Raeann Bayless v. Coloplast Corp

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[DO NOT PUBLISH]
In the
United States Court of Appeals
For the Eleventh Circuit
____________________
No. 21-14397
____________________
RAEANN BAYLESS,
Plaintiff-Appellee-Cross-Appellant,
versus
BOSTON SCIENTIFIC CORPORATION,
Defendant,
COLOPLAST CORP,
Defendant-Appellant-Cross-Appellee.
____________________
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2 Opinion of the Court 21-14397
Appeals from the United States District Court
for the Middle District of Florida
D.C. Docket No. 6:20-cv-00831-RBD-GJK
____________________
Before ROSENBAUM and LAGOA, Circuit Judges, and WETHERELL,*
District Judge.
PER CURIAM:
After delivering four children, Raeann Bayless experienced
symptoms of stress urinary incontinence and pelvic organ prolapse.
To try to treat these conditions, she underwent a surgical operation
in which two polypropylene meshes—including Coloplast Corp.’s
Restorelle Y—were inserted into her pelvic region. But the surgery
did not cure her ailments. Bayless continued to experience debili-
tating symptoms, and she was ultimately diagnosed with vaginal
erosion.
Bayless attributed her post-operation injuries to the prod-
ucts inserted during surgery and brought suit against Coloplast and
another manufacturer alleging, among other things, that Restorelle
Y is defectively designed and that it caused her injuries. After an
eleven-day trial, a jury agreed on these points and awarded her
$500,000 in compensatory damages.
* The Honorable T. Kent Wetherell, II, United States District Judge for the
Northern District of Florida, sitting by designation.
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21-14397 Opinion of the Court 3
Coloplast now challenges the jury’s verdict, arguing that
Bayless did not present sufficient evidence to establish general cau-
sation and that Restorelle Y’s risks outweighed its benefits. The
district court rejected Coloplast’s motions, finding that there was
ample evidence to support the jury’s verdict. After thorough re-
view of the record, and with the benefit of oral argument, we af-
firm.
I. Background
Raeann Bayless is a mom. After giving birth to her youngest
son in 1987, she began experiencing symptoms of stress urinary in-
continence1 and pelvic organ prolapse. 2 Bayless’s symptoms wors-
ened over time, and she had long sought medical treatment for
them.
In 2012, Bayless was referred to Dr. Kathy Jones, an obstetri-
cian-gynecologist. Dr. Jones offered Bayless multiple surgical op-
tions and Bayless selected a “robotic-assisted laparoscopic sacrocol-
popexy with mesh, a possible sling, and cystocele repair and cystos-
copy.” More specifically, Dr. Jones was going to use two different
1 Stress urinary incontinence is a condition in which involuntary urination oc-
curs when a person makes abdominal movements such as coughing, laughing,
or exercise.
2 Pelvic organ prolapse is a condition that occurs when the natural supports
of the female structures are broken or loosened such that the pelvic organs
drop or even protrude out of the vaginal opening.
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4 Opinion of the Court 21-14397
synthetic meshes made of polypropylene3 to treat Bayless’s condi-
tions—Coloplast’s Restorelle Y to treat her pelvic organ prolapse,
and Boston Scientific Corp.’s Advantage Fit to treat her stress uri-
nary incontinence.
On August 9, 2013, Dr. Jones performed the surgery, which
included inserting the Restorelle Y and Advantage Fit meshes and
performing a hysterectomy. There were no complications or diffi-
culties during the surgery. But six weeks after the operation, an
examination revealed that there was a “foreign body” visible at the
top of Bayless’s vagina.
In 2014, Bayless noticed blood spotting in her underwear
and continued to experience pain. She “felt something protruding
into [her] vagina canal from the top [wall] of [her] vagina,” and she
described the feeling as a “piece of wire poking through,” and “[t]he
end of it was sharp like a needle.” Her pain continued to worsen—
in her words it was “different” and “more constant” than the pain
she had experienced before the operation. A speculum exam re-
vealed that mesh was exposed in her vagina. And she was eventu-
ally diagnosed with vaginal erosion due to surgical mesh and vagi-
nal infections.
