Vesoulis v. ReShape Lifesciences, Inc.

UNITED STATES DISTRICT COURT

EASTERN DISTRICT OF LOUISIANA

PAUL VESOULIS CIVIL ACTION

v. NO. 19-1795

RESHAPE LIFESCIENCES, INC. SECTION “F”

ORDER AND REASONS

Before the Court are two motions for summary judgment. In

one, defendant ReShape Lifesciences, Inc. seeks dismissal of all

of the plaintiff’s claims against them. In another, ReShape’s co-

defendants, Dr. Thomas Lavin and Surgical Specialists of

Louisiana, LLC, seek dismissal of the plaintiff’s informed consent

claims against them. For the reasons that follow, both motions

are GRANTED.

Background

This case pits Ohio dentist Dr. Paul Vesoulis against a

Louisiana bariatric surgeon (Dr. Thomas Lavin), his employer

(Surgical Specialists of Louisiana, LLC, or “SSL”), and the maker

of a weight-loss device1 that perforated Vesoulis’s esophagus when

1 The device at issue is alternatively styled in the record as

an “Integrated Dual Balloon” and a “Duo Gastric Balloon.” Whatever

its official name though, there is no dispute over its essential

characteristics and function – as ReShape describes its own

product, the device is little more than a “balloon” that “is

it was removed from his stomach (ReShape Lifesciences, Inc.).

Vesoulis sued the defendants in Louisiana state court on January

10, 2019. On February 27, 2019, the defendants removed the action

to this Court. In the controlling complaint,2 Vesoulis advances

separate, but related, theories for recovery against both sets of

defendants.

Vesoulis’s claims against ReShape sound in product liability

and failure to warn. Specifically, Vesoulis alleges that ReShape

“is 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.” See Second Am. Compl.,

¶ 7 (citations omitted). In particular, he asserts that ReShape

is liable for failing to comply with a variety of FDA regulations

regarding labeling and warnings, “communicating instances of death

inserted into the stomach and removed several months later,” and

“designed to occupy space in the stomach [to] produce a sensation

of satiety [and] promote weight loss.” See ReShape Mot. at 3.

2 Vesoulis’s second amended complaint in this Court – with all

applicable incorporations by reference – controls for present

purposes. The Court accordingly disregards Vesoulis’s state-court

petition because he chose not to reference it in his subsequent

federal-court pleadings. See, e.g., Eason v. Holt, 73 F.3d 600,

603 (5th Cir. 1996) (observing “the well-settled law of this

circuit” that an amended complaint supersedes an original

complaint where a plaintiff does not specifically incorporate

allegations in the original complaint by reference).

or serious injury,” “reporting of instances of death or serious

injury through the required filing of reports with the FDA,” and

“communicat[ing] instances of death or serious incidents to” Dr.

Lavin and SSL. Id. ¶ 8. In the briefs Vesoulis filed in opposition

to the current motions – if not in his complaint – Vesoulis focuses

on ReShape’s failure to “advise” Vesoulis or Dr. Lavin of two

deaths of which it “knew [to have] occurred before [Vesoulis’s]

balloons were inserted but after PMA approval when the FDA

specifically [required] in the PMA Order [that ReShape] update

labeling and be ‘truthful and not misleading.’” See Opp’n to

ReShape Mot. at 6. In essence, Vesoulis claims that he would not

have elected to have a ReShape weight-loss balloon implanted in

his stomach if he had been appropriately warned that balloon-

related complications had killed two prior patients. ReShape seeks

dismissal of all such claims in its present motion for summary

judgment.

Vesoulis also brings a variety of medical malpractice claims

against Dr. Lavin and SSL. Specifically, he asserts that his

injuries “were [] caused by the medical negligence” of Dr. Lavin

and SSL in failing to:

(1) “render proper and professional health care”;

(2) “exercise the degree of skill and care employed under

similar circumstances by physicians and health care

professionals in good standing” in Louisiana and within

Dr. Lavin’s specialty;

(3) “properly diagnose [Vesoulis’s] condition and promptly

treat [the] same”;

(4) remove the balloon at issue from Vesoulis’s stomach

without negligently tearing his esophagus; and

(5) “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.”

See Second Am. Compl., ¶ 9(a).3

I.

Federal Rule of Civil Procedure 56 provides that summary

judgment is appropriate where the record reveals no genuine dispute

as to any material fact such that the moving party is entitled to

judgment as a matter of law. No genuine dispute of fact exists

where the record taken as a whole could not lead a rational trier

of fact to find for the nonmoving party. See Matsushita Elec.

Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986). A

genuine dispute of fact exists only “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 Supreme Court has emphasized that the mere assertion of

a factual dispute does not defeat an otherwise properly supported

motion. See id. Therefore, where contradictory “evidence is

merely colorable, or is not significantly probative,” summary

3 This paragraph of the controlling complaint concludes with a

catch-all allegation of “other acts of neglect, fault, or omission

or commission which may become apparent through the discovery

process.” See Second Am. Compl., ¶ 9(a).

judgment remains appropriate. Id. at 249–50 (citation omitted).

Likewise, summary judgment is appropriate where the party opposing

the motion fails to establish an essential element of its case.

See Celotex Corp. v. Catrett, 477 U.S. 317, 322–23 (1986). In

this regard, the nonmoving party must do more than simply deny the

allegations raised by the moving party. See Donaghey v. Ocean

Drilling & Expl. Co., 974 F.2d 646, 649 (5th Cir. 1992). Instead,

it must come forward with competent evidence, such as affidavits

or depositions, to buttress its competing claim. Id. Hearsay

evidence and unsworn documents that cannot be presented in a form

that would be admissible at trial do not qualify as competent

opposing evidence. FED. R. CIV. P. 56(c)(2); Martin v. John W.

Stone Oil Distrib., Inc., 819 F.2d 547, 549 (5th Cir. 1987) (per

curiam).

Finally, in evaluating a summary judgment motion, the Court

must read the facts in the light most favorable to the nonmoving

party. Anderson, 477 U.S. at 255.

II.

With the foregoing legal standards in view, the Court

evaluates each present motion in turn.

A. Dr. Lavin and SSL’s Motion for Summary Judgment

In a comparatively narrow motion, Dr. Lavin and SSL urge the

Court to dismiss Vesoulis’s informed consent claims. Their

argument is straightforward. In essence, they contend that

Vesoulis’s informed consent claim falls flat factually for three

related reasons. First, because “Dr. Lavin [could not] disclose

risks of which he [was] unaware.” See Lavin & SSL Mot. at 7.

Second, because every consent form that Vesoulis signed did in

fact advise him of the very risks he claims he would not have

accepted with regard to the elective procedure at issue if he had

been appropriately warned – namely, death and/or esophageal

perforation.4 See id. at 8. And third, because any specific

warning about the one gastric perforation that Dr. Lavin did learn

about during his course of dealing with Vesoulis could not possibly

have influenced Vesoulis’s decision to undergo the balloon-removal

operation that ultimately injured him. See id.

The record reveals that Dr. Lavin and SSL are correct in all

such regards. For starters, it is undisputed that the “adverse

events” Vesoulis complains of not being warned about were known to

ReShape but “not made known to Dr. Lavin, SSL,” or Vesoulis. See

Pl.’s Resp. to Statement of Uncontested Fact No. 8, at 8 (emphasis

added). Thus, to the extent that Vesoulis seeks damages for not

being warned of adverse events, his assertion fails on this record.

4 Vesoulis’s position on this point is admittedly more nuanced.

With the record clearly revealing that he was warned of a

possibility of death and esophageal perforation in consent forms

that he surely has above-average experience in reviewing as a

doctor himself, he claims that a specific warning about two

patients that did in fact die from the balloon procedure at issue

would have made the risk of death more tangible and altered his

mental calculation with regard to the procedure.

Obviously, one cannot warn of adverse events without knowledge of

such events. And the record is clear; Dr. Lavin and SSL had no

such knowledge.

Moreover, it is undeniable that an “Endoscopic Balloon

Procedure Consent Form” bearing Vesoulis’s signature did warn of

risks of “Death (very rare)” and “[harm to] upper gastrointestinal

tract or intra-abdominal organs including perforation (tearing).”

See Lavin & SSL Mot., Ex. C at 1. In light of this clear warning,

Vesoulis’s central argument that the ReShape balloon Instructions

for Use and/or Dr. Lavin’s warning to Vesoulis failed to “warn

that the ReShape device was associated with two deaths . . . prior

to [Vesoulis’s] implant” is unavailing on this record,

particularly as it relates to Vesoulis’s informed consent claim

against Dr. Lavin and SSL. See Pl.’s Resp. to Statement of

Uncontested Fact No. 8, at 8–9. Even clearer on the record is

that Vesoulis signed a form that warned of the injury he did

suffer.

Applying these undisputed facts to Louisiana’s well-settled

law on informed consent, it is clear that Vesoulis’s informed

consent claim against Dr. Lavin and SSL fails as a matter of law.

