Judge Paul Engelmayer
Simon was allegedly injured by a purportedly defective REFLECTION 3 Acetabular System—used in her 2010, hip replacement surgery—designed and made by Smith & Nephew Inc. (SNI). Her amended complaint alleged negligence, strict products liability, and breach of implied warranty. The FDA approved SNI’s R3 Acetabular System, under 21 USC §510(k), in 2007. It granted supplemental pre-market approvals (PMAs), in 2008 and 2009, for R3 system’s optional metal liner—a separate PMA device designed by Birmingham Hip Resurfacing (BHR) System. SNI voluntarily recalled the metal liner following a June 2012 field safety notice. District court granted SNI dismissal. Simon’s state law-based causes of action, premised on theories of design defect, did not state a claim against SNI. Among other things, Simon’s made no concrete allegations tying SNI to the decision to use the optional liner. Nor did SNI’s recall of the liner support her claim that the R3 system was defectively designed. Further, to the extent Simon’s complaint implied that inclusion of an optional metal liner in SNI’s R3 system rendered it defective, that claim was defeated by the fact that the R3 system, as reviewed and approved by the FDA, did not contain any such liner.
