Rebotix Repair LLC v. Intuitive Surgical, Inc.

Filing 183

ORDER: Defendant Intuitive Surgical, Inc.'s Daubert Motion to Exclude the Opinions of Dr. T. Kim Parnell. (Doc. # 115) is GRANTED in part and DENIED in part to the extent set forth in this Order. Signed by Judge Virginia M. Hernandez Covington on 8/10/2022. (SGM)

Case 8:20-cv-02274-VMC-TGW Document 183 Filed 08/10/22 Page 1 of 16 PageID 36732

UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
TAMPA DIVISION
REBOTIX REPAIR, LLC,
Plaintiff /
Counterclaim Defendant,
v.

Case No. 8:20-cv-2274-VMC-TGW

INTUITIVE SURGICAL, INC.,
Defendant /
Counterclaim Plaintiff.
______________________________/
ORDER
This matter comes before the Court upon consideration of
Defendant

Intuitive

Surgical,

Inc.’s

Daubert

Motion

to

Exclude the Opinions of Dr. T. Kim Parnell. (Doc. # 115).
Plaintiff Rebotix Repair, LLC has responded. (Doc. # 142).
For the reasons that follow, the Motion is granted in part
and denied in part.
I.

Background
The Court and the parties are well familiar with the

background facts and claims in this case, and the Court will
not belabor them here. Suffice it to say that this is an
antitrust suit initiated by Rebotix, a company that offers a
service whereby it “repairs” the EndoWrist surgical implement
originally manufactured by Intuitive.

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Rebotix seeks to offer Dr. Parnell’s testimony on the
issues of EndoWrist performance and safety, both as to new
EndoWrists and those that have been repaired by Rebotix. Dr.
Parnell is a professional mechanical engineer (PE) with a
Ph.D. in mechanical engineering. (Doc. # 115-2 at 1). He has
multiple years of experience in manufacturing, including the
design

and

development

of

medical

devices,

and

failure

analysis. (Id. at 2-5).
In his report, Dr. Parnell opines that: (1) traditional
laparoscopic
EndoWrists

instruments

can

be

are

similarly

routinely

repaired;

repaired,

and

(2)

and

Rebotix’s

service procedure ensures that EndoWrists can be repaired and
used safely. (Id. at 7-26). It is Dr. Parnell’s opinion that
Rebotix’s

repair

procedure

“ensures

that

EndoWrists

can

continue to be used safely” and, indeed, the repair process
“results in instruments that have a higher degree of safety
and

reliability”

than

new

EndoWrists

manufactured

by

Intuitive. (Id. at 6). He offers the opinion that the usage
counter has numerous flaws and does not promote patient
safety, and that Intuitive has “no basis” to assert that
EndoWrists

repaired

by

Rebotix

are

less

EndoWrists sold by Intuitive. (Id. at 6-7).

2

safe

than

new

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Now, Intuitive seeks to exclude Dr. Parnell’s testimony,
Rebotix has responded, and the Motion is ripe for review.
II.

Discussion
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 all scientific testimony or evidence admitted is both
relevant and reliable. See Id. at 589–90. The Daubert analysis
also applies to non-scientific expert testimony. Kumho Tire
Co. v. Carmichael, 526 U.S. 137, 147 (1999). 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).

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The Eleventh Circuit “requires trial courts acting as
gatekeepers to engage in a ‘rigorous three-part inquiry.’”
Hendrix 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 bears the burden of
showing,

by

a

preponderance

of

the

evidence,

that

the

testimony satisfies each of these requirements. Id.
Intuitive does not contest Dr. Parnell’s qualifications,
but

instead

performance

contends
are

that

his

unreliable

opinions

and

about

unhelpful,

EndoWrist
and

thus

inadmissible.
1.

Reliability

“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 Notes (2000)). There are four
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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

Dr.

Parnell

account

as

well.

Id.

