UNITED STATES COURT OF APPEALS
                            FOR THE THIRD CIRCUIT

                                       No. 19-3574



                     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)



 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.
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

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.

       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)


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

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.