Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-alnd-4_24-cv-01328/USCOURTS-alnd-4_24-cv-01328-0/pdf.json

Parties Involved:
Boston Scientific Corp.
Defendant
Charity Walters
Plaintiff

Document Text:

UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF ALABAMA

MIDDLE DIVISION

CHARITY WALTERS,

Plaintiff,

v.

BOSTON SCIENTIFIC CORP.,

Defendant.

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}

}

}

}

}

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Case No.: 4:24-cv-01328-RDP

MEMORANDUM OPINION

This case is before the court on Defendant Boston Scientific Corporation’s (“BSC”) 

Motion to Dismiss. (Doc. # 2). The Motion has been fully briefed (Docs. # 2, 6, 7). After careful 

consideration, the court concludes that BSC’s Motion (Doc. # 2) is due to be granted.

I. Background and Procedural History

Plaintiff Charity Walters (“Walters”), as personal representative of the estate of Naomi Joy 

Lee (“Lee”), has filed suit against Defendant BSC, asserting claims of products liability, 

negligence, breach of warranty, and wrongful death. (Doc. # 1-1). 

In her complaint, Walters alleges that on or about March 22, 2022, Lee was prescribed and 

began using a defibrillator that was manufactured by BSC. (Id. ¶ 5). According to Walters, the 

defibrillator was model number 82191and was intended to “monitor Lee’s heart rhythm and 

deliver an electric shock if necessary to restore normal heart rhythm.” (Id. ¶ 6). However, Walters 

alleges that on September 7, 2024, the defibrillator failed to operate as intended. (Id. ¶ 7). Although 

Plaintiff alleges that Lee suffered a cardiac event and died on September 7, 2024 (Doc. # 1-1 ¶ 7), this 

1

In its motion to dismiss, BSC contends that the defibrillator is an “EMBLEM MRI S-ICD® product bearing 

the identification number A219/150459.” (Doc. # 2 at 1). It also describes the defibrillator as a “‘Class III’ 

subcutaneous implantable defibrillator system that provides defibrillation therapy in patients who are at risk for sudden 

cardiac arrest.” (Id. at 1-2).

FILED

 2024 Dec-17 PM 01:50

U.S. DISTRICT COURT

N.D. OF ALABAMA

Case 4:24-cv-01328-RDP Document 10 Filed 12/17/24 Page 1 of 9
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action was filed the day prior on September 6, 2024. (Doc. # 1-1). BSC alleges in its Notice of Removal 

that “[u]pon information and belief, Lee actually died on September 27, 2022.” (Doc. # 1 at 2 n.1). For 

these reasons, the court assumes that the alleged cardiac event and Lee’s death actually occurred on 

September 27, 2022. On that day, Lee experienced a “cardiac event requiring intervention,” but the 

defibrillator failed to send a signal to the monitoring clinic, “as it was designed and intended to 

do.” (Id.). Walters further alleges that “[a]s a result of the defibrillator’s failure, Lee did not receive 

timely medical intervention.” (Id. ¶ 8). Additionally, Walters alleges that the defibrillator caused 

burns to Lee’s body (id. ¶ 9) and that “[a]s a direct and proximate result of the defibrillator’s 

failure, Lee suffered severe injuries and ultimately died on September [27, 2022].” (Id. ¶ 10).

This action was originally filed in the Circuit Court of St. Clair County, Alabama. (Doc. # 

1-1). BSC timely removed the case on September 30, 2024. (Doc. # 1).

II. Standard of Review

The Federal Rules of Civil Procedure require that a complaint provide “a short and plain 

statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). 

However, the complaint must include enough facts “to raise a right to relief above the speculative 

level.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). Pleadings that contain nothing more 

than “a formulaic recitation of the elements of a cause of action” do not meet Rule 8 standards, 

nor do pleadings suffice that are based merely upon “labels and conclusions” or “naked 

assertion[s]” without supporting factual allegations. Id. at 555, 557. In deciding a Rule 12(b)(6) 

motion to dismiss, courts view the allegations in the complaint in the light most favorable to the 

non-moving party. Watts v. Fla. Int’l Univ., 495 F.3d 1289, 1295 (11th Cir. 2007).