(citations

omitted).
Here,
professional

experience

relies
as

explicitly

forming

the

on
basis

his
for

past
his

opinions. See (Doc. # 115-2 at 5 (“My opinions and conclusions
in

this

report

are

based

on

my

years

of

professional

experience in mechanical engineering, failure analysis, and
other work in medical devices, medical instruments, consumer
electronics, and other sophisticated technology devices.”)).
“If the [expert] witness is relying solely or primarily on
experience, then,” in establishing reliability, “the witness
must explain how that experience leads to the conclusion
reached, why that experience is a sufficient basis for the
opinion, and how that experience is reliably applied to the
facts.” Frazier, 387 F.3d at 1261 (citation and internal
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quotation

marks

omitted).

The

Court’s

analysis

as

to

reliability “focus[es] ‘solely on principles and methodology,
not on the conclusions that they generate.’” Seamon, 813 F.3d
at 988 (citation omitted).
Here, Intuitive argues that Dr. Parnell’s opinions are
unreliable.

According

to

Intuitive,

Dr.

Parnell

has

not

himself tested the performance or safety of EndoWrists and
has

set

forth

repairability

no

methodology

of

whatsoever

EndoWrists

to

compare

vis-à-vis

the

traditional

laparoscopic instruments or the performance and safety of
EndoWrists that have been repaired by Rebotix. As Intuitive
lays out: Dr. Parnell has not seen an EndoWrist perform in
the operating room; his opinions derive from a one-day visit
to Rebotix’s facility at a time when the facility was not
repairing

EndoWrists;

and

his

descriptions

of

Rebotix’s

procedures come not from his own testing or experience but
rather from the descriptions of a Rebotix employee.
In response, Rebotix argues that Dr. Parnell analyzed
Rebotix’s process of repairing EndoWrists through the lens of
reverse engineering. According to Rebotix, Dr. Parnell used
methodologies

that

are

generally

accepted

in

the

field,

including comparing failure modes and reverse engineering.

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Intuitive

takes

issue

with

five

of

Dr.

Parnell’s

proffered opinions. See (Doc. # 115 at 13). The Court will
discuss each one.
a.

Opinion: That Rebotix’s repair procedures ensure
that EndoWrists can continue to be used safely
(Doc. # 115-2 at 6, 14-28).

In his report, Dr. Parnell wrote that, in his experience,
“reverse

engineering

the

original

specifications

of

an

instrument is a common practice used by mechanical engineers
in understanding instruments and their functions.” (Doc. #
115-2 at 14). Reverse engineering typically involves two
steps:

testing

a

new

instrument

to

understand

its

capabilities and then testing a repaired instrument to see if
it functions in the same manner as a new instrument. (Id.).
Dr. Parnell sets out how Rebotix used reverse engineering at
the

outset

of

its

business

to

make

sure

that

repaired

EndoWrists would work in the same manner as a new EndoWrist,
that Rebotix utilized third-party testing at the end of that
reverse engineering process to verify its results, and that
“[t]he result of this robust initial reverse engineering
process and subsequent testing is a repair process that safely
and effectively ensures that repaired EndoWrists can continue
to be used by hospital customers.” (Id. at 14-15). Dr. Parnell

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then went on to describe that repair process, as set forth
below.
According

to

Dr.

Parnell’s

report,

he

“inspected”

Rebotix’s repair facility and was there able to “observe
several

complete

EndoWrist

repair

processes,

compare

EndoWrists repaired by Rebotix to brand new EndoWrists sold
by Intuitive, and examine a number of EndoWrists . . . [that]
were not suitable candidates for repair.” (Id. at 15). He
“personally reviewed each step of the Rebotix Repair service
process,” which process Dr. Parnell described as follows: (1)
when it first receives an EndoWrist from a customer, Rebotix
will clean the instrument; (2) a technician will then perform
“an initial visual inspection” of the instrument to check for
obvious damage and to check the number of uses left on the
device; (3) the technician will then inspect the tool end
under a microscope, test the instrument’s range of motion,
and/or

