DENNIS GODELIA, individually and as personal representative of the Estate of Debra Godelia, S.Y., surviving minor child of Debra Godelia, Plaintiffs-Appellants,
John Doe 1, et al., Defendants, ZOLL SERVICES, LLC, as successor in interest to ZOLL Lifecor Corporation, SAMANTHA ORSINI, ANA CECELIA-MASTERS, Defendants-Appellees.
from the United States District Court for the Southern
District of Florida D.C. Docket No. 0:16-cv-60471-DPG
MARTIN, JORDAN, and GINSBURG, [*] Circuit Judges.
MARTIN, Circuit Judge.
Godelia and Sterling Youmas appeal the District Court's
dismissal of their case against ZOLL Services, LLC
("ZOLL"), which brought seven claims under Florida
law. Mr. Godelia is suing individually and as the personal
representative of the estate of Debra Godelia, who was his
wife. Mr. Youmas was Ms. Godelia's son. Ms. Godelia went
into cardiac arrest while wearing an external defibrillator
device manufactured by ZOLL, and known as the LifeVest. Ms.
Godelia died as a result of this heart attack. The claims
against ZOLL for strict products liability, negligence,
fraudulent misrepresentation, fraudulent marketing and
promotion, breach of express warranty, negligent
misrepresentation, and negligent infliction of emotional
distress all relate to the operation (or failure to operate)
of Ms. Godelia's LifeVest. After careful consideration,
and with the benefit of oral argument, we affirm the District
Court's dismissal of the plaintiffs' negligent
infliction of emotional distress claim. However, in light of
developing and binding precedent in our circuit, we reverse
the District Court's dismissal of the remaining claims.
we are reviewing the District Court's ruling based on the
pleadings, we accept the factual allegations in the complaint
as true, and indeed we construe them in the light most
favorable to the plaintiffs. Hill v. White, 321 F.3d
1334, 1335 (11th Cir. 2003) (per curiam). Our account of the
facts therefore comes from the plaintiffs' complaint.
designs, manufactures, and markets the LifeVest, which is a
wearable, external defibrillator designed for patients at
risk of sudden cardiac arrest. The LifeVest is designed to
detect a threatening heartbeat pattern, then administer a
treatment shock, for the purpose of restoring the normal
heart rhythm. The Food and Drug Administration
("FDA") originally approved the LifeVest for sale
in 2001 and classified it as a Class III medical device,
which is the highest risk category. A LifeVest must be
prescribed by a doctor. But once the LifeVest has been
prescribed, ZOLL enters into a contract directly with the
patient and the patient's insurance provider.
advertised the LifeVest as providing "constant
monitoring, immediate protection, and  peace of mind for
patients" and family members. According to ZOLL,
"if [a] patient experiences a life-threatening heart
rhythm, the LifeVest will detect the rhythm and will deliver
a treatment shock to restore the normal heart rhythm."
ZOLL also advertised the LifeVest as having "a 98
percent first treatment shock success rate for resuscitating
November 1, 2013, Ms. Godelia went to the hospital
complaining of abdominal and back pain. When medical staff
recognized she was having a heart problem, she was admitted
for urgent cardiac catheterization. Before she was
discharged, a ZOLL employee, Samantha Orsini, spoke with Ms.
Godelia about using a LifeVest. According to the complaint,
Ms. Godelia "had significant reservations about and was
reluctant to use the LifeVest." Among other things, she
was concerned "that the LifeVest would administer a
shock when one was not needed and that it would detect a
treatable heart event, but fail to administer the
shock." In response to Ms. Godelia's concerns, Ms.
Orsini told her: (1) the LifeVest would never administer a
shock when one wasn't needed; (2) it would administer a
shock if a heart event was detected; (3) the success rate for
detecting and administering a shock was higher than 98%; and
(4) that LifeVest had a 98% first treatment shock success
rate for resuscitating patients. Relying on these
representations, Ms. Godelia agreed to use the LifeVest and
did not ask about alternative treatment options. But because
she still had concerns about the product, Ms. Godelia asked
for another ZOLL representative to visit her at her home. Ana
Cecilia Masters, another ZOLL employee, met with Ms. Godelia
and made substantially similar representations. Ms. Godelia
continued wearing a LifeVest.
November 18, 2013, Ms. Godelia went to the doctor, who
confirmed that she was using the LifeVest as ZOLL had
instructed. Later that same day, Ms. Godelia experienced a
"Defibrillation Event" and lost consciousness. The
LifeVest detected a problem with Ms. Godelia's heart,
making an audible alarm. However, the LifeVest did not shock
Ms. Godelia as it was supposed to. Mr. Godelia saw this
happen but, following the instructions of ZOLL, he did not
touch his wife. Ms. Godelia's son, Mr. Youmas, called
911. When Mr. Youmas realized the shock wasn't being
administered, he began performing CPR on his mother. Ms.
