The opinion
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
TAMPA DIVISION
DIANA DYER,
Plaintiff,
v. Case No. 8:24-cv-2867-VMC-SPF
COLOPLAST CORP. and COLOPLAST
MANUFACTURING US, LLC,
Defendants.
/
ORDER
This matter is before the Court on consideration of
Defendant Coloplast Corp.’s (“Coloplast”) Rule 702 Motion to
Exclude Expert Opinions of Neeraj Kohli, M.D. (Doc. # 92),
filed on April 15, 2026. Plaintiff Diana Dyer responded on
May 6, 2026. (Doc. # 120). Coloplast replied on May 22, 2026.
(Doc. # 137). The Motion is granted in part and denied in
part.
I. Background
In December 2020, Ms. Dyer “was surgically implanted
with an Aris™ Trans-Obturator Sling System (hereinafter the
‘Aris’), a pelvic mesh product and medical device designed,
manufactured, and marketed by Defendants,” which “was
intended to treat pelvic organ prolapse and stress urinary
incontinence.” (Doc. # 1 at 1). Ms. Dyer alleges that neither
she “nor her healthcare providers were warned that the Aris
was defective and negligently designed and manufactured.”
(Id. at 1-2). Ms. Dyer claims that she “has suffered, and
continues to suffer, debilitating injuries” “[a]s a result of
being surgically implanted with Defendants’ unreasonably
dangerous defective pelvic mesh device.” (Id. at 2).
Ms. Dyer initiated this action to recover damages for
her claimed injuries. (Id.). In the complaint, Ms. Dyer
asserts three causes of action: (1) negligence, (2) strict
liability design defect, and (3) strict liability failure to
warn. (Id. at 33-47).
The case then proceeded through discovery. Ms. Dyer
retained as a general and specific causation expert Dr. Neeraj
Kohli, “an active surgeon, teacher, entrepreneur, inventor,
lecturer, and researcher.” (Doc. # 111-1 at 4). Dr. Kohli is
“a board certified Ob/Gyn and fellowship trained
urogynecologist practicing strictly in the field of
Urogynecology and Reconstructive Pelvic Surgery since 1997.”
(Id. at 1). Dr. Kohli has “extensive experience with pelvic
repair surgery of all types with and without biologic or
synthetic materials.” (Id. at 4). Dr. Kohli has used and is
familiar with the Aris device, “including its technique of
insertion, efficacy, and risks.” (Id.). As chief medical
officer of a medical device company, Dr. Kohli has “experience
and exposure in development of medical devices including FDA
approval and material safety standards.” (Id.). He was
involved in developing and reviewing the Instructions for Use
{“IFU”) for his company’s product, a “4 way catheter for
diagnostic cystoscopy.” (Id.).
Dr. Kohli has “reviewed numerous [IFUs] for a variety of
medical products including mesh products in order to
understand the proper way to use the devices and to gain
knowledge about the complications and adverse events
associated with the devices.” (Id.). Dr. Kohli has “extensive
clinical experience with IFUs and instructing patients about
the adverse events and risks contained in IFUs and those
related to surgery.” (Id.).
Dr. Kohli offers the following general causation
opinions: (1) the “inherent properties of polypropylene mesh
make it an unsuitable material for placement in the
transobturator space,” (2) the Aris is “defective in its
technique and [its] material design,” (3) the Aris “has an
unacceptably high rate of mesh exposure/erosion, dyspareunia,
and chronic pain complications,” (4) the Aris’s IFU “and
brochure warnings were inadequate to allow physicians to make
responsible treatment choices and allow patients to give
proper informed consent,” (5) Coloplast did not perform
adequate safety testing on the Aris and failed to warn about
known “complications related to transobturator mesh
placement,” (6) there “are safer alternatives that are
equally or more effective” than the Aris, and (7) the risks
of the Aris outweigh its benefits. (Id. at 12-13).
As to specific causation, Dr. Kohli opines that the
“vaginal/groin pain and persistent [overactive
bladder]/incontinence suffered by Ms. Dyer is the direct
result of the defects described throughout this report.” (Id.
at 32). Dr. Kohli arrived at this opinion after performing a
differential diagnosis. (Id. at 27-28). Dr. Kohli “first
ruled in the mesh as a primary cause because [Ms. Dyer’s]
pelvic pain symptoms began . . . immediately after mesh
implantation and are unique to mesh placement in the vagina
and particularly the Aris” transobturator sling. (Id. at 28-
29). Dr. Kohli then “ruled out a number of other conditions
as the causes of her current injury, including vaginal atrophy
and lumbar disc involvement.” (Id. at 29).
Now, Coloplast moves to exclude the opinions of Dr.
Kohli. (Doc. # 92). Ms. Dyer has responded (Doc. # 120), and
Coloplast has replied. (Doc. # 137). The Motion is ripe for
review.
