Rebotix Repair LLC v. Intuitive Surgical, Inc.

Filing 184

ORDER: Plaintiff Rebotix Repair, LLC's Daubert Motion to Exclude the Opinions of Dr. John Bomalaski (Doc. # 109) is GRANTED in part and DENIED in part. Signed by Judge Virginia M. Hernandez Covington on 8/10/2022. (SGM)

Case 8:20-cv-02274-VMC-TGW Document 184 Filed 08/10/22 Page 1 of 11 PageID 36748

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
Plaintiff Rebotix Repair, LLC’s Daubert Motion to Exclude the
Opinions of Dr. John Bomalaski. (Doc. # 109). Defendant
Intuitive Surgical, Inc. has responded. (Doc. # 150). 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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Intuitive seeks to introduce the testimony of Dr. John
Bomalaski to demonstrate a surgeon’s view of the “risks” or
“dangers” of using repaired EndoWrists. Dr. Bomalaski is a
gynecologic oncologist who practices in Melbourne, Florida.
(Doc. # 109-2 at 4). He is a trained surgeon, having performed
thousands

of

surgeries

using

a

traditional

laparoscopic

technique. (Id.). Dr. Bomalaski has also performed over 2,600
robotically assisted surgeries using Intuitive’s da Vinci
surgical system. (Id.).
In

his

report,

Dr.

Bomalaski

compares

traditional

laparoscopic surgery and robotic-assisted surgery using the
da Vinci system, noting the different tools and techniques
used in each. (Id. at 7-9). It is his opinion that da Vinci
surgical robots offer benefits to surgeons, patients, and
hospitals.
Dr.

Bomalaski’s

report

contains

a

section

entitled

“Risks and dangers of using an EndoWrist instrument beyond
the usage limits set by Intuitive” (“Section VII”). (Id. at
12-15).

Dr.

Bomalaski

writes

that

he

“would

not

feel

comfortable using [EndoWrists “repaired” by Rebotix to exceed
the

usage

limits]

in

the

operating

room

because

[he]

believe[s] that they would present undue risks to [his]
patients and [his] surgical team, as well as the hospital.
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[He] believe[s] that the regulatory process and adherence to
manufacturer specifications are valuable means to enhancing
patient safety.” (Id. at 6-7). He explains that surgical
instruments wear out over time and that he relies on the FDA
and

the

manufacturer’s

instructions

regarding

quality

control. (Id. at 13). What’s more, Dr. Bomalaski reviewed a
video of an EndoWrist undergoing Rebotix’s repair procedure
and he wrote that his patients would be “quite concerned” if
they saw the video. (Id. at 15).
Now, Rebotix seeks to exclude Dr. Bomalaski’s testimony.
As an initial matter, Rebotix concedes that the first portion
of Dr. Bomalaski’s report presents opinions that are within
the scope of his expertise and are sufficiently supported.
(Doc. # 109 at 3). In the Motion, Rebotix specifically attacks
Section VII of Dr. Bomalaski’s report, arguing that Dr.
Bomalaski is not qualified to present the opinions presented
in that section and those opinions are unsupported by any
reliable methodology. (Id.). Intuitive 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
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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. 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).
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
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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.
1.

Qualifications

The first question under Daubert is whether the proposed
expert witness is qualified to testify competently regarding
the matters he or she intends to address. City of Tuscaloosa
v. Harcros Chems., Inc., 158 F.3d 548, 563 (11th Cir. 1998).
An expert may be qualified “by knowledge, skill, experience,
training, or education.” Fed. R. Evid. 702. “Determining
whether

a

witness

is

qualified

to

testify

as

an

expert

‘requires the trial court to examine the credentials of the
proposed expert in light of the subject matter of the proposed
testimony.’” Clena Invs., Inc. v. XL Specialty Ins. Co., 280
F.R.D. 653, 661 (S.D. Fla. 2012) (quoting Jack v. Glaxo
Wellcome, Inc., 239 F. Supp. 2d 1308, 1314–16 (N.D. Ga.
2002)).
Rebotix argues that Dr. Bomalaski is not qualified to
testify competently regarding (1) the safety of Rebotix’s
repair process or (2) the requirements of FDA regulations.
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But Intuitive counters that Dr. Bomalaski’s opinions do not
go so far, and he is merely relying on his “extensive medical
training and decades of surgical experience [to] support his
opinions that overriding the use limit in EndoWrists without
manufacturer or federal regulator approval increases the risk
to patient safety.” (Doc. # 150 at 9).
Dr. Bomalaski’s qualifications is an issue inextricably
bound up in the issue of whether the specific opinions he
wishes to give are reliable. Thus, the Court will move on to
the reliability prong.
2.

Reliability

The next question is whether the expert’s methodology is
reliable. “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
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
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has
been
generally
scientific community.

accepted

in

the

proper

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).
“If the [expert] witness is relying solely or primarily
on

experience,

witness

must

then,”

explain

in

establishing

how

that

reliability,

experience

leads

to

“the
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 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).
Rebotix argues, first, that Dr. Bomalaski does not have
a reliable methodology for concluding that Rebotix’s repair
service is unsafe. Dr. Bomalaski opines in his report that,
as

a

surgeon,

he

relies

on

manufacturer

instructions

regarding whether and in what circumstances certain surgical
tools are safe to use, recognizing that surgeons can exert
great force during surgeries and surgical tools can wear out

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over time. (Doc. # 109-2 at 13-15). Dr. Bomalaski then writes
that:
I have given due consideration to Rebotix’s views
that it can “repair” EndoWrist instruments so they
can be safely and reliably used beyond their usage
limits.
However,
after
reviewing
the
video
demonstrating what the “process” actually entails,
I would not feel comfortable using an instrument on
a patient that had been “repaired” in that manner.
In my opinion, the video did not show any real
measures of quality control concerning instrument
refurbishing. The EndoWrist instrument was shown
being pried open, and the components changed out
forcibly. Based on my experience, I believe
patients would be quite concerned if they saw the
Rebotix “repair” process on an instrument used for
their surgery. I have cared for thousands of
surgical patients. They are often anxious and
vulnerable. In my opinion, the Rebotix video of its
“process” would be a source of little comfort and
more anxiety because it provides no factual basis
for concluding that patient safety was studied by
Rebotix.
(Id. at 15).
First, the Court holds that Dr. Bomalaski’s decades of
experience as a surgeon qualify him to opine on the potential
consequences to patient health and safety of using inadequate
instruments

to

perform

surgical

procedures.

Although

Dr.

Bomalaski may not understand precisely how EndoWrists are
manufactured

or

repaired

in

an

engineering

sense,

Dr.

Bomalaski can testify that he relies on a relationship of
trust with the hospital, the instrument manufacturer, and
government

regulators

to

ensure
8

adherence

to

appropriate

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safety standards. Accordingly, Dr. Bomalaski has an adequate
basis to explain to the factfinder how he personally feels
about using repaired robotic surgical instruments in his
capacity as a surgeon. To the extent Rebotix seeks to undercut
those worries or concerns (by, for example, exposing Dr.
Bomalaski’s lack of knowledge about any flaws in Rebotix’s
repair

process),

Rebotix

may

address

that

on

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)).
That leads, however, to Rebotix’s second argument on
reliability. Rebotix argues that the doctor’s opinions about
what

“would

be”

concerning

to

other

surgeons,

patients,

and/or payors must be excluded as unreliable. The Court
agrees. Rebotix points out that Dr. Bomalaski has not used
any method to learn of the perceptions of these other groups,
outside of his own speculation. He did not conduct any surveys
or polls, did not read any report about how other physicians
felt about the repair process, and did not show the Rebotix
repair video to any patient. The Court agrees with Rebotix
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that Dr. Bomalaski’s own experience is not a sufficient basis
to permit him to testify as to what other doctors might think.
See In re 3M Combat Arms Earplug Prod. Liab. Lit., No. 3:19md-2885, 2021 WL 684183, at *4 (N.D. Fla. Feb. 11, 2021)
(excluding testimony where the expert “has not provided any
other

basis,

such

as

a

survey

or

widely

distributed

publication or even an email, to support the extrapolation of
his knowledge to the entire . . .

community [of medical

personnel]”); Bartlett v. Mut. Pharm. Co., Inc., 742 F. Supp.
2d 182, 195 (D.N.H. 2010) (“[M]ost courts have prohibited
experts from testifying . . . about ‘what doctors generally
think,’ unless the testimony is based on something more
reliable

than

simply

the

expert’s

own

experience

as

a

doctor.”); In re Seroquel Prod. Liab. Lit., No. 6:06-md-1769ACC-DAB, 2009 WL 3806436, at *8 (M.D. Fla. July 20, 2009)
(excluding expert witnesses from testifying about whether
doctors

“generally

read

and

comprehend

drug

labels,

or

whether doctors generally understand the contents” of such
labels).
Similarly, although Dr. Bomalaski may testify as to the
actual known perceptions of his patients over the course of
his

career

(assuming

such

testimony

10

to

be

otherwise

Case 8:20-cv-02274-VMC-TGW Document 184 Filed 08/10/22 Page 11 of 11 PageID 36758

admissible under the Federal Rules of Evidence), he may not
speculate as to the opinions of patients in general.
In sum, Dr. Bomalaski may testify to the extent such
testimony is unchallenged by Rebotix and to the extent set
forth in this Order.
Accordingly, it is hereby
ORDERED, ADJUDGED, and DECREED:
Plaintiff

Rebotix

Repair,

LLC’s

Daubert

Motion

to

Exclude the Opinions of Dr. John Bomalaski (Doc. # 109) is
GRANTED in part and DENIED in part.
DONE and ORDERED in Chambers in Tampa, Florida, this
10th day of August, 2022.

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