The opinion
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
service whereby it “repairs” the EndoWrist surgical implement
originally manufactured by Intuitive.
Rosecrans and Stevens offer competing expert opinions as
to whether Rebotix’s “repair” service violates certain
regulatory requirements of the federal Food 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
case. Her first report, dated July 26, 2021 (the “First
Rosecrans Report”), provides an overview of the FDA’s
regulation of medical devices, specifically the 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 Use Devices; (2) Rebotix’s argument that
EndoWrists can be treated the same way as traditional
laparoscopic instruments is flawed; (3) Intuitive’s marketing
and sale of EndoWrist instruments with usage limits is
consistent with the FDA’s regulatory requirements; (4)
Rebotix is the manufacturer of a Medical Device (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 disagrees with Dr.
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.
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.’”
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
was lawful in order to establish antitrust injury, which
Intuitive claims Rebotix cannot do because of their
noncompliance with Section 510(k) requirements. 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.”
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 compliance with regulatory requirements or
espouse her own personal interpretations of 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,
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 qualified, objections to the level of the
expert’s expertise [go] to credibility and 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’ report reveals that over his four-
decades-long career, he has personally prepared several
510(k) submissions, has advised companies 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
standard,” Delta T, LLC v. Dan’s Fan City, Inc., No. 8:19-
cv-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 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
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, 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 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).
“An expert may not present testimony that merely
‘parrots’ the opinions of others, without 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-cv-
277-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 he wrote that, since
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
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.
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, 45-
46).
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).
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.
tani Munenbey Cree.
VIRGINIA M. HERNANDEZ'COVINGTON
UNITED STATES DISTRICT JUDGE
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