Michelle Arevalo v. Coloplast Corp

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 1 of 23

[DO NOT PUBLISH]

In the

United States Court of Appeals

For the Eleventh Circuit

____________________

No. 21-11768

____________________

MICHELLE AREVALO,

Plaintiff-Appellant,

versus

MENTOR WORLDWIDE LLC, et al.,

Defendant,

COLOPLAST CORP,

Defendant-Appellee.

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 2 of 23

2 Opinion of the Court 21-11768

____________________

Appeal from the United States District Court

for the Northern District of Florida

D.C. Docket No. 3:19-cv-03577-TKW-MJF

____________________

Before LUCK, BRASHER, and ED CARNES, Circuit Judges.

PER CURIAM:

In 2010 Michelle Arevalo was surgically implanted with two

of Coloplast Corp.’s pelvic mesh products: the Aris Transobturator

Sling System and the Exair Prolapse Repair System. She suffered

pain and complications after the surgeries and sued Coloplast un-

der theories of strict liability and negligence.

The district court granted Coloplast’s Daubert motion to ex-

clude as unreliable the specific causation opinion of Dr. Bruce

Rosenzweig, Arevalo’s retained specific causation expert. It later

struck her belated disclosure of Dr. John Miklos as a non-retained

specific causation expert. The court then granted Coloplast sum-

mary judgment because Arevalo did not have admissible expert tes-

timony on specific causation. This is Arevalo’s appeal.

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 3 of 23

21-11768 Opinion of the Court 3

I. BACKGROUND

Arevalo’s pelvic area issues began in childhood when she

started having bladder and urinary tract infections (UTIs). 1 Later

she developed pelvic pain, heavy and painful periods, and pain dur-

ing intercourse. Her three pregnancies each resulted in vaginal de-

liveries, some with complications. During her first delivery in

1994, she suffered a torn sphincter and had an episiotomy. Her

second and third deliveries (1997 and 2001) were both precipi-

tous (unusually fast). In 1995 she had a loop electrosurgical exci-

sion procedure (LEEP) to remove abnormal tissue from her cervix,

and in 2002 she had her tubes tied.

In 2010 Arevalo sought treatment from gynecologist Dr.

Glenn Bankert for her heavy and painful periods, pain during inter-

course, and occasional urine leakage. Dr. Bankert diagnosed her

with menorrhagia (heavy or prolonged periods), dysmenorrhea

(painful periods), pelvic pain, and stress urinary incontinence. He

also gave her a pelvic exam and found that she had an enlarged

uterus, a second-degree uterine prolapse, and a first-degree cysto-

cele. 2 In September 2010 he performed a total vaginal hysterec-

tomy to remove Arevalo’s uterus and cervix. At the same time, he

1 At this stage “we are required to view the evidence and all factual inferences

therefrom in the light most favorable to [Arevalo], and resolve all reasonable

doubts about the facts in [her] favor.” Feliciano v. City of Miami Beach, 707

F.3d 1244, 1247 (11th Cir. 2013) (quotation marks omitted).

2 A uterine prolapse occurs when the uterus drops down into the vaginal canal.

A cystocele occurs when the bladder drops down into the vaginal canal.

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 4 of 23

4 Opinion of the Court 21-11768

implanted her with Coloplast’s Aris mesh to treat her stress urinary

incontinence.

Less than two months later Dr. Bankert diagnosed Arevalo

with significant pelvic organ prolapse. Her first-degree cystocele

had progressed to second-degree, meaning that her bladder had

fallen about halfway down her vaginal canal. She also had a sec-

ond- to third-degree rectocele. 3 That December Dr. Bankert per-

formed a second pelvic reconstructive surgery, this time to repair

her prolapsing organs. To strengthen her front and back vaginal

walls, he implanted them with Coloplast’s Exair mesh. He thought

both surgeries were successful.

Three and a half years later, Arevalo saw gynecologist Dr.

Marjorie Kahn for help with persisting pelvic area issues. Arevalo

complained of incomplete bladder emptying, vaginal bulging, uri-

nary frequency, occasional urine leakage, UTIs, uncomfortable uri-

nation, fecal incontinence, and pain during intercourse. During Dr.

