117-5] (Rosenzweig Dep. Tr.), Tr. 38:4-18. Again, Rosenzweig's testimony about the mesh "flaking" was in response to questions about the lack of evidence that mesh remained in Plaintiff after her explant procedure. Doc. No. [117-5] (Rosenzweig Dep. Tr.), Tr. 38:4-18.

At bottom, each piece of evidence Defendant objects to involves Rosenzweig responding to defense counsel's questions. Moreover, equivalent descriptions of the mesh and its adverse effects can be found in Rosenzweig's 2014 General Report, which opines on the mesh's characteristics creating risks of "(2) degradation of the mesh; (3) chronic foreign body reaction; [and] (4) roping, curling, cording, rolling, deformation, loss of pore size with tension, abrasiveness, and fraying of the mesh . . . ." Doc. No. [106-3], 14. Rosenzweig incorporated his 2014 General Report in his 2021 Case Specific Report, and thus his deposition testimony not so "significantly" or "radically" different for it to be excluded.⁷ Zimmer, 2004 WL 5644163, at *2. For these reasons, the Court denies Defendant's motion to exclude this deposition testimony.

7 Plaintiff, moreover, concedes that Rosenzweig is unable to testify on matters actually outside his report, and indicates that he will not do so. Doc. No. [117], 10.

2. Qualifications to Make Design Defect Conclusions

Defendant also objects to Rosenzweig's qualifications to make conclusions about the Ajust device being defective. Namely, Defendant argues that Rosenzweig is unqualified because he (1) has never implanted or explanted an Ajust device, (2) has never been part of a surgery to address an Ajust-related issue, (3) did not examine, experiment, or test the Ajust, and (4) is only familiar with the Ajust from viewing its marketing materials years ago. Doc. No. [106-1], 18-19. Plaintiff maintains conversely that Rosenzweig is qualified to testify about the Ajust and its polypropylene mesh given "his experience as a surgeon explanting polypropylene mesh products, along with his review of thousands of published peer-reviewed medical articles and thousands of Defendant's own internal documents." Doc. No. [117], 13.

The Court agrees with Plaintiff: Rosenzweig is qualified to testify as an expert about the Ajust's design and use of polypropylene mesh. Rosenzweig graduated with his medical degree in 1984 and has completed an obstetrics and gynecology residency program, attended fellowships for pelvic survey, urogynecology, and urodynamics, worked in a urogynecology university program, started his own private practice, and held leadership positions in several hospitals' gynecology departments. Doc. No. [106-2], 2-3. He has written a number of published articles and given lectures on various gynecological topics. Doc. No. [106-2], 3. Furthermore, Rosenzweig has performed "over a thousand pelvic floor surgical procedures," "used numerous synthetic pelvic mesh products," "performed over 350 surgeries dealing with complications related to synthetic mesh," and has "expertise and knowledge regarding the pelvic floor and its reaction to materials and devices." Id.

The Court concludes that this experience and education qualify Rosenzweig to testify an expert on Plaintiff's Ajust device and its polypropylene mesh sling. This case involves various urogynecology issues, such as SUI diagnosis and its sling/mesh-implant curative procedures. The Court cannot and will not exclude Rosenzweig's opinions and report solely because he has not specifically handled the Ajust or conducted a surgical procedure involving the Ajust. See Moore v. Intuitive Surgical, Inc., 995 F.3d 839, 854 (11th Cir. 2021) (deeming "too high" an admissibility standard for expert testimony that requires "an expert witness [be] qualified to testify regarding the cause of an injury only if he personally has used the allegedly defective product"). The Court therefore determines that Defendant's objections to Rosenzweig's qualifications—such as that Rosenzweig never tested the Ajust or only had familiarity with the Ajust through marketing materials—go to the weight to accord his testimony, not its admissibility. See Rosenfeld v. Oceania Cruises, Inc., 654 F.3d 1190, 1193 (11th Cir. 2011) ("[I]t is not the role of the district court to make ultimate conclusions as to the persuasiveness of the proffered evidence." (quoting Quiet Tech. DC-8, Inc. v. Hurel-Dubois UK Ltd., 326 F.3d 1333, 1341 (11th Cir. 2003))). Thereby, the Court will not exclude Rosenzweig's design defect opinions as unqualified.

3. Methodology Used to Make Design Defect Conclusions

Defendant next argues that Rosenzweig's opinion on the Ajust's design defect should be excluded because they are unreliable. Doc. No. [106-1], 19. Specifically, Defendant argues that Rosenzweig made his 2014 General Report prior to ever seeing or touching an Ajust device, that he did not consider Ajust documents, and that his conclusions are not supported by other scientific study or literature. Id. Plaintiff responds that Rosenzweig's 2014 General Report's conclusions about the Align device's polypropylene mesh can reliably apply to the Ajust, which uses the polypropylene mesh as well. Doc. No. [117], 14-15. Plaintiff also notes that Rosenzweig considered two Ajust-specific articles in his 2021 Case Specific Report (Doc. Nos. [106-10], 57, 67; [117-5] (Rosenzweig Dep. Tr.), 210:3-11) and that Rosenzweig's supplemental disclosure included nearly 30 Ajust-specific materials that he reviewed. Doc. Nos. [117], 15-17; [97-2].

The Court concludes that Rosenzweig's methodology—while no gold standard—meets Daubert's requirements. Rosenzweig made his conclusions and submitted his report after reviewing numerous documents from Defendant about its sling devices and the scientific literature on polypropylene mesh. Doc. Nos. [97-2]; [106-9]; [106-10]. Rosenzweig directly connects the scientific studies he reviewed and their results to his conclusions that slings using polypropylene mesh should not be permanently implanted in the human body. See, e.g., Doc. No. [106-3], 15-17 (explaining that mesh is not meant to be used inside the body because of the risks of its interaction with strong oxidizing agents, such as the vagina), 19-27 (citing two scholarly articles in support of how mesh is likely to degrade inside the body), 27-29 (explaining how scientific studies on foreign body reactions applies to mesh implantation). Rosenzweig's general opinions about polypropylene mesh are linked to the Ajust specifically because it uses the polypropylene mesh. Doc. No. [106-2], 4-5. Notably, Defendant does not object that these studies as discussed by Rosenzweig are unreliable. Doc. No. [106-1], 18-19.

The Court thus concludes that Rosenzweig's conclusions flow from a reliable basis—that is from his extensive review of the relevant scientific literature on polypropylene mesh and sling devices generally, and Defendant's Ajust device specifically. Doc. Nos. [106-3], 12-44 (describing the dangers of polypropylene mesh in relation to the scientific literature); [106-2], 25 ("My general liability Align report describes the literature and material characteristics of urethral slings and I incorporate that report as if fully contained herein."). As such, Defendant's objection relates more to "the persuasive weight to be accorded [Rosenzweig's] testimony and report, not their relevance or reliability." Emps. Ins. of Wausau v. Latex Const. Co., No. 1:01-CV-1909-BBM, 2003 WL 26087498, at *7 (N.D. Ga. Sept. 2, 2003). The Court thereby will not exclude this testimony as unreliable.

