On Monday, the Maryland Court of Special Appeals revived an injury lawsuit against Medtronic Inc. over the off-label use of its Infuse bone graft. The court said federal law does not preempt claims about misrepresentations to doctors or the public about the risks of such uses.
The court ruled that the Medical Device Amendments to the federal Food Drug and Cosmetic Act do not preempt state-law claims that a device maker violated federal prohibitions against the misleading off-label marketing of a device, Law 360 reports. The case was brought by a man who underwent spinal fusion surgery in 2007 for back pain. He claimed that the Infuse device was inserted in a way that was not approved by the U.S. Food and Drug Administration (FDA) and caused him serious injury.
Although claims that focus on statements by Medtronic on labels approved by the FDA are preempted, claims that the device maker allegedly made in discussions with doctors and the public are not, according to Law360. “Insofar as Medtronic’s alleged misrepresentations consist of false statements of material fact in the context of off-label promotion, outside the scope of the safe harbor, a state-law misrepresentation claim would parallel the FDCA prohibitions on off-label marketing . . .To that extent, therefore, a state-law misrepresentation claim would not impose any requirements different from or in addition to those imposed under federal law,” the court said.
The plaintiff claims his surgeon inserted the device by the posterior approach, through his back, rather than the anterior approach approved by the FDA. Court documents say a Medtronic sales representative was present during surgery to oversee the off-label use of the device, Law360 reports. The plaintiff alleges that the posterior approach resulted in serious complications including unwanted bone growth, for which he needed a second surgery in 2010. In 2011, he learned that he developed two nodules in his lungs. He claims Medtronic knew of cancer risks of implanting the device in some off-label procedures.
The FDA’s approval for Infuse required Medtronic to put a warning on the label that Infuse could only be used in the anterior approach. The plaintiff contends that Medtronic promoted the off-label use of the device by giving “financial incentives” and by stationing sales representatives at surgeries, according to Law360. The Senate Finance Committee, after an investigation that lasted more than a year, concluded that the device maker was “shaping” articles that appeared in medical journals by making “significant” payments to consultants.