Kaiser v. DePuy Spine, Inc.
944 F. Supp. 2d 1187
M.D. Fla.2013Background
- Plaintiff, who had a Charite Disc implanted in 2005, filed suit in state court in 2012 for negligence and strict liability.
- Defendant DePuy Spine, Inc. removed the case to federal court shortly after filing its first motion to dismiss in 2012.
- Defendant argued the claims are preempted by the FDA PMA framework for medical devices under the MDA.
- Plaintiff amended the complaint in January 2013, alleging PMA requirements and FDA design/manufacture shortcomings.
- Court previously granted dismissal without prejudice, allowing amendment; Plaintiff again asserts preemption and parallel claims.
- Court granted motion to dismiss with prejudice, finding no viable parallel claim and no private FDCA remedy under Florida law.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether MDA preempts Plaintiff's claims. | Plaintiff argues parallel to FDA requirements. | Defendant argues claims are preempted as different or additional requirements. | Preemption applies to parallel claim—dismissed. |
| Whether Plaintiff states a parallel claim to avoid preemption. | Alleged PMA compliance constitutes a parallel claim. | Fails to plead specific FDA regulations or PMA requirements violated. | No parallel claim; claims preempted. |
| Whether Florida recognizes a private right of action to enforce FDA regulations. | FDCA/private right of action not recognized in Florida. | No private right; claims dismissed. | |
| Whether leave to amend to add breach of express warranty is futile. | Privity lacking; warranty claims futile. | Leave to amend denied; warranty claim futile. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (FDA preemption framework for PMA devices; dual-prong test)
- Wolicki-Gables v. Arrow Intern., Inc., 634 F.3d 1296 (11th Cir. 2011) (parallel claim requires genuinely equivalent federal and state requirements)
- Stokes v. I-Flow Corp., 2013 WL 1715427 (M.D. Fla. 2013) (confirms parallel claim standard and preemption analysis)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (FDCA preemption and parallel claims under MDA framework)