To prevail on such a claim, Vesoulis must show that:

(1) the adverse results of [his] surgery were known,

significant, and material risks which should have been

disclosed to [him] by [Dr. Lavin]; (2) those risks were

not disclosed by [Dr. Lavin]; (3) [Vesoulis] was unaware

of those risks; and (4) a reasonable person would have

refused the surgery because of the risks.

Hondroulis v. Schuhmacher, 553 So. 2d 398, 404 (La. 1988) (footnote

omitted).

Vesoulis’s claim on this record fails to make a prima facie

case under this standard. Vesoulis’s arguments to the contrary

are unavailing and shroud the fundamental reality at the heart of

the matter: namely, that Vesoulis suffered an esophageal

perforation that was a known and warned risk of a procedure to

which he consented in writing. See Celotex, 477 U.S. at 322.

B. ReShape’s Motion for Summary Judgment

That leaves ReShape’s motion for summary judgment. Before

evaluating Vesoulis’s ability to state a plausible claim for relief

on the developed record, the Court briefly addresses ReShape’s

initial argument that Vesoulis’s claims are expressly preempted

under the Supremacy Clause. See U.S. CONST. art. VI.

1. Express Preemption

ReShape devotes the bulk of its motion to arguing that

Vesoulis’s claims – all of which are based on Louisiana law – are

expressly preempted by the Medical Device Amendments Act of 1976.

However, while the parties’ extensive briefing on the question of

express preemption was welcome and helpful, the Court need not

address the issue because Vesoulis’s claims fail for other reasons

anyway.

2. Liability Under Louisiana Law and Implied Preemption

a. Standard

Rule 56 “mandates the entry of summary judgment, after

adequate time for discovery and upon motion, against a party who

fails to make a sufficient showing 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, 477 U.S. at

322. Urged at this stage in the proceedings, the state-law portion

of ReShape’s motion for summary judgment reads and functions like

a Rule 12(b)(6) motion to dismiss for failure to state a claim

upon which relief can be granted. In essence, ReShape argues that

the undisputed facts in the record, even when read in the light

most favorable to Vesoulis, do not establish that Vesoulis has a

plausible claim for relief against ReShape. If ReShape is correct,

then the Court must indeed grant summary judgment in its favor and

dismiss Vesoulis’s claims as legally baseless. See id. The Court

thus proceeds to evaluate Vesoulis’s ability to state a viable

claim on the developed facts in the record.

As the Court explains below, Vesoulis’s claims against

ReShape fare no better than his informed consent claim against Dr.

Lavin and SSL.

b. Analysis

Because Vesoulis lacks an express or implied right of action

under the federal law he claims that ReShape has violated,5 he

premises his claims against ReShape on asserted violations of the

Louisiana Products Liability Act’s (LPLA) provisions on failure to

warn. In particular, Vesoulis alleges that ReShape’s actions

violated subsections (A) and (C) of § 2800.57 of the LPLA.6

Together with its surrounding provisions, § 2800.57 supplies a

state-law cause of action to plaintiffs who are injured by a

product that is “[u]nreasonably dangerous because of inadequate

warning” by its manufacturer. In full, that section of the statute

provides as follows:

A. A product is unreasonably dangerous because an

adequate warning about the product has not been provided

if, at the time the product left its manufacturer’s

control, the product possessed a characteristic that may

cause damage and the manufacturer failed to use

5 See Bausch v. Stryker Corp., 630 F.3d 546, 557–58 (7th Cir.

2010) (noting, under the general rule that federal courts are loath

to imply rights of action that Congress could have just as easily

expressly provided, that similarly situated “plaintiffs . . . did

not have an implied right of action under federal law”). The

federal courts of appeals have done yeoman’s work in elucidating

this challenging area of the law. For a helpful explanation of

the “narrow gap” that a plaintiff’s state-law medical-products

liability claim must thread to avoid federal preemption, see In re

Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623

F.3d 1200, 1204 (8th Cir. 2010).

6 In the pertinent paragraph of the controlling complaint,

Vesoulis actually references § 9:2800(C), but because that

provision is not a part of the LPLA and appears to have no relevance

in this case, the Court assumes that this was a typographical error

(i.e., omitting the “57” in “§ 9:2800.57(C)”).

reasonable care to provide an adequate warning of such

characteristic and its danger to users and handlers of

the product.

B. A manufacturer is not required to provide an

adequate warning about his product when:

(1) The product 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

(2) The user or the 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.

C. A manufacturer of a product who, after the product

has left his control, acquires knowledge of a

characteristic of the product that may cause damage and

the danger of such characteristic, or who would have

acquired such knowledge had he acted as a reasonably

prudent manufacturer, is liable for damage caused by his

subsequent failure to use reasonable care to provide an

adequate warning of such characteristic and its danger

to users and handlers of the product.

