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Case No. 3:20cv5611-MCR-MJF

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF FLORIDA

PENSACOLA DIVISION

JUDY L. TEDDER,

Plaintiff,

v. CASE NO. 3:20cv5611-MCR-MJF

ETHICON, INC. and

JOHNSON & JOHNSON,

Defendants.

________________________/

ORDER1

This case is before the Court on remand from the Southern District of West 

Virginia, In re: Ethicon, Inc., Pelvic Repair Sys. Prod. Liab. Litig., No. 2012-MD2327-JRG. On May 15, 2007, and May 25, 2010, respectively, Plaintiff Judy L. 

Tedder had two pelvic mesh devices surgically implanted by Dr. Basil D. Fossum—

TVT-Secur (TVT-S) and TVT-Oturator (TVT-O), both of which were manufactured 

1 The Court assumes the parties’ familiarity with the nature of this litigation, the claims and 

defenses, and the current evidentiary record. Thus, this Order sets out only what is necessary to 

explain the Court’s rulings.

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and sold by Defendant Ethicon, Inc.2 Tedder alleges she was injured as a result of 

defects in the devices.

Tedder moves to exclude certain opinions and testimony of four of 

Defendants’ five “general experts”—Dr. Salil Khandwala, Dr. Brian Schwartz, Dr. 

Jamie Sepulveda, and Dr. Shelby Thames—pursuant to Federal Rules of Evidence 

104, 403, and 702 and Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993)

(ECF No. 116). Tedder requests that the Court adopt the prior Daubert orders 

entered by the MDL court and rule on issues as to which the MDL court reserved 

ruling. Having reviewed the orders of the MDL court, the undersigned finds they 

are well-reasoned and thus adopts them. This Order thus addresses only issues as to 

which the MDL court reserved ruling. 

I. Legal Standard

Rule 702, as explained by Daubert and its progeny, governs the admissibility 

of expert testimony. Rink v. Cheminova, Inc., 400 F.3d 1286, 1291 (11th Cir. 2005). 

Under Rule 702 and Daubert, district courts must act as “‘gatekeepers’” to ensure 

2 Ethicon is a part of the Johnson & Johnson Medical Device Companies. See 

https://www.jnjmedicaldevices.com/en-US/companies/ethicon. 

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the reliability and relevancy of expert testimony. Id. (citing Daubert, 509 U.S. at 

589, 113 S. Ct. 2795). Expert testimony is reliable and relevant—and, therefore, 

admissible—when the following criteria are met: (1) the expert is sufficiently 

qualified to testify about the matters he intends to address; (2) the methodology used 

is “sufficiently reliable as determined by the sort of inquiry mandated in Daubert; 

and (3) the testimony assists the trier of fact, through the application of scientific, 

technical, or specialized expertise, to understand the evidence or to determine a fact 

in issue.” Id. The Eleventh Circuit refers to these criteria separately as 

“qualification, reliability, and helpfulness,” United States v. Frazier, 387 F.3d 1244, 

1260 (11th Cir. 2004), and has emphasized that they are “distinct concepts that courts 

and litigants must take care not to conflate,” Quiet Tech. DC-8, Inc. v. Hurel–Dubois

UK Ltd., 326 F.3d 1333, 1341 (11th Cir. 2003). The party offering the expert has 

the burden of showing, by a preponderance of the evidence, that each of these 

requirements is met. Rink, 400 F.3d at 1292.

To meet the qualification requirement, a party must show that its expert has 

sufficient “knowledge, skill, experience, training, or education” to form a reliable 

opinion about an issue that is before the court. Hendrix ex. Rel. G.P. v. Evenflo Co.,

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Inc., 609 F.3d 1183, 1193 (11th Cir. 2010) (citing Fed. R. Evid. 702) (“Hendrix

II”), aff’g 255 F.R.D. 568 (N.D. Fla. 2009) (“Hendrix I”). If a “‘witness is relying 

solely or primarily on experience, then the witness must explain how that experience 

leads to the conclusion reached, why that experience is a sufficient basis for the 

opinion, and how that experience is reliably applied to the facts.’” Frazier, 387 F.3d 

at 1261 (quoting Fed. R. Evid. 702 advisory committee’s note to 2000 amendments). 