Kahn’s pelvic exam of Arevalo, she could feel the Exair mesh in

Arevalo’s front vaginal wall. When Dr. Kahn touched the mesh,

Arevalo felt tenderness. Dr. Kahn ultimately diagnosed Arevalo

with a litany of conditions, including organ prolapse, scar pain, and

mesh implant complications. For treatment she recommended

physical therapy and trigger point injections in the tender areas to

break up any scar tissue. Arevalo reported some improvement af-

ter the injections but still felt pain during intercourse. Believing it

3 A rectocele occurs when the rectum protrudes through the back vaginal wall.

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 5 of 23

21-11768 Opinion of the Court 5

would help relieve the pain and tenderness, Dr. Kahn proposed re-

moving some of the mesh.

In February 2014 Dr. Kahn performed a graft removal sur-

gery during which she removed most of the Exair mesh from Are-

valo’s front vaginal wall. 4 She also repaired and strengthened Are-

valo’s front vaginal wall and repaired her sphincter. Dr. Kahn

noted that Arevalo’s vaginal tissue was more pliable after surgery,

which she hoped would lessen the pain. But Arevalo continues to

have pelvic pain, pain during intercourse, and stress urinary incon-

tinence.

II. PROCEDURAL HISTORY

In February 2013 Arevalo filed a short form complaint

against Coloplast and other entities in a multidistrict litigation pro-

ceeding in the Southern District of West Virginia. In re: Coloplast

Corp., Pelvic Support Sys. Prods. Liab. Litig., No. 2:12-md-2387

(S.D. W. Va. 2012). Her short form complaint adopted sixteen

counts from the MDL master complaint, but she ultimately pur-

sued only the following claims: negligent design and failure to

warn, strict liability design defect, strict liability failure to warn, and

gross negligence. She also sought punitive damages.

In September 2019 Arevalo’s case was transferred to the

Northern District of Florida, and the transfer order stated that the

4 Dr.Kahn testified that she never felt or located the Exair mesh in Arevalo’s

back vaginal wall.

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 6 of 23

6 Opinion of the Court 21-11768

case was ready to be set for trial. At the time of transfer, Coloplast

had two outstanding motions. One was a motion for partial sum-

mary judgment on Arevalo’s uncontested claims. 5 The other was

a Daubert motion to exclude or limit opinions offered by Dr. Bruce

Rosenzweig, one of Arevalo’s general causation experts and her

only retained specific causation expert. The parties had also filed

other Daubert motions in the MDL action that had been denied

without prejudice, giving them the option to refile those motions

in the transfer court. Upon transfer, the parties told the district

court that they intended to renew these motions, and Coloplast

asked for the chance to re-brief them under our circuit’s law. Are-

valo opposed any re-briefing.

The district court held a case management conference, con-

cluded that the case was not ready for trial, and allowed the parties

to re-brief their Daubert motions. Arevalo re-filed four Daubert

motions and Coloplast re-filed five. One of Coloplast’s re-briefed

motions sought to exclude or limit Dr. Rosenzweig’s opinions.

Coloplast argued that Dr. Rosenzweig’s specific causation opinion

was unreliable because his differential diagnosis methodology —

5 Coloplast moved for partial summary judgment on Arevalo’s claims for neg-

ligent manufacturing, strict liability manufacturing defect, strict liability defec-

tive product, breach of express warranty, breach of implied warranty, con-

structive fraud, “discovery rule, tolling, and fraudulent concealment,” negli-

gent infliction of emotional distress, violation of consumer protection laws,

and unjust enrichment. Arevalo conceded that Coloplast was entitled to sum-

mary judgment on these claims, and the district court granted Coloplast’s mo-

tion.

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 7 of 23

21-11768 Opinion of the Court 7

the scientific process of identifying and ruling out other possible

causes of an injury — was deficient. The district court granted all

nine Daubert motions in part. Relevant to this appeal, it excluded

as unreliable Dr. Rosenzweig’s specific causation opinion.

Coloplast promptly moved for summary judgment on the

grounds that Arevalo lacked competent specific causation evi-

dence. Seeing the writing on the wall, Arevalo moved for recon-

sideration of parts of the district court’s order excluding Dr.

Rosenzweig’s opinions and for the first time asked for an eviden-

tiary hearing. The district court denied the motion.

Arevalo made one last attempt to salvage her case. On July

27, 2020, less than three weeks after the district court excluded Dr.

Rosenzweig’s specific causation opinion, she had her first and only

appointment with Dr. John Miklos (who had served as a retained

expert in other pelvic mesh cases). On January 26, 2021 — nearly

three months after Coloplast’s motion for summary judgment was

fully briefed and with trial less than two months away6 — Arevalo

filed a supplemental Rule 26 expert witness disclosure naming Dr.

