Last Wednesday an Arizona federal judge rejected a number of device maker Medtronic Inc.’s arguments that federal law preempted a personal injury lawsuit involving claims the company promoted off-label use of Infuse, its bone graft substitute.
U.S. District Judge G. Murray Snow granted part of Medtronic’s motion to dismiss Cristina Ramirez’s lawsuit claiming she has suffered from back pain since undergoing a lumbar fusion procedure using the company’s Infuse bone graft substitute, Law360 reports. Medtronic sought to have the entire complaint dismissed on the grounds that Ramirez’s claims are preempted by the Medical Device Amendments to the federal Food Drug and Cosmetic Act. The judge found, however, that the majority of the plaintiff’s clams are not preempted by federal law.
Ramirez, suffering from back pain, underwent a lumbar fusion operation in 2009 in which her surgeon used an Infuse device despite the fact the device was not approved for use in such a procedure, Law360 reports. The procedure allegedly caused uncontrolled bone growth near the site of the Infuse implant, the complaint says. In March, Ramirez sued Medtronic for fraud, failure to warn, defective design, misrepresentation, negligence, and breach of express warranty.
While a physician can legally use a medical device for purposes other those that are FDA-approved—”off-label” uses—a device manufacturer cannot promote off-label uses. Ramirez’s complaint accuses Medtronic of inducing physicians to employ Infuse for off-label uses by promoting such uses in journal articles and advertisements, despite being aware of potentially severe side effects, according to Law360.
Judge Snow ruled that some of Ramirez’s claims could be pursued under state law, according to Law360. “When Medtronic allegedly violated federal law by engaging in off-label promotion that damaged the plaintiff and thereby misbranded the Infuse device, it departed the realm of federal regulation and returned to the area of traditional state law remedies,” Snow’s order said.
Medtronic’s alleged failure to comply with MDA and FDCA standards is preempted because the responsibility for enforcing those laws lies exclusively with the federal government, Judge Snow wrote. The judge also dismissed the portions of Ramirez’s claims that contain allegations of harm solely based on her doctor’s off-label use of Infuse, absent any off-label promotion by Medtronic.