Feeser v. Medtronic Inc.

• Decision Date: 08 February 2022
• Docket Number: 2:21-cv-03808-DCN
• Parties: EMERY I. FEESER, Plaintiff, v. MEDTRONIC, INC., Defendant.
• Court: U.S. District Court — District of South Carolina

EMERY I. FEESER, Plaintiff, v. MEDTRONIC, INC., Defendant.

No. 2:21-cv-03808-DCN

United States District Court, D. South Carolina, Charleston Division

February 8, 2022

ORDER

DAVID C. NORTON UNITED STATES DISTRICT JUDGE

The following matter is before the court on defendant Medtronic Inc.'s (“Medtronic”) motion to dismiss, ECF No. 5. For the reasons set forth below, the court grants in part and denies in part the motion.

I. BACKGROUND

On or about July 7, 2018, plaintiff Emery I. Feeser (“Feeser”) underwent surgery at Roper Hospital in Charleston, South Carolina to implant a Medtronic pacemaker-the Azure™ S DR MRI SureScan™ Model W3DR01, serial number RNJ201863H (the “Pacemaker”). The Pacemaker is a Class III medical device that received premarket approval (“PMA”) from the U.S. Food and Drug Administration (“FDA”) in August 2017 to treat multiple heart conditions that require chronic heart rate regulation. Following the procedure, Feeser allegedly started having problems with the Pacemaker, and it stopped working altogether. According to Feeser, the Pacemaker was inadvertently manufactured without its usual protective coating that allegedly reduces the likelihood of a pacemaker being rejected by a recipient. On October 16, 2018, Feeser underwent a second surgery to remove the Pacemaker and replace it with a new Medtronic pacemaker-model DDDR S1 serial number NWA 238501H-with the protective coating.

On October 11, 2021, Feeser filed this action in the Charleston County Court of Common Pleas. ECF No. 1-1, Compl. On November 19, 2021, Medtronic removed the action to this court. ECF No 1. On November 24, 2021, Medtronic filed a motion to dismiss for failure to state a claim. ECF No. 5. On December 8, 2021, Feeser responded in opposition, ECF No. 7, and on December 15, 2021, Medtronic replied, ECF No. 8. As such, the motion to dismiss has been fully briefed and is now ripe for review.

II. STANDARD

A Federal Rule of Civil Procedure 12(b)(6) motion for failure to state a claim upon which relief can be granted “challenges the legal sufficiency of a complaint.” Francis v. Giacomelli, 588 F.3d 186, 192 (4th Cir. 2009) (citations omitted); see also Republican Party of N.C. v. Martin, 980 F.2d 943, 952 (4th Cir. 1992) (“A motion to dismiss under Rule 12(b)(6) . . . does not resolve contests surrounding the facts, the merits of a claim, or the applicability of defenses.”). To be legally sufficient, a pleading must contain a “short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). A Rule 12(b)(6) motion should not be granted unless it appears certain that the plaintiff can prove no set of facts that would support his claim and would entitle him to relief. Mylan Labs., Inc. v. Matkari, 7 F.3d 1130, 1134 (4th Cir. 1993). When considering a Rule 12(b)(6) motion, the court should accept all well-pled allegations as true and should view the complaint in a light most favorable to the plaintiff. Ostrzenski v. Seigel, 177 F.3d 245, 251 (4th Cir. 1999); Mylan Labs., Inc., 7 F.3d at 1134. “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.'” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007)). “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 for the misconduct alleged.” Id.

III. DISCUSSION

Medtronic requests that the court dismiss Feeser's complaint in its entirety for failure to state a claim upon which relief may be granted pursuant to Rule 12(b)(6). Medtronic brings its motion on two grounds. First, Medtronic argues that every claim is preempted by the Medical Device Amendments of 1976 (“MDA”) to the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 360k(a). Second, Medtronic argues that Feeser's complaint does not contain sufficient facts to give rise to a plausible claim for relief. The court addresses each argument in turn.

