Naquin v. Medtronic ( 2021 )

Case: 20-30793 Document: 00516058015 Page: 1 Date Filed: 10/18/2021
United States Court of Appeals
for the Fifth Circuit
United States Court of Appeals
Fifth Circuit
FILED
October 18, 2021
No. 20-30793 Lyle W. Cayce
Clerk
Matthew Naquin,
Plaintiff—Appellant,
versus
Medtronic, Incorporated,
Defendant—Appellee.
Appeal from the United States District Court
for the Eastern District of Louisiana
USDC No. 2:20-CV-2401
Before Davis, Elrod, and Oldham, Circuit Judges.
Per Curiam: *
Medtronic manufactures, among other things, implantable cardiac
defibrillators. In 2016, a surgeon implanted a Medtronic defibrillator into
Matthew Naquin’s chest. Claiming the defibrillator was defective, Naquin
sued Medtronic. The district court dismissed Naquin’s claims. We affirm.
*
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opinion should not be published and is not precedent except under the limited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.
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No. 20-30793
I.
To mitigate various heart conditions, an unidentified cardiologist
recommended that Matthew Naquin use a Medtronic Evera XT VR
Implantable Cardiac Defibrillator (the “ICD”). On March 30, 2016, an
unidentified surgeon implanted the ICD into Naquin’s chest, along with a
Medtronic Sprint Quattro Lead (the “lead”). 1 The FDA has designated both
the ICD and the lead as Class III medical devices, which means, among other
things, that both underwent a lengthy FDA premarket approval (“PMA”)
process before their commercial use. According to Naquin, the ICD shocked
him unnecessarily, caused severe pain, and created a burning sensation in his
chest. Naquin also claims that the lead was defective and caused the whole
device to fail roughly three years after implantation, necessitating surgery to
replace the device. The replacement surgery was performed on June 23,
2019, and resulted in a three-month hospitalization.
Naquin sued Medtronic in Louisiana state court, bringing products
liability and breach of contract claims. The products liability claim sought
damages under the Louisiana Products Liability Act (“LPLA”) for defective
construction, defective design, failure to warn, and breach of express
warranty. See La. Rev. Stat. Ann. § 9:2800.54. Naquin also asserted a
breach of contract claim, arguing that Medtronic had agreed to provide
“reliable 24 hour and 7 day a week service to Matthew Naquin.” Naquin
alleged that the contract was breached because “Medtronic Inc. and its
1
In total, Naquin asserts that seven Medtronic products were defective: (1) the
ICD; (2) the lead; (3) the Medtronic Reveal LINQ; (4) the Medtronic Reveal Insertable
Loop Recorder; (5) the My Carelink Patient Monitor and Software; (6) the “Medtronic
and EDevice Inc. Wirex”; and (7) the Vital Sync Virtual Patient Monitoring Platform. The
first four products were surgically implanted as part of the ICD system; the final three were
used in conjunction with the first four but not surgically implanted. Naquin’s particularized
allegations of defect and injury only relate to the ICD and the lead.
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employees and representative provided bad service to Matthew Naquin.”
Medtronic also allegedly failed to provide “appropriate qualified staff and
professionals for service” to Naquin, and “failed to provide reliable
software.” 2
Medtronic filed a motion to dismiss. The district court granted the
motion with respect to the products liability claim, finding it preempted by
21 U.S.C. § 360k. That statute expressly preempts state laws which impose
“different” or “addition[al]” safety requirements on medical devices
subject to the FDA’s PMA process. 21 U.S.C. § 360k(a). The devices that
Naquin claims harmed him were concededly subject to the PMA process. So,
to the extent that the LPLA imposed different or additional requirements on
those devices, it was preempted. And Naquin failed to specifically plead any
non-preempted “parallel” claim—that is, a claim where LPLA requirements
align with FDA requirements and thus avoid preemption.
