HARRIS v. MEDTRONIC INC USA (2024)

ORDER

Plaintiff Terry Harris brings this putative class action, in which he asserts numerous state-law consumer and product-liability claims on behalf of himself and other similarly situated third-party consumers against Defendants Medtronic Inc. and Medtronic USA, Inc. (together, Medtronic). Medtronic moves to dismiss Harris's Amended Class Action Complaint (Amended Complaint) for failure to state a claim under Fed. R. Civ. P. 12(b)(6). Medtronic also moves to strike the class allegations from the Amended Complaint. For the reasons explained below, the Court dismisses in its entirety the Amended Complaint.

BACKGROUND

Medtronic researches, designs, and manufactures medical devices, including implantable cardioverter defibrillators (ICDs). (Doc. No. 38 [hereinafter, Am. Compl.] ¶¶ 15, 20.) An ICD is a device that is implanted in a patient to monitor the rhythm of their heart. (Id. ¶ 20.) If the device detects life-threatening irregularities in that rhythm, it “produc[es] an electric shock (cardioversion or defibrillation) to restore a normal heartbeat.” (Id. ¶ 26 n.16.)¹ Once implanted in a patient, the patient's physician monitors the ICD via an external computer. (Id. ¶ 21.)

Harris is a resident of Fulton County, Georgia. (Id. ¶ 10.) In June 2018, for a medical reason not known to the Court, Harris's doctor implanted an ICD in him that was manufactured by Medtronic. (Id. ¶¶ 11, 19.)

On May 10, 2023, Medtronic issued a statement on its website advising of a “potential” malfunction in ICD devices manufactured after July 2017.² Specifically, it advised that the affected devices had a “potential for reduced-energy or no-energy high-voltage therapy.” (Id. ¶ 22 & n.12; see also id. ¶ 27 & n.18.) The statement further explained that Medtronic was “aware of 27 devices out of ~816,000 distributed worldwide, as of April 10, 2023, that have experienced a reduced or no-energy high-voltage therapy.” (Id. ¶ 23.) That same day, Medtronic issued a voluntary recall. (Id. ¶ 27.)

The U.S. Food and Drug Administration (FDA) thereafter issued a notice regarding Medtronic's recall, which it classified as “a Class I recall, the most serious type of recall.” (Id. ¶ 26) In it, the FDA advised that the reason for the recall was that the affected ICDs “may deliver low or no energy output when high voltage therapy is needed due to inappropriate activation of the Short Circuit Protection (SCP) feature,” and as a result “may fail to correct a life-threatening arrhythmia, which can lead to cardiac arrest, other serious injury, or death.” (Id. ¶ 26 n.16.) It further advised that “additional risks of harm” arise “if a patient with one of these devices needs additional surgical procedures to remove and replace the device.” (Id.) The FDA advised that the “issue is more likely to occur for devices with a glassed feedthrough that are configured to deliver therapy in the AX>B delivered pathway.”³ (Id.) The FDA reported that, as of July 18, 2023, there had been “28 incidents, 22 injuries, and no deaths for this issue.” (Id. ¶¶ 24, 26 n.16.) Notwithstanding the recall, the FDA admonished that physicians and patients: should “not prophylactically replace devices for this issue;” that risks can be minimized through reprogramming the affected devices and that patients with “a history of high voltage therapy and Rx1 programmed AX>B” devices should be prioritized; and that providers should remotely monitor patients “following normal clinical protocol.” (Id. ¶¶ 22 & n.12, 26 & n.16.)

The seven-count Amended Complaint alleges two claims under Minnesota's consumer-protection statutes and five common-law claims, including claims for unjust enrichment, breach of express warranty, breach of implied warranty, strict product liability—manufacturing defect, and negligent design defect.⁴ (See generally Am. Compl.) Harris alleges that he has been injured in the following three ways: (1) his ICD device “is causing severe discomfort and blood clots in his arm” (id. ¶¶ 13–14); (2) he is “at risk of additional extensive medical procedures in order to rectify the defective Device” (id. ¶ 14); and (3) he “spent money to purchase the medical device he would not otherwise have purchased absent Defendants’ misconduct and failure to adhere to current good manufacturing practices.” (Id. ¶ 13.) Harris purports to bring these claims on behalf of himself, a “Nationwide Class,” and a “Georgia Sub-Class” of consumers. (Id. ¶¶ 29–38.)