II. Legal Standard
Federal Rule of Evidence 702 states:
A witness who is qualified as an expert by
knowledge, skill, experience, training, or
education may testify in the form of an opinion or
otherwise if: (a) the expert’s scientific,
technical, or other specialized knowledge will help
the trier of fact to understand the evidence or to
determine a fact in issue; (b) the testimony is
based on sufficient facts or data; (c) the
testimony is the product of reliable principles and
methods; and (d) the expert has reliably applied
the principles and methods to the facts of the case.
Fed. R. Evid. 702.
Implementing Rule 702, Daubert v. Merrell Dow Pharms.,
Inc., 509 U.S. 579 (1993), requires district courts to ensure
that any scientific testimony or evidence admitted is both
relevant and reliable. See Id. at 589–90. District courts
must conduct this gatekeeping function “to ensure that
speculative, unreliable expert testimony does not reach the
jury under the mantle of reliability that accompanies the
appellation ‘expert testimony.’” Rink v. Cheminova, Inc., 400
F.3d 1286, 1291 (11th Cir. 2005).
The Eleventh Circuit “requires trial courts acting as
gatekeepers to engage in a ‘rigorous three-part inquiry.’”
Hendrix ex rel. G.P. v. Evenflo Co., 609 F.3d 1183, 1194 (11th
Cir. 2010). The district court must assess whether:
(1) the expert is qualified to testify competently
regarding the matters he intends to address; (2)
the methodology by which the expert reaches his
conclusions 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 proponent of the expert testimony must show, by a
preponderance of the evidence, that the testimony satisfies
each requirement. Id.
III. Analysis
Coloplast challenges the reliability of Dr. Kohli’s
specific causation opinions. (Doc. # 92 at 5-15). Coloplast
also argues that many of Dr. Kohli’s general causation
opinions are unreliable, unhelpful, or irrelevant. (Id. at
15-28). Coloplast further argues that Dr. Kohli is
unqualified to opine on the adequacy of the Aris’s safety
testing and IFU. (Id. at 27-29). Finally, Coloplast contends
that the Court should exclude Dr. Kohli’s opinions “stating
legal standards, conclusions, and terms of art, as well as
opinions about Coloplast’s knowledge, state of mind, or
conduct.” (Id. at 29). The Court addresses each contention in
turn.
A. Dr. Kohli’s Case-Specific Opinions
Coloplast argues that Dr. Kohli’s case-specific opinions
are not reliable because he based his differential diagnosis
on a cherry-picked selection of medical records and did not
adequately rule out alternative possible causes of Ms. Dyer’s
injuries. (Doc. # 92 at 5-15). The Court is not persuaded.
“Exactly how reliability is evaluated may vary from case
to case, but what remains constant is the requirement that
the trial judge evaluate the reliability of the testimony
before allowing its admission at trial.” United States v.
Frazier, 387 F.3d 1244, 1262 (11th Cir. 2004) (citing Fed. R.
Evid. 702 advisory committee’s note to 2000 amendment). There
are four recognized, yet non-exhaustive, factors a district
court may consider in evaluating reliability:
(1) whether the expert’s methodology has been
tested or is capable of being tested; (2) whether
the technique has been subjected to peer review and
publication; (3) the known and potential error rate
of the methodology; and (4) whether the technique
has been generally accepted in the proper
scientific community.
Seamon v. Remington Arms Co., 813 F.3d 983, 988 (11th Cir.
2016) (citations omitted). A district court can take other
relevant factors into account as well. Id. (citations
omitted).
Coloplast argues that Dr. Kohli’s specific causation
opinions are unreliable because he: (1) failed to adequately
consider medical records that did not support his opinion,
(2) only reviewed the medical records provided to him by Ms.
Dyer’s counsel, and (3) did not conduct a pelvic exam of Ms.
Dyer. (Doc. # 92 at 5-10). None of the alleged factual
discrepancies or mischaracterizations warrant excluding Dr.
Kohli’s opinions.
“As a general rule, the factual basis of an expert
opinion goes to the credibility of the testimony, not the
admissibility, and it is up to the opposing party to examine
the factual basis for the opinion in cross-examination.”
Coquina Invs. v. Rothstein, No. 10-60786-CIV, 2011 WL
4949191, at *8 (S.D. Fla. Oct. 18, 2011) (quoting Synergetics,
Inc. v. Hurst, 477 F.3d 949, 955–56 (8th Cir. 2007)).
Coloplast’s challenges go to the weight rather than the
admissibility of Dr. Kohli’s opinions. See X Soc. Media LLC
v. X Corp., No. 6:23-cv-1903-JA-NWH, 2025 WL 2578249, at *4
(M.D. Fla. Sept. 5, 2025) (“Plaintiff argues Professor Golder
‘cherry-picked’ evidence by declining to evaluate evidence of
actual confusion and by emphasizing factors favorable to
Defendant. But such criticisms ordinarily go to weight, not
admissibility, absent methodological unreliability.”
