A Missouri woman Has filed a product liability lawsuit over problems with the Medtronic Infuse, alleging that she suffered nerve damage as result of the use of the bioengineered bone graft device during a posterior lumbar fusion, which was not an approved indication.
The complaint (PDF) was filed by Patricia Caplinger on June 4, in the U.S. District Court for the Western District of Oklahoma.
Medtronic Infuse is a bone morphogenetic protein (BMP), which is used to encourage bone growth and replace spinal disks by filling the gaps between vertebrae. It is promoted as an alternative to bone graft procedures where bone is harvested from another part of the body or from cadavers.
The FDA approved the Infuse bone graft in 2002, indicating that it should only be used during spinal surgery for a single-level anterior lumbar fusion, where the spine is approached from the front. However, it has been widely used during other types of spinal surgery, which has been found to carry a risk of severe inflammation, airway compression, nerve damage and other health problems.
According to allegations raised in Caplinger’s lawsuit, Medtronic promoted the Infuse bone graft for uses that were never approved by the FDA as safe or effective, and the manufacturer knew such “off-label” use exposed patients to an increased risk of serious and potentially debilitating injuries.
Caplinger’s doctors implanted the Medtronic Infuse Bone Graft during a posterior lumbar internode fusion in August 2010, where the spine is approached through an incision in the back. The device allegedly caused “ectopic” or “exuberant” bone growth onto and around Caplinger’s spinal cord, which compressed her nerves, resulting in severe pain, weakness and foot drop in her right leg and foot.
Although doctors are allowed to use approved medical devices for any purpose, manufacturers are not allowed to promote or encourage such “off-label” use. Medtronic has faced multiple allegations of promoting the Infuse bone graft for use during spinal surgery that they never established with the FDA was safe or effective, and which they knew carried a potential risk of serious side effects.
Caplinger alleges that Medtronic minimized or downplayed the risk of problems, even though the earliest trials involving the Infuse showed uncontrolled or ectopic bone growth, inflammatory reactions, adverse back and leg pain events, radiculitis, retrograde ejaculation, urinary retention, bone resorption and implant displacement. More recent research has also linked the Medtronic Infuse to a risk of cancer and sterility.
In 2008, the FDA issued an alert advising doctors not to use the Medtronic Infuse in upper spinal fusion procedures, after receiving a large number of reports involving deaths and other complications that resulted from swelling of the neck and breathing difficulties.
The case joins a growing number of lawsuits filed over the Medtronic Infuse bone graft in state and federal courts throughout the United States. Caplinger seeks compensatory and punitive damages, accusing Medtronic of fraud, failure to warn, manufacturing, designing and marketing a defective medical device, breach of warranty and negligence.