Bayless was later referred to Dr. Lisa Rose for a mesh im-
plant evaluation. Dr. Rose saw and felt a hard, gray substance
3 Polypropylene is a type of plastic. Common examples of polypropylene in-
clude fishing line, bottle caps, and carpet backing.
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protruding into Bayless’s vagina from where the Restorelle Y was
implanted. Dr. Rose recommended that the mesh be removed as
soon as possible since there was a high risk of infection.
In 2016, Bayless filed this action against Coloplast and Bos-
ton Scientific Corp. She filed her complaint directly into a multi-
district litigation about the synthetic pelvic meshes. 4 Her com-
plaint raised eight claims against each defendant, including, as rel-
evant here, strict liability for defective design.
In May 2020, the case was transferred from the MDL court
to the Middle District of Florida for case-specific resolution. 5
Coloplast then moved to exclude testimony from Bayless’s
two expert witnesses: Dr. Jimmy Mays, a polymer scientist, and Dr.
Bruce Rosenzweig, a urogynecologist. The district court granted
those motions in part and denied them in part.
The district court concluded that Dr. Mays was “clearly
qualified to testify on the oxidative degradation of a polymer, and
his methodology is reliable.” But because Dr. Mays is not a medical
4 There are two relevant multi-district litigations (“MDLs”): MDL 2326 (for
Boston Scientific) and MDL 2387 (for Coloplast), which were both assigned to
the Southern District of West Virginia. The MDL court allowed a plaintiff
implanted with multiple products (like Bayless) to choose the MDL for her
suit and bring claims against multiple defendants.
5 When this litigation began, Bayless lived in Florida. During its pendency,
she moved to Georgia. We previously granted Bayless’s motion to amend her
complaint to now allege that she lives in Georgia.
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6 Opinion of the Court 21-14397
doctor, the district court concluded he could not “testify as to the
clinical implications of that degradation.”
As for Dr. Rosenzweig, the district court did not permit him
“to offer any general expert testimony about whether the Re-
storelle Y mesh is defective” because he had represented in the
MDL proceedings that he wouldn’t offer opinions about Restorelle
Y. Nor did the district court allow Dr. Rosenzweig to offer “gen-
eral opinion testimony as to causation, including on general causa-
tion opinions in his case specific expert report.” So he could not
testify, for example, that “Bayless’s injuries were the result of a de-
fect in the Restorelle Y” or that Restorelle Y is “defective because it
contains polypropylene that degrades in vivo or that this defect
[wa]s the cause of Bayless’s injuries.”
But the district court did allow Dr. Rosenzweig to testify
about the differential diagnosis he made regarding Bayless’s ail-
ments, which he disclosed in his case-specific expert report. 6 And
he was “permitted to testify that he believes the mesh caused Bay-
less’s injuries.” Under the district court’s ruling, Dr. Rosenzweig
could also use his experience “to conclude the mesh could be
6 “Differential diagnosis is a term used to describe a process whereby medical
doctors experienced in diagnostic techniques provide testimony countering
other possible causes of the injuries at issue. It is well-settled that an expert’s
use of differential diagnosis to arrive at a specific causation opinion is a meth-
odology that is generally accepted in the relevant scientific community.” Cas-
tillo v. E.I. Du Pont De Nemours & Co., 854 So. 2d 1264, 1270–71 (Fla. 2003)
(citations and internal quotation marks omitted) (alteration adopted).
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degrading in vivo and causing [Bayless’s] injuries.” So ultimately,
the district court concluded Dr. Rosenzweig “was justified in ‘opt-
ing-in’ the Restorelle Y device with his differential diagnosis when
considering Bayless’s mesh erosions, vaginal bleeding, and infec-
tion.” In other words, there was a scientific basis for Dr.
