Shuker v. Smith & Nephew — civil — reversal in part — Krause

By federal statute, the makers of certain medical devices who comply with stricter federal safety requirements get preemption from any state safety requirements. But some medical devices are made up of multiple components–if some components comply with the stricter federal standards, while others don’t, is a suit challenging the design of the entire device pre-empted?

Today, the Third Circuit described that question as an issue of first impression in the circuit courts. It answered it by holding that pre-emption is assessed component-by-component, not device-by-device, which in turn means that if the alleged defect in the device does not involve a freestanding defect in the non-preempted component — if it challenges only a defect in the preempted component, or (I think) the interaction between preempted and non-preempted components –then the claim is preempted.

Joining Krause were Jordan and Greenaway. Arguing counsel were Robert Astrachan of Zajac & Arias for the plaintiffs below and Sara Gourley of Sidley Austin and Joseph Lang of Florida for the device makers.