Thacker v. Ethicon, Inc. et al

Filing 268

MEMORANDUM OPINION & ORDER: 1) Dft's 159 Motion for Summary Judgment is GRANTED IN FULL. 2) Dfts' and Pla's pending Motions in Limine and Motions to Exclude [DE 112- 158, 160-166] are DENIED AS MOOT. Signed by Judge Joseph M. Hood on 11/17/2021. (MDC) cc: COR

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UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF KENTUCKY
CENTRAL DIVISION at LEXINGTON
CONNIE J. THACKER
Plaintiff,
v.
ETHICON, INC., et al.,
Defendants.

)
)
)
)
)
)
)
)
)

Case No.:
5:20-cv-0050-JMH-MAS

***
This matter is before the Court on Defendants’ Motion for
Summary Judgment [DE 159]. Plaintiff Connie J. Thacker filed suit
against

Defendants,

Ethicon,

Inc.

and

Johnson

&

Johnson

(collectively “Ethicon”), for claims arising out of the surgical
implantation of Pelvic Mesh Products manufactured by Ethicon. For
the reasons set forth below, Defendants’ motion will be granted in
full.
I. BACKGROUND
On May 8, 2009, Dr. Michael Guiler surgically implanted the TVTSecur (TVT-S) mesh sling and Prolift posterior mesh for Ms. Thacker
to treat her stress urinary incontinence and rectocele. [Second A.
Short Form Complaint,

DE 19 at ¶ 10-12]. After experiencing

continued problems, Ms. Thacker attempted to have the devices
removed. [Defendants’ Separate Statement of Undisputed Facts in
Support of Motion for Summary Judgment, DE 159-10 at ¶¶ 3 & 8-9,
undisputed by Plaintiffs, DE 225 at 2].

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Ms. Thacker alleges the TVT-Secur and Prolift devices caused
pain,

voiding

dysfunction

and

urge

incontinence,

fecal

incontinence (only a “couple” of times), and painful intercourse.
[Connie J. Thacker Dep., DE 159-8 at 111:25–112:13; 115:2-18;
116:24–117:16]. Ms. Thacker brought suit in 2012 against Ethicon,
the maker and seller of the device in question, alleging several
counts

related

to

the

surgical

implantation

of

the

devices:

Negligence (Count I), Strict Liability - Manufacturing Defect
(Count II), Strict Liability - Failure to Warn (Count III), Strict
Liability - Defective Product (Count IV), Strict Liability – Design
Defect (Count V), Fraud (Count VI), Fraudulent Concealment (Count
VII), Constructive Fraud (Count VIII), Negligent Misrepresentation
(Count IX), Negligent Infliction of Emotional Distress (Count X),
Breach of Express Warranty (County XI), Breach of Implied Warranty
(Count XII), Violation of the Kentucky Consumer Protection Act
(Count XIII), Gross Negligence (Count XIV), Unjust Enrichment
(Count XV), Punitive Damages (Count XVII), Discovery Rule/ Tolling
(Count XVIII).
II. DISCUSSION
A. SUMMARY JUDGMENT
“The court shall grant summary judgment 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).
A “genuine dispute” exists when “a reasonable jury could return a
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verdict for the non-moving party.” Olinger v. Corporation of the
President of the Church, 521 F. Supp. 2d 577, 582 (E.D. Ky. 2007)
(quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255
(1986)); Smith v. Perkins Bd. Of Educ., 708 F. 3d 821, 825 (6th
Cir. 2013). In the Court’s analysis, “the evidence should be viewed
in the light most favorable to the non-moving party.” Ahlers v.
Schebil, 188 F. 3d 365, 369 (6th Cir. 1999) (citing Anderson, 477
U.S. at 255).
The initial burden falls on the moving party, who must identify
portions of the record establishing the absence of a genuine issue
of material fact. Chao v. Hall Holding Co., 285 F. 3d 415, 424
(6th Cir. 2002) (citing Celotex Corp. v. Catrett, 477 U.S. 317,
323 (1986)). If established, the non-moving party “must go beyond
the pleadings and come forward with specific facts to demonstrate
that there is a genuine issue for trial.” Id. The nonmoving party
will not overcome a motion for summary judgment by simply showing
“some metaphysical doubt as to the material facts.” Id. (citing
Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S.
574, 586 (1986)). In other words, “the respondent must adduce more
than a scintilla of evidence to overcome the motion.” Street v.
J.C. Bradford & Co., 886 F. 2d 1472, 1479 (6th Cir. 1989). As a
“mere scintilla of evidence” is insufficient, the non-movant must
show the existence of “evidence on which the jury could reasonably
find for the non-moving party.” Sutherland v. Mich. Dept. of
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Treasury, 344 F. 3d 603, 613 (6th Cir. 2003) (citing Anderson, 477
U.S. at 251). Instead, the non-moving party is required to “present
significant probative evidence in support of its opposition.”
Chao, 285 F. 3d at 424.
“As a federal court exercising diversity jurisdiction, the
choice-of-law rules of the forum state, Kentucky, determine what
substantive law to apply.” State Farm Mut. Auto. Ins. Co. v.
Norcold, Inc., 849 F.3d 328, 331 (6th Cir. 2017)(citing NILAC Int’l
Mktg. Grp. v. Ameritech Servs., Inc., 362 F.3d 354, 358 (6th Cir.
2004)). “When applying Kentucky's choice of law rules, ‘a strong
preference exists in Kentucky for applying Kentucky law.’” Brass
Reminders Co. v. RT Eng'g Corp., 462 F. Supp. 3d 707, 716 (E.D.
Ky. 2020), aff'd, 844 F. App'x 813 (6th Cir. 2021)(citing Asher v.
Unarco Material Handling, Inc., 737 F. Supp. 2d 662, 667 (E.D. Ky.
2010)). For tort claims, Kentucky law will apply if there is
significant contact. Foster v. Leggett, 484 S.W.2d 827, 829 (Ky.
1972); Bell v. Kokosing Indus., Inc., No. CV 19-53-DLB-CJS, 2020
WL 4210701, at *11 (E.D. Ky. July 22, 2020). Because Plaintiff, a
Kentucky resident, had her implantation surgery in Kentucky, the
state

with

the

most

significant

relationship

is

Kentucky.

Additionally, Plaintiff does not dispute that Kentucky substantive
law applies. [See Plaintiff’s Response In Opposition to Summary
Judgment, DE 225 at 7].

