A recent motion to remand was granted in a Medtronic InFuse case. The case will be returned back to its Circuit Court to continue with trial.
InFuse is a genetically engineered, synthetic, recombinant human Bone Morphogenetic Protein (rhBMP-2). The product received U.S. Food and Drug Administration (FDA) for very specific uses: To stimulate spine growth in patients suffering from lower spinal degenerative disease, for use in one type of spinal surgery, and for use in some dental procedures. InFuse has not yet been approved for use on the cervical (upper) spine. Despite this, the bone graft product is widely used in these off label procedures. In fact, on July 1, 2008 the FDA issued a notification warning of serious complications tied to use of InFuse in cervical spinal fusions.
Lawsuit allegations brought over InFuse involve patients implanted with InFuse during off-label procedures. Patients allege suffering from significant complications that include bone overgrowth and neuropathy.
On July 1, 2008 the FDA issued a notification about dangers connected to off-label use of InFuse, which included information on numerous and serious complications when InFuse is used in cervical spine fusions. These complications include excessive swelling in the neck, compressed airways, swallowing and breathing difficulties, and nerve damage. The FDA specifically noted that it received reports of “life-threatening complications associated with” InFuse when used off-label in the cervical spine, reiterating that, “these products are not approved by FDA for this use.”
The FDA also indicated that it received nearly 40 reports of complications associated with off-label InFuse use in cervical spine fusion that took place within two days and two weeks after the InFuse procedure. The reports were received from 2003-2004 to June 2008. “[w]hen airway complications occurred, medical intervention was frequently necessary. Treatments needed included respiratory support with intubation, anti-inflammatory medication, tracheotomy and, most commonly, second surgeries to drain the surgical site,” the agency indicated.
The FDA announced that patients who have been implanted with InFuse in their cervical spines should be aware that airway complication symptoms—difficulty breathing or swallowing and/or swelling of the neck, tongue, mouth, throat and shoulders, or upper chest area—may occur. Medical attention must be immediately sought at the first sign of an airway complication; the FDA noted that airway complications are likelier to occur from two to 14 days following the procedure.
Medtronic’s marketing of InFuse has long been the focus of growing controversy over the way in which InFuse research was conducted, including that research was Medtronic-funded. Medtronic has also been accused of promoting InFuse off label, of minimizing InFuse’s risks, and of overstating the benefits of InFuse benefits. These accusations have led to a Senate probe, the FDA warning, and independent studies.