DISCUSSION

I. MEDTRONIC'S MOTION TO DISMISS

Medtronic moves to dismiss the Amended Complaint on grounds that Harris has failed to state any plausible claim for relief. On a motion to dismiss under Fed. R. Civ. P. 12(b)(6), courts consider all facts alleged in the complaint to be true and then determine whether it states a “claim to relief that is plausible on its face.” Braden v. Wal-Mart Stores, Inc., 588 F.3d 585, 594 (8th Cir. 2009) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009)). A pleading has facial plausibility when its factual allegations “allow[ ] the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678, 129 S.Ct. 1937. In this analysis, the Court construes the allegations and draws inferences from them in the light most favorable to the plaintiff. Park Irmat Drug Corp. v. Express Scripts Holding Co., 911 F.3d 505, 512 (8th Cir. 2018). However, the Court will not give the plaintiff the benefit of unreasonable inferences, Brown v. Medtronic, Inc., 628 F.3d 451, 461 (8th Cir. 2010), and is “not bound to accept as true a legal conclusion couched as a factual allegation.” Papasan v. Allain, 478 U.S. 265, 286, 106 S.Ct. 2932, 92 L.Ed.2d 209 (1986).

Medtronic argues that Harris lacks standing to raise his seven claims and that all of his claims are federally preempted. Medtronic further asserts that, even absent their standing and preemption defects, each of Harris's claims fails for other reasons. As discussed below, the Court agrees that the Amended Complaint must be dismissed for lack of Article III standing and because all claims are preempted.

A. Article III Standing

Medtronic argues that Harris lacks standing to pursue any of his claims under Article III of the U.S. Constitution. Standing is a jurisdictional prerequisite; as a result, it must be established before this Court can reach the merits of Harris's claims. City of Clarkson Valley v. Mineta, 495 F.3d 567, 569 (8th Cir. 2007); see also Fed. R. Civ. P. 12(h)(3) (providing that courts must dismiss any part of lawsuit over which it lacks subject-matter jurisdiction). Standing is determined based on the facts as they existed at the time the complaint was filed. Lujan v. Defs. of Wildlife, 504 U.S. 555, 561, 569 n.4, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). When assessing Article III standing, courts assume “that on the merits the plaintiff[ ] would be successful in [his] claims.” Am. Farm Bureau Fed'n v. U.S. Env't Prot. Agency, 836 F.3d 963, 968 (8th Cir. 2016) (quotation omitted). Courts then determine whether a plaintiff alleges the following three elements: (1) the plaintiff has experienced an injury-in-fact; (2) the claimed injury is “fairly traceable” to the conduct complained of; and (3) the relief sought will redress the claimed injury. E.g., Lujan, 504 U.S. at 560–61, 112 S.Ct. 2130 (listing elements and noting that the party invoking federal jurisdiction carries the burden of proof).

i. Injury-in-Fact

In the Amended Complaint, Harris alleges that Medtronic's ICDs are defective because they fail to deliver sufficient voltage therapy and, as a result, he suffered an economic injury. “[Harris] suffered injury in fact when he spent money to purchase the [ICD] he would not otherwise have purchased absent Defendants’ misconduct and failure to adhere to current good manufacturing practices ․” (Am. Compl. ¶ 13.) Medtronic contends that Harris's alleged economic injury is insufficient to confer standing because his ICD has not manifested the complained-of defect. (Doc. No. 44 at 9–12.) The Court agrees.

An injury-in-fact is “an invasion of a legally protected interest” that is both “concrete and particularized” and “actual or imminent, not conjectural of hypothetical.” Lujan, 504 U.S. at 560, 112 S.Ct. 2130. An injury is “particularized” when it “affect[s] the plaintiff in a personal and individual way.” Wallace v. ConAgra Foods, Inc., 747 F.3d 1025, 1030 (8th Cir. 2014) (quoting Lujan, 504 U.S. at 560 n.1, 112 S.Ct. 2130).