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1. VOLUNTARILY DISMISSED CLAIMS
Plaintiff agrees this Court’s recent case involving Ethicon’s
Pelvic Mesh Products, Chasity Sexton v. Ethicon, Inc., 2021 WL
4138399

(E.D.

Ky.

Sept.

10,

2021),

should

be

adopted

where

applicable. [DE 225 at 1]. Therefore, Ms. Thacker voluntarily
dismisses the following causes of action: Manufacturing Defect
(Count

II),

Defective

Product

(Count

IV),

Fraud

(Count

VI),

Fraudulent Concealment (Count VII), Constructive Fraud (Count
VIII),

Negligent

Misrepresentation

(Count

IX),

Negligent

Infliction of Emotional Distress (Count X), Breach of Express
Warranty (County XI), Breach of Implied Warranty (Count XII),
Violation of the Kentucky Consumer Protection Act (Count XIII),
and Unjust Enrichment (Count XV). However, several claims remain.
2. FAILURE TO WARN (COUNT III)
To maintain her claim for failure to warn, Ms. Thacker must show
Ethicon (1) had a duty to warn, (2) Ethicon provided inadequate
warnings, and (3) the inadequate warnings were the proximate cause
of her injuries. See Manuel v. Traditional Sporting Goods, Inc.,
No. 5:09-cv-406, 2011 WL 6091710, at *6 (E.D. Ky. Dec. 7, 2011)
(citing Stewart v. General Motors, 102 F. App’x 961, 964 (6th Cir.
2004)). Under Kentucky law, which applies the learned intermediary
doctrine, the manufacturer is relieved of its duty to warn the
patient if the manufacturer provides an adequate warning to the
prescribing physician “regardless of how or if the physician warns
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the patient.” Larkin v. Pfizer, Inc., 153 S.W. 3d 758, 765 (Ky.
2004).
Defendants assert that Ms. Thacker’s claim must fail because
she cannot establish proximate causation for three independent
reasons. [DE 159-1, at 4]. Kentucky law applies the substantial
factor test for proximate causation where the Court asks, “was the
defendant's

conduct

a

substantial

factor

in

bringing

about

plaintiff's harm?” Cutter v. Ethicon, Inc., No. CV 5:19-443-DCR,
2020 WL 109809, at *7 (E.D. Ky. Jan. 9, 2020)(citing Morales v.
American Honda Motor Co., Inc., 71 F.3d 531, 537 (6th Cir. 1995)).
Circumstantial evidence may be used to prove causation, but “in
that situation the evidence must be sufficient to tilt the balance
from possibility to probability.” Id.
First, Defendants argue proximate cause is not met because
Plaintiff cannot show Dr. Guiler relied upon Ethicon’s warnings
via the Instructions for Use (“IFU”) in making his treatment
decision for Ms. Thacker. Instead, Defendants claim Dr. Guiler
became aware of the risks involving the TVT-Secur and Prolift
through his own experience and research. [James Michael Guiler,
M.D. Deposition, DE 159-2 at 70:16-71:10]. Defendants further
refute

reliance

on

the

IFU

because

even

though

Dr.

Guiler

“probably” reviewed the IFUs at his initial training [Id. at 7:258:18; 114:21-115:1], he does not review the IFU before every
surgery [Id. at 114:16-20], does not remember the last time he
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reviewed the IFU [Id. at 115:7-9], did not review the IFU with Ms.
Thacker as a part of her risk analysis because he was already aware
of the listed complications [Id. at 115:15-116:1], and he did not
rely on the words in the IFU in making his recommendations. [Id.
at 116:25-117:12].
Under Kentucky law to prove the causation element in a failureto-warn claim, the doctor must have relied on the manufacturer’s
warning in accessing risks and making treatment decisions. At the
summary judgment stage, failure-to-warn claims have survived as
long as some reliance on the IFU is shown, even if it is not the
main consideration. Sexton, 2021 WL 4138399, at *3. Precedent
illustrates that if the doctor never reviewed the IFU, reliance is
impossible and proximate cause cannot be established requiring
summary judgment to be granted. Cutter v. Ethicon, Inc., 2020 U.S.
Dist. LEXIS 4016, at *23.
In Cutter, the failure to warn claim was dismissed at the summary
judgment stage because it was “clear that any inadequate warning
in the instructions for use...was not the proximate cause of the
alleged injuries.” Id. at *20. The doctor testified that “he did
not consult these materials [the IFUs] to obtain information about
the risks of implanting...and, in fact, has never relied on them
for such information.” Id. The doctor not only did not rely on the
IFUs, he did not read them at all. Id. at *23. The doctor clarified
that “he relied on personal surgical experience and demonstrations
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by preceptors to inform his knowledge of risks involved in similar
surgeries.” Id. at *20.
In Sexton, the failure to warn claim survived a motion for
summary judgment. The implanting physician, Dr. Voss, read the IFU
and relied on it in part. Sexton, 2021 WL 4138399, at *3. Even
though Dr. Voss did not rely upon the IFU as “the sole source of
information when learning or the risks,” the Court found the
“relevant inquiry is whether Dr. Voss relied on the IFU” and
concluded there was sufficient evidence to show Dr. Voss did rely
on the IFU. Id.
In Huskey, the failure to warn claim survived summary judgment
in part because there was sufficient evidence that the prescribing
doctor, Dr. Byrkit, did rely on the IFU. Huskey v. Ethicon, Inc.,
29 F. Supp. 3d 736, 742 (S.D.W. Va. 2014), at *742. Even though
the moving party argued there was no reliance because Dr. Byrkit
could not “recall the last time” she reviewed the IFU, the court
iterated that Dr. Byrkit had “read the IFU before implanting the
TVT-O” and used the “’the same’ implantation procedure described
in the IFU on every patient.” Id. The court distinguishes the case
from Lewis v. Johnson & Johnson, where the failure to warn claim
was dismissed. Id. at n.2 (citing In re Ethicon, Inc., Pelvic
Repair Sys. Products Liab. Litig., No. 2:12–cv–2327, 2014 WL
186869, at *4 (S.D.W.Va. Jan. 15, 2014)(reversed on other grounds).
In Lewis, “the treating physician affirmatively testified that she
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did not rely on the IFU when prescribing the device” but “relied
on a number of other factors. Id. at n.2. Since, there was no
similar testimony from Dr. Byrkit denouncing reliance, the Huskey
court found there was “sufficient evidence that Dr. Byrkit relied
on the IFU.” Id. at *742.
Unlike Cutter, where the court granted summary judgment, it is
clear or at least genuinely disputed that Dr. Guiler did actually
read the IFUs. [See DE 159-2 at 7:17-8:18]. While the doctor in
Cutter testified that he did not consult or rely on the IFUs to
obtain information about the risks, Dr. Guiler testifies that he
“probably” reviewed and read the IFUs when training, received
materials from Ethicon that were associated with the products, and
received information at Ethicon summits and trainings. Therefore,
this Court is unable to use Cutter to immediately grant summary
judgment as there is evidence Dr. Guiler read the IFU.
However, as Sexton makes clear, the question is not whether the
doctor read the warning, but whether the doctor relied on the
warning. Sexton, 2021 WL 4138399, at *3. While Plaintiff points to
parts of Dr. Guiler’s deposition that show Dr. Guiler had read the
IFU [DE 159-2, 7:25-8:18] and received information related to the
products
regarding

