The Maryland Court of Special Appeals ruled that an injury lawsuit in state court against Medtronic Inc. over the off-label use of its Infuse bone graft is not preempted by the Medical Device Amendments to the federal Food Drug and Cosmetic Act.
The court ruled that the Medical Device Amendments do not preempt claims under state law that a device maker violated prohibitions against the misleading off-label marketing of a device, Law 360 reports. The Maryland case was brought by a man who claims he suffered serious complications after Infuse was inserted in a way not approved by the Food and Drug Administration (FDA) during 2007 spinal fusion surgery to relieve back pain.
The plaintiff alleges that the posterior approach resulted in serious complications including unwanted bone growth, for which he needed a second surgery in 2010. The posterior approach – through the back – is not approved by the FDA and constitutes an off-label use of the device. In 2011, the man learned he had developed two nodules in his lungs that could become cancerous, Law360 reports. He claims Medtronic knew of this cancer risk at the time of his surgery.
Claims that target Medtronic statements on labels approved by the FDA are preempted under federal law, but claims the device maker allegedly made in discussions with doctors and the public are not. “[A] state-law misrepresentation claim would not impose any requirements different from or in addition to those imposed under federal law,” the court said, according to Law360.
The FDA required Medtronic to put a warning on the Infuse label that it could only be used in the anterior approach. The plaintiff contends that Medtronic promoted the off-label use of the device by giving doctors “financial incentives,” according to Law360. Some 85 percent of more than $900 million in Medtronic sales in 2010 were from off-label uses of its products, according to the lawsuit. After an investigation that lasted more than a year, the Senate Finance Committee concluded that Medtronic was “shaping” articles that appear in medical journals through “significant” payments to researchers.