Miklos as a non-retained expert witness and treating physician. She

attached a case report Dr. Miklos prepared in which he opined that

based on a “differential diagnosis” process, the mesh implants are

the sole cause of her pain. Coloplast moved to strike the disclosure

under Federal Rule of Civil Procedure 37(c) as untimely. The

6 In February 2021, the parties agreed to continue trial to November 2021 for

reasons related to the COVID-19 pandemic.

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 8 of 23

8 Opinion of the Court 21-11768

district court agreed that the disclosure was untimely and excluded

Dr. Miklos’ testimony.

Having resolved the expert witness issues, the district court

turned to Coloplast’s motion for summary judgment. It granted

Coloplast summary judgment on all remaining claims, finding that

Arevalo lacked sufficient proof of specific causation without Dr.

Rosenzweig’s excluded testimony. Arevalo timely appealed the fi-

nal judgment, listing in her notice of appeal the Daubert order ex-

cluding Dr. Rosenzweig’s opinions, the order excluding Dr. Mi-

klos’ testimony, and the order granting summary judgment.

III. DISCUSSION

A. Dr. Rosenzweig

We begin with the question of whether the district court

properly excluded Dr. Rosenzweig’s specific causation opinion that

Coloplast’s mesh implants caused Arevalo’s pain. We review for

abuse of discretion a district court’s Daubert rulings. Chapman v.

Procter & Gamble Distrib., LLC, 766 F.3d 1296, 1305 (11th Cir.

2014). A district court has abused its discretion if it “applied an in-

correct legal standard, followed improper procedures, or made

clearly erroneous findings of fact.” Crawford v. ITW Food Equip.

Grp., LLC, 977 F.3d 1331, 1338 (11th Cir. 2020). We must apply

this standard “stringently, even if a decision on expert testimony is

outcome determinative.” Chapman, 766 F.3d at 1305 (quotation

marks omitted).

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 9 of 23

21-11768 Opinion of the Court 9

“[W]e engage in a rigorous three-part inquiry” to determine

the admissibility of expert testimony under Federal Rule of Evi-

dence 702: (1) the expert must be qualified, (2) his methodology

must be sufficiently reliable as determined by the sort of inquiry

mandated by Daubert v. Merrell Dow Pharmaceuticals, Inc., 509

U.S. 579 (1993), and (3) his testimony must assist the trier of fact.

United States v. Frazier, 387 F.3d 1244, 1260 (11th Cir. 2004) (en

banc). This appeal concerns the second prong — the reliability of

Dr. Rosenzweig’s differential diagnosis methodology.

To evaluate the reliability of a scientific expert opinion, the

district court assesses “whether the reasoning or methodology un-

derlying the testimony is scientifically valid and whether that rea-

soning or methodology properly can be applied to the facts in is-

sue.” Id. at 1261–62 (alteration adopted and quotation marks omit-

ted). There 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. Guinn v. AstraZeneca Pharms. LP, 602 F.3d 1245,

1255–56 (11th Cir. 2010). As the proponent of Dr. Rosenzweig’s

expert opinion, Arevalo has the burden of establishing its reliabil-

ity. Frazier, 387 F.3d at 1260.

Dr. Rosenzweig intended to offer the opinion that within a

reasonable degree of medical certainty, the Aris and Exair mesh im-

plants directly caused Arevalo’s pelvic pain, vaginal pain, pain dur-

ing intercourse, frequent UTIs, urinary and fecal incontinence, and

mesh removal procedure. In his case-specific expert report, Dr.

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 10 of 23

10 Opinion of the Court 21-11768

Rosenzweig explained that he arrived at this specific causation

opinion by employing a differential diagnosis methodology.

The differential diagnosis methodology is “a medical process

of elimination whereby the possible causes of a condition are con-

sidered and ruled out one-by-one, leaving only one cause remain-

ing.” Chapman, 766 F.3d at 1308 (quotation marks omitted). It

requires three steps: “(1) the patient’s condition is diagnosed, (2) all

potential causes of the ailment are considered, and (3) differential

etiology is determined by systematically eliminating the possible

causes.” Id. To be reliable, a differential analysis “need not rule

out all possible alternative causes” but “must at least consider other

factors that could have been the sole cause of the plaintiff’s injury.”

Id. at 1308–09 (quotation marks omitted).