4. Helpfulness of the 2014 General Report Opinions on Polypropylene Mesh

Defendant raises several objections to the helpfulness of Rosenzweig's opinions on polypropylene mesh. Rosenzweig's 2014 General Report makes conclusions about the polypropylene mesh used in Defendant's Align device specifically. Doc. No. [106-3], 4. Defendant specifically objects that because Rosenzweig's 2014 General Report does not mention Plaintiff's Ajust device it is irrelevant and unhelpful for a trier of fact assessing the facts of this case. Doc. No. [106-1], 16-17. Moreover, Defendant argues that to the extent Rosenzweig testifies that polypropylene mesh broadly was unsafe for implantation, this conclusion is unhelpful because the same mesh was used in all sling-implants at the time of Plaintiff's implant. Therefore, Defendant's Ajust device did not present unique risks for general causation to be proven. Finally, Defendant argues that because Rosenzweig generally concludes that the risks of polypropylene mesh were too high and that all slings used this mesh, no safer device was available at the time of Plaintiff's implant. Doc. No. [106-1], 17. Thereby, according to Defendant, Rosenzweig's general testimony on polypropylene mesh used in Defendant's sling devices cannot help Plaintiff prove her design defect claim. Id. The Court disagrees and will not exclude this testimony for the following reasons.

a) The Align Device

Defendant objects that Rosenzweig's 2014 General Report only discusses the Align device, not the Ajust, and thus is unreliable and unhelpful for this case, which involves the Ajust device. Doc. No. [106-1], 16-17. Plaintiff responds that the undisputed facts are that Defendant uses the same polypropylene mesh both in its Align and Ajust devices, and therefore Rosenzweig's conclusions about the Align's mesh is relevant to the Ajust. Doc. No. [117], 14.

The Court concludes that Rosenzweig's 2014 General Report's opinions on the Align device meet the admissibility standard for helpfulness. An opinion is helpful when there is a "fit" between its conclusion and the facts of the case.⁸ There is no "fit" when "a large analytical leap must be made between the facts and the opinion." McDowell v. Brown, 392 F.3d 1283, 1298-99 (11th Cir. 2004).

8 There appears to be conceptual overlap between the reliability analysis above and the helpfulness (or "fit") analysis, though both must be proven for expert testimony to be admissible. Quiet Tech., 326 F.3d at 1341 ("Importantly, although there is some overlap among the inquiries into an expert's qualifications, the reliability of his proffered opinion and the helpfulness of that opinion, these are distinct concepts that courts and litigants must take care not to conflate."). Generally, reliability focuses on the expert's methodology used, whereas helpfulness pertains to the facts in a specific case. Discussions of a conclusion's "fit" derived, however, have been recently discussed in determining reliability for the Daubert analysis. See, e.g., Arevalo, 2022 WL 16753646, at *3 ("To evaluate the reliability of a scientific expert opinion . . . [t]here can't be too great an analytical gap between the data and the expert's opinion, and the expert cannot bridge this gap with mere ipse dixit." (emphasis added)). Ultimately, under either prong, the Court concludes that Rosenzweig's 2014 General Report's opinions on the Align device are supported by reliable methods and would be helpful to the trier of fact in this case—which involves a similar device that also uses the polypropylene mesh.

No such leap is required here, however. Plaintiff successfully submitted undisputed evidence that Defendant uses the same polypropylene mesh in both the Align and Ajust devices. Both parties' experts testified as such. Doc. Nos. [117-5] (Rosenzweig Dep. Tr.), 208:9-18, 209:12-21; [117-6] (Culligan Dep. Tr.), 35:18-20, 37:25-38:5. In fact, Defendant's own expert's report included conclusions about the Align device and the expert later confirmed at his deposition that these conclusions were relevant to his opinions about the Ajust device. Doc. Nos. [110-1], 13-14, 100-02; [117-6] (Culligan Dep. Tr.), 36:5-8. When Defendant sought FDA approval for the Ajust device, it listed the Align device as a "predicate" for the Ajust and ensured that the devices had the "same indications for use, intended use, and fundamental technology." Doc. No. [117-7], 23. Given (a) there is the undisputed evidence that Defendant used the same polypropylene mesh in both the Align and Ajust devices and (b) the risks of polypropylene mesh is the basis of Rosenzweig's expert conclusions, the Court concludes that Rosenzweig's 2014 General Report's opinions about the Align device would be helpful to a trier of fact—the differences in the devices is a subject better left for cross-examination. Rosenfeld, 654 F.3d at 1193.

b) General Causation

Defendant also objects to Rosenzweig's conclusion that polypropylene mesh should not be used as a permanent implant. Defendant argues that this opinion cannot support Plaintiff's case because polypropylene mesh, at the time of implantation, was used in all slings aimed at resolving SUI diagnoses. Doc. No. [106-1], 17. Thus, because there is not a uniquely defective aspect to the Ajust device, Rosenzweig's conclusion that the Ajust's polypropylene mesh rendered the device too risky for use is insufficient for Plaintiff to prove her design defect claim, which requires showing that the Ajust specifically could have caused Plaintiff's injuries. Id.

Plaintiff responds that there is no authority supporting Defendant's argument that a device must have a unique defect for a defective design claim. Doc. No. [117], 12. Plaintiff furthermore argues that Rosenzweig unequivocally concludes in his 2014 General Report that polypropylene mesh—which is used in the Ajust device—can cause the type of injuries Plaintiff sustained. Id. at 11-12. Thus, Plaintiff maintains that Rosenzweig's opinions will help the trier of fact assess whether Plaintiff has proven the general causation element.

The Court denies Defendant's motion to exclude this testimony as the objections made are not an appropriate inquiry on a Daubert motion. While the Court's Daubert analysis must consider the "fit" between an expert's opinions and the claims at issue, Defendant's argument here extends beyond "fit" into the viability of Plaintiff's claims and evidence—quintessential merits issues. The Court, moreover, has already concluded that Rosenzweig's 2014 General Report's assessment of the risks of polypropylene mesh is relevant to the Plaintiff's case about the Ajust device. Accordingly, Rosenzweig's general causation opinions are admissible.

c) Safer and Effective Alternatives

Similarly, the Court rejects Defendant's argument that Rosenzweig's testimony should be excluded because it fails to name a safer and effective alternative to the Ajust. While Rosenzweig identifies four safer alternatives to the polypropylene mesh used in the Ajust, Defendant argues that three of Rosenzweig's named alternatives—"(1) the use of sutures, including delayed absorbable sutures like PDS, in a colposuspension procedure like the Burch; (2) autologous fascia sling; (3) an allograft sling such as Repliform" (Doc. No. [117-3], 25)—are procedures, not designs, and therefore cannot be used to support Plaintiff's claim. Doc. No. [106-1], 20. As for the fourth alternative—"(4) a sling with less polypropylene such as Ultrapro" (Doc. No. [117-3], 25)—Defendant claims this alternative is insufficient because Rosenzweig admitted that even a reduced amount of polypropylene mesh would have made a device defective. Doc. Nos. [117-5] (Rosenzweig Dep. Tr.) Tr. 203:13-25; [106-1], 20-22. Moreover, a sling with less polypropylene mesh was not available at the time of Plaintiff's implant, so it could not be a safer alternative (Doc. No. [106-1], 22).

Plaintiff responds that Defendant fails to properly state the requirements of Georgia's design defect action, maintaining that: (1) Georgia law considers safer alternatives as one factor among many non-dispositive factors for determining if a product's design was defective, (2) Rosenzweig's first three alternatives qualify as safer alternatives because Georgia law allows assessing alterative procedures, not just designs, and (3) Georgia law does not require an alternative to completely "fix" the design defect, but merely identify a safer—even if not curative—alternative. Doc. No. [117], 11-13.

Again, the Court concludes that these are merits issues exceeding the scope of the instant Daubert motion. Sustaining Defendant's objection would require assessing the contours of Georgia law on design defects—an inquiry exceeding Rule 702's analysis of qualification, reliability, and relevance. Thus, these issues will be addressed more properly on summary judgment. As Rosenzweig's qualifications enable him to render an opinion on safer alternative designs to the Ajust—an opinion relevant to the design defect claim at issue—the Court will not exclude this testimony.

5. Specific Case Opinions

Defendant then moves to exclude Rosenzweig's case specific opinions on Plaintiff's mesh implant and reaction because they lack a factual foundation. Doc. No. [106-1], 23. Specifically, Defendant argues that Rosenzweig fails to connect Plaintiff's medical records with his general conclusions that polypropylene mesh "degrades over time, causes chronic foreign body reactions, fibrotic bridging, mesh contracture/shrinkage, fraying, particle loss, biofilm formation and infections, has sharp edges, ropes, curls and deforms, and the pores collapse with tension." Doc. No. [106-1], 23 (citing Doc. No. [106-2], 4).

