Vesoulis v. ReShape LifeSciences ( 2022 )

Case: 21-30367 Document: 00516264660 Page: 1 Date Filed: 04/01/2022
United States Court of Appeals
for the Fifth Circuit United States Court of Appeals
Fifth Circuit
FILED
April 1, 2022
No. 21-30367
Lyle W. Cayce
Clerk
Paul Vesoulis,
Plaintiff—Appellant,
versus
ReShape LifeSciences, Incorporated, formerly known as
EnteroMedics, Incorporated; Thomas Lavin, M.D.;
Surgical Specialists of Louisiana, L.L.C.,
Defendants—Appellees.
Appeal from the United States District Court
for the Eastern District of Louisiana
USDC No. 2:19-CV-1795
Before Higginson, Willett, and Ho, Circuit Judges.
Per Curiam:*
Appellant Paul Vesoulis sued several defendants in connection with
injuries he suffered during the removal of a medical device from his stomach.
The district court entered summary judgment for Defendants on some of
*
Pursuant to 5th Circuit Rule 47.5, the court has determined that this
opinion should not be published and is not precedent except under the limited
circumstances set forth in 5th Circuit Rule 47.5.4.
Case: 21-30367 Document: 00516264660 Page: 2 Date Filed: 04/01/2022
No. 21-30367
Vesoulis’s claims but allowed the remaining claim to proceed to trial. The
jury subsequently rendered a verdict for Defendants. Vesoulis now appeals
both the verdict and the entry of partial summary judgment. For the reasons
explained below, we AFFIRM the district court’s judgment in all respects.
I
In 2017, Vesoulis underwent an elective procedure at a Louisiana
surgical facility in which an intra-gastric balloon device manufactured by
ReShape LifeSciences was placed in his stomach. The device is intended to
facilitate weight loss by occupying space in the patient’s stomach so as to
reduce appetite. Dr. Thomas Lavin performed the procedure, but only after
Vesoulis signed a consent form that warned of possible complications.
Among them were “Death (very rare)” and “damage to the . . .
gastrointestinal tract or intra-abdominal organs including perforation
(tearing).”
Consistent with ReShape’s instructions for use of the intra-gastric
balloon, Vesoulis saw Lavin again six months later in January 2018 to have
the device removed via endoscopy. Vesoulis signed another consent form,
which warned of possible complications, including a “less than 1 [in] 10,000”
risk of “bleeding or perforation of the esophagus, stomach or duodenum.”
Lavin removed the device on January 11. Vesoulis left the surgical facility
with no signs of distress but contacted Lavin later that day complaining of
abdominal pain. Lavin ordered a chest x-ray, which was performed the next
morning. Based on a radiologist’s review of the results, Lavin suspected
atelectasis and a pleural effusion requiring emergency surgery. While
performing the exploratory laparoscopy in preparation for surgery, however,
Lavin found no abnormalities in Vesoulis’s esophagus and stomach except
for gastric distension. An NG tube was used to relieve the distension and
Vesoulis was transferred to the facility’s fourth floor while he recovered.
2
Case: 21-30367 Document: 00516264660 Page: 3 Date Filed: 04/01/2022
No. 21-30367
Later that evening, Vesoulis began experiencing swelling and crepitus of the
jaw, neck, and clavicle areas. Lavin examined Vesoulis, noting that his
respirations were shallow. Lavin ordered an upper GI study, which took place
the following morning. On the morning of January 13, Lavin was notified that
Vesoulis was having some difficulty breathing. Lavin ordered a STAT CT
scan of the chest and neck. The results reflected the presence of air and led
to the discovery of a small tear in his esophagus. Lavin repaired the
perforation without issue. Afterwards, Vesoulis remained in stable condition
and was discharged from the facility on January 19, 2018.
Vesoulis initiated the present litigation in Louisiana state court in
January 2019. He sued Reshape and Lavin, as well as Lavin’s employer,
Surgical Specialists of Louisiana, LLC (“SSL”). Defendants then removed
the action to federal district court. Vesoulis’s claims against ReShape
sounded in product liability and failure to warn. Specifically, Vesoulis alleged
that ReShape was “liable based solely upon [its] failure to comply with [the
FDA’s premarket approval (PMA)] Order and applicable FDA regulations,
and thereby, is also liable under the Louisiana Products Liability Act’s
parallel provisions regarding failure to warn and . . . post-sale duty to warn,”
referring to La. Stat. § 9:2800.57(A) and (C). Vesoulis also brought a
medical negligence claim against Lavin and SSL, asserting that Lavin failed
to “use reasonable care and diligence when rendering medical services to
[Vesoulis], including [negligently] failing to disclose the risks or hazards that
could have influenced a reasonable person in making a decision to give or
withhold consent pursuant to La. R.S. 40:1299.40.”
