Pre-emption defense loses to twin laws

Trial Notebook

By Steven P. Garmisa

Hoey & Farina

Posted December 13, 2017 12:30 PM

Senayda Norabuena’s failure-to-warn claims under Illinois common law against Medtronic Inc. and Medtronic Sofamor Danek USA for injuries she allegedly suffered because of off-label use of an “Infuse Bone Graft/LT–Cage Lumbar Tapered Fusion Device” presented tricky questions about pre-emption under Sections 360k(a) and 337(a) of the Federal Food, Drug and Cosmetic Act.The Infuse was a Class III medical device, and the premarket approval Medtronic received from the FDA required use of a specific …

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