Naquin v. Medtronic, Inc.
| Decision Date | 02 December 2020 |
| Docket Number | CIVIL ACTION NO. 20-2401 SECTION M (5) |
| Parties | MATTHEW NAQUIN v. MEDTRONIC, INC. |
| Court | U.S. District Court — Eastern District of Louisiana |
Before the Court is the motion of defendant Medtronic, Inc. ("Medtronic") to dismiss.1 Plaintiff Matthew Naquin opposes the motion.2 Medtronic replies in further support of its motion.3 Having considered the parties' memoranda, the record, and the applicable law, the Court issues this Order & Reasons allowing Naquin the opportunity to seek leave to amend his complaint to plead with specificity his breach-of-contract claim for services, but dismissing all other claims with prejudice.
This case arises from personal injuries resulting from allegedly defective medical devices. Naquin has a history of heart problems including coronary heart disease, congestive heart failure, two heart attacks, and a previous "heart surgery placing stents and angioplasty."4 An unidentified cardiologist recommended a Medtronic Evera XT VR Implantable Cardiac Defribrillator ("ICD") which was surgically implanted into Naquin's chest on March 30, 2016.5 The ICD included a wire component, the Sprint Quattro (the "Lead").6 The Lead was allegedlydefective which caused the entire device to fail.7
On June 23, 2019, the entire device had to be removed and replaced three years and three months after the original implantation.8 Naquin spent the next three months in the hospital recovering and faced significant medical consequences as a result.9 He alleges that the ICD was meant to last a lifetime while the Lead was represented to have a product life of ten to eleven years.10
Naquin filed suit under two primary theories of liability under Louisiana law: (1) the Louisiana Products Liability Act ("LPLA") for seven Medtronic devices11 and (2) breach of contract.12
Medtronic argues that all of Naquin's claims are preempted by federal law and should bedismissed.13 It asserts that the two core medical devices, the ICD and Lead, are Class III medical devices which complied with the federal premarket approval ("PMA") process,14 and that state-law claims seeking to impose different or additional requirements on PMA-approved medical devices are preempted by federal law.15 In addition, Medtronic argues that Naquin cannot plead a parallel state-law claim that falls within the narrow exception to federal preemption.16 In the alternative, Medtronic argues that all of Naquin's claims are subsumed under the LPLA and he has not pleaded sufficient facts to allege such a claim.17
In opposition, Naquin argues that Medtronic's motion does not address all seven of the medical devices at issue or all three of the causes of action he alleges in his complaint.18 To avoid the preemption that accompanies the "rigorous" PMA process, he argues that Medtronic may have used an abbreviated PMA process.19 Naquin urges that he pleaded a non-preempted parallel claim under the LPLA.20 His breach-of-contract claim, he contends, should not be subsumed under the LPLA because Medtronic is not just a manufacturer but also a provider of services.21 He asserts that motions to dismiss are viewed with disfavor and rarely granted and that he has sufficiently pleaded the elements of his claims.22
The Federal Rules of Civil Procedure require a complaint to contain "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2). Rule 8 "does not require 'detailed factual allegations,' but it demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)). The statement of the claim must "'give the defendant fair notice of what the ... claim is and the grounds upon which it rests.'" Twombly, 550 U.S. at 555 (quoting Conley v. Gibson, 355 U.S. 41, 47 (1957)). A pleading does not comply with Rule 8 if it offers "labels and conclusions," "a formulaic recitation of the elements of a cause of action," or "'naked assertions' devoid of 'further factual enhancement.'" Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 555, 557) (alteration omitted).
