Knoth v. Keith et al

Filing 149

ORDER denying 126 Motion for Summary Judgment. Signed by District Judge David C. Bramlette, III on 12/9/2020. (cp)

Case 5:18-cv-00049-DCB-MTP Document 149 Filed 12/09/20 Page 1 of 11

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 for Summary Judgment. [ECF No. 126].
Having read the Motion, the responsive submissions of the parties,
the record, applicable statutory and case law, and being otherwise
fully informed of the premises, the Court denies the Motion for
Summary Judgment.
Background
This is a medical malpractice and products liability dispute,
arising from the implant of an ORBERA® gastric balloon manufactured
by Apollo. On November 29, 2016, Dr. Stephen Keith implanted the
ORBERA® balloon in Ms. Knoth (“Plaintiff”). Soon after, Plaintiff
experienced nausea and vomiting. On December 2, 2016, Dr. Keith
opted to reposition the balloon and remove three to four liters of

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Case 5:18-cv-00049-DCB-MTP Document 149 Filed 12/09/20 Page 2 of 11

fluid from Plaintiff’s stomach. After the Plaintiff continued to
experience

complications,

Dr.

Keith

removed

the

balloon

on

December 9, 2016.
On May 4, 2018, Knoth, representing herself pro se, filed
this lawsuit against Apollo and other defendants. [ECF No. 1]. In
October 2018, Plaintiff retained counsel and sought leave to amend
her Complaint to plead state-law claims that “parallel” federal
law, agreeing that her original state-law claims were preempted.
[ECF No. 11 and ECF No. 23]. This Court granted her leave to amend
the Complaint, and she did so. [ECF No. 29 and ECF No. 30]. Apollo
moved to dismiss Plaintiff’s claims against it, pursuant to FED.
R. CIV. P. 12(b)(6). [ECF No. 46]. This Court granted the motion
in part. [ECF No. 67]. Apollo now brings a Motion for Summary
Judgment on the only two remaining parallel state claims: (1)
manufacturing defect and (2) breach of express warranty. The Court
incorporates in this Order a lengthy description of the background
and underlying facts in this action, discussed in its previous
orders. [ECF No. 29 and ECF No. 67].
Summary Judgment Standard
Summary judgment is appropriate, pursuant to Rule 56 of the
Federal Rules of Civil Procedure, “if the movant shows that there
is no genuine dispute as to any material fact and the movant is
entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a).
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Case 5:18-cv-00049-DCB-MTP Document 149 Filed 12/09/20 Page 3 of 11

The evidence must be reviewed in a light most favorable to the
nonmoving party. See Sierra Club, Inc. v. Sandy Creek Energy
Assocs., L.P., 627 F.3d 134, 138 (5th Cir. 2010) (internal citation
omitted). An issue of material fact is genuine if a reasonable
jury could return a verdict for the non-movant. Anderson v. Liberty
Lobby, 477 U.S. 242, 248 (1986). Summary judgment must be rendered
when the nonmovant “fails to make a showing sufficient to establish
the existence of an element essential to that party’s case, and on
which that party will bear the burden of proof at trial.” Celotex
Corp. v. Catrett, 477 U.S. 317, 323 (1986).
Discussion
1. Manufacturing Defect
To

prevail

in

a

products

liability

case,

Mississippi

law

requires plaintiff to prove at the time the product left control
of the manufacturer or seller that “[t]he product was defective
because it deviated in a material way from the manufacturer's
specifications or from otherwise identical units manufactured to
the same manufacturing specifications . . . .” Miss. Code Ann. §
11–1–63(a)(i)(1); Leverette v. Louisville Ladder Co., 183 F.3d
339, 341 (5th Cir. 1999). “In order to survive summary judgment,
a plaintiff must present expert testimony that the product is
defective,

and

that

the

defect

3

was

a

medical

cause

of

the

Case 5:18-cv-00049-DCB-MTP Document 149 Filed 12/09/20 Page 4 of 11

plaintiff’s

injuries.”

