     Case: 17-50010   Document: 00514218676     Page: 1   Date Filed: 10/31/2017




          IN THE UNITED STATES COURT OF APPEALS
                  FOR THE FIFTH CIRCUIT
                                                                 United States Court of Appeals
                                                                          Fifth Circuit

                                 No. 17-50010                           FILED
                                                                 October 31, 2017
                                                                   Lyle W. Cayce
RAY WILDMAN,                                                            Clerk

             Plaintiff - Appellant

v.

MEDTRONIC, INCORPORATED; MEDTRONIC USA, INCORPORATED,

             Defendants - Appellees




                Appeal from the United States District Court
                     for the Western District of Texas


Before WIENER, HIGGINSON, and COSTA, Circuit Judges.
GREGG COSTA, Circuit Judge:
      Ray Wildman contends that a Medtronic device implanted in his back to
relieve pain did not last as long as the company promised. The result was an
infection that required surgery and caused him to miss months of work.
Wildman brought suit alleging breach of express warranty under Texas law.
If this state-law claim would impose a requirement that is “different from, or
in addition to” those imposed by the Food and Drug Administration when it
approved the medical device, then federal law preempts the claim. 21 U.S.C.
§ 360k; see Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008). On the other
hand, if the claim “parallels” federal requirements—that is, if it would enforce
a duty also imposed by federal law—then it is not preempted. Id. at 330. We
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thus must decide whether Wildman’s claim alleging false representations
about the “device life” of the product would undermine FDA regulation or
reinforce it.
                                       I.
      Wildman suffered from chronic back and leg pain. In an attempt to
manage that pain, he had a Medtronic RestoreUltra neurostimulator (the
Device) surgically implanted into his back.         The Device is designed,
manufactured, and marketed by Medtronic, and once inserted, it “delivers mild
electrical signals to the epidural space near [the] spine through one or more
thin wires that provide electrical impulses to thin plastic leads.”        These
electrical impulses block pain signals before they reach the brain.
      The Device malfunctioned about a year and a half after it had been
implanted. Wildman started to experience additional pain and consulted with
two doctors about removing the device.       He first met with a doctor who
determined that the stimulator had stopped working and that the additional
pain did not seem to be the result of any physiological change in Wildman’s
condition. The doctor’s notes suggest Medtronic representatives were present
at Wildman’s medical appointments, and the company was notified of problems
with his device. Wildman was then referred to another doctor to “look into
getting his stimulator battery replaced.”
      This doctor concluded that the “left side quit working and Medtronic[]
tried to get it to work and they said it need[ed] to come out.” Medtronic
representatives present at this appointment determined that the “entire device
[was] dead.” About a month later, Wildman had surgery to remove the Device.
The area where the surgical staples had been became infected, with the wound
site draining liquid and causing significant pain.        After about a month,
Wildman saw yet another doctor who discovered that an abscess had formed,
which required additional surgery. Wildman maintains that he was unable to
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                                       No. 17-50010
work for five months due to the multiple surgeries required to remove the
Device and address the resulting infection.
       Wildman sued Medtronic in state court alleging breach of express
warranty. He contends that the Device functioned properly for roughly a year
and a half when Medtronic claimed in written marketing material that the
neurostimulator had a device life of nine years. His amended complaint, filed
after the case was removed to federal court, says that Wildman relied on the
following statement (the Statement) from Medtronic’s website about the
Device:
            While other manufacturers may state that their batteries
            have a longevity greater than 9 years, it’s important to
            understand that many other factors and components are
            involved in determining the overall longevity of an
            implanted medical device. The result of extensive design
            and testing involved in manufacturing rechargeable
            neurostimulators give Medtronic the confidence that our
            device is reliable for 9 years.
            To achieve this distinction, Medtronic rigorously verified
            and validated the many components that impact device
            longevity, not just the battery.       The result is a
            rechargeable neurostimulator that delivers reliable
            performance over the entire period of predicted service.
            Medtronic is the only company to offer a
            Neuromodulation Product Performance Report.
The complaint further alleges that this warranty language was “never
reviewed by or submitted to the FDA for approval.”
       As a Class III device regulated by the FDA, 1 the Device underwent a
rigorous premarket approval process that resulted in a finding that there was



