Simon v. Smith & Nephew, Inc.
990 F. Supp. 2d 395
S.D.N.Y.2013Background
- Simon sues Smith & Nephew for negligence, strict products liability, and implied warranty over the R3 Acetabular System used in her 2010 hip replacement.
- Postoperative complications included clicking, pain, and elevated chromium/cobalt levels; revision surgery occurred in 2013 replacing the metal liner and head.
- Simon filed suit in NY state court; it was removed to federal court; Smith & Nephew moved to dismiss under Rule 12(b)(6).
- Regulatory framework: MDA preemption framework; PMA vs 510(k) approvals; FDA oversight for Class III devices; potential preemption of state-law claims tied to PMA-approved devices.
- The R3 system's FDA PMA approvals were separate from the BHR system’s PMA approvals; the optional metal liner was approved with the BHR system.
- Court analyzes whether Simon’s state-law claims relate to PMA-approved aspects and whether they plead plausible facts to state claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Are Simon's claims preempted by the MDA? | Simon argues PMA status governs preemption; 510(k) not fully preemptive. | Smith & Nephew contends PMA-approved components (including the metal liner) preempt claims; other claims fall outside PMA. | Yes; PMA-related claims preempted; parallel claims limited; design-defect claims tied to PMA-approved device improperly stated. |
| Does strict products liability design-defect survive preemption? | Design defect in R3 as designed caused harm; metal-on-metal issue not properly tied to PMA. | Device design claimed violates PMA-approved specs; claims are preempted when premised on PMA device. | Dismissed for failure to state a claim; device design inconsistent with FDA-approved description; PMA preemption applies. |
| Is the negligence claim preempted for PMA-approved components? | Negligence damages can be sought for non-PMA aspects and general design; not limited to PMA. | Negligence claims tied to PMA-approved components are preempted; generic negligence theories insufficiently pleaded. | Preempted to the extent based on PMA-approved components; broader negligence theory fails to plead non-PMA alternative. |
| Is the breach of implied warranty claim viable given PMA status? | Implied warranties may cover non-PMA elements; not all must be PMA-related. | Warranty claims premised on PMA-approved device are preempted; bare assertions insufficient. | Dismissed; implied warranty claim fails as to PMA-approved device and lacks non-PMA basis. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. Supreme Court 2008) (PMA approval preempts state tort claims to the extent they relate to PMA device safety/effectiveness)
- Gelber v. Stryker Corp., 788 F.Supp.2d 145 (S.D.N.Y. 2011) (parallel claims require FDA regulation violations, not mere allegations of violation)
- Gale v. Smith & Nephew, Inc., 989 F.Supp.2d 243 (S.D.N.Y. 2013) (to state parallel claim, plead specific PMA requirements violated and link to injury)
- Lewkut v. Stryker Corp., 724 F.Supp.2d 648 (S.D.Tex. 2010) (component-level preemption considerations; treating PMA components as part of system)
- Riley v. Cordis Corp., 625 F.Supp.2d 769 (D.Minn. 2009) (separating components of PMA-approved device for preemption analysis)