Christina McClellan v. I-Flow Corporation
776 F.3d 1035
| 9th Cir. | 2015Background
- McClellan underwent two shoulder surgeries with continuous PainBuster infusion pumps manufactured by I-Flow and distributed by DJO; she developed chondrolysis of the glenohumeral joint resulting in complete loss of articular cartilage and near-total elbow mobility in the shoulder; she asserted state tort claims for negligent failure to warn and strict products liability; district court refused to give certain federal-law instructions, citing MDA preemption; the court severed DJO, Inc. from the case and denied costs on I-Flow’s cross-appeal; the judgment was entered for the defendants and McClellan appeals while I-Flow cross-appeals on costs.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption of the requested instructions | McClellan argues MDA does not preempt state-law negligence/safety instructions | I-Flow and DJO contend MDA preempts federal-style instructions | Not preempted; remanded for new trial |
| Appellate jurisdiction | McClellan contests whether final judgment exists for appeal | I-Flow argues lack of final judgment due to severance | Jurisdiction exists; proceed to merits |
| Impact of pretrial/federal-law instructions on jury | Instructions referencing federal standards are proper parallel to state tort claims | Instructional error if preempted under MDA; harmed trial | Instructional error requiring vacatur and new trial; not harmless |
Key Cases Cited
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (fraud-on-the-FDA claims preempted; limits on policing FDA interactions)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (MDA preemption analysis; parallel state tort claims allowed)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (preemption in premarket approval context; state-law claims vs. FDA process)
- Wyeth v. Levine, 555 U.S. 555 (2009) (presumption against preemption; doubts about exclusive federal enforcement)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) (paralleling MDA duties; non-preemption of some state claims)