The district court entered summary judgment for Lavin and SSL on
Vesoulis’s informed-consent claim and for ReShape on his products-liability
claim. See No. CV 19-1795, 2021 WL 1909725 (E.D. La. May 12, 2021). As
for the issue of informed consent, the district court held that Lavin and SSL
were entitled to summary judgment because the consent form that Vesoulis
3
Case: 21-30367 Document: 00516264660 Page: 4 Date Filed: 04/01/2022
No. 21-30367
signed before having the intra-gastric balloon inserted into his stomach
adequately warned him of the risks of esophageal perforation and death
therefrom. The district court held that ReShape was likewise entitled to
summary judgment on Vesoulis’ failure-to-warn claim because ReShape was
shielded from liability by a provision of Louisiana law specifying that
A manufacturer is not required to provide an adequate warning
about his product when [it] is not dangerous to an extent
beyond that which would be contemplated by the ordinary user
or handler of the product, with the ordinary knowledge
common to the community as to the product’s characteristics;
or . . . the user or handler of the product already knows or
reasonably should be expected to know of the characteristic of
the product that may cause damage and the danger of such
characteristic.
La. Stat. § 9:2800.57(B). The summary-judgment evidence showed that
Lavin was an experienced bariatric surgeon who understood the risks of using
ReShape’s device, the district court explained, and so the provision quoted
above shielded ReShape from liability for failure to warn of those risks. The
district court rejected Vesoulis’s argument that ReShape’s alleged violation
of the federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et
seq., and associated regulations was a per se violation of a state-law duty of
care. The district court reasoned that this theory was foreclosed by Supreme-
Court precedent holding that a state-law claim is preempted by federal law if
a defendant’s conduct would not be actionable under state law but for the fact
that the conduct allegedly violated the FDCA and associated regulations.
Vesoulis’s medical negligence claim against Lavin and SSL proceeded
to trial. The jury ultimately rendered a unanimous verdict for Defendants.
Vesoulis appealed both the verdict and the earlier partial summary judgment.
4
Case: 21-30367 Document: 00516264660 Page: 5 Date Filed: 04/01/2022
No. 21-30367
II
We begin by considering the district court’s entry of summary
judgment for ReShape and partial summary judgment for Lavin and SSL. We
review the grant of a motion for summary judgment de novo. Fennell v.
Marion Indep. Sch. Dist., 804 F.3d 398, 407 (5th Cir. 2015). Summary
judgment is proper “if the movant shows that there is no genuine dispute as
to any material fact” and that he or she “is entitled to judgment as a matter
of law.” FED. R. CIV. P. 56(a). A “dispute about a material fact is ‘genuine’
. . . if the evidence is such that a reasonable jury could return a verdict for the
nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
* * *
The district court granted Lavin’s and SSL’s motion for summary
judgment on the informed-consent claim. Vesoulis challenges this grant on
appeal, contending that Lavin violated a duty imposed by Louisiana law (or
at least that there is a genuine dispute of material fact as to whether Lavin
violated such a duty) because he failed to secure Vesoulis’s informed consent
for the procedures for inserting and removing the intra-gastric balloon device.
The law of Louisiana, “both statutory and jurisprudential,” requires a
physician to secure a patient’s informed consent to medical treatment, Tipton
v. Campbell, 996 So. 2d 27, 36 (La. Ct. App. 2008), but establishes “an
evidentiary presumption that a patient’s written consent is valid,”
Hondroulis v. Schuhmacher, 553 So. 2d 398, 402 (La. 1988) (citing La. Stat.
§ 40:1299.40 (now codified with immaterial changes at La. Stat.
§ 40:1157.1)). To overcome this presumption, a plaintiff must “show that: (1)
the adverse results of [a procedure] were known, significant, and material
risks which should have been disclosed to [the patient] by [the physician]; (2)
those risks were not disclosed by [the physician]; (3) [the patient] was
5
Case: 21-30367 Document: 00516264660 Page: 6 Date Filed: 04/01/2022
No. 21-30367
unaware of those risks; and (4) a reasonable person would have refused the
[procedure] because of the risks.” Id. at 404.
Vesoulis argues that Lavin did not adequately warn before inserting
the intra-gastric balloon that the procedure could result in esophageal tearing
or death. Like the district court, however, we think Vesoulis was so warned.
