Andrea Irizarry; Manuel Irizarry v. Abbott Laboratories

NOT PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
____________
No. 19-3574
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ANDREA IRIZARRY; MANUEL IRIZARRY,
Appellants
v.
ABBOTT LABORATORIES; ABBOTT LABORATORIES, INC.; ABBOTT
VASCULAR, INC.; JOHN DOE DISTRIBUTION, INC.
____________
On Appeal from the United States District Court
for the Eastern District of Pennsylvania
(D.C. Civ. No. 5-18-cv-04232)
District Judge: Honorable Edward G. Smith
____________
Argued September 29, 2020
Before: SHWARTZ and PHIPPS, Circuit Judges.†
(Filed: November 3, 2020)
___________
OPINION*
___________
† After oral argument in this matter, the Honorable D. Michael Fisher determined that it
was necessary to recuse. This opinion is filed by a quorum of the panel pursuant to
28 U.S.C. § 46(d) and Third Circuit I.O.P. Chapter 12.1.
* This disposition is not an opinion of the full Court and pursuant to I.O.P. 5.7 does not
constitute binding precedent.

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Andrew Theyken Bench [ARGUED]
Andrew Theyken Bench Legal
131 North 8th Street
Allentown, PA 18101
Counsel for Appellants
Thomas J. Elliott
Elliott Greenleaf
Union Meeting Corporate Center V
925 Harvest Drive, Suite 300
Blue Bell, PA 19422
Kristina K. Cercone
José A. Isasi, II
Paula S. Quist [ARGUED]
Jones Day
77 West Wacker Drive, Suite 3500
Chicago, IL 60601
Counsel for Appellees
PHIPPS, Circuit Judge.
This suit involves four claims under Pennsylvania law premised on the alleged
failure of a medical device. That device, the Perclose Closure Device, received
premarket approval by the Food & Drug Administration as a Class III medical device
under the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act.
Nonetheless, when used during a coronary and peripheral vascular catheterization at
Lehigh Valley Hospital–Muhlenberg, the device failed to retract. Afterwards, the patient,
Manuel Irizarry, a citizen of Pennsylvania, suffered a lacerated femoral artery, resulting
in a serious groin bleed that required emergency surgery to save his life. Now joined by
his wife, Andrea, who is also a citizen of Pennsylvania, Irizarry sues the manufacturer of
the device, Abbott Laboratories, along with its subsidiaries and the distributor of the

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device (collectively “Abbott”), none of whom are citizens of Pennsylvania either by
incorporation or through principal place of business. The Irizarrys seek over $75,000
each in damages.
In response to the third amended complaint, the operative complaint, Abbott
moved to dismiss for failure to state a claim for relief. See Fed. R. Civ. P. 12(b)(6). In
that motion, Abbott asserted two affirmative defenses – express preemption under
21 U.S.C. § 360k(a) and implied preemption under 21 U.S.C. § 337(a). The Irizarrys
opposed that motion by arguing that they stated plausible, non-preempted claims, and to
bolster that contention, they relied on an expert report attached to the complaint.
Exercising diversity jurisdiction over this suit, see 28 U.S.C. § 1332, the District
Court granted Abbott’s motion. Irizarry v. Abbott Lab’ys, 2019 WL 5061127, at *1 (E.D.
Pa. Oct. 8, 2019). In doing so, the District Court excluded the expert report and analyzed
whether the Irizarrys stated a non-preempted claim. Id. at *1 n.1. It concluded that
express and implied preemption left only a “narrow gap” for state law claims, and that the
Irizarrys had not stated a claim within that gap. Id. On that basis, the District Court
dismissed the third amended complaint with prejudice.
The Irizarrys timely appealed that order, bringing the case within the jurisdiction
of this Court. See 28 U.S.C. § 1291. Reviewing de novo the District Court’s order, see
City of Edinburgh Council v. Pfizer, Inc., 754 F.3d 159, 166 (3d Cir. 2014), we will
affirm, resolving this case not directly on preemption grounds but indirectly.

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Abbott argues that the order dismissing the complaint should be upheld on either
express or implied preemption grounds. In anticipation of Abbott’s preemption defenses,
the Irizarrys attempted to plead only non-preempted claims, commonly referred to as
“parallel” claims. See Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008). For a claim
to be parallel in the context of Class III medical devices, which have received premarket
approval from the FDA, see 21 U.S.C. § 360e, the state law on which the claim is based
must not differ from or add to the FDA-approved premarket requirements. See id. §
360k(a)(1) (expressly preempting state requirements for medical devices that are
“different from, or in addition to” federal requirements); Riegel, 552 U.S. at 330
(explaining that state-law claims that parallel federal requirements are not subject to
preemption). But those premarket approval requirements are generally not subject to
public disclosure. See 21 C.F.R. § 814.9(h)(1) (providing that, absent previous public
disclosure or the abandonment of premarket approval, a new device’s required
“[m]anufacturing methods or processes, including quality control procedures” are not
available for public disclosure). And here, in their complaint, the Irizarrys do not set
forth the premarket approval requirements for the Perclose Closure Device. Without
doing so, they do not provide any non-conclusory, non-speculative allegations to support
a parallel claim. See, e.g., Third Am. Compl. ¶ 54(h) (JA178–79) (alleging the
conclusion that Abbott “manufactur[ed] the device in deviation of the manufacturing
specifications approved by the FDA in the defendants’ premarket approval application in
violation of the Federal Food, Drug and Cosmetic Act”); accord id. ¶ 74(h) (JA185).

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Absent reference to actual premarket approval requirements, the Irizarrys do not
plausibly allege that Abbott abridged a state-law duty that neither adds to nor differs from
the federal premarket approval requirements.
As a workaround, the Irizarrys rely on an expert, whose report they attach to the
complaint. But that report does not constitute a “written instrument” and therefore cannot
be incorporated into the complaint for purposes of the plausibility analysis. Fed. R. Civ.
P. 10(c); see Rose v. Bartle, 871 F.2d 331, 339 n.3 (3d Cir. 1989). Nor do the allegations
in the complaint based on the expert report – that two devices from the same
manufacturing lot failed – carry the case past the threshold of plausibility for stating
parallel claims, even with all reasonable inferences drawn in favor of the Irizarrys. See
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (“Where a complaint pleads facts that are
‘merely consistent with’ a defendant’s liability, it ‘stops short of the line between
possibility and plausibility of entitlement to relief.’” (quoting Bell Atl. Corp. v. Twombly,
550 U.S. 544, 557 (2007))); In re Schering Plough Corp. Intron/Temodar Consumer
Class Action, 678 F.3d 235, 243 (3d Cir. 2012) (“While the plausibility standard does not
impose a ‘probability requirement,’ it does demand ‘more than a sheer possibility that a
defendant has acted unlawfully.’” (quoting Iqbal, 550 U.S. at 678)).
In sum, the civil rules do not require the Irizarrys to plead parallel, non-preempted
claims. But in anticipation of Abbott’s preemption affirmative defenses, the Irizarrys
attempt to plead not merely state-law claims, but parallel, non-preempted state-law
claims. The Irizarrys fail to meet their self-imposed heightened pleading standard

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because, by not setting forth the federal premarket approval requirements for the Perclose
Closure Device, they do not plausibly allege a violation of state law parallel to those
requirements. Accordingly, we will affirm the District Court’s judgment dismissing this
case with prejudice.

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