[Id.

at

whether

22:7-23:3],

there

Dr.

actually

Guiler

is

contradicting
relied

on

the

evidence
IFU

in

accessing risks for Ms. Thacker. Defendants point to parts of Dr.
Guiler’s testimony where he specifically said he did not rely on
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the words in the IFU in making his recommendations [Id. at 116:25–
117:12] (Q. (BY MS. HAMMOND) Okay. At – at the time of Ms. Thacker’s
surgery, did you rely on the actual words in the IFU when you made
your recommendation to Ms. Thacker to have Prolift and TV – TVTSecur implanted? A. No. Q. At the time of Ms. Thacker’s surgery in
May of 2009, did you rely on the actual words in the IFU to inform
you about the risks of the TVT-Secur and Prolift procedures? A.
No.). However, in support of reliance, Ms. Thacker identifies
portions of Dr. Guiler’s testimony indicating that he did rely on
the IFU for his risk/ benefit analysis [Id. at 22:2-6] (“Q. So you
mentioned the training. Then it would be fair to say that the
instructions for use for the device would have been a part of your
risk/ benefit analysis, correct? A. I suppose so, yes.”). Although
Dr. Guiler directly states that he did not rely on the IFU for Ms.
Thacker’s surgery, he later stated that he did rely on the IFU in
forming his risk/ benefit analysis related to using the device.
The conflicting testimony creates a genuine issue of material fact
regarding whether Dr. Guiler relied on the IFU.
Two final points are worth mentioning. First, that Dr. Guiler
cannot

remember

the

last

time

he

reviewed

the

IFU

is

not

detrimental to proving reliance. The doctor in Huskey similarly
could not “recall the last time” she reviewed the IFU, but the
court allowed the claim to survive partially because it was clear
that the doctor had read the IFU in the past. Huskey, 29 F. Supp.
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3d at 742. Similarly, here, Dr. Guiler read the IFU in the past
and, therefore, the lack of recent reliance is not fatal to the
claim. Second, Dr. Giuler’s testimony that he did not review the
IFU as part of his discussion of risks with Ms. Thacker because he
was already aware of all the risk does not makes it “illogical to
say that he relied on the IFU for her surgery” as Defendants claim.
[DE 251 at 5]. That Dr. Guiler did not sit down and go through the
IFU immediately prior to discussing the risks with Ms. Thacker,
does equate to the absence of any reliance on the IFUs. Defendants’
first argument against the finding of proximate causation fails.
Second, Defendants argue proximate cause is not met because Dr.
Guiler independently knew the risks of using the TVT-Secur and
Prolift devices, therefore, there was no duty to warn. [DE 159-1
at 5]. However, Defendants cite to Cutter, which this Court has
already

factually

Additionally,

this

distinguished
Court

finds

from

the

the

case

argument

to

at

simply

hand.
be

a

combination of the other two theories and generally unpersuasive.
Third, Defendants argue proximate cause cannot be established
because even if Dr. Guiler had read the IFU, Plaintiff cannot
establish

that

additional

warnings

would

have

altered

Dr.

Gueiler’s treatment decisions. [DE 159-1 at 6]. Ms. Thacker’s
response does not deny that Dr. Guiler’s actions would have
changed, but rather she argues the plaintiff is not required to
prove supplemental warnings would have changed the doctor’s mind
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to establish the causation element in a failure to warn claim. [DE
225 at 15]. Many of the moving parties in the aforementioned
precedential cases also presented this argument. However, courts
in the Sixth Circuit have conjured an irresolute response, claiming
there is no “bright-line rule” in Kentucky regarding the necessity
of

proving

the

doctor

would

have

changed

his

mind

with

the

additional warning. Mitchell v. Ethicon Inc., No. CV 5:20-157-DCR,
2020 WL 4550898, at *6 (E.D. Ky. Aug. 6, 2020). While many courts
have at least discussed or engaged in an application of the rule,
in the end they have been able to avoid ruling on whether it is a
required element of causation because the case could be decided
via alternative means.
Ms. Thacker cites Corder to support her argument that showing
the doctor would have changed their course of action is not a
required element. Corder v. Ethicon, Inc., 473 F. Supp. 3d 749,
759 (E.D. Ky. 2020). In Corder, the failure-to-warn claim survived
summary judgment as the court found a genuine issue of material
fact remained regarding whether the failure to warn was the
proximate cause of the plaintiff’s injuries. Id. at 761. Defendants
claimed the failure of the plaintiff to elicit testimony from the
implanting physician, Dr. Bush, stating that an adequate warning
would

have

led

to

a

different

course

of

treatment

meant

no

causation could be proven. Id. at 758. However, the court was wary
to make such direct evidence a “mandatory predicate to prove
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causation.” Id. “The Court is not convinced that here Corder must
prove that supplemented warnings would have changed Dr. Bush's
recommendation to establish the necessary causal nexus.” Id. at
759. While neither the plaintiff nor the defendants deposed Dr.
Bush, the court held the lack of testimony is not detrimental as
a reasonable juror could infer from the silent record that either
Dr. Bush, knowing all the information, would have continued on the
same treatment plan or that he would have changed his course. Id.
Corder, obviously factually distinct from this case, cannot be
used to support Ms. Thacker’s notion that establishing the doctor
would have acted differently is never required. Unlike Corder,
where the doctor was never deposed so there was no testimonial
evidence, here Dr. Guiler was deposed and clearly indicated even
if he knew at the time of implantation what he knows now, he still
believed the devices to be safe and effective with the benefits
outweighing the costs. [DE 159-2 at 119:10-120:8 (“Q. Putting
yourself back at the time you implanted TVT-Secur and Prolift into
Ms. Thacker in May of 2009, but with the knowledge you have today,
do you agree that TVT-Secur and Prolift were safe and effective
treatments for – A. Yes. Q. – SUI and POP [pelvic organ prolapse]
in women? A. Yes)]. While in Corder the lack of evidence one way
or the other created a genuine issue of material fact concerning
the matter, here there is direct evidence and Ms. Thacker has been
unable, nor does she even attempt, to present any evidence to the
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contrary. Corder thus stands for the proposition that at the
summary judgment stage where there is no direct testimony from the
doctor,