It is well-established in this Circuit that because an injury must be particular to the plaintiff, “purchasers of an allegedly defective product have no legally recognizable claim where the alleged defect has not manifested itself in the product they own.” O'Neil v. Simplicity, Inc., 574 F.3d 501, 503 (8th Cir. 2009). The Eighth Circuit's decision in In re Polaris Mktg., Sales Pracs., & Prod. Liab. Litig., 9 F.4th 793 (8th Cir. 2021), a putative class action brought by fourteen consumers against an offroad vehicle manufacturer, illustrates this principle. In Polaris, the plaintiffs alleged that a design defect caused their vehicles’ engines to produce excessive heat, which increased the risk of catastrophic fires. Id. at 794–95. Half of the putative plaintiffs’ vehicles had caught fire and were consequently destroyed; however, vehicles belonging to the other half (the no-fire plaintiffs) had not. Id. at 795. The Eighth Circuit affirmed the district court's dismissal of the no-fire plaintiffs’ claims on grounds that they lacked Article III standing. Id. In doing so, the court noted that the no-fire plaintiffs did not allege that “any manifest defect is present in their vehicles,” but instead alleged “nothing more than the existence of a defect in a product line or ownership of a product that is at risk for manifesting a defect.” Id. at 797. This, the court concluded, was insufficient to confer Article III standing.⁵ Id.; see also O'Neil, 574 F.3d at 503 (affirming dismissal of product-liability action brought by owners of cribs that were subject to manufacturer recall on grounds that plaintiffs’ failure to allege that their crib had manifested defect was “fatal to their case”).

Just as the no-fire plaintiffs in Polaris, Harris does not allege that his ICD has manifested the claimed defect. In fact, at the hearing on this motion, when asked whether Harris's ICD has manifested the alleged defect, Harris's counsel conceded that it had not: “This device has not manifested the defect in that it has not failed to send enough charge or no charge at all in this particular instance.” Moreover, the FDA's recall notice explains that the risk of injury from the recalled ICDs can be resolved by external reprogramming. (Am. Compl. ¶ 27 n.18).⁶ Harris has not alleged that this statement is false or that, despite external reprogramming, his ICD remains defective. Thus, Harris cannot satisfy his standing requirements as set forth in Polaris.

After conceding that his ICD has not manifested the complained-of defect, however, Harris argued that Polaris is inapposite because the nature of his potential injury in the event his device manifested the claimed defect was more severe than the potential injury a plaintiff would experience in Polaris. He contended that demonstrating a high probability of a severe injury is sufficient to state an injury-in-fact. However, Harris did not cite,⁷ and the Court is not aware of, any legal authority that supplants Polaris or otherwise sets forth such a standard.⁸ Indeed, adoption of this alternative standard would conflict with well-settled precedent that precludes standing for injuries that are “conjectural or hypothetical.” Lujan, 504 U.S. at 560, 112 S.Ct. 2130. Because Harris has not alleged more than a mere “risk” or “potential” for future harm, the Court declines to depart from binding precedent here. In addition, even if Harris's urged standard existed, the allegations in the Amended Complaint would not satisfy it. Harris does not allege that his ICD poses a high probability of serious injury or harm to him. To the contrary, the FDA's recall notice describes a “rare potential for reduced- or no-energy output during high voltage (HV) therapy.” (Am. Compl. ¶ 27 n.18 (emphasis added).) As a result, Harris only alleges that, at most, his device has a “rare potential” to manifest a defect, not that his device has a high probability of severe injury.

Like the no-fire plaintiffs in Polaris, Harris alleges only a “potential” defect in a product line and has admitted that his ICD has not manifested the complained-of defect. As a result, his alleged economic injury is not an injury-in-fact.

ii. Traceability of Injury

Harris also alleges that he has experienced personal injury in the form of “severe discomfort and blood clots in his arm” and that he will experience future personal injury in the form of “additional extensive medical procedures in order to rectify the defective Device.” (Am. Compl. ¶ 14.) Medtronic argues that these claimed personal injuries are not “fairly traceable” to Medtronic's allegedly wrongful conduct and, as a result, are insufficient to confer standing. The Court agrees.

Harris does not allege that the “severe discomfort and blood clots in his arm” are caused by the alleged defect in his device (i.e., failure to produce sufficient voltage therapy). In fact, Harris admits that his device has not manifested the defect at all. Further, Harris's allegations that he is at risk of future medical procedures to rectify the ICD's defect directly conflict with the statement from the FDA (which he incorporated into the Amended Complaint) instructing treating physicians not to perform invasive procedures to remove the device, but to resolve the defect by externally reprograming the ICDs. (E.g., Am. Compl. ¶¶ 22 n.12, 26 n.16.) The Court concludes that Harris fails to allege any causal connection between his alleged personal injuries and the defects in his ICD and, as a result, he lacks standing. Lujan, 504 U.S. at 560, 112 S.Ct. 2130.