A. Preemption

Medtronic first asks the court to dismiss all of Feeser's claims as preempted by federal law. In 1976, Congress passed the MDA in order to impose detailed federal oversight to govern medical devices. Walker v. Medtronic, Inc., 670 F.3d 569, 572 (4^th Cir. 2012). “To that end, the MDA includes a provision expressly preempting state regulation of medical devices.” Id. It states in relevant part:

[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). “The MDA also establishes three classes of medical devices, organized according to the level of oversight required to ensure their safety.” Walker, 670 F.3d at 572. “Class III devices require the highest level of federal oversight, ” and the Pacemaker in this case is a Class III device. Id. “Because of the risks associated with them, Class III devices are required to go through [PMA] ‘to provide reasonable assurance of [their] safety and effectiveness.'” Id. (quoting 21 U.S.C. § 360c(a)(1)(C)).

PMA is a rigorous process. Id. To obtain PMA, “a device manufacturer must submit to the FDA full reports of all investigations relating to the device's safety or effectiveness; a full statement of the components, ingredients, and properties and of the principle or principles of operation of the device, a full description of the manufacturing methods and the facilities and controls used for the device's manufacturing; references to any performance standards applicable to the device; samples of the device and any component parts; examples of the proposed labeling for the device; and other information as requested.” Id. at 572-73 (citing 21 U.S.C. § 360e(c)(1)) (internal quotations omitted).

Given the extensive regulation of Class III medical devices and the preemption provision in the MDA, the Supreme Court has offered guidance on what claims survive the MDA's express preemption clause. In Riegel v. Medtronic, “the Supreme Court considered whether a plaintiff's common law claims based on the failure of a Class III medical device were precluded by the MDA's express preemption clause, which preempts state requirements ‘different from, or in addition to' requirements applicable under federal law.” Id. at 577 (citing Riegel v. Medtronic, 552 U.S. 312, 321 (2008)) (quoting 21 U.S.C. § 360k(a)(1)). To resolve this question, the court undertook a two-part inquiry. Riegal, 552 U.S. at 321-22. First, the Supreme Court examined whether the federal government established requirements applicable to the device. Id. at 321. The Supreme Court determined that, because Class III devices are required to undergo the PMA process, this first requirement is met in regard to all Class III devices. Id. Second, the Supreme Court considered whether the state common law claims imposed requirements that were different from or in addition to the federal requirements and “relate[d] to the safety or effectiveness of the device or to any other matter included in a requirement of the device.” Id. at 323.

“In sum, the Supreme Court held that the terms of a Class III device's [PMA] constitute federal requirements and that a common law tort claim premised on different or additional requirements is preempted by the MDA.” Walker, 670 F.3d at 577. “The Supreme Court did recognize one situation in which a plaintiff's common law claims would not be preempted under the MDA: when ‘state duties . . . parallel, rather than add to, federal requirements.'” Id. (quoting Riegel, 552 U.S. at 330) (internal quotation marks omitted). “This situation occurs when claims are ‘premised on a violation of FDA regulations.'” Id. (quoting Riegel, 552 U.S. at 330). With this guidance in mind, the court turns to Feeser's claims in this case.

Feeser asserts three causes of action in his complaint: (1) negligence/gross negligence; (2) strict products liability; and (3) breach of warranty. The Supreme Court has held that state common law claims for negligence, strict liability, and breach of warranty, among other claims, qualify as “requirements . . . with respect to devices” for the purpose of the MDA's express preemption clause. Riegel, 552 U.S. at 324, 327. Thus, to determine whether these claims are preempted by the MDA, the court must decide whether they parallel federal requirements or impose requirements that differ from or add to those requirements. In so deciding, the court acknowledges that “[p]laintiffs cannot simply incant the magic words ‘[the defendant] violated FDA regulations' in order to avoid preemption.” In re Medtronic, Inc. Sprint Fidelis Leads Prod. Liab. Litig., 592 F.Supp.2d 1147, 1158 (D. Minn. 2009).

District courts in the Fourth Circuit have unanimously held that a well-pleaded parallel state law claim “must at least (1) identify the federal requirement applicable to the device with which it allegedly failed to comply and (2) explain how that violation of a federal requirement caused the plaintiff's injury.” See Wells v. Allergan USA, Inc., 2014 WL 117773 *2 (D.S.C. Jan. 13, 2014) (collecting cases); Ellis v. Smith & Nephew, Inc., 2016 WL 7319397, at *2 (D.S.C. Feb. 16, 2016)

The critical factual allegation underlying Feeser's three claims against Medtronic boils down to the following “The device sent and tested for approval included a coating as an essential element of the...