Wolicki-Gables v. Doctors Same Day Surgery Center, Ltd.
216 So. 3d 665
| Fla. Dist. Ct. App. | 2017Background
- Linda Wolicki‑Gables received an Arrow-manufactured intrathecal pain-pump system (Class III device, PMA-approved). The connector was suspected to have caused the device malfunction and was removed during surgery.
- Arrow representative took the removed connector for testing; Arrow later reported no defect and destroyed the connector per company policy.
- The Gableses sued Arrow in federal court asserting product-liability and negligence claims; the federal courts held those claims preempted by the MDA and related federal law and entered summary judgment for Arrow.
- The Gableses then sued the Surgery Center in Florida state court for third‑party spoliation, alleging that, but for the Surgery Center allowing Arrow to take the connector, they could have (1) brought a first‑party spoliation claim against Arrow or (2) pursued a "parallel" negligent design/manufacture claim against Arrow based on violations of PMA-related FDA requirements.
- The trial court granted summary judgment for the Surgery Center; the Second District affirmed, holding any state-law negligent-design/manufacture claim against Arrow would be preempted and Florida does not recognize the necessary "parallel" private remedy.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether a state-law negligent design/manufacture claim against Arrow could proceed despite PMA preemption | Gables: If Surgery Center had preserved the connector, they could have proved Arrow violated PMA/FDA requirements and pursued a state-law claim (a "parallel" claim) | Surgery Center/Arrow: Claims challenging a PMA-approved device are preempted by 21 U.S.C. § 360k and § 337; Florida provides no private cause of action to enforce FDA/MDA requirements | Held: Preempted; Florida does not recognize the parallel private remedy, so no viable claim against Arrow |
| Whether a first‑party spoliation claim against Arrow would have been viable | Gables: Destruction of the connector prevented their ability to prevail against Arrow | Surgery Center/Arrow: (implicitly) federal preemption and lack of private remedy; also federal court found connector’s absence did not prevent meaningful expert testimony | Held: Trial court’s rejection of the Gableses’ asserted first‑party spoliation theory was affirmed (court affirmed without extended discussion) |
| Whether spoliation suit against third party (Surgery Center) survives absent a viable underlying claim against Arrow | Gables: Third‑party spoliation permitted because loss of the connector destroyed a probable expectancy against Arrow | Surgery Center: No recoverable expectancy because any underlying claim against Arrow would be preempted or otherwise unavailable | Held: No third‑party spoliation recovery — even with the connector, Gableses would not have been able to proceed against Arrow; summary judgment affirmed |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (discusses difference between § 510(k) and PMA processes and that some state claims may survive for non‑PMA devices)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (state-law fraud-on-the-agency claims impliedly preempted because enforcement is reserved to federal government)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (state common-law claims imposing requirements different from PMA-approved federal requirements are expressly preempted)
- Martino v. Wal‑Mart Stores, Inc., 908 So. 2d 342 (Fla. 2005) (defines third‑party spoliation claim as recovery for loss of probable expectancy against first‑party tortfeasor)
- Wolicki‑Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir.) (affirming federal judgment that MDA preempted Gableses’ claims against Arrow)
- Murthy v. N. Sinha Corp., 644 So. 2d 983 (Fla. 1994) (Florida will not judicially create private causes of action when legislature has not clearly intended one)