(internal citation omitted)); Demeritt v. Wal-Mart Stores E.,
LP, No. 6:20-cv-89-PGB-GJK, 2021 WL 2835363, at *3 (M.D. Fla.
May 17, 2021) (“Dr. Koenigsberg’s failure to . . . review
Plaintiff’s entire medical history, review every available
deposition, or conduct a physical examination of Plaintiff
does not warrant exclusion under the Daubert framework.”).
Coloplast also argues that Dr. Kohli’s differential
diagnosis is unreliable because he did not adequately rule
out alternative possible causes of Ms. Dyer’s injuries. (Doc.
# 92 at 11-15). The Court disagrees.
Differential diagnosis is “a medical process of
elimination whereby the possible causes of a condition are
considered and ruled out one-by-one, leaving only one cause
remaining.” Chapman v. Procter & Gamble Distrib., LLC, 766
F.3d 1296, 1308 (11th Cir. 2014) (internal quotation marks
omitted). “A reliable differential analysis need not rule out
all possible alternative causes, but it must at least consider
other factors that could have been the sole cause of the
plaintiff’s injury.” Id. at 1308-09 (internal quotation marks
omitted).
Dr. Kohli explained his differential diagnosis as
follows. First, he “ruled in the mesh as a primary cause
because [Ms. Dyer’s] pelvic pain symptoms began . . .
immediately after mesh implantation and are unique to mesh
placement in the vagina and particularly the Aris”
transobturator sling.” (Doc. # 111-1 at 28-29). Dr. Kohli
noted that Ms. Dyer “has no significant medical, surgical, or
social history or risk factors contributing to her present
mesh complication symptoms or current pelvic floor
complaints.” (Id. at 29). Dr. Kohli “ruled out a number of
other conditions as the causes of her current injury,
including vaginal atrophy and lumbar disc involvement.”
(Id.). Dr. Kohli stated that “the mere fact a woman has
vaginal atrophy does not mean she will suffer the injuries
that Ms. Dyer has endured – her presentation was specific to
mesh use and her pain symptoms began specifically after
placement of the transobturator Aris sling mesh.” (Id.). Dr.
Kohli noted that Ms. Dyer “denied any prior diagnosis of
sciatica, lumbar disc disease, or sacroiliac joint
disorders,” but acknowledged “that records from other
providers later suggested lumbar degenerative changes that
she was unaware of before surgery.” (Id. at 26). In ruling
out lumbar disc involvement, Dr. Kohli explained that “[m]any
women have mild variants of lumbar disc herniation,” which
“does not typically present with acute onset groin/pelvic
pain immediately after sling mesh placement.” (Id. at 30).
Moreover, Dr. Kohli noted that “therapies including steroid
injection to the lumbar area were ineffective in providing
any relief further reducing the chance of lumbar pathology
contributing to her symptoms.” (Id.). Dr. Kohli acknowledged
that Ms. Dyer also underwent an anterior/posterior
colporrhaphy, or vaginal wall repair, at the time the Aris
was implanted but stated that such procedure “does not
typically cause significant myofascial pain or
obturator/pudendal neuralgia.” (Id. at 16, 30). Dr. Kohli
opined that Ms. Dyer’s “subsequent treatments including two
separate mesh revision surgeries confirm the clinical
etiology of her presenting pain symptoms related to the ARIS
suburethral mesh.” (Id. at 29-30).
Coloplast argues that Dr. Kohli failed to adequately
rule out lumbar disc and sacroiliac joint issues, sciatica,
and surgical positioning as being sources of Ms. Dyer’s pelvic
pain. (Doc. # 92 at 12). However, Dr. Kohli explained that he
ruled out lumbar disc involvement as it typically would not
cause the symptoms experienced by Ms. Dyer immediately
following mesh implantation and as post-surgical therapies to
the lumbar area were not effective. (Doc. # 111-1 at 30).
With respect to sacroiliac joint issues and sciatica,
Coloplast does not challenge Dr. Kohli’s assertion that Ms.
Dyer denied suffering from such problems prior to the mesh
implantation. (Id. at 26). Further, Coloplast does not
allege, let alone establish, that these conditions or Ms.
Dyer’s position during the surgery could be the sole cause of
her claimed pelvic injuries. Accordingly, this is not a basis
for finding Dr. Kohli’s opinion unreliable. See Chapman, 766
F.3d at 1308–09 (“A reliable differential analysis need not
rule out all possible alternative causes, but it must at least
consider other factors that could have been the sole cause of
the plaintiff’s injury.” (internal quotation marks omitted)
(emphasis added)); Messina v. Ethicon, Inc., No. 6:20-cv-
1170-PGB-LHP, 2020 WL 13441462, at *5 (M.D. Fla. Dec. 21,
2020) (“[T]he Defendants[’] uncorroborated allegations are
inadequate to cast doubt on Dr. Hoyte’s differential
diagnosis.”).