Plaintiff responds that Rosenzweig in fact did connect Plaintiff's evidence with his general conclusions on polypropylene mesh. Namely, Plaintiff cites the report of her treating physician, which indicates that at the time of observation that "there was tension and banding on [the mesh]." Doc. No. [117], 23 (citing [Doc. No. 117-4] (Moore Dep. Tr.), Tr. 38:1). Plaintiff then cites Rosenzweig's report, which concluded that such banding and contraction can, at the least, relate to a reduced pore size. Doc. No. [117], 23. According to Rosenzweig's 2014 General Report, reduced pore size can impede "the intended purpose of the mesh" and cause complications like "pain with the rigid mesh, shrinkage, contraction of the mesh, erosions due to mechanical irritation in the tissue of a rigid, scar-plated mesh, nerve entrapment, chronic pain and dyspareunia." Doc. No. [106-3], 39.

The Court understands Rosenzweig's conclusions to generally explain why someone might be experiencing pain once the polypropylene mesh has been implanted, an explanation that might not practically be included in a personal medical record. For example, Rosenzweig identifies that Plaintiff's pain was likely due to an adverse reaction to the foreign body implant or that the sling's mesh was incompatible with the vagina, a strong oxidizing agent. Doc. No. [106-2], 20-21. These conclusions would not necessarily be included in a patient-specific medical record because they instead look broadly at the problems with using polypropylene mesh, trying to explain its propensity for causing pain like Plaintiff experienced here. While Rosenzweig's 2021 Case Specific Report could certainly more clearly connect Plaintiff's medical evidence with his broader conclusions, the Court concludes that this lack of clarity once again goes to the weight, not the admissibility of Rosenzweig's conclusions. Rosenzweig's conclusions are based on Plaintiff's treating physician's records that the Ajust implant was the source of her pain and the scientific literature that a polypropylene mesh implant can cause the type of pain Plaintiff experienced. Doc. No. [106-2], 20-21. Thus, Rosenzweig's testimony is admissible under Daubert to support the case-specific cause of Plaintiff's pain.

6. Post-Explant Pain

Defendant next objects to Rosenzweig's conclusion that the Ajust caused Plaintiff's pain after the device had been explanted. Specifically, Defendant argues this testimony is speculative, unreliable, and does not fit the evidence submitted. Doc. No. [106-1], 26-28. Plaintiff responds that the evidence clearly shows that Plaintiff continued to experience pain post-explant and that the scientific literature supports Rosenzweig's conclusions. Doc. No. [117], 25-26. On this issue, the Court agrees with Defendant. It accordingly GRANTS Defendant's Motion and so EXCLUDES Rosenzweig's testimony because it directly contradicts undisputed evidence, thus would not be helpful to a trier of fact. Quiet Tech., 326 F.3d at 1347 ("Expert testimony which does not relate to any issue in the case is not relevant and, ergo, non-helpful." (quoting Daubert, 509 U.S. at 591, 113 S.Ct. 2786)).

Rosenzweig's case-specific report concludes that the Ajust caused Plaintiff's post-explant injuries and pain. Doc. No. [106-2], 21-23. Namely, Rosenzweig speculates that pieces of the Ajust likely remain in Plaintiff's body after the explant procedure, and these remaining pieces continue to and will continue to cause Plaintiff pain. Id. at 21. This speculation is Rosenzweig's only support of his conclusion that the Ajust is causing Plaintiff's post-explant pain.⁹ Id.

9 Rosenzweig's broad assertion that nothing else in Plaintiff's medical records would explain Plaintiff's symptoms is not supported by any reasoning or methodology. Doc. No. [106-2], 21. Thus, the Court determines that it is unreliable.

While scientific literature might very well support Rosenzweig's conclusion that polypropylene mesh is often left inside patients after explant surgery, these studies alone do not make Rosenzweig's testimony relevant and helpful in Plaintiff's case. Quiet Tech., 326 F.3d at 1347 (discussing Daubert's helpfulness requirement as requiring "relevance" and "fit" to the case in which the expert is testifying). Defendant here has presented undisputed evidence that no mesh remains in Plaintiff's body post-explant. Plaintiff's explant report specifically accounts that the doctors "were able to remove both sides [of the Ajust] completely intact [so that] 100 percent of the mesh and the sling [was removed]." Doc. No. [117-4] (Moore Dep. Tr.), Tr. 72:11-14. Plaintiff's treating physician testified that he was "confident" that he fully removed all the mesh from Plaintiff's body. Id. at Tr. 21:13-14. Rosenzweig himself acknowledged that the pathology report "describes that [the mesh] was removed in two segments which together were the length of the original mesh implanted," indicating that the mesh had been fully removed. Doc. No. [117-5] (Rosenzweig Dep. Tr.), Tr. 38:21-23. Rosenzweig further acknowledged that when doctors observed Plaintiff in 2014, they did not find any mesh in Plaintiff when they conducted exploratory surgery. Id. at Tr. 39:17-20. Rosenzweig finally admitted that a "transvaginal ultrasound" determined that no mesh remained in Plaintiff. Id. at Tr. 148:12-13. Rosenzweig's only response is that because mesh is difficult to fully remove it is "more likely than not" that mesh remains in Plaintiff, but otherwise fails to cite any specific evidence. Id. at Tr. 39:7-14. Thus, Plaintiff has offered no evidence to dispute Defendant's extensive evidence that no mesh remains in Plaintiff.

Given these undisputed facts that no mesh remains in Plaintiff post-explant, the Court concludes that Rosenzweig's conclusions that mesh is "more likely than not" left in Plaintiff does not meet Rule 702's requirements to be "relev[ant]" and "fit" expert testimony. Quiet Tech., 326 F.3d at 1347. The Court therefore GRANTS Defendant's motion to exclude Rosenzweig's opinions that the Ajust implant continued to cause Plaintiff's pain and health issues post-explant.

7. The Ajust's IFU Warning

Defendant finally objects to Rosenzweig's opinions on the adequacy of the Ajust's IFU warning. Defendant again raises the issue that Rosenzweig's 2014 General Report only discusses the Align device and therefore is not relevant for Plaintiff's case involving the Ajust device. Doc. No. [106-1], 28-29. Defendant argues that Rosenzweig merely assumes that the two devices are similar without providing any support for that assumption.¹⁰ Id. Plaintiff responds that Rosenzweig did review the Ajust IFU. Doc. No. [117], 27; see also Doc. No. [97-2]. Moreover, Plaintiff contends that because the Ajust and Align devices are "substantially equivalent designs" any conclusions about the Align device's IFU can be reliably applied to the Ajust. Doc. No. [117], 14-15, 27.

10 Defendant did not object to Rosenzweig's qualifications to make these opinions on Defendant's warnings and the Court agrees that he is qualified to opine on the adequacy of the IFU's warnings. See Doc. No. [106-3], 50 (discussing Rosenzweig's experience in reviewing IFUs generally and for mesh products, his clinical experience in discussing IFU information with patients, and his review of numerous of Defendant's IFUs).

The Court has previously agreed with Plaintiff that the similarities between the two devices' use of polypropylene mesh render Rosenzweig's 2014 General Report's conclusions helpful and reliable as applied to the Ajust device. The objection to Rosenzweig's IFU warning opinions, however, is not about the Align and Ajust devices' design, but rather the IFU's warnings for each device. An IFU enables physicians to discuss a specific procedure's risks and obtain informed consent for that procedure from the patient. Thus, the Ajust's specific warnings are of a particular relevance and cannot merely be assumed from the warnings of the Align device. No argument, however, has been made that the IFUs for the Align and the Ajust were substantially similar.

