United States District Court, S.D. Florida
P. GAYLES UNITED STATES DISTRICT JUDGE.
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
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
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”) 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 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.
Dennis Godelia and Sterling Youmas
(“Plaintiffs”), relying on their expert, Richard
J. Daken, and other record evidence,  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
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.
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. 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
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
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).
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).
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
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 ...