Rosenzweig’s conclusion that Restorelle Y caused Bayless’s inju-
ries. The district court held that Dr. Rosenzweig “was thorough
and used reliable methodology for excluding other possible
causes,” as he “clearly explained his reasons for rejecting alternative
explanations” and determining that “Restorelle Y was responsible.”
In May and June 2021, the parties conducted an eleven-day
jury trial to determine whether Boston Scientific’s Advantage Fit
and Coloplast’s Restorelle Y caused Bayless’s injuries. Several wit-
nesses, including Bayless, Dr. Jones, Dr. Mays, and Dr.
Rosenzweig, testified.
At trial, Dr. Mays testified about the properties of polypro-
pylene, including oxidative degradation, a process in which poly-
propylene “crumble[s]” when it “reacts with oxygen or other oxy-
gen-containing molecules.” He testified that, once polypropylene
is implanted into the body, it is subject to a process known as for-
eign body response, in which the body “detects” and “attack[s]” a
foreign substance. This process generates “very strong oxidizing
agents” and “catalyze[s] oxidative degradation.” And the foreign
body response occurs wherever the implant is placed in the body,
including the pelvic region. He explained that a polypropylene
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8 Opinion of the Court 21-14397
mesh—such as Restorelle Y—is “initially flexible” but “stiffe[ns]
during th[e] oxidation process.”
Dr. Mays concluded that the oxidation issues in polypropyl-
ene would occur in all its forms because “[t]he polypropylene
chemistry is the same” and “[i]ts reactivity is the same,” regardless
of form. He testified there is nothing unique about the polypropyl-
ene that is in Restorelle Y and that Restorelle Y’s “properties change
. . . for the worse” when it is inserted in the human body. Nor did
Dr. Mays need to do specific tests on Restorelle Y because
“[p]olypropylene is polypropylene,” and “eventually that polypro-
pylene is going to degrade in vivo.” So, Dr. Mays told the jury,
because Restorelle Y cannot hold its properties and functions, it is
not a suitable choice for permanent implantation. He further tes-
tified that he believed Restorelle Y was “defective from a materials
selection and design standpoint.” While Dr. Mays did not see or
examine the mesh implanted in Bayless, he testified that he had “no
doubt whatsoever” that it had gone through oxidative degradation.
The jury also heard testimony from Dr. Rosenzweig. As a
practicing urogynecologist, Dr. Rosenzweig began using polypro-
pylene to treat his patients in 2005. But a few years later, he
stopped doing so because “it was not worth using these products
any more” given their risks and complications. Those included
symptoms like “pain, pain with intercourse, [and] difficulty urinat-
ing.” He explained that the complications from the mesh were
“fairly significant,” as the mesh would “erod[e] or be[] exposed into
the vagina.” Dr. Rosenzweig testified that he has surgically treated
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21-14397 Opinion of the Court 9
around 350 patients for mesh-related injuries and roughly four
times as many nonsurgically.
He further explained that these injuries were traceable to the
foreign body response. Through that process, certain cells “try [to]
destroy [the polypropylene] by releasing strong acids that will
break it down.” The body then “send[s] little nerve roots to this
area,” which can then “grow through the opening or the pores of
the mesh.” These nerves “get trapped,” which ultimately causes
pain. According to Dr. Rosenzweig, the “mesh undergoes degra-
dation that leads to mesh exposure,” and that “mesh undergoes fi-
brosis and scar plating, and that leads to pain.”
As part of his testimony, Dr. Rosenzweig reviewed Bayless’s
medical records in front of the jury. The records showed that she
could “feel mesh in her vaginal wall” and that she had a “mesh ex-
posure” that was “due to a chronic foreign body reaction.” She also
experienced “pelvic pain,” “vaginal bleeding,” “persistent vaginal
discharge,” “dysuria, which is pain during urination,” and “pain
with sexual intercourse,” all of which are symptoms of mesh expo-
sure.