The district court concluded that Naquin’s breach of contract claim
was “vague and conclusory” and granted Naquin 14 days from its December
2, 2020, order to “amend his complaint to state with specificity the basis of
the legal relationship, who is the obligor, what performance was promised,
2
In his opposition to Medtronic’s motion to dismiss, Naquin for the first time
added a third claim, alleging unfair trade practices under the Louisiana Unfair Trade
Practices Act (“LUTPA”), La. Rev. Stat. Ann. §§ 51:1401–30. Because Naquin first
raised this claim in his opposition, the district court construed it as a motion for leave to
amend. The court then denied the motion as futile because the LUTPA claim was
subsumed by the LPLA claim. We agree that the LPLA bars Naquin’s LUTPA claim. See
id. § 9:2800.52 (LPLA provides “the exclusive theories of liability for manufacturers for
damage caused by their products”); see also Touro Infirmary v. Sizeler Architects, 2004-2210,
p. 6 (La. App. 4 Cir. 11/21/06), 947 So. 2d 740, 744 (“Courts have consistently held the
LPLA subsumes all possible causes of action, with the exception of a claim in
redhibition.”); Pitre v. Yahama Motor Co., Ltd., 51 F. Supp. 3d 644, 662 (E.D. La. 2014)
(“[F]ederal courts applying Louisiana law have concluded that the LPLA bars plaintiffs
from maintaining an action under the LUTPA.”).
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how the contract was breached, and what damages have resulted.” Naquin
did not amend his complaint. Instead, he filed a premature notice of appeal
on December 11, 2020. Because Naquin had not amended his complaint, the
district court entered final judgment on January 14, 2021. Naquin then
appealed to us.
II.
Naquin asserts that the district court erred by dismissing his products
liability and breach of contract claims. Our review is de novo. Cornerstone
Christian Schs. v. Univ. Interscholastic League, 563 F.3d 127, 133 (5th Cir.
2009).
A.
Naquin asserts that he has adequately pleaded LPLA claims that are
not preempted by 21 U.S.C. § 360k. Congress passed that provision as part
of the Medical Device Amendments of 1976 (“MDA”), which brought
medical devices into the FDA’s regulatory ambit. Section 360k(a) provides,
in relevant part:
[N]o State or political subdivision of a State may establish or
continue in effect with respect to a device intended for human
use any requirement—
(1) which is different from, or in addition to, any re-
quirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the de-
vice or to any other matter included in a requirement applicable
to the device under this chapter.
21 U.S.C. § 360k(a).
In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the Supreme Court
set forth a framework for determining whether state law claims are
preempted by § 360k. First, the court “must determine whether the Federal
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Government has established requirements applicable to [the medical de-
vice].” Id. at 321. Second, if so, the court must determine whether the state
law claims are based upon “requirements with respect to the device that are
different from, or in addition to, the federal ones, and that relate to safety and
effectiveness.” Id. at 322 (quotation omitted). If the answer to both questions
is yes, then the state law claims are preempted. See id. at 321–22.
The first prong of the Riegel test is satisfied here. Riegel held that if a
device has been approved through the PMA process, it satisfies the federal
requirements prong. See id. at 322 (“Premarket approval . . . imposes ‘re-
quirements’ under the MDA . . . .”); Bass v. Stryker Corp., 669 F.3d 501, 507
(5th Cir. 2012) (“Devices that are approved through PMA procedures auto-
matically satisfy the ‘federal requirements’ prong.” (citing Riegel, 552 U.S.
at 322)). All of the devices that Naquin alleges were surgically implanted and
caused him harm—most notably, the ICD and the lead—are FDA-regulated
medical devices that have been approved through the PMA process.
The second prong asks whether the plaintiff’s state law claims impose
requirements “that are different from, or in addition to, the federal ones, and
that relate to safety and effectiveness.” Riegel, 552 U.S. at 322 (quotation
omitted). Evaluating Naquin’s LPLA claims would require a jury to decide
whether “[t]here existed an alternative design for the product that was capa-
ble of preventing [Naquin’s] damage” and whether the safety benefits of that
design “outweighed the burden on the manufacturer of adopting such alter-
native design.” La. Rev. Stat. Ann. § 9:2800.56; see also id. § 9:2800.57
(failure-to-warn claim requires that “the manufacturer failed to use reasona-
ble care to provide an adequate warning” of a dangerous characteristic of a
product). Because these Louisiana standards relate to safety and effective-
ness, they are preempted to the extent they are “different from, or in addition
to” federally imposed requirements. 21 U.S.C. § 360k(a); see Gomez v. St.
Jude Medical Daig Div. Inc., 442 F.3d 919, 930 (5th Cir. 2006) (finding LPLA
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defective-design and failure-to-warn claims for an allegedly defective PMA-
approved medical device preempted by § 360k).