Rule 12(b)(6) of the Federal Rules of Civil Procedure permits a party to move to dismiss for "failure to state a claim upon which relief can be granted." Fed. R. Civ. P. 12(b)(6). "To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.'" Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 570). A claim is plausible on the face of the complaint "when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. (citing Twombly, 550 U.S. at 556). Plausibility does not equate to probability, but rather "it asks for more than a sheer possibility that a defendant has acted unlawfully." Id. (citing Twombly, 550 U.S. at 556). "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."'" Id. (quoting Twombly, 550 U.S. at 557). Thus, if the facts pleaded in the complaint "do not permit the court to infer more than the mere possibility ofmisconduct, the complaint has alleged - but it has not 'shown' - 'that the pleader is entitled to relief.'" Id. at 679 (quoting Fed. R. Civ. P. 8(a)(2)) (alteration omitted).
In considering a Rule 12(b)(6) motion to dismiss for failure to state a claim, a court employs the two-pronged approach utilized in Twombly. The court "can choose to begin by identifying pleadings that, because they are no more than conclusions [unsupported by factual allegations], are not entitled to the assumption of truth." Iqbal, 556 U.S. at 679. However, "[w]hen there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement to relief." Id. "[The] task, then, is to determine whether the plaintiff has stated a legally cognizable claim that is plausible, not to evaluate the plaintiff's likelihood of success." Body by Cook, Inc. v. State Farm Mut. Auto. Ins., 869 F.3d 381, 385 (5th Cir. 2017) (quoting Doe ex rel. Magee v. Covington Cty. Sch. Dist., 675 F.3d 849, 854 (5th Cir. 2012)). Motions to dismiss are disfavored and rarely granted. Turner v. Pleasant, 663 F.3d 770, 775 (5th Cir. 2011) (citing Harrington v. State Farm Fire & Cas. Co., 563 F.3d 141, 147 (5th Cir. 2009)).
A court's review of a Rule 12(b)(6) motion to dismiss "is limited to the complaint, any documents attached to the complaint, and any documents attached to the motion to dismiss that are central to the claim and referenced by the complaint." Lone Star Fund V (U.S.), L.P. v. Barclays Bank PLC, 594 F.3d 383, 387 (5th Cir. 2010) (citing Collins v. Morgan Stanley Dean Witter, 224 F.3d 496, 498-99 (5th Cir. 2000)). A court may also take judicial notice of certain matters, including public records and government websites. Dorsey v. Portfolio Equities, Inc., 540 F.3d 333, 338 (5th Cir. 2008); see also Kitty Hawk Aircargo, Inc. v. Chao, 418 F.3d 453, 457 (5th Cir. 2005). Thus, in weighing a Rule 12(b)(6) motion, district courts primarily look to the allegations found in the complaint, but courts may also consider "documents incorporated into the complaint by reference or integral to the claim, items subject to judicial notice, mattersof public record, orders, items appearing in the record of the case, and exhibits attached to the complaint whose authenticity is unquestioned." Meyers v. Textron, Inc., 540 F. App'x 408, 409 (5th Cir. 2013) (citing Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322 (2007)).
The Medical Device Amendments of 1976, 21 U.S.C. §§ 360c et seq. ("MDA") were enacted by Congress to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq., to provide a uniform federal regulatory framework for medical devices. The MDA requirements preempt state-law claims concerning medical devices except in narrow circumstances:
To determine whether state-law claims are preempted by the MDA, a court engages in a two-step inquiry. First, a court must determine whether the federal government has established requirements applicable to the medical device in question. Riegel v. Medtronic, Inc., 552 U.S. 312, 321 (2008). Second, if there are applicable federal requirements, the inquiry shifts to consider whether the state-law claims "rely upon 'any requirement' of [state] law applicable to the [device] that is 'different from, or in addition to,' federal requirements and that 'relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device.'" Id. at 323 (quoting 21 U.S.C. § 360k(a)). If the answer is yes, the state-lawclaims are preempted by federal law and must be dismissed. Id. at 326.
The first prong of the inquiry asks whether there are federal requirements for the medical device in question. The PMA process - a "rigorous regime" in which the "FDA spends an average of 1,200 hours reviewing each application and grants premarket approval only if it finds there is a 'reasonable assurance' of the device's ...
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