Dr. Rosenzweig also observed that the records showed a
hard, gray substance near Bayless’s vaginal cuff. He explained that
Restorelle Y was the mesh located at the cuff and that the gray col-
oring was likely “a sign of degradation,” because Restorelle Y is
white when it comes out of the box. The records revealed to Dr.
Rosenzweig that Bayless “ha[d] a mesh exposure from the Re-
storelle Y mesh,” which was responsible for her pain.
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In Dr. Rosenzweig’s view, Restorelle Y was “eroding,” “de-
grading,” and “contracting” in Bayless. He concluded that was a
cause of her “pain and pain with sex,” “repeated infections,” “bleed-
ing,” “chronic inflammation and chronic foreign body reaction,”
“fibrotic bridging,” “scar plate formation,” and “mesh encapsula-
tion.” Ultimately, Dr. Rosenzweig concluded that Restorelle Y was
not suitable for implantation in Bayless.
Bayless’s operating physician, Dr. Jones, also testified. Dr.
Jones said that mesh can yield complications including “mesh ex-
posure and/or chronic vaginal discharge, vaginal bleeding, or pain
with intercourse.” She said she had “observed exposures or ero-
sions in women who have been implanted with mesh,” and she had
removed mesh because of “pain associated with mesh” and
“chronic exposure associated with discharge or bleeding.”
After receiving all the evidence, the jury concluded that
Coloplast was liable because Restorelle Y was defectively designed,
and the defect was a legal cause of Bayless’s injuries. 7 The jury
awarded Bayless $500,000 in compensatory damages.
At every opportunity, Coloplast has argued that it is entitled
to judgment as a matter of law. Before trial, it sought summary
judgment because, in its view, Bayless did not submit expert testi-
mony on general causation and specific causation. During trial, it
7 The jury concluded that Boston Scientific was not liable for Bayless’s injuries,
so we do not discuss Boston Scientific further.
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moved for judgment as a matter of law, arguing that Bayless had
not met her burden to prove general causation or a design defect.
And after trial, it renewed its motion for judgment as a matter of
law, reiterating its arguments that there was no evidence of general
causation and that no witness testified that Restorelle Y’s risks out-
weighed its benefits.
The district court denied each motion. At the summary-
judgment stage, it held that Bayless had presented enough admis-
sible evidence to raise a triable issue of material fact on whether
Restorelle Y was a defectively designed product that caused her in-
juries. And after Bayless’s case-in-chief, the district court concluded
that there was sufficient evidence to support a jury verdict in Bay-
less’s favor. So it denied the motions for judgment as a matter of
law.
Coloplast timely appealed the district court’s judgment en-
tering the jury’s verdict. And Bayless cross-appealed the district
court’s decision to exclude Dr. Rosenzweig’s testimony about gen-
eral causation. 8
II. Standard of Review
We review de novo a district court’s order denying a defend-
ant’s renewed motion for judgment as a matter of law. Yates v.
8 Because we affirm the district court’s judgment, we do not consider Bayless’s
cross-appeal. Appellee’s Br. at 70 (“If this Court affirms the final judgment,
then Ms. Bayless will abandon her cross appeal.”).
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Pinellas Hematology & Oncology, P.A., 21 F.4th 1288, 1298 (11th
Cir. 2021). In conducting our review, we determine whether the
record, viewed in the light most favorable to the prevailing party,
“points so overwhelmingly in favor of the [moving party] that the
jury’s verdict cannot stand.” Id.We draw all reasonable inferences in favor of the nonmov-
ing party, and we cannot make credibility determinations, weigh
evidence, or consider evidence that the jury need not have be-
lieved. Chmielewski v. City of St. Pete Beach, 890 F.3d 942, 948
(11th Cir. 2018). Nor will we overturn a jury’s verdict “unless no
rational trier of fact could have reached the same conclusion based
upon the evidence in the record.” Mamani v. Sanchez Bustamante,
968 F.3d 1216, 1230 (11th Cir. 2020) (quoting Nat’l Fire Ins. Co. of
Hartford v. Fortune Constr. Co., 320 F.3d 1260, 1267 (11th Cir.
