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9th Circuit Grants New Trial for Medication Pump Bone Fusion Injury

animated x-ray view on a human skeleton showing shoulder pain
Pain pump manufacturer did not warn surgeons of cartilage loss that caused bone fusion in the plaintiff's shoulder.

The Ninth Circuit appeals court granted a new trial in a products liability lawsuit against I-Flow, manufacturers of the PainBuster device, which allegedly causes shoulder bones to fuse.

The PainBuster pain pump is used to infuse painkillers continuously to the site of a surgery through a medication reservoir and attached catheter. Christina McClellan of Oregon underwent two shoulder surgeries, both times receiving medication through the device.

Shoulder bones fused together

McClellan claims the pain pump caused the loss of cartilage in her shoulder resulting in the fusion of her shoulder ball and socket into a single bone.  She no longer has any motion in her joint and her shoulder is restricted to only a few degrees of movement, according to the opinion.

McClellan filed suit against I-Flow under common law theories of negligence and strict products liability in 2007 for its negligent failure to warn physicians against use of the pain pump in the joint space between bones and for selling an unreasonably dangerous product without adequate warnings.

Jury instructions preempted by federal law

The district court declined to submit to the jury instructions describing “federal safety standards applicable to defendants” and the effect of violating those standards -- improperly ruling that they were preempted by federal law, according to the appeals court.

The jury returned a verdict in favor of I-Flow in October of 2010 and McClellan appealed in February of 2011.

The three-judge appeals court panel disagreed with the district court's reliance on the Supreme Court’s decision in Buckman Co. v. Plaintiffs' Legal Comm., in which a defendant obtained improper market clearance for medical bone screws through their fraudulent representations to the FDA.

Lower court ruling vacated

The judges in this case distinguished McClellan’s claim because she “has not alleged any fraud on the FDA. Instead, McClellan has alleged failure-to-warn theories that are clearly concerned with the labeling and regulation of medical devices” which are “largely left to the States to supervise” and are not preempted by federal law, according to the opinion.

The judgment for I-Flow was vacated and remanded for a new trial, as the failure to include the request jury instructions given “was far weaker than the requested negligence per se instruction” and the circuit judges in this case could not “say the error was more probably than not harmless.”

McClellan is represented by  R. Daniel Lindahl of Bullivant Houser Bailey PC , Leslie W. O'Leary of Williams O’Leary LLC and  Jeffrey B. Wihtol of Law Offices of Jeffrey B. Wihtol.

I-Flow is represented by Andrew G. Klevorn of Katten Muchin Rosenman, LLP,  James W. Joseph of Elmer Stahl LLP, and Eric J. Neiman, George S. Pitcher of Williams, Kastner & Gibbs, PLLC,

The case is McClellan v. I­Flow Corp. et al., case number 11­35134, in the U.S. Court of Appeals for the Ninth Circuit.

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