818 F. Supp. 2d 1032
W.D. Ky.2011Background
- Plaintiff John White injured by the Trident Hip Replacement System implanted May 25, 2004 and removed five years later; Stryker designed, manufactured, distributed the device.
- Plaintiff filed suit in Jefferson Circuit Court; Stryker removed to federal court and moved to dismiss, arguing MDA express preemption of state-law claims.
- Plaintiff sought leave to amend; Stryker contended even amended pleadings fail to plead plausible, non-preempted claims under Iqbal/Twombly standards.
- Amended complaint alleges FDA standards violations in broad terms but cites no specific PMA or GMP standard or deviation.
- Court reviews MDA express preemption framework per Riegel, noting PMA process for Class III devices and the parallel-claim concept, and analyzes pleadings under Twombly/Iqbal.
- Court sustains Stryker’s motion to dismiss and dismisses the Amended Complaint with prejudice; granted leave to amend was acknowledged but not allowed to salvage claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether MDA express preemption bars the state claims here | White argues parallel claims survive if they mirror FDA PMA requirements. | Stryker argues PMA-derived requirements preempt state-law claims. | Yes, but only if parallel claims are sufficiently pled; here pleadings fail. |
| Whether the Amended Complaint plausibly asserts parallel (non-preempted) claims | Plaintiff alleges FDA standards compliance and device defect generally, seeking parallelism. | Defendant contends no specific PMA/GMP violations are pled, so no parallel claims. | Amended complaint not plausibly stating parallel PMA/GMP violations; dismissed. |
| What pleading level is required to plead parallel claims post-Riegel, Iqbal, Twombly | Discovery may later reveal precise federal standards; a more lenient approach is acceptable. | Requires specific PMA or GMP violations or device-specific standards in pleadings. | Pleading must be more than mere labels; sufficiently specific to show parallelism is required. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006) (two-step framework for MDA preemption; PMA requirements vs. state claims)
- Ashcroft v. Iqbal, 129 S. Ct. 1937 (Supreme Court 2009) (plausibility standard for pleading)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (Supreme Court 2007) (fact-based pleading required; avoid conclusory allegations)
- Howard v. Sulzer Orthopedics, Inc., 382 Fed. Appx. 436 (6th Cir. 2010) (GMP-specific pleading may create parallel claims; unpublished Sixth Circuit)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (plausible parallel claims where plaintiff identified FDA regulation; device-specific)
- Medtronic Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (design/manufacturing defect claims; district court dismissal for lack of specifics)
- Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011) (second amended complaint may reference FDA standards; issue of specificity)
- Wolicki-Gables v. Arrow Intl., Inc., 634 F.3d 1296 (11th Cir. 2011) (requires specific PMA-specification violations for parallel claims; higher pleading standard)
- Parker v. Stryker Corp., 584 F. Supp. 2d 1298 (D. Colo. 2008) (district-level discussion of parallel claims and FDA standards)
- Horowitz v. Stryker Corp., 613 F. Supp. 2d 271 (E.D.N.Y. 2009) (recall-related claims; related to parallel claim pleading)