the

Court

will

allow

the

case

to

proceed

because

circumstantial evidence might prove the doctor would have changed
his course. Corder is not meant to be used by plaintiffs to escape
summary

judgment

when

there

is

direct

testamentary

evidence

proving the doctor’s decision would be the same even with the
additional information and the plaintiff is unable to present
refuting evidence.
Other

decisions

relied

upon

by

the

parties

do

not

affirmatively renounces the element, but rather the courts are
able to skirt the question because they found the plaintiffs had
presented

sufficient

evidence

showing

the

doctor

might

have

changed their mind if given a proper warning so as to make it a
genuine issue of material fact. The court in Huskey, rejected
defendant’s

argument

that

that

proximate

cause

could

not

be

established because “Dr. Byrkit would not have changed her decision
to prescribe the TVT–O if she had received a better warning” since
Dr. Byrkit’s testimony was inconsistent when asked about the
matter, thus presenting a genuine issue of material fact. Huskey,
29 F. Supp. 3d 736 at 743. While the court questioned whether as
a part of causation plaintiffs are required to show the doctor
would have acted differently if she had received a better warning,
ultimately

the

court

left

the
14

issue

unresolved

because

the

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plaintiffs presented refuting evidence that the doctor would have
acted differently. Id. at n.3. The Sexton court also avoided
deciding on the issue because the plaintiff was able to point to
areas of Dr. Voss’ testimony that “at minimum” created a genuine
dispute of material fact. Sexton, 2021 WL 4138399, at *4 (Despite
testimony from Dr. Voss that he would still have used the device
even with a revision of the wording in the IFU, Plaintiff presented
other testimony from Dr. Voss' “showing that he was under the
assumption the information Ethicon provided him was accurate, that
he

identified

additional

risks

found

in

Ethicon's

IFU

after

Plaintiff's procedure that were not present in the IFU prior to
the procedure, that the additional risks may have been helpful to
know, and that if he, in fact, received misleading information
from Ethicon, that would have influenced his decision to use their
product.”).
Sexton and Huskey do not apply when the plaintiff is unable to
put forward any evidence indicating that the doctor would have
acted differently if given a different warning. Unlike Huskey and
Sexton, here there is no inconsistent testimony.1 Plaintiff is

While Plaintiff points to Dr. Guiler’s deposition where he agrees that
information that the device causes chronic pain would have been considered in
his risk/ benefit analysis as “all information would be important in that
decision” [DE 159-2 at 36:19-27:10; 44:21-45:], Dr. Guiler goes on to testify
that the benefits nonetheless outweighed the risks [Id. at 119:10-120:8]. That
Dr. Guiler would have considered that information as he considered all relevant
information does not create a factual dispute because Dr. Guiler is clear that
even if he knew then what he knows now, he would not have changed his mind.
[Id.]. Thus, even if the additional warning had been given and Dr. Guiler would
1

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unable to present any evidence contradicting Dr. Guiler’s clear
declaration that even with the knowledge he has today he considers
the procedure are safe, effective, and the benefits outweigh the
risks. [DE 159-2 at 119:10-120:8]. In fact, Plaintiff seems to
admit that Dr. Guiler “stands by his decision to use the Prolift
and TVT-Secur devices,” so her only argument to refute Defendants’
point is that plaintiffs do not need to prove this element, that
additional warning would have changed the prescribing doctor’s
recommendations, to survive summary judgment. [DE 225 at 15].
However, other courts dealing with more similar cases, have denied
summary judgment where defendants show that that an additional
warning would not have altered the doctor’s course of action and
plaintiff is unable to present refuting evidence.
In Cutter, even though the claim was barred by the statute of
limitations, the court further declared that proximate cause could
not

be

satisfied

because

after

gaining

knowledge

of

the

implantation risks, the doctor “continued to believe that the
benefits outweighed the risks”, so “further information” about the
risks “would not have affected his decision.” Cutter, 2020 WL
109809, at *8.
In Mitchell, the court held the failure to warn claim was unable
to

survive

summary

judgment

partially

because

the

plaintiffs

have considered the information in the analysis, he still would not have changed
his decision.

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“failed to come forward with sufficient evidence indicating that
a deficient warning was the proximate cause of their harm.”
Mitchell, 2020 WL 4550898, at *5. The defendants focused their
argument for lack of causation on the idea that an adequate warning
would not have changed the implanting doctor’s decision to use the
product.

The

court

speculated

whether

proof

of

the

treating

physician standing by their decision in the face of additional
information is required. “While it does not appear that any
Kentucky court has issued a bright-line rule for causation in this
scenario, many others have required the plaintiff to produce
evidence that an additional warning would have changed the treating
physician's prescribing decision.” Id. at *6. The court goes on to
weigh the evidence of whether additional information would have
changed the doctor’s mind. The implanting doctor testified that
“she did not recall reviewing the IFU prior to [the plaintiff’s
surgery] and did not rely on it to learn the risks associated with
the procedure” because “she learned the potential complications”
about the procedure “during her medical education a decade prior
to

[the

plaintiff’s]

surgery.”

Id.

Additionally,

the

doctor

testified that “she stands by her decision to use” the device in
question. Ultimately, the court concluded that causation could not
be proven because the element was not met. Id.
While Ms. Thacker was able to present sufficient evidence to
create a genuine issue of fact regarding consultation of the IFU,
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12008

she, like the plaintiff in Cutter, was unable to do the same for
proof of the doctor changing his mind. Very similar to Mitchell
where the doctor directly testified that she stood by her decision
to use the devise in question, Dr. Guiler stays committed to his
choice even with the additional knowledge he has gained since the
implantation in 2009. [DE 159-2 at 119:10-120:8]. Dr. Guiler goes
on to affirm his belief that benefits of using the devices outweigh
the risks. [Id. (Q. Do you agree that the potential benefits of
using TVT-Secur and Prolift to treat stress urinary incontinence
and pelvic organ prolapse outweighed the potential risks? A. Yes,
I believe that to be a fact. Q. Do you agree that TVT-Secur was an
appropriate treatment option for Ms. Thacker’s stress urinary
incontinence? A. I do. Q. Do you agree that Prolift was an
appropriate

treatment

option

for

Ms.