Thus, Rosenzweig incorporating his 2014 General Report into the 2021 Case Specific Report does not resolve potential reliability and fit issues. Doc. No. [106-2], 25. Rosenzweig's IFU analysis in his 2014 General Report does not focus on the risks of polypropylene mesh generally, but about the disclosure of these risks in the Align device's IFU. Doc. No. [106-3], 49-60. He discusses the three versions of the Align IFU and the risks disclosed in each. Id. at 51-58. Rosenzweig ultimately concludes that the disclosures were inadequate for the Align device specifically.¹¹ Doc. No. [106-3], 58-61. In neither Rosenzweig's 2021 Case Specific Report or 2014 General Report does he ever contend that the Ajust and the Align IFUs make the same disclosures. The only connection Rosenzweig makes between the Align and the Ajust devices in his inadequate disclosure opinions is that "[t]he Ajust sling is inserted in a similar manner to other urethral slings and the polypropylene material in this device is substantially similar to the polypropylene material used in other urethral sling devices, including the Align device." Doc. No. [106-2], 25. Without any basis that the Ajust and Align IFUs suffer from the same disclosure defects, the Court cannot reliably credit Rosenzweig's Align IFU opinions to the Ajust IFU as helpful to a trier of fact in this Ajust case.

11 The only conclusion in the 2014 General Report that might apply to the Ajust is that the MSDS disclosure recommending not to implant polypropylene mesh permanently in a human body. Doc. No. [106-3], 61-62. Even this statement, however, is in reference to the lack of disclosure of the MSDS recommendation in Align device materials. Id. The Court's holding that Rosenzweig's opinions involving the MSDS in the Ajust's disclosures nevertheless does not alter Rosenzweig's ability to testify about the MSDS in reference to the Ajust's design defect. The MSDS makes a broad statement about the general risks of polypropylene mesh and is thus relevant testimony about the Ajust device's safety specifically. Because, however, Rosenzweig did not connect his Align opinions about inadequate disclosure of risks to the Ajust device or its disclosure documents for it to be relevant in this case's failure to warn claim, his testimony on this limited issue is inadmissible.

Accordingly, the Court must focus on the substance of Rosenzweig's failure to warn conclusions in his 2021 Case Specific Report to determine if the expert opinions are admissible. Rosenzweig's 2021 Case Specific Report broadly asserts that the Ajust IFU did not contain adequate information on the risks of the device and failed to make appropriate disclosures. Doc. No. [106-2], 23 ("[Defendant] failed to include and/or describe the significant adverse events and risks in its Instructions for Use (IFU) for the device. [Defendant] did not fully inform physicians about numerous adverse reactions/risks associated with the Ajust."), 26 ("[Defendant's] warnings and disclosures of adverse events in its Ajust Instructions for Use ('IFU') have been inadequate based on the adverse reactions and risks associated with the Ajust that have been known to [Defendant] from the time the Ajust was first sold and marketed, and [Defendant] did not disclose information to physicians in its IFUs regarding characteristics of the mesh that makes it unsuitable for its intended application as a permanent prosthetic implant for stress urinary incontinence . . . ."). Rosenzweig goes on to state that these risks were known by Defendant, that the IFU mischaracterized the risks, and that Defendant did not update the IFU's risks when possible. Doc. No. [106-2], 25. These general statements, however, do not reliably support a conclusion that the Ajust's IFU warnings were inadequate.

The Court must accordingly conclude that these opinions do not meet Rule 702's requirements. Rosenzweig's 2021 Case Specific Report does not discuss the Ajust IFU's content or the information it failed to disclose. Id. at 23-26. Instead Rosenzweig makes sweeping conclusions about Defendant's failure to warn in the Ajust IFU that are not reliably supported. Id. at 26. This testimony, therefore, does not meet Daubert's requirements. Consequently, the Court GRANTS Defendant's motion to exclude Rosenzweig's conclusions relating to the Ajust IFU's inadequate warnings.¹²

12 Defendant makes a final objection to Rosenzweig's opinions and testimony about Defendant's failure to appropriately test its devices. Plaintiff, however, disclaims that Rosenzweig will testify to the adequacy of Defendant's testing of the Ajust device. See Doc. No. [117], 23 ("Dr. Rosenzweig does not intend to opine at trial regarding specific additional or different tests be believes should have been conducted on the Ajust device . . . ."). Thus, Defendant's motion to exclude to this testimony is mooted based on Plaintiff's concession.

B. Dr. Guelcher

The Court now turns to Defendant's motion to exclude to Plaintiff's general causation expert, Dr. Scott Guelcher, who is submitted as expert in biomedical materials. Guelcher holds his Ph.D. in chemical engineering and namely will be offered to discuss the polypropylene mesh used in Defendant's sling devices. Doc. Nos. [115-3], [115-1]. Guelcher specifically studied the polypropylene mesh in Defendant's Align device and concluded that the properties of polypropylene mesh, when implanted in the human body, cause a reaction that often leads to degradation. Doc. No. [115-3], 4. Defendant objects to Guelcher's opinions and testimony, arguing are inadmissible as they pertain to: (1) the Align device, (2) mesh degradation, (3) antioxidants stabilizing the polypropylene mesh, (4) the MSDS's statement that polypropylene mesh is never suitable for permanent implant in the human body, and (5) his personal experiments of pelvic mesh explants. The Court ultimately concludes that Guelcher lacks qualification to assert his conclusions about permanent implantation and that these conclusions are derived from unreliable methods. Thus, this piece of testimony is inadmissible. Otherwise, however, the Court concludes that Guelcher's testimony is admissible under Daubert.

1. The Align Device

Like its objection to Rosenzweig's testimony, Defendant objects to Guelcher's opinions about the Align device being used in Plaintiff's Ajust case. Doc. No. [107-1], 13-14. For the same reasons that the Court allowed Rosenzweig's opinions about the polypropylene mesh in the Align device, the Court will also allow Guelcher's opinions on the same. See supra 1328-29. In short, because both devices undisputedly use the same polypropylene mesh, no "large analytical leap must be made between the facts and the opinion," and Guelcher's opinions on polypropylene mesh in the Ajust are helpful and fit for Daubert purposes. McDowell, 392 F.3d at 1298-99.

2. Polypropylene Mesh Degradation

Defendant next objects to Guelcher's opinions about polypropylene mesh degrading over time. Defendant argues that Guelcher's opinions on mesh degradation are: (1) unhelpful because there is no evidence that Plaintiff's mesh degraded, (2) unqualified, and (3) based on unreliable methodology. Doc. No. [107-1], 14-17. Ultimately, the Court concludes that Guelcher's testimony meets Daubert's requirements and thereby is admissible.

Defendant first argues that Guelcher's opinions are unhelpful and unfit for this case because there is no evidence that Plaintiff's mesh degraded. Doc. No. [107-1], 15-16. Plaintiff argues that she has presented sufficient evidence of degradation for Daubert purposes. Doc. No. [115], 8-10.