Finally, Coloplast argues that Dr. Kohli’s opinion that
the Aris caused Ms. Dyer to suffer persistent overactive
bladder and incontinence is unreliable as Dr. Kohli failed
“to rule out that Ms. Dyer’s pre-existing overactive bladder
and prior incontinence are the cause of her current urinary
complaints.” (Doc.# 92 at 14). In response, Ms. Dyer states
that she “will not claim at trial that the Aris caused or
contributed to [her] incontinence or overactive bladder.”
(Doc. # 120 at 11). Therefore, this issue is moot.
The Court finds Dr. Kohli’s methodology regarding the
cause of Ms. Dyer’s pelvic pain sufficiently reliable. The
alleged flaws in Dr. Kohli’s methodology raised by Coloplast
should be addressed during cross-examination. See Maiz v.
Virani, 253 F.3d 641, 666 (11th Cir. 2001) (“Vigorous cross-
examination, presentation of contrary evidence, and careful
instruction on the burden of proof are the traditional and
appropriate means of attacking [debatable] but admissible
evidence.” (citations and internal quotation marks omitted)).
Thus, the Motion is denied as to the exclusion of Dr. Kohli’s
specific causation opinions.
B. Dr. Kohli’s General Causation Opinions
1. Surgical Technique
Dr. Kohli opines that the Aris “was defective in its
technique and it[s] material design. This includes blind
insertion of a permanent device through the transobturator
space, through and in close proximity to vital anatomic
structures including muscles and nerves.” (Doc. # 92-1 at
12).
Coloplast argues that “Dr. Kohli’s criticisms about the
Aris’s transobturator approach amount to no more than
personal opinions on a particular surgical technique, which
does not speak to a ‘defect’ in the Aris that resulted in
injury,” and, therefore, are irrelevant. (Doc. # 92 at 15-
16). Coloplast also contends that “Dr. Kohli’s criticism that
Aris ‘requires blind placement’” is irrelevant because “he
admits that ‘all aspects of vaginal meshes have some level of
blind placement,’ including the retropubic approach he uses
and prefers.” (Id. at 16). The Court disagrees.
As another court in this Circuit recognized in a products
liability case involving the Aris, “[a] comparison of the
risks associated with implanting in the transobturator region
as opposed to the retropubic region is relevant to the defect
analysis because the location of the device within the body
and the method of insertion are inherent attributes of the
device’s design.” Arevalo v. Coloplast Corp., No. 3:19-cv-
3577-TKW-MJF, 2020 WL 3958505, at *3 (N.D. Fla. July 7, 2020),
aff’d sub nom. Arevalo v. Mentor Worldwide LLC, No. 21-11768,
2022 WL 16753646 (11th Cir. Nov. 8, 2022). Accordingly, Dr.
Kohli’s opinions regarding the transobturator approach are
not irrelevant.
Coloplast further argues that “Dr. Kohli’s blind
placement opinion is also divorced from any scientifically
reliable methodology.” (Doc. # 92 at 17). Specifically,
Coloplast notes that Dr. Kohli relies upon scientific studies
that “discuss the effects of mesh placed in the abdominal
wall” rather than the obturator space as well as other studies
“concerning hernia mesh placed in rabbits and dogs.” (Id.)
(emphasis in original). The Court is not persuaded.
“[I]n 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.”
Quiet Tech. DC-8, Inc. v. Hurel-Dubois UK Ltd., 326 F.3d 1333,
1345 (11th Cir. 2003). However, “[a] court may conclude that
there is simply too great an analytical gap between the data
and the opinion proffered.” Gen. Elec. Co. v. Joiner, 522
U.S. 136, 146 (1997). Here, Coloplast has not demonstrated
that there is too great an analytical gap between the studies
Dr. Kohli cited and his opinion.
The Motion is denied as to this issue.
2. Defective Design
Dr. Kohli opines that “[t]he inherent properties of
polypropylene mesh make it an unsuitable material for
placement in the transobturator space. . . . This is
especially true of the Coloplast mesh given its increased
weight and stiffness.” (Doc. # 92-1 at 5).
Coloplast argues that the Court should exclude Dr.
Kohli’s opinion that the Aris is defectively designed because
“Dr. Kohli does not provide support for his opinions on
Aris’[s] design properties or that the Aris is unsuitable for
use in the transobturator space.” (Doc. # 92 at 18). However,
Dr. Kohli cites multiple scientific articles to support his
opinions regarding the properties of polypropylene mesh and
its unsuitability for use in the transobturator space. (Doc.
# 92-1 at 5-9). Accordingly, Coloplast has not demonstrated
that Dr. Kohli’s opinions are unreliable. See In re Boston
Sci. Corp. Pelvic Repair Sys. Prods. Liab. Litig., No. MDL
2326, 2018 WL 2425955, at *2 (S.D.W. Va. May 29, 2018)
(denying motion to exclude Dr. Kohli’s opinions on the
properties of polypropylene mesh as “Dr. Kohli cite[d] to
numerous medical articles in support of his opinions”).