Harris v. Stryker Spine,

39 F.

Supp. 3d 846, 850 (S.D. Miss. 2014).
Dr. Hollis’s expert opinion does not address the specific
ORBERA® balloon that was implanted in and removed from Plaintiff,
inasmuch as Dr. Keith, the physician who removed the ORBERA®
balloon from Plaintiff, disposed of it. [ECF No. 142] at 3; [ECF
No. 142-2] at 29 (111:6-17). Notwithstanding the absence of this
evidence, Dr. Hollis was able to opine that:
. . . The Mallory-Weiss tear in the lower esophagus, and
the tear in the upper stomach, were both caused by vomiting
for an extended period-of-time which was caused by the
balloon.
. . .
The Apollo Balloon implant more likely than not,
significantly contributed to the pathology experienced by
Ms. Knoth (Plaintiff), specifically the tear in her
stomach, the tear in her esophagus and the aspirational
pneumonia and respiratory failure of the lungs and the
sepsis related to the gastric content leaking through the
stomach tear. Furthermore, it is my opinion that for Ms.
Knoth, the placement of the Apollo balloon was
significantly more likely to have produced these
pathologies than an endoscopic procedure alone.
[ECF No. 126-4] at 6-7.
Apollo’s

internal

investigation

report

[ECF

No.

145],

a

standard fill-in-the-blank form document, confirms that relevant
information suggested that the device caused Plaintiff’s injuries
and that the ORBERA® balloon was not available for analysis:

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Case 5:18-cv-00049-DCB-MTP Document 149 Filed 12/09/20 Page 5 of 11

Death/Injury NOT Caused by Device
No
. . .
Does information suggest serious injury?
Yes
Info suggests Device Caused Injury?
Yes
Info suggests Device Malfunctioned
[left blank]
. . .
The device will not be returned for analysis.
. . .
Assessment of the device involved in this complaint was not
possible. . . .
Id. at 5, 8-9.
Claiming spoliation of evidence, Plaintiff argues that summary
judgment is not appropriate because Dr. Keith, whom Apollo marketed
as an ORBERA® specialist and who was acting as an agent with
apparent authority for Apollo, destroyed the very piece of evidence
that is critical to Plaintiff’s manufacturing defect claim.
No. 137] at 2-8.

[ECF

Apollo counters that there is no spoliation of

evidence because Dr. Keith was not Apollo’s agent, he did not
satisfy the federal law standard of acting in bad faith or with
bad conduct, King v. Illinois Cent. R.R., 337 F.3d 550, 555–56
(5th Cir. 2003), and he had no duty to preserve the evidence.
Guzman v. Jones, 804 F.3d 707, 713 (5th Cir. 2015) (a party's duty
to preserve evidence comes into being when the party has notice
that the evidence is relevant to the litigation or should have
known that the evidence may be relevant).
In order to attribute the destruction of the evidence to Apollo,
Plaintiff must show that Dr. Keith, the spoliator, was acting as
an agent under Apollo’s apparent authority.

5

To do so, Plaintiff

Case 5:18-cv-00049-DCB-MTP Document 149 Filed 12/09/20 Page 6 of 11

must show: (1) acts or conduct by the principal indicating the
agent's authority; (2) reasonable reliance by a third party upon
those acts or conduct; and (3) detrimental change in position by
the third party as a result of such reliance.

Barnes, Broom,

Dallas & McLeod, PLLC v. Estate of Cappaert, 991 So. 2d 1209, 1212
(Miss. 2008).
The first prong of the apparent authority test is the most
problematic.1 To meet the first prong, Plaintiff claims that: the
patient brochure, television commercials and the ORBERA® website
listed Dr. Keith as an ORBERA® specialist; she saw a standing lifesized poster that included images of Dr. Keith pictured with the
ORBERA® gastric balloon; and it was apparent to her that Dr. Keith
was deeply intertwined with the ORBERA® gastric balloon system.
[ECF No. 136-1] at 1.
Questions of apparent authority are questions of fact, and
typically are for the jury to determine. Wood v. Holiday Inns,
Inc., 508 F.2d 167, 176 (5th Cir. 1975); Sys. Inv. Corp. v.
Montview Acceptance Corp., 355 F.2d 463 (10th Cir. 1966); Frank
Sullivan Co. v. Midwest Sheet Metal Works, 335 F.2d 33 (8th Cir.
1964); Lind v. Schenley Indus., Inc., 278 F.2d 79 (3d Cir. 1960).