The Court agrees with Plaintiff. Guelcher's report states that "[a]fter implantation, the surface of the polypropylene mesh reacts with reactive oxygen specifies that are secreted by inflammatory cells, causing it to degrade." Doc. No. [107-2], 4. Plaintiff's treating physician testified in his deposition that Plaintiff's pain post-explant could be on account of "chronic inflammatory reaction . . . from the initial sling and from the removal." Doc. No. [117-4] (Moore Dep. Tr.), Tr. 120:13-21. He also testified that Plaintiff's mesh had contracted while the Ajust was implanted. Id. at Tr. 38:11-15, 104:14-15. Thus, Plaintiff has shown that her mesh contracted, that such contraction could be due to inflammation following the implant, and that inflammation can cause mesh to degrade.¹³ The Court further determines that Plaintiff sufficiently connected the evidence of her inflammatory reaction and polypropylene mesh contraction to Guelcher's general causation conclusions about polypropylene mesh contracting and degrading. Thus, there is a sufficient "fit" between Guelcher's general causation opinion and the facts of this case.¹⁴

13 For his part, both Rosenzweig's 2021 Case Specific Report and 2014 General Report discuss that characteristics of the mesh can cause degradation and contraction, that an inflammatory response in the body causes mesh contraction, and that he could conclude with a reasonable degree of certainty that Plaintiff's mesh had degraded. Doc. Nos. [106-2], 3, 18; [106-3], 35-36. Defendant asserts that Plaintiff has "agreed that Dr. Rosenzweig would not opine that there was evidence of degradation in Plaintiff's Ajust." Doc. No. [120], 7. The Court, however, finds no such admission by Plaintiff in its opposition response. Plaintiff argues that Rosenzweig "discusses his review of Ms. Kelley's medical records and provides his medical opinion regarding how the polypropylene mesh caused Ms. Kelley's injuries" in his case-specific report and that to the extent Rosenzweig's deposition testimony exceeds his report it was in response to questions asked by opposing counsel. Doc. No. [117], 10. Plaintiff concede that it is "certainly underst[ood] that [Rosenzweig] cannot offer opinions beyond those disclosed, and he will not offer opinions that do not appear in his general report or case-specific reports." Doc. No. [117], 10. This concession, however, does not appear to indicate that Rosenzweig will not testify about Plaintiff's mesh degradation at all.

14 Because the Court concludes that Guelcher is qualified to make his opinions on mesh degradation and that these opinions are reliable and fit for this case under Daubert's requirements, the Court denies Defendant's request for a Rule 104 hearing to determine the admissibility of this evidence. Federal Rule of Evidence 104(a) allows the court to "decide any preliminary question about whether a witness is qualified, a privilege exists, or evidence is admissible." The Court can conduct a hearing outside the presence of the jury to make this determination, if it is so needed. Fed. R. Evid. 104(c). A Rule 104 hearing, however, is not necessary in this case given the extensive reports and arguments submitted for the Daubert motion. See United States v. Roberts, No. 2:05-CR-119-MEF, 2006 WL 8441439, at *1 (M.D. Ala. Mar. 15, 2006) ("[N]e[i]ther Rule 104(a) itself nor Daubert require that the district court hold a pretrial hearing to determine the admissibility of expert testimony. It is within the court's discretion to decide when and how it will determine the reliability of expert testimony.").

Defendant next objects to Guelcher's qualifications to discuss a patient's clinical symptoms arising from the degradation of polypropylene mesh because he is not a medical doctor and has no experience in diagnosis or treatment of medical problems from degraded polypropylene mesh. Doc. No. [107-1], 17-19.

The Court concludes, however, that Guelcher's statements about clinical symptoms are general and limited to discussing chronic inflammation arising from polypropylene mesh as a biomaterial. Guelcher's specific conclusions are that (1) "the literature has supported the notion that less material, less surface, and larger pore reduce the adverse events in PP mesh implantees" (Doc. No. [107-2], 12), (2) the degradation "triggered by the presence of a chronic inflammatory response . . . can be maintained for years following the implantation" (id. at 13), (3) "explants [often] showed evidence of chronic inflammation" (id.), and (4) "the persistence of a foreign body reaction at the mesh-tissue interface might cause severe problems, particularly in the young patients, in whom the mesh is expected to hold for several decades" (id. at 14). Given Guelcher's qualifications to testify about polypropylene mesh as a biomaterial and its reaction to the chemical characteristics of the human body, the Court concludes he is qualified to testify generally about the specified adverse effects and inflammation resulting from a mesh implant, as he has done here.¹⁵ See id. at 3.

15 Defendant also objects to Guelcher testifying about matters disclaimed in his deposition and outside his report, such as specific causation of Plaintiff's clinical complications, design defect, and alternative designs. Doc. No. [107-1], 31. Plaintiff concedes that Guelcher is unable to give opinions on clinical complications and alternative designs. Doc. No. [115], 15. Plaintiff further says that the only opinion Guelcher will render on the design defect is that "polypropylene degrades in the human body, which triggers an inflammatory response in the body." Id. at 15-16. This limited opinion is general causation opinion relevant to the design defect claim, which the Court has already determined will not be excluded under Daubert. Thus, Plaintiff's concession moots most of Defendant's objection, which is otherwise denied.

Finally, Defendant argues that Guelcher did not use reliable methods to form his conclusions about the adverse consequences of degraded mesh. Doc. No. [107-1], 19. The Court, however, concludes that Guelcher's opinions are reliably supported because he derives them from his knowledge and experience in biochemistry and the peer-tested medical literature.¹⁶ Even if Guelcher is not a medical doctor, his experience with chemical engineering and biomaterials qualify him to discuss clinical literature, which is also a reliable basis for him to make him conclusions. Any issue Defendant raises is better addressed on cross examination.

16 In fact, opinion (3) noted above, supra 1336, is a direct quote from a published paper. Doc. No. [107-2], 14 & n.43.

3. Antioxidants as Stabilizers

Defendant next objects to Guelcher's opinions about the stabilizing effect antioxidants have on polypropylene mesh. Doc. No. [107-1], 21-22. Defendant specifically argues that these opinions should be excluded because: (a) they discuss the Align device, not the Ajust, (b) there is no proof of degradation in this case, (c) these opinions are irrelevant because they do not comment on the final Ajust device's safety, and (d) Guelcher's only methodology relies on his personal, undisclosed experiments. Doc. No. [107-1], 21-22.

The Court concludes that Guelcher can testify on antioxidants' effect on mesh degradation. Defendant's first two arguments have already been addressed by the Court: first, conclusions about the polypropylene mesh used in the Align device are helpful in this Ajust case because the same mesh is used in both devices, and second, there is adequate evidence for Daubert purposes connecting Plaintiff's inflammatory response to the implant with a conclusion that the mesh had degraded.

The Court further concludes that Guelcher's antioxidant opinions are helpful and fit despite Defendant's objection that the opinions do not relate to the final Ajust device after being tested. Defendant's objection does not impugn the reliability of Guelcher's opinions, and any problem raised is better left to cross examination.

Finally, the Court will more fully address Guelcher's use of materials undisclosed in his report below, infra 1338-40, but concludes Guelcher appropriately looked at Defendant's records describing the use of polypropylene mesh and cited to scientifically tested literature to support his conclusions. Thus, his opinions are reliable. See Doc. No. [107-2], 12 n.35.

4. The MSDS and Permanent Implantation

Defendant argues that Guelcher's opinion that permanent implantation of polypropylene mesh in the human body is unsafe should be excluded because (a) his opinions about degradation are irrelevant and unreliable, (b) these opinions rely on inadmissible hearsay, and (c) his opinions about the contents of the mesh are not based on scientific data or testing, but instead a legal disclaimer. Doc. No. [107-1], 23.

Plaintiff, in response, cites the MDL court which allowed experts to use MSDS warnings in forming their opinions on how the mesh reacts in the human body. Doc. No. [115], 11-12. Thus, the Court will address what effect the MDL court's rulings have in this now-transferred case. The MDL court allowed a urogynecologist expert (Dr. Rosenzweig) to use and testify to the MSDS statements "to support his concerns about mesh use in the vagina" even if "[t]he MSDS [does] not expressly forbid implantation in humans." In re Ethicon Inc. Pelvic Repair Sys. Prod. Liab. Litig., No. MDL 2327, 2016 WL 8788207, at *4 (S.D. W. Va. Aug. 26, 2016).

