11th Circuit Rejects Preemption Defense in Medical Device Case
By Sharon D. Stuart, Partner
On Feb. 8, 2018, in an opinion to be published, the Eleventh Circuit reversed the trial court’s dismissal of a Plaintiff’s product liability suit relating to an allegedly defective defibrillator vest manufactured by Zoll.
“In light of developing and binding precedent in our circuit” the appellate court found that the Plaintiff’s state law claims for product liability, negligence, fraudulent misrepresentation, marketing and promotion, breach of express warranty, and negligent misrepresentation are plausible on their face, and are not expressly or impliedly preempted under the Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360c et seq.
The Plaintiff alleged under Florida law that the defibrillator vest was defectively manufactured and that the violation of federal law identified in an FDA warning letter caused the defect. The Eleventh Circuit held that these allegations are sufficient to state a plausible claim for strict liability and negligence relating to a manufacturing defect. The court further found that the Plaintiff sufficiently pled his manufacturing defect claims to avoid express preemption, because he pled that the manufacturing defect was the direct result of Zoll’s failure to comply with the federal regulations cited in the warning letter.
The court noted that on appeal, with guidance from the Eleventh Circuit’s recent decision in Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017), the Plaintiff made clear that his claims are “premised only on Zoll’s violation of federal regulations, which also caused a violation of Florida’s common law duty to use due care in manufacturing the Life Vest.” Thus, at least at the pleading stage, the Plaintiff satisfactorily limited his claims to violations of federal regulations such that he could avoid preemption. Likewise, citing Mink, the court found that the Plaintiff avoided dismissal of his claims based on the manufacturing defect due to implied preemption because he is attempting to enforce the traditional state tort duty of a manufacturer to use due care in manufacturing.
Similarly, the court found that the Plaintiff stated plausible claims for misrepresentation and breach of express warranty, and that those claims are not preempted because representations and warranties are made by the manufacturer, not imposed by the state. Finally, the court affirmed the trial court’s dismissal of the Plaintiff’s claim for negligent infliction of emotional distress, finding that the Plaintiff had failed to allege particularized harm.
Dennis Godella, etc. v. Zoll Servs., LLC, No. 17-10736, D.C. Docket No. 0:16-cv-60471-DPG (Feb. 8, 2018).