The second and third prongs are satisfied given Plaintiff’s
reliance on Dr. Keith as an ORBERA® specialist and her resulting
injuries.
1

6

Case 5:18-cv-00049-DCB-MTP Document 149 Filed 12/09/20 Page 7 of 11

Courts have held that the concept of apparent authority is based
upon manifestations by the alleged principal to third persons, and
the reasonable belief by those persons that the alleged agent is
authorized to bind the principal.
Texaco,

Inc.,

437

F.2d

308,

Wood, 508 F.2d at 176; Gizzi v.

309

(3d

Cir.

1971);

Johnson

v.

Shenandoah Life Ins. Co., 281 So.2d 636, 640 (Ala. 1973). “The
manifestations of the principal may be made directly to the third
person,

or

advertising.”

may

be

made

to

the

community,

Gizzi, 437 F.2d at 309.

by

signs

or

Apollo’s advertising of

the ORBERA® device creates a factual issue regarding Dr. Keith’s
apparent authority.
Apollo further argues that, even if Dr. Keith was acting as
Apollo’s agent, there was no spoliation because (1) he did not act
in bad faith, and (2) he had no duty to preserve the evidence given
that: (i) he had no notice that the evidence was relevant to any
litigation, and (ii) there was no reason that he should have known
the evidence was relevant.

Guzman, 804 F.3d at 713. Apollo relies

on Dr. Keith’s deposition testimony as proof that Dr. Keith did
not act in bad faith.2 [ECF No. 142] at 3, 6-7.

2

In his deposition, Dr. Keith testified:

Q. . . . -you removed
A. I didn't
at the time
perforation
achieved by

why did you feel like this should not have gone to pathology when
the balloon?
see any benefit clinically in doing so. The balloon was intact
I removed it and obviously it was a damaged balloon with
when I took it out. So I don't see any valuable information being
a pathologist looking at it.

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Case 5:18-cv-00049-DCB-MTP Document 149 Filed 12/09/20 Page 8 of 11

The Fifth Circuit standard encompasses not only “bad faith”
but also “bad conduct.” King, 337 F.3d at 556; Consol. Aluminum
Corp. v. Alcoa, Inc., 244 F.R.D. 335, 340 (M.D. La. 2006). Dr.
Keith disposed of evidence that is at the core of Plaintiff’s
manufacturing defect claim.

He did so after being the surgeon in

charge of a procedure which placed his patient in ICU with a
diagnosis of septic shock, gastric perforation, acute peritonitis,
bilateral aspiration pneumonia, and a Mallory-Weiss tear.
No. 126-4] at 3-4.

[ECF

Apollo’s internal investigation report affirms

that the reported information suggests serious injury and that the
device caused Plaintiff’s injury.

[ECF No. 145] at 5.

On these

facts, it would not be unreasonable for a jury to conclude that
Dr. Keith should have known that the balloon would be relevant
evidence in a subsequent investigation. Regarding Dr. Keith’s
deposition testimony that he did not see any need to return the
balloon to Apollo, see note 1, supra, and accompanying text,
Apollo’s mandatory FDA report states: “The reporter of the event
was asked to return the product for analysis.

To date, Apollo has

not received the device.” [ECF 136-6] at 3. Furthermore, Dr. Keith
knowingly had a duty to send the ORBERA® balloon to pathology under
the hospital’s policy. [ECF No. 136-9] at 3. The Court thus finds

Q. Did you have any duty to deliver the balloon to Apollo for inspection?
A. I didn't see any need for that, either.
[ECF No. 142-2] at 29 (111:6-17).

