Hundreds of people allegedly injured following procedures involving Medtronic’s InFuse are utilizing a different legal approach.
The arguments planned include that the U.S. Food and Drug Administration (FDA) issued a warning in 2008 to physicians concerning “life-threatening complications” from unapproved applications of InFuse, according to the Star Tribune. InFuse, is a synthetic, or genetically engineered, recombinant human Bone Morphogenetic Protein (rhBMP-2) approved by the FDA in 2002 for specific uses. Meant to stimulate spine growth in patients suffering from lower spinal degenerative disease, InFuse is approved for use in one type of spinal surgery and some dental procedures. InFuse has never been approved for use on the upper, or cervical spine, where it is now widely used in off-label procedures.
The way in which Medtronic marketed InFuse has been the subject of fierce controversy. There are concerns over how Medtronic-funded research was conducted for InFuse and Medtronic has also been accused of touting InFuse off label and of downplaying the device’s risks while overstating its benefits. Medtronic and InFuse have been the subject of a Senate probe, in addition to the FDA warning, and the subject of two recently completed independent studies. The studies reveal that InFuse is not any better than traditional, patient-harvested bone grafting and is also associated with serious adverse events, including increased cancer risks.
Senate investigators charged that Medtronic intentionally influenced studies to downplay adverse reaction data associated with InFuse, while touting its off label uses. The U.S. Senate Finance Committee found issues with most of the initial Medtronic-supported InFuse research that was used to promote the bone graft product. Also, a special 2011 publication of The Spine Journal was devoted to reports that critiqued InFuse research conducted by surgeons who received millions of dollars from Medtronic and accused Medtronic of not reporting serious complications associated with InFuse.
Because of a legal concept known as “pre-emption,” InFuse has never been the focus of a personal injury trial. This is because federal law takes precedence over state law, the Star Tribune explained. In fact, the Supreme Court extended pre-emption so that consumers are unable to bring about lawsuits for damages caused by medical devices that received pre-market FDA approval, which includes InFuse. The new lawsuits are seeking a way to circumvent pre-emption and accuse Medtronic of illegally touting InFuse for purposes not approved by the agency, according to the Star Tribune.
Although physicians are free to use devices off-label as they see fit, device makers are banned from marketing devices for purposes not approved by the FDA. Significantly, Infuse is used in off-label procedures in massive 85 percent of all cases. “If you are injured by a product that was used in a way not approved by the FDA,” who is responsible? asks Jennifer Fuson, spokeswoman for the American Association for Justice, the Star Tribune reported. “Promotional materials are unlawful if they promote an unapproved use for the product; contain claims relating to the dosing, safety or effectiveness of the product that are inconsistent with the approved labeling; or if they lack a fair and balanced presentation of information, i.e., of benefits and risks,” the FDA says.
At least one attorney points out that significant off-label InFuse use points to some type of promotion occurring, according to the Star Tribune. In excess of eight out of every 10 cases in which InFuse is used, the device is used in ways that are not approved by the FDA. The figures are significant.
Despite all this, Medtronic continues to market InFuse and has not implemented a recall. Most patients and physicians are unaware of the notorious history connected to Medtronic’s InFuse and that traditional bone grafting—in which bone is patient harvested—is a viable option.
Meanwhile, InFuse has been associated with an array of adverse reactions, including bone dissolution; Cauda Equina Syndrome (“Horse Tail” Syndrome); compressed airways; cysts; difficulty swallowing, breathing, and/or speaking; gastrointestinal problems; excessive swelling in the neck; increased cancer risks; infections; male infertility, sterility; nerve injuries and nerve damage; pain, chronic pain; retrograde ejaculation; swelling of the neck resulting in injury or death; uncontrolled bone growth; and worsened back and leg pain.