To survive a motion to dismiss, a complaint must “state a claim to relief that is plausible 

on its face.” Twombly, 550 U.S. at 570. “A claim has facial plausibility when the plaintiff pleads 

factual content that allows the court to draw the reasonable inference that the defendant is liable 

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for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). Although “[t]he 

plausibility standard is not akin to a ‘probability requirement,’” the “complaint must demonstrate 

‘more than a sheer possibility that a defendant has acted unlawfully.’” Id. A plausible claim for 

relief requires “enough fact[s] to raise a reasonable expectation that discovery will reveal 

evidence” to support the claim. Twombly, 550 U.S. at 556.

In considering a motion to dismiss, a court should “1) eliminate any allegations in the 

complaint that are merely legal conclusions; and 2) where there are well-pleaded factual 

allegations, ‘assume their veracity and then determine whether they plausibly give rise to an 

entitlement to relief.’” Kivisto v. Miller, Canfield, Paddock & Stone, PLC, 413 F. App’x 136, 138 

(11th Cir. 2011) (quoting Am. Dental Ass’n v. Cigna Corp., 605 F.3d 1283, 1290 (11th Cir. 2010)). 

That task is context specific and, to survive the motion, the allegations must permit the court based 

on its “judicial experience and common sense . . . to infer more than the mere possibility of 

misconduct.” Iqbal, 556 U.S. at 679. If the court determines that all the well-pleaded facts, 

accepted as true, do not state a claim that is plausible, the claims are due to be dismissed. Twombly, 

550 U.S. at 570.

III. Analysis

Walters asserts four claims against BSC: strict products liability, negligence, breach of 

warranty, and wrongful death. (Doc. # 1-1). In its Motion to Dismiss, BSC argues that none of 

Walters’s allegations state a claim upon which relief can be granted because they are expressly 

preempted by federal law. (Doc. # 2). Below, the court considers BSC’s preemption argument and 

ultimately concludes that Walters’s claims are in fact preempted. 

Preemption finds its authority in the Supremacy Clause of the United States Constitution, 

which provides: “the Laws of the United States . . . shall be the supreme Law of the Land.” U.S. 

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Const. art. VI, cl. 2. Thus, “it has been settled that state law that conflicts with federal law is 

‘without effect.’” Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992) (quoting Maryland 

v. Louisiana, 451 U.S. 725, 746 (1981)).

Congress passed the Medical Device Amendments (“MDA”) of 1976 to the Federal Food, 

Drug, and Cosmetic Act (“FDCA”), giving the FDA regulatory authority over medical devices. 

Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008) (citing 21 U.S.C. § 360(c)). Under this 

authority, the FDA classifies medical devices into three categories (depending on the level of risk 

presented) and then approves the medical devices for entry into the market by evaluating each 

device’s effectiveness and safety – known as premarket approval (“PMA”). Mink v. Smith & 

Nephew, 860 F.3d 1319, 1325 (11th Cir. 2017). 

The approval process for medical devices (particularly Class III devices, which is the 

highest category of risk) is rigorous and requires the FDA to spend (on average) over 1,200 hours 

reviewing each application. Riegel, 552 U.S. at 317-18 (internal citations omitted). Unsurprisingly 

then, an application includes large amounts of data on the effectiveness and safety of the device 

under review, descriptions of facilities, manufacturing specifications, processes for device 

production, and proposed product labeling. Id.; 21 U.S.C. § 360e(c). Based on this data, and only 

after weighing the health benefits of the device’s use against the risks of injury associated with the 

device, and only after concluding that “there is a reasonable assurance” of the device’s “safety and 

effectiveness,” may the FDA grant PMA. Riegel, 552 U.S. at 318-19 (citing 21 U.S.C. §§ 360c, 

360e(d)). After the FDA grants PMA, the applicant may not make any changes to “design 

specifications, manufacturing processes, labeling, or any other attribute” that would “affect [its] 

safety or effectiveness” without first obtaining FDA approval. Id. at 319; Mink, 860 F.3d at 1325 

(citing 21 U.S.C. § 360e(d)(5)(A)(i)). 