Thacker's

pelvic

organ

prolapse? A. I do.”). Ms. Thacker offers no conflicting testimony.
Therefore, it is undisputed that Dr. Guiler would not have changed
his mind with the additional warning.
In conclusion, under Kentucky law a plaintiff does not have to
present evidence showing the doctor would have changed his mind
when the defendant also has not presented evidence that the doctor
would not have changed their mind. Corder, 473 F. Supp. 3d 749.
However, when the defendant does present affirmative testamentary
evidence that the doctor would not have changed his course of
action with the additional warning, the plaintiff must present
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12009

evidence to the contrary in order to show a genuine issue of
material fact exists. Sexton, 2021 WL 4138399, at *4; Huskey, 29
F. Supp. 3d 736 at 743. If the plaintiff is unable to come forward
with such evidence, then causation, a necessary element in a
failure-to-warn claim, cannot be proven and the moving party is
entitled to judgment as a matter of law. Since here Defendants
have presented clear testimony from Dr. Guiler that he stands by
his decision even with the additional information [DE 159-2 at
119:10-120:8], and Plaintiff has not presented refuting testimony,
Ms. Thacker will be unable to prove the element of causation. Even
though there is likely a genuine issue of material fact regarding
whether Dr. Guiler relied on the IFU, Ms. Thacker must still
present evidence contradicting the defendants’ proof that Dr.
Guiler would not have changed his mind even with the additional
warning in order to establish causation. In this situation, it is
a

necessary

element.

Since

Ms.

Thacker

has

not

presented

conflicting evidence, she is unable to prove causation exists and
her failure to warn claim must fail as a matter of law.
3. DESIGN DEFECT CLAIM (COUNT V)
Under Kentucky law, a risk-utility test is used in design defect
cases. Burgett v. Troy-Bilt LLC, 579 F. App'x 372, 378 (6th Cir.
2014) (referencing Toyota Motor Corp. v. Gregory, 136 S.W.3d 35,
42 (Ky. 2004)). The applicable test is "whether an ordinarily
prudent company being fully aware of the risk, would not have put
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12010

the product on the market." Id. For there to be liability in a
design defect claim, there must be proof of a safer and feasible
alternative design. Owens v. Ethicon, Inc., No. 3:19-cv-00080GFVT, 2020 U.S. Dist. LEXIS 72587, at *7-8 (E.D. Ky. Apr. 24,
2020).
Ms. Thacker, through a case-specific report by Dr. Rosenzweig,
puts forward four alternatives to the mesh products:
(1)

the use of sutures, including delayed absorbable sutures like
PDS, in a colposuspension procedure like the Burch or a native
tissue rectocele repair with absorbable suture;

(2)

autologous fascia sling or rectocele repair;

(3)

an allograft sling or rectocele repair using a product such
as Repliform; and

(4)

a

sling

or

rectocele

repair

using

a

product

with

less

polypropylene such as Ultrapro.
[Rosenzweig Report, DE 159-6 at 81-82]
In order to qualify as a proper alternative and thus withstand
summary judgment, the alternative must be properly analogous to
the product at issue. In Burton, the court found the techniques of
two alternatives proposed by the case-specific expert, sutures and
Fascia POP repair with Biologics, not to be alternative designs to
Prolift because they were “entirely different procedures.” Burton
v. Ethicon Inc., No. CV 5:20-280-DCR, 2021 WL 1725514, at *2 (E.D.
Ky.

Apr.

30,

2021).

“[E]vidence
20

of

surgical

procedures

not

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12011

involving

mesh

has

no

bearing

on

the

existence

of

a

safer

alternative design for the defendant's Prolift product.” Id. at *2
(referencing Owens, 2020 WL 1976642, at *3).
The first three listed alternatives do not qualify as proper
alternatives because they are not appropriately analogous to the
mesh products actually used. First, similar alternatives were
rejected in Burton. Second, the first three proposed alternatives
are “entirely different procedures” because they do not involve
mesh. Id. at *2. Third, Ms. Thacker does not dispute that “courts
have concluded that alternative procedures are not sufficient to
prove an alternative safer design for a design defect claim as
they are not a product” [DE 225 at 13] nor does she argue that the
three proposed alternatives should not fall into this rejected
category. Instead, Plaintiff requests the court “reserve ruling on
this evidence until the time of trial because the procedure may be
relevant for other issues.” [Id.]. While it is possible the first
three proposed alternatives may be relevant down the road, that is
immaterial to the current issue of whether they constitute proper
alternative designs, which Plaintiff is required to put forward to
survive summary judgment on a design defect claim. As noted above,
the first three alternatives do not constitute proper alternative
designs, and therefore, cannot be relied upon to defeat summary
judgment.

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12012

This leaves the fourth proposed alternative—the use of a mesh
with

less

polypropylene,

like

Ultrapro—as

the

only

possible

alternative. This Court holds that the fourth proposal cannot
constitute a proper alternative because Plaintiff has failed to
show

there

is

a

genuine

issue

of

material

fact

regarding

feasibility.2
Specifically at issue is whether Ms. Thacker has met her
burden of showing feasibility. The Federal Rules of Civil Procedure
require the nonmoving party to present specific facts showing that
a genuine factual issue exists by “citing to particular parts of
materials in the record” or by “showing that the materials cited
do not establish the absence ... of a genuine dispute[.]” Fed. R.
Civ. P. 56(c)(1)). “Rule 56(c) mandates the entry of summary
judgment ... against a party who fails to make a showing sufficient
to establish the existence of an element essential to that party's
case, and on which that party will bear the burden of proof at
trial.” Celotex Corp., 106 S. Ct. at 2552.
Kentucky law is clear that a valid alternative design must be
feasible. Low v. Lowe's Home Ctrs., Inc., 771 F. Supp. 2d 739, 741
(E.D. Ky. 2011)(citing Toyota Motor Corp., 136 S.W.3d at 42)(“To

2

Since this Court grants summary judgment based off lack of proof of
feasibility, the Court does not need to address the merits of Defendants’ other
two arguments. Defendants assert that Ultrapro cannot be considered a proper
alternative because (1) they claim Dr. Rosenzweig admits that a sling or
posterior repair using Ultrapro would not have prevented Ms. Thacker’s injuries,
which they claim is a mandatory prerequisite and (2) absent FDA clearance,
Ultrapro was not feasible.