If properly followed, differential diagnosis can be a reliable

methodology under Daubert. Id. at 1309. But “an expert does not

establish the reliability of his techniques or the validity of his con-

clusions simply by claiming that he performed a differential diag-

nosis on a patient.” McClain v. Metabolife Int’l, Inc., 401 F.3d 1233,

1253 (11th Cir. 2005). “[A] differential diagnosis that fails to take

serious account of other potential causes may be so lacking that it

cannot provide a reliable basis for an opinion on causation.” Guinn,

602 F.3d at 1253 (quotation marks omitted).

Dr. Rosenzweig’s expert report stated that he had used a dif-

ferential diagnosis methodology, but it was short on details. The

entirety of his report about that methodology was this:

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 11 of 23

21-11768 Opinion of the Court 11

Based upon my medical education, experience, my

review of the currently available medical literature,

and [Arevalo’s] medical records, I have formed opin-

ions regarding her current complications. In coming

to these conclusions, a broad differential diagnosis

was reviewed and considered her medical and surgi-

cal history, which includes: she was a G3 P3. Her

medical history includes: Kidney stones, Asthma, Bi-

polar disorder, Headaches, rectocele, cystocele, uter-

ine prolapse, Human papilloma virus and dysplasia of

uterine cervix. Her surgical history was remarkable

for T.L. and LEEP procedure. None of these condi-

tions lead to the current injuries she is suffering from.

I ruled out the hysterectomy as there are no findings

of tenderness at the vaginal cuff.

1. The District Court’s Daubert Order

Coloplast moved to exclude as unreliable Dr. Rosenzweig’s

specific causation opinion, arguing that he did not perform an ade-

quate differential diagnosis methodology because he failed to pro-

vide a medically sound basis for how he ruled out aspects of Are-

valo’s medical history as possible alternative causes. Coloplast at-

tached to its motion Dr. Rosenzweig’s case-specific expert report

and a few pages of his case-specific deposition transcript. Arevalo

responded that Dr. Rosenzweig reviewed her medical records and

properly ruled out other potential causes, but she did not attach

or even refer to any part of Dr. Rosenzweig’s deposition testimony.

Instead she relied exclusively on his expert report.

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 12 of 23

12 Opinion of the Court 21-11768

The district court granted Coloplast’s motion, finding that

Dr. Rosenzweig did “not explain how he systematically and scien-

tifically ruled out the other potential causes” for Arevalo’s condi-

tion, “such as her rectocele, cystocele, or uterine prolapse.” With-

out more information about how he had ruled out potential alter-

native causes, the court could not ensure that he had made a relia-

ble differential diagnosis. In excluding Dr. Rosenzweig’s differen-

tial diagnosis methodology, the district court excluded his entire

specific causation opinion.

The district court did not abuse its discretion when it ex-

cluded Dr. Rosenzweig’s specific causation opinion. In his cursory

report, Dr. Rosenzweig offered no explanation — let alone any sci-

entific support — for ruling out the potential alternative causes that

he had identified (other than the hysterectomy). A reliable differ-

ential diagnosis requires the expert to offer some explanation for

how he ruled out an alternative cause. Hendrix ex rel. G.P. v.

Evenflo Co., 609 F.3d 1183, 1197 (11th Cir. 2010); see also Chap-

man, 766 F.3d at 1310 (“The expert must provide reasons for reject-

ing alternative hypotheses using scientific methods and procedures

and the elimination of those hypotheses must be founded on more

than subjective beliefs or unsupported speculation.”) (quotation

marks omitted). Dr. Rosenzweig’s assurances that he had done a

differential diagnosis are not enough to establish the reliability of

his methodology. McClain, 401 F.3d at 1253.

Arevalo argues that the district court should not have faulted

Dr. Rosenzweig for failing to explain why he ruled out Arevalo’s

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 13 of 23

21-11768 Opinion of the Court 13

rectocele, cystocele, and uterine prolapse. According to Arevalo,

there was no need to rule out those potential causes because the

Exair mesh fixed her rectocele and cystocele, and it was impossible

for her to still have uterine prolapse because she no longer had a

uterus. Arevalo’s argument is wrong on the facts about the cysto-

cele; the record shows that during the mesh removal procedure,

Dr. Kahn found that Arevalo had another cystocele. And, in any

event, it is not Arevalo’s post hoc explanations that matter to the

reliability analysis. The district court’s criticism of Dr. Rosenzweig

for omitting an explanation for ruling out those three potential

causes is valid. 7 See, e.g., Hendrix, 609 F.3d at 1197; Chapman, 766

F.3d at 1310.