Coloplast further argues that Dr. Kohli’s opinions are
unhelpful to the jury because Dr. Kohli “fails to provide a
measuring stick for assessing the propriety of Aris’s
specifications, and instead advances a ‘trust me, I’m a
doctor’ approach.” (Doc. # 92 at 20). The Court disagrees.
Expert testimony must assist the trier of fact. Fed. R.
Evid. 702. “By this requirement, expert testimony is
admissible if it concerns matters that are beyond the
understanding of the average lay person.” Frazier, 387 F.3d
at 1262 (citation omitted). “[T]he court must ensure that the
proposed expert testimony is relevant to the task at hand, .
. . i.e., that it logically advances a material aspect of the
proposing party’s case.” Allison v. McGhan, 184 F.3d 1300,
1312 (11th Cir. 1999) (internal quotation marks omitted).
“Proffered expert testimony generally will not help the trier
of fact when it offers nothing more than what lawyers for the
parties can argue in closing arguments.” Frazier, 387 F.3d at
1262-63 (citation omitted).
To succeed on any of her claims, Ms. Dyer must prove
that the Aris “is defective or unreasonably dangerous.” Brown
v. DePuy Orthopaedics, Inc., 978 F. Supp. 2d 1266, 1272 (M.D.
Fla. 2013). Dr. Kohli explains the basis for his opinion that
the properties of polypropylene mesh make it unsuitable for
use in the transobturator space and cites to multiple
scientific studies. (Doc. # 92-1 at 5-9, 13). Dr. Kohli’s
opinion logically advances a material aspect of Ms. Dyer’s
case: whether the Aris is defective or unreasonably
dangerous. This information is “beyond the understanding of
the average lay person.” Frazier, 387 F.3d at 1262 (citation
omitted). Thus, Dr. Kohli’s opinions would be helpful to the
jury.
The Motion is denied as to this issue.
3. Unacceptably High Rate of Complications
Dr. Kohli opines that the Aris “has an unacceptably high
rate of mesh exposure/erosion, dyspareunia, and chronic pain
complications.” (Doc. # 92-1 at 16). Coloplast argues that
Dr. Kohli’s opinion is unreliable because “Dr. Kohli
identifies no methodology (much less a reliable one) for
determining what constitutes an acceptable versus
‘unacceptably high’ rate of complications.” (Doc. # 92 at
21). The Court agrees.
Dr. Kohli does not identify the alleged complication
rate of the Aris or explain the scientific basis for his
opinion that the Aris’s rate is “unacceptably high.”
Accordingly, Dr. Kohli’s opinion on this issue is unreliable
and is excluded. See Arevalo, 2020 WL 3958505, at *4
(excluding Dr. Kohli’s opinion that the Aris has an
unacceptably high rate of complications because Dr. Kohli did
not identify any “methodology for determining what
constitutes an acceptable versus ‘unacceptably high’ rate”
(internal quotation marks omitted)); In re Boston Sci. Corp.,
2018 WL 2425955, at *3 (“Dr. Kohli offers no scientific
support or methodology for opining on what constitutes an
‘unacceptably high’ complication rate. The unreliability of
Dr. Kohli’s opinion is highlighted by the fact that he does
not even opine on what the actual complication rates are.”).
The Motion is granted as to this issue.
4. Safer Alternatives
Dr. Kohli opines that “the Burch procedure, autologous
fascial slings, and appropriate retropubic slings are safer
than the Aris.” (Doc. # 92-1 at 30). The Court will first
consider Coloplast’s challenges to Dr. Kohli’s opinions
regarding safer alternative procedures and then will address
Coloplast’s arguments regarding Dr. Kohli’s opinions on safer
alternative products.
a. Safer Alternative Procedures
Coloplast argues that Dr. Kohli’s opinions regarding the
Burch procedure and autologous fascial slings are irrelevant
as they are not safer alternative product designs for a
transobturator sling but are “entirely different surgeries.”
(Doc. # 92 at 22) (emphasis in original). In response, Ms.
Dyer contends that “Dr. Kohli’s opinion that alternate
medical procedures, the use of [the] Burch procedure or
autologous or allograft slings, are safer than the Aris and
were feasible for Ms. Dyer are relevant to demonstrating that
the Aris’s inherent risks outweigh its benefits.” (Doc. # 120
at 19-20). The Court agrees with Ms. Dyer.
“In Florida, a plaintiff need not demonstrate the
existence of a reasonable alternative design for a strict
liability design defect claim.” Geery v. Ethicon, Inc., No.
6:20-cv-1975-RBD-LRH, 2021 WL 2580144, at *5 (M.D. Fla. Apr.
9, 2021); Aubin v. Union Carbide Corp., 177 So. 3d 489, 511
(Fla. 2015). “In proving strict liability, Florida courts use
both the consumer expectations test and the risk utility
test.” Geery, 2021 WL 2580144, at *5. “[U]nder the risk
utility test, a product is considered unreasonably dangerous
when the risk of danger in the design outweighs the benefits.”
