A lawsuit accusing Medtronic (NYSE:MDT) of fraud and negligence in promoting off-label use of its Infuse bone-growth protein creeps closer to trial following a California judge’s decision to dismiss the medical device giant’s request for dismissal.
The lawsuit, filed by a woman who received an Infuse bone graft procedure in her neck, claims Medtronic trained surgeons to use the product in an off-label manner and paid doctors millions of dollars to publish articles about off-label use.
Medtronic had requested that the case be dismissed on summary judgment, but Los Angeles Superior Court Judge Michael Paul Linfield spiked that motion.
The Infuse bone growth protein has been on the U.S. market since 2002, when the FDA approved the product for use in the lower spine. The lawsuit accuses the medical device titan of marketing Infuse for use in the neck without FDA approval.
Medtronic remains in the hot seat over the controversial product, despite the U.S. Justice Dept.’s decision earlier this year to close its years-long criminal and civil investigation without finding evidence of wrongdoing.
The device giant has been batting back accusations about Infuse, which is used in spinal fusion surgeries, since a Spine Journal issue dedicated to highlighting serious concerns about the morphogenetic protein came out last summer.
The journal warned that off-label use of the product might increase a patient’s cancer risk nearly 5-fold after 3 years; others questioned the credibility of researchers who hid financial ties to Medtronic.
The medtech titan is still on the hook in a separate shareholder suit accusing it of inflating share prices using misleading statements about Infuse as well as other patient injury lawsuits, including one alleging that Medtronic installed a paid crony at the Journal of Spinal Disorders and Techniques in order to push positive – and possibly premature – data on its Infuse bone growth stimulant.