       1 The Medical Device Amendments to the Food Drug and Cosmetics Act created three
classes of medical devices, the most highly regulated of which is Class III. A Class III device
is one that: (1) insufficient information exists to determine that the application of a lower
level of control is sufficient to provide reasonable assurance of its safety and effectiveness;
(2) is purported or represented to be for a use in supporting or sustaining human life or for a
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a “‘reasonable assurance’ of the device’s ‘safety and effectiveness.’” Riegel, 552
U.S. at 318 (quoting 21 U.S.C. § 360e(d)). This process also includes a review
of a device’s labeling to ensure it is “neither false nor misleading.” 21 U.S.C
§ 360e(d)(1)(A). As part of this process, the FDA reviewed the Device’s “System
Eligibility, Battery Longevity, Specifications Reference Manual.”                          After
considering this report, the FDA approved a statement that the Device’s
“battery life” was “9 years.”           The agency also evaluated the criteria for
determining battery longevity and verified that nine years after implant, the
Device would output the message “EOS (End of service)” when electronically
analyzed by a doctor or Medtronic employee. Medtronic has not identified
anything in the FDA record showing that the agency endorsed or evaluated
any claim about the longevity of Device components other than the battery. 2
       Wildman’s original complaint included assertions that the malfunction
was due to the battery, but his amended complaint contends that the
neurostimulator did not conform to a “nine-year device life.” Medtronic moved
for judgment on the pleadings under Rule 12(c) on three grounds: (1) that the
claim was preempted by federal law, (2) that Wildman failed to adequately
plead reliance on the warranty, and (3) that Medtronic’s Limited Warranty is
the exclusive remedy available to Wildman. The district court concluded the




use which is of substantial importance in preventing impairment of human health; or (3)
presents a potential unreasonable risk of illness or injury. 21 U.S.C. § 360c(C).
       2 At the Rule 12 stage, the court is usually limited to considering the pleadings.

Because the approval process is part of the public record, however, the court is entitled to
take judicial notice of the information presented in the FDA documents. See Funk v. Stryker
Corp., 631 F.3d 777, 783 (5th Cir. 2011) (holding that it was appropriate for the court to take
judicial notice “under Rule 12(b)(6), of the PMA the FDA granted” the defendant because the
documents and transcripts produced by the FDA were “matters of public record directly
relevant to the issue at hand”); see also Norris v. Hearst Tr., 500 F.3d 454, 461 n.9 (5th Cir.
2007) (“[I]t is clearly proper in deciding a 12(b)(6) motion to take judicial notice of matters of
public record.”).
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claim was preempted. We review de novo that Rule 12 dismissal. See Bass v.
Stryker Corp., 669 F.3d 501, 506 (5th Cir. 2012).
                                       II.
                                       A.

      The FDA, which for decades had been reviewing the safety and
effectiveness of drugs before they were allowed to enter the market, began
doing the same for medical devices after a 1976 amendment to the Food, Drug,
and Cosmetic Act.      The Medical Device Amendments of 1976 imposed
comprehensive and nationally uniform regulations for an increasing number
of complex medical devices. See Riegel, 552 at 315-16. The Amendments
include an express preemption provision stating that:
      [N]o 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 requirement
         applicable under this chapter to the device, and
         (2) which relates to the safety or effectiveness of the device or
         to any other matter included in a requirement applicable to the
         device under this chapter.
21 U.S.C. § 360k(a).     In Riegel, the Supreme Court concluded that this
provision preempts not just state administrative regulation but also state tort
law. Riegel, 552 U.S. at 325. Tort claims are preempted because jury verdicts
holding device manufacturers liable under the common law for requirements
the FDA did not impose would undermine the FDA’s central oversight role.
See id. at 323-26.
      But preemption of state common law is not absolute.                Because
preemption’s concern is with state requirements that conflict with FDA
determinations or that require more than the premarket approval process
does, Riegel clarified that state claims “premised on a violation of FDA
regulations” may go forward. See id. at 330; Bass, 669 F.3d at 509-10 (finding