Id. (internal quotation marks omitted).
Dr. Kohli’s opinions regarding safer alternative
procedures are relevant to the question of whether the risks
of the Aris outweigh the benefits. See Id. (“Dr. Rosenzweig’s
opinions are relevant to the risk utility test because it
will assist the jury in determining whether the risks of the
TVT-O and Prolift outweighed the benefits, given the safety
of alternative medical procedures.”); Messina v. Ethicon,
Inc., No. 6:20-cv-1170-PGB-LHP, 2020 WL 7419586, at *4 (M.D.
Fla. Dec. 17, 2020) (“Dr. Rosenzweig’s opinion that alternate
medical procedures were safe and effective — that is, they
are safer than the accused product and were feasible for Ms.
Messina — are relevant to demonstrating that the TVT Abbrevo’s
inherent risks outweigh its benefits.”); Ellerbee v. Ethicon,
Inc., No. 8:20-cv-1514-TPB-AEP, 2020 WL 4815818, at *3 (M.D.
Fla. Aug. 19, 2020) (declining to exclude expert’s opinions
on safer alternative procedures as they were relevant to the
pelvic mesh products liability action).
Alternatively, Coloplast argues that Dr. Kohli’s
opinions are unreliable. (Doc. # 92 at 24-25). Regarding the
Burch procedure, Coloplast notes that “Dr. Kohli admits that
the Burch procedure results in a higher risk of having voiding
dysfunction and needing a catheter” and that Dr. Kohli has
“all but given up using Burches.” (Id. at 24) (internal
quotation marks omitted). Coloplast asserts that “[a]s for
tissue-based slings — both autologous fascial and allograft
slings — Dr. Kohli admits many people feel like there are
advantages to synthetic mesh over autologous slings.” (Id.).
The Court is not persuaded.
“[C]ontrary evidence goes not to the admissibility of
the expert testimony; rather, it goes to the weight of that
testimony.” Souder v. Floyd Cnty., No. CIV.A. 4:03CV0085HLM,
2005 WL 6218033, at *6 (N.D. Ga. Mar. 22, 2005). Here,
Coloplast has not demonstrated that Dr. Kohli’s opinions are
unreliable – it has only pointed to countervailing facts to
undermine the credibility of Dr. Kohli’s opinions. This is an
issue to be addressed in cross-examination. See Quiet Tech.,
326 F.3d at 1345 (holding that the identification of “flaws
in generally reliable scientific evidence” that “impugn the
accuracy of” the evidence “is precisely the role of cross-
examination”); Maiz, 253 F.3d at 666 (“Vigorous cross-
examination, presentation of contrary evidence, and careful
instruction on the burden of proof are the traditional and
appropriate means of attacking [debatable] but admissible
evidence.” (citations and internal quotation marks omitted)).
b. Safer Alternative Products
Coloplast further argues that “Dr. Kohli’s ‘safer
alternative’ opinions about polypropylene retropubic slings
and PVDF mid-urethral slings are unreliable.” (Doc. # 92 at
25). The Court disagrees.
Coloplast contends that “Dr. Kohli makes unsupported,
inferential leaps from the cited literature to find that
retropubic and mid-urethral PVDF slings are safer than the
Aris.” (Id. at 26). However, Coloplast’s challenge to “the
sufficiency of scientific literature on which” Dr. Kohli
relies “is a matter that more properly goes to the weight of
the evidence and can be probed during cross-examination.”
Swintelski v. Am. Med. Sys., Inc., No. 20-60410-CIV, 2021 WL
4527451, at *4 (S.D. Fla. Aug. 6, 2021); see Jackson v.
Johnson & Johnson, No. 1:11-CV-3903-TWT, 2022 WL 110422, at
*5 (N.D. Ga. Jan. 12, 2022) (“The Defendants’ arguments amount
to an attack on the sufficiency of the medical literature
undergirding his opinions, and the ‘identification of such
flaws in generally reliable scientific evidence is precisely
the role of cross-examination.’” (quoting Quiet Tech., 326
F.3d at 1345)).
Coloplast also argues that Dr. Kohli’s opinions
regarding PVDF mesh mid-urethral slings should be excluded
because such slings are not available in the United States.
(Doc. # 92 at 26-27). In support, Coloplast cites a case from
the District of Colorado, which held that an expert’s
testimony about two alternative devices was irrelevant
because neither was available in the United States. Wood v.