22

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12013

prove a design defect, he must show that the defendants could have
used a safer, and still feasible, design.”). To prove feasibility,
a plaintiff must provide “proof of an alternative, safer design
that is practicable under the circumstances.” Owens v. Ethicon,
Inc., No. 3:19-cv-00080-GFVT, 2020 U.S. Dist. LEXIS 72587, at *78 (E.D. Ky. Apr. 24, 2020)(citing Bosch v. Bayer Healthcare Pharm.,
Inc., 13 F. Supp. 3d 730, 742 (W.D. Ky. 2014)); see also Jackson
v. E-Z-GO Div. of Textron, Inc., 326 F. Supp. 3d 375, 395 (W.D.
Ky. 2018)(quoting Johnson v. Manitowoc Boom Trucks, Inc., 484 F.3d
426,

433

testimony

(6th

Cir.

establish

2007)(Kentucky
the

alternative

law

requires

design

that

“could

expert

have

been

practically adopted at the time of sale.”). Kentucky courts have
defined feasibility as “[t]he possibility that something can be
made, done, or achieved, or that it is reasonable; practicability.”
Smith v. Ethicon, Inc., No. 6:20-CV-222-REW-HAI, 2021 WL 4098408,
at *4 (citing Feasibility, BLACK'S LAW DICTIONARY (11th ed. 2019)).
“[T]he onus is on Plaintiffs to provide expert testimony setting
forth ‘competent evidence of some practicable, feasible, safer,
alternative design.’” Estate of Bigham v. DaimlerChrysler Corp.,
462 F. Supp. 2d 766, 773 (E.D. Ky. 2006)(citing Gray v. General
Motors Corp., 133 F. Supp. 2d 530, 535 (E.D. Ky. 2001)). In a
design defect claim, because the subject is outside the scope of
lay

knowledge,

a

plaintiff

must

offer

“sufficiently

detailed

expert testimony to establish that a reasonable alternative design
23

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12014

could have been practically adopted at the time of the sale.”
Burton, 2021 WL 1725514, at *4 (granting summary judgment on the
design defect claim because the plaintiff did not offer specific
evidence

of

an

alternative

feasible

design);

Smith,

2021

WL

4098408, at *4 (granting summary judgment on the design defect
claim because the expert’s “statement, lacking any indication of
or

probativeness

regarding

contemporaneous

feasibility,

is

insufficient for a juror to reasonably find Smith's burden met”);
see also Lambert v. G.A. Braun Int'l, Ltd., No. 3:14-CV-00390-JHM,
2016 WL 3406155, at *1 (W.D. Ky. June 17, 2016)(granting summary
judgment where “Plaintiff has failed to show that a feasible
alternative or safer design existed” by offering no specific
evidence). “It is well-settled that Plaintiffs are required, by
way of expert testimony, to provide proof of an alternative design
through ‘competent evidence’ that there was available to Defendant
a ‘practicable, feasible, safer, alternative design’ at the time
of

manufacturing...the

lack

of

evidence

establishing

an

alternative design proves fatal to Plaintiffs' claims.” Est. of
Bigham v. DaimlerChrysler Corp., 462 F. Supp. 2d 766, 776 (E.D.
Ky. 2006)(citing Gray, 133 F.Supp.2d at 535)(granting summary
judgment where the plaintiff was “under the mistaken belief that
the

mere

mention

sufficient”

and,

that

alternative

therefore,

failed

possibilities
to

put

exist

forward

[was]

evidence

establishing an alternative design). “A failure to offer ‘the
24

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12015

required proof of a feasible, alternative design’ dooms the claim.”
Smith, 2021 WL 4098408, at *5 (citing Gray, 133 F.Supp.2d at 242).
The Plaintiff has not presented sufficient evidence to create
a genuine issue of material fact regarding the feasibility of the
fourth alternative. In her Response to Defendants’ Motion for
Summary Judgment, Plaintiff argues that lack of FDA approval does
not warrant summary judgment and then simply declares:
In sum, Plaintiff has provided evidence of a
safer alternative feasible design product that
is “more than that it was theoretically
probable.” Brock v. Caterpillar, Inc., 94 F.3d
220, 224 (6th Cir. 1996). Dr. Rosenzweig’s
opinions explain how the Ultrapro device is a
“practicable, safer, alternative design” that
not only was feasible, but actually existed,
at the time Plaintiff had the Prolift and TVTSecur devices implanted in 2009. See Gray v.
Gen. Motors Corp., 133 F. Supp. 2d 530, 535
(E.D. Ky. 2001). This evidence is more than
sufficient to defeat summary judgment.
[DE 225 at 11-12]. Yet Plaintiff cites no portion of the record,
does not provide evidence proving such feasibility, nor attempt to
explain how the device was feasible. Compare this lack of evidence
to that produced by the plaintiff in Sexton, where the court found
there to be a genuine issue of material fact regarding feasibility:
Ultrapro is a lightweight, large-pore
mesh that was originally developed for hernia
treatment. (Id. at 37). As early as 1997,
Ethicon knew that its Prolene mesh was not
ideal for vaginal tissues, but it never used
Ultrapro or another larger-pore material for
treatment of SUI because it wanted to be able
to rely on studies done to support the
25