The qualifications standard for expert testimony is “not stringent,” and “[s]o long as 

the witness is minimally qualified, objections to the level of [his] expertise [go] to 

credibility and weight, not admissibility.” Hendrix I, 255 F.R.D. at 585 (internal 

marks omitted).

To meet the reliability requirement, an expert’s opinion must be based on 

scientifically valid principles, reasoning, and methodology that are properly applied 

to the facts at issue. Frazier, 387 F.3d at 1261–62. The reliability analysis is guided 

by several factors, including: (1) whether the scientific technique can be or has been 

tested; (2) whether the theory or technique has been subjected to peer review or 

publication; (3) whether the technique has a known or knowable rate of error; and 

(4) whether the technique is generally accepted in the relevant community. Daubert, 

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509 U.S. at 593–94, 113 S. Ct. 2786. “[T]hese factors do not exhaust the universe 

of considerations that may bear on the reliability of a given expert opinion, and a 

federal court should consider any additional factors that may advance its Rule 702 

analysis.” Quiet Tech., 326 F.3d at 1341. The court’s focus must be on the expert’s 

principles and methodology, not the conclusions they generate. Daubert, 509 U.S. 

at 595, 113 S. Ct. 2786. The test for reliability is “flexible,” and courts have “broad 

latitude” in determining both how and whether this requirement is met. Kumho Tire

Co., Ltd. v. Carmichael, 526 U.S. 137, 141–42 (1999).

Finally, to satisfy the helpfulness requirement, expert testimony must be 

relevant to an issue in the case and offer insights “beyond the understanding and 

experience of the average citizen.” United States v. Rouco, 765 F.2d 983, 995 (11th 

Cir. 1985). Relevant expert testimony “‘logically advances a material aspect’” of 

the proposing party’s case and “‘fit[s]’” the disputed facts. McDowell v. Brown, 392 

F.3d 1283, 1298–99 (11th Cir. 2004) (quoting Daubert, 509 U.S. at 591, 113 S. Ct. 

2786). Expert testimony does not “fit” when there is “too great an analytical gap” 

between the facts and the proffered opinion. Gen. Elec. Co. v. Joiner, 522 U.S. 136, 

146 (1997).

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“Because of the powerful and potentially misleading effect of expert evidence, 

sometimes expert opinions that otherwise meet the admissibility requirements may 

still be excluded [under Federal Rule of Evidence] 403.” Frazier, 387 F.3d at 1263 

(internal citation omitted). “Exclusion under Rule 403 is appropriate if the probative 

value of otherwise admissible evidence is substantially outweighed by its potential 

to confuse or mislead the jury, or if the expert testimony is cumulative or needlessly 

time consuming,” or if it is otherwise unfairly prejudicial. Id. (internal citation 

omitted). “Indeed, the judge in weighing possible prejudice against probative force 

under Rule 403 . . . exercises more control over experts than over lay witnesses.” Id. 

(internal marks omitted). “Simply put, expert testimony may be assigned talismanic 

significance in the eyes of lay jurors, and, therefore, . . . district courts must take care 

to weigh the value of such evidence against its potential to mislead or confuse.” Id.

When scrutinizing the reliability, relevance, and potential prejudice of expert 

testimony, a court must remain mindful of the delicate balance between its role as a 

gatekeeper and the jury’s role as the ultimate factfinder. Id. at 1272. The court’s 

gatekeeping role “is not intended to supplant the adversary system or the role of the 

jury.” Allison v. McGhan Med. Corp., 184 F.3d 1300, 1311 (11th Cir. 1999). Only 

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the jury may determine “where the truth in any case lies,” and the court “may not 

usurp this function.” Frazier, 387 F.3d at 1272. Thus, a court may not “evaluate 

the credibility of opposing experts” or the persuasiveness of their conclusions, Quiet

Tech., 326 F.3d at 1341; instead, the court’s duty is limited to “ensur[ing] that the 

fact-finder weighs only sound and reliable evidence,” Frazier, 387 F.3d at 1272.

