Thelen v. Somatics, LLC

CourtDistrict Court, M.D. Florida
DecidedFebruary 26, 2021
Docket8:20-cv-01724
StatusUnknown

This text of Thelen v. Somatics, LLC (Thelen v. Somatics, LLC) is published on Counsel Stack Legal Research, covering District Court, M.D. Florida primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Thelen v. Somatics, LLC, (M.D. Fla. 2021).

Opinion

UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA TAMPA DIVISION

JEFFREY THELEN,

Plaintiff,

v. Case No. 8:20-cv-1724-TPB-JSS

SOMATICS, LLC, and ELEKTRIKA, INC.,

Defendants. ______________________________________/

ORDER GRANTING IN PART AND DENYING IN PART DEFENDANT SOMATICS’ MOTION TO DISMISS

This matter is before the Court on “Defendant Somatics, LLC’s Motion to Strike and Dismiss Plaintiff’s Complaint,” filed September 11, 2020.1 (Doc. 15). Plaintiff filed his response in opposition on September 25, 2020. (Doc. 16). After reviewing the motion, response, court file, and record, the Court finds as follows: Background2 From May 16, 2014 to July 27, 2016, Plaintiff Jeffrey Thelen underwent 92 sessions of Electroconvulsive Therapy (“ECT”) using the Thymatron System IV

1 While Somatics’ motion nominally requests the Court strike certain allegations, it cites no legal authority or analysis under Rule 12(f) for doing so. As such, the Court will treat this motion solely as a motion to dismiss. 2 The Court accepts as true the facts alleged in the complaint for purposes of ruling on the pending motion to dismiss. See Erickson v. Pardus, 551 U.S. 89, 94 (2007) (“[W]hen ruling on a defendant’s motion to dismiss, a judge must accept as true all of the factual allegations contained in the complaint.”). The Court is not required to accept as true any legal conclusions couched as factual allegations. See Papasan v. Allain, 478 U.S. 265, 286 (1986). device in Omaha, Nebraska. This ECT device was manufactured by Elektrika and supplied to Somatics who, in addition to also manufacturing the ECT device, promotes and distributes the device. Plaintiff alleges that undergoing ECT

treatment with this device caused permanent neurological damage impairing his ability to memorize, retain, and recall information. Plaintiff further alleges that despite knowing of the substantial risks associated with ECT treatment, Somatics and Elektrika manufactured and distributed the device and failed to warn Plaintiff of these risks. On July 24, 2020, Plaintiff filed his seven-count complaint against Somatics and Elektrika, alleging: (1) negligence (Count I), (2) strict liability (Count II), (3)

breach of implied warranty of merchantability (Count III), (4) breach of implied warranty of fitness (Count IV), (5) breach of express warranty (Count V), (6) violation of the Nebraska Consumer Protection Act (“NCPA”) (Count VI), (7) 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. Federal Rule of Civil Procedure 9(b) requires a party alleging fraud or mistake to “state with particularity the circumstances constituting fraud or mistake.” Fed. R. Civ. P. 9(b). As courts have explained, the purpose of rule (9)(b)

is to ensure that defendants have sufficient notice and information to formulate a defense. See Trinity Graphic, USA, Inc. v. Tervis Tumbler Co., 320 F. Supp. 3d 1285, 1294 (M.D. Fla 2018). “Essentially, a plaintiff satisfies Rule 9(b) by alleging who, what, when, where, and how.” Id. (citing Garfield v. NDC Health Corp., 466 F.3d 1255, 1262 (11th Cir. 2006). 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, Somatics presents the following arguments to dismiss Plaintiff’s claims: (1) Count I is preempted, (2) Count VII fails to meet the heightened pleading requirements of Rule 9, (3) Counts I, II, and VII fails to allege proximate cause, (4) Counts III, IV, and V fail to allege privity, (5) Count I is barred by the learned-intermediary doctrine, and (6) Count VI fails to state a claim under the NCPA. Preemption

Somatics first argues that Plaintiff’s negligence claim (Count I) is preempted by 21 U.S.C. § 360k(a). Plaintiff disagrees, and he instead argues that this statute does not preempt state law negligence claims for products – like the Thymatron device – approved via the 510(k) process.3 21 U.S.C. § 360k(a) precludes states from implementing requirements “with respect to a [medical] device” that are “different from, or in addition to” FDA requirements. However, the Supreme Court has previously held that this statute

does not preempt state law negligence claims for medical devices approved by the 510(k) process. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 500-02 (1996) (holding Florida negligence claims escape preemption because state requirements were not developed “with respect to” medical devices). As this decision remains binding case law, Plaintiff’s state law negligence claim (Count I) is not preempted. Rule 9 Pleading Requirements

Next, Somatics argues that Plaintiff’s fraudulent misrepresentation claim (Count VII) should be dismissed for failing to satisfy the pleading requirements of

3 The Thymatron ECT device is regulated by the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the subsequent Medical Device Amendments (“MDA”). As required by these statutes, it appears to be undisputed that this device went through the 510(k)-approval process, which provides expedited approval to medical devices that are substantially equivalent to those already in use. This process allows medical devices on the market before the MDA to be grandfathered in without forcing them to undergo the more arduous and time-intensive Premarket Approval process that would otherwise be required. Rule 9.

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Thelen v. Somatics, LLC, Counsel Stack Legal Research, https://law.counselstack.com/opinion/thelen-v-somatics-llc-flmd-2021.