2003)).
III. Discussion
The central issue we must decide is whether sufficient evi-
dence supported the jury’s verdict. After reviewing the record and
our precedent, we conclude it did.
We divide our analysis in two parts. First, we address Colo-
plast’s argument that Bayless failed to present evidence about gen-
eral causation—that is, as Coloplast defines it, whether Restorelle
Y is even capable of causing the type of injuries that Bayless suf-
fered. Second, we show why the testimony presented at trial,
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along with our precedent, forecloses Coloplast’s argument that the
trial lacked evidence about Restorelle Y’s risks.
A. A reasonable jury could find sufficient evidence of
general causation.
The parties agree that Florida law governs their dispute. But
they disagree about the controlling legal standard for causation in
a products-liability action brought under Florida law.
Coloplast argues that causation must be divided into two
separate and independent inquiries: general causation and specific
causation. On its reading, general causation asks whether the prod-
uct is capable of causing the type of injury that is alleged, while
specific causation asks whether the particular unit of the product
actually caused the specifically alleged injury.
Meanwhile, Bayless contends that causation in Florida is a
single inquiry that asks whether the alleged defect “directly and in
natural and continuous sequence produced or contributed substan-
tially to producing [the plaintiff’s injury], so that it can reasonably
be said that, but for the defect, the injury would not have oc-
curred.” Aubin v. Union Carbide Corp., 177 So. 3d 489, 513 (Fla.
2015).
For purposes of this appeal, we assume, without deciding,
that Florida law mandates separate inquiries for general causation
and specific causation. We do so because, even under Coloplast’s
preferred standard, Bayless presented sufficient evidence to allow
a reasonable jury to find in her favor on both general and specific
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14 Opinion of the Court 21-14397
causation. So we need not scrutinize the parties’ competing inter-
pretations of Florida law.
Coloplast does not dispute that Bayless presented sufficient
evidence of specific causation. In other words, it effectively con-
cedes that a jury could find that Restorelle Y caused Bayless’s par-
ticular post-operation injuries. Coloplast contends only that Bay-
less did not present sufficient evidence of general causation—that
is, that Restorelle Y is even capable of causing the type of injuries
that Bayless suffered.
We cannot agree. The testimony presented at trial provided
ample evidence for the jury to reasonably conclude that Restorelle
Y is capable of causing Bayless’s injuries. Because Restorelle Y is a
polypropylene mesh, the jury could impute the evidence about pol-
ypropylene and its properties to Restorelle Y. And the jury heard
testimony about the specific injuries Restorelle Y inflicted on Bay-
less. So it could have reasonably inferred that Restorelle Y was ca-
pable of causing those types of injuries.
Dr. Mays testified about polypropylene’s physical proper-
ties. He told the jury that polypropylene undergoes oxidative deg-
radation after it is inserted into a living organism (like a person) and
how it is subsequently attacked through foreign body response.
And Dr. Mays connected his testimony about polypropylene to Re-
storelle Y, explaining that, because Restorelle Y is a polypropylene
mesh, it can be expected to experience the same degradation that
occurs to all forms of polypropylene.
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Dr. Rosenzweig followed with testimony about the body’s
clinical reactions to polypropylene degradation. He outlined the
“fairly significant” complications he had observed in patients who
had polypropylene mesh inserted. He explained that the mesh deg-
radation can lead to mesh exposure, which causes many of the
symptoms that Bayless experienced. And he explained that chronic
foreign body reaction can cause nerves to grow through the mesh
and lead to erosion, which also explains Bayless’s symptoms.
All told, the record contains significant testimony about the
potential harmful effects of polypropylene mesh. Based on Dr.
