881 F.3d 1309
11th Cir.2018Background
- Debra Godelia wore a ZOLL LifeVest (a Class III wearable external defibrillator); on Nov. 18, 2013 the device alarmed but did not deliver a shock during a life‑threatening event; she died two days later.
- ZOLL employees allegedly told Ms. Godelia the LifeVest would always shock when needed and touted a ~98% first‑shock success rate; plaintiffs say these representations induced use.
- An FDA Warning Letter (Sept. 2014) identified multiple Quality System Regulation violations at ZOLL’s facility and noted device shock errors and usability issues.
- Plaintiffs (husband as estate representative and son) sued in Florida state court asserting: strict products liability (manufacturing defect), negligence, fraudulent misrepresentation, fraudulent marketing/promotion, breach of express warranty, negligent misrepresentation, and negligent infliction of emotional distress; case was removed to federal court.
- District Court dismissed all claims as preempted by the Medical Device Amendments (MDA) and dismissed the emotional‑distress claim for failure to allege sufficient physical injury; Eleventh Circuit reviewed de novo.
- Eleventh Circuit (MARTIN, J.) affirmed dismissal of negligent infliction of emotional distress but reversed dismissal of the remaining claims, holding most state‑law tort and warranty claims survived express and implied preemption at the pleadings stage.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether manufacturing‑defect strict liability/negligence claims survive MDA preemption | Claims are tied to specific FDA regulatory violations (per FDA Warning Letter) that caused the defect; thus state claims enforce common‑law duties, not new state requirements | MDA expressly preempts because claims rest on device safety/effectiveness and could proceed even if ZOLL complied with federal law | Survive: Pleadings adequately allege specific federal regulation violations and causation; not expressly or impliedly preempted (Mink controlling) |
| Whether misrepresentation/marketing/warranty claims are preempted | Claims attack ZOLL’s own statements/promises about performance (manufacturer‑imposed obligations), not state‑imposed requirements | Preemption applies because statements relate to device effectiveness and safety | Survive: Statements create manufacturer’s own obligations; claims are traditional state‑law causes and not preempted |
| Whether plaintiffs adequately pleaded breach of express warranty (privity) | Plaintiff alleges a direct contract between Ms. Godelia and ZOLL for LifeVest rental/purchase; privity exists | ZOLL argued no privity because device requires prescription and patient does not buy directly | Pleading suffices at this stage to allege privity; claim survives dismissal |
| Whether negligent infliction of emotional distress was sufficiently pled under Florida law | Plaintiffs allege physical symptoms (insomnia, depression, muscle/stomach pain) from witnessing death | Symptoms are too generalized and mirror insufficient allegations in Florida precedent | Dismissed: Alleged physical injuries insufficient under Florida’s Zell/R.J. framework; dismissal affirmed |
Key Cases Cited
- Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017) (controls preemption analysis for MDA; allows manufacturing‑defect state claims tied to federal violations to survive)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (explains MDA premarket approval and change/approval constraints for Class III devices)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (implied preemption bars suits that are essentially fraud‑on‑the‑FDA claims)
- Wolicki‑Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) (distinguishes cases where plaintiffs failed to allege specific FDA regulation violations)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (discusses narrow gap: plaintiffs can plead federal violations as evidence of state‑law duty without suing solely to enforce federal law)
- Zell v. Meek, 665 So. 2d 1048 (Fla. 1995) (Florida standard for negligent infliction of emotional distress: requires demonstrable physical injury resulting from witnessing harm)