Rebotix Repair LLC v. Intuitive Surgical, Inc.

Filing 186

ORDER: Plaintiff Rebotix Repair, LLC's Daubert Motion to Exclude the Opinions of Heather Rosecrans (Doc. # 110) is GRANTED in part and DENIED in part. Defendant Intuitive Surgical, Inc.'s Daubert Motion to Exclude the Opinions of J. Lawrence Stevens (Doc. # 116) 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 186 Filed 08/10/22 Page 1 of 16 PageID 36778

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 Heather Rosecrans (Doc. # 110) and Defendant
Intuitive Surgical, Inc.’s Daubert Motion to Exclude the
Opinions of J. Lawrence Stevens. (Doc. # 116). Both parties
have responded. (Doc. ## 143, 151). For the reasons that
follow, both Motions are 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

1

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 2 of 16 PageID 36779

service whereby it “repairs” the EndoWrist surgical implement
originally manufactured by Intuitive.
Rosecrans and Stevens offer competing expert opinions as
to

whether

regulatory

Rebotix’s

“repair”

requirements

of

the

service
federal

violates
Food

certain

and

Drug

Administration (“FDA”), specifically whether Rebotix needed
Section 510(k) clearance from the FDA for its activities.
Since the Motions were filed, the FDA has sent email
correspondence to Rebotix indicating that the FDA does view
Rebotix’s activities as “remanufacturing” of the type that
requires regulatory review and approval. However, for the
reasons detailed in the Court’s accompanying summary judgment
order,

the

Court

does

not

believe

this

to

be

a

final,

definitive decision from the FDA. The issue of FDA clearance
may go to the issues of causation and damages. Thus, these
Motions are not moot and the Court will proceed to consider
the instant Daubert motions.
1. Rosecrans’ Report
Heather

Rosecrans

is

an

FDA

regulatory

affairs

consultant with an expertise in matters concerning premarket
regulation of medical devices. (Doc. # 110-2 at 6). She worked
for more than 30 years at the FDA, including on the agency’s
510(k) staff. Rosecrans issued two expert reports in this
2

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 3 of 16 PageID 36780

case. Her first report, dated July 26, 2021 (the “First
Rosecrans

Report”),

regulation

of

provides

medical

an

devices,

overview

of

the

specifically

the

FDA’s
510(k)

procedure. The First Rosecrans Report contains the following
opinions: (1) the usage limits on EndoWrists cannot be removed
without 510(k) clearance because the FDA approved EndoWrists
as

Limited

EndoWrists

Use
can

Devices;
be

treated

(2)

Rebotix’s

the

same

way

argument
as

that

traditional

laparoscopic instruments is flawed; (3) Intuitive’s marketing
and

sale

of

consistent
Rebotix

EndoWrist

with

is

the

the

instruments

FDA’s

with

regulatory

manufacturer

of

a

usage

limits

requirements;

Medical

Device

is
(4)

(the

Interceptor board) and, without 510(k) clearance, is selling
a device that is “misbranded and adulterated”; and (5) in the
alternative, Rebotix was required to obtain 510(k) clearance
as a remanufacturer. (Doc. # 110-2).
Rosecrans’ second expert report, dated August 30, 2021
(the “Second Rosecrans Report”), was submitted in rebuttal to
a report submitted by Dr. Joshua Sharlin, an expert retained
by Rebotix. (Doc. # 110-3). In short, the Second Rosecrans
Report

details

Dr.

Sharlin’s

conclusion

that

Rebotix’s

“repair” service does not require 510(k) clearance and then
explains

the

reasons

that

Rosecrans
3

disagrees

with

Dr.

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 4 of 16 PageID 36781

Sharlin. Intuitive did not move to exclude the testimony of
Dr. Sharlin. Instead, it challenges Rebotix’s other proffered
expert on this topic, J. Lawrence Stevens.
2. Stevens’ Report
J. Lawrence Stevens has more than 40 years’ experience
with the FDA, both within the agency and in the private
sector. (Doc. # 116-3 at 4). He served as a small business
representative

at

the

FDA,

where

he

provided

regulatory

guidance to developers of new medical devices. He also worked
for the FDA as a compliance officer, inspecting “high-risk
medical device firms.” After he left the FDA, Stevens founded
a regulatory consulting company.
Rebotix

hired

Stevens

to

provide

a

rebuttal

to

Rosecrans’ opinions. In Stevens’ opinion, Rebotix was not
required to seek FDA approval (via section 510(k) clearance
or

otherwise)

for

the

services

Rebotix

performs

on

the

EndoWrists. Moreover, Stevens opines that (1) Rebotix is not
a

manufacturer

of

a

medical

device

requiring

510(k)

clearance; (2) Rebotix is not the remanufacturer of a medical
device; and (3) various other aspects of Rosecrans’ opinions
are flawed. (Doc. # 116-3 at 11-54).
Both Motions are now ripe for review.

