Gelber v. Stryker Corp.
788 F. Supp. 2d 145
S.D.N.Y.2011Background
- Mrs. Gelber received a Trident hip prosthesis in July 2004; system manufactured at Stryker plants in Mahwah, NJ or Cork, Ireland.
- She experienced pain and squeaking from 2007, leading to Revision surgery in January 2009.
- Amended complaint alleges Class III device PMA-based manufacturing defects and related FDA CGMP violations.
- FDA approval and subsequent 510(k) modifications of the Trident are described; recalls and a warning letter are cited.
- Court previously dismissed similar state-law claims as preempted, and the Amended Complaint broadens to include additional regulatory theories.
- Court granted part and denied part of defendants’ Rule 12(b)(6) motion, allowing some manufacturing-defect and warranty claims to proceed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether manufacturing-defect claims are preempted or not. | Gelber alleges adulteration via CGMP violations linked to PMA device. | Stryker argues preemption under 21 U.S.C. § 360k(a). | Not preempted; claims may proceed. |
| Whether failure-to-warn and failure-to-report claims survive. | Warnings and reports should be updated; FDA findings post-date implant. | Claims are preempted or fail to state a claim. | Preempted and dismissed. |
| Whether CGMP-based failure-to-identify/correct device problems survive. | CGMP violations—failure to identify/correct—are actionable. | Such failures impose no state-law burden beyond federal requirements. | Preempted and dismissed. |
| Whether failure to control nonconforming product claims survive. | Defendants failed to control nonconforming Trident components. | CGMPs do not mandate timely identification/control pre-delivery. | Preempted and dismissed. |
| Whether breach of express/implied warranty claims survive and are time-barred. | Express warranties survive; implied warranty claims timely or not; some continue. | Implied warranty time-barred; express warranty claims may be time-barred depending on future-performance language. | Implied warranty time-barred; some express warranty claims survive for now; rest to be revisited on summary judgment. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (premarket approval imposes device-specific federal requirements; parallel claims may survive if truly equivalent)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (U.S. 2001) (implied preemption; private actions cannot enforce FDA requirements)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (CGMP-based parallel claims; device-specific vs general requirements; not purely generic)
- Medtronic Leads, 623 F.3d 1200 (8th Cir. 2010) (parallel claims and PMA context for class III devices)
- Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582 (E.D.N.Y. 2009) (CGMP-based parallel claims; pleading requirements)