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 stated that federal law does not preempt claims about misrepresentations to doctors or to the public regarding the risks of such uses, thus reviving a man’s lawsuit over Medtronic’s Infuse bone growth device.
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 bans against the misleading, off-label marketing of a device.
The plaintiff filed the suit following a spinal fusion surgery he had in 2007 for back pain. He claimed the way in which the Infuse device was inserted, was not approved by the U.S. Food and Drug Administration (FDA), and caused his serious injuries.
In documents obtained by Law360, the court said, “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 plaintiff claims that his surgeon inserted the device via the posterior approach, through his back, rather than the anterior approach approved by the FDA, via the abdomen. A Medtronic sales representative was allegedly present during surgery to oversee the off-label use of the device. The plaintiff contends that the posterior approach resulted in significant complications, including unwanted bone growth, for which he required a second surgery in 2010. In 2011, he was told that he had developed two nodules in his lungs. He claims Medtronic knew of the cancer risks of implanting the device in some off-label procedures.
The FDA’s approval for Infuse required Medtronic to place a warning on the label stating 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 claims that they stationed sales representatives at surgeries. After a yearlong investigation, the Senate Finance Committee concluded that the device maker was “shaping” articles that appeared in medical journals by making “significant” payments to consultants. The man claims in the lawsuit that nearly 85 percent of Medtronic’s $900 million revenue in 2010 was from off-label uses of its products, according to Law360.
For more information, contact Gacovino Lake and Associates at 1-800-246-HURT (4878).