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Case 5:18-cv-00049-DCB-MTP Document 149 Filed 12/09/20 Page 9 of 11

that

there

are

enough

material

facts

in

dispute

for

the

manufacturing defect claim to survive summary judgment.
2. Breach of Express Warranties
An "express warranty,” as referenced in the Mississippi Products
Liability Act (“MPLA”) Miss. Code Ann. § 11-1-63, is defined as
"any affirmation of fact or promise which concerns the product and
becomes part of the basis for the purchase of such a product."
Forbes v. Gen. Motors Corp., 935 So. 2d 869, 876 (Miss. 2006). To
prevail on a claim for breach of express warranty, plaintiff must
prove by a preponderance of the evidence that at the time the
product

left

the

control

of

the

manufacturer

“[t]he

product

breached an express warranty or failed to conform to other express
factual representations upon which the claimant justifiably relied
in

electing

to

use

the

product.”

Miss.

Code

Ann.

§

11-1-

63(a)(i)(4).
Plaintiff claims that she relied to her detriment on the
ORBERA® brochure that Dr. Keith gave her and the 2016 ORBERA®
website, which allegedly contained representations that were not
approved by the FDA.

[ECF No. 137] at 10-14; 21-22.

Plaintiff

cites to Wildman v. Medtronic, Inc., 874 F.3d 862, 870 (5th Cir.
2017), in which the Fifth Circuit considered whether a warranty on
Medtronic’s website was consistent with assessments made during
the FDA approval process (in which case the lawsuit would be
9

Case 5:18-cv-00049-DCB-MTP Document 149 Filed 12/09/20 Page 10 of 11

preempted), or whether the warranty went beyond what the FDA
approved.

Id. at 869.

Finding that the website statement went

beyond the FDA’s approval and was therefore not preempted, the
Fifth Circuit reversed the district court’s Rule 12 dismissal and
remanded the case.

Id. at 870-71.

Also relying on Wildman, Apollo claims that Plaintiff has
failed to prove that any statements in either the ORBERA® website
or brochure are false or misleading.

[ECF No. 142] at 7; Wildman,

874 F.3d at 870 (Medtronic may make representations that are not
approved by the FDA but faces state law liability if they are
proven false).

Apollo further argues that Plaintiff cannot base

her express warranty claim on risks that were omitted from the
list of warnings in the brochure, Young v. Bristol Myers Squibb
Co., No. 4:16-CV-00108-DMB-JMV, 2017 WL 706320, at *n.10 (N.D.
Miss. Feb. 22, 2017), and that, at most, the statements criticized
by Plaintiff are “puffery”, which is not actionable. Presidio
Enterprises, Inc. v. Warner Bros. Distrib. Corp., 784 F.2d 674,
682 (5th Cir. 1986).
Plaintiff has introduced the expert opinion of Joshua S.
Sharlin, Ph.D. [ECF No. 136-12], who concludes that the ORBERA®
brochure and the 2016 ORBERA® website were not reviewed or approved
by the FDA and opines that express warranties for the device were
breached.

Id.

at

3,

17-20.

Apollo

10

vigorously

disputes

Dr.

Case 5:18-cv-00049-DCB-MTP Document 149 Filed 12/09/20 Page 11 of 11

Sharlin’s conclusions.

[ECF No. 127] at 7-8, 14. This dispute

creates a triable issue of material fact.

Apollo’s “puffery”

defense [ECF No 142], is also a jury issue.

In re TETRA Techs.,

Inc. Sec. Litig., No. 4:08-CV-0965, 2009 WL 6325540, at *4 (S.D.
Tex. July 9, 2009), order clarified, No. CIV.A. 4:08-CV-0965, 2009
WL

6326865

statements

(S.D.
were

Tex.

Aug.

material

and

10,

2009)

not,

as

(jury determined
the

defendant

that

alleged,

immaterial puffery); see also Pizza Hut, Inc. v. Papa John's Int'l,
Inc., 227 F.3d 489, 499–501 (5th Cir. 2000). Because issues of
material fact remain, summary judgment is not appropriate.
Conclusion
Accordingly,
IT IS HEREBY ORDERED that Apollo’s Motion for Summary Judgment
is DENIED.
SO ORDERED this the 9th day of December 2020.
____/s/ David Bramlette_____
UNITED STATES DISTRICT JUDGE

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