test

the

instrument’s

“insulation

and

electrical

isolation”; (4) any instruments deemed unsuitable for repair
will be returned or placed aside; (5) once an instrument has
been identified as a candidate for repair, Rebotix will reset
the usage counter by installing the Interceptor; (6) Rebotix
will then perform any necessary repairs to the tool end of
the instrument (e.g., sharpening scissors, aligning graspers,
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or ensuring tightness on needle drivers); (7) Rebotix will
test and inspect the repaired instrument; and (8) lastly, the
instrument will be cleaned, packaged, and shipped to the
customer. (Id. at 15-26).
According to Dr. Parnell’s deposition testimony, on the
day of his visit, Rebotix’s director of operations, Greg
Fiegel, “walked [him] through the [repair] process and showed
[him] the steps involved in the process.” (Doc. # 115-3 at
63:6-12). Only Mr. Fiegel, not any technicians, touched the
instruments that Dr. Parnell observed, and Dr. Parnell did
not observe anyone who appeared to be actively involved in
repairing EndoWrists on that day. (Id. at 64:1-3, 14-18).
The

Court

is

persuaded

that

Dr.

Parnell

used

sufficiently reliable methodologies to opine on the safety of
Rebotix’s repair process. While Intuitive faults him for not
conducting his own testing, Dr. Parnell’s opinion is based on
his professional experience involving reverse engineering and
device testing and his first-hand observations at the Rebotix
repair facility. See Kumho Tire Co., 526 U.S. at 156 (“[N]o
one denies that an expert might draw a conclusion from a set
of

observations

based

on

extensive

and

specialized

experience.”). Any alleged flaws in Dr. Parnell’s methodology
should be addressed in cross-examination. See Maiz v. Virani,
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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)).
b.

Opinion: That EndoWrists modified by Rebotix have
a higher degree of safety and reliability than new
EndoWrists manufactured by Intuitive (Doc. # 115-2
at 6, 57-65).

Dr. Parnell writes that “[i]n [his] experience with
medical devices . . . manufacturing issues can frequently
cause medical devices to fail unexpectedly and in ways not
accounted for during design testing. This is evidenced by the
creation of the FDA’s Good Manufacturing Practices (GMPs) in
addition to the extensive pre-market approval process.” (Doc.
# 115-2 at 57). Dr. Parnell then states that, in his review
of the relevant evidence here, he determined that Intuitive’s
manufacturing protocols were defective.
To the extent supported by his experience, Dr. Parnell
may explain the FDA’s manufacturing guidelines to the jury,
along with what can generally go wrong in medical-device
manufacturing. He may also give his opinion that Intuitive
does not adequately address potential manufacturing defects.
He may also testify about the safety and reliability of

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repaired versus new EndoWrists. Dr. Parnell’s experience with
medical-device manufacturing and his understanding of the
Rebotix

repair

process

lend

his

opinion

sufficient

reliability to pass the Daubert bar. Intuitive may address
any flaws in his methodology during cross-examination.
c.

Opinion: That the EndoWrist use counter does not
promote patient safety (Doc. # 115-2 at 6, 36-57).

According to his report, Dr. Parnell bases this opinion
on five contentions: (1) the use counter does not measure
actual wear experienced by instruments during surgeries; (2)
the use counter does not reflect the number of times an
instrument has been “reprocessed” by a hospital; (3) the use
counter does not take into account mishandling or misuse; (4)
the use counter cap (10 uses) is determined by Intuitive’s
marketing needs, not failure testing; and (5) the use counter
does

not

independently

verify

the

condition

of

the

instrument.
With one exception, the Court fails to see how Dr.
Parnell’s

training

as

a

mechanical

engineer

makes

him

qualified to opine on patient safety. Most of the facts
undergirding this opinion could just as easily be offered by
surgeons or surgical technicians who work with the EndoWrists
in the operating room or a Rebotix representative.

