Wolicki-Gables v. Arrow International, Inc.
2011 U.S. App. LEXIS 4596
11th Cir.2011Background
- Linda Wolicki-Gables received an Arrow intrathecal pump system (pump, intrathecal catheter, and a connector linking pump and catheter) for chronic pain management in 2002.
- In 2003, a series of tests and a replacement connector occurred after concerns about bolus function; Dr. James replaced the connector and reimplanted the pump.
- Nelson, initially involved with Arrow, later became a Codman employee; Nelson allegedly told Gables that the connector had been returned to the manufacturer and later that the manufacturer destroyed the connector.
- Postoperative complications led to paralysis and a diagnosis of transverse myelitis; she subsequently required rehabilitation and became partially paraplegic.
- The Gableses filed state-law claims against Arrow, Codman, Johnson & Johnson, and Nelson in Florida state court; defendants removed to federal court but moved for summary judgment on preemption grounds.
- The district court concluded that all claims were expressly preempted or derivative of preempted claims under the Medical Device Amendments (MDA) and granted summary judgment, which the Eleventh Circuit affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law claims are preempted by the MDA | Gableses contend parallel claims survive preemption. | Appellees argue claims are preempted as they add to or differ from FDA requirements. | Claims are preempted; no parallel claims alleged. |
| Whether the complaint states parallel claims linking to FDA PMA requirements | Gableses allege design, manufacture, and warnings violations tied to FDA standards. | Allegations lack specific PMA references; not genuinely equivalent to federal requirements. | No parallel claims; insufficient factual basis to connect to PMA requirements. |
| Whether destroyed catheter connector supports a presumption of defect | Cassisi-based presumption should apply because connector was destroyed. | No sufficient evidence to infer defect; cannot apply Cassisi. | Cassisi presumption not warranted; no defect shown. |
| Whether Nelson's involvement establishes an agency relationship with Codman/Johnson & Johnson | Agency theory could support liability against those entities. | No evidence of agency relationship; manufacturer designed/sold devices. | No agency relationship established; preemption remains. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (Supreme Court 2008) (parallel claim framework under §360k)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (Supreme Court 1996) (premarket approval creates device-specific requirements)
- Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582 (E.D.N.Y. 2009) (requires specific factual links to FDA requirements for parallel claims)
- Parker v. Stryker Corp., 584 F. Supp. 2d 1298 (D. Colo. 2008) (illustrates limitations on parallel claims without detailed PMA references)
- Cassisi v. Maytag, 396 So. 2d 1140 (Fla. Dist. Ct. App. 1981) (presumption where product destruction may indicate defect (state court))
- Worsham v. A.H. Robins Co., 734 F.2d 676 (11th Cir. 1984) (res ipsa-like inference allowed where device destroyed; probative evidence)