Although a lower court Illinois state court judge very recently denied device maker, Medtronic Inc.’s, bid to dismiss a lawsuit brought over its InFuse bone graft product, a Minneapolis judge did grant Medtronic’s motion to dismiss the InFuse claims there.
Judge Laurie Miller based her ruling, in part, on some recent United States Court rulings that found that patients could not sue device makers if the U.S. Food and Drug Administration (FDA) granted approval for the product, according to the StarTribune Business.
Although Judge Miller’s ruling is a disappointment for dozens of individuals who allege the spinal device, Infuse, led to serious injury, the decision does enable them to re-file their cases to include specific fraud allegations that involve Medtronic’s promotion of unapproved InFuse uses, the StarTribune report pointed out.
Physicians always have the discretion to use medical device products and pharmaceuticals in ways that they deem appropriate, including so-called “off label” or unapproved uses. Industry—device and pharmaceutical makers—is legally banned from promoting their products for uses that are not approved by the FDA. The law is clear on this point and Medtronic, according to many experts, appears to have crossed that legal line when it comes to InFuse.
InFuse, a bone graft product marketed by Medtronic is synthetic, or genetically engineered, recombinant human Bone Morphogenetic Protein (rhBMP-2). The FDA approved InFuse in 2002 for very specific uses.
InFuse was designed to stimulate spine growth in patients suffering from lower spinal degenerative disease and was approved for use in one type of spinal surgery and some dental procedures. InFuse is not approved for use on the upper, or cervical spine; however, the bone graft product is very widely used in off label procedures. In fact, on July 1, 2008 the agency issued a notification warning about InFuse’s association with serious complications when used in cervical spinal fusions.
Medtronic’s marketing of InFuse has been the focus of growing controversy and there are concerns over how InFuse research was conducted, including that it was Medtronic-funded. Medtronic has been accused of promoting InFuse off label, of downplaying the device’s risks, and of overstating InFuse benefits. This led to a Senate probe, and FDA warning, and independent studies.
Recent Supreme Court decisions have applied a legal concept known as pre-emption, which make it difficult for claims brought over FDA-approved devices to advance in state court, and pre-emption does enable federal law to take precedence over state law, according to the StarTribune. Medtronic was, as expected, happy with the ruling, stating, “This court’s decision is consistent with conclusions reached by other courts around the country based on the pre-emption doctrine.”
Although the recent decisions are conflicting and do confuse the hotly debated matter, spine experts and lawmakers have long claimed that Medtronic-sponsored studies overstated InFuse’s benefits and minimized the bone growth product’s risks. Medtronic also paid $210 million over a period of years to a number of doctors who tested and wrote scholarly articles about InFuse, including its off label use, the StarTribune noted. Meanwhile, new Yale University studies, which were Medtronic funded, found that InFuse provided worse results than those previously published in the Medtronic-funded journal articles.
The plaintiffs are expected to re-file fraud charges that will likely focus on Medtronic’s providing false or misleading information about InFuse that led them to believe Infuse was safe for their procedures, according to the StarTribune.
Meanwhile, most patients and physicians are not aware of the notorious history connected to InFuse and that traditional bone grafting, which utilizes bone harvested from the patient, is a safer option. InFuse remains on the market and continues to be used in surgical procedures.