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However, Dr. Parnell does state in his report that: “In
my experience studying the failures experienced by mechanical
components and medical instruments, testing instruments to
failure and observing at which points those failures occur
helps

to

establish

instrument.

the

potential

Establishing

the

range

potential

of

life

failure

for

an

modes

accurately is important and highly relevant.” (Doc. # 115-2
at 50). Dr. Parnell then goes on to explain that, according
to his review of the testimony and other relevant records,
“Intuitive’s

life

testing

is

designed

to

validate

an

arbitrarily set use limit set by marketing, rather than to
establish the failure point of an instrument. To accurately
establish a use limit or failure point, tests would need to
actually test instruments to failure. . . . Rather than
establishing where failures naturally occur by testing each
instrument to failure, the testing process is stopped after
passing the target number of instrument lives.” (Id. at 50,
53).
The Court will permit Dr. Parnell to testify regarding
failure-mode testing in general and his conclusions that
Intuitive failed to perform such testing adequately because
that opinion is based on his experience as a mechanical
engineer and would be helpful to the trier of fact.
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d. Opinion: That Intuitive has “no basis” to assert that
modified EndoWrists are less safe than new EndoWrists
(Doc. # 116-2 at 7, 65-76).
The Court will permit Dr. Parnell to testify, based on
his

experience

as

a

professional

engineer,

about

what

measures he would expect Intuitive to take to deem Rebotix
repairs unsafe and whether his review of the record revealed
evidence of those measures. But his experience does not lend
itself to the legal conclusion or argument that Intuitive has
“no basis” to make a claim about the safety or reliability of
EndoWrists.
2.

Assistance to Trier of Fact

Expert testimony must also 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
Med. Corp., 184 F.3d 1300, 1312 (11th Cir. 1999).
So, while “[t]he ‘basic standard of relevance . . . is
a liberal one,’ Daubert, 509 U.S. at 587, . . .[,] if an
expert opinion does not have a ‘valid scientific connection
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to the pertinent inquiry[,]’ it should be excluded because
there is no ‘fit.’” Boca Raton Cmty. Hosp., Inc. v. Tenet
Health Care Corp., 582 F.3d 1227, 1232 (11th Cir. 2009)
(citations 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).
Intuitive takes issue with Dr. Parnell’s opinion that
“EndoWrists can be routinely repaired in the same manner as
traditional laparoscopic instruments.” (Doc. # 115-2 at 12).
In his report, Dr. Parnell wrote that EndoWrists have “similar
failure modes” as traditional laparoscopic instruments – for
example, scissors can become dull and graspers can become
misaligned.

(Id.).

To

support

this

opinion,

Dr.

Parnell

relied on the deposition testimony of a Mr. Ed Harrich, a
hospital employee, that: (1) hospitals will inspect both
EndoWrists

and

traditional

surgical

implements

prior

to

surgeries; and (2) EndoWrists can fail in multiple mechanical
ways,

such

as

misaligned

teeth,

frayed

wires,

or

dull

scissors. (Id. at 12-13). Dr. Parnell then concludes that
Rebotix’s

service

procedures

failures.

14

addresses

these

mechanical

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The fact that mechanical implements can become dull,
misaligned, or otherwise damaged with repeated use is not a
concept “beyond the understanding of the average lay person.”
See Frazier, 387 F.3d at 1262. Dr. Parnell and Rebotix do not
explain how the testimony of a mechanical engineer sheds any
special light on this issue. Further, Dr. Parnell admitted
that he had no experience with laparoscopic instruments prior
to this litigation, and he did not examine any laparoscopic
instruments in connection with this case. The Motion is
granted as to this opinion. However, to the extent Intuitive
presents admissible testimony about the purported differences
between traditional laparoscopic instruments and EndoWrists
that render EndoWrists unsuitable for repair, the Court will
re-evaluate this testimony.
Accordingly, it is hereby
ORDERED, ADJUDGED, and DECREED:
Defendant Intuitive Surgical, Inc.’s Daubert Motion to
Exclude the Opinions of Dr. T. Kim Parnell. (Doc. # 115) is
GRANTED in part and DENIED in part to the extent set forth in
this Order.

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DONE and ORDERED in Chambers in Tampa, Florida, this
10th day of August, 2022.

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