DESABIO v. Howmedica Osteonics Corp.
817 F. Supp. 2d 197
W.D.N.Y.2011Background
- Desabio filed suit in NY state court asserting breach of warranty, negligence, and res ipsa claims regarding a Trident hip prosthesis.
- Defendants removed the case to WDNY and moved to dismiss; Plaintiff amended to include negligent design/manufacture, warranty, and res ipsa claims.
- Trident System is a Class III device, requiring FDA PMA approval, which the FDA granted after extensive review.
- Plaintiff sought to amend to reference FDA standards; Defendants argued preemption under MDA and FDCA, and failure to plead parallel claims.
- Court analyzed MDA preemption under Riegel, concluded common-law negligence and implied warranty claims are preempted; denied leave to amend; granted motion to dismiss.
- Case closed with dismissal of amended complaint and denial of Plaintiff’s proposed amendment.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether negligence claims are preempted by MDA | Plaintiff argues claims are parallel to FDA rules. | Defendant contends preemption applies; claims rest on state duties. | Preempted; negligence claims dismissed. |
| Whether express warranty claim is preempted | Plaintiff claims warranty breach aligns with FDA-approved labeling. | Defendant argues preemption via FDA scheme. | Preempted; express warranty claim dismissed. |
| Whether leave to amend should be granted | Proposed amendment would state explicit FDA violations. | Amendment futile; lacks sufficient facts to state parallel claim. | Leave to amend denied as futile. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (preemption of state-law claims by PMA device-specific requirements)
- Lohr v. Medtronic, Inc., 518 U.S. 470 (U.S. 1996) (FDA regulations may furnish parallel, not add-on, duties)
- Gelber v. Stryker Corp., 752 F. Supp. 2d 328 (S.D.N.Y. 2010) (district court on parallel claims after Riegel)
- Hofts v. Howmedica Osteonics Corp., 597 F. Supp. 2d 830 (S.D. Ind. 2009) (parallel-claim considerations; caution against conclusory pleading)
- Rollins v. St. Jude Medical, 583 F. Supp. 2d 790 (W.D. La. 2008) (parallel claim mechanics; specific federal requirements)