An approved programmable pump for delivering medication into a patient requiring a chronic infusion of drugs had been used successfully by the plaintiff’s decedent for two years, when the pump delivered an excess of medication resulting in the patient’s death. The plaintiff sued in state court for negligence, strict liability and breach of warranty.
The Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. Section 360c et seq., established a federal regulatory scheme governing medical devices. Manufacturers must submit to a rigorous pre-market approval process, and once approved, any changes in design specifications, manufacturing process, labeling, or any other attribute that would affect safety or effectiveness are strictly forbidden without additional FDA approval. Sometimes approval is conditioned upon specified performance standards. The MDA preempts all state tort claims concerning the performance of an approved device, except claims paralleling those that could be brought under the MDA.
The pump’s manual, part of the pre-market approval application, specified that medication would accurately flow from the pump within fifteen percent of the programmed rate, but also warned that the pump’s accuracy could be compromised by various factors. The plaintiff argued that the flow accuracy specification constituted a performance standard, the standard was deviated from, and therefore the device was not in compliance with the MDA, so the claims paralleled those which could be made under the MDA.
The court held that the flow accuracy specification was intended to inform the medical community of the results the device was likely to achieve under optimal circumstances, but did not constitute a performance standard required by the FDA to be met. The plaintiff’s claims sought to impose requirements more restrictive than those imposed by the MDA so were therefore preempted. Walker v. Medtronic, Inc., 2012 WL 208036 (4th Cir.(W.Va.) Jan 25, 2012) (not designated for publication).