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state common law claims not preempted when premised on violation of federal
requirements); Hughes v. Bos. Sci. Corp., 631 F.3d 762, 769-70 (5th Cir. 2011)
(same); see also Daniel W. Whitney, Guide to Preemption of State-Law Claims
Against Class III PMA Medical Devices, 65 FOOD & DRUG L.J. 113, 120 (2010)
(“In order to avoid preemption by § 360k(a), a state-law claim against a PMA
Class III device should be premised on a breach of a state-law duty that is the
same as a duty imposed under the PMA or one of its implementing
regulations.”). These are called “parallel” claims because they enforce FDA
regulations rather than add to or undermine them. Riegel, 552 U.S. at 330.
       Many courts have navigated the course between preempted and parallel
express warranty claims. The essence of an express warranty claim is a broken
promise. 3 When the promise was one the FDA approved, tort liability for
breaking it would conflict with the FDA’s view that the representation was a
sound one. So when a claim challenges a representation the FDA blessed in
the approval process, it is preempted. See Gomez v. St. Jude Med. Daig Div.
Inc., 442 F.3d 919, 931-32 (5th Cir. 2006) (holding a breach of express warranty
claim preempted when the warranty was part of a medical device’s
“Instructions for Use” that was reviewed and approved by the FDA). But when
a claim challenges a warranty that goes above and beyond any guarantee the
FDA expressly or implicitly approved, it is a parallel one. See id. at 932
(discussing the principle that express warranties can escape preemption). 4 It


       3  The claim has six elements under Texas law: “(1) the defendant sold services to the
plaintiff; (2) the defendant made a representation to the plaintiff about the characteristics of
the services by affirmation of fact, by promise, or by description; (3) the representation
became part of the basis of the bargain; (4) the defendant breached the warranty; (5) the
plaintiff notified the defendant of the breach; and (6) the plaintiff suffered injury.” Paragon
Gen. Contractors, Inc. v. Larco Constr., Inc., 227 S.W.3d 876, 886 (Tex. App.—Dallas 2007).
        4 See also Mitchell v. Collagen Corp., 126 F.3d 902, 915 (7th Cir. 1997) (“A state

judgment based on the breach of an express representation by one of the parties does not
necessarily interfere with the operation of the PMA, and therefore we cannot say that such a
cause of action is preempted.”); Schouest v. Medtronic, Inc., 13 F. Supp. 3d 692, 707 (S.D. Tex.
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is parallel because, as we have mentioned, federal law requires that
representations about medical devices be truthful. 5 This comes from the Food,
Drug, and Cosmetic Act’s prohibition on the sale of “any . . . device . . . that is
adulterated or misbranded.” 21 U.S.C. § 331(a). A device is misbranded if it is
sold using “false or misleading advertising.” Id. § 352(q)(1). 6
                                             B.
       The preemption question thus comes down to whether the warranty on
Medtronic’s website was consistent with assessments made during the
approval process, in which case this lawsuit would be preempted as a challenge
to the FDA’s determination of safety and effectiveness, or whether the
warranty goes beyond what the FDA considered. 7


2014) (explaining that an “express warranty claim can survive to the extent [the plaintiff]
seeks to recover based on false warranties that Medtronic voluntarily and falsely made
beyond the federally approved warning”) (quoting Riley v. Cordis Corp., 625 F. Supp. 2d 769,
788 (D. Minn. 2009)); Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1180 (C.D. Cal. 2013)
(same); Parra v. Coloplast Corp., 2017 WL 24794, at *4 (E.D. La. Jan. 3, 2017) (same) (citing
Gomez, 442 F.3d at 932); Heisner v. Genzyme Corp., 2008 WL 2940811, at *8 (N.D. Ill. July
25, 2008) (holding same).
        5 Medtronic notes that most of the cases recognizing the viability of parallel express