LA. R.S. § 9:2800.57 (emphasis added).

Note the emphasized text above. Vesoulis’s decision to omit

any reference to this subsection – which would be hard to miss,

sandwiched as it is between two friendlier provisions that Vesoulis

chose to predicate his entire case against ReShape on – is perhaps

telling.

But whether he missed it or not, subsection (B) is fatal to

any non-preempted state-law claim Vesoulis may have otherwise had

under § 9:2800.57. In plain terms, subsection (B) eliminates any

duty “to provide an adequate warning” about a product when “The

product 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.” Id. § 9:2800.57(B)(1). The ordinary users and

handlers of the ReShape balloon at issue are bariatric surgeons

like Dr. Lavin, and there is no evidence in the record that Dr.

Lavin lacked “ordinary knowledge common to [his] community [of

physicians] as to the product’s characteristics.”

To the contrary, the evidence reveals that Dr. Lavin was quite

familiar with the ReShape balloon and the dangers it could pose to

an unfortunate patient. For one, ReShape’s Instructions for Use

notified Dr. Lavin that the balloon could cause the injury Vesoulis

suffered, and the consent form Dr. Lavin prepared for Vesoulis did

the same. See ReShape Mot., Ex. A at 5; Dr. Lavin & SSL Mot.,

Ex. C at 1. For another, Dr. Lavin was clearly aware that

esophageal perforation is a common complication of any endoscopy.

See Lavin Dep., ReShape Mot., Ex. K.

Without a federal right of action to stand on, and in

presumable recognition of the difficulty posed by the LPLA itself,

Vesoulis attempts to salvage his claims against ReShape by alleging

that ReShape “is liable based solely on [its] failure to comply

with the [FDA’s] PMA Approval Order and applicable FDA

regulations.” See Second Am. Compl., ¶ 7; Opp’n to ReShape Mot.

at 17–18 (fleshing out Vesoulis’s allegations in this regard).

But this line of thinking is unimpressive. Clearly, the Court

cannot hold on the one hand that Vesoulis’s claims are unpreempted

state-law claims and on the other hand ignore provisions of the

same state law that plainly undercut Vesoulis’s ability to recover

under state-law provisions he claims to “parallel” federal

requirements. Federal courts across the nation have consistently

disallowed such assertions. Referring to the Supreme Court’s

holdings in Riegel (see supra note 5) and Buckman Co. v.

Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), Judge Schiltz

forcefully sums up the medical-product-liability plaintiff’s

challenging task:

In sum, Riegel and Buckman create a narrow gap though

which a plaintiff’s state-law claim must fit if it is to

escape express or implied preemption. The plaintiff

must be suing for conduct that violates the [FDA’s

organic statute] (or else his claim is expressly

preempted by § 360k(a)), but the plaintiff must not be

suing because the conduct violates the FDCA (such a claim

would be impliedly preempted under Buckman). For a

state-law claim to survive, then, the claim must be

premised on conduct that both (1) violates the FDCA and

(2) would give rise to a recovery under state law even

in the absence of the FDCA.

Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009).

Like countless plaintiffs before him, Vesoulis fails to

thread the needle here. Indeed, although ReShape’s actions

conceivably violated FDA regulations and PMA provisions rooted in

the FDCA, they – as detailed above – would not afford Vesoulis a

plausible basis for recovery under Louisiana state law in the

absence of ReShape’s violation of requirements spelled out in FDA

regulations and the FDA’s PMA Approval Order.

Consequently, because Vesoulis’s state-law claims against

ReShape “exist solely by virtue of [federal] requirements” enacted

as part of a comprehensive regulatory scheme by Congress, they are

either preempted by federal law,’ meritless under Louisiana law, ®

or both. See Buckman, 531 U.S. at 352-53; supra.

* * *

Accordingly, for the foregoing reasons, IT IS ORDERED: that

the defendants’ motions for summary judgment are GRANTED. The

plaintiff’s informed consent claim against Dr. Lavin and SSL, and

the plaintiff’s claims against ReShape, are DISMISSED WITH

PREJUDICE.

New Orleans, Louisiana, May 12, 2021

MARTIN . C. ELDMAN

UNITED STATHS DISTRICT JUDGE

7 Because “although Medtronic can be read to allow certain

state-law causes of action that parallel federal safety

requirements, it does not and cannot stand for the proposition

that any violation of the FDCA will support a state-law claim.”

Buckman, 531 U.S. at 353.

8 Because LA. R.S. 9:2800.57(B) plainly relieves ReShape of any

duty to warn Dr. Lavin about dangers he already “contemplated [as

an] ordinary user or handler of the product” at issue.

14