Am. Med. Sys. Inc., No. 120CV00441DDDKLM, 2021 WL 1178547, at
*10 (D. Colo. Mar. 26, 2021). As the Wood court noted, “[t]o
recover for a claim of negligent design in Colorado, a
plaintiff must show not only that the alternative is safer
but that it was practicable and available at the time the
allegedly dangerous product was sold.” Id. (internal
quotation marks omitted). However, as previously discussed,
under Florida law, “a plaintiff need not demonstrate the
existence of a reasonable alternative design for a strict
liability design defect claim.” Geery, 2021 WL 2580144, at
*5; Aubin, 177 So. 3d at 511. Accordingly, the fact that PVDF
mid-urethral slings were not available in the United States
at the time of Ms. Dyer’s surgery does not render Dr. Kohli’s
opinion irrelevant in this case.
Although a plaintiff is not required to offer evidence
of a reasonable alternative design, the Florida Supreme Court
has stated that “nothing precludes the plaintiff in proving
his or her case from showing that alternative safer designs
exist — or for that matter precludes the defendant from
showing that it could not have made the product any safer
through reasonable alternative designs.” Aubin, 177 So. 3d at
511. Here, Dr. Kohli stated that PVDF mid-urethral slings
were FDA cleared in 2007 and that “[t]here appears to be no
reason other than costs that PVDF midurethral slings are not
offered in the United States.” (Doc. # 111-1 at 11). The Court
finds Dr. Kohli’s opinions on PVDF mid-urethral slings
relevant to the issue of whether “alternative safer designs
exist.” Aubin, 177 So. 3d at 511; see Jackson, 2022 WL 110422,
at *6 (declining to exclude expert testimony regarding an
alternative PVDF mesh device that was not on the market at
the time of plaintiff’s surgery because “whether or not the
PVDF mesh was commercially available at the time . . . does
not bear on the feasibility of a safer an[d] equally
efficacious design” (internal quotation marks omitted)).
The Motion is denied as to this issue.
5. Inadequate Safety Testing
Dr. Kohli opines that Coloplast failed to perform
adequate safety testing on the Aris. (Doc. # 92-1 at 26).
Coloplast argues that Dr. Kohli is unqualified to opine on
the matter and, alternatively, that his opinion is
unreliable. (Doc. # 92 at 27-28). The Court agrees.
Dr. Kohli is a urogynecologist with decades of
experience as a pelvic surgeon. (Doc. # 92-1 at 1). But
“[e]xperience as a surgeon alone . . . does not translate
into experience with or knowledge about the appropriate
testing a medical device manufacturer should undertake when
preparing a product for the market.” Trevino v. Boston Sci.
Corp., No. 2:13-CV-01617, 2016 WL 2939521, at *13 (S.D.W. Va.
May 19, 2016). Although Dr. Kohli is also chief medical
officer of a medical device company, there is no indication
that he has experience in testing medical devices. (Doc. #
92-1 at 4). Accordingly, Dr. Kohli is not qualified to testify
as to the adequacy of Coloplast’s safety testing.
In any event, even if Dr. Kohli were qualified to opine
on the adequacy of the safety testing, Dr. Kohli has not
offered any support for his conclusory opinion that Coloplast
“rushed to market with Aris to avoid loss of market share
without adequate safety testing.” (Id. at 11). Dr. Kohli
references an internal Coloplast document stating that the
“promising results” from a study of the Aris “need long-term
investigation,” but he does not explain how this demonstrates
that Coloplast failed to adequately test the Aris prior to
its commercial release. (Id.). Accordingly, Dr. Kohli’s
opinion is unreliable. See Frazier, 387 F.3d at 1261 (“[I]t
remains a basic foundation for admissibility that ‘[p]roposed
[expert] testimony must be supported by appropriate
validation — i.e., ‘good grounds,’ based on what is known.’”
(quoting Daubert, 509 U.S. at 590)); Hudgens v. Bell
Helicopters/Textron, 328 F.3d 1329, 1344 (11th Cir. 2003)
(“[A]n expert’s failure to explain the basis for an important
inference mandates exclusion of his or her opinion.”).
The Motion is granted as to this issue.
6. Deficient IFU
Dr. Kohli opines that the Aris’s IFU “were inadequate to
allow physicians to make responsible treatment choices and
allow patients to give proper informed consent.” (Doc. # 92-
1 at 26). Coloplast argues that Dr. Kohli is not qualified to
render an opinion on the IFU and, in any event, that Dr. Kohli
has not provided any “basis for reaching the conclusion that
the purported inadequacy of Aris’s IFU renders the device
‘not reasonably safe’ or makes it ‘impossible’ for implanting
physicians to obtain informed consent.” (Doc. # 92 at 28).
The Court finds Dr. Kohli qualified to opine on the
adequacy of the Aris’s IFU as, in addition to his surgical
experience, Dr. Kohli “assist[s] in the drafting and editing
of IFUs” at a medical device company. (Doc. # 92-1 at 27).