B. Federal Preemption

Medtronic also argues that Harris's claims are preempted by the Food, Drug, and Cosmetic Act (FDCA), as amended by the Medical Device Amendments (MDAs), 21 U.S.C. § 301, et seq., pursuant to the reasoning set forth in In re Medtronic, Inc. Sprint Fidelis Leads Prod. Liab. Litig. (Sprint Fidelis II), 623 F.3d 1200 (8th Cir. 2010). Even if Harris had standing, the Court alternatively concludes that federal law preempts all of Harris's claims.

Congress enacted the MDAs to create a pre-market approval (PMA) process to ensure the safety and effectiveness of medical devices intended for human use. Medtronic, Inc. v. Lohr, 518 U.S. 470, 474, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). The MDA sorts medical devices into three categories or “classes,” which are meant to denote the varying degrees of risk of injury or illness a device may pose to the public. 21 U.S.C. § 360c(a)(1); Riegel v. Medtronic, Inc., 552 U.S. 312, 317, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). Under this scheme, Class I devices are the least risky to the public and require few, if any, manufacturing controls. Class III devices pose the highest risk and therefore are subject to the highest level of scrutiny by the agency. 21 U.S.C. § 360c(a)(1); Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 344, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). Before Class III devices may be marketed to the public, they must undergo a “rigorous” process to obtain pre-market approval. In re Medtronic, Inc. Sprint Fidelis Leads Prod. Liab. Litig. (Sprint Fidelis I), 592 F. Supp. 2d 1147, 1150 (D. Minn. 2009) (citing 21 U.S.C. § 360e(d)(2)). Once approved, a manufacturer may not alter its design, manufacturing process, labeling, or other attributes that bear on the device's safety unless the manufacturer makes certain supplemental filings with the FDA. Sprint Fidelis II, 623 F.3d at 1203 (citing 21 C.F.R. § 814.39(a)). This PMA process is meant to provide the FDA with “reasonable assurance” that the device is both safe and effective.⁹ Sprint Fidelis I, 592 F. Supp. 2d at 1150 (citing 21 U.S.C. § 360e(d)(2)).

Medtronic argues that Harris's claims, all of which arise under state law, are preempted by the FDCA.¹⁰ Congress “does not cavalierly pre-empt state-law causes of action,” and instead does so only in cases where such preemption is the “clear and manifest purpose” of a federal statute. Lefaivre v. KV Pharm. Co., 636 F.3d 935, 938 (8th Cir. 2011). The MDA's preemption clause provides as follows:

Except as provided in subsection (b), no 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 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).

The Supreme Court has ruled that, for purposes of FDCA preemption, the PMA process is a safety review that results in “federal requirements” specific to the approved device. Accordingly, common law product liability claims result in “state requirements” that are preempted to the extent they relate to the safety and effectiveness of the device and are different from, or in addition to, the federal requirements. Sprint Fidelis II, 623 F.3d at 1204–05 (citing 21 U.S.C. § 360k(a) and Riegel, 552 U.S. at 322–24, 128 S.Ct. 999). However, a state may provide a damages remedy for claims premised on a violation of the FDCA—these duties are considered “parallel” federal requirements instead of “additional” requirements—and do not run afoul of section 360k(a). Id. Further, the FDCA provides that all actions to enforce FDA requirements “shall be by and in the name of the United States.” Id. (citing 21 U.S.C. § 337(a)). This means that suits by private citizens simply alleging noncompliance with the FDA's medical device provision are barred. Buckman, 531 U.S. at 349 n.4, 121 S.Ct. 1012.