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12016

original TVT, using the old-construction
Prolene
mesh.
(Id.;
see
also
Brigitte
Hellhammer Dep., Sept. 11/12, 2013, portions
attached as Exhibit B, at 119:24-121:11,
754:12-20).
Ethicon’s primary argument is that
Plaintiffs cannot establish that it was
feasible to use Ultrapro to treat SUI in 2014,
when Ms. Sexton had her implant. Ethicon is
incorrect. Ethicon began using lighterweight,
larger
pore
meshes
for
hernia
treatment in the late 1990s. (General Report,
Ex. A-Ex. 2, at 14-15). In 2004, Ethicon
obtained clearance for use of Ultrapro mesh
from the FDA. [citation omitted]. From 200507, there was a clinical trial in which
Ultrapro mesh was used in a sling to treat
SUI. The trial was ultimately successful, and
the results were published in 2013. (Okulu, et
al., Use of three types of synthetic mesh
material in sling surgery: A prospective
randomized
clinical
trial
evaluating
effectiveness and complications, Scandinavian
J. of Urology, 2013:47:217-224, at p. 223,
attached as Exhibit C (“Ultrapro mesh...can be
reliably and effectively used in sling
surgery.”).[citation omitted]. Nonetheless,
Ethicon claims that its own failure involving
a different product should shield it from
liability. Ethicon asserts that because the
FDA rejected a mesh that was supposedly
“similar
to
Ultrapro,”
this
somehow
establishes that it was impossible to gain
clearance for a mesh actually using Ultrapro.
(See Dkt. No. 69-1 at 9). Ethicon makes this
remarkable argument even though the FDA did
approve the use of Ultrapro in a pelvic floor
device—specifically the Prolift +M, an Ethicon
device used to treat pelvic organ prolapse.
[citation omitted]. Thus, Ethicon claims it
was impossible to gain clearance for a
material that had been cleared by the FDA six
years earlier, based on a failed attempt to
gain clearance for a different material. The
Court should reject this absurd argument

26

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12017

Response in Opposition to Motion for Summary Judgment at 10-11,
Sexton, 2021 WL 4138399 (No. 70). The plaintiff in Sexton cited to
specific parts of the record and explained how the evidence shows
it was at least possible for the alternative to be practically
adopted at the time. Ms. Thacker has not.
As Defendants met their initial burden of establishing the
absence of a genuine issue of material fact, Plaintiff was required
to “go beyond the pleadings and come forward with specific facts
to demonstrate there is a genuine issue for trial.” Chao, 285 F.
3d 415 at 424. Plaintiff has failed to do so. Ms. Thacker cites to
no particular parts of the record that establish feasibility nor
does she offer sufficiently detailed expert testimony to establish
that a reasonable alternative design could have been practically
adopted at the time of the sale. Since Plaintiff fails to make a
showing sufficient to establish the existence of feasibility, an
element essential to that party's case and on which that party
will bear the burden of proof at trial, the Federal Rules require
the Court to grant summary judgment.
Giving Plaintiff the benefit of the doubt, the Court completed
a generous review of the record looking for evidence of feasibility
since Plaintiff provided none. First, in Dr. Rosenzweig’s casespecific expert report, Dr. Rosenzweig states the four alternative
designs were “safer and feasible.” [DE 159-6 at 81]. However, this
is a mere declaration with no support. This is not sufficiently
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12018

detailed specific evidence of how the design was practicable under
the circumstances. Burton, 2021 WL 1725514, at *4. Second, the
Court notes portions of the Expert Report of Bruce Rosenzweig,
M.D, that suggest Ultrapro existed and was being used for the
treatment of organ prolapse.3 However, even if the product existed
at the time of Ms. Thacker’s surgery, Plaintiff has not shown nor
attempted to explain how Ultrapro “could have been practically
adopted at the time of sale” simply because it existed. Jackson,
326 F. Supp. 3d 375, 394–96. Instead, Plaintiff simply says lack
of FDA approval does not doom the claim. Whether FDA approval is
or is not required for feasibility is immaterial now because
Plaintiff has failed to argue feasibility in the first place.4 In
3

“Ethicon did not change the Prolene mesh in its TVT device despite having
better and safer options available for economic reasons. Ethicon believed that
continued use of the TVT mesh gave the company an economic and competitive
advantage in marketing the product because they could continue to use the
existing clinical data on the product to market the device, even though because
the mesh was changed, the existing clinical data would be obsolete. Dr. Brigitte
Hellhammer testified that despite having incorporated the use of the
lightweight, large pore Ultrapro mesh in vaginal tissues for the treatment of
pelvic organ prolapse, the Ultrapro was never used by Ethicon in a device used
for the treatment of stress urinary incontinence largely because the company
wanted to continue to rely on the Ulmsten/Nilsson series of studies on 130
patients performed with the TVT device. Dr. Arnaud also confirmed that the
company did not want to change anything with the mesh because of the existing
clinical data on the product. It is my opinion to a reasonable degree of medical
certainty that Ethicon was negligent in failing to correct the defects in the
TVT mesh as the company had knowledge of the defects and failed to correct the
defects with products and solutions that were already available to the company
because it valued its economic interests above patient safety.” [DE 225-9 at
390-91].
4
Whether FDA approval is necessary for an alternative design to be feasible
remains uncertain in Kentucky. Several courts have addressed feasibility as
related to relevance, but not feasibility. However, it seems to be implied that
for a design to be feasible it must “comply with federal, state, or local
regulations.” See Jones v. IC Bus, LLC, 626 S.W.3d 661, 678 (Ky. Ct. App. 2020).
While the Kentucky case, Sexton, briefly addresses the issue finding lack of
FDA approval “unavailing” to defeat feasibility, they based part of their
conclusion on defendants’ failure to “cite any authority requiring FDA approval

28

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12019

conclusion, Ms. Thacker cannot survive summary judgment on the
design defect claim as she fails to provide any evidence showing
the alternative was feasible, a required element of the claim.

