Simon v. Smith & Nephew, Inc.
18 F. Supp. 3d 423
S.D.N.Y.2014Background
- Plaintiff Susan Simon sues Smith & Nephew for injuries from the REFLECTION 3 Acetabular System and an optional metal liner used in her hip replacement.
- The court previously dismissed Simon’s negligence, strict products liability, and implied warranty claims as preempted or failing to state a claim.
- Simon alleged the metal liner, approved via PMA for a separate device, was defectively used with the R3 System.
- The December 3, 2013 Opinion held the Amended Complaint did not plead that Smith & Nephew designed the R3 System to include the liner or prompted its use in a non-PMA context.
- The court found the core theory—metal-on-metal injury from the liner with the R3 System—premised on the PMA-approved liner and thus preempted or failing to state a claim.
- Simon sought reconsideration and leave to amend or obtain discovery, which the court denied.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Simon’s claims are preempted by the MDA | Simon argues the liner design/use implicates PMA-approved device issues. | Smith & Nephew contends the device as a whole is the PMA-approved device and claims fall within preemption. | Yes; claims preempted. |
| Whether the Amended Complaint plausibly alleges design/marketing of the liner with R3 | Simon alleges Smith & Nephew introduced and marketed the liner with the R3 system. | Defendant argues the complaint lacks concrete facts tying Smith & Nephew to such design/marketing. | No; allegations were conclusory and insufficient. |
| Whether leave to amend or limited discovery should be granted | Simon requests amendment and discovery to bolster nonconclusory facts. | Defendant argues amendment would be futile and discovery nonproductive given preemption. | Denied; amendment and discovery denied. |
Key Cases Cited
- Riegel v. Medtronic, 552 U.S. 312 (Supreme Court 2008) (PMA preemption of state-law claims relating to PMA-approved devices)
- Gelber v. Stryker Corp., 788 F.Supp.2d 145 (S.D.N.Y.2011) (parallel claims may survive where regulations parallel federal requirements)
- Bertini v. Smith & Nephew, Inc., 8 F.Supp.3d 246 (E.D.N.Y.2014) (preemption analysis focuses on device as a whole; PMA-approved component drives preemption)
- Associated Press v. U.S. Dep’t of Def., 395 F.Supp.2d 17 (S.D.N.Y.2005) (motion for reconsideration standards; no new arguments)
- Tyler v. Liz Claiborne, Inc., 814 F.Supp.2d 323 (S.D.N.Y.2011) (courts do not credit mere conclusory statements)
- Dougherty v. Town of North Hempstead Bd. of Zoning Appeals, 282 F.3d 83 (2d Cir.2002) (amendments futile if fail to state a claim)
- Foman v. Davis, 371 U.S. 178 (Supreme Court 1962) (leave to amend freely given absent undue prejudice or futility)