warranty claims involved representations about “off-label” uses of a device and suggests that
is a limitation. But Gomez was not an off-label case and it would not have needed to analyze
whether the representation concerned matters reviewed by the FDA if such claims were
categorically preempted. 442 F.3d at 931-32. We see no reason why false representations
that go beyond matters considered by the FDA should escape preemption only when they
relate to off-label use.
        6 Parallel claims sometimes face another obstacle: implied preemption that is in

addition to the express preemption dealt with in Riegel. Implied preemption precludes state
tort claims that “exist solely by virtue of” the federal regulatory scheme. Buckman Co. v.
Plaintiffs Legal Comm., 531 U.S. 341, 353 (2001). Such claims—the paradigmatic one being
fraud in connection with the FDA approval process—cannot be brought under state law
because the FDA is the exclusive enforcer of its regulations. Id. at 347-50. But implied
preemption does not apply to common law claims that would reach the alleged wrong
independent of the FDA process. Id. at 352. As a breach of express warranty claim parallels,
but does not exist solely because of, the FDA requirement—a warranty claim can be brought
against products in all types of industries—implied preemption is not a problem. Indeed,
Medtronic does not urge that defense.
        7 The express preemption inquiry normally proceeds in two steps. The first asks

whether the FDA established requirements applicable to the medical device at issue. Riegel¸
552 U.S. at 322. The answer to that question is almost always yes once a device has gone
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       What did the warranty promise?              Medtronic argues that it equates
battery life with device life, which makes “eminent sense” because the Device’s
“primary component [is] the battery.”             Medtronic goes on to say that its
warranty claimed that battery longevity was the limiting factor to overall
longevity and thus “battery life was the device life.”
       But a plain reading of the warranty is at odds with Medtronic’s
interpretation. It repeatedly makes a “distinction” between the battery and
the “many components” and focuses on guaranteeing the reliability of the
latter. The Statement begins by asserting that although other manufacturers
“may state that their batteries have a longevity greater than 9 years, it’s
important to understand that many other factors and components are involved
in determining the overall longevity of an implanted medical device” (emphasis
added). The next sentence states that “extensive design and testing . . . give
Medtronic the confidence that our device is reliable for 9 years.” Why does it
have that confidence? Because “Medtronic rigorously verified and validated
the many components that impact device longevity, not just the battery.” By