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The court begins its analysis by examining the scope of preemption. Again, a Class III 

device is subject to “rigorous” scrutiny before the FDA approves it for commercial use. Riegel, 

552 U.S. at 312, 316. Congress, recognizing that a manufacturer cannot deviate from requirements 

in the PMA and MDA, enacted an express preemption provision that applies to Class III devices 

after their approval: 

[N]o 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) (emphasis added). Preemption goes beyond state regulatory enforcement and 

includes state common law or statutory liability. The reason for preempting state-law claims is 

simple: if a state imposes liability on a manufacturer for producing a medical device in a manner 

different from what is required under the device’s PMA (i.e., requiring a manufacturer to meet 

additional requirements), then that could upset the FDA’s “cost-benefit analysis” that a device, 

approved only after weighing the “probable benefit to health from the use of the device against 

any probable risk of injury or illness from such use,” provides a “reasonable assurance” of “safety 

and effectiveness.” Riegel, 552 U.S. at 318-19, 325.

However, this express preemption provision does not preempt state-law claims “premised 

on a violation of the FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, 

federal requirements.” Id. at 312. Unsurprisingly, these state-law claims are commonly referred to 

as “parallel claims.” Mink, 860 F.3d at 1325-26 (internal citations omitted). When analyzing a 

claim for express preemption, the issue is whether a plaintiff’s theories of liability and the facts 

supporting his or her cause of action, if enforced, would hold a defendant liable for violating 

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requirements that are beyond the FDA’s. See Purcel v. Advanced Bionics Corp., 2008 WL 

3874713, at *3 (N.D. Tex. Aug. 13, 2008). Parallel claims may be based on any requirement, 

including device-specific requirements in the PMA and the generally-applicable Good 

Manufacturing Practices (“GMP”). Mink, 860 F.3d at 1331.

There is also an implied preemption provision stating that “all such proceedings for the 

enforcement, or to restrain violations, of this chapter shall be by and in the name of the United 

States.” 21 U.S.C. § 337(a) (emphasis added); Mink, 552 U.S. at 1327. Implied preemption 

requires that the “MDA [is] . . . enforced exclusively by the Federal Government.” 21 U.S.C. § 

337(a); Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (citing 21 U.S.C. § 337(a)). 

Thus, private litigants are not “authorized to file suit for noncompliance with the medical device 

provisions.” In re Medtronic, Inc. Sprint Fidelis Leads Prod. Liab. Litig., 592 F. Supp. 2d 1147, 

1161 (D. Minn. 2009) (quoting Buckman, 531 U.S. at 349 n.4), aff’d, 623 F.3d 1200, 1205 (8th 

Cir. 2010). In other words, private litigants cannot “seek to privately enforce a duty owed to the 

FDA.” Mink, 860 F.3d at 1320. 

These two preemption provisions, when considered together, leave only a narrow gap for 

a private litigant to bring a state-law claim related to medical devices. The Eleventh Circuit has 

defined this “narrow gap” as follows:

To make it through, a plaintiff has to sue for conduct that violates a federal 

requirement (avoiding express preemption), but cannot sue only because the 

conduct violated that federal requirement (avoiding implied preemption). Putting 

these ideas into practice, . . . a plaintiff may proceed on her claim so long as she 

claims the ‘breach of a well-recognized duty owed to her under state law’ and so 

‘long as she can show that she was harmed by a violation of applicable federal law.’

Mink, 552 U.S. at 1327 (emphasis added) (internal citations omitted) (quoting Bausch v. Stryker 

Corp., 630 F.3d 546, 558 (7th Cir. 2010)). 

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Not only must the claim be premised on a duty equivalent to one required by the FDA and 

cognizable under state law, but the claim must also be connected to the alleged injury. Kubicki ex 

rel. v. Medtronic, Inc., 293 F. Supp. 3d 129, 172 (D.D.C. 2018); see id. at 1331 (citing WolickiGables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301-02 (11th Cir. 2011)).

Once a defendant invokes preemption under the MDA, the burden falls on the plaintiff to 

show that her claims are not preempted. Kubicki, 293 F. Supp. 3d at 172. This is, by necessity, a 

high burden. A plaintiff must “set forth [evidence] pointing to specific PMA requirements that 

have been violated” and that those violations caused the plaintiff’s injury. Wolicki-Gables v. Arrow 

Int’l, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011) (emphasis added) (internal citations omitted); 

Godelia, 881 F.3d at 1319-20. In other words, if a plaintiff simply claims that a defendant violated 

a federal regulation without identifying (1) the specific facts showing how a defendant violated 

either a PMA specification or a specific GMP and (2) the specific facts showing that the violation 

caused the injury at issue, then that plaintiff fails to adequately assert a parallel claim. WolickiGables, 634 F.3d at 1301 (internal citations omitted).