As a result, there is but a “narrow gap” through which state-law claims like Harris's “must fit if [they] [are] to escape express or implied preemption”—these are so-called “parallel” claims. Sprint Fidelis II, 623 F.3d at 1204 (quotation omitted). The “critical question” when determining whether a claim is “parallel” is whether it implicates or otherwise involves “conduct that violates the FDCA” but not “because the conduct violates the FDCA.” Id. at 1204 (quotation omitted) (emphasis in original). Such a claim is one that “would not impose safety or effectiveness requirements that are different from or in addition to the federal requirements.” Edwards v. Thoratec LLC, 532 F. Supp. 3d 786, 792 (D. Minn. 2021). To elude FDCA preemption, “parallel” claims must be “pled with sufficient specificity regarding how a device deviated from its PMA specifications.” Id. (denying motion to dismiss manufacturing defect claim against medical-device manufacturer where plaintiff pleaded “a violation of a specific PMA requirement” that “caused the injury”); Cf. Reed v. St. Jude Med., No. 17-CV-5560 (JRT/HB), 2018 WL 4293146, at *4 (D. Minn. Jul. 24, 2018), report and recommendation adopted 2018 WL 4251872 (Sept. 6, 2018) (concluding plaintiff's state-law claims that a medical device was defective were preempted because plaintiff did not “describe how the alleged defect violates a specification of the device's PMA”).

Non-“parallel” claims are consistently barred as preempted by the FDCA at the pleading stage in this Circuit and District. E.g., Sprint Fidelis II, 623 F. 3d at 1203 (holding that plaintiff's claims against medical device manufacturer, as pleaded, for design defect, manufacturing defect, failure to warn, breach of express warranty, and fraud are preempted by MDA); ASEA/AFSCME Loc. 52 Health Benefits Tr. v. St. Jude Med., LLC, 362 F. Supp. 3d 642, 645, 649 (D. Minn. 2019) (dismissing claims for failure to warn, breaches of express and implied warranties, negligence, strict liability—manufacturing defect, product liability—manufacturing defect, violation of consumer-protection statutes, misrepresentation by omission, and unjust enrichment regarding allegedly defective medical device as preempted); Kinetic Co., Inc. v. Medtronic, Inc., No. 08-CV-6062 (PJS/AJB), 2011 WL 1485601 (D. Minn. Apr. 19, 2011) (dismissing claims regarding safety of medical device under state consumer-protection statutes, for breach of express warranty, and unjust enrichment as “squarely preempted” by Sprint Fidelis II, and for breach of implied warranty and breach of assumed contractual warranty obligations as preempted as pleaded); see also Pinsonneault v. St. Jude Med., Inc., 953 F. Supp. 2d 1006, 1013–20 (D. Minn. 2013) (denying motion to amend complaint to include proposed claims for negligence, failure to warn, and breach of express warranty as futile because such claims are preempted under Sprint Fidelis II and Kinetic).

Here, Medtronic argues that the FDCA preempts all of Harris's seven claims, which challenge the safety and effectiveness of his ICD, because his ICD is a Class III devices that was subject to the FDCA, including the PMA process. Harris counters that his claims are “parallel” claims that elude FDCA preemption. For the reasons discussed below, the Court cannot agree.

In Counts One through Five, Harris alleges that Medtronic misrepresented the safety and effectiveness of the ICDs to the public in violation of Minnesota's consumer-protection statutes, was unjustly enriched by their sale, and is in breach of the express and implied warranties of merchantability. To succeed on these claims, Harris would be required to show that the ICDs were unsafe and defective or not reasonably safe for their intended use, “which is no different than persuading a jury that the devices are not ‘safe and effective.’ ” Kinetic, 2011 WL 1485601, at *4 (dismissing Minnesota consumer-protection claims, unjust enrichment claim, and implied warranty claim as preempted by FDCA); see also Sprint Fidelis II, 623 F.3d at 1207–08 (affirming dismissal of state-law warranty claims as conflict preempted by FDCA); ASEA/AFSCME Loc. 52, 362 F. Supp. 3d at 650. Such a finding would necessarily be “contrary to the FDA's approval of the PMA,” which, in turn, means the claims cannot be parallel. Kinetic, 2011 WL 1485601, at *4.