4

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 5 of 16 PageID 36782

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 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.’”

5

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 6 of 16 PageID 36783

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.
1.

Motion to exclude Rosecrans’ opinions

Rebotix argues that Rosecrans’ opinions address an issue
that is not properly before the Court and should therefore be
disallowed as irrelevant. As more fully described in the
Court’s accompanying summary judgment Order, it is Rebotix’s
position that only the FDA can make the determination of
whether Rebotix’s services are compliant with and/or require
FDA approval or regulation. And, as described in that Order,
the Court agrees and will not intrude upon a decision left to
the sole discretion of the FDA.
Intuitive counters that Rosecrans’ opinions are relevant
to numerous issues bearing on Intuitive’s Sherman Act claims.
First, Intuitive argues that Rebotix must prove its business
6

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 7 of 16 PageID 36784

was lawful in order to establish antitrust injury, which
Intuitive

claims

noncompliance

Rebotix

with

cannot

Section

510(k)

do

because

of

requirements.

their
Second,

Intuitive argues that it had a reasonable pro-competitive
reason for representing in customer communications that use
of Rebotix’s “repaired” instruments lacking 510(k) clearance
was unsafe. And finally, her opinion is relevant to the
regulatory justification for EndoWrist use limits and the
scope of EndoWrists’ 510(k) clearance. And Intuitive argues
that, with respect to its counterclaims, Rosecrans’ testimony
will assist the trier of fact to understand “the regulatory
framework and the reasonableness of the process Rebotix used
to analyze 510(k) clearance.”
The Court believes that Rosecrans’ testimony will be
helpful to the trier of fact insofar as her opinions are
offered

to

help

the

jury

understand

the

Section

510(k)

regulatory framework and provide an explanation of the FDA’s
practices and procedures. In that regard, Rosecrans’ opinions
will help the jury understand the complex regulatory scheme
at issue in this case. However, Rosecrans cannot offer an
ultimate opinion as to Rebotix’s compliance or noncompliance
with

regulatory

requirements

because

“an

expert

may

not

testify that certain conduct did or did not violate the law.”
7

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 8 of 16 PageID 36785

In re Delta/Airtran Baggage Fee Antitrust Lit., 245 F. Supp.
3d 1343, 1362 (N.D. Ga. 2017).
Thus, Rebotix’s Motion to exclude Rosecrans’ opinions is
granted in part and denied in part to the extent set forth
herein. Rosecrans may not give an ultimate legal opinion as
to

Rebotix’s

espouse

her

compliance
own

with

personal

regulatory

requirements

interpretations

of

or

relevant

regulations to the extent they differ from the FDA’s public
interpretations.
2.

Motion to exclude Stevens’ opinions

Intuitive argues that Stevens’ opinions are inadmissible
because: (1) he is not qualified to opine on Section 510(k)
issues; (2) the methodology Stevens used is not sufficiently
reliable; (3) Stevens failed to consider sufficient facts and
data in conducting his analysis; (4) Stevens used improper
hearsay to “prop up” his opinions; and (5) Stevens’ opinions
do not rebut Rosecrans’ affirmative opinions.
a.