Here, Plaintiff has not met her burden to establish that her claims are premised on binding 

federal requirements. Moreover, Plaintiff has also not shown that Defendant’s product caused 

Lee’s injuries. Kubicki, 293 F. Supp. 3d at 172; Wolicki-Gables, 634 F.3d at 1301. 

There is a two-step inquiry for determining whether a claim is parallel or expressly 

preempted: 

First, a court must determine whether the Federal Government has established 

requirements applicable to the device. If so, [second] the court must then determine 

whether the plaintiff’s common-law claims are based upon state law requirements 

with respect to the device that are different from, or in addition to the federal ones, 

and that relate to the safety and effectiveness.

Mink, 552 U.S. at 1326. BSC argues that the first prong is satisfied because “the EMBLEM MRI 

S-ICD® is a Class III medical device that received FDA approval for commercial distribution 

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through the PMA process, resulting in a finding that the EMBLEM MRI S-ICD® is safe and 

effective.” (Doc. # 2 at 11) (see also id. (citing Original PMA Approval Order Re: P110042 (Sept. 

28, 2012)). Plaintiff does not contest this point. As such, after reviewing BSC’s cited authority, 

the court takes judicial notice of the fact that EMBLEM MRI S-ICD® was approved for 

commercial distribution by the FDA through the PMA process. 

Considering the second prong, the court finds that Walters’s state law claims are premised 

on state-law duties different from those imposed by the PMA Approval Order and relate to the 

safety and effectiveness of the defibrillator. Therefore, they are expressly preempted. 

In her Complaint, Walters does not cite to (or even mention) any relevant federal 

requirements that BSC violated in the design, manufacture, or labeling of the defibrillator. Walters 

asserts a claim for strict products liability, alleging only that “[t]he defibrillator was defective and 

unreasonably dangerous when it left Defendant’s control.” (Doc. # 1-1 ¶ 12). Similarly, she asserts 

a negligence claim, alleging that BSC “owed a duty of care to Naomi Joy Lee to design, 

manufacture, and sell a safe and effective defibrillator” (id. ¶ 14) and that BSC “breached this duty 

by failing to provide a product that performed as expected and relied upon for maintaining proper 

heart rhythm.” (Id. ¶ 15). And, pursuant to her claim for breach of warranty, Walters alleges that 

BSC “expressly and impliedly warranted that the defibrillator was safe and fit for its intended 

purpose” (id. ¶ 18) and “[t]he defibrillator was not safe or fit for its intended purpose, breaching 

these warranties.” (Id. ¶ 19). Finally, in her claim for wrongful death, Walters alleges that “[a]s a 

direct and proximate result of Defendant’s wrongful conduct as described above, Naomi Joy Lee 

died.” (Id. ¶ 22). Again, there is no mention of any federal requirement that was allegedly violated 

by BSC.

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Additionally, in response to BSC’s motion to dismiss, Walters does not address BSC’s 

preemption argument. Nor does she cite to any federal regulations that BSC allegedly violated. 

Walters’s response only includes this bare argument: “Plaintiff has sufficiently pled necessary 

elements of strict products liability, negligence, breach of warranty, and wrongful death claims.” 

(Doc. # 6 at 1).

For all of these reasons, Walters has not met her burden to plead specific violations of 

federal regulations. Wolicki-Gables, 634 F.3d at 1301-02 (holding that in order to survive § 

360k(a)’s preemptive effect, “[a] plaintiff must allege that the defendant violated a particular 

federal specification referring to the device at issue”) (internal quotation makes omitted). Thus, 

Walters’s claims are preempted under § 360k(a) and they fail as a matter of law.

IV. Conclusion

For the reasons explained above, BSC’s Motion (Doc. # 2) is due to be granted. A separate 

order in accordance with this memorandum opinion will be entered contemporaneously.

DONE and ORDERED this December 17, 2024.

_________________________________

R. DAVID PROCTOR

CHIEF U.S. DISTRICT JUDGE

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