In Counts Six and Seven, Harris alleges that the ICDs suffer from manufacturing and design defects. However, his allegations in support of these claims are conclusory and lack the requisite detail and particularity to elude preemption as a parallel claim. A manufacturing or design defect claim may survive FDCA preemption only if a plaintiff adequately alleges a specific violation of the device's PMA process. Cf. Sprint Fidelis II, 623 F.3d at 1206–07 (dismissing manufacturing defect claim because it was preempted “as pleaded and argued” because plaintiff did not identify which PMA requirement defendant allegedly breached and dismissing design defect claim for lack of allegations that device deviated from device as approved in PMA process (emphasis in original)); Edwards, 532 F. Supp. 3d at 792 (concluding plaintiff's medical-device manufacturing claim was not preempted because he identified in his complaint specific PMA provisions to which device did not adhere and that also constituted violation of state law). Harris does not reference the PMA process anywhere in the Amended Complaint, much less a specific violation of or deviation from it. (See generally Am. Compl.) As a result, he does not identify which specific PMA requirement Medtronic allegedly violated during the manufacturing and/or design of the ICDs. (See Am. Compl.) Therefore, Counts Six and Seven, as pleaded, are preempted. See Sprint Fidelis II, 623 F.3d at 1206–07.¹¹

II. TYPE OF DISMISSAL

Courts ultimately have discretion to decide between a dismissal with prejudice and one without prejudice. See Paisley Park Enters., Inc. v. Boxill, 361 F. Supp. 3d 869, 880 n.7 (D. Minn. 2019). In general, dismissals without prejudice are favored in this Circuit. E.g., Michaelis v. Neb. State Bar Ass'n, 717 F.2d 437, 438–39 (8th Cir. 1983). However, a dismissal with prejudice is typically appropriate when a plaintiff has shown “persistent pleading failures” despite one or more opportunities to amend or when the record makes clear that amendment would be futile. See Paisley Park, 361 F. Supp. 3d at 880 n.7; O'Neil v. Simplicity, Inc., 553 F. Supp. 2d 1110, 1119 (D. Minn. 2008) (dismissing with prejudice after plaintiff had three opportunities to replead but failed to do so with success); Milliman v. Cnty. of Stearns, No. 13-CV-136 (DWF/LIB), 2013 WL 5426049, at *16 (D. Minn. Sept. 26, 2013) (dismissing with prejudice for consistent pleading failures). Dismissal without prejudice may also be justified when a plaintiff's claims “might conceivably be repleaded with success.” Washington v. Craane, No. 18-CV-1464 (DWF/TNL), 2019 WL 2147062, at *5 (D. Minn. Apr. 18, 2019), report and recommendation adopted, 2019 WL 2142499 (D. Minn. May 16, 2019).

Most of Harris's claims cannot “conceivably be repleaded with success.” See Craane, 2019 WL 2147062, at *5. As discussed above in Part I.B., Counts One through Five are squarely preempted by the FDCA. As a consequence, Harris cannot conceivably replead these claims with success and they will be dismissed with prejudice. Counts Six and Seven, on the other hand, could “conceivably be repleaded with success” if Harris adequately alleged a specific violation of the device's PMA process and if Harris cures his standing defect. For that reason, Counts Six and Seven will be dismissed without prejudice.

ORDER

Based on the foregoing, and on all of the files, records, and proceedings herein, IT IS HEREBY ORDERED THAT:

1. Medtronic's motion to dismiss (Doc. No. 43) is GRANTED.

a. Counts One through Five are dismissed WITH PREJUDICE.

b. Counts Six and Seven are dismissed WITHOUT PREJUDICE.

2. Medtronic's motion to strike Harris's class allegations (Doc. No. 47) is DENIED as moot.

LET JUDGMENT BE ENTERED ACCORDINGLY.

FOOTNOTES

1.   Generally, the Court may not consider matters outside of the pleadings on a motion to dismiss under Fed. R. Civ. P. 12(b)(6). E.g., Enervations, Inc. v. Minn. Mining & Mfg. Co., 380 F.3d 1066, 1069 (8th Cir. 2004). However, the Court may consider documents that are “necessarily embraced by the pleadings” (i.e., those documents “whose contents are alleged in a complaint and whose authenticity no party questions, but which are not physically attached to the pleading”). Kushner v. Beverly Enters., Inc., 317 F.3d 820, 831 (8th Cir. 2003) (citation omitted). Harris provides citation to several websites to support his allegations in the Amended Complaint, including the notice of recall published by the U.S. Food and Drug Administration. (See, e.g., Am. Compl. ¶¶ 20–27, 33.) Medtronic does not dispute the authenticity of these materials; in fact, it provided the Court with printed copies of them in support of its motion to dismiss. (See Doc. No. 45 at Exs. C–G.) The Court thus considers these documents when resolving this motion, as they are “necessarily embraced by” the Amended Complaint.

