THELEN

v.

SOMATICS, LLC

DEFENDANT ELEKTRIKA’S MOTION TO DISMISS

This matter is before the Court on “Elektrika, Inc.’s Motion to Dismiss Plaintiff’s Complaint,” filed November 16, 2020. (Doc. 24). Plaintiff filed his response in opposition on November 30, 2020. (Doc. 30). After reviewing the motion, response, court file, and record, the Court finds as follows: Background¹ From May 16, 2014 to July 27, 2016, Plaintiff Jeffrey Thelen underwent 92 sessions of Electroconvulsive Therapy (“ECT”) using the Thymatron System IV device in Omaha, Nebraska. This ECT device was manufactured by Elektrika and supplied to Somatics which, in addition to also manufacturing the ECT device,

Consumer Protection Act (“NCPA”) (Count VI), and fraudulent misrepresentation (Count VII). Plaintiff seeks punitive damages. Legal Standard Federal Rule of Civil Procedure 8(a) requires that a complaint contain “a short and plain statement of the claim showing the [plaintiff] is entitled to relief.” Fed. R. Civ. P. 8(a). While Rule 8(a) does not demand “detailed factual allegations,” it does require “more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). In order to survive a motion to dismiss, factual allegations must be sufficient “to state a claim to relief that is plausible on its face.” Id. at 570. When deciding a Rule 12(b)(6) motion, review is generally limited to the four corners of the complaint. Rickman v. Precisionaire, Inc., 902 F. Supp. 232, 233 (M.D. Fla. 1995). Furthermore, when reviewing a complaint for facial sufficiency, a court “must accept [a] [p]laintiff’s well pleaded facts as true, and construe the [c]omplaint in the light most favorable to the [p]laintiff.” Id. (citing Scheuer v. Rhodes, 416 U.S. 232, 236 (1974)). “[A] motion to dismiss should concern only the complaint’s legal sufficiency, and is not a procedure for resolving factual questions or addressing the merits of the case.” Am. Int’l Specialty Lines Ins. Co. v. Mosaic Fertilizer, LLC, 8:09-cv-1264-T-26TGW, 2009 WL 10671157, at *2 (M.D. Fla. Oct. 9, 2009) (Lazzara, J.). Analysis In its motion, Elektrika reiterates arguments its co-Defendant Somatics brought in its motion to dismiss and argues several new grounds for dismissal. (Doc. 15). Specifically – in addition to arguments previously raised by Somatics – Elektrika contends: (1) Plaintiff’s claims are impliedly preempted, and (2) Counts III and IV should be merged with Count II. As the Court has already addressed Somatics’ arguments – and dismissed Counts VI and VII – this Order is restricted to Elektrika’s remaining arguments. See (Doc. 40).

Preemption Elektrika first argues Plaintiff’s claims are implicitly preempted by the Food Drug and Cosmetic Act (“FDCA”) and the Medical Device Amendments “(MDA”). Plaintiff disagrees, contending that his state-law tort claims are not preempted. Implied preemption here is governed by 21 U.S.C. § 337(a), which requires that all actions to enforce FDA requirements “shall be by and in the name of the United States.” See McClelland v. Medtronic, Inc., 944 F. Supp. 2d 1193, 1200 (M.D. Fla. 2013). The Supreme Court has interpreted this statute as allowing private individuals to bring state-law tort claims, so long as they do not seek to enforce a duty owed to the FDA. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353 (2001); see also Mink v. Smith & Nephew, Inc., 860 F. 3d 1319, 1327 (11th Cir. 2017). In this case, Counts II-V are strictly state-law claims that do not seek to enforce FDA requirements. Therefore, these claims are not implicitly preempted. In Count I (negligence), however, Plaintiff presents multiple theories as to why Elektrika was negligent, some of which may be construed as violating FDA obligations. Nevertheless, further discovery and argument by the parties are needed to determine whether Plaintiff’s negligence claim is preempted. See Bausch v. Stryker Corp., 630 F. 3d 546, 559 (7th Cir. 2010). Elektrika’s motion to dismiss based on implied preemption is, therefore, denied at this time.² Merger Next, Elektrika argues that, if the Court finds Nebraska law governs Count

III (implied warranty of merchantability), and Count IV (implied warranty of fitness), those claims should be dismissed because implied warranty claims are subsumed into strict liability claims. In its February 26, 2021, Order, the Court found Nebraska law applies to these claims. See (Doc. 40 at 5-7). The Supreme

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-TOMBARBER aws—‘“C:sts~™S

UNITED STATES DISTRICT JUDGE