Godelia v. Zoll Servs., LLC, CASE NO. 16-CV-60471-GAYLES

Decision Date18 January 2017
Docket NumberCASE NO. 16-CV-60471-GAYLES
PartiesDENNIS GODELIA, et al., Plaintiffs, v. ZOLL SERVICES, LLC, et al., Defendants.
CourtU.S. District Court — Southern District of Florida

THIS CAUSE came before the Court upon Defendant Zoll Services, LLC's Motion to Dismiss Second Amended Complaint [ECF No. 26]. The Court has reviewed the Motion and the record and is otherwise fully advised. For the reasons that follow, the Motion is granted.

I. The LifeVest

Defendant Zoll Services, Inc. ("Zoll") designs, manufactures and markets the LifeVest, a wearable defibrillator for patients at risk for sudden cardiac arrest. The LiveVest is made to detect life-threatening heart rhythms and automatically deliver a shock to restore the rhythm. The LifeVest is a Class III medical device, initially approved for sale in 2001 by the Food and Drug Administration ("FDA"), and must be prescribed by a medical doctor.

II. Debra Godelia's LifeVest

In November, 2013, Debra Godelia was in the hospital recovering from a cardiac operation. Following a review of her medical records, Zoll determined that Mrs. Godelia was a candidate for the LifeVest and sent Defendant Samantha Orsini ("Orsini"), a Zoll employee, to visit Mrs. Godelia to explain the benefits of and how to use the LifeVest. Mrs. Godelia expressed her concerns that the LifeVest would either administer a shock when one was not needed or fail to administer a shock when one was needed. Orsini represented to Mrs. Godelia that (1) the LifeVest would never administer a shock when one was not needed, (2) the LifeVest would administer a shock if a treatable heart event was detected, (3) LifeVest's success rate in detecting and administering a treating shock was higher than 98%, and (4) the LifeVest has a 98% first treatment shock success rate for resuscitating patients from sudden cardiac arrest. Based on Orsini's representations, Mrs. Godelia agreed to use the LifeVest and did not inquire about alternative options.

Mrs. Godelia remained concerned about the LifeVest working as promised. As a result, Zoll sent Defendant Ana Cecilia Masters ("Masters"), also a Zoll employee, to visit the Godelias to further explain the benefits of the LifeVest. Masters reassured the Godelias that their concerns were unwarranted and made the same or substantially similar representations as Orsini.

III. LifeVest Fails to Administer a Lifesaving Shock

On November 18, 2013, Mrs. Godelia experienced a defibrillation event2 and lost consciousness. Mrs. Godelia's LifeVest detected her defibrillation event and made an audible alarm, but did not administer the requisite shock. As Zoll instructed, Plaintiff Dennis Godelia did not touch his unconscious wife and waited for the LifeVest to work. At the same time, PlaintiffSterling Youmas, Mrs. Godelia's minor child, called 911. After he realized that the LifeVest was not administering a shock, Youmas, pursuant to instructions from a 911 operator, administered CPR on his mother to no avail. Mrs. Godelia remained unconscious until she died in the hospital on November 20, 2013.

IV. The Warning Letter

From May 22, 2014, through June 20, 2014, the FDA inspected the Zoll facility that manufactures and distributes LifeVest devices. On September 23, 2014, the FDA issued a warning letter informing Zoll that "the methods used in, or the facilities or controls used for, their manufacture, processing, packing or installation are not in conformity with the current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation found at Title 21, Code of Federal Regulations (CFR), Part 820." [ECF No. 23 at ¶ 21]. The Warning Letter also informed Zoll that the FDA found various violations during the inspection, including a "failure to document results for corrective and preventive actions, as required by 21 CFR 820.100(b) . . . as a result of a high noise artifact and/or vibration causing the LifeVest device to inappropriately deliver shock treatments to patients." [Id. Ex. A, at 23] (emphasis added).

V. Zoll's Marketing Statements

Zoll markets that the LifeVest (1) allows its users to return to their activities of daily living, while having the peace of mind that they are protected from sudden cardiac arrest and (2) detects life-threatening heart rhythms and automatically delivers a treatment shock, usually in less than a minute, to restore the normal heart rhythm. Zoll represents that the LifeVest has a first treatment shock success rate of 98% for resuscitating patients, dependent on a patient receiving a timely and appropriate treatment shock.

