Godelia et al v. ZOLL Services, LLC
Filing
146
ORDER DENYING Defendant's Motion for Summary Judgment. Signed by Judge Darrin P. Gayles See attached document for full details. (hs01)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF FLORIDA
Case No. 16-60471-CIV-GAYLES
DENNIS GODELIA and
STERLING YOUMAS,
Plaintiffs,
v.
ZOLL SERVICES, LLC,
Defendant.
/
ORDER
THIS CAUSE comes before the Court upon Defendant’s Motion for Summary Judgment
[ECF No. 64]. The Court has carefully reviewed the Motion and the record and is otherwise fully
advised. For the reasons set forth below, the Motion is denied.
BACKGROUND
Defendant Zoll Services, Inc. (“Defendant”) designs, manufactures, and markets the
LifeVest, a wearable defibrillator for patients at risk for sudden cardiac arrest. The LifeVest is
made to detect life-threatening heart rhythms and automatically deliver a shock to restore normal
rhythm. The LifeVest is a Class III medical device, initially approved for sale in 2001 by the Food
and Drug Administration (“FDA”).
In November 2013, after recovering from a cardiac operation, Debra Godelia began using
the LifeVest. On November 18, 2013, Mrs. Godelia experienced a defibrillation event (the
“Event”) 1 and lost consciousness. Although the parties dispute why, it is undisputed that Mrs.
Godelia’s LifeVest did not administer the requisite shock. After realizing that the LifeVest was
1 A defibrillation event is either ventricular tachycardia (“VT”) (150 beats per minute) or ventricular fibrillation
(“VF”) (200 beats per minute).
not administering a shock, Mrs. Godelia’s son called 911. Emergency personnel performed CPR
on Mrs. Godelia and transported her to the hospital. Mrs. Godelia remained unconscious until she
died in the hospital on November 20, 2013.
Plaintiffs Dennis Godelia and Sterling Youmas (“Plaintiffs”), relying on their expert,
Richard J. Daken, and other record evidence, 2 argue that the LifeVest failed to deliver the shock
to Mrs. Godelia because the cable connecting the rear therapy electrode set to the LifeVest’s
distribution network (“DN”) was separated from the circuit board within the DN and that this
separation was the result of defective soldering. Defendant does not dispute that the cable is
currently separated from the LifeVest’s circuit board. However, Defendant argues, through its
own experts and record evidence, that the cable could not have been separated at the time of the
Event and that it must have disconnected from the circuit board after the Event.
Plaintiffs also argue that Zoll failed to implement regulatory-required processes to ensure
that its manufacturing of the LifeVest, and in particular, the soldering at issue, was non-defective
and that the soldering defect was a direct result of Zoll’s failure to implement such manufacturing
processes.
Plaintiffs assert claims for strict products liability based on a manufacturing defect;
negligence based on a manufacturing defect; fraudulent misrepresentation; fraudulent marketing
and promotion; breach of express warranty; and negligent misrepresentation. 3 Defendant has
moved for summary judgment arguing that (1) Plaintiffs’ manufacturing defect claims fail because
Plaintiffs cannot establish a product defect or that Defendant’s failure to comply with federal
2 The Court denied Defendant’s motion to exclude Mr. Daken’s opinions, finding them to be admissible under
Federal Rule of Evidence 702. [ECF No. 145].
3 The Second Amended Complaint lists eight counts, however, Plaintiffs dropped their claim for fraudulent omission
and the Eleventh Circuit affirmed the Court’s dismissal of Plaintiffs’ claim for negligent infliction of emotional
distress.
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regulations caused the defect, and (2) Plaintiffs’ remaining claims fail because they incorporate
the same product defect as the manufacturing defect claims and because Plaintiffs cannot establish
that they detrimentally relied on Defendant’s representations.
ANALYSIS
Summary judgment, pursuant to Federal Rule of Civil Procedure 56(a), “is appropriate only
if ‘the movant shows that there is no genuine issue as to any material fact and the movant is entitled
to judgment as a matter of law.’” Tolan v. Cotton, 134 S. Ct. 1861, 1866 (2014) (per curiam)
(quoting Fed. R. Civ. P. 56(a)). “By its very terms, this standard provides that the mere existence
of some alleged factual dispute between the parties will not defeat an otherwise properly supported
motion for summary judgment; the requirement is that there be no genuine issue of material fact.”