through the PMA process. See id. at 322-23 (“Premarket approval, in contrast, imposes
‘requirements’ under the MDA as we interpreted it in Lohr.”). We conclude it is that simple
here, although the question whether the warranty was limited to the battery or extended to
other components was considered in the district court as part of this inquiry. But the
approval of the Device itself through the premarket approval process seems to be all the first
inquiry requires. See Bass, 669 F.3d at 508 (holding that an entire device, including its
component parts, satisfied the first step of Riegel when the FDA reviewed those components
during the PMA process). The dispositive question—does the Statement cover topics
considered by the FDA—relates to the second Riegel inquiry: whether the claim imposes
requirements “‘different from, or in addition to’ federal requirements.” Riegel, 552 U.S. at
323; Hughes, 631 F.3d at 767-68 (analyzing express preemption claim under step two of
Riegel); Houston, 957 F. Supp. 2d at 1180 (“The Court concludes that Plaintiff's breach of
express warranty claim is not expressly preempted because it would not impose any
requirement different from or in addition to what federal law demands.”); Hofts v. Howmedica
Osteonics Corp., 597 F. Supp. 2d 830, 839 (S.D. Ind. 2009) (finding a breach of express
warranty claim against a medical device manufacturer passed the second step of Riegel and
was not preempted).
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its own terms, the Statement says that longevity of many components other
than the battery contributes to the Device’s overall longevity.
      The Statement cannot reasonably be read as anything other than a claim
of comparative advantage over competitors that vouch only for the life of their
batteries. Medtronic is telling consumers why its product is superior. When
the Statement says nine years, it means the many components—in its words,
“not just the battery”—are guaranteed to last that long. It cannot have it both
ways by claiming that as an advantage over competitors in the marketplace
and now contending that only the battery life matters. Nor has Medtronic
convinced us that battery life would be the only factor affecting the Device’s
longevity. Of course, when the battery dies, the device would cease to function.
But it does not follow that the failure of the device would only be attributable
to a drained battery. There are other potential points of failure—such as the
casing, the connections between the wires and battery, or the embedded
computer and software. The Statement says each of the many components
were tested in guaranteeing “reliable performance” over the “entire period of
predicted service.” So like any number of products—consider a car’s drivability
which depends not just on a working battery but also a functioning engine or
alternator—Medtronic offered an express warranty on the longevity of the
entire Device.
      Whether Wildman can challenge the truthfulness of that Statement thus
depends on whether the FDA evaluated the longevity of the “many
components.” As we mentioned at the outset, the FDA did test battery life and
approved a statement that the Device’s “battery life” was “9 years.”         But
Medtronic has not identified anything in the administrative record showing
that the FDA evaluated the longevity of other components. At oral argument,
it could point to only two pages of the record to support its contention that the
nine-year battery life was synonymous with a nine-year device life: first, a
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                                 No. 17-50010
table outlining the physical characteristics of the Device that lists “[b]attery
life” at “9 years;” and second, a section on “battery longevity” that states the
device will output the message “end of service” nine years after implant.
Neither passage indicates the FDA was suggesting that every component was
certified to last for nine years in the manner represented by Medtronic on its
website.
      As a result, the Statement goes beyond what the FDA evaluated in its
approval process. Medtronic may make such representations, but it faces state
law liability if they are proven false. A verdict finding that Medtronic misled
consumers like Wildman in making this representation—something Wildman
is a long way from proving as this case is just at the pleading stage—would not
undermine any FDA finding concerning the safety of the device. It would
instead be enforcing a duty that also exists under federal law: to not make
misleading representations about the Device. And to escape such liability,
Medtronic would not need to redesign the Device, but only to limit its
warranties to those approved by the FDA. Accordingly, the narrow breach of
express warranty claim Wildman asserts is not preempted.
                                    III.
      Although many courts have recognized that an express warranty claim
challenging representations that go beyond what the FDA approved may
escape preemption, those claims often fail for other reasons. One is a failure
to allege the claim with particularity, which Medtronic says is true of
Wildman’s allegations and provides an alternative ground for affirming.
      Most of the express warranty claims that have been subject to
Twombly/Iqbal dismissals in medical device cases have failed to plead the
specifics of the warranty. Rather than point to a written guarantee from the
medical manufacturer, as Wildman has, the unsuccessful plaintiffs have
asserted vague allegations about representations the device manufacturer
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made to doctors or consumers. See Schouest, 13 F. Supp. 3d at 707 (“[W]hat is
missing from Schouest’s complaint, in its current form, is a description of what
specific warranties Medtronic made to Schouest or her physicians.”); Beavers-
Gabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021, 1043 (D. Haw. 2014) (same);
Houston, 957 F. Supp. 2d at 118 (same); see also Bass, 669 F.3d at 515-16
(dismissing an express warranty claim because the plaintiff pleaded the
company’s affirmative representations in “wholly conclusory fashion”).
Although Wildman has identified a specific representation on the website,
Medtronic alleges another defect in his allegations. It argues that even if
claims about longevity of components other than the battery can theoretically
escape preemption, Wildman has not sufficiently alleged that one of those
other components caused the Device to fail. Wildman ultimately needs to make
that showing or he would not be able to establish that Medtronic breached the
warranty about those other components.
      But initial review of this pleading issue is better suited for the district
court. On remand the district court should also consider the other grounds
Medtronic asserted in its motion to dismiss, including another argument
challenging the plausibility of Wildman’s claim: that he did not allege reliance
on the warranty.
                                     * * *

      The judgment is REVERSED and the case REMANDED for further
consideration consistent with this opinion.




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