II. Discussion

A. Opinions of Dr. Khandwala, Dr. Schwartz, Dr. Sepulveda, and Dr. 

Thames regarding design process and control standards

Defendants do not intend to elicit these opinions at trial. See ECF No. 155 at 

2. Thus, the motion is DENIED as moot. 

B. Dr. Khandwala’s opinions regarding mesh properties 

Dr. Khandwala opined that polypropylene mesh, such as that implanted in 

Tedder, does not shrink or contract. Tedder seeks to exclude Dr. Khandwala’s

opinions on the contraction, degradation, porosity, and stiffness of mesh as 

unreliable, arguing Dr. Khandwala relied on a limited and flawed body of evidence 

in formulating his opinions. 

Dr. Khandwala is a board-certified obstetrician/gynecologist with a 

subspecialty in female pelvic medicine and reconstructive surgery. Dr. Khandwala

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has performed more than 1,000 implantations of mesh to treat stress urinary 

incontinence (SUI) and more than 800 surgical implantations of mesh to treat pelvic 

organ prolapse (POP). He also has performed numerous mesh revision surgeries. In 

addition, Dr. Khandwala designed and participated in clinical trials related to pelvic 

reconstruction surgery and pelvic mesh. He has spoken on, published, and taught in 

the areas of urinary incontinence and POP. In preparing his opinions, Dr. 

Khandwala relied on his clinical experience, as well as a review of medical literature 

and other information, including dozens of peer-reviewed scientific articles, Federal 

Drug Administration sources, and medical society statements. 

The MDL court denied a motion to exclude Dr. Khandwala’s opinions 

regarding safety and efficacy and mesh properties, including biomaterials, 

biocompatibility, and foreign body response, finding the plaintiffs failed to 

demonstrate Dr. Khandwala’s opinions regarding safety and efficacy were unreliable 

and that Dr. Khandwala was qualified, based on clinical experience, to render an 

opinion on mesh’s reaction to and effect on the human body. See ECF No. 96-13 at 

6. The court denied as moot a motion to exclude Dr. Khandwala’s opinion regarding 

degradation because Ethicon indicated Dr. Khandwala would not offer this opinion 

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at trial. See id. at 6–7. The MDL court found Dr. Khandwala’s opinion as to 

contraction supported by extensive clinical experience and analysis of scientific 

literature, which the court noted “[i]n the abstract,” constitute “reliable bases on 

which to form an expert opinion” Id. at 7. The court was “unable to judge the 

reliability of Dr. Khandwala’s observations,” however, “without more information 

about his methodology.” Id. Specifically, the court determined it was “without 

sufficient information . . . to draw the fine line between reliable and unreliable expert 

testimony based primarily on a doctor’s clinical experience not observing 

something.” Id. (emphasis in original). The court thus reserved ruling on the 

admissibility of Dr. Khandwala’s opinions regarding contraction, porosity, and 

stiffness “until further testimony may be offered and evaluated firsthand at trial.” Id.

Tedder’s objections to Dr. Khandwala’s opinions regarding mesh properties 

go more to the weight of the evidence than to its admissibility. See Quiet Tech., 326 

F.3d at 1345 (noting that “in most cases, objections to the inadequacies of a study 

are more appropriately considered an objection going to the weight of the evidence 

rather than its admissibility”) (internal marks omitted). Dr. Khandwala’s extensive 

experience with vaginal mesh procedures and reliance on medical literature and 

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other information provide a sufficiently reliable basis on which to opine on mesh 

properties. See Mason v. Ethicon, Inc., No. 6:20-CV-1078-RBD-DCI, 2021 WL 

2580165, at *2 (M.D. Fla. June 10, 2021) (finding plaintiff’s “objections to the 

inadequacies of a study are more appropriately considered an objection going to the 

weight of the evidence rather than its admissibility” and that “Dr. Khandwala’s 

extensive experience with vaginal mesh augmentation procedures and reliance on 

numerous studies, is a sufficiently reliable basis to opine on mesh contraction”)

(citing Huksey v. Ethicon, Inc., 29 F. Supp. 3d 691, 735 (S.D.W. Va. 2014)); In re: 

Ethicon, Inc. Pelvic Repair Sys. Prod. Liab. Litig., No. 2:12-MD-02327, 2016 WL 

4536885, at *3 (S.D.W. Va. Aug. 30, 2016) (finding urogynecologist who had 

performed over 1,500 pelvic mesh surgeries and over 300 explant surgeries qualified 

to testify regarding biomaterial properties, including mesh reaction to and effect on 

the human body, based on his clinical experience and review of and contributions to 

the medical literature); Carlson v Boston Sci. Corp., No. 2:16-v-05475, 2015 WL 

1931311, at *9–19 (S.D.W. Va. Apr. 28, 2015) (finding clinical experience and 

review of scientific literature qualified urologist to opine on polypropylene, 

including degradation, leaching, shrinkage, and contraction); Tyree v. Boston Sci. 