Preliminarily, and substantively, the MDL's determination here does not resolve the instant objections to Guelcher's testimony because Guelcher is not a urogynecologist relying on the MSDS for his conclusions about medical procedures. Even if the MDL's determination on this issue applied, however, the Court, is not bound by its determinations. Cf. In re Jan. 2021 Short Squeeze Trading Litig., 584 F. Supp. 3d 1161, 1179 (S.D. Fla. 2022) ("Consolidated pleadings in multidistrict litigation are generally a procedural device that facilitates streamlined litigation."); In re Jan. 2021 Short Squeeze Trading Litig., 580 F. Supp. 3d 1243, 1250 (S.D. Fla. 2022) ("MDL member cases are 'intended to resume their independent status once the pretrial stage of litigation is over.' ") (quoting In re Mortg. Elec. Registration Sys. (Mers) Litig., No. MD-09-02119-PHX-JAT, 2016 WL 3931820, at *8 (D. Ariz. July 21, 2016)); Tenn. Med. Ass'n v. United Healthgroup Inc., No. 00-1334-MD, 2014 WL 12837582, at *4 (S.D. Fla. Jan. 16, 2014) ("[T]he purpose of an MDL is to conduct whatever 'coordinated or consolidated pretrial proceedings' are necessary among 'civil actions involving one or more common questions of fact.' ") (emphasis in original) (quoting 28 U.S.C. § 1407(a)). Thus, as the MDL court transferred this case back to this Court, its determinations about the MSDS's admissibility are non-binding on these Daubert issues.

Turning now to Defendant's objections, the Court has already determined that Guelcher is able to testify about degradation of polypropylene mesh generally, supra 1334-37. Next, while the Court acknowledges Defendant's hearsay argument, it also recognizes that this is a motion to exclude under Daubert and Rule 702. The inquiry, therefore, focuses on scientific, technical, and other expertise that will assist the factfinders in this case. Adams, 760 F.3d at 1328. The Court, accordingly, will not exclude Guelcher's expert testimony based on potential hearsay contained in the MSDS document. See, e.g., Anderson v. Hunte Delivery Sys., Inc., No. 2:11-CV-355-TFM, 2012 WL 1392918, at *2 (M.D. Ala. Apr. 23, 2012) ("While there are potential hearsay issues with these statements as well as exceptions to the rule presented by the Plaintiffs, the Court considers the statements for the purposes of the Daubert Motion."); cf. Fed. R. Evid. 703 ("An expert may base an opinion on facts or data in the case that the expert has been made aware of or personally observed. If experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject, they need not be admissible for the opinion to be admitted." (emphasis added)).

Finally, the Court considers Defendant's argument that the MSDS is a legal disclaimer that does not provide a scientific or testable method for Guelcher to make conclusions about the polypropylene mesh's safety. Having considered Guelcher's report and the MSDS, the Court agrees with Defendant that Guelcher's conclusions derived solely from the MSDS are not based on reliable methods or matters on which his expertise qualifies him to testify.

Plaintiff's offer Guelcher as general causation expert who will testify about polypropylene mesh as a biochemical material. See Doc. No. [115], 4. Guelcher concludes, however, that "[t]he [polypropylene] used to Make the Align is not Intended for Human Implantation." This conclusion rests solely only on the MSDS, which warns to "not use [the polypropylene materials] in medical applications involving permanent implantation in the human body . . . ." Doc. No. [107-2], 14. Guelcher's biochemical engineering experience does not qualify him to testify about the safety of a medical implantation procedure or to opine on the veracity of this warning. The only support for Guelcher's opinion that polypropylene mesh is not suitable for permanent implantation is the MSDS's comment on the effect of oxidizing agents on the polypropylene. Doc. No. [107-2], 14. While Guelcher's experience would qualify him to testify about the biomaterials in the polypropylene mesh, the MSDS's statement alone does not support a conclusion about the safety of permanent implantation or otherwise qualify him to testify about an implantation procedure. Thus, the Court GRANTS Defendant's motion to exclude Guelcher's opinion testimony about the suitability of polypropylene mesh for permanent implantation according to the MSDS.

5. Undisclosed Personal Experiments

Defendant finally objects to Guelcher's deposition testimony about his experimental testing of pelvic mesh explants.¹⁷ Doc. No. [107-1], 27. Guelcher's experiments created a "microenvironment between the inherent cell and the polymer surface" to determine (a) if polypropylene mesh degrades in response to oxygen and (b) how long antioxidants last to support the mesh. Doc. No. [107-6] (Guelcher Dep. Tr.), Tr. 63:3-64:24. These experiments ultimately concluded that oxygen causes polypropylene mesh to degrade and that antioxidants last twice as long to support the mesh. Id. In these experiments, Guelcher specifically advised on what tests to run and how to interpret the data collected. Id. at Tr. 44:21-46:25. Guelcher also admits that his team conducted these experiments for litigation against a different mesh manufacturer and did not test any of Defendant's mesh. Id.

17 Defendant objects furthermore to Guelcher's testimony on Defendant's state of mind. Doc. No. [107-2], 26 (emphasizing opinions such as that Defendant " 'ignored' scientific principles and sought 'to hide' its supply chain."). Plaintiff, however, concedes Guelcher will not testify about state of mind or intent. Doc. No. [115], 12 ("Guelcher only intends to testify as to [Defendant] corporate documents" to explain "the basis for his opinions."). Thus, Plaintiff's concession moots Defendant's objection.

Defendant first argues that Guelcher's testing of the mesh explants was not discussed or disclosed in his expert report and thus should be excluded as untimely disclosed. Doc. No. [107-1], 28-29. The Federal Rules require Guelcher's report to include "a complete statement of all opinions the witness will express and the basis and reasons for them." Fed. R. Civ. Pro. 26(a)(2)(B)(i). Here, the parties received Guelcher's report and took his deposition testimony while the MDL was still in charge of the case's proceedings. Guelcher is certainly able—and, Plaintiff indicates, willing (Doc. No. [115], 13 n.6)—to supplement his report with an updated CV to include these additional experiments and the paper published as a result (the "Talley Paper"). These updated disclosures still fall within the Rule 26(a)(2)(D)(i) pre-trial period for disclosing expert testimony. See also Fed. R. Civ. Pro. 26(e)(1)(A) (allowing "additional or corrective information" to be supplemented to expert disclosures). The Talley Paper speaks to matters relevant to this case, specifically the characteristics and risks of polypropylene mesh, and if supplemented expeditiously, will adequately afford Defendant "reasonable opportunity to prepare for effective cross examination." Stand "N Seal, 623 F. Supp. 2d at 1361 (quoting Reese, 527 F.3d at 1265).

Defendant also objects to Guelcher's experiment and the Talley Paper as being unreliable and methodologically flawed. Specifically, Defendant contends that its testing (a) did not rely on Defendant's mesh, (b) does not control for similar attributes in the in vitro and in vivo samples, (c) pose a high risk of contamination and error, and (d) failed to examine control samples in the in vitro testing.

As for the first issue, the Court has already determined that it will not exclude opinions (or, as relevant here, experiments) on similar devices that use polypropylene mesh solely because they involve different mesh sling devices. As long as there is a sufficient similarity in the devices' use of the polypropylene mesh, then any differences in the devices do not alter the reliability of the conclusions reached and is a subject better for cross examination.

As for the other substantive issues raised about the Talley Paper's methods, some sister district courts, when presented with similar objections, have allowed Guelcher to use the Talley Paper to support his conclusions, while others have not. Compare, e.g., Wood v. Am. Med. Sys. Inc., No. 120CV00441DDDKLM, 2021 WL 1178547, at *4 (D. Colo. Mar. 26, 2021) (admitting the Talley Paper because the arguments against "fail[ed] to explain why any of these features of the Talley Study render the Doctor's opinions unreliable") with, e.g., Salinero v. Johnson & Johnson, No. 1:18-CV-23643-UU, 2019 WL 7753453, at *15 (S.D. Fla. Sept. 5, 2019) (disallowing the Talley Paper because of reliability issues, "including that (1) the authors purported to 'recapitulate' in vivo conditions by using an oxidative medium composed of, inter alia, 20% hydrogen peroxide (the 'Talley Medium'), and cited to one particular study (the 'Zhao study') to support the composition of the Talley Medium, but the Zhao study used an oxidative medium with only 10% hydrogen peroxide,—the discrepancy between the Talley Medium and the Zhao study's medium was never explained; and (2) the Talley testing examined both untreated fibers and fibers that had been 'scraped' in efforts to remove an outer layer of tissues and proteins, yet did not identify any protocol for 'scraping,' much less adhere to any protocol . . . ." (citations omitted)).