Mays’s testimony, the jury could have believed that, as a polypro-
pylene product, Restorelle Y could undergo oxidative degradation
after it is implanted in vivo. And based on Dr. Rosenzweig’s testi-
mony, the jury could have believed that oxidative degradation
leads to injuries such as mesh exposure and vaginal erosion. Even
though Dr. Rosenzweig did not testify about the general effects of
Restorelle Y, he did testify about the general effects of polypropyl-
ene mesh, and a sufficient basis existed for the jury to connect
them.
To put it another way, the jury could have relied on Dr.
Rosenzweig’s testimony about specific causation—combined with
Dr. Mays’s testimony about polypropylene—to infer that the gen-
eral causation requirement was satisfied. Dr. Rosenzweig testified
that the particular Restorelle Y mesh inside Bayless is degrading
and causing her injuries. And Dr. Mays testified about the oxida-
tive degradation process and that all polypropylene, including
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16 Opinion of the Court 21-14397
Restorelle Y, will eventually experience this phenomenon after the
polypropylene is implanted. So the jury reasonably could have in-
ferred that, as a general matter, Restorelle Y experiences degrada-
tion and causes injuries when it does so.
Coloplast suggests that, under our precedent, evidence of
specific causation cannot establish general causation because spe-
cific causation only assumes the existence of general causation. See
Kilpatrick v. Breg, Inc., 613 F.3d 1329 (11th Cir. 2010); McClain v.
Metabolife Int’l, Inc., 401 F.3d 1233 (11th Cir. 2005); see also Chap-
man v. Procter & Gamble Distrib., LLC, 766 F.3d 1296 (11th Cir.
2014); Hendrix ex rel. G.P. v. Evenflo Co., 609 F.3d 1183 (11th Cir.
2010). In Kilpatrick, we reviewed a district court’s decision to ex-
clude an expert witness’s testimony (rather than whether there was
sufficient evidence to support a jury’s verdict). 613 F.3d at 1333.
We concluded that the district court did not abuse its discretion in
finding that the expert used “flawed” and unreliable methodology
to support his conclusions on general causation and on specific cau-
sation. Id. at 1341–43. Similarly, in McClain, we analyzed an expert
witness’s methodology and concluded that his differential diagno-
sis did not “offer[] a reliable explanation” for his conclusion because
there was no “foundation” for his analysis. 401 F.3d at 1253; see
also Chapman, 766 F.3d at 1309 (affirming decision to exclude ex-
pert’s differential diagnosis because expert “did not follow” the
“scientifically accepted methodology”); Hendrix, 609 F.3d at 1198–
1201 (affirming decision to exclude expert’s testimony after district
court identified several errors in expert’s analysis so expert’s
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“testimony is the type of ‘speculation, conjecture, or inference’”
that should not be admitted (citation omitted)).
But here the district court affirmatively held that Dr.
Rosenzweig used reliable methodology to prove specific causation.
And Coloplast does not challenge that decision on appeal. The dis-
trict court explained that because of Dr. Rosenzweig’s training and
experience and the scientific literature, he had a valid, science-
based explanation for his conclusion that Restorelle Y caused Bay-
less’s injuries. And it held that his differential diagnosis “was thor-
ough and used reliable methodology for excluding other possible
causes.” It does not follow, from our precedent on the admissibil-
ity of expert testimony, that the jury could not use Dr.
Rosenzweig’s testimony about specific causation, in combination
with Dr. Mays’s testimony on the oxidative degradation of poly-
propylene, to infer that Restorelle Y was capable of causing Bay-
less’s injuries. 9
Coloplast also attempts to rebut the key expert testimony.
Its efforts to do so for Dr. Mays’s testimony are unavailing.
9 Coloplast also cites Byrd v. Janssen Pharmaceuticals, Inc., in which a district
court applied New York law and awarded judgment as a matter of law because
an expert witness’s differential-diagnosis opinions were speculative and there-
fore could not reliably establish general causation. 333 F. Supp. 3d 111, 130–
31 (N.D.N.Y. 2018). But here, as we explained, the district court held that Dr.
