Thelen v. Somatics, LLC et al
ORDER Granting in Part and Denying in Part "Elektrika, Inc.'s Motion to Dismiss Plaintiff's Complaint" (Doc. 24). The motion is Granted to the extent that Counts III and IV are merged into Count II. Counts III and IV are Dismissed. The Motion is otherwise Denied. Signed by Judge Thomas P. Barber on 3/31/2021. (MLW)
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
Case No. 8:20-cv-1724-TPB-JSS
SOMATICS, LLC, and
ORDER GRANTING IN PART AND DENYING IN PART
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:
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,
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).
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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 those risks.
On July 24, 2020, Plaintiff filed a seven-count complaint against Somatics
and Elektrika, alleging: negligence (Count I), strict liability (Count II), breach of
implied warranty of merchantability (Count III), breach of implied warranty of
fitness (Count IV), breach of express warranty (Count V), violation of the Nebraska
Consumer Protection Act (“NCPA”) (Count VI), and fraudulent misrepresentation
(Count VII). Plaintiff seeks punitive damages.
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
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(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.).
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).
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
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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
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
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
The Court notes that, upon further review of Somatics’ arguments in its Motion to Dismiss
(Doc. 15), this holding applies to Count I as against both Elektrika and Somatics. However,
as the result is the same under both express and implied preemption, no further action is
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Court of Nebraska has unequivocally stated breach of implied warranty claims are
merged with strict liability claims. See Freeman v. Hoffman, 618 N.W. 2d 827, 84244 (Neb. 2000). As such, the motion is granted as to this ground. Counts III and IV
are hereby dismissed.
Accordingly, it is
ORDERED, ADJUDGED, and DECREED:
(1) “Elektrika, Inc.’s Motion to Dismiss Plaintiff’s Complaint” (Doc. 24) is hereby
GRANTED IN PART and DENIED IN PART.
(2) The motion is GRANTED to the extent that Counts III and IV are merged
into Count II.
(3) Counts III and IV are DISMISSED.
(4) The motion is otherwise DENIED.
DONE and ORDERED in Chambers, in Tampa, Florida, this 31st day of
UNITED STATES DISTRICT JUDGE
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