McClellan v. I-Flow Corporation

Because there is no conflict with the Medical Device Amendment of 1976, preemption of state law does not apply to failure-to-warn theory jury instructions.

Christina McClellan underwent two different shoulder surgeries. During her recovery, she received painkiller medication that was administered through I-Flow Corporation’s (“I-Flow”) device directly into where the surgery took place. During the recovery, McClellan suffered from chondrolysis of the shoulder, her shoulder fusing with the “ball and socket” portion of her joint. She subsequently lost motion in her joints and is unable to move her shoulder more than a few degrees. McClellan filed suit against I-Flow, the device’s manufacturer, for negligence and strict product liability. McClellan alleged two different theories of liability against I-Flow: “(1) I-Flow negligently failed to warn that its pain pump should not be used in intra-articular spaces such as the glenohumeral joint; and (2) I-Flow was strictly liable for selling a product that was unreasonably dangerous due to a lack of adequate warnings.” The district court held that McClellan’s negligence per se instructions were preempted by the Medical Device Amendment of 1976 (“MDA”). I-Flow additionally contended that the Ninth Circuit lacked the jurisdiction to hear this appeal. The panel dismissed I-Flow’s allegation, and held that “presumption against federal preemption of state law applied to this case,” and that the instruction should have been read. The panel held that allowing the jury instructions would not have been contrary to the congressional intent behind the MDA, which requires “reasonable assurance of safety and effectiveness.” The panel thus concluded that there was no federal preemption, and that the district court made a harmless error. VACATED AND REMANDED. Defendant-Appellant I-Flow Corporation’s cross-appeal is DISMISSED as moot.