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,
8

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 9 of 16 PageID 36786

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)).
“This inquiry is not stringent, and so long as the expert
is

minimally

expert’s

qualified,

expertise

objections

[go]

to

to

the

credibility

level

and

of

the

weight,

not

admissibility.” Id. (citations and internal quotation marks
omitted). The Court is mindful that its “gatekeeper role under
Daubert ‘is not intended to supplant the adversary system or
the role of the jury.’” Maiz v. Virani, 253 F.3d 641, 666
(11th Cir. 2001)(quoting Allison v. McGhan, 184 F.3d 1300,
1311 (11th Cir. 1999)).
Here,

Stevens’

decades-long
510(k)

career,

submissions,

report
he
has

reveals

has

that

personally

advised

over

his

prepared

companies

four-

several

navigating

the

510(k) process, and has authored warning letters to medical
device

firms

for

failure

to

submit

the

required

510(k)

paperwork. The qualifications prong of Daubert is a “lenient
9

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 10 of 16 PageID 36787

standard,” Delta T, LLC v. Dan’s Fan City, Inc., No. 8:19cv-1731-VMC-SPF, 2021 WL 2103074, at *3 (M.D. Fla. May 25,
2021),

and

an

expert

need

only

show

“some

reasonable

indication of qualifications,” at which point “qualifications
become an issue for the trier of fact rather than the court
in its gate-keeping capacity.” Worley v. State Farm Mut. Auto.
Ins. Co., No. 3:12-CV-1041-MCR, 2013 WL 6478425, at *3 (M.D.
Fla. Dec. 10, 2013) (citing Rushing v. Kansas City S. Ry.
Co., 185 F.3d 496, 507 (5th Cir. 1999), superseded by rule on
other grounds as recognized in Mathis v. Exxon Corp., 302
F.3d 448, 459 n.16 (5th Cir. 2002)). Stevens’ specialized
knowledge and experience makes him qualified to discuss the
FDA’s

510(k)

procedures

and

any

shortcomings

in

his

experience can be addressed on cross-examination.
b.

Reliability

Intuitive also attacks Stevens as unqualified to opine
on technical issues concerning the Interceptor or EndoWrists
because he lacks an engineering background. Relatedly, it
argues that Stevens offers no reliable analysis to support
these engineering-related opinions but, rather, merely adopts
the opinions of Dr. Sharlin.
The second question in the Daubert analysis is whether
the

expert’s

methodology

is
10

reliable.

“Exactly

how

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 11 of 16 PageID 36788

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 nonexhaustive,

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

experience,

witness

must

then,”

explain

in
how

establishing
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
11

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 12 of 16 PageID 36789

reliability “focus[es] ‘solely on principles and methodology,
not on the conclusions that they generate.’” Seamon, 813 F.3d
at 988 (citation omitted).
“An
‘parrots’

expert
the

may

not

opinions

present

of

others,

testimony
without

that

merely

providing

an

independent evaluation of the evidence.” Delta T, 2021 WL
2103074, at *4 (citing Morales v. Kraft Foods Grp., Inc., No.
LA CV-14-04387 JAK (PJWx), 2017 WL 2598556, at * 10 (C.D.
Cal. June 9, 2017)); see also Sabal Trail Transmission, LLC
v. 0.589 Acres of Land in Hamilton Cnty., Fla., No. 16-cv277-MMH-JBT, 2018 WL 3655556, at *7-8 (M.D. Fla. Aug. 2, 2018)
(inappropriate

parroting

occurs

when

an

expert

“simply

repeat[s] or adopt[s] the findings of another expert without
attempting to assess the validity of the opinions relied
upon”).
Intuitive argues that Stevens’ wholesale adoption of Dr.
Sharlin’s

now-withdrawn

report,

with

minimal

independent

investigation, warrants exclusion. Rebotix agrees that an
expert’s wholesale adoption of another’s work without an
independent evaluation would be improper, but argues that
Stevens used his own skill and knowledge to “corroborate every
opinion he adopted in [Dr. Sharlin’s] report.” Rebotix points
to

Stevens’

declaration,

in

which

12

he

wrote

that,

since

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 13 of 16 PageID 36790

submitting his report, he “re-reviewed all of the materials
cited therein, and re-confirmed that the cited materials
support [his] opinions.” (Doc. # 143-6 at 3). While Intuitive
points to the length and complexity of Dr. Sharlin’s report
and Stevens’ deposition testimony that he only reviewed the
report

for

a

“couple

of

hours”

and

would

view

specific

documents only when he had questions, this is evidence that
may

be

used

on

cross-examination

to

undercut

Stevens’

opinions. Stevens stated in his report and later in his
declaration that he independently considered the materials in
Dr. Sharlin’s report and reached the same conclusions, which
is sufficient at this point to proceed.
Similarly, Intuitive takes issue with Stevens’ adoption
of a discussion he had with Rebotix employee Greg Fiegel,
which forms the basis of Stevens’ opinion regarding the repair
process and whether Rebotix needed 510(k) clearance. But
Rebotix argues that Stevens relied on his conversation with
Fiegel only to provide certain background facts and then used
those facts to reach his own conclusions. This goes to the
weight

of

Stevens’

opinion,

not

its

admissibility.