See In re: Ethicon Inc., No. 2327, 2016 WL 4582220, at *3
(S.D.W. Va. Sept. 1, 2016), adopted sub nom. In re Ethicon
Inc. Pelvic Repair Sys. Prod. Liab. Litig., No. 2327, 2017 WL
4769671 (S.D.W. Va. July 21, 2017) (“While an expert who is
an obstetrician and gynecologist may testify about the
specific risks of implanting mesh and whether those risks
appeared on the relevant IFU, the same expert must possess
additional expertise to offer expert testimony about what
information should or should not be included in an IFU.”);
Arevalo, 2020 WL 3958505, at *5 (finding Dr. Kohli qualified
to opine about the adequacy of the Aris’s IFU).
However, as the Arevalo court determined, “Dr. Kohli
does not provide an adequate basis for, or a reliable
methodology used, in reaching his conclusions that the
inadequacy of the instructions and warnings renders Aris ‘not
reasonably safe’ and made it ‘impossible’ to obtain informed
consent.” Arevalo, 2020 WL 3958505, at *5. Accordingly, Dr.
Kohli’s opinions in this regard are excluded.
The Motion is granted as to this issue.
7. Legal Conclusions, Summaries, and Opinions on
Coloplast’s Knowledge, Intent, or State of
Mind
Finally, Coloplast asks the Court to exclude Dr. Kohli’s
opinions to the extent they contain impermissible legal
conclusions, summaries, and speculation on Coloplast’s
corporate intent, knowledge, or state of mind. (Doc. # 92 at
29).
a. Legal Conclusions
“While it is well established that a qualified expert in
a civil case may offer his opinion on an ultimate issue in a
case, experts may not testify to the legal implications of
conduct or tell the jury what result to reach.” Commodores
Ent. Corp. v. McClary, 879 F.3d 1114, 1128 (11th Cir. 2018)
(internal citation and quotation marks omitted).
In response to the Motion, Ms. Dyer states that she “does
not intend to elicit opinions that draw a legal conclusion”
but argues that “Dr. Kohli should not be precluded from
testimony that uses terms that do not have a separate,
distinct, and specialized meaning in the law.” (Doc. # 120 at
24). The Court agrees with Ms. Dyer.
The Motion is granted on this issue. But Dr. Kohli “is
not precluded from offering testimony that uses terms that do
not have a separate, distinct, and specialized meaning in the
law.” Warren v. C. R. Bard, Inc., No. 8:19-cv-2657-TPB-JSS,
2020 WL 3567299, at *4 (M.D. Fla. July 1, 2020).
b. Summaries of Corporate Documents and
Speculation on Coloplast’s Knowledge,
Intent, or State of Mind
“Generally, experts may not render opinions as to a
party’s knowledge or state of mind.” Redding v. Coloplast
Corp., No. 6:19-cv-1857-CEM-DAB, 2020 WL 13882977, at *7
(M.D. Fla. Nov. 30, 2020) (internal quotation marks omitted).
But “an expert may testify as to a review of internal
corporate documents solely for the purpose of explaining the
basis for his or her opinions — assuming the opinions are
otherwise admissible.” Id. (internal quotation marks
omitted); Humleker v. Boston Sci. Corp., No. 6:19-cv-121-GAP-
EAK, 2020 WL 6870852, at *10 (M.D. Fla. Oct. 2, 2020).
“[S]imply parroting documents or other testimony does nothing
to assist the trier of fact.” Salinero v. Johnson & Johnson,
No. 1:18-cv-23643-UU, 2019 WL 7753453, at *18 (S.D. Fla. Sept.
5, 2019).
Ms. Dyer represents that she will not elicit opinions on
Coloplast’s state of mind. (Doc. # 120 at 25). However, Ms.
Dyer argues that this “does not mean that Dr. Kohli should be
prohibited from providing testimony on factual information
found in Defendant’s documents, to the extent that
information forms the basis of his opinions.” (Doc. # 120 at
25). The Court agrees with Ms. Dyer.
The Motion is granted on this issue. Dr. Kohli “will not
be permitted to testify as to the knowledge, state of mind,
or corporate intent of [Coloplast]” or summarize corporate
documents “but will be allowed to testify as to his review of
the corporate documents solely for the purpose of explaining
the basis of his opinions.” Redding, 2020 WL 13882977, at *7.
Accordingly, it is hereby
ORDERED, ADJUDGED, and DECREED:
(1) Defendant Coloplast Corp.’s Rule 702 Motion to Exclude
Expert Opinions of Neeraj Kohli, M.D. (Doc. # 92) is
GRANTED in part and DENIED in part.
(2) Dr. Kohli may not opine that: (1) the Aris has an
unacceptably high rate of complications, (2) the Aris
was not adequately tested, or (3) the Aris’s IFU render
the device not reasonably safe or make it impossible for
physicians to obtain informed consent.
(3) Dr. Kohli also may not offer legal conclusions,
summarize Coloplast documents, or speculate on
Coloplast’s intent, knowledge, or state of mind.
DONE and ORDERED in Chambers in Tampa, Florida, this 2nd
day of July, 2026.
VIR IA M. HERNANDEZ’COVINGTON
UNITED STATES DISTRICT JUDGE
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