7 Citing the law of the case doctrine, Arevalo also suggests that the district

court reversed the MDL court’s transfer order when it allowed Coloplast to

challenge the differential diagnosis methodology in its re-briefed Daubert mo-

tion even though it had not done so in its MDL briefing. Arevalo’s law of the

case argument fails because the district court did not reverse the MDL transfer

order. Indeed, the MDL order itself acknowledged that the parties had filed

dispositive and Daubert motions that were to be resolved by the transferee

court.

“District courts have unquestionable authority to control their own dockets,”

which includes “broad discretion in deciding how best to manage the cases

before them.” Smith v. Psychiatric Sols., Inc., 750 F.3d 1253, 1262 (11th Cir.

2014) (quotation marks omitted). The district court in this case ordered re-

briefing on the Daubert motion because it decided that was the best way to

make the correct ruling on that motion. The district court did not abuse its

discretion in doing so.

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 14 of 23

14 Opinion of the Court 21-11768

2. The District Court’s Denial of Reconsideration

Arevalo next contends that the district court erred when it

refused to reconsider its order excluding Dr. Rosenzweig’s specific

causation opinion. We review a district court’s decision about

whether to reconsider its own interlocutory order only for abuse

of discretion. See Harper v. Lawrence County, 592 F.3d 1227,

1231–32 (11th Cir. 2010); Region 8 Forest Serv. Timber Purchasers

Council v. Alcock, 993 F.2d 800, 805–06 (11th Cir. 1993).

It wasn’t until Arevalo moved for reconsideration that she

gave the court the complete transcript of Dr. Rosenzweig’s deposi-

tion and pointed out the specific testimony relevant to his differen-

tial diagnosis. This oversight occurred even though, according to

Arevalo, Dr. Rosenzweig’s differential diagnosis methodology was

fleshed out in his deposition testimony.8 Citing the legal standard

for reconsideration of a final judgment, Arevalo argued that it

would be manifestly unjust for the district court to decline to re-

consider its Daubert order in light of the full deposition testimony.

The district court denied reconsideration. It agreed with

Arevalo that the only grounds for granting reconsideration are

newly discovered evidence or manifest errors of law or fact. See,

8 Arevalo never explained to the district court why she failed to provide or

reference the deposition testimony when she first opposed the Daubert mo-

tion to exclude Dr. Rosenzweig’s differential diagnosis methodology. The tes-

timony was available for nearly a year before she filed her response in opposi-

tion to Coloplast’s Daubert motion. She now concedes that attaching the

complete deposition transcript to her response “might’ve been best practice.”

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 15 of 23

21-11768 Opinion of the Court 15

e.g., Samara v. Taylor, 38 F.4th 141, 149 (11th Cir. 2022) (reviewing

the denial of a motion for reconsideration under Federal Rule of

Civil Procedure 59(e)). For this reason, it explained, a party cannot

use a motion for reconsideration “to relitigate old matters, raise ar-

gument or present evidence that could have been raised prior to

the entry of judgment.” Id. (quotation marks omitted). It then

found that Arevalo had not met this high bar for reconsideration:

she either rehashed old arguments or presented evidence (the dep-

osition testimony) that was available while the Daubert motion

was pending.

Arevalo argues that the district court abused its discretion by

applying the standard for reconsideration of final judgments under

Rules 59(e) or 60(b). 9 She asserts the court should have used its

inherent power under Rule 54(b) to reconsider its own interlocu-

tory order. See Fed. R. Civ. P. 54(b) (“[A]ny order or other deci-

sion, however designated, that adjudicates fewer than all the claims

or the rights and liabilities of fewer than all the parties . . . may be

revised at any time before the entry of a [final] judgment.”); Toole

v. Baxter Healthcare Corp., 235 F.3d 1307, 1315 (11th Cir. 2000)

(“Since an order granting a new trial is an interlocutory order, the

district court has plenary power over it and this power to

9 “A motion for reconsideration made after final judgment falls within the am-

bit of either Rule 59(e) (motion to alter or amend a judgment) or Rule 60(b)

(motion for relief from judgment or order).” Region 8 Forest Serv. Timber

Purchasers Council, 993 F.2d at 806 n.5.

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 16 of 23

16 Opinion of the Court 21-11768

reconsider, revise, alter or amend the interlocutory order is not

subject to the limitations of Rule 59.”) (quotation marks omitted).