Rosenzweig’s differential diagnosis “was thorough and used reliable method-
ology for excluding other possible causes.” And again, Coloplast does not
challenge that finding on appeal.
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Coloplast makes several arguments, including that Dr. Mays im-
properly testified about pain, relied on irrelevant studies and mate-
rials, and offered some of his general-causation testimony during
Boston Scientific’s cross-examination. But Coloplast has no answer
for Dr. Mays’s key testimony about the oxidative degradation of
polypropylene and the foreign body response that causes stiffening
after implantation. From that testimony, the jury reasonably could
have believed that Restorelle Y degrades in the body.
At bottom, many of Coloplast’s critiques about the persua-
sive force of Dr. Mays’s testimony are more relevant to the admis-
sibility of his testimony than to its ability to support the jury’s ver-
dict. For example, Coloplast’s argument that Dr. Mays relied on
studies about products other than Restorelle Y closely mirrors a
challenge to the reliability of Dr. Mays’s methods and conclusions.
But as we have explained, Coloplast has abandoned any admissibil-
ity challenges (and understandably so, as it failed to object to much
of the testimony it now complains about). And because the district
court admitted the evidence, the jury was entitled to credit it, and
we cannot now disturb the jury’s decision. See Hastings v. Bonner,
578 F.2d 136, 142 (5th Cir. 1978) (“If the evidence is received with-
out objection, it becomes part of the evidence in the case, and is
usable as proof to the extent of the rational persuasive power it may
have. The incompetent evidence, alone or in part may support a
verdict or finding.” (quoting 1 McCormick on Evid. § 54 (2d ed.
1972) (alterations adopted)).
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Coloplast’s attempts to rebuff Dr. Rosenzweig’s testimony
fare no better. It suggests that his general-causation testimony
about polypropylene mesh came in the context of Boston Scien-
tific’s Advantage Fit rather than Coloplast’s Restorelle Y. But the
record reveals otherwise. Dr. Rosenzweig testified that he stopped
using both types of products because of the complications he ob-
served from polypropylene mesh. His testimony did not purport
to draw a distinction between the two products that were on trial
together.
Coloplast next references the district court’s directives, cor-
rectly observing that the district court instructed the jury to “disre-
gard” Dr. Rosenzweig’s testimony about Restorelle Y “at large,”
and instructing the jury to credit only his testimony about “the spe-
cific causation of the Coloplast product in Ms. Bayless.” But that
instruction does not mean that Dr. Rosenzweig could not make
statements about the general effects of polypropylene mesh (like
the ones Dr. Mays had already made) or that the jury could not
connect the statements about polypropylene mesh to Restorelle Y
and to the injuries that Bayless suffered.
In sum, between Dr. Mays’s testimony about the properties
of polypropylene mesh and Dr. Rosenzweig’s testimony about the
body’s reaction to polypropylene mesh and the specific injuries that
Bayless suffered from Restorelle Y, there was sufficient evidence
for a reasonable jury to conclude that Restorelle Y could cause the
type of injuries that Bayless suffered.
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20 Opinion of the Court 21-14397
B. A reasonable jury could conclude that Restorelle Y’s
risks outweighed its benefits.
Coloplast next argues that Bayless failed to establish that Re-
storelle Y’s risks outweigh its benefits such that it can be a defective
productive. We disagree.
A product is defectively designed “if the plaintiff proves that
the design of the product proximately caused the plaintiff’s injuries
and the defendant fails to prove that on balance, the benefits of the
design outweigh the risk of danger inherent in the design.”
Eghnayem v. Boston Sci. Corp., 873 F.3d 1304, 1319 (11th Cir.
2017) (quoting Force v. Ford Motor Co., 879 So. 2d 103, 106 (Fla.
Dist. Ct. App. 2004)); see also In re Standard Jury Instructions in
Civ. Cases–Rep. No. 13–01 (Prods. Liab.), 160 So. 3d 869, 873–74
(Fla. 2015).
