Medtronic continues to face new product liability lawsuits over its Infuse bone graft product, which has been linked to reprots of nerve damage and other injuries caused by the excessive growth of bone around the spinal cord following off-label use of the device for purposes that the FDA never approved.
In one of the latest complaints (PDF) filed on April 24, Gerard and Sharonda Ledet claim that Medtronic aggressively marketed off-label of use of the Infuse without the LT-Cage, which is a device meant to control the bone growth protein. According to the lawsuit filed in the U.S. District Court for the Southern District of Mississippi, Gerard Ledet had Infuse implanted in April 2007, and has suffered back pain and other complications caused by bone overgrowth.
Medtronic Infuse is a bone morphogenetic protein (BMP) that is designed to be 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.
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.
Ledet’s procedure involved the use of Infuse on multiple levels and did not include the cage. The lawsuit claims Ledet and his doctor were mislead by Medtronic about the safety of Infuse and about the need for the LT-Cage.
As a result of complications following Medtronic Infuse surgery, Ledet indicates that he suffered uncontrolled bone growth, resulting in back pain, leg pain and foot numbness. He underwent revision surgery in 2009 to remove the overgrown bone, but the bone grew back and he continues to suffer chronic pain and disability.
Allegations of Off-Label Promotion of Medtronic Infuse
Medtronic has faces a number of similar injury lawsuits that allege the company illegally promoted Infuse off-label, and the company has also faced government investigations that suggested Medtronic intentionally mislead the medical community about the safety of Infuse.
Last year, a congressional investigation determined that Medtronic paid $210 million to study authors that failed to include data on Infuse complications in their reports. Those authors not only failed to disclose links to Medtronic, but the investigation also determined that Medtronic employees secretly edited and sometimes wrote parts of the studies before they were published.
Although the FDA only approved Infuse for use with the LT-cage, Medtronic has sold the products separately. The FDA specifically warned Medtronic not to promote the use of the Infuse off-label due to the risk of harm to patients, however, Medtronic allegedly paid spine surgery “opinion leaders” in the medical community to do just that.
After receiving numerous reports of adverse events and deaths, in 2008 the FDA issued a warning against the off-label use of Infuse and the LT-Cage.
Ledet’s lawsuit charges Medtronic with fraud, failure to warn, designing a defective product, negligence, negligent misrepresentation, and breach of warranty. His wife is suing for loss of consortium. The couple seeks compensatory and punitive damages.