If the district court erred by applying the wrong standard,

the error was invited. 10 Arevalo urged the district court to apply

the legal standard for reconsideration under Rule 59(e). She can’t

now complain that the district court applied the standard she re-

quested. See EEOC v. Mike Smith Pontiac GMC, Inc., 896 F.2d

524, 528 (11th Cir. 1990) (declining to reverse the district court’s

decision where the appellant had invited error as to the application

of the wrong legal standard); FTC v. AbbVie Prods. LLC, 713 F.3d

54, 65–66 (11th Cir. 2013). 11

10Though Coloplast did not argue that Arevalo invited error, we apply the

doctrine anyway. See United States v. Brown, 934 F.3d 1278, 1301 (11th Cir.

2019).

11 Arevalo briefly asserts that even under Rule 59(e)’s reconsideration stand-

ard, the district court clearly erred because Dr. Rosenzweig’s full deposition

established that the court initially misunderstood Arevalo’s medical history,

including the significance of her rectocele, cystocele, and uterine prolapse. But

motions for reconsideration may not be used to present testimony that could

have been introduced earlier. See, e.g., Grange Mut. Cas. Co. v. Slaughter,

958 F.3d 1050, 1059–60 (11th Cir. 2020). Denial of a Rule 59(e) motion for

reconsideration “is especially soundly exercised” when, as here, “a party gives

no reason for not previously raising an issue.” Wilchombe v. TeeVee Toons,

Inc., 555 F.3d 949, 957 (11th Cir. 2009) (quotation marks omitted). And as

discussed, the district court did not err, much less clearly err, by finding that

Dr. Rosenzweig’s expert report failed to explain how he ruled out Arevalo’s

rectocele, cystocele, or uterine prolapse. So under the standard the district

court applied, it did not abuse its discretion in denying reconsideration.

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 17 of 23

21-11768 Opinion of the Court 17

B. Dr. Miklos

Arevalo next challenges the district court’s decision to strike

her belated disclosure of Dr. Miklos. Federal Rule of Civil Proce-

dure 26(a)(2)(D) requires a party to disclose the identities of her ex-

pert witnesses at the time and in the sequence the court orders.

Rule 26(e)(1)(A) requires a party to supplement these disclosures

“in a timely manner” if she later learns that in some material respect

they are incomplete or incorrect. If a party violates those disclosure

requirements, Rule 37 sanctions may be applied. See Fed. R. Civ.

P. 37(c)(1). One of those sanctions is that “the party is not allowed

to use that information or witness to supply evidence on a motion,

at a hearing, or at a trial,” unless the failure to disclose “was sub-

stantially justified or is harmless.” Id. The court may also impose

“other appropriate sanctions.” Fed. R. Civ. P. 37(c)(1)(C).

The district court found that Arevalo had violated Rule 26.

Her disclosure came more than three years after the court’s dead-

line for disclosing specific causation experts, and even if it could be

considered a supplemental disclosure under Rule 26(e) it was not

made “in a timely manner.” At Arevalo’s appointment with Dr.

Miklos in July 2020, the doctor told her that the mesh implants

were the cause of her pelvic pain. So Arevalo could have and

should have disclosed him as an expert witness in July 2020 instead

of six months later at the end of January 2021. The court found

that the late disclosure was neither substantially justified nor harm-

less, and it excluded Dr. Miklos’ testimony under Rule 37(c)(1).

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 18 of 23

18 Opinion of the Court 21-11768

We review a district court’s Rule 37(c)(1) decision only for

abuse of discretion. Crawford, 977 F.3d at 1341. When deciding

whether the exclusion of a late-disclosed witness was an abuse of

discretion, we “consider the explanation for the failure to disclose

the witness, the importance of the testimony, and the prejudice to

the opposing party.” Fabrica Italiana Lavorazione Materie Or-

ganiche, S.A.S v. Kaiser Aluminum & Chem. Corp., 684 F.2d 776,

780 (11th Cir. 1982).

Applying those factors, we conclude that the district court

did not abuse its discretion by excluding Dr. Miklos’ testimony.

The record supports the district court’s findings that Arevalo didn’t

have a good reason for the late disclosure and that the disclosure

prejudiced Coloplast. Arevalo explains that she didn’t disclose Dr.