But as the Supreme Court explained in Riegel, state law claims can
avoid preemption if they are “parallel” to the federal requirements:
State requirements are pre-empted under the MDA only to the
extent that they are “different from, or in addition to” the re-
quirements imposed by federal law. § 360k(a)(1). Thus, § 360k
does not prevent a State from providing a damages remedy for
claims premised on a violation of FDA regulations; the state
duties in such a case “parallel,” rather than add to, federal re-
quirements.
Riegel, 552 U.S. at 330 (citation omitted).
Naquin asserts that he has adequately pleaded parallel claims under
Riegel. But parallel state law claims fail if they are pleaded in an “impermis-
sibly conclusory and vague” fashion. Funk v. Stryker Corp., 631 F.3d 777, 782
(5th Cir. 2011). In Funk, we considered a pleading that, inter alia, alleged that
“[t]he [device] contained a manufacturing defect in that it was manufactured
in such a manner that impurities, residues and bacteria remained on the [de-
vice] in violation of the FDA standards and requirements and in violation of
the manufacturing processes and design approved by the FDA.” Ibid. We
held that this pleading, and other similarly conclusory pleadings, did not state
a parallel claim for products liability because it “d[id] not specify the manu-
facturing defect,” did not “specify a causal connection between the failure
of the specific manufacturing process and the specific defect in the process
that caused the personal injury,” and did not “tell us how the manufacturing
process failed, or how it deviated from the FDA approved manufacturing
process.” Ibid.Naquin similarly fails to adequately plead parallel claims. He baldly
asserts that the lead “was adulterated, defective, malfunctioned, and failed.”
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And he makes numerous conclusory allegations, such as that “[t]he FDA re-
quires Medtronic to use conforming material in their manufacturing and
Medtronic used non-conforming material.” But nowhere does Naquin pro-
vide details as to how a violation of federal regulations produced a manufac-
turing or design defect or how a specific defect caused his alleged harms.
Naquin’s failure-to-warn claim is similarly conclusory, simply asserting that
“[t]he Medtronic products are unreasonably dangerous because an adequate
warning about the product has not been provided concerning the numerous
problems, and malfunctions of these products and their component parts.”
Naquin’s pleadings are insufficient to plead a non-preempted parallel claim.
See Funk, 631 F.3d at 782.
Naquin also fails to adequately plead a non-preempted claim for
breach of express warranty because the warranty was not alleged “with par-
ticularity” as our precedent requires. See Wildman v. Medtronic, Inc., 874
F.3d 862, 870 (5th Cir. 2017). In Wildman, where this court found that a par-
allel breach-of-warranty claim was adequately pleaded and not preempted,
the plaintiff’s amended complaint directly quoted a two-paragraph statement
from the manufacturer’s website that contained the warranty allegedly relied
on. Id. at 866. By contrast, Naquin in this case failed to reproduce any specific
warranty in his pleadings or specify its precise source. Rather, Naquin stated
that the lead “failed to comply with the 10 and 11 year warranty that was pro-
vided to Matthew Naquin through his physicians, and medical providers, and
by Medtronic, Inc. and its employees, agents and representative, and busi-
ness affiliates.” The pleadings failed to identity when, where, or how Med-
tronic made the alleged warranty, instead listing a variety of alleged sources
in conclusory fashion. This is insufficient to adequately plead a non-
preempted warranty claim. See id. at 870; Bass, 669 F.3d at 515–16. In his ap-
pellate briefing, Naquin gets more specific and claims that the warranty
comes from an “advertise[ment] on [Medtronic’s] website,” but still fails to
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identify a specific web page or specific warranty terms, as the plaintiff did in
Wildman. See Wildman, 874 F.3d at 866.
B.
Naquin also appeals the district court’s dismissal of his breach of con-
tract claim. But Naquin forfeited this claim by failing to replead it in the dis-
trict court. “[A] failure to replead claims after being granted leave to replead
constitutes [forfeiture] of any such claims on appeal.” Shakeri v. ADT Sec.
Servs., 816 F.3d 283, 291 (5th Cir. 2016). Naquin chose not to replead and
instead chose to appeal. He thus lost his contract claim.
* * *
The judgment of the district court is AFFIRMED.
8