Godelia remained unconscious and died two days later, on
November 20, 2013.
came September 23, 2014, when the FDA sent ZOLL a Warning
Letter. The letter said the FDA had conducted an inspection
of ZOLL's facilities between May 22 and June 20, 2014,
and as a result of that inspection, determined that the
medical devices ZOLL produced were "adulterated within
the meaning of Section 501(h) of the [Federal Food, Drug, and
Cosmetic] Act." The letter listed a number of regulatory
violations identified by FDA inspectors relating to quality
control procedures at the ZOLL manufacturing
facility. But the letter was also clear that the
list of regulatory violations was not all-inclusive. The
letter also referenced problems with LifeVests administering
"inappropriate shocks, " some of which were caused
by noise or vibration, and difficulties in using the device
by patients with cognitive or physical limitations.
November 17, 2015, Mr. Godelia filed a complaint in Florida
state court relating to the malfunction of Ms. Godelia's
LifeVest. The suit was brought against ZOLL and two unknown
ZOLL representatives, later identified as Ms. Orsini and Ms.
Masters. On March 9, 2016, ZOLL removed the case to
Godelia then amended his complaint, raising eight claims for
relief: (1) strict products liability based on a
manufacturing defect; (2) negligence based on a manufacturing
defect; (3) fraudulent misrepresentation; (4) fraudulent
omission and concealment; (5) fraudulent marketing and
promotion; (6) breach of express warranty; (7) negligent
misrepresentation; and (8) negligent infliction of emotional
distress. Mr. Godelia said the LifeVest had a manufacturing
defect that caused it to fail, and that the defect "was
the direct result of ZOLL's failure to comply with
relevant federal regulations in the manufacturing of the
LifeVest." Mr. Godelia based these claims on violations
of regulations implementing the Medical Device Amendments
("MDA") that were identified in the FDA Warning
Letter, although he noted that the Warning Letter itself said
its list of violations was not all-inclusive. Mr. Godelia
said the violations described in the Warning Letter
"also existed at the time the subject LifeVest was
manufactured in May 2013." Mr. Godelia also based a
number of his claims on statements made by ZOLL and its
employees, which he said overstated the effectiveness of the
days after Mr. Godelia filed the amended complaint, ZOLL
moved to dismiss it. ZOLL argued that the MDA preempted all
of Mr. Godelia's claims. In response, Mr. Godelia
acknowledged that the District Court would be justified in
dismissing his fraudulent omission and concealment claim on
preemption grounds, and he dropped that claim. But he stood
by the remaining claims, saying they should survive under
both Florida and federal law.
District Court then granted ZOLL's motion to dismiss in
full. Indeed, the District Court determined that all of Mr.
Godelia's claims were expressly preempted by the MDA
because they were premised on the LifeVest being defective.
The District Court reasoned that claims of defects in the
LifeVest would be at odds with the FDA's determination
that LifeVests were safe. The District Court also found that
Mr. Godelia failed to allege a parallel claim, as is required
in order to avoid preemption, because "there is no nexus
between the warning letter, Ms. Godelia's LifeVest, and
her injuries." In addition, the District Court held that
the breach of express warranty claim failed under Florida law
because there was no privity between Ms. Godelia and ZOLL,
and that the negligent infliction of emotional distress claim
failed under Florida law because Mr. Godelia and Mr. Youmas
did not "allege a discernible physical injury."
Finally, the court said that even if some of the
plaintiffs' claims were not expressly preempted, they
were likely impliedly preempted.
appeal followed. After Mr. Godelia filed his brief on appeal,
but before ZOLL filed its answer brief, this Court issued its
decision in Mink v. Smith & Nephew, Inc., 860
F.3d 1319 (11th Cir. 2017). Mink addressed
preemption questions very much like those raised here, and
brought under similar circumstances.
STANDARD OF REVIEW
review de novo the District Court's dismissal of
a complaint for failure to state a claim under Federal Rule
of Civil Procedure 12(b)(6). Hill, 321 F.3d at 1335.
In doing so, we accept the plaintiff's allegations in the
complaint as true, and we construe them in the light most
favorable to the plaintiff. Id. Even so, "only
a complaint that states a plausible claim for relief survives
a motion to dismiss." Ashcroft v. Iqbal, 556
U.S. 662, 679, 129 S.Ct. 1937, 1950 (2009). We also review
de novo ...