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By: Irvin Jackson | Published: September 24th, 2012
A Missouri woman has joined a growing number of individuals throughout the country who are pursuing a lawsuit over the Medtronic Infuse Bone Graft and LT-Cage, alleging that the spinal fusion implant failed after it was used “off-label” for a procedure that was never established as safe or effective.
A complaint (PDF) was filed by Laura Blankenship on September 13, in the U.S. District Court for the Central District of California against Medtronic, Inc., claiming that complications from a Medtronic Infuse spine fusion have left her with persistent neck and back pain.
According to the lawsuit, Blankenship underwent surgery where her surgeon used the Medtronic Infuse Bone Graft and LT-Cage to promote the fusion of vertebrae in her spine. However, the surgeon used the product “off-label” after Medtronic allegedly promoted Infuse for applications beyond what was approved by the FDA.
Blankenship claims that the Medtronic Infuse spine fusion failed, leaving her with worse neck and back pain that was caused by excessive bone growth around the implant.
Medtronic Infuse is a bone morphogenetic protein (BMP) that is applied to an absorbable collagen sponge placed within a device known as an LT-Cage, which is then implanted to encourage bone growth and fuse the gaps between vertebrae. Since introducing the product in 2002, Medtronic has aggressively promoted Infuse bone graft surgery as an alternative to traditional spine fusions, where bone is harvested from another part of the body or from cadavers.
However, although the FDA only approved the Medtronic Infuse and LT-Cage for the limited spinal procedures involving a single-level anterior lumbar interbody fusion (ALIF), where the spine is approached from the front, the Medtronic Infuse has been widely used “off-label” for other types of spine fusion surgery, which have been linked to an increased risk of severe and painful complications caused by excessive or ectopic bone growth.
In 2008, the FDA issued an alert about the risks associated with such unapproved uses of Medtronic Infuse, after receiving a number of reports involving serious complications and deaths, often involving use in the cervical spine where the bone growth problems may impact the airway.
Medtronic has been accused of illegally promoting off-label use of Infuse by providing false and misleading statements and paying “opinion leaders” to encourage uses beyond what was approved by the FDA. As a result, some estimates such that as much as 85% of all sales for Medtronic Infuse were for such off-label uses.
Blankenship’s case joins a growing number of Medtronic Infuse and LT-Cage lawsuits filed in state and federal courts throughout the country. The complaints involve similar allegations that Medtronic negligently designed and manufactured a defective product, failing to adequately research the device or warn about the risk of complications. Many of the lawsuits also seek punitive damages against the company for its alleged reckless behavior in Infuse illegal promotions.