The family of a woman who died after receiving a Medtronic device has filed the first lawsuit alleging the Fridley medical device maker's bone graft product caused a death.
The infuse bone graft product is approved for a procedure in the lower back, but Shirley Nesbit's physician used it in her neck. The month before, the FDA issued a warning that using the device in the neck had caused life-threatening complications.
The lawsuit alleges Medtronic wrongly promoted the product's use in Nesbit's case. Doctors have the legal right to use devices in unapproved ways, but companies are not allowed to promote so-called off-label uses.
A Medtronic statement says the company did not promote off-label use of its product in the Nesbit case, and quoted her surgeon saying the choice was his.
Still, Medtronic's practices regarding the infuse product are drawing government scrutiny. Despite the lawsuit, Medtronic stock rose 3 percent today.