The form he signed before undergoing the procedure clearly alerted him of
the possibility of “Death (very rare)” and “[harm to] upper gastrointestinal
tract”—of which the esophagus is a part—“or intra-abdominal organs
including perforation (tearing).” Vesoulis protests that Lavin was obligated
to supplement these warnings by notifying Vesoulis of the two specific deaths
to which the ReShape device had been linked. But Louisiana’s informed-
consent standard has never, to our knowledge, been held to require such fine-
grained information; on the contrary, it seems sufficient that the consent
form warned of death and accurately noted that such a complication was
“very rare.” See Hondroulis, 553 So. 2d at 404. Vesoulis has identified no
Louisiana decisions holding that a physician must disclose the specific
number of adverse events that have occurred as a result of a procedure, and
we struggle to understand why such data would have been material to a
reasonable patient in Vesoulis’s position (unless the specific number of
deaths were so high as to make the claim that death was “very rare”
misleading, which is certainly not the case here). Given that Louisiana law
does not require that specific risk percentages be disclosed to patients in
order to obtain their informed consent, see Kennedy v. St. Charles Gen. Hosp.
Auxiliary, 630 So. 2d 888, 892 (La. Ct. App. 1993), there is no reason why the
even less useful information of the number of adverse events must be
disclosed, either.
The district court said nothing of Vesoulis’s other argument regarding
informed consent, but we find it equally unpersuasive. Vesoulis contends
that, on the consent form he signed before getting the intra-gastric balloon
6
Case: 21-30367 Document: 00516264660 Page: 7 Date Filed: 04/01/2022
No. 21-30367
removed, the risk of esophageal perforation when devices of the same kind
were removed via endoscopy was reported as being less than 1 in 10,000,
when in fact the risk from the particular ReShape device was 38 in 10,000 (or
1 in 265). But for an informed-consent claim to succeed under Louisiana law,
the risk that the defendant failed to disclose must have been material—that
is, a risk that would lead a reasonable patient informed of it to decline the
procedure. See Hondroulis, 553 So. 2d at 403. A factor in determining
materiality is whether the procedure was elective, or whether alternatives to
it were available. See id.; LaCaze v. Collier, 434 So. 2d 1039, 1048 (La. 1983).
Here, per ReShape’s instructions (which were admitted as evidence), “[t]he
maximum placement period for the ReShape Dual Balloon is 6 months, and
it must be removed at that time or earlier.” And as the form Vesoulis signed
prior to the device’s removal explained, “[t]here are currently no alternatives
to removal of the intragastric balloon”—a statement Vesoulis does not
contest. The necessity of the procedure and the lack of alternatives make it
less likely that a given risk of complication is “material.”
Moreover, even if one accepts Vesoulis’s argument that Lavin had to
disclose the higher risk figure specific to the ReShape device beforehand in
order to secure Vesoulis’s informed consent to remove it, the risk still would
not have been material under Louisiana law. The Louisiana Supreme Court
has “held that a .5% possibility of a correctable complication would not be a
determining factor to a reasonable patient.” Hondroulis, 553 So. 2d at 404.
Here, Vesoulis suffered a correctable complication, the risk of which (even
according to the figures he urges should have been disclosed) was 0.38%. This
was not a material risk. All things considered, summary judgment for Lavin
and SSL on Vesoulis’s informed-consent claim was proper.
* * *
7
Case: 21-30367 Document: 00516264660 Page: 8 Date Filed: 04/01/2022
No. 21-30367
Vesoulis also appeals the district court’s entry of summary judgment
for ReShape on Vesoulis’s failure-to-warn claim. The district court reasoned
that, per the applicable Louisiana statute, ReShape is not liable for failure to
warn because its intra-gastric balloon was marketed and sold to Lavin, a
“user or handler of the product [who] already knows or reasonably should be
expected to know of the characteristic of the product that may cause damage
and the danger of such characteristic.” La. Stat. § 9:2800.57(B). Vesoulis
does not dispute the district court’s conclusion regarding ReShape’s
nonliability under Section 9:2800.57(B), but instead argues that ReShape
violated the FDCA, 21 U.S.C. § 301 et seq., and associated regulations—
which he contends supply a standard of care the violation of which is
actionable under Louisiana law.
