Bertini v. Smith & Nephew, Inc.
8 F. Supp. 3d 246
E.D.N.Y2014Background
- Diversity products liability action involving Smith & Nephew R3 System hip implant.
- Plaintiffs attack the R3 System, then focus on PMA-approved liner vs. 510(k) system.
- R3 System comprises acetabular shell and possible liners, used with various stems/heads.
- R3 liner received PMA approval for use with the BHR System; R3 System approved via 510(k).
- Plaintiff Bertini experienced loosening and mechanical failures leading to revision surgery; recall of R3 metal liner occurred in 2012.
- Procedural posture: defendant moved to dismiss for federal preemption and failure to state claims; court granted in full.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law claims are preempted by the MDA. | Bertini claims rely on PMA-approved device aspects not preempted. | Claims premised on PMA requirements are preempted; 510(k) aspects may proceed. | Preemption largely applies to PMA-approved liner; system-wide claims analyzed as one unit. |
| Whether the R3 System/liner claims survive given PMA vs 510(k) approvals. | Claims against both liner and system can be pursued. | Liner PMA preempts related claims; system 510(k) aspects may not. | Liner-related claims preempted; system-related claims largely not preempted but diluted by interdependence. |
| Whether design defect claims are preempted as adding safety requirements beyond FDA standards. | Design defect claims should not be preempted if they rely on PMA approvals. | Design defects would impose additional state requirements; preempted. | Design defect claims involving PMA-approved liner preempted; system-design claims dismissed as preempted when tied to liner. |
| Whether failure-to-warn, manufacturing defect, negligence, fraudulent misrepresentation, and implied warranty claims survive. | Some claims should parallel FDA requirements and survive. | Parallel claims may still be preempted if they impose new safety duties. | Failure-to-warn, manufacturing defect, negligence, and implied warranty claims largely dismissed as preempted; fraud claim dismissed for lack of reliance. |
| Whether loss of consortium is viable given dismissal of Bertini's claims. | Derivative claim depends on Bertini’s injuries. | If primary claims fail, derivative cannot proceed. | Loss of consortium dismissed as derivative. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (preemption framework for PMA-approved devices; parallel vs. add-to requirements)
- Lohr v. Medtronic, Inc., 518 U.S. 470 (U.S. 1996) (distinctions between PMA and 510(k) processes; FDA framework)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (federal preemption and misrepresentation limitations)
- Horowitz v. Stryker Corp., 613 F. Supp. 2d 271 (E.D.N.Y. 2009) (post-Riegel preemption analysis for implied warranty/related claims)
- Reed v. Pfizer, Inc., 839 F. Supp. 2d 571 (E.D.N.Y. 2012) (manufacturing design and reliance principles in product-liability context)