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247–48 (1986). An issue is “genuine” when a
reasonable trier of fact, viewing all of the record evidence, could rationally find in favor of the
nonmoving party in light of his burden of proof. Harrison v. Culliver, 746 F.3d 1288, 1298 (11th
Cir. 2014). And a fact is “material” if, “under the applicable substantive law, it might affect the
outcome of the case.” Hickson Corp. v. N. Crossarm Co., 357 F.3d 1256, 1259–60 (11th Cir. 2004).
“Where the material facts are undisputed and all that remains are questions of law, summary
judgment may be granted.” Eternal Word Television Network, Inc. v. Sec’y of U.S. Dep’t of Health
& Human Servs., 818 F.3d 1122, 1138 (11th Cir. 2016). The Court must construe the evidence in
the light most favorable to the nonmoving party and draw all reasonable inferences in that party’s
favor. SEC v. Monterosso, 756 F.3d 1326, 1333 (11th Cir. 2014). However, to prevail on a motion
for summary judgment, “the nonmoving party must offer more than a mere scintilla of evidence for
its position; indeed, the nonmoving party must make a showing sufficient to permit the jury to
reasonably find on its behalf.” Urquilla-Diaz v. Kaplan Univ., 780 F.3d 1039, 1050 (11th Cir. 2015).
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Here, the Court finds that genuine issues of material fact exist on all of Plaintiffs’ claims.
Indeed, there are clear factual disputes as to whether the cable connecting the rear therapy electrode
was detached at the time of the Event and whether this separation was due to defective soldering.
Moreover, there is a genuine issue of material fact as to whether the soldering defect—if one existed—
was the result of Defendant’s failure to implement regulatory-required processes. These disputes are
for a jury to resolve. 4
The Court also finds that there are genuine issues of material fact as to whether Mrs.
Godelia detrimentally relied on Defendant’s representations about the LifeVest. Defendant argues
that Mrs. Godelia could not have detrimentally relied on the representations because there were no
alternative options to the LifeVest. The Court disagrees. While there might not have been any
other appropriate external or internal defibrillation device for Mrs. Godelia, she might have
chosen, as an alternative option, to not wear the defibrillation device at all and seek another form
of treatment. Without the LifeVest, her family, who had been instructed by Defendant to stay
away from Mrs. Godelia while the LifeVest sounded an alarm, might have attempted CPR the
minute she fell to the ground. As with the questions surrounding the detached cable, questions
about Mrs. Godelia’s reliance on Defendant’s representations are for a jury. 5
4 Although Mr. Daken will be able to offer his expert opinion as to the detached cable and soldering to the jury, the
Court also finds that Plaintiff is entitled to a Cassisi inference that the LifeVest malfunctioned during normal
operations. See Cassisi v. The Maytag Co, 396 So. 2d 1140 (Fla. 1st DCA 1981) (holding that a product may be
deemed defective at the time of injury and at the time of sale if it malfunctions during normal operations). However,
even “where a Cassisi inference is appropriate, the inference does not establish defectiveness, as a matter of law, but
only permits a Plaintiff to submit the case to the jury to consider the inference when determining whether there is a
defect in the product.” Pantages v. Cardinal Health 200, Inc., 508-CV-116-OC-GRJ, 2009 WL 2244536, at *2 (M.D.
Fla. July 27, 2009).
5 Defendant also argues that, without a product defect, Plaintiffs cannot seek noneconomic damages on their
misrepresentation claims. As the Court finds that the question of whether the LifeVest was defective must go to the
jury, it need not address Defendant’s arguments regarding the availability of damages for Plaintiffs’ fraud and
misrepresentation claims at this time.
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CONCLUSION
Based on the foregoing, it is
ORDERED AND ADJUDGED that Defendant’s Motion for Summary Judgment [ECF
No. 64] is DENIED.
DONE AND ORDERED in Chambers at Miami, Florida, this 13th day of August, 2019.
________________________________
DARRIN P. GAYLES
UNITED STATES DISTRICT JUDGE
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