Medtronic Sued in California for Off-Label Infuse Bone Graft Complications

A California man recently filed yet another Medtronic Infuse spine surgery lawsuit, shedding further light on the controversial off-label use of the Infuse Bone Graft medical device. The 85-page complaint was filed against manufacturer Medtronic, Inc. in in Los Angeles Superior Court on June 19, 2013. The plaintiff includes allegations of products liability, and seeks an unspecified amount of compensatory and punitive damages.

Approved and unapproved Infuse Bone Graft uses

Medtronic introduced its Infuse Bone Graft, a device which releases a bone-growth protein into a patient’s body during spinal fusion surgery, in 2002. The Food and Drug Administration approved the device, but only for one procedure in one spinal area. The plaintiff alleges that Medtronic was frustrated by the limited approval, and the consequential lack of sales, and turned to off-label uses for its Infuse Bone Graft product in order to increase demand for the device.

It is not illegal to use medical devices off-label, or in an unapproved manner. It is illegal for a device manufacturer to promote off-label use or provide financial incentives for such use. Specifically, according to the lawsuit, the FDA told Medtronic prior to approval that the Infuse Bone Graft could be dangerous when used off-label. These dangers primarily include Infuse bone overgrowth problems, which can inhibit nerve tissue and, in the case of neck surgeries, even inhibit airways and become life-threatening.

INFUSE bone grafts: off-label hazards

The FDA logged hundreds of complaints between 2002 and 2011 stemming from off-label Infuse Bone Graft uses. According to the lawsuit, Medtronic began a systematic campaign to discredit these complaints. The campaign allegedly included falsifying medical studies, suppressing adverse information, and downplaying the verified off-label hazards as isolated incidents.

The lawsuit points out that Medtronic is the defendant in a pair of whistleblower actions and a shareholder derivative action. Each of these lawsuits alleges that Medtronic knew the risks of off-label uses and, despite knowing that patients would be jeopardized, forged ahead with its illegal campaign to promote the off-label uses. According to the Plaintiff, this illegal promotion began with specifically informing salespersons to promote off-label uses when selling the Infuse Bone Graft and even included kick-backs to doctors who performed and/or promoted off-label procedures, including Dr. Timothy Kuklow.

Medtronic Infuse spine surgery lawsuit

The Infuse bone graft lawsuit plaintiff underwent spinal surgery in September 2011. He alleges that Medtronic informed neither him nor his doctor of the off-label risks. He developed bone overgrowth, causing nerve compression near his spine. Doctors were unable to find the source of his excessive post-operative pain for nearly a year. By then, the Plaintiff had to undergo a series of painful corrective surgeries.

To seek compensation for past, current and future damages stemming from Infuse bone graft problems, he alleges fraudulent misrepresentation, failure to warn, defective product design, illegal product misrepresentation, negligence, breach of warranty, medical malpractice and battery.

The Medtronic Infuse spine surgery lawsuit plaintiff claims compensatory damages including medical bills, lost wages and pain and suffering. The Plaintiff also claims punitive damages are appropriate due to Medtronic’s alleged intentional misconduct.