A panel of the Ninth Circuit U.S. Court of Appeals reversed a defense verdict in McClellan v. I-Flow Corp, a pain pump case. The case was remanded for a new trial upon the panel's conclusion that the plaintiff's negligence per se claims were not preempted by federal law. The facts were fairly straight forward. The plaintiff had surgery on her shoulder. Afterwards, a local anesthetic was continuously administered using a PainBuster continuous infusion pump, which delivers pain medication directly into the surgical site through a catheter. The pain pump was manufactured or distributed by the defendants. The direct infusion of pain medication into her shoulder joint lead to the plaintiff's shoulder joint fusing into a single bone, limiting her to a few degrees of movement. The pain pump is a medical device subject to the regulation by the FDA's premarket approval process.
In the ensuing lawsuit, the plaintiff advanced state law claims for negligence and strict product liability, claiming the defendants negligently failed to warned that its pain pump should not be used in places like the shoulder joint and were strictly liable for selling a product that was unreasonably dangerous in light of the inadequate warning. Before trial, the trial court refused to provide the jury with negligence per se and other instructions involving federal law, citing Buckman Co. v. Plaintiffs’ Legal Comm, 531 U.S. 341 (2001), generally referred to as Buckman preemption.
The panel reversed the trial court's decision to exclude the negligence per se instruction because the plaintiff's allegations occurred outside the regulatory process, in other words, the allegations were outside the line of communication between the defendants and the FDA. The court noted that in Buckman, the allegations involved fraudulent representations made during the market approval process. The requested instructions in McClellan had little to do with the regulatory interaction. According to the panel, Congress could not have intended to displace all traditional tort law. States were permitted to police medical labels and warnings outside of the FDA approval process. Because the claim was not preempted by federal law, the instruction should have been provided to allow the jury to review the federal statutes in establishing the standard of care.
