McClellan v. I-Flow Corp., No. 11-35109 (9th Cir. 2015)Annotate this Case
Plaintiff 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.