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Corp., 54 F. Supp. 3d 501 (S.D.W. Va. 2014) (finding urogynecologist who had 

performed almost 3,000 sling procedures and focused his practice largely on the 

treatment of female urinary incontinence over the past twenty years qualified to 

testify that mesh does not shrink, contract, degrade, or cause systemic infection 

based on his experience and the fact that he cited numerous studies and academic 

papers in his report). The motion, therefore, is DENIED.

C. Dr. Thames’ opinions regarding degradation

Tedder moves to exclude Dr. Thames’ opinion that Prolene does not degrade 

in vivo, arguing the opinion is precluded by an admission of Ethicon’s corporate 

representative, Dr. Thomas Barbolt, who Tedder contends acknowledged that 

Prolene undergoes in vivo surface degradation. Tedder argues Ethicon is bound by 

Dr. Barbolt’s admission and should be precluded from introducing contradictory 

testimony from Dr. Thames. 

Defendants dispute that Dr. Barbolt admitted that Prolene degrades in vivo 

and argue that in the testimony Tedder cites in support of her motion, Dr. Barbolt 

was referring to subjective observations of surface cracking rather than in vivo

degradation, which Dr. Barbolt explained were not the same as objective 

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assessments necessary to establish that Prolene meaningfully degrades in vivo. 

Defendants say Dr. Barbolt testified that certain Ethicon tests contain subjective 

observations of some Prolene fibers exhibiting surface cracking but that those were 

not quantitative tests needed to demonstrate that Prolene meaningfully degrades. 

According to Defendants, Dr. Barbolt’s testimony is consistent with Ethicon’s 

position and Dr. Thames’s opinion that Prolene does not undergo meaningful or 

harmful in vivo degradation, and Dr. Thames definitively shows that the cracked 

material is protein from the human body, not degraded mesh. 

Defendants further argue that before the mesh litigation, Ethicon had no 

reason to further explore the alleged degradation of Prolene because there was no 

evidence of any clinical significance in that regard. It was only after the issue 

became legally significant that Defendants hired Dr. Thames to examine issues 

regarding degradation, which he has done over an extended period of time. 

Moreover, Defendants contend, Ethicon is not bound by Dr. Barbolt’s testimony in 

the manner Tedder asserts. 

The Court agrees. Under Rule 30(b)(6), a corporation designates individuals 

to testify on its behalf. Fed. R. Civ. P. 30(b)(6). The Eleventh Circuit has not 

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addressed whether the testimony of a Rule 30(b)(6) representative constitutes a 

judicial admission, with conclusive effect, or merely an evidentiary admission, 

which can be contradicted or explained at trial. See Ussery v. Allstate Fire & Cas. 

Ins. Co., 150 F. Supp. 3d 1329, 1344–45 (M.D. Ga. 2015) (distinguishing judicial 

and evidentiary admissions). Every other circuit to consider the issue has treated 

30(b)(6) testimony as an evidentiary admission that is binding in the sense that it can 

be used against the corporation but not “in the sense that it precludes the 

[corporation] from [later] correcting, explaining, or supplementing” that testimony. 

R&B Appliance Parts, Inc. v. Amana Co., L.P., 258 F.3d 783, 786–87 (8th Cir. 

2001); see also Vehicle Mkt. Research., Inc. v. Mitchell Int’l, Inc., 839 F.3d 1251, 

1260–61 (10th Cir. 2016); Keepers, Inc. v. City of Milford, 807 F.3d 24, 35–36 (2d 

Cir. 2015); A.I. Credit Corp. v. Legion Ins. Co., 265 F.3d 630, 637 (7th Cir. 2001). 

In other words, a corporation “is no more bound than any witness by his or her 

deposition testimony. A witness is free to testify differently from the way he or she 

testified in a deposition, albeit at the risk of having his or her credibility impeached 

by the introduction of the deposition.” R&B Appliance, 258 F.3d at 786; see also 

Cont’l Cas. Co. v. First Fin. Emp. Leasing, Inc., 716 F. Supp. 2d 1176, 1190–91 

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(M.D. Fla. 2010). The motion to exclude Dr. Thames’ testimony thus is DENIED. 

