Claims Challenging Safety, Effectiveness of Hip Component Used Off-Label are Preempted, Pa. Federal Judge Rules

PHILADELPHIA — Claims challenging the safety and effectiveness of an acetabular liner used off-label as part of Smith & Nephew’s R3 Acetabular System are preempted even though the liner received premarket approval as part of a different hip replacement system, a Pennsylvania judge has ruled.

In a March 31 order, Judge Juan R. Sanchez of the U.S. District Court for the Eastern District of Pennsylvania explained that because the R3 System’s metal-on-metal cup received FDA Premarket Approval, the acetabular liner, as a component of the cup, is also subject to federal requirements for purposes of § 360k(a).

The judge further …