This Court agrees with the district courts that have allowed Guelcher to testify on the Talley Paper. While Defendant may raise valid criticisms of the Talley Paper's methods and conclusions, "flaws like these ones are fodder for cross-examination—they don't fundamentally undermine the Talley study or Dr. Guelcher's limited reliance on it." Wood, 2021 WL 1178547, at *4. Thus, as long as the requisite disclosures are made, Guelcher's testimony made in reliance on these experiments and the Talley Paper's conclusions will be admissible.

C. Dr. Culligan

Plaintiff moves to exclude Defendant's expert, Dr. Patrick Culligan. Culligan is a medical doctor who specializes in Obstetrics and Gynecology. Doc. No. [110-1], 2. His report discusses generally the urogynecology issues Plaintiff suffers from and potential treatments. Id. at 3-14. He concludes that "these products are safe and effective" and that they "were developed over a significant amount of time and with thoughtful consideration," despite several risks. Id. at 14-17. Culligan disagrees with Plaintiff's experts that Plaintiff's medical problems were because of the polypropylene mesh in the Defendant's Ajust product. Doc. No. [110-1], 18 (indicating that Defendant developed its mesh products "appropriately in the context of existing vaginal mesh products offered . . . ."). Culligan also disagrees with Plaintiff's experts' conclusions that the IFU warnings were inadequate and that other safer alternatives to synthetic mesh were available. Id. at 18-21. Finally, Culligan concludes, after a review of Plaintiff's specific medical history, that her medical conditions preexisted her implant and that the Ajust did not cause or worsen her current medical conditions. Id. at 98-99.

Plaintiff specifically objects to Culligan's opinions regarding (1) the reasonableness of Defendant's design and marketing the Ajust device; (2) the adequacy of the IFU warnings for the Ajust device; (3) Plaintiff's implanting physician's knowledge of the risks of the polypropylene mesh in the Ajust; and (4) medical society statements. Doc. No. [110]. The Court ultimately excludes Culligan's testimony on the IFU warnings and Plaintiff's implanting physician's knowledge of the Ajust's risks, but otherwise determines that Culligan's testimony is admissible.

1. The Ajust's Design Defects

Plaintiff argues that Culligan's opinions on the design of the Ajust are unqualified and unreliable. Doc. No. [110], 3-5. Plaintiff asserts that Culligan's expert testimony inappropriately discusses Defendant's knowledge, state of mind, and corporate conduct. Id. at 4. Plaintiff relies on the MDL's prior exclusion of similar opinions by Culligan. Id. (citing In re C.R. Bard, 948 F. Supp. 2d 589, 611 (S.D. W. Va. 2013)). In response, Defendant asserts that Culligan does not opine on Defendant's state of mind but instead directly responds to Rosenzweig's opinions by discussing the appropriateness of Defendant's design. Doc. No. [114], 11. Defendant further argues that Culligan's knowledge, skill, and experience qualify him to testify on these matters. Id. at 11-12.

As a preliminary matter, the Court concludes that the statements Plaintiff objects to do not refer to Defendant's state of mind. In his report, Culligan discusses Defendant's decision to use polypropylene mesh in its devices, such as the Ajust. See, e.g., Doc. No. [110-1], 10 (discussing the development of sling devices, which eventually led to a procedure that "was faster and had lower recovery times"). These conclusions do not remark on Defendant's mental state, however, but rather speak generally to the mesh devices' developments.

Furthermore, the Court concludes that Culligan is qualified to make these opinions. Culligan is a board-certified urogynecologist with decades of experience implanting synthetic mesh slings (including Defendant's Ajust device) in his practice, has taught courses on Defendant's mesh slings, and has consulted on various designs for sling devices. Culligan thus has the requisite education, training, and experience to make these statements. Doc. Nos. [110-1], 2-3; [110-2] (Culligan Dep. Tr.), Tr. 24:13-15, 98:6-15, 46:20-21.

Finally, the Court concludes that Culligan's opinions on Defendant's design and marketing of the mesh slings are reliable. In support of his conclusions on the various designs, Culligan cites peer-reviewed and published studies on mesh slings with similar designs and risks. Doc. No. [110-1], 9-11, 20. He also has had extensive experience in his clinical urogynecology practice and his personal development of medical devices to draw upon in rendering opinions about the design and marketing of the Ajust. Id. at 2-3. Accordingly, the Court concludes that Culligan's opinions about the Ajust's design and marketing are admissible.

2. The Ajust IFU

Plaintiff also objects to Culligan's conclusion that the Ajust IFU adequately warned of potential complications. Doc. [110-1], 101. Specifically, Culligan stated in his report that it would be "impossible" for Defendant to update their rates of complications in the IFU. Id. at 19. Plaintiff argues that these statements should be excluded because Culligan is unqualified to make these conclusions and also used unreliable methods in doing so. Doc. No. [110], 5. Plaintiff supports this argument by citing the MDL's exclusion of Culligan's warning opinions because he had never personally drafted an IFU. Id. at 5-6 (citing Tyree v. Bos. Sci., 54 F. Supp. 3d 501, 582 (S.D.W. Va. 2014)); see also Doc. No. [118], 3 (citing In re C.R. Bard, MDL No. 2187, 2018 U.S. Dist. LEXIS 152147 at *12-13 (S.D. W. Va. Sept. 4, 2018)). In response, Defendant asserts that Culligan's lack of drafting experience does not render him unqualified. Doc. No. [114], 14-15. Defendant points out that courts routinely permit experienced urogynecologists to opine on the devices they use, despite their lack of experience in drafting IFUs. Id.

The Court concludes that Culligan is qualified to testify regarding the adequacy of the IFU warnings. First, since the MDL's exclusion of his IFU warning opinions, Culligan has been "actively involved" in the preparation of several IFUs. Doc. No. [114-2], ¶ 4. Thus, while the Court is not bound (or even persuaded¹⁸) by the MDL's reasoning to exclude Culligan's testimony on this matter, it also notes that factual developments since the MDL's decision call its continued viability into question.

18 An expert witness offer testimony where they have "knowledge, skill, experience, training, or education." Fed. R. Evid. 702. Thus, Culligan's lack of experience in designing products alone does not render him disqualified. Cf. Seamon v. Remington Arms, 813 F.3d 983, 988 (11th Cir. 2016) (acknowledging that "experts may be qualified in various ways"); Moore v. Intuitive Surgical, Inc., 995 F.3d 839, 854 (11th Cir. 2021) (refusing to require an expert have personally used the device at issue to render qualified, expert opinions).

Culligan is a urogynecologist who relied on these warnings in his practices. Doc. No. [114-1], 60-1. As Defendant acknowledges, a doctor relying on a product warning in his or her practice qualifies him or her to make conclusions on the adequacy of the product's warning. See Ethicon Physiomesh Flexible Composite Hernia Mesh Prod. Liab. Litig. v. Ethicon, No. CV 1:17-MD-2782-RWS, 2020 WL 9887625, *5 (N.D. Ga. Nov. 25, 2020) (citing Huskey v. Ethicon, 29 F. Supp. 3d 691, 719 (S.D.W. Va. 2014)). As IFUs are designed for and disclosed specifically to doctors, these doctors are qualified to testify about the adequacy of warnings contained therein. Thus, the Court finds that Culligan, as an experienced urogynecologist who has implanted mesh devices, is qualified to testify about the adequacy of the IFU's warning. Cf. Cason v. C.R. Bard, Inc., No. 1:12-CV-1288-MHS, 2015 WL 9913809, at *10 (N.D. Ga. Feb. 9, 2015) (excluding expert warning opinions where the proposed expert had no experience in drafting warnings, and furthermore did not have a medical degree, medical training, or surgery experience).