for a product to be a feasible, safer alternative.” Sexton, 2021 WL 4138399.
However, Defendants now offer two Texas cases to support their argument.
A Texas case from 2020 granted summary judgment on the defective design
claim because the alternative design was not technologically feasible as it had
not been approved by the FDA. Pizzitola v. Ethicon, Inc., No. 4:20-CV-2256,
2020 WL 6365545, at *4 (S.D. Tex. Aug. 31, 2020) (“FDA regulates the sale of
medical devices...[b]efore a medical device can be used in a hospital, the
device must have FDA clearance.”). The second case, decided after Sexton, also
granted summary judgment finding that Ultrapro was not a viable alternative
because it lacked FDA approval. Labiche v. Johnson & Johnson, No. H-20-4249,
2021 U.S. Dist. LEXIS 161087, at *5 (S.D. Tex. Aug. 19, 2021) (“The mere
existence of alternative mesh designs is inadequate alone to be a safer
alternative design. The alternative design must have been legally available at
the time for proper use. Ultrapro was not approved by the Food & Drug
Administration at the time, so it could not have been used.”).
The Texas cases are not binding on this Court and Texas law requires the
alternative be “economically and technologically feasible,” while Kentucky does
not have this standard. Meindertsma v. Ethicon Inc., No. 1:20-CV-00708-RP, 2021
WL 2010355, at *2 (W.D. Tex. May 17, 2021); Moore v. Lowe's Cos., No. 1:13-CV00005-GNS-HBB, 2016 U.S. Dist. LEXIS 39137, at *20 (W.D. Ky. Mar. 25, 2016)
(noting that Kentucky does not “impose this two-pronged requirement for
feasibility). However, Kentucky does require that expert testimony establish
the alternative design “could have been practically adopted at the time of
sale.” Jackson, 326 F. Supp. 3d 375, 394–96 (W.D. Ky. 2018). Because
“practically adopted” and “technologically feasible” are far more alike than
they are different, it is likely that Kentucky courts would side with Texas
courts.
However, this Court also acknowledges a New York court, which held
differently. Applying New York law, which also requires an alternative design
be “economically and technologically feasible,” the Court denied summary
judgment finding that Ultrapro was a proper alternative regardless of FDA
approval. Baccaro v. Coloplast Corp., No. 1:19-CV-1088, 2021 U.S. Dist. LEXIS
136476, at *43 (N.D.N.Y. July 22, 2021) “Accordingly, the Court is satisfied
that the appropriate standard under New York law is the feasibility of a
hypothetical alternative design, not whether an alternative design has been
actively approved by the FDA for a manufacturer to use for a specific purpose.”
Id. Yet, New York law explicitly allows alternative designs to be hypothetical
opposed to Kentucky law. Estate of Bigham, 462 F. Supp. 2d at 776 (quoting Brock
v. Caterpillar, Inc., 94 F.3d 220, 224 (6th Cir. 1996))(“Plaintiffs must show
‘something more than that it was ‘theoretically probable that a different design
would have been feasible.’”). Nonetheless, the court’s reasoning for not
requiring FDA approval is compelling. The court notes how requiring FDA approval
would change the design defect inquiry to more of a medical malpractice claim
because instead of the plaintiff needing “to present evidence of a hypothetical
alternative product that would improve on the manufacturer's...the question
would have to be whether the physician selected the proper, approved drug or
device among those available.” Id.

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12020

4. NEGLIGENCE (COUNT I) AND GROSS NEGLIGENCE (COUNT II)
In Kentucky, "[a] party injured by a product can bring suit
for that injury under three different theories: (1) breach of
warranty under the Uniform Commercial Code, (2) negligence, or (3)
strict liability in tort." Ostendorf v. Clark Equip. Co., 122
S.W.3d 530, 535 (Ky. 2003). Defendants sought product liability
claims under both strict liability and negligence. As described
above, Plaintiff’s failure-to-warn claim failed due to lack of
causation and the design defect claim failed due to lack of
feasibility. Because a negligence theory under the two claims
requires the same, the negligence claim must fail as well. Snawder
v. Cohen, 749 F. Supp. 1473, 1476 (W.D. Ky. 1990) (citing Feldman
v. Lederle Laboratories, 97 N.J. 429, 479 A.2d 374, 386 (1984)
(“Thus, theories of negligence and strict liability in failure to
warn cases have been deemed to be ‘functional equivalents.’”); Duff
v. C.R. Bard, No. 5:20-CV-00060-GNS-CHL, 2021 U.S. Dist. LEXIS
41658, at *5 (W.D. Ky. Mar. 4, 2021) (citing Holbrook v. Rose, 458
S.W.2d 155, 157 (Ky. 1970))(“To be clear, ‘[a] plaintiff's...claims
of negligence...and strict liability...have [a] common denominator
which is that causation must be established.’"); Red Hed Oil, Inc.
v.

H.T.

Hackney

Co.,

292

F.

Supp.

3d

764,

773

(E.D.

Ky.

2017)(citing Halsey v. Agco Corp., No. 16-cv-461-JMH, 2017 U.S.
Dist. LEXIS 174075, 2017 WL 4767679, at *1 (E.D. Ky. Oct. 20,
2017)("The causation analysis ‘is the same under a negligence
30

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12021

theory in a products liability case as...under a strict liability
theory.’"); Jackson, 326 F. Supp. 3d at 391 (citing Toyota Motor
Corp., 136 S.W.3d at 42)(“Under Kentucky law, a plaintiff can bring
a defective design claim under a theory of strict liability or
negligence, the foundation of both theories being that the product
is unreasonably dangerous...Regardless of which theory a plaintiff
chooses, design defect liability requires proof of a feasible
alternative design.”)(internal quotations omitted); Smith, 2021 WL
4098408, at *4 (noting that although in product liability design
defect

cases

negligence

is

the
of

“distinction
no

practical

between

strict

significance”

liability
they

are

and
“not

interchangeable” but, nonetheless, dismissing the negligence claim
alongside the strict liability design claim because the “deficits”
were the same); Burton, 2021 WL 1725514, at *4 (citing Estate of
Bigham, 426 F. Supp. 2d 766, 773)(“Whether the claim is based in
negligence or strict liability, the plaintiff in a design defect
case

must

evidence

provide
of

some

expert

testimony

practicable,

‘setting

feasible,

forth

safer,

competent

alternative

design.’"). Ms. Thacker’s inability to demonstrate negligence also
precludes a finding of gross negligence.
5. PUNITIVE DAMAGES (COUNT XVII) AND TOLLING (COUNT XVIII)
First, while Defendants seek dismissal of Punitive Damages
(Count XVII) and Tolling (count XVIII), Plaintiff is clear that
they are not attempting to assert these as causes of action. [DE
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12022

225 at 17]. Therefore, there is no claim to grant or deny summary
judgment upon. Second, since the Court has granted summary judgment
on all claims for the defendants, there can be no punitive damages.
B. OTHER PENDING MOTIONS
With the Motion for Summary Judgment [DE 159], both Plaintiff
and Defendants filed several related Motions in Limine and Motions
to Exclude [DE 112-58, 160-66]. Because the Court finds Defendants
are entitled to summary judgment even if all their motions to
exclude are denied and all expert testimony permitted, there is no
need to address the merits of the motions. Additionally, in
granting the Motion for Summary Judgment [DE 159], the Court does
not rely on any evidence that Plaintiff wished to have excluded.
For these reasons, all pending motions to exclude and motions in
limine are denied as moot.
III. Conclusion
Having

considered

the

matter

fully,

and

being

otherwise

sufficiently advised,
It is ordered as follows:
(1)

Defendants’ Motion for Summary Judgment [DE 159] is GRANTED
IN FULL.

(2)

Defendants’ and Plaintiff’s pending Motions in Limine and
Motions to Exclude [DE 112-158, 160-166] are DENIED AS
MOOT.

This the 17th day of November, 2021.
32