TEDDER v. ETHICON INC

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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-MD-

2327-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. Sepulveda-

Toro’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, meta-

analyses 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

Case No. 3:20cv5611-MCR-MJF