VI. The Second Amended Complaint

On July 17, 2016, Plaintiffs filed their Second Amended Complaint asserting claims under Florida law for (1) strict liability manufacturing defect, (2) negligent manufacturing defect, (3) fraudulent misrepresentation, (4) fraudulent omission/concealment, (5) fraudulent marketing/promotion, (6) breach of express warranty, (7) negligent misrepresentation, and (8) negligent infliction of emotional distress.3 Plaintiffs allege that Defendants knew or should have known that (1) the number of inappropriate shocks administered by LifeVest devices were equal or almost equal to the number of appropriate shocks administered, (2) the LifeVest devices were not adequately validated under actual and simulated use conditions to ensure that they conformed to defined user needs and intended uses, (3) Zoll was not adequately identifying, investigating, and remedying non-conformities with the LifeVest devices, (4) Zoll was not adequately reviewing, evaluating and investigating incidents where LifeVest devices may have caused or contributed to a death or serious injury, and (5) normal day to day activities would create noise artifact and/or vibration that would result in the LifeVest devices administering inappropriate shocks. On July 27, 2016, Defendants moved to dismiss arguing that the Medical Device Amendment ("MDA") of the Food, Drug, and Cosmetic act ("FDCA") preempts all of Plaintiffs' claims.


"To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.'" Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). Although this pleading standard "does not require 'detailed factual allegations,' . . . it demands more thanan unadorned, the defendant-unlawfully-harmed-me accusation." Id. (alteration added) (quoting Twombly, 550 U.S. at 555). Pleadings must contain "more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Twombly, 550 U.S. at 555 (citation omitted). Indeed, "only a complaint that states a plausible claim for relief survives a motion to dismiss." Iqbal, 556 U.S. at 679 (citing Twombly, 550 U.S. at 556). To meet this "plausibility standard," a plaintiff must "plead[ ] factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. at 678 (citing Twombly, 550 U.S. at 556).

When reviewing a motion to dismiss, a court must construe the complaint in the light most favorable to the plaintiff and take the factual allegations therein as true. See Brooks v. Blue Cross & Blue Shield of Florida, Inc., 116 F.3d 1364, 1369 (11th Cir. 1997). However, pleadings that "are no more than conclusions are not entitled to the assumption of truth. While legal conclusions can provide the framework of a complaint, they must be supported by factual allegations." Iqbal, 556 U.S. at 678.

I. Background on Class III Medical Devices

Medical devices, like the LifeVest, are regulated by the FDCA, 21 U.S.C. §§ 301-399f. In 1976, Congress enacted the MDA, 21 U.S.C. § 360c, which amended the FDCA and "swept back some state obligations and imposed a regime of detailed federal oversight" for medical devices. Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). Under the MDA, medical devices are divided into three classes with the most federal oversight imposed upon devices in Class III. Id. at 317. A Class III device is "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment ofhuman health," or "presents a potential unreasonable risk of illness or injury." 21 U.S.C. § 360c(a)(1)(C)(ii).

Before a Class III device is introduced to the market, "the manufacturer must provide the FDA with 'reasonable assurance' that the device is both safe and effective" through a process known as the "premarket approval" or "PMA." Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996) (quoting 21 U.S.C. § 360e(d)(2)). Once a device is granted premarket approval, the manufacturer may not change the design, manufacturing, labeling or any other element that would affect safety or effectiveness of the device without FDA permission. § 360e(d)(6)(A)(i). Furthermore, the manufacturer of approved devices must provide reports of, among other things, "incidents in which the device may have caused or contributed to death or serious injury, or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred." Riegel, 552 U.S. at 319 (citing § 803.50(a)). The FDA retains the power to withdraw approval and must do so if a device is unsafe. Id. at 320.

II. Preemption

Defendants argue that the MDA preempts all of Plaintiffs' state law claims and, therefore, must be dismissed.

A. Express Preemption

The MDA includes an express preemption provision for medical devices that provides:

no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter

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