See, e.g., Mason v. Ethicon, No. 6:20-cv-1078-RBD-DCI, 2021 WL 2580165, at * 

(M.D. Fla. June 10, 2021). 

D. Dr. Sepulveda-Toro’s opinions

Dr. Jaime L. Sepulveda-Toro is a board-certified pelvic surgeon and 

urogynecologist who Ethicon designated to offer opinions on its SUI products, 

including TVT-S and TVT-O. The MDL court issued a ruling on Dr. SepulvedaToro’s testimony, denying many of the MDL plaintiffs’ challenges, granting others, 

and reserving ruling on several issues, to be decided by the trial court. Tedder seeks 

to exclude Dr. Sepulveda-Toro’s opinions on the adequacy of Defendants’ brochures 

and on information extrapolated from studies regarding cytotoxicity, degradation, 

and inflammatory response. 

With regard to Defendants’ brochures, Tedder’s motion is DENIED as moot, 

as Defendants state they do not intend to elicit any such testimony from Dr. 

Sepulveda-Toro at trial. See ECF No. 155 at 11. 

With regard to information extrapolated from studies, Tedder argues Dr. 

Sepulveda-Toro overstates the number of studies supporting his opinions related to 

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Ethicon’s products, which undermines his opinions on cytotoxicity, degradation, and 

inflammation. The MDL court reserved ruling on the issue, stating it lacked 

sufficient information to judge the reliability of Dr. Sepulveda-Toro’s methodology 

in considering the relevant literature and would rule once able to evaluate the 

evidence firsthand at trial. 

In support of her motion, Tedder points to two of Dr. Sepulveda-Toro’s 

opinions—that ‘‘[t]he medical literature including over 100 Gynemesh PS [a POP 

product] studies, meta-analyses and systematic reviews do not support that the mesh 

is cytotoxic, that it degrades or leads to a harmful inflammatory response in 

humans’” and that “‘[t]he medical literature including over 1,000 studies, metaanalyses and systematic reviews, and the endorsement of the TVT mesh by the 

pertinent medical societies do not support that the mesh is cytotoxic, that it degrades 

or leads to a harmful inflammatory response in humans.’” ECF No. 117 at 16. 

Tedder argues the statements are not supported by citations to the studies and that 

the accuracy of Dr. Sepulveda-Toro’s characterizations, therefore, cannot be 

verified. Tedder also says Dr. Sepulveda-Torro admitted in his deposition that he 

overstated the number of studies in his report. Finally, Tedder challenges Dr. 

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Sepulveda-Torro’s statement that “‘[t]he monofilament knitted Prolene TVT sling 

has pores which are microporous (over 75 microns).’” ECF No. 117 at 17. 

According to Tedder, Defendants’ own engineers classify Prolene mesh as “small 

pore.” ECF No. 117 at 18.

In formulating his opinions, Dr. Sepulveda-Toro relied on an in-depth review 

of the medical literature, including studies comparing mesh to non-mesh procedures, 

as well as literature and long-term studies regarding the safety, efficacy, and 

complications associated with Ethicon’s products. Considering Dr. Sepulveda-Toro 

provided an extensive list of the medical literature he reviewed and explained that

he has regularly reviewed the literature in connection with his practice, Dr. 

Sepulveda-Torro may opine on the general number of studies he contends support 

his opinions. See Mason, 2021 WL 2580165, at *3 (allowing Dr. Sepulveda-Toro 

to testify to the general number of studies he contends support his opinion); Geery 

v. Ethicon, Inc., No. 6:20-CV-1975-RBD-LRH, 2021 WL 2580144, at *2 (M.D. Fla. 

Apr. 9, 2021) (same); see also In re 3M Combat Arms Earplug Prods. Liab. Litig., 

No. 3:19md2885, 2021 WL 765019, at *16 (N.D. Fla. Feb. 28, 2021). The motion, 

therefore, is DENIED. 

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SO ORDERED this 31st day of March 2022.

M. Casey Rodgers M. CASEY RODGERS

UNITED STATES DISTRICT JUDGE

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