2.   The Amended Complaint does not contain any allegations concerning the manufacturing date of the specific device implanted in Harris. (See generally Am. Compl.)

3.   Harris does not specify whether his device was configured to deliver therapy in the AX>B pathway. (See generally Am. Compl.)

4.   In the Amended Complaint, Harris did not specify under which state's laws his five common-law claims (i.e., Counts Three through Seven) arise. However, at oral argument on Medtronic's motions, Harris's counsel clarified, and Medtronic's counsel did not dispute, that Harris's claims arise under Minnesota law.

5.   In his briefing, Harris suggested that the utility of Polaris is limited because here the alleged defect is endemic to all of the ICDs sold after 2017, whereas in Polaris, the alleged defect did not affect all vehicles. (See Doc. No. 53 at 12.) Harris relies on a single sentence from Johannessohn v. Polaris Indus., Inc., 9 F.4th 981, 987 (8th Cir. 2021), but the Court does not agree with this characterization. Contrary to Harris's suggestion, the Johannessohn decision reiterates the holding from Polaris that plaintiffs alleging economic injury do not have an injury-in-fact unless they “allege that their product actually exhibited the alleged defect.” Johannessohn, 9 F.4th at 987 (emphasis added).

6.   Further, the recall notice state that “[t]he issue is more likely to occur for devices with a glassed feedthrough that are configured to deliver therapy in the AX>B delivered pathway.” (Am. Compl. ¶ 26 n.16.) Harris does not allege that his device had such a feature or programming. (See id.)

7.   Although Harris referenced In re Zurn Pex Plumbing Prods. Liab. Litig., 644 F.3d 604 (8th Cir. 2011), in his oral argument, the Court is not persuaded to adopt Harris's interpretation of this case. Contrary to the factual allegations in the Amended Complaint, the defect in Zurn Pex (that brass fittings disposed to corrosion cracking existed in plaintiffs’ piping systems) was alleged to be “already manifest in all systems,” and expert testimony indicated that the defect would inevitably manifest. 644 F.3d at 608–09, 617. As noted above, Harris does not allege that his ICD will inevitability fail to deliver appropriate voltage therapy but that his ICD has, at most, “a potential for reduced-energy or no-energy high-voltage therapy.” (Am. Compl. ¶¶ 11, 19, 22–27.) A “potential” is not an inevitability, and Harris's reliance on Zurn Pex is misplaced.

8.   Such a standard is also elusive, and Harris's counsel was unable to articulate what degree of probability is high enough, and what nature of injury is serious enough, to satisfy it.

9.   Class III devices also may enter the market through an FDA review for substantial equivalence (which focuses on equivalence, not safety) under section 510(k). Riegel, 552 U.S. at 317, 323, 128 S.Ct. 999.

10.   In the Amended Complaint, Harris does not make any allegations regarding the FDA's regulation of the ICDs (including into which “class” they belong under the MDAs) and, therefore, whether the devices are subject to the rigors of the PMA process. (See generally Am. Compl.) Harris does, however, provide citation in the Amended Complaint to an FDA website regarding Medtronic's recall of ICDs that refers to a “PMA Number” that corresponds to the ICDs. (Am. Compl. ¶ 27 n.18.) From this, and Harris's lack of affirmative challenge to the applicability of an FDCA preemption analysis, the Court can make the reasonable inference that the ICDs are Class III devices and, thus, that Medtronic's urged FDCA preemption analysis is appropriate.

11.   In light of the Court's decisions regarding standing and preemption, the Court declines to consider Medtronic's other alternative arguments. Likewise, because the Court has concluded that the Amended Complaint should be dismissed, it need not consider Medtronic's ancillary motion to strike the class action allegations under Fed. R. Civ. P. 12(f). Where, as here, a case has just one class representative who lacks standing at the time the complaint was filed, “then the court lacks jurisdiction over the case and it must be dismissed.” Oetting v. Norton, 795 F.3d 886, 892 (8th Cir. 2015); see also Thunander v. Uponor, Inc., 887 F. Supp. 2d 850, 863 (D. Minn. 2012); Fed. R. Civ. P. 23(a) (providing that class representatives be members of class). Thus, Medtronic's motion to strike is moot.

Jeffrey M. Bryan, United States District Judge