Miklos sooner because he wasn’t sure whether she had all her mesh

removed, and he wanted to obtain her medical records before sug-

gesting treatment. But as the district court pointed out, Dr. Miklos

received Arevalo’s medical records within days after her appoint-

ment with him. He had all the information he needed to form his

opinion in July 2020. Though Dr. Miklos may have needed time to

review the records, Arevalo could have immediately given notice

that he would be providing an expert opinion (even if he could not

yet make his final treatment recommendation). At the least, she

was aware of his causation opinion as early as July 2020 and should

have asked at that point for the disclosure deadline to be reopened.

As for the prejudice to Coloplast, Arevalo waited until after

the close of discovery to disclose Dr. Miklos’ opinions, which

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 19 of 23

21-11768 Opinion of the Court 19

deprived Coloplast of an opportunity to depose the doctor or pre-

pare rebuttal evidence. The district court considered reopening

discovery but decided not to do so because it would have increased

litigation costs and delayed any trial. Coloplast may have needed

additional discovery for rebuttal, it would have likely filed another

Daubert motion, and its summary judgment motion would have

needed to be re-briefed.

The district court recognized that Dr. Miklos’ testimony was

“clearly important” to Arevalo’s case. But we have held that the

first and third factors together can outweigh the second. Romero

v. Drummond Co., 552 F.3d 1303, 1321 (11th Cir. 2008); see also

Bearint ex rel. Bearint v. Dorell Juv. Grp., Inc., 389 F.3d 1339, 1353

(11th Cir. 2004) (“Regardless of the importance of [the] testimony,

the reasons for the delay in the . . . disclosure and the consequent

prejudice that [the] testimony would have caused [the nonmoving

party] require us to affirm the district court’s ruling.”).

Our review of a district court’s Rule 37 sanctions decision is

limited and deferential. “[W]e will not reverse the imposition of

sanctions under Rule 37 unless we are left with a definite and firm

conviction that the court below committed a clear error of judg-

ment in the conclusion it reached upon a weighing of relevant fac-

tors.” Josendis v. Wall to Wall Residence Repairs, Inc., 662 F.3d

1292, 1313 (11th Cir. 2011) (quotation marks omitted); see also OFS

Fitel, LLC v. Epstein, Becker & Green, P.C., 549 F.3d 1344, 1360

(11th Cir. 2008) (“Our review of a district court’s decision to impose

sanctions under Rule 37 is sharply limited to a search for an abuse

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 20 of 23

20 Opinion of the Court 21-11768

of discretion and a determination that the findings of the trial court

are fully supported by the record”) (quotation marks omitted). We

conclude that the district court acted within its considerable discre-

tion when it struck Arevalo’s untimely disclosure of Dr. Miklos and

prohibited her from using his expert opinion testimony. See, e.g.,

Guevara v. NCL (Bah.) Ltd., 920 F.3d 710, 718–19 (11th Cir. 2019)

(concluding that the district court did not abuse its “broad discre-

tion” in striking a supplemental expert report where the plaintiff

unreasonably delayed in filing it until after the close of discovery

and after the defendant had filed its motion for summary judgment

and Daubert motions, and the plaintiff had done so without seeking

leave of court or moving to extend discovery). 12

12 Arevalo alternatively contends that the court abused its discretion by refus-

ing to impose a lesser sanction. She argues that because the grant of Colo-

plast’s motion to strike Dr. Miklos’ disclosure led to its summary judgment

victory, the exclusion of Dr. Miklos’ testimony ultimately “amounted to a dis-

missal.” According to Arevalo, to exclude the evidence entirely the district

court was required to find bad faith or willfulness.

We have not decided whether an untimely disclosure, even one that is not

substantially justified or harmless, always requires exclusion of the evidence.

Crawford, 977 F.3d at 1342 n.4. But we cannot say that the district court

abused its discretion by excluding Dr. Miklos’ testimony in its entirety. First,

“[o]ur caselaw is clear that only in a case where the court imposes the most

severe [Rule 37] sanction — default or dismissal — is a finding of willfulness

or bad faith failure to comply necessary.” BankAtlantic v. Blythe Eastman

Paine Webber, Inc., 12 F.3d 1045, 1049 (11th Cir. 1994). The court did not

impose either of those Rule 37 sanctions. Instead, it excluded the testimony

of the witness. Second, the court did consider other options short of preclud-

ing Arevalo from using Dr. Miklos’ testimony but found that exclusion of the

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 21 of 23

21-11768 Opinion of the Court 21

C. Summary Judgment

Finally, we consider Arevalo’s challenge to the grant of sum-

mary judgment in favor of Coloplast on her strict liability and neg-

ligence claims. Our review is de novo. See Chapman, 766 F.3d at

1312. Summary judgment is proper “if the movant shows that

there is no genuine dispute as to any material fact and the movant

is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a).