We believe the district court was right to reject this argument. There
is no private right of action to sue for violations of the FDCA or associated
regulations. See Morris v. PLIVA, Inc., 713 F.3d 774, 778 (5th Cir. 2013); 21
U.S.C. § 337. Nevertheless, a “claim[] ar[ising] from [a defendant’s] alleged
failure” to comply with a duty imposed by state law, even if that failure
happens to violate the FDCA and regulations issued thereunder, likely raises
no preemption concerns so long as the claim is not premised “solely [on] the
violation of FDCA requirements.” Buckman Co. v. Plaintiffs’ Legal Comm.,
531 U.S. 341, 352 (2001). But while federal law does not necessarily preempt
“state-law causes of actions that parallel [FDCA] requirements,” it does
preempt “claims [that] exist solely by virtue of ... [those]
requirements.” Id. at 353. This holding forecloses Vesoulis’s claim against
ReShape. As we have explained, the court below correctly held that ReShape
falls within the protections of La. Stat. § 9:2800.57(B) and therefore is not
liable for failure to warn under Louisiana law. And Vesoulis’s attempt to
overcome this obstacle by alleging that ReShape violated the FDCA and
associated regulations runs headlong into the holdings of Buckman and
8
Case: 21-30367 Document: 00516264660 Page: 9 Date Filed: 04/01/2022
No. 21-30367
subsequent cases on preemption. 1 For these reasons, the district court’s
entry of summary judgment for ReShape was proper.
III
We now consider Vesoulis’s appeal of the jury’s verdict for Lavin and
SSL on Vesoulis’s medical negligence claim. Vesoulis argues on appeal that
the evidence was so strongly against the verdict that he was entitled to
judgment as a matter of law, an issue Vesoulis raised below by unsuccessfully
moving for such a judgment pursuant to Federal Rule of Civil Procedure
50(a). “[W]hen a case is tried by a jury, a Rule 50(a) motion is a challenge to
the legal sufficiency of the evidence. In resolving such challenges, we draw
all reasonable inferences and resolve all credibility determinations in the light
most favorable to the nonmoving party.” Foradori v. Harris, 523 F.3d 477,
485 (5th Cir. 2008) (citations omitted). “[W]e will uphold a jury verdict
unless the facts and inferences point so strongly and so overwhelmingly in
favor of one party that reasonable men could not arrive at any verdict to the
contrary.” Cousin v. Trans Union Corp., 246 F.3d 359, 366 (5th Cir. 2001).
Moreover, because the “the proper allocation of the burden of proof
necessarily implicate[s] the standard of review of a challenge to the
sufficiency of the evidence,” Bayle v. Allstate Ins. Co., 615 F.3d 350, 358 (5th
Cir. 2010), we are mindful of the fact that Vesoulis bore the burden of proving
medical negligence under Louisiana law, see Pfiffner v. Correa, 643 So. 2d
1228, 1231 (La. 1994).
According to Vesoulis, the jury’s verdict cannot stand because the fact
that Lavin did not review Vesoulis’s x-rays himself, but instead relied on
1
It makes no difference that the state-law duty at issue here is at least partially
established by statute rather than purely by judicial common law. See Lofton v. McNeil
Consumer & Specialty Pharms., 672 F.3d 372, 379 (5th Cir. 2012).
9
Case: 21-30367 Document: 00516264660 Page: 10 Date Filed: 04/01/2022
No. 21-30367
board-certified radiologists’ assessments of the x-rays, establishes as a matter
of law that Lavin breached the accepted standard of care in the medical field.
At trial, Vesoulis supported his argument to that effect with the testimony of
a single expert—and even he vacillated on the issue during cross
examination, admitting, “I’m not sure that I would agree that [personally
reviewing patients’ x-rays] [i]s a standard of care,” and, “[i]t would depend”
on how one “define[s] ‘breach.’” Meanwhile, Defendants offered testimony
from three experts who firmly stated their view that Lavin did not breach the
standard of care expected of those in his field, either in his reliance on board-
certified radiologists’ assessment of x-rays or in the course of treatment he
administered to Vesoulis. Testimony of this sort is significant, given that
Louisiana law places a high premium on expert testimony as evidence of
whether a defendant in a medical negligence case violated the applicable
standard of care. See Pfiffner, 643 So. 2d at 1233.
In our view, the evidence offered at trial as to whether Lavin breached
the standard of care quite clearly does not “point so strongly and so
overwhelmingly in favor” of Vesoulis “that reasonable men could not arrive
at [a] verdict” in favor of Lavin and SSL. Cousin, 246 F.3d at 366. If anything,
the weight of the evidence favors Defendants’ position. And even if both
sides had presented equally strong evidence, we would still uphold the
verdict in observance of our obligation to “draw all reasonable inferences and
resolve all credibility determinations in the light most favorable to the
nonmoving party”—here, Lavin and SSL. Foradori, 523 F.3d at 485. That
Vesoulis bore the burden of proof further fortifies our conclusion that he was
not entitled to judgment as a matter of law. See Bayle, 615 F.3d at 358.
IV
For these reasons, the judgment of the district court is AFFIRMED.
10