On August 18, 2026, in a products liability action brought against medical device manufacturer Zoll Medical Corporation (“Zoll”), the United States District Court for the Eastern District of Louisiana granted Zoll’s Rule 12(b)(6) motion to dismiss the plaintiffs’ first amended complaint with prejudice. The plaintiffs asserted four claims under the Louisiana Products Liability Act (“LPLA”) arising from alleged inappropriate discharges from a Zoll LifeVest wearable cardioverter defibrillator.
The Court held that the plaintiffs’ LPLA claims were preempted by federal law because the LifeVest is a Class III medical device that underwent the FDA’s rigorous Premarket Approval (“PMA”) process. The Court explained that, while state-law claims may survive preemption if they parallel federal requirements, plaintiffs must identify the specific federal requirement allegedly violated and plead the state-law claim with sufficient particularity.
Applying that standard, the Court found that the plaintiffs failed to plausibly plead a parallel manufacturing defect claim because they did not identify any FDA design or manufacturing requirements applicable to the LifeVest or explain how Zoll’s manufacturing process deviated from those requirements. The Court similarly dismissed the plaintiffs’ design defect claim, finding that their challenge to the FDA-approved design was expressly preempted.
The Court also dismissed the plaintiffs’ inadequate warning claim, finding that they failed to allege any violation of an FDA-approved warning or instruction or otherwise identify a corresponding federal requirement. Finally, the Court dismissed the express warranty claim because the plaintiffs failed to identify any specific express warranty, when or where it was made, or how it induced use of the LifeVest. The Court further rejected the plaintiffs’ reliance on discovery to establish the substance of the alleged warranties, finding that their vague and conclusory allegations did not provide a sufficient factual basis to warrant discovery.
Because the plaintiffs had already amended their complaint once and had not requested further leave to amend, the Court dismissed all four LPLA claims with prejudice. The Court also dismissed a derivative loss of consortium claim asserted by Mark Pellegrin.
Liskow attorney Michael Mims represented Zoll in the matter. A copy of the Court’s decision can be found here.