The District of Arizona recently denied a motion to dismiss by Medtronic Inc., rejecting the argument that federal law preempted a plaintiff’s personal injury claims related to a product that had obtained premarket approval.
Infuse is a bio-engineered liquid bone graft substitute. It is classified as a Class III device under the Medical Device Amendments of 1976. Medtronic submitted a Premarket Approval for Infuse on January 12, 2001. On July 2, 2002, the Food and Drug Administration (FDA) approved Infuse for use in spinal fusion procedures in skeletally mature patients with degenerative disc disease through an anterior approach.
Plaintiff Cristina Ramirez filed a personal injury action against Medtronic alleging she sustained an injury after her doctor used Infuse in a posterior approach lumbar fusion procedure, a use not approved by the FDA. In her complaint, Ramirez alleges that Medtronic promoted the unapproved or “off-label” use of Infuse through sales personnel and agreements with physicians that advocate such uses. Ramirez further alleges that Medtronic failed to report adverse events to the FDA and tried to conceal studies that showed severe side effects associated with off-label uses. Medtronic has not yet filed its answer, which will respond to those allegations.
Medtronic filed a motion to dismiss the complaint in its entirety on the basis of preemption. It argued that the premarket approval preempted all of Ramirez’s state law claims. In considering the motion to dismiss, consistent with applicable law, the court considered all allegations of material fact to be true and construed them in the light most favorable to Ramirez.
In reaching its decision, the court focused on Ramirez’s assertions that her surgeon used Infuse off-label because of Medtronic’s active promotion of its off-label merits. The court noted that “[t]here is a crucial difference between a claim premised on a physician’s use of a device that is unsanctioned by both the FDA and the manufacturer, and one based on a use that still lacks FDA scrutiny but is actively promoted by the manufacturer.” After a thorough analysis, the court found that Ramirez’s claims for fraud, failure to warn, design defect, misrepresentation, negligence and breach of express warranty were not subject to preemption because they were all premised on an off-label use promoted by Medtronic.
The court did dismiss with prejudice Ramirez’s negligence per se claim and any claim based solely on the fact that her doctor used Infuse in an off-label manner, except for her Stengel claim that Medtronic should have warned the FDA of the adverse reports it was receiving about the off-label use of Infuse. The court dismissed Ramirez’s breach of warranty claim without prejudice finding her claim is “premised on Medtronic’s statements during off-label promotion” and fails to state a claim under Arizona law.
On September 4, 2013, Medtronic filed a Motion for Reconsideration. That Motion is pending.
The case is Ramirez v. Medtronic Inc., United States District of Arizona, CV13-00512-PHX-GMS.