Culligan's IFU opinions must also be reliable, however. See Moore, 995 F.3d at 852 (declaring it legal error to conflate the two elements); see also Quiet Tech., 326 F.3d at 1341 (noting that the qualification and reliability are "distinct" concepts). Culligan maintains that it would be "impossible" for Defendant to include rates of potential complications for its mesh devices in the IFUs. Doc. No. [110-1], 19. This is a probabilistic statement, but "the probability it expresses is unclear, imprecise and ill-defined. And the basis for that probabilistic opinion is left unstated." Frazier, 387 F.3d at 1265. Thus, such statement requires a quantified basis—"such as scientific studies or quantified personal experiences"—to be admissible. See United States v. Barnes, 481 F. App'x 505, 513-14 (11th Cir. 2012) (citing Frazier, 387 F.3d at 1265). Because Culligan relies "solely or primarily on his experience" it is his burden "to explain how that experience led to the conclusion he reached, why that experience was a sufficient basis for the opinion, and just how that experience was reliably applied to the facts of the case." Frazier, 387 F.3d at 1265; see also id. ("[T]he court's gatekeeping function requires more than simply taking the expert's word for it." (citations and quotations omitted)). Culligan has failed to provide such foundation to support his opinion that these IFU updates would be "impossible."¹⁹ Thus, the Court EXCLUDES Culligan's opinion on the adequacy of the Ajust's IFU warning as unreliable.

19 The Court's prior ruling on the admissibility of Rosenzweig's testimony about the IFU also rested on the reliability prong of the Daubert analysis. See supra 1332-34. In so holding, the Court looked at Rosenzweig's inadequate review of the Ajust IFU. Plaintiff does not raise a similar objection to Culligan's review. While Culligan made some effort to connect his IFU opinions about similar devices to the Ajust IFU specifically, see Doc. No. [110-1], 20-21 ("The Avaulta Solo IFU warns adequately of these risks and their consequences . . . The Align and Ajust IFUs similarly warned adequately of the risks associated with the surgery."), because Plaintiff does not object to Culligan's IFU testimony on this basis, the Court does not comment about whether this link between the other, similar device's IFU and the Ajust's IFU is sufficient for reliability purposes.

3. Plaintiff's Implanting Physician Knowledge

Plaintiff also moves to exclude Culligan's statements that the Plaintiff's implanting physician "absolutely" knew about the risks of Ajust mesh before Plaintiff's surgery. Doc. No. [110], 7. Plaintiff insists that these statements are speculative, relying once again on the MDL's decision to exclude expert opinions on "what physicians know or should know about specified topics," because such opinions "usurp the jury's fact-finding duties." Doc. No. [110], 6-8 (citing In re: Ethicon, Inc. Pelvic Repair Sys. Prod. Liab. Litig., MDL No. 2327, 2016 WL 4493457, at *3 (S.D. W. Va. Aug. 25, 2016)). In response, Defendant argues that these statements are based on Culligan's personal observations, and therefore are admissible under Federal Rule of Evidence 703. Doc. No. [114], 16. Defendant also maintains that Culligan's opinions concerning the risks of mesh slings are "well known" within his profession and thus proper for expert testimony. Id. at 17-18.

The Court concludes that Culligan's statements about Plaintiff's implanting physician's knowledge of the Ajust's risks are inadmissible expert testimony. "[A]n expert cannot speculate as to an individual's state of mind. Giusto v. Int'l Paper Co., No. 1:19-CV-00646-SDG, 2021 WL 3603374, at *6 (N.D. Ga. Aug. 13, 2021). Speculative state of mind statements are not admissible as expert testimony because they are "legal conclusions as to another person's state of mind" and thus are not of the type of evidence that a jury "need[s] the assistance of an expert to understand."²⁰ Omar v. Babcock, 177 F. App'x 59, 63 n.6 (11th Cir. 2006) (citing Federal Rule of Evidence 702). Thus, these statements about what Plaintiff's treating physician knew, and any testimony about them, are EXCLUDED.

20 Even if Culligan's statement about Rayburn's knowledge of the risks of using an Ajust device were permissible expert testimony under Rule 702, such testimony would not meet the Rule 703 requirements for being otherwise inadmissible facts or data that an expert can testify to because other "experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject." Fed. R. Evid. 703. Culligan provides no evidence that the opinions in question are regularly relied on by others in his profession. Instead, his opinions rely on a personal conversation with Plaintiff's doctor and other materials that are not before the court. Even under Rule 703, the admission of such evidence is improper. Schafer v. Time, 142 F.3d 1361, 1374 (11th Cir. 1998) ("Rule 703 . . . is not an open door to all inadmissible evidence disguised as expert opinion."). Furthermore, because Plaintiff's motion and this order address only if Culligan is qualified under Daubert, the Court declines to comment on whether Culligan's statements would be admissible as fact testimony.

The Court does not read Plaintiff's objection to include contesting Culligan's opinions about the risks of mesh slings being "well known" within the medical community, as the Defendant defends in its response. See Doc. No. [114], 17. Nevertheless, this opinion is proper expert testimony. Knowledge of an industry's business practices can be "gleaned from years of working within the industry and with its professionals." United States v. Jennings, 599 F.3d 1241, 1249 (11th Cir. 2010). As a urogynecologist with decades of experience working with mesh slings, Culligan may opine on general knowledge in his profession. Doc. No. [110-2] (Culligan Dep. Tr.), Tr. 24:15-24.

4. Reliance on Medical Society Statements

Finally, Plaintiff objects to Culligan's opinions regarding the safety and efficacy of Defendant's products as unreliable and unhelpful to the trier of fact, specifically Culligan's reliance on position statements issued by the American Urogynecologic Society (AUGS) and the American Urological Association (AUA). Doc. No. [110], 8-9. Defendant responds that these statements are from the leading journals on urogynecology and thus are reliable foundations for Culligan's opinions and helpful to the urogynecology issues presented in this case. Doc. No. [114], 19-20.

The Court agrees with Plaintiff that it would be improper expert testimony for Culligan to read the position statements into evidence because a mere reading does not require "scientific, technical, or other specialized knowledge." Fed. R. Evid. 702. Culligan does not merely repeat the position statements in his report, however. Instead, Culligan uses the two position statements to "confirm[ ]" the long-term safe and efficacious use of the mesh slings. Doc. No. [110-1], 12-13. Defendant, furthermore, disclaims that Culligan will solely read the position statements as testimony. Doc. No. [114], 19. The Court concludes that Culligan's statements about the position statements will assist the trier of fact as it "concerns matters that are beyond the understanding of the average lay person"—that is, the safety and efficacy of mesh slings. Frazier, 387 F.3d at 1262. Thus, this expert testimony is admissible.

IV. CONCLUSION

For the foregoing reasons, the Court concludes that Defendant's motion to exclude Rosenzweig's expert testimony (Doc. No. [106]) is GRANTED IN PART and DENIED IN PART. Rosenzweig will be able to testify as an expert on all matters except the Ajust implant causing Plaintiff's post-explant medical problems and the adequacy of Defendant's disclosures of the Ajust's risks in its IFU. Defendant's motion to exclude Guelcher's testimony (Doc. No. [107]) is likewise GRANTED IN PART and DENIED IN PART. Guelcher will be able to testify as an expert on the materials in his report except whether the Ajust was suitable for permanent implantation as described in the MSDS. Finally, the Court will GRANT IN PART and DENY IN PART Plaintiff's motion to partially exclude Culligan's expert testimony (Doc. No. [110]). Culligan is able to testify on all matters in his report except the adequacy of the Ajust's disclosures in its IFU and the personal knowledge of Plaintiff's treating physician of the Ajust's potential risks.

IT IS SO ORDERED this 5th day of December, 2022.