Godelia v. Doe, 020818 FED11, 17-10736
|Court:||United States Courts of Appeals, Court of Appeals for the Eleventh Circuit|
|Judge Panel:||Before MARTIN, JORDAN, and GINSBURG, Circuit Judges.|
|Opinion Judge:||MARTIN, Circuit Judge.|
|Party Name:||DENNIS GODELIA, individually and as personal representative of the Estate of Debra Godelia, S.Y., surviving minor child of Debra Godelia, Plaintiffs-Appellants, v. John Doe 1, et al., Defendants, ZOLL SERVICES, LLC, as successor in interest to ZOLL Lifecor Corporation, SAMANTHA ORSINI, ANA CECELIA-MASTERS, Defendants-Appellees.|
|Case Date:||February 08, 2018|
Appeal from the United States District Court for the Southern District of Florida D.C. Docket No. 0:16-cv-60471-DPG
Before MARTIN, JORDAN, and GINSBURG, [*] Circuit Judges.
MARTIN, Circuit Judge.
Dennis 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.
A. THE FACTS
Because 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.
ZOLL 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.
ZOLL 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 patients."
On 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.
On 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.
Then 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.1 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.
B. PROCEDURAL HISTORY
On November 17, 2015, Mr. Godelia2 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.3 On March 9, 2016, ZOLL removed the case to federal court.
Mr. 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 LifeVest.
Ten 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.
The 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...
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