We decided a similar challenge in Eghnayem. There, plain-
tiffs from a transvaginal mesh multi-district litigation argued that
they suffered injuries from the defendant’s pelvic floor repair kit.
Id. at 1310–11. After a jury found for each plaintiff on all claims,
the defendant argued, among other things, that the plaintiffs failed
to present sufficient evidence to prove their design-defect claims.
Id. at 1319.
We affirmed the jury’s verdict. Id. We observed that the
plaintiffs presented expert testimony that polypropylene may expe-
rience oxidative degradation, which can cause their injuries. Id. at
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21-14397 Opinion of the Court 21
1319–20. Indeed, Dr. Mays was one of the experts who testified in
that trial. Id. at 1320.
The record in Eghnayem included many statements that re-
semble those in the record here. For example, Dr. Mays testified
in that case that the polypropylene “stiffens,” “loses its mechanical
properties,” and “deteriorate[s]” after oxidation. Id. (alterations
adopted). He also testified there that polypropylene’s degradation
after insertion in the female pelvic area can cause “a sawing effect.”
Id. And another expert in Eghnayem testified that there are “mesh-
specific risks” of injuries including “pelvic pain, erosion, painful ac-
tivity, and permanent tissue damage.” Id.
We determined that “[w]hen taken in concert, this expert
testimony provided a sufficient foundation for a reasonable jury to
conclude that the design of the mesh increased … the potential for
degradation.” Id. Therefore, we said that “[t]he ultimate question
whether these risks outweighed the [product’s] benefits was for a
jury to decide.” Id.
Our decision here follows directly from Eghnayem. As Bay-
less highlights in her brief, the key testimony in this case largely
resembles the testimony in Eghnayem. Appellee’s Br. at 59–63.
For example, in both cases, Dr. Mays testified about polypropyl-
ene’s reactions with oxygen, which can cause polypropylene to
stiffen and lose flexibility. And in both cases, a medical doctor tes-
tified about mesh-specific risks, including pain, erosion, and the risk
of subsequent surgery.
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22 Opinion of the Court 21-14397
Coloplast argues that Dr. Mays’s testimony here does not
link the properties of polypropylene mesh to the risks and benefits
of Restorelle Y. But Dr. Mays’s testimony explained the risk that
mesh will stiffen in the body and that the resulting loss in flexibility
will affect its performance. And the jury could connect Dr. Mays’s
testimony about polypropylene mesh to Restorelle Y. And Dr.
Rosenzweig’s testimony about the medical risks of polypropylene
mesh filled in any missing links to the medical risks of Restorelle Y.
Coloplast also rehashes its arguments that Dr. Rosenzweig
could not testify about the risks of Restorelle Y. But as we’ve
noted, Dr. Rosenzweig was permitted to (and did) testify about the
medical risks of polypropylene mesh and explained that he had
long stopped using it with his patients because he was uncomfort-
able with the risks. A reasonable jury could infer that the same risks
associated with polypropylene mesh generally apply to Restorelle
Y specifically.
Finally, Coloplast suggests that a decision endorsing Bay-
less’s theory of liability means that mesh automatically equals de-
fect. Coloplast overstates the implications of our decision. A jury
observed eleven days’ worth of evidence from several fact and ex-
pert witnesses. And it reasonably concluded that Restorelle Y’s
risks outweighed its benefits. Its decision neither obviates Florida’s
risk-utility test nor creates absolute liability for prescription-only
products. The evidence presented at trial drove the outcome here.
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21-14397 Opinion of the Court 23
IV. Conclusion
Based on the evidence presented at trial, a jury could reason-
ably conclude that sufficient evidence supported a finding of gen-
eral causation and a finding that Restorelle Y’s risks outweighed its
benefits.
For these reasons, we affirm the district court’s judgment
and dismiss Bayless’s cross-appeal as moot.
AFFIRMED.