When a party fails to proffer sufficient evidence to establish an ele-

ment on which she will bear the burden of proof at trial, there is

no genuine dispute of material fact. Chapman, 766 F.3d at 1312.

To prove causation under Florida law, which applies to Are-

valo’s strict liability and negligence claims, the plaintiff must intro-

duce evidence that “it is more likely than not that the conduct of

the defendant was a substantial factor in bringing about the result.”

Guinn, 602 F.3d at 1256 (quoting Gooding v. Univ. Hosp. Bldg.,

Inc., 445 So. 2d 1015, 1018 (Fla. 1984)). To avoid summary judg-

ment in this products liability case, Arevalo must have “Daubert-

qualified, general and specific-causation-expert testimony that

would be admissible at trial.” Chapman, 766 F.3d at 1316. Dr.

Rosenzweig’s and Dr. Miklos’ specific causation opinions are inad-

missible. But Arevalo argues that Dr. Kahn’s opinions are enough

testimony was the appropriate remedy under the circumstances. It explained

that “[a]ny lesser sanction would frustrate the purpose and intent of Rule 26

and the discovery process and frustrate the orderly (and long-overdue) dispo-

sition of this case.” We are not persuaded that this was a clear error of judg-

ment. Josendis, 662 F.3d at 1313.

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 22 of 23

22 Opinion of the Court 21-11768

to create a factual dispute about specific causation sufficient to

withstand summary judgment. We disagree.

Dr. Kahn testified that when she gave Arevalo a physical

exam and touched Exair mesh in the front vaginal wall, Arevalo felt

tenderness and pain (distinct from the pain at the site of her hyster-

ectomy scar). Dr. Kahn described the band of mesh as tight and

unpliable and thought that removing it would relieve the pain and

tenderness. She testified that after removing “a good portion” of

the front mesh, she felt an “appreciable decrease in the band” —

meaning that it had “loosen[ed]” — which gave her hope that Are-

valo’s pain would improve. And during Arevalo’s final post-op

exam, Dr. Kahn’s notes don’t reflect that Arevalo complained of

any tenderness.

But when it came to offering a causation opinion, Dr. Kahn’s

testimony was speculative and equivocal. When asked whether

the “pain that [Arevalo] had been experiencing before [the mesh

removal] was caused or contributed to have been caused by the

mesh,” Dr. Kahn answered, “It’s possible, but she didn’t come

back, so I don’t know.” She opined that the pain and tenderness at

the site of the front mesh implant were “more likely than not . . .

related to the graft,” but she didn’t know whether the mesh re-

moval procedure was successful in relieving the tenderness that

Arevalo had reported. She explained that the “real test” of the re-

moval surgery’s success would be if Arevalo no longer had pain

during intercourse. And Arevalo testified that after the surgery she

has continued to have that pain. Dr. Kahn also ruled out the mesh

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 23 of 23

21-11768 Opinion of the Court 23

as a cause of Arevalo’s mixed urge and stress incontinence, urinary

urgency and frequency, fecal smearing, fecal incontinence, myal-

gia, and hysterectomy scar pain.

Dr. Kahn’s testimony is not enough to create a genuine issue

about whether the mesh implants were substantial factors in caus-

ing Arevalo’s injuries. 13 Because Arevalo lacks sufficient admissible

expert testimony on specific causation, Coloplast is entitled to sum-

mary judgment. See Rink v. Cheminova, Inc., 400 F.3d 1286, 1295–

96 (11th Cir. 2005) (affirming summary judgment based on exclu-

sion of expert testimony on causation).

IV. CONCLUSION

The district court did not abuse its discretion by excluding

Dr. Rosenzweig’s specific causation opinion and Dr. Miklos’ expert

testimony. Nor did it err in granting summary judgment in favor

of Coloplast.

The final judgment of the district court is AFFIRMED.

13 There are lingering questions about whether Dr. Kahn’s specific causation

opinion was properly disclosed under Rule 26(a)(2)(C) and whether it could

survive Daubert scrutiny. The district court left these questions unanswered.

Because we do not believe that Dr. Kahn’s testimony creates a factual dispute

about specific causation in any event, we need not remand for the district

court to consider these issues.