Any

alleged flaws in Stevens’ methodology should be addressed in
cross-examination.

See

Maiz,

253

F.3d

at

666

(“Vigorous

cross-examination, presentation of contrary evidence, and
13

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 14 of 16 PageID 36791

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)).
Finally,

Intuitive

attacks

Stevens’

reliance

on

a

Deutsche Bank report that claims companies like Rebotix do
not need Section 510(k) clearance based on the word of unnamed
“regulatory consultants.” “An expert may base an opinion on
facts or data in the case that the expert has been made aware
of or personally observed. If experts in the particular field
would reasonably rely on those kinds of facts or data in
forming an opinion on the subject, they need not be admissible
for the opinion to be admitted.” Fed. R. Evid. 703. While
“Rule 703 provides that an expert may base his opinion on
inadmissible facts or data,” including hearsay, it must be
“of a type reasonably relied upon by experts in the particular
field in forming opinions or inferences upon the subject.”
Riverside Apartments of Cocoa, LLC v. Landmark Am. Ins. Co.,
No. 6:18-cv-1639-PGB-DCI, 2020 WL 8184710, at *3 (M.D. Fla.
Dec. 4, 2020). “Though courts have afforded experts wide
latitude in picking and choosing sources on which to base
opinions, Rule 703 nonetheless requires courts to examine the
reliability of these sources.” Id.

14

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 15 of 16 PageID 36792

There is no evidence in the record that analyst reports
like the one prepared by Deutsche Bank are relied upon by FDA
experts. Stevens even testified that he could not recall
whether he had ever relied upon an analyst report to help
form his opinion on an FDA issue. Rebotix has not shown how
the Deutsche Bank report is “of a type reasonably relied upon
by experts in the field” in forming their opinions. Thus, to
the

extent

Stevens

wishes

to

rely

on

the

Deutsche

Bank

document to state that: (1) his opinion on FDA clearance is
the “consensus opinion held by FDA experts”; or (2) “other
FDA experts” also believe that the FDA’s “silence” means it
has determined that Rebotix’s services do not violate FDA
regulations, he may not do so. See (Doc. # 143-2 at 18, 4546).
Finally,

Intuitive

attacks

Section

III

of

Stevens’

report – which details his affirmative opinions that FDA
clearance is not required for Rebotix’s activities – as
outside the scope of his role as a rebuttal expert. This
argument is unavailing because Stevens is addressing here the
same subject matter – FDA section 510(k) clearance – as
Rosecrans discussed in her report. See Adacel, Inc. v. Adsync
Techs., No. 6:18-cv-1176-EJK-WWB, 2020 WL 4588415, at *2
(M.D. Fla. July 9, 2020).
15

Case 8:20-cv-02274-VMC-TGW Document 186 Filed 08/10/22 Page 16 of 16 PageID 36793

Thus, Intuitive’s Motion to exclude Stevens’ opinion is
granted in part and denied in part to the extent set forth
herein. Like Rosecrans, Stevens may not give an ultimate legal
opinion

as

to

Rebotix’s

compliance

with

regulatory

requirements or espouse his own personal interpretations of
relevant regulations to the extent they differ from the FDA’s
public interpretations. He also may not proffer opinions that
rely on the Deutsche Bank report. The Motion is otherwise
denied.
Accordingly, it is hereby
ORDERED, ADJUDGED, and DECREED:
(1)

Plaintiff

Rebotix

Repair,

LLC’s

Daubert

Motion

to

Exclude the Opinions of Heather Rosecrans (Doc. # 110)
is GRANTED in part and DENIED in part.
(2)

Defendant Intuitive Surgical, Inc.’s Daubert Motion to
Exclude the Opinions of J. Lawrence Stevens (Doc. # 116)
is GRANTED in part and DENIED in part.
DONE and ORDERED in Chambers in Tampa, Florida, this

10th day of August, 2022.

16