McClellan v. I-Flow Corp., No. 11-35109 (9th Cir. 2015)
Annotate this CasePlaintiff filed suit against I-Flow, manufacturer of the PainBuster continuous infusion pump, alleging state common law claims for negligence and strict products liability. Plaintiff alleged that I-Flow negligently failed to warn that its pain pump should not be used in intra-articular spaces such as the glenohumeral joint; and that I-Flow was strictly liable for selling a product that was unreasonably dangerous due to the lack of adequate warnings. The PainBuster is regulated under the Medical Device Amendments of 1976 (MDA) to the Food, Drug & Cosmetics Act (FDCA), 21 U.S.C. 360c(a)(1)(A)(i), (B), (C)(i). Concluding that it has jurisdiction to hear the appeal where judgment was entered as to all defendants, the court concluded that the requested jury instructions regarding negligence and federal standards were not preempted by the MDA. Therefore, the court remanded and declined to reach the evidentiary issues. The court dismissed I-Flow's cross appeal as moot.
Court Description: Preemption. The panel vacated the district court’s judgment, and remanded for a new trial, in a diversity action alleging common law claims for negligence and strict products liability. The panel dismissed, as moot, the cross appeal challenging the district court’s denial of costs. Christina McClellan alleged she suffered injuries after she was prescribed continuous infusion of a painkiller, delivered through a PainBuster infusion pump device, I-Flow. The PainBuster is regulated under the Medical Device Amendments of 1976 (MDA) to the Food, Drug & Cosmetics Act. The district court declined to give some of McClellan’s requested jury instructions under Oregon law based on the court’s conclusion that they were preempted by federal law. The panel held that there was appellate jurisdiction because judgment was entered as to all the defendants. The panel held that the presumption against federal preemption of state law applied to this case. The panel held that McClellan’s case was not controlled by Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (holding that the state law claims were preempted because the state law claims enjoyed no presumption against preemption and were in conflict with the MDA). The panel further held that McClellan’s requested jury instructions did not conflict with the congressional intent behind the MDA, and would not 4 MCCLELLAN V. I-FLOW CORPORATION usurp the exclusive federal enforcement power over the MDA. The panel concluded that no federal preemption applied, and the district court’s refusal to give the requested jury instruction was not harmless error. The panel remanded for a new trial due to the instructional error with leave to the district court to determine in the first instance whether the requested instructions were otherwise appropriate under Oregon law.
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