Knoth v. Keith et al

Filing 187

ORDER denying 165 Motion in Limine to Exclude Plaintiff's MDR. Signed by District Judge David C. Bramlette, III on 2/1/2021. (cp)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF MISSISSIPPI
WESTERN DIVISION

STEPHANIE KNOTH

PLAINTIFF

VS.

CAUSE ACTION NO.: 5:18-CV-49-DCB-MTP

DR. STEPHEN P. KEITH, ET AL.

DEFENDANTS

Order
This matter is before the Court on Apollo Endosurgery US,
Inc., (“Apollo”)’s Motion in Limine to Exclude Plaintiff’s Medical
Device

Report.

[ECF

No.

165].

Having

read

the

Motion,

the

submissions of the parties, applicable statutory and case law, the
record, and being otherwise fully informed of the premises, the
Court denies Apollo’s Motion in Limine.
Background
This case is a medical malpractice and products liability
dispute, arising from the implant of an ORBERA® gastric balloon
manufactured by Apollo. Dr. Stephen Keith implanted the ORBERA®
balloon in Ms. Knoth (“Plaintiff”). The Plaintiff experienced
complications which ultimately led to the removal of the ORBERA®.

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Apollo has filed a Motion in Limine to exclude Plaintiff’s Medical
Device Report. [ECF No. 165].
Discussion
It is unclear to the Court which document Apollo seeks to
exclude. There are two documents: an internal complaint form [ECF
No. 145]; and a Form 3500A Medical Device Report (“MDR”) that
Apollo submitted to the Food and Drug Administration (“FDA”) [ECF
No. 136-6].

The Court will assume that Apollo seeks to exclude

both documents and will address each.
A.

Internal Complaint Form [ECF No. 145]
The internal complaint form was the result of an internal

investigation by Apollo. This document does not qualify as an MDR
under 21 U.S.C. § 360i(a)(1) and (b)(1). It is strictly an internal
form prepared by Apollo, which was not submitted to the FDA.

It

is not inadmissible under 21 U.S.C. § 360i(b)(3) because it was
not made by: (A) a device user facility (i.e., the hospital), (B)
an individual employed by or affiliated with such a facility, or
(C) a physician not required to make such a report.
§

360i(b)(3).

The

document

was

prepared

by

See 21 U.S.C.
Apollo,

the

manufacturer. Apollo argues that because the information contained
in its internal complaint form was used to prepare the Form 3500A
MDR, which it ultimately submitted to the

FDA, the internal

complaint form (like an MDR described in Section 360i(b)(3)) should

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not be admitted into evidence.

The Court finds that there is no

basis in the statute for this argument.
B.

The MDR [ECF No. 136-6]
Apollo submitted a Form 3500A MDR to the FDA. Although this

document is an “MDR”, it is not the type that is inadmissible under
Section 360i(b)(3) because, as noted above, it was not made by:
(A) a device user facility (i.e., the hospital), (B) an individual
employed by or affiliated with such a facility, or (C) a physician
not required to make such a report.

See 21 U.S.C. § 360i(b)(3).

In its Form 3500A MDR, Apollo listed Dr. Keith as the “Initial
Reporter”, [ECF No. 136-6 at 1], and it argues that Form 3500A MDR
is therefore inadmissible because it is based on information
reported

by

Dr.

Keith,

who

is

an

individual

employed

by

or

affiliated with a device user facility and a physician not required
to make an MDR. The Court finds that this argument is not supported
by the plain language of the statute.

In addition, the Form 3500A

MDR indicates that a “Company Representative” also was a source of
the report.

[ECF No. 136-6 at 2].

It implausible for Apollo to

argue that Dr. Keith is responsible for its Form 3500A MDR, while
the MDR itself attributes a “Company Representative” and a “Health
Professional” as report sources.
C.

[ECF No. 136-6 at 2].

Federal Rule of Evidence 403
Apollo argues, in the alternative, that F.R.E. 403 provides

grounds for excluding “Plaintiff’s MDR.”
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[ECF No. 166 at 4-6].

Apollo’s Memorandum is unclear as to which document(s) it seeks to
exclude

under

its

alternative

Rule

403

argument.

Apollo’s

Memorandum only refers to excluding “Plaintiff’s MDR” but does not
provide a cite to a docket number.

Plaintiff’s Response in

Opposition [ECF No. 173 at 4] assumes that Apollo solely seeks to
exclude its internal complaint form under Rule 403.

The Court

finds that the probative value of neither document [ECF Nos. 1366 & 145] is substantially outweighed by the danger of unfair
prejudice, confusing the issues, misleading the jury, undue delay,
wasting time, or needlessly presenting cumulative evidence. See
F.R.E. 403.
Conclusion
Neither the internal complaint form [ECF No. 145] nor the
Form 3500A MDR [ECF No. 136-6] is inadmissible document under 21
U.S.C. § 360i(b)(3). As stated above, the Court finds that the
probative value of these documents is not substantially outweighed
by a danger of unfair prejudice, confusing issues, misleading the
jury,

undue

delay,

wasting

time,

or

needlessly

presenting

cumulative evidence.

Accordingly,
IT IS HEREBY ORDERED that Apollo’s Motion in Limine to Exclude
Plaintiff’s MDR [ECF No. 165] is DENIED.
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SO ORDERED, this the 1st day of February, 